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Implementation Science Communications Nov 2023Improving access to high-quality healthcare for individuals in correctional settings is critical to advancing health equity in the United States. Compared to the general... (Review)
Review
BACKGROUND
Improving access to high-quality healthcare for individuals in correctional settings is critical to advancing health equity in the United States. Compared to the general population, criminal-legal involved individuals experience higher rates of chronic health conditions and poorer health outcomes. Implementation science frameworks and strategies offer useful tools to integrate health interventions into criminal-legal settings and to improve care. A review of implementation science in criminal-legal settings to date is necessary to advance future applications. This systematic review summarizes research that has harnessed implementation science to promote the uptake of effective health interventions in adult criminal-legal settings.
METHODS
A systematic review of seven databases (Academic Search Premier, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Social Work Abstracts, ProQuest Criminal Justice Database, ProQuest Sociological Abstracts, MEDLINE/PubMed) was conducted. Eligible studies used an implementation science framework to assess implementation outcomes, determinants, and/or implementation strategies in adult criminal-legal settings. Qualitative synthesis was used to extract and summarize settings, study designs, sample characteristics, methods, and application of implementation science methods. Implementation strategies were further analyzed using the Pragmatic Implementation Reporting Tool.
RESULTS
Twenty-four studies met inclusion criteria. Studies implemented interventions to address infectious diseases (n=9), substance use (n=6), mental health (n=5), co-occurring substance use and mental health (n=2), or other health conditions (n=2). Studies varied in their operationalization and description of guiding implementation frameworks/taxonomies. Sixteen studies reported implementation determinants and 12 studies measured implementation outcomes, with acceptability (n=5), feasibility (n=3), and reach (n=2) commonly assessed. Six studies tested implementation strategies. Systematic review results were used to generate recommendations for improving implementation success in criminal-legal contexts.
CONCLUSIONS
The focus on implementation determinants in correctional health studies reflects the need to tailor implementation efforts to complex organizational and inter-agency contexts. Future studies should investigate policy factors that influence implementation success, design, and test implementation strategies tailored to determinants, and investigate a wider array of implementation outcomes relevant to criminal-legal settings, health interventions relevant to adult and juvenile populations, and health equity outcomes.
TRIAL REGISTRATION
A study protocol (CRD42020114111) was registered with Prospero.
PubMed: 38001546
DOI: 10.1186/s43058-023-00521-4 -
Archivos de Bronconeumologia May 2024The effectiveness of home high flow nasal cannula (HFNC) for the treatment of chronic respiratory failure in patients with chronic respiratory diseases (CRDs) has not... (Review)
Review
INTRODUCTION
The effectiveness of home high flow nasal cannula (HFNC) for the treatment of chronic respiratory failure in patients with chronic respiratory diseases (CRDs) has not been summarized. We aimed to conduct a systematic review of the effectiveness, adherence, and safety of HFNC in the long-term treatment of patients with chronic respiratory diseases and respiratory failure.
METHODS
A systematic review was conducted. PubMed, Web of science, and SCOPUS were search up to August 2023. Long-term HFNC studies (≥4 weeks) reporting dyspnea; exacerbations, hospitalizations; peripheral oxygen saturation (SpO), comfort; patient experience, health-related quality of life or partial pressure of carbon dioxide (paCO) were included.
RESULTS
Thirteen articles (701 patients) based on 10 studies were selected: randomized control trials (n=3), randomized crossover trials (n=2), crossover (n=3) and retrospective (n=2) studies. COPD (n=6), bronchiectasis (n=2), COPD/bronchiectasis (n=1) and ILD (n=1) were the underlined CRDs. HFNC reduced exacerbations when compared to usual care/home respiratory therapies (n=6). Quality of life outcomes were also in favor of HFNC in patients with COPD and bronchiectasis (n=6). HFNC had significant effects on hospitalizations, paCO, and lung function. Adherence ranged from 5.2 to 8.6h/day (n=5). Three studies reported no events, 3 non-serious events and 2 no differences compared with other home respiratory therapies.
