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European Respiratory Review : An... Sep 2023The Global Initiative for Chronic Obstructive Lung Disease 2023 report recommends medication adherence assessment in COPD as an action item. Healthcare databases provide... (Review)
Review
BACKGROUND
The Global Initiative for Chronic Obstructive Lung Disease 2023 report recommends medication adherence assessment in COPD as an action item. Healthcare databases provide opportunities for objective assessments; however, multiple methods exist. We aimed to systematically review the literature to describe existing methods to assess adherence in COPD in healthcare databases and to evaluate the reporting of influencing variables.
METHOD
We searched MEDLINE, Web of Science and Embase for peer-reviewed articles evaluating adherence to COPD medication in electronic databases, written in English, published up to 11 October 2022 (PROSPERO identifier CRD42022363449). Two reviewers independently conducted screening for inclusion and performed data extraction. Methods to assess initiation (dispensing of medication after prescribing), implementation (extent of use over a specific time period) and/or persistence (time from initiation to discontinuation) were listed descriptively. Each included study was evaluated for reporting variables with an impact on adherence assessment: inpatient stays, drug substitution, dose switching and early refills.
RESULTS
160 studies were included, of which four assessed initiation, 135 implementation and 45 persistence. Overall, one method was used to measure initiation, 43 methods for implementation and seven methods for persistence. Most of the included implementation studies reported medication possession ratio, proportion of days covered and/or an alteration of these methods. Only 11% of the included studies mentioned the potential impact of the evaluated variables.
CONCLUSION
Variations in adherence assessment methods are common. Attention to transparency, reporting of variables with an impact on adherence assessment and rationale for choosing an adherence cut-off or treatment gap is recommended.
Topics: Humans; Pulmonary Disease, Chronic Obstructive; Medication Adherence
PubMed: 37758274
DOI: 10.1183/16000617.0103-2023 -
JAMA Cardiology Oct 2023The association between changes in atherosclerotic plaque induced by lipid-lowering therapies (LLTs) and reduction in major adverse cardiovascular events (MACEs) remains... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
The association between changes in atherosclerotic plaque induced by lipid-lowering therapies (LLTs) and reduction in major adverse cardiovascular events (MACEs) remains controversial.
OBJECTIVE
To evaluate the association between coronary plaque regression assessed by intravascular ultrasound (IVUS) and MACEs.
DATA SOURCES
A comprehensive, systematic search of publications in PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science was performed.
STUDY SELECTION
Clinical prospective studies of LLTs reporting change in percent atheroma volume (PAV) assessed by IVUS and describing MACE components were selected.
DATA EXTRACTION AND SYNTHESIS
Reporting was performed in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The association between mean change in PAV and MACEs was analyzed by meta-regression using mixed-effects, 2-level binomial logistic regression models, unadjusted and adjusted for clinical covariates, including mean age, baseline PAV, baseline low-density lipoprotein cholesterol level, and study duration.
MAIN OUTCOME AND MEASURES
Mean PAV change and MACE in intervention and comparator arms were assessed in an updated systematic review and meta-regression analysis of IVUS trials of LLTs that also reported MACEs.
RESULTS
This meta-analysis included 23 studies published between July 2001 and July 2022, including 7407 patients and trial durations ranging from 11 to 104 weeks. Mean (SD) patient age ranged from 55.8 (9.8) to 70.2 (7.6) years, and the number of male patients from 245 of 507 (48.3%) to 24 of 26 (92.3%). Change in PAV across 46 study arms ranged from -5.6% to 3.1%. The number of MACEs ranged from 0 to 72 per study arm (17 groups [37%] reported no events, 9 [20%] reported 1-2 events, and 20 [43%] reported ≥3 events). In unadjusted analysis, a 1% decrease in mean PAV was associated with 17% reduced odds of MACEs (unadjusted OR, 0.83; 95% CI, 0.71-0.98; P = .03), and with a 14% reduction in MACEs in adjusted analysis (adjusted OR, 0.86; 95% CI, 0.75-1.00; P = .050). Further adjustment for cardiovascular risk factors showed a 19% reduced risk (adjusted OR, 0.81; 95% CI, 0.68-0.96; P = .01) per 1% decrease in PAV. A 1% reduction of PAV change between intervention and comparator arms within studies was also associated with a significant 25% reduction in MACEs (OR, 0.75; 95% CI, 0.56-1.00; P = .046).
