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The Cochrane Database of Systematic... May 2014Cultural competence education for health professionals aims to ensure all people receive equitable, effective health care, particularly those from culturally and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cultural competence education for health professionals aims to ensure all people receive equitable, effective health care, particularly those from culturally and linguistically diverse (CALD) backgrounds. It has emerged as a strategy in high-income English-speaking countries in response to evidence of health disparities, structural inequalities, and poorer quality health care and outcomes among people from minority CALD backgrounds. However there is a paucity of evidence to link cultural competence education with patient, professional and organisational outcomes. To assess efficacy, for this review we developed a four-dimensional conceptual framework comprising educational content, pedagogical approach, structure of the intervention, and participant characteristics to provide consistency in describing and assessing interventions. We use the term 'CALD participants' when referring to minority CALD populations as a whole. When referring to participants in included studies we describe them in terms used by study authors.
OBJECTIVES
To assess the effects of cultural competence education interventions for health professionals on patient-related outcomes, health professional outcomes, and healthcare organisation outcomes.
SEARCH METHODS
We searched: MEDLINE (OvidSP) (1946 to June 2012); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) (June 2012); EMBASE (OvidSP) (1988 to June 2012); CINAHL (EbscoHOST) (1981 to June 2012); PsycINFO (OvidSP) (1806 to June 2012); Proquest Dissertations and Theses database (1861 to October 2011); ERIC (CSA) (1966 to October 2011); LILACS (1982 to March 2012); and Current Contents (OvidSP) (1993 Week 27 to June 2012).Searches in MEDLINE, CENTRAL, PsycINFO, EMBASE, Proquest Dissertations and Theses, ERIC and Current Contents were updated in February 2014. Searches in CINAHL were updated in March 2014.There were no language restrictions.
SELECTION CRITERIA
We included randomised controlled trials (RCTs), cluster RCTs, and controlled clinical trials of educational interventions for health professionals working in health settings that aimed to improve: health outcomes of patients/consumers of minority cultural and linguistic backgrounds; knowledge, skills and attitudes of health professionals in delivering culturally competent care; and healthcare organisation performance in culturally competent care.
DATA COLLECTION AND ANALYSIS
We used the conceptual framework as the basis for data extraction. Two review authors independently extracted data on interventions, methods, and outcome measures and mapped them against the framework. Additional information was sought from study authors. We present results in narrative and tabular form.
MAIN RESULTS
We included five RCTs involving 337 healthcare professionals and 8400 patients; at least 3463 (41%) were from CALD backgrounds. Trials compared the effects of cultural competence training for health professionals, with no training. Three studies were from the USA, one from Canada and one from The Netherlands. They involved health professionals of diverse backgrounds, although most were not from CALD minorities. Cultural background was determined using a validated scale (one study), self-report (two studies) or not reported (two studies). The design effect from clustering meant an effective minimum sample size of 3164 CALD participants. No meta-analyses were performed. The quality of evidence for each outcome was judged to be low.Two trials comparing cultural competence training with no training found no evidence of effect for treatment outcomes, including the proportion of patients with diabetes achieving LDL cholesterol control targets (risk difference (RD) -0.02, 95% CI -0.06 to 0.02; 1 study, USA, 2699 "black" patients, moderate quality), or change in weight loss (standardised mean difference (SMD) 0.07, 95% CI -0.41 to 0.55, 1 study, USA, effective sample size (ESS) 68 patients, low quality).Health behaviour (client concordance with attendance) improved significantly among intervention participants compared with controls (relative risk (RR) 1.53, 95% CI 1.03 to 2.27, 1 study, USA, ESS 28 women, low quality). Involvement in care by "non-Western" patients (described as "mainly Turkish, Moroccan, Cape Verdean and Surinamese patients") with largely "Western" doctors improved in terms of mutual understanding (SMD 0.21, 95% CI 0.00 to 0.42, 1 study, The Netherlands, 109 patients, low quality). Evaluations of care were mixed (three studies). Two studies found no evidence of effect in: proportion of patients reporting satisfaction with consultations (RD 0.14, 95% CI -0.03 to 0.31, 1 study, The Netherlands, 109 patients, low quality); patient scores of physician cultural competency (SMD 0.11 95% CI -0.63 to 0.85, 1 study, USA, ESS 68 "Caucasian" and "non-Causcasian" patients (described as Latino, African American, Asian and other, low quality). Client perceptions of health professionals were significantly higher in the intervention group (SMD 1.60 95% CI 1.05 to 2.15, 1 study, USA, ESS 28 "Black" women, low quality).No study assessed adverse outcomes.There was no evidence of effect on clinician awareness of "racial" differences in quality of care among clients at a USA health centre (RR 1.37, 95% CI 0.97 to 1.94. P = 0.07) with no adjustment for clustering. Included studies did not measure other outcomes of interest. Sensitivity analyses using different values for the Intra-cluster coefficient (ICC) did not substantially alter the magnitude or significance of summary effect sizes.All four domains of the conceptual framework were addressed, suggesting agreement on core components of cultural competence education interventions may be possible.