CONCLUSIONS
HFNC seems more effective than usual care or other home respiratory therapies in reducing exacerbations and improving quality of life in patients with COPD and bronchiectasis, while presenting good adherence and being safe. Its apparently superior effectiveness needs to be better studied in future real-world pragmatic trials.
PubMed: 38782632
DOI: 10.1016/j.arbres.2024.05.001 -
Archives of Physiotherapy 2024Manual therapy is an often-utilized intervention for the management of knee osteoarthritis (OA). The interpretation of results presented by these trials can be affected... (Review)
Review
INTRODUCTION
Manual therapy is an often-utilized intervention for the management of knee osteoarthritis (OA). The interpretation of results presented by these trials can be affected by how well the study designs align applicability to real-world clinical settings.
AIM
To examine the existing body of clinical trials investigating manual therapy for knee OA to determine where they fall on the efficacy-effectiveness spectrum.
METHODS
This systematic review has been guided and informed by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Randomized controlled trials that investigated manual therapy treatments for adults with knee OA were retrieved via searches of multiple databases to identify trials published prior to April 2023. The Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool was used to objectively rate the efficacy-effectiveness nature of each trial design. The Cochrane Risk of Bias 2.0 assessment tool (RoB-2) was used to assess the risk of bias across five domains.
RESULTS
Of the 36 trials, a higher percentage of trials had a greater emphasis on efficacy within all four domains: participant characteristics (75.0%), trial setting (77.8%), flexibility of intervention (58.3%), and clinical relevance of experimental and comparison intervention (47.2%). In addition, 13.9% of the trials had low risk of bias, 41.7% had high risk of bias, and 44.4% had some concerns regarding bias.
CONCLUSIONS
While many trials support manual therapy as effective for the management of knee OA, a greater focus on study designs with an emphasis on effectiveness would improve the applicability and generalizability of future trials.
PubMed: 38444787
DOI: 10.33393/aop.2024.2916 -
Health Technology Assessment... Jan 2024Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional...
BACKGROUND
Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear.
OBJECTIVE
To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented.
METHODS
Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains.
RESULTS
Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps.
SCOPING REVIEW
651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations.
EFFECTIVENESS SYSTEMATIC REVIEWS
studies explored service delivery models ( = 15); interventions delivered by families/carers ( = 32), wider children's workforce ( = 21), continence teams ( = 31) and specialist consultant-led teams ( = 42); complementary therapies ( = 15); and psychosocial interventions ( = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators.
CONCLUSIONS
Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42019159008.
FUNDING
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in ; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.
Topics: Child; Adult; Humans; Systematic Reviews as Topic; Health Personnel; Constipation
PubMed: 38343084
DOI: 10.3310/PLTR9622 -
Therapeutic Advances in... 2024Long-acting injectable antipsychotics (LAIs) have advantages over oral antipsychotics (OAPs) in preventing relapse and hospitalization in chronically ill patients with...
Efficacy and safety of long-acting injectable oral antipsychotics in the treatment of patients with early-phase schizophrenia-spectrum disorders: a systematic review and meta-analysis.
BACKGROUND
Long-acting injectable antipsychotics (LAIs) have advantages over oral antipsychotics (OAPs) in preventing relapse and hospitalization in chronically ill patients with schizophrenia-spectrum disorders (SSDs), but evidence in patients with first-episode/recent-onset, that is, early-phase-SSDs is less clear.
OBJECTIVES
To assess the relative medium- and long-term efficacy and safety of LAIs OAPs in the maintenance treatment of patients with early-phase SSDs.
METHOD
We searched major electronic databases for head-to-head randomized controlled trials (RCTs) comparing LAIs and OAPs for the maintenance treatment of patients with early-phase-SSDs.
DESIGN
Pairwise, random-effects meta-analysis. Relapse/hospitalization and acceptability (all-cause discontinuation) measured at study-endpoint were co-primary outcomes, calculating risk ratios (RRs) with their 95% confidence intervals (CIs). Subgroup analyses sought to identify factors moderating differences in efficacy or acceptability between LAIs and OAPs.