CONCLUSIONS AND RELEVANCE
In this meta-analysis, regression of atherosclerotic plaque by 1% was associated with a 25% reduction in the odds of MACEs. These findings suggest that change in PAV could be a surrogate marker for MACEs, but given the heterogeneity in the outcomes, additional data are needed.
Topics: Humans; Male; Middle Aged; Plaque, Atherosclerotic; Coronary Artery Disease; Prospective Studies; Regression Analysis
PubMed: 37647074
DOI: 10.1001/jamacardio.2023.2731 -
European Review For Medical and... Aug 2023This study aimed to investigate the effect of mechanical ventilation guided by transpulmonary pressure in patients diagnosed with acute respiratory distress syndrome... (Meta-Analysis)
Meta-Analysis
Effect of mechanical ventilation guided by transpulmonary pressure in acute respiratory distress syndrome patients: a systematic review and meta-analysis of randomized control trials.
OBJECTIVE
This study aimed to investigate the effect of mechanical ventilation guided by transpulmonary pressure in patients diagnosed with acute respiratory distress syndrome (ARDS).
MATERIALS AND METHODS
Randomized control trials of ARDS patients that received mechanical ventilation guided by transpulmonary pressure vs. mechanical ventilation guided by traditional lung protective ventilation strategies in adults were retrieved by two reviewers independently from PubMed, EMBASE, The Cochrane Library, The China National Knowledge Infrastructure, and WanFang database before October 2022. The protocol has been registered on PROSPERO (CRD42022307816). The primary outcome was mortality. The secondary outcomes included mechanical ventilation days, oxygenation function and ventilation parameters, hemodynamics, and cytokines level.
RESULTS
Thirteen articles (819 patients) were finally included through our search strategy. The total mortality (RR, 0.68; 95% CI, 0.54-0.85; p = 0.0006) and mechanical ventilation days (MD, -2.77; 95% CI, -4.60 - -0.94; p = 0.003) reduced when compared with the control group. Patients in the transpulmonary pressure group had higher oxygen index (MD, 40.74; 95% CI 9.81-71.68, p = 0.010) and lung compliance (MD, 7.98; 95% CI 4.55-11.41, p < 0.00001). Positive end-expiratory pressure (PEEP) was higher in the transpulmonary pressure group (MD, 5.47; 95% CI, 3.59 - 7.35; p < 0.00001). The Interlukin-6 (IL-6) level in the control group decreased obviously compared with that in the transpulmonary pressure group (SMD, -2.03; 95% CI, -3.50 - -0.56; p = 0.007).
CONCLUSIONS
Mechanical ventilation guided by transpulmonary pressure tended to have a beneficial prognosis on ARDS patients. Oxygenation and lung mechanics parameters were also improved. The clinical effect of mechanical ventilation directed by transpulmonary pressure was superior to the traditional lung protective ventilation strategies in ARDS patients.
Topics: Adult; Humans; China; Positive-Pressure Respiration; Respiration; Respiration, Artificial; Respiratory Distress Syndrome; Randomized Controlled Trials as Topic
PubMed: 37606111
DOI: 10.26355/eurrev_202308_33274 -
Journal of General Internal Medicine Nov 2023Results from high-profile randomized controlled trials (RCTs) are routinely reported through press release months prior to peer-reviewed publication. There are potential...
IMPORTANCE
Results from high-profile randomized controlled trials (RCTs) are routinely reported through press release months prior to peer-reviewed publication. There are potential benefits to press releases (e.g., knowledge dissemination, ensuring regulatory compliance), but also potential drawbacks (e.g., selective reporting, positive "spin").
