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BMC Complementary Medicine and Therapies May 2024Pragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting. This study aimed to provide a...
BACKGROUND
Pragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting. This study aimed to provide a comprehensive methodological analysis of PATs using the PRECIS-2(PRagmatic Explanatory Continuum Indicator Summary-2) tool to determine their pragmatism.
METHODS
The MEDLINE, EMBASE, Cochrane Central Register for Controlled Trials, CINAHL, Allied and Complementary Medicine Database, China National Knowledge Infrastructure, VIP, WANFANG, Taiwan Periodical Literature Database, KoreaMed, KMbase, Research Information Service System, Oriental Medicine Advanced Searching Integrated System, CiNii and ClinicalTrials.gov were searched. The search included randomised controlled trials (RCTs) and protocols of RCTs that investigated all types of acupuncture and used self-declared pragmatic design. Two authors independently collected the basic information and characteristics of the studies and assessed their pragmatism using the nine PRECIS-2 domains and the additional domain of control.
RESULTS
A total of 93 studies were included. The means of eligibility, recruitment, organisation, primary outcome, primary analysis, and control domains were statistically larger than three and were shown to be pragmatic. The means of setting, flexibility:delivery, and follow-up domains were not greater than three and were shown to be non-pragmatic. For flexibility:adherence domain was inappropriate for assessment owing to insufficient information in the studies.
CONCLUSIONS
PATs were pragmatic in the domain of eligibility, recruitment, organisation, primary outcome, primary analysis, and control and were not pragmatic in the domain of setting, flexibility:delivery, and follow-up. Future PATs need to strengthen the pragmatism in the setting, flexibility:delivery, and follow-up domains and to describe the flexibility:adherence domain in more detail.
TRIAL REGISTRATION
CRD42021236975.
Topics: Humans; Acupuncture Therapy; Pragmatic Clinical Trials as Topic; Randomized Controlled Trials as Topic; Research Design
PubMed: 38702632
DOI: 10.1186/s12906-024-04473-7 -
Pain Physician Sep 2023Extensive research into potential sources of thoracic pain with or without referred pain into the chest wall has demonstrated that thoracic facet joints can be a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Extensive research into potential sources of thoracic pain with or without referred pain into the chest wall has demonstrated that thoracic facet joints can be a potential source of pain confirmed by precise, diagnostic blocks.The objective of this systematic review and meta-analysis is to evaluate the effectiveness of medial branch blocks and radiofrequency neurotomy as a therapeutic thoracic facet joint intervention.
METHODS
Systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies of medial branch blocks and the radiofrequency neurotomy in managing thoracic pain utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was performed. A comprehensive literature search of multiple databases of RCTs and observational studies of medial branch blocks and radiofrequency neurotomy in managing chronic thoracic pain were identified from 1996 to December 2022 with inclusion of manual searches of the bibliography of known review articles and multiple databases. Methodologic quality and risk of bias assessment was also conducted. Evidence was synthesized utilizing principles of quality assessment and best evidence synthesis, with conventional and single meta-analysis. The primary outcome measure of success was 3 months of pain reduction for medial branch blocks and 6 months for radiofrequency thermoneurolysis for a single treatment. Short-term success was defined as up to 6 months and long-term was more than 6 months.
RESULTS
This literature search yielded 11 studies meeting the inclusion criteria, of which 3 were RCTs and 8 were observational studies. Of the 3 RCTs, 2 of them assessed medial branch blocks and one trial assessed radiofrequency for thoracic pain. The evidence for managing thoracic pain with qualitative analysis and single-arm meta-analysis and GRADE system of appraisal, with the inclusion of 2 RCTs and 3 observational studies for medial branch blocks was Level II. For radiofrequency neurotomy, with the inclusion of one RCT of 20 patients in the treatment group and 5 observational studies, the evidence was Level III in managing thoracic pain.
LIMITATIONS
There was a paucity of literature with RCTs and real-world pragmatic controlled trials. Even observational studies had small sample sizes providing inadequate clinically applicable results. In addition, there was heterogeneity of the available studies in terms of their inclusion and exclusion criteria, defining their endpoints and the effectiveness of the procedures.
CONCLUSION
This systematic review and meta-analysis show Level II evidence of medial branch blocks and Level III evidence for radiofrequency neurotomy on a long-term basis in managing chronic thoracic pain.
KEY WORDS
Chronic spinal pain, thoracic facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks, diagnostic accuracy, radiofrequency neurotomy.
