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BMJ Open Jun 2024To explore if there are differences in the design and/or conduct of studies that have tested the STarTBack treatment approach for the management of low back pain (LBP),... (Review)
Review
Evaluating the STarTBack stratified treatment approach for low back pain: exploring study-level factors potentially explaining differences in results of studies - a literature review.
OBJECTIVE
To explore if there are differences in the design and/or conduct of studies that have tested the STarTBack treatment approach for the management of low back pain (LBP), potentially explaining differences in study results.
DESIGN
A literature review.
DATA SOURCES
MEDLINE, CINAHL and EMBASE were searched from inception to 26 July 2023.
ELIGIBILITY CRITERIA
We included studies that included (1) participants with LBP and/or leg pain, (2) randomised controlled trials, controlled clinical trials and interrupted time series designs, (3) used the STarTBack Tool to stratify participants into subgroups and (4) studies provided matched treatments according to participants STarTBack score.
DATA EXTRACTION AND SYNTHESIS
Two review authors independently reviewed the search results and extracted data into the data extraction form. Due to the exploratory nature of this study, results are presented descriptively.
RESULTS
11 studies conducted across 5 countries were included. There were substantial differences in the proportion of participants allocated to the different risk groups; low-risk group (range: 19%-58%), medium risk group (range: 31%-52%) and high-risk group (range: 6%-38%). There were large differences between studies in the implementation of the STarTBack approach. The original STarTBack trial (Hill 2011) had a more explanatory design while in many subsequent studies, the design was more pragmatic/real world. Only the two original studies provided clear evidence that the implementation of the STarTBack tool led to a higher proportion of participants receiving matched treatment. In the other studies, there was no evidence of a difference, or it was unclear. In two studies, a researcher made the decision about which matched treatment participants received based on the STartTback Tool, while in nine studies, this was done by a clinician. Most studies recommended the same matched treatment for each risk group as per the original study except for a small number of studies. Only three studies reported whether the clinician delivering matched treatment followed the recommended treatment as per the tool. There was substantial variability in the training clinicians received.
CONCLUSIONS
Reporting of important study-level factors (eg, differences in study design, whether clinicians were trained and how the tool was used in each study) in how the STarTBack approach was implemented was unclear. There is some suggestion that key factors may include the individual who implemented the STarTBack tool, whether the recommendations of the tool were followed, the amount of training the clinician delivering the matched treatment received, and whether clinicians actually delivered the matched treatment.
Topics: Low Back Pain; Humans; Randomized Controlled Trials as Topic
PubMed: 38925707
DOI: 10.1136/bmjopen-2023-081704 -
Frontiers in Neurology 2024Painful diabetic neuropathy (PDN) is a common chronic neurological complication of diabetes mellitus. Medications are often used to relieve pain, but with significant...
BACKGROUND
Painful diabetic neuropathy (PDN) is a common chronic neurological complication of diabetes mellitus. Medications are often used to relieve pain, but with significant side effects. Acupuncture is now a component of pragmatic and integrative treatment for PDN. An increasing number of relevant randomized controlled trials have been published in recent years, but a comprehensive meta-analysis has not yet been performed. The aim of this paper is to verify the effectiveness and safety of acupuncture for PDN by meta-analysis and trial sequential analysis (TSA).
METHODS
All participants in this study should have had a PDN diagnosis and the trial group was treated with acupuncture. Eight databases, including EMbase, PubMed, Web of science, Cochrane Library, China Biology Medicine disc (CBM), China National Knowledge Infrastructure (CNKI), Wanfang and Chongqing VIP (CQVIP) were retrieved from inception to 5 April 2023. Meta-analysis was conducted utilizing RevMan 5.3 and Stata 15.0. TSA was performed to assess the adequacy of sample size for the outcomes.
RESULTS
A total of 36 studies, comprising 2,739 PDN patients, were included. Among them, 1,393 patients were assigned to the trial group and 1,346 patients were treated in the control group. Outcomes covers the primary indicator Total effective rate (RR = 1.42, 95%CI [1.34, 1.52], < 0.00001), with 21 studies reported, Pain intensity (SMD = -1.27, 95%CI [-1.58, -0.95], p < 0.00001), with 23 studies reported, and other outcomes, including motor nerve conduction velocity (MCV; MD = 3.58, 95%CI [2.77, 4.38], < 0.00001), sensory nerve conduction velocity (SCV; MD = 3.62, 95%CI [2.75, 4.49], < 0.00001), Depression score (SMD = -1.02, 95%CI [1.58, 0.46]), Toronto clinical scoring system (TCSS; MD = -2.41, 95%CI [-3.37, -1.45], < 0.00001), Quality of life (SMD = 1.06, 95%CI [0.66, 1.46]), traditional Chinese medicine (TCM) syndrome score (MD = -4.99, 95%CI [-6.79, -3.18], < 0.00001), suggesting that acupuncture have an ameliorating effect on PDN in various respect. Egger's test revealed publication bias for four outcomes. TSA showed that as for Total effective rate, Pain Intensity, MCV and SCV, the number of included studies was sufficient to support the conclusions.
CONCLUSION
Acupuncture demonstrates significant effectiveness in improving PDN outcomes, including Total effective rate, Pain intensity, MCV, SCV, Depression score, TCSS, Quality of life, TCM syndrome score. But the Adverse events rate is no different in trail group and control group. The publication bias presented in Total effective rate, Pain intensity, MCV and SCV can be remedied by Trim and filling method.
SYSTEMATIC REVIEW REGISTRATION
Prospero, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=477295.
PubMed: 38903165
DOI: 10.3389/fneur.2024.1402458 -
International Journal of Medical... Jun 2024The surge in emergency head CT imaging and artificial intelligence (AI) advancements, especially deep learning (DL) and convolutional neural networks (CNN), have... (Review)
Review
BACKGROUND
The surge in emergency head CT imaging and artificial intelligence (AI) advancements, especially deep learning (DL) and convolutional neural networks (CNN), have accelerated the development of computer-aided diagnosis (CADx) for emergency imaging. External validation assesses model generalizability, providing preliminary evidence of clinical potential.
OBJECTIVES
This study systematically reviews externally validated CNN-CADx models for emergency head CT scans, critically appraises diagnostic test accuracy (DTA), and assesses adherence to reporting guidelines.
METHODS
Studies comparing CNN-CADx model performance to reference standard were eligible. The review was registered in PROSPERO (CRD42023411641) and conducted on Medline, Embase, EBM-Reviews and Web of Science following PRISMA-DTA guideline. DTA reporting were systematically extracted and appraised using standardised checklists (STARD, CHARMS, CLAIM, TRIPOD, PROBAST, QUADAS-2).
RESULTS
Six of 5636 identified studies were eligible. The common target condition was intracranial haemorrhage (ICH), and intended workflow roles auxiliary to experts. Due to methodological and clinical between-study variation, meta-analysis was inappropriate. The scan-level sensitivity exceeded 90 % in 5/6 studies, while specificities ranged from 58,0-97,7 %. The SROC 95 % predictive region was markedly broader than the confidence region, ranging above 50 % sensitivity and 20 % specificity. All studies had unclear or high risk of bias and concern for applicability (QUADAS-2, PROBAST), and reporting adherence was below 50 % in 20 of 32 TRIPOD items.
CONCLUSION
0.01 % of identified studies met the eligibility criteria. The evidence on the DTA of CNN-CADx models for emergency head CT scans remains limited in the scope of this review, as the reviewed studies were scarce, inapt for meta-analysis and undermined by inadequate methodological conduct and reporting. Properly conducted, external validation remains preliminary for evaluating the clinical potential of AI-CADx models, but prospective and pragmatic clinical validation in comparative trials remains most crucial. In conclusion, future AI-CADx research processes should be methodologically standardized and reported in a clinically meaningful way to avoid research waste.
PubMed: 38901270
DOI: 10.1016/j.ijmedinf.2024.105523 -
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 -
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 -
Heart, Lung & Circulation May 2024Although there are evolving techniques and technologies for treating ventricular tachycardia (VT), the current landscape of clinical trials for managing VT remains...
BACKGROUND
Although there are evolving techniques and technologies for treating ventricular tachycardia (VT), the current landscape of clinical trials for managing VT remains understudied.
OBJECTIVE
The objective of this study was to provide a systematic characterisation of the interventional management of VT through an analysis of the ClinicalTrials.gov, clinicaltrialsregister.eu, anzctr.org.au and chictr.org.cn databases.
METHODS
We queried all phase II to IV interventional trials registered up to November 2023 that enrolled patients with VT. Published, completed but unpublished, terminated, or ongoing trials were included for final analysis.
RESULTS
Of the 698 registered studies, 135 were related to VT, with 123 trials included in the final analysis. Among these trials, 25 (20%) have been published, enrolling a median of 35 patients (interquartile range [IQR] 20-132) over a median of 43 months (IQR 19-62). Out of the published trials, 14 (56%) were randomised, and 12 (48%) focused on catheter ablation. Twenty-two (18%) have been completed but remain unpublished, even after a median of 36 months (IQR 15-60). Furthermore, 27 (22%) trials were terminated or withdrawn, with the most common cause being poor enrolment. Currently, 49 (40%) trials are ongoing and novel non-ablative technologies, such as radioablation and autonomic modulation, account for 35% and 8% of ongoing trials, respectively.
CONCLUSIONS
Our analysis revealed that many registered trials remain unpublished or incomplete, and randomised controlled trial evidence is limited to only a few studies. Furthermore, many ongoing trials are focused on non-catheter ablation-based strategies. Therefore, larger pragmatic trials are needed to create stronger evidence in the future.
PubMed: 38821759
DOI: 10.1016/j.hlc.2024.01.041 -
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 -
BMC Geriatrics May 2024Randomized clinical trials have shown that, under optimal conditions, statins reduce the risk of cardiovascular events in older adults. Given the prevalence and...
BACKGROUND
Randomized clinical trials have shown that, under optimal conditions, statins reduce the risk of cardiovascular events in older adults. Given the prevalence and consequences of suboptimal adherence to statin among older adults, it is essential to document strategies designed to increase statin adherence in this population. The objective of this systematic review is to describe and summarize the effectiveness of interventions to improve statin adherence in older adults (≥ 65 years old).
METHODS
This review followed PRISMA guidelines. Studies were identified from PubMed, PsycINFO, Embase, CINAHL and Web of Science. Study selection was conducted independently by four reviewers working in pairs. Included studies reported data on interventions designed to increase adherence to statin therapy in older adults and were original trials or observational studies. Interventions were pragmatically regrouped into 8 different categories going from patient to administrative level. Two reviewers extracted study data and assessed study quality independently. Given the heterogeneity between the included studies, a narrative critique and summary was conducted.
RESULTS
Twelve out of the 2889 identified articles were included in the review. Our review showed that simplifying patients' drug regimen, administrative improvements and large-scale pharmacy-led automated telephone interventions show positive effects on patient adherence to statin therapy, with odds ratios between > 1.0 and 3.0, while education-based strategies and intensified patient care showed mixed results.
CONCLUSIONS
Current evidence suggests that some interventions can increase statin adherence in older adults, which could help in the reduction of the risk of a cardiovascular event in this population.
Topics: Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Medication Adherence; Aged; Cardiovascular Diseases
PubMed: 38773394
DOI: 10.1186/s12877-024-05031-z -
PloS One 2024To synthesize the impact of improvement interventions related to care coordination, discharge support and care transitions on patient experience measures.
AIM
To synthesize the impact of improvement interventions related to care coordination, discharge support and care transitions on patient experience measures.
METHOD
Systematic review. Searches were completed in six scientific databases, five specialty journals, and through snowballing. Eligibility included studies published in English (2015-2023) focused on improving care coordination, discharge support, or transitional care assessed by standardized patient experience measures as a primary outcome. Two independent reviewers made eligibility decisions and performed quality appraisals.
RESULTS
Of 1240 papers initially screened, 16 were included. Seven studies focused on care coordination activities, including three randomized controlled trials [RCTs]. These studies used enhanced supports such as improvement coaching or tailoring for vulnerable populations within Patient-Centered Medical Homes or other primary care sites. Intervention effectiveness was mixed or neutral relative to standard or models of care or simpler supports (e.g., improvement tool). Eight studies, including three RCTs, focused on enhanced discharge support, including patient education (e.g., teach back) and telephone follow-up; mixed or neutral results on the patient experience were also found and with more substantive risks of bias. One pragmatic trial on a transitional care intervention, using a navigator support, found significant changes only for the subset of uninsured patients and in one patient experience outcome, and had challenges with implementation fidelity.
CONCLUSION
Enhanced supports for improving care coordination, discharge education, and post-discharge follow-up had mixed or neutral effectiveness for improving the patient experience with care, compared to standard care or simpler improvement approaches. There is a need to advance the body of evidence on how to improve the patient experience with discharge support and transitional approaches.
Topics: Humans; Patient Discharge; Transitional Care; Patient-Centered Care; Patient Satisfaction; Continuity of Patient Care; Randomized Controlled Trials as Topic
PubMed: 38771768
DOI: 10.1371/journal.pone.0299176 -
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