OBJECTIVE
To characterize the practice of press release predating the publication of a drug-related RCT in a peer-reviewed journal ("preemptive press release"), including factors associated with this practice.
DESIGN, SETTING, AND PARTICIPANTS
We systematically reviewed all RCTs of medications published between 2015 and 2019 in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), and Lancet. Press releases were identified using a systematic search of the grey literature (e.g., press release databases, study sponsor websites). An RCT was considered to have a preemptive press release if the press release was published at least three months (90 days) prior to the date of publication in a peer-reviewed journal.
MAIN OUTCOMES AND MEASURES
Presence of preemptive press release, defined as a press-release at least 90 days prior to the date of publication in a peer-reviewed journal. As secondary measures for dissemination, we also assessed citation count and Altmetric score.
RESULTS
We identified 988 RCTs, of which 172 (17%) had a press release published at least 90 days before the date of peer-reviewed publication. Press releases were published a median of 246 days (interquartile range [IQR] 169-366 days) before publication in a peer-reviewed journal. In the multivariable logistic regression model, the strongest predictor of having a preemptive press release was funding by a pharmaceutical company (odds ratio 13, 95% CI 7, 25). Approximately 85% of RCTs with preemptive press releases had a positive primary outcome and, concordantly, 81% of the corresponding press releases had a positive headline. Multivariable regression models identified studies with a preemptive press release had a similar Altmetric score (median - 15, 95% CI - 33, 12) and higher median citation count (median 22 [95% CI 10 to 33] compared to studies without a preemptive press release.
CONCLUSIONS AND RELEVANCE
Preemptive press releases were common, most often issued for trials funded by a pharmaceutical company, and typically preceded publication in a peer-reviewed journal by approximately eight months.
Topics: United States; Humans; Journal Impact Factor; Periodicals as Topic; Peer Review; Observational Studies as Topic; Randomized Controlled Trials as Topic
PubMed: 37532876
DOI: 10.1007/s11606-023-08313-1 -
Frontiers in Public Health 2023Medication non-adherence is an important public health issue, associated with poor clinical and economic outcomes. Globally, self-reported instruments are the most...
INTRODUCTION
Medication non-adherence is an important public health issue, associated with poor clinical and economic outcomes. Globally, self-reported instruments are the most widely used method to assess medication adherence. However, the majority of these were developed in high-income countries (HICs) with a well-established health care system. Their applicability in low- and middle-income countries (LMICs) remains unclear. The objective of this study is to systematically review the applicability of content and use of self-reported adherence instruments in LMICs.
METHOD
A scoping review informed by a literature search in Pubmed, EBSCO, and Cochrane databases was conducted to identify studies assessing medication adherence using self-reported instruments for patients with five common chronic diseases [hypertension, diabetes, dyslipidemia, asthma, or Chronic Obstructive Pulmonary Disease (COPD)] in LMICs up to January 2022 with no constraints on publication year. Two reviewers performed the study selection process, data extraction and outcomes assessment independently. Outcomes focused on LMIC applicability of the self-reported adherence instruments assessed by (i) containing LMIC relevant adherence content; (ii) methodological quality and (iii) fees for use.
FINDINGS
We identified 181 studies that used self-reported instruments for assessing medication adherence in LMICs. A total of 32 distinct types of self-reported instruments to assess medication adherence were identified. Of these, 14 self-reported instruments were developed in LMICs, while the remaining ones were adapted from self-reported instruments originally developed in HICs. All self-reported adherence instruments in studies included presented diverse potential challenges regarding their applicability in LMICs, included an underrepresentation of LMIC relevant non-adherence reasons, such as financial issues, use of traditional medicines, religious beliefs, lack of communication with healthcare provider, running out of medicine, and access to care. Almost half of included studies showed that the existing self-reported adherence instruments lack sufficient evidence regarding cross cultural validation and internal consistency. In 70% of the studies, fees applied for using the self-reported instruments in LMICs.