RESULTS
Across 11 head-to-head RCTs ( = 2374, median age = 25.2 years, males = 68.4%, median illness duration = 45.8 weeks) lasting 13-104 (median = 78) weeks, no significant differences emerged between LAIs and OAPs for relapse/hospitalization prevention (RR = 0.79, 95%CI = 0.58-1.06, = 0.13) and acceptability (RR = 0.92, 95%CI = 0.80-1.05, = 0.20). The included trials were highly heterogeneous regarding methodology and patient populations. LAIs outperformed OAPs in preventing relapse/hospitalization in studies with stable patients (RR = 0.65, 95%CI = 0.45-0.92), pragmatic design (RR = 0.67, 95%CI = 0.54-0.82), and strict intent-to-treat approach (RR = 0.64, 95%CI = 0.52-0.80). Furthermore, LAIs were associated with better acceptability in studies with schizophrenia patients only (RR = 0.87, 95%CI = 0.79-0.95), longer illness duration (RR = 0.88, 95%CI = 0.80-0.97), unstable patients (RR = 0.89, 95%CI = 0.81-0.99) and allowed OAP supplementation of LAIs (RR = 0.90, 95%CI = 0.81-0.99).
CONCLUSION
LAIs and OAPs did not differ significantly regarding relapse prevention/hospitalization and acceptability. However, in nine subgroup analyses, LAIs were superior to OAPs in patients with EP-SSDs with indicators of higher quality and/or pragmatic design regarding relapse/hospitalization prevention (four subgroup analyses) and/or reduced all-cause discontinuation (five subgroup analyses), without any instance of OAP superiority LAIs. More high-quality pragmatic trials comparing LAIs with OAPs in EP-SSDs are needed.
TRIAL REGISTRATION
CRD42023407120 (PROSPERO).
PubMed: 38831918
DOI: 10.1177/20451253241257062 -
Registry-based randomised controlled trials: conduct, advantages and challenges-a systematic review.Trials Jun 2024Registry-based randomised controlled trials (rRCTs) have been described as pragmatic studies utilising patient data embedded in large-scale registries to facilitate key...
BACKGROUND
Registry-based randomised controlled trials (rRCTs) have been described as pragmatic studies utilising patient data embedded in large-scale registries to facilitate key clinical trial procedures including recruitment, randomisation and the collection of outcome data. Whilst the practice of utilising registries to support the conduct of randomised trials is increasing, the use of the registries within rRCTs is inconsistent. The purpose of this systematic review is to explore the conduct of rRCTs using a patient registry to facilitate trial recruitment and the collection of outcome data, and to discuss the advantages and challenges of rRCTs.
METHODS
A systematic search of the literature was conducted using five databases from inception to June 2020: PubMed, Embase (through Ovid), CINAHL, Scopus and the Cochrane Controlled Register of Trials (CENTRAL). The search strategy comprised of MESH terms and key words related to rRCTs. Study selection was performed independently by two reviewers. A risk of bias for each study was completed. A narrative synthesis was conducted.
RESULTS
A total 47,862 titles were screened and 24 rRCTs were included. Eleven rRCTs (45.8%) used more than one registry to facilitate trial conduct. Six rRCTs (25%) randomised participants via a specific randomisation module embedded within a registry. Recruitment ranged between 209 to 106,000 participants. Advantages of rRCTs are recruitment efficiency, shorter trial times, cost effectiveness, outcome data completeness, smaller carbon footprint, lower participant burden and the ability to conduct multiple trials from the same registry. Challenges are data collection/management, quality assurance issues and the timing of informed consent.
CONCLUSIONS
Optimising the design of rRCTs is dependent on the capabilities of the registry. New registries should be designed and existing registries reviewed to enable the conduct of rRCTs. At all times, data management and quality assurance of all registry data should be given key consideration. We suggest the inclusion of the term 'registry-based' in the title of all rRCT manuscripts and a clear simple breakdown of the registry-based conduct of the trial in the abstract to facilitate indexing in the major databases.