Topics: Humans; Nerve Block; Pain Management; Chronic Pain; Denervation; Anesthesia, Local; Chest Pain; Zygapophyseal Joint; Treatment Outcome
PubMed: 37774177
DOI: No ID Found -
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 -
Child and Adolescent Mental Health Aug 2023Effective evidence-based practices (EBP) for children and young people's (CYP) mental health exist, however, there is low uptake in clinical practice and interventions... (Review)
Review
BACKGROUND
Effective evidence-based practices (EBP) for children and young people's (CYP) mental health exist, however, there is low uptake in clinical practice and interventions do not always reach those in need. This review aimed to comprehensively identify and synthesise the barriers and facilitators to implementing EBP in CYP mental health care, mapped according to an implementation framework in order to make pragmatic recommendations for practitioners, commissioners and researchers.
METHODS
Following the PRISMA guidelines, an electronic search of PsycINFO, MEDLINE, CINAHL and Embase in 2021 yielded 1830 results. In total, 107 abstracts were screened, 57 of which were included for full-text review and 26 were included for data extraction and analysis.
RESULTS
We identified a number of organisational and clinician-level barriers which impede the implementation of evidence in 'real world' practice. Barriers included lack of access to funding; poor access to resources; clinician attitudes and flexibility of EBP. Facilitators included targeted funding and access to resources; supportive staff and leadership committed to innovation and skills in the EBP.
CONCLUSIONS
Although the process of translating research into practice is challenging and the solutions are not straightforward, we have identified a set of practical recommendations for ways in which implementation practices can improve. Researchers, commissioners, funders and practitioners can work together to improve the implementation of EBP in CYP mental health settings by ensuring funding is available, prioritise implementation beyond the end of trials, upskill staff on integrating EBP into care, ensure EBPs are flexible and are co-produced with service users.
REGISTRATION
This review was registered on PROSPERO international prospective register of systematic reviews (CRD42021252995).
PubMed: 37608642
DOI: 10.1111/camh.12672 -
Child and Adolescent Mental Health Sep 2023School-based mental health literacy interventions aim to prevent mental disorders and promote mental wellbeing through improving the knowledge and understanding of... (Review)
Review
BACKGROUND
School-based mental health literacy interventions aim to prevent mental disorders and promote mental wellbeing through improving the knowledge and understanding of mental health, mental disorders, and reducing stigma. Evidence suggests that good mental health literacy helps young people recognise mental health difficulties in themselves and in others, and seek help for mental health problems. Improved help-seeking can allow for early intervention, which prevents the progression of mental disorders and ultimately reduces the burden of mental disorders. The aim of this review is to identify and synthesise evidence on the effectiveness of school-based mental health literacy interventions in improving help-seeking outcomes.
METHODS
We searched MEDLINE, Embase, PsycINFO, ERIC, Child Development and Adolescent Studies, British Education Index and ASSIA (June 2020). Additional searches were conducted a year later to identify any new publications (June 2021). We included randomised controlled trials (RCTs) assessing the effectiveness or cost-effectiveness of school-based interventions to improve help-seeking outcomes for children and young people aged 4-18 years. Included studies were critically appraised.
RESULTS
We identified 11 studies investigating help-seeking outcomes of school-based mental health literacy interventions including a total of 7066 participants from 66 secondary schools. Overall, there is no strong evidence for the effectiveness of school-based mental health literacy interventions in improving help-seeking outcomes, including general attitudes towards help-seeking, personal intentions to seek help, knowledge of when and how to seek help for mental disorders, confidence to seek help, and actual help-seeking behaviours. None of the studies investigated the cost-effectiveness of the interventions.
CONCLUSION
The lack of standardised measures with established reliability and validity for help-seeking outcomes, and the incomprehensive consideration of the multi-faceted concepts of MH literacy and MH stigma have contributed to the scarcity of evidence for the effectiveness. Future research should focus on developing standardised measurement tools and including economic evaluations to understand pragmatic and financial aspects of school-based mental health literacy interventions.
Topics: Child; Adolescent; Humans; Mental Health; Health Literacy; Mental Disorders; School Nursing; Schools
PubMed: 36377083
DOI: 10.1111/camh.12609 -
JAMA Network Open Mar 2024Platform trials have become increasingly common, and evidence is needed to determine how this trial design is actually applied in current research practice.
IMPORTANCE
Platform trials have become increasingly common, and evidence is needed to determine how this trial design is actually applied in current research practice.
OBJECTIVE
To determine the characteristics, progression, and output of randomized platform trials.
EVIDENCE REVIEW
In this systematic review of randomized platform trials, Medline, Embase, Scopus, trial registries, gray literature, and preprint servers were searched, and citation tracking was performed in July 2022. Investigators were contacted in February 2023 to confirm data accuracy and to provide updated information on the status of platform trial arms. Randomized platform trials were eligible if they explicitly planned to add or drop arms. Data were extracted in duplicate from protocols, publications, websites, and registry entries. For each platform trial, design features such as the use of a common control arm, use of nonconcurrent control data, statistical framework, adjustment for multiplicity, and use of additional adaptive design features were collected. Progression and output of each platform trial were determined by the recruitment status of individual arms, the number of arms added or dropped, and the availability of results for each intervention arm.