CONCLUSION
There seems insufficient emphasis on applicability and methodological rigor of self-reported medication adherence instruments used in LMICs. This presents an opportunity for developing a self-reported adherence instrument that is suitable to health systems and resources in LMICs.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier: CRD42022302215.
Topics: Humans; Developing Countries; Self Report; Medication Adherence; Income; Communication
PubMed: 37521968
DOI: 10.3389/fpubh.2023.1104510 -
BMJ Open Jul 2023The objectives of this systematic review are to identify studies that assess the effectiveness of patient-directed financial incentive interventions to improve asthma...
OBJECTIVES
The objectives of this systematic review are to identify studies that assess the effectiveness of patient-directed financial incentive interventions to improve asthma management behaviours, determine overall effectiveness of financial incentives, identify design characteristics of effective interventions and assess the impact on longer-term outcomes in the context of asthma.
DESIGN
Systematic review with narrative synthesis.
DATA SOURCES
Electronic databases (MEDLINE, Embase, Global Health, PsycINFO, CINAHL, PubMed and Web of Science) and grey literature sources (NHS Digital, CORE, ProQuest, Clinical Trials Register and EU Clinical Trials Register) were searched in November 2021 and updated March 2023.
ELIGIBLITY CRITERIA
Eligible articles assessed financial incentives to improve asthma management behaviours (attendance at appointments, medication adherence, tobacco smoke/allergen exposure, inhaler technique and asthma education) for patients with asthma or parents/guardians of children with asthma. Eligible study design included randomised controlled, controlled or quasi-randomised trials and retrospective/prospective cohort, case-controlled or pilot/feasibility studies.
SYNTHESIS
A narrative synthesis was conducted; eligible studies were grouped by asthma management behaviours and financial incentive framework domains.
RESULTS
We identified 4268 articles; 8 met the inclusion criteria. The studies were from the USA (n=7) and the UK (n=1). Asthma management behaviours included attendance at appointments (n=4), reduction in smoke exposure (n=1) and medication adherence (n=3). Five studies demonstrated positive behaviour change, four of which were significant (attendance at appointments (n=3) showed significant differences between intervention and control: 73% and 49% in one study, 46.3% and 28.9% in another, and 35.7% and 18.9%, respectively; medication adherence (n=1) showed significant change from 80% during intervention to 33% post intervention). These four significant studies used 'positive gain', 'certain', 'fixed' financial incentives of smaller magnitude, given for 'all' instances of behaviour.
CONCLUSION
There is some evidence that patient-directed financial incentives improve asthma management behaviours. However, in view of the wide heterogeneity in study design and measured outcomes, determining overall effectiveness was challenging.
PROSPERO REGISTRATION NUMBER
CRD42021266679.
Topics: Child; Humans; Motivation; Prospective Studies; Retrospective Studies; Asthma; Medication Adherence
PubMed: 37518086
DOI: 10.1136/bmjopen-2022-070761 -
Korean Journal of Anesthesiology Dec 2023Mechanical ventilation, particularly one-lung ventilation (OLV), can cause pulmonary dysfunction. This meta-analysis assessed the effects of dexmedetomidine on the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Mechanical ventilation, particularly one-lung ventilation (OLV), can cause pulmonary dysfunction. This meta-analysis assessed the effects of dexmedetomidine on the pulmonary function of patients receiving OLV.
METHODS
The Embase, PubMed, MEDLINE, Cochrane Library, ClinicalTrials.gov, and Chinese Clinical Trial Registry databases were systematically searched. The primary outcome was oxygenation index (OI). Other outcomes including the incidence of postoperative complications were assessed.