Topics: Humans; Patient Selection; Pragmatic Clinical Trials as Topic; Randomized Controlled Trials as Topic; Registries; Research Design
PubMed: 38863017
DOI: 10.1186/s13063-024-08209-3 -
Orphanet Journal of Rare Diseases Feb 2024Metachromatic leukodystrophy (MLD) is an autosomal recessive lysosomal storage disease caused by deficiency in arylsulfatase A (ASA) activity arising primarily from ASA...
BACKGROUND
Metachromatic leukodystrophy (MLD) is an autosomal recessive lysosomal storage disease caused by deficiency in arylsulfatase A (ASA) activity arising primarily from ASA gene (ARSA) variants. Late-infantile, juvenile and adult clinical subtypes are defined by symptom onset at ≤ 2.5, > 2.5 to < 16 and ≥ 16 years, respectively. Epidemiological data were sought to address knowledge gaps and to inform decisions regarding the clinical development of an investigational drug.
METHODS
To synthesize all available estimates of MLD incidence and birth prevalence worldwide and in selected countries, Ovid MEDLINE and Embase were searched systematically (March 11, 2022) using a population, intervention, comparator, outcome, time and setting framework, complemented by pragmatic searching to reduce publication bias. Where possible, results were stratified by clinical subtype. Data were extracted from non-interventional studies (clinical trials, non-clinical studies and case reports were excluded; reviews were used for snowballing only).
RESULTS
Of the 31 studies included, 14 reported birth prevalence (13 countries in Asia-Pacific, Europe, the Middle East, North America and South America), one reported prevalence and none reported incidence. Birth prevalence per 100,000 live births ranged from 0.16 (Japan) to 1.85 (Portugal). In the three European studies with estimates stratified by clinical subtypes, birth prevalence was highest for late-infantile cases (0.31-1.12 per 100,000 live births). The distribution of clinical subtypes reported in cases diagnosed over various time periods in 17 studies varied substantially, but late-infantile and juvenile MLD accounted for at least two-thirds of cases in most studies.
CONCLUSIONS
This review provides a foundation for further analysis of the regional epidemiology of MLD. Data gaps indicate the need for better global coverage, increased use of epidemiological measures (e.g. prevalence estimates) and more stratification of outcomes by clinical and genetic disease subtype.
Topics: Adult; Humans; Cerebroside-Sulfatase; Europe; Leukodystrophy, Metachromatic; Lysosomal Storage Diseases; Prevalence
PubMed: 38383398
DOI: 10.1186/s13023-024-03044-w -
BJUI Compass May 2024To systematically summarise the current clinical evidence for de novo malignant upper urinary tract obstruction treatment with a focus on standards of reporting, patient... (Review)
Review
OBJECTIVE
To systematically summarise the current clinical evidence for de novo malignant upper urinary tract obstruction treatment with a focus on standards of reporting, patient outcomes and future research needs.
METHODS
This review protocol was published via PROSPERO (CRD42022341588). OVID MEDLINE (R), EMBASE, Cochrane Central Register of Controlled Trials-CENTRAL were searched up to June 2022 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses. Prospective and retrospective studies were included.
RESULTS
Of 941 articles identified, 82 with 8796 patients were eligible for inclusion.Most studies in the published literature are retrospective and investigate heterogenous malignancies. Percutaneous nephrostomy and ureteric stenting are the most studied interventions. Few studies describe the outcomes from no intervention or investigate patient perspectives. Overall reported median survival after intervention was around 11.7 months. A lack of standardised reporting of outcomes was evident.
CONCLUSIONS
Malignant upper urinary tract obstruction is an important clinical condition affecting patients globally. Overall survival after intervention appears poor however the current evidence base has significant limitations due to studies of low methodological quality and the lack of a standardised framework for reporting outcomes.We have provided a pragmatic framework for future studies based on the review to ensure a uniform methodology is utilised moving forward.