AUTHORS' CONCLUSIONS
Cultural competence continues to be developed as a major strategy to address health inequities. Five studies assessed the effects of cultural competence education for health professionals on patient-related outcomes. There was positive, albeit low-quality evidence, showing improvements in the involvement of CALD patients. Findings either showed support for the educational interventions or no evidence of effect. No studies assessed adverse outcomes. The quality of evidence is insufficient to draw generalisable conclusions, largely due to heterogeneity of the interventions in content, scope, design, duration, implementation and outcomes selected.Further research is required to establish greater methodological rigour and uniformity on core components of education interventions, including how they are described and evaluated. Our conceptual framework provides a basis for establishing consensus to improve reporting and allow assessment across studies and populations. Future studies should measure the patient outcomes used: treatment outcomes; health behaviours; involvement in care and evaluations of care. Studies should also measure the impact of these types of interventions on healthcare organisations, as these are likely to affect uptake and sustainability.
Topics: Canada; Cultural Competency; Cultural Diversity; Health Personnel; Healthcare Disparities; Humans; Minority Groups; Netherlands; Randomized Controlled Trials as Topic; United States
PubMed: 24793445
DOI: 10.1002/14651858.CD009405.pub2 -
Osteoarthritis and Cartilage Open Jun 2023Genicular artery embolization (GAE) is a novel, minimally invasive procedure for treatment of knee osteoarthritis (OA). This meta-analysis investigated the safety and... (Review)
Review
OBJECTIVE
Genicular artery embolization (GAE) is a novel, minimally invasive procedure for treatment of knee osteoarthritis (OA). This meta-analysis investigated the safety and effectiveness of this procedure.
DESIGN
Outcomes of this systematic review with meta-analysis were technical success, knee pain visual analog scale (VAS; 0-100 scale), WOMAC Total Score (0-100 scale), retreatment rate, and adverse events. Continuous outcomes were calculated as the weighted mean difference (WMD) versus baseline. Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) rates were estimated in Monte Carlo simulations. Rates of total knee replacement and repeat GAE were calculated using life-table methods.
RESULTS
In 10 groups (9 studies; 270 patients; 339 knees), GAE technical success was 99.7%. Over 12 months, the WMD ranged from -34 to -39 at each follow-up for VAS score and -28 to -34 for WOMAC Total score (all p < 0.001). At 12 months, 78% met the MCID for VAS score; 92% met the MCID for WOMAC Total score, and 78% met the SCB for WOMAC Total score. Higher baseline knee pain severity was associated with greater improvements in knee pain. Over 2 years, 5.2% of patients underwent total knee replacement and 8.3% received repeat GAE. Adverse events were minor, with transient skin discoloration as the most common (11.6%).
CONCLUSIONS
Limited evidence suggests that GAE is a safe procedure that confers improvement in knee OA symptoms at established MCID thresholds. Patients with greater knee pain severity may be more responsive to GAE.
PubMed: 36865988
DOI: 10.1016/j.ocarto.2023.100342 -
The Cochrane Database of Systematic... Apr 2016Use of topical nonsteroidal anti-inflammatory drugs (NSAIDs) to treat chronic musculoskeletal conditions has become widely accepted because they can provide pain relief... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Use of topical nonsteroidal anti-inflammatory drugs (NSAIDs) to treat chronic musculoskeletal conditions has become widely accepted because they can provide pain relief without associated systemic adverse events. This review is an update of 'Topical NSAIDs for chronic musculoskeletal pain in adults', originally published in Issue 9, 2012.
OBJECTIVES
To review the evidence from randomised, double-blind, controlled trials on the efficacy and safety of topically applied NSAIDs for chronic musculoskeletal pain in adults.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and our own in-house database; the date of the last search was February 2016. We also searched the references lists of included studies and reviews, and sought unpublished studies by asking personal contacts and searching online clinical trial registers and manufacturers' web sites.
SELECTION CRITERIA
We included randomised, double-blind, active or inert carrier (placebo) controlled trials in which treatments were administered to adults with chronic musculoskeletal pain of moderate or severe intensity. Studies had to meet stringent quality criteria and there had to be at least 10 participants in each treatment arm, with application of treatment at least once daily.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion and extracted data. We used numbers of participants achieving each outcome to calculate risk ratio and numbers needed to treat (NNT) or harm (NNH) compared to carrier or other active treatment. We were particularly interested to compare different formulations (gel, cream, plaster) of individual NSAIDs. The primary outcome was 'clinical success', defined as at least a 50% reduction in pain, or an equivalent measure such as a 'very good' or 'excellent' global assessment of treatment, or 'none' or 'slight' pain on rest or movement, measured on a categorical scale.