RESULTS
Fourteen randomized controlled trials involving 845 patients were included in this meta-analysis. Dexmedetomidine improved the OI at 30 (mean difference [MD]: 40.49, 95% CI [10.21, 70.78]), 60 (MD: 60.86, 95% CI [35.81, 85.92]), and 90 min (MD: 55, 95% CI [34.89, 75.11]) after OLV and after surgery (MD: 28.98, 95% CI [17.94, 40.0]) and improved lung compliance 90 min after OLV (MD: 3.62, 95% CI [1.7, 5.53]). Additionally, dexmedetomidine reduced the incidence of postoperative pulmonary complications (odds ratio: 0.44, 95% CI [0.24, 0.82]) and length of hospital stay (MD: -0.99, 95% CI [-1.25, -0.73]); decreased tumor necrosis factor-α, interleukin (IL)-6, IL-8, and malondialdehyde levels; and increased superoxide dismutase levels. However, only the results for the OI and IL-6 levels were confirmed by the sensitivity and trial sequential analyses.
CONCLUSIONS
Dexmedetomidine improves oxygenation in patients receiving OLV and may additionally decrease the incidence of postoperative pulmonary complications and shorten the length of hospital stay, which may be related to associated improvements in lung compliance, anti-inflammatory effects, and regulation of oxidative stress reactions. However, robust evidence is required to confirm these conclusions.
Topics: Humans; One-Lung Ventilation; Dexmedetomidine; Lung; Blood Gas Analysis; Randomized Controlled Trials as Topic
PubMed: 36924790
DOI: 10.4097/kja.22787 -
Australian Critical Care : Official... Nov 2023Patients requiring mechanical ventilation in the intensive care unit (ICU) have diminished respiratory defences and are at high risk of respiratory compromise, leading... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Patients requiring mechanical ventilation in the intensive care unit (ICU) have diminished respiratory defences and are at high risk of respiratory compromise, leading to an increased risk of pulmonary infection and prolonged ventilation. Ventilator hyperinflation (VHI) is an airway clearance technique used by physiotherapists and is suggested to improve respiratory mechanics. The objective of this study was to review the evidence for the benefits and risks of VHI in intubated and mechanically ventilated patients in the ICU.
REVIEW METHOD USED
We conducted a systematic review.
DATA SOURCES
We searched PubMed, Embase, CINAHL, CENTRAL, and Scopus from inception to 31st May 2022 for all randomised control trials evaluating VHI in intubated and mechanically ventilated adults in the ICU.
REVIEW METHODS
Two authors independently performed study selection and data extraction. Individual study risk of bias was assessed using the Physiotherapy Evidence Database scale, and certainty in outcomes was assessed using the Grading of Recommendations, Assessment, Development and Evaluations framework.
RESULTS
We included 10 studies enrolling 394 patients. Compared to standard care, VHI had significant effects on sputum clearance (Standardise mean difference: 0.36, 95% confidence interval [CI]: 0.12 to 0.61; very low certainty), static pulmonary compliance (mean difference [MD]: 4.77, 95% CI: 2.40 to 7.14; low certainty), dynamic pulmonary compliance (MD: 1.59, 95% CI: 0.82 to 2.36; low certainty) and oxygenation (MD: 0.28, 95% CI: 0.01 to 0.55; low certainty). No significant adverse events or immediate side effects relating to VHI were reported. There is a paucity of data available on the effects of VHI on clinical outcomes including mechanical ventilation duration, ICU length of stay, and mortality.
CONCLUSIONS
Our findings suggest VHI has potential short-term respiratory benefits including increased secretion clearance, pulmonary compliance, and oxygenation, with no immediate adverse effects in intubated and mechanically ventilated ICU patients. However, there remains limited data on the longer term influence of VHI on clinical outcomes, and further research to inform clinical practice is needed.
REGISTRATION
This study is registered with the International Prospective Register of Systematic Reviews (PROSPERO; CRD42022341421).
Topics: Adult; Humans; Respiration, Artificial; Critical Care; Ventilators, Mechanical; Intensive Care Units; Risk Assessment
PubMed: 36822978
DOI: 10.1016/j.aucc.2023.01.005