PubMed: 38751956
DOI: 10.1002/bco2.340 -
Open Heart May 2024Despite maximal treatment, heart failure (HF) remains a major clinical challenge. Besides neurohormonal overactivation, myocardial energy homoeostasis is also impaired... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Despite maximal treatment, heart failure (HF) remains a major clinical challenge. Besides neurohormonal overactivation, myocardial energy homoeostasis is also impaired in HF. Trimetazidine has the potential to restore myocardial energy status by inhibiting fatty acid oxidation, concomitantly enhancing glucose oxidation. Trimetazidine is an interesting adjunct treatment, for it is safe, easy to use and comes at a low cost.
OBJECTIVE
We conducted a systematic review to evaluate all available clinical evidence on trimetazidine in HF. We searched Medline/PubMed, Embase, Cochrane CENTRAL and ClinicalTrials.gov to identify relevant studies.
METHODS
Out of 213 records, we included 28 studies in the meta-analysis (containing 2552 unique patients), which almost exclusively randomised patients with HF with reduced ejection fraction (HFrEF). The studies were relatively small (median study size: N=58) and of short duration (mean follow-up: 6 months), with the majority (68%) being open label.
RESULTS
Trimetazidine in HFrEF was found to significantly reduce cardiovascular mortality (OR 0.33, 95% CI 0.21 to 0.53) and HF hospitalisations (OR 0.42, 95% CI 0.29 to 0.60). In addition, trimetazidine improved (New York Heart Association) functional class (mean difference: -0.44 (95% CI -0.49 to -0.39), 6 min walk distance (mean difference: +109 m (95% CI 105 to 114 m) and quality of life (standardised mean difference: +0.52 (95% CI 0.32 to 0.71). A similar pattern of effects was observed for both ischaemic and non-ischaemic cardiomyopathy.
CONCLUSIONS
Current evidence supports the potential role of trimetazidine in HFrEF, but this is based on multiple smaller trials of varying quality in study design. We recommend a large pragmatic randomised clinical trial to establish the definitive role of trimetazidine in the management of HFrEF.
Topics: Female; Humans; Heart Failure; Stroke Volume; Treatment Outcome; Trimetazidine; Vasodilator Agents; Ventricular Function, Left
PubMed: 38719498
DOI: 10.1136/openhrt-2023-002579 -
International Journal of Medical... Apr 2024Emergency department overcrowding could be improved by upstream telephone triage. Emergency telephone triage aims at managing and orientating adequately patients as... (Review)
Review
OBJECTIVES
Emergency department overcrowding could be improved by upstream telephone triage. Emergency telephone triage aims at managing and orientating adequately patients as early as possible and distributing limited supply of staff and materials. This complex task could be improved with the use of Clinical decision support systems (CDSS). The aim of this scoping review was to identify literature gaps for the future development and evaluation of CDSS for Emergency telephone triage.
MATERIALS AND METHODS
We present here a scoping review of CDSS designed for emergency telephone triage, and compared them in terms of functional characteristics, technical design, health care implementation and methodologies used for evaluation, following the PRISMA-ScR guidelines.
RESULTS
Regarding design, 19 CDSS were retrieved: 12 were knowledge based CDSS (decisional algorithms built according to guidelines or clinical expertise) and 7 were data driven (statistical, machine learning, or deep learning models). Most of them aimed at assisting nurses or non-medical staff by providing patient orientation and/or severity/priority assessment. Eleven were implemented in real life, and only three were connected to the Electronic Health Record. Regarding evaluation, CDSS were assessed through various aspects: intrinsic characteristics, impact on clinical practice or user apprehension. Only one pragmatic trial and one randomized controlled trial were conducted.
CONCLUSION
This review highlights the potential of a hybrid system, user tailored, flexible, connected to the electronic health record, which could work with oral, video and digital data; and the need to evaluate CDSS on intrinsic characteristics and impact on clinical practice, iteratively at each distinct stage of the IT lifecycle.
Topics: Humans; Triage; Decision Support Systems, Clinical; Delivery of Health Care; Emergency Service, Hospital; Telephone
PubMed: 38290244
DOI: 10.1016/j.ijmedinf.2024.105347