FINDINGS
The search identified 127 randomized platform trials with a total of 823 arms; most trials were conducted in the field of oncology (57 [44.9%]) and COVID-19 (45 [35.4%]). After a more than twofold increase in the initiation of new platform trials at the beginning of the COVID-19 pandemic, the number of platform trials has since declined. Platform trial features were often not reported (not reported: nonconcurrent control, 61 of 127 [48.0%]; multiplicity adjustment for arms, 98 of 127 [77.2%]; statistical framework, 37 of 127 [29.1%]). Adaptive design features were only used by half the studies (63 of 127 [49.6%]). Results were available for 65.2% of closed arms (230 of 353). Premature closure of platform trial arms due to recruitment problems was infrequent (5 of 353 [1.4%]).
CONCLUSIONS AND RELEVANCE
This systematic review found that platform trials were initiated most frequently during the COVID-19 pandemic and declined thereafter. The reporting of platform features and the availability of results were insufficient. Premature arm closure for poor recruitment was rare.
Topics: Humans; Pandemics; COVID-19; Cognition; Data Accuracy; Medical Oncology
PubMed: 38506807
DOI: 10.1001/jamanetworkopen.2024.3109 -
The Journal of Manual & Manipulative... Mar 2024Disorders of the cervical spine are some of the costliest musculoskeletal conditions to manage globally. Joint mobilization and manipulation have been shown to be an... (Review)
Review
BACKGROUND
Disorders of the cervical spine are some of the costliest musculoskeletal conditions to manage globally. Joint mobilization and manipulation have been shown to be an effective treatment for neck pain. However, the generalizability and clinical translation depends on the nature of the trial designs that inform its use. The extent to which randomized control trials (RCTs) assessing manual therapy treatments for cervical spine disorders fall on the efficacy (explanatory) -effectiveness (pragmatic) spectrum often informs how the findings are translated into clinical practice.
OBJECTIVE
The aim of this systematic review was to determine where RCTs of manual therapy for neck disorders fall on the efficacy-effectiveness spectrum.
METHODS
A search of three electronic databases including PubMed, CINAHL, and CENTRAL were completed for trials published from inception to May 2023. RCTs in which joint mobilization or manipulation were used to treat cervical spine disorders were assessed on the effectiveness-efficacy spectrum using the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool and risk of bias using the Revised Cochrane Risk of Bias tool.
RESULTS
A total of 174 trials met eligibility. RITES domain two trial setting (71.3% vs 16.1%), domain three flexibility of intervention(s) (62.1% vs 23%), and domain four clinical relevance of experimental and comparison intervention(s) (51.7% vs 29.3%) all favored efficacy over effectiveness. Domain one participant characteristic(s) had a slightly greater emphasis on effectiveness compared to efficacy (36.8% vs 44.8%). Most studies (96%) had at least some risk of bias.
CONCLUSION
Over half of the RCTs assessing the treatment effect of joint mobilization and manipulation for neck pain favor efficacy (explanatory) over effectiveness (pragmatic) designs. Future RCTs on this topic should consider a greater emphasis on pragmatic trial design components in order to better reflect real-world translation to clinical practice.
PubMed: 38525785
DOI: 10.1080/10669817.2024.2327127 -
Obesity Reviews : An Official Journal... May 2024Consideration of how applicable the results of surgical trials are to clinical practice is important to inform decision-making. Randomized controlled trials comparing at... (Review)
Review
Randomized controlled trials comparing gastric bypass, gastric band, and sleeve gastrectomy: A systematic review examining validity and applicability to wider clinical practice.
Consideration of how applicable the results of surgical trials are to clinical practice is important to inform decision-making. Randomized controlled trials comparing at least two surgical interventions (of gastric bypass, gastric band, and sleeve gastrectomy) for severe and complex obesity were examined using the PRagmatic Explanatory Continuum Indicator Summary-2 tool, to consider how applicable the trial results are to clinical practice, and the Risk of Bias 2 tool, to examine validity. MEDLINE, Embase, and CENTRAL databases were searched for studies published between November 2013 and June 2021, and 15 were identified. Using the PRagmatic Explanatory Continuum Indicator Summary-2 tool, three were classified as pragmatic, with good applicability to clinical practice. Ten had more explanatory domains but did include some pragmatic characteristics, and two were predominantly explanatory. This was due to some trial design features that would not be considered applicable to the wider clinical setting, including being single-centered, having prescribed intervention delivery methods, and intensive follow-up regimens. Only two trials had low risk of bias, of which one was considered pragmatic. Three had high risk of bias. Overall, few trials in bariatric surgery are pragmatic with low risk of bias. Well-designed pragmatic trials are needed to inform practice and reduce research waste.
Topics: Humans; Gastric Bypass; Research Design; Randomized Controlled Trials as Topic; Obesity; Gastrectomy
PubMed: 38346786
DOI: 10.1111/obr.13718 -
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