MAIN RESULTS
We identified five new studies for this update, which now has information from 10,631 participants in 39 studies, a 38% increase in participants from the earlier review; 33 studies compared a topical NSAID with carrier. All studies examined topical NSAIDs for treatment of osteoarthritis, and for pooled analyses studies were generally of moderate or high methodological quality, although we considered some at risk of bias from short duration and small size.In studies lasting 6 to 12 weeks, topical diclofenac and topical ketoprofen were significantly more effective than carrier for reducing pain; about 60% of participants had much reduced pain. With topical diclofenac, the NNT for clinical success in six trials (2343 participants) was 9.8 (95% confidence interval (CI) 7.1 to 16) (moderate quality evidence). With topical ketoprofen, the NNT for clinical success in four trials (2573 participants) was 6.9 (5.4 to 9.3) (moderate quality evidence). There was too little information for analysis of other individual topical NSAIDs compared with carrier. Few trials compared a topical NSAID to an oral NSAID, but overall they showed similar efficacy (low quality evidence). These efficacy results were almost completely derived from people with knee osteoarthritis.There was an increase in local adverse events (mostly mild skin reactions) with topical diclofenac compared with carrier or oral NSAIDs, but no increase with topical ketoprofen (moderate quality evidence). Reporting of systemic adverse events (such as gastrointestinal upsets) was poor, but where reported there was no difference between topical NSAID and carrier (very low quality evidence). Serious adverse events were infrequent and not different between topical NSAID and carrier (very low quality evidence).Clinical success with carrier occurred commonly - in around half the participants in studies lasting 6 to 12 weeks. Both direct and indirect comparison of clinical success with oral placebo indicates that response rates with carrier (topical placebo) are about twice those seen with oral placebo.A substantial amount of data from completed, unpublished studies was unavailable (up to 6000 participants). To the best of our knowledge, much of this probably relates to formulations that have never been marketed.
AUTHORS' CONCLUSIONS
Topical diclofenac and topical ketoprofen can provide good levels of pain relief beyond carrier in osteoarthritis for a minority of people, but there is no evidence for other chronic painful conditions. There is emerging evidence that at least some of the substantial placebo effects seen in longer duration studies derive from effects imparted by the NSAID carrier itself, and that NSAIDs add to that.
Topics: Administration, Topical; Adult; Anti-Inflammatory Agents, Non-Steroidal; Chronic Pain; Diclofenac; Humans; Ketoprofen; Musculoskeletal Pain; Numbers Needed To Treat; Randomized Controlled Trials as Topic
PubMed: 27103611
DOI: 10.1002/14651858.CD007400.pub3 -
The Cochrane Database of Systematic... Apr 2020Lumbosacral radicular pain (commonly called sciatica) is a syndrome involving patients who report radiating leg pain. Epidural corticosteroid injections deliver a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Lumbosacral radicular pain (commonly called sciatica) is a syndrome involving patients who report radiating leg pain. Epidural corticosteroid injections deliver a corticosteroid dose into the epidural space, with the aim of reducing the local inflammatory process and, consequently, relieving the symptoms of lumbosacral radicular pain. This Cochrane Review is an update of a review published in Annals of Internal Medicine in 2012. Some placebo-controlled trials have been published recently, which highlights the importance of updating the previous review.
OBJECTIVES
To investigate the efficacy and safety of epidural corticosteroid injections compared with placebo injection on pain and disability in patients with lumbosacral radicular pain.
SEARCH METHODS
We searched the following databases without language limitations up to 25 September 2019: Cochrane Back and Neck group trial register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, International Pharmaceutical Abstracts, and two trial registers. We also performed citation tracking of included studies and relevant systematic reviews in the field.
SELECTION CRITERIA
We included studies that compared epidural corticosteroid injections of any corticosteroid drug to placebo injections in patients with lumbosacral radicular pain. We accepted all three anatomical approaches (caudal, interlaminar, and transforaminal) to delivering corticosteroids into the epidural space. We considered trials that included a placebo treatment as delivery of an inert substance (i.e. one with no pharmacologic activity), an innocuous substance (e.g. normal saline solution), or a pharmacologically active substance but not one considered to provide sustained benefit (e.g. local anaesthetic), either into the epidural space (i.e. to mimic epidural corticosteroid injection) or adjacent spinal tissue (i.e. subcutaneous, intramuscular, or interspinous tissue). We also included trials in which a local anaesthetic with a short duration of action was used as a placebo and injected together with corticosteroid in the intervention group.
DATA COLLECTION AND ANALYSIS
Two authors independently performed the screening, data extraction, and 'Risk of bias' assessments. In case of insufficient information, we contacted the authors of the original studies or estimated the data. We grouped the outcome data into four time points of assessment: immediate (≤ 2 weeks), short term (> 2 weeks but ≤ 3 months), intermediate term (> 3 months but < 12 months), and long term (≥ 12 months). We assessed the overall quality of evidence for each outcome and time point using the GRADE approach.
MAIN RESULTS
We included 25 clinical trials (from 29 publications) investigating the effects of epidural corticosteroid injections compared to placebo in patients with lumbosacral radicular pