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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 -
American Journal of Perinatology May 2024Palivizumab is a humanized monoclonal antibody approved for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus...
OBJECTIVE
Palivizumab is a humanized monoclonal antibody approved for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children at high risk of RSV disease. This systematic review summarized evidence on the effectiveness and safety of palivizumab when used in approved populations.
STUDY DESIGN
A systematic review of Phase III trials and observational studies was conducted according to the population, intervention, comparator, outcome, timing, setting (PICOTS) approach (PROSPERO, CRD42021281380). Target populations consisted of infants with a history of premature birth (≤35-week gestational age) and children aged <2 years with bronchopulmonary dysplasia (BPD) or with hemodynamically significant congenital heart disease (hs-CHD). Outcomes of interest included RSV-related hospitalization, admission to intensive care unit (ICU), requirement for mechanical ventilation, treatment-related adverse events (AEs), and RSV-related deaths. Information sources were literature search (Ovid MEDLINE and Embase), pragmatic searches, and snowballing (covering the period up to 07 September 2021).
RESULTS
A total of 60 sources were included (5 Phase III trials and 55 observational studies). RSV-related hospitalization rates following palivizumab prophylaxis in Phase III trials were 1.8% in premature infants and 7.9% in children with BPD, which were significantly lower than rates in placebo arms. In the real-world setting, similar hospitalization rates were found (0.7-4.0% in premature infants [16 studies] and 0-5.5% in patients with BPD [10 studies]) with ICU admission reported in 0 to 33.3% of patients hospitalized for RSV. In Phase III trials, RSV-related mortality rates were 0.2 and 0.3%, while AEs occurred in 11% of premature and/or BPD patients and 7.2% of hs-CHD patients, consisting mainly of injection site reaction, fever, and diarrhea. Similar results were found in observational studies.
CONCLUSION
This systematic review supports the effectiveness and safety of palivizumab in the indicated populations.
KEY POINTS
· Systematic review supports the positive benefit-risk profile of palivizumab in the indicated populations.. · Real-world safety and effectiveness of palivizumab are consistent with Phase III trials results.. · Palivizumab reduces RSV-related hospitalizations, ICU admissions, and need for mechanical ventilation..
Topics: Humans; Palivizumab; Respiratory Syncytial Virus Infections; Antiviral Agents; Infant; Infant, Newborn; Infant, Premature; Hospitalization; Bronchopulmonary Dysplasia; Heart Defects, Congenital; Respiration, Artificial; Respiratory Tract Infections; Observational Studies as Topic; Clinical Trials, Phase III as Topic
PubMed: 36452969
DOI: 10.1055/a-1990-2633 -
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 -
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 -
Critical Reviews in Oncology/hematology Mar 2024Exercise has been shown to play an important role in managing chemotherapy-related side effects, preserving skeletal muscle mass, and attenuating decline in...
BACKGROUND
Exercise has been shown to play an important role in managing chemotherapy-related side effects, preserving skeletal muscle mass, and attenuating decline in cardiorespiratory fitness associated with chemotherapy treatment, however, the feasibility of how these exercise programs are being delivered has yet to be synthesized. The objective of this review was to measure the rates of recruitment, adherence, and retention to exercise programs delivered for cancer patients during chemotherapy.
METHODS
Relevant studies were identified through a search of MEDLINE, Cochrane, EMBASE and CINAHL databases from January 2002 to July 2022 using keywords relating to exercise interventions during chemotherapy. Title and abstract screening, full text review, data extraction, and quality assessment were all performed independently by two reviewers.
RESULTS
A total of 36 studies were included in the review. The mean recruitment rate for the included studies was 62.39% (SD = 19.40; range 25.7-95%). Travel was the most common reason for declining recruitment in these trials. Adherence rates ranged from 17-109%, however the definition of adherence varied greatly between studies. Mean retention rates for the exercise groups was 84.1% (SD = 12.7; range 50-100%), with chemotherapy side effects being the most common reason why participants dropped out of these trials.
CONCLUSION
Multiple challenges exist for cancer patients during chemotherapy and careful consideration needs to be given when designing an exercise program for this population. Future research should include public and patient involvement to ensure exercise programs are pragmatic and patient centred.
Topics: Humans; Exercise Therapy; Neoplasms
PubMed: 38272152
DOI: 10.1016/j.critrevonc.2024.104272 -
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 -
The Journal of the American Academy of... Apr 2024Depression is a notable contributor to suboptimal outcomes after total joint arthroplasty (TJA). We conducted a systematic review of comparative studies to review the...
PURPOSE
Depression is a notable contributor to suboptimal outcomes after total joint arthroplasty (TJA). We conducted a systematic review of comparative studies to review the available evidence of interventions that affected depression scores and/or outcomes for patients undergoing TJA.
METHODS
EMBASE, Ovid MEDLINE, PubMed, and Scopus were reviewed systematically from inception until November 15, 2022. Studies that were relevant for this review included comparative studies between patients who received an intervention within 3 months before or after their primary total hip or knee arthroplasty procedure. The interventions included a wide range of modalities, which were grouped into psychotherapy, enhanced perioperative support, and pharmacotherapy. Other interventions included physiotherapy techniques with a psychological focus, art/music-based therapy, occupational therapy support, and educational interventions. Meta-analysis was conducted for psychotherapy and enhanced support.
RESULTS
The final systematic review consisted of 28 relevant studies, most of which were randomized controlled trials. A total of 3,702 patients, with a mean age of 66 years, were considered, of whom 59% were female. Most of the studies reported a notable reduction in depressive symptoms and/or scores based on the interventions being analyzed. At 3 months postoperatively, psychotherapy and enhanced support both resulted in markedly better depression and function scores compared with control subjects, with psychotherapy additionally improving pain scores.
CONCLUSIONS
Overall, a wide range of interventions aimed at psychological optimization of patients undergoing TJA can improve depressive symptoms, pain, and function, even in the absence of a formal diagnosis of depression. Specifically, cognitive-based psychotherapy and enhanced perioperative support had the best evidence. Routine pharmacotherapy plays a limited role, if any, in the care of TJA. Additional efforts to develop pragmatic, evidence-based, and reproducible interventions are warranted to continue to optimize outcomes in TJA patients.
PubMed: 38626430
DOI: 10.5435/JAAOS-D-23-01130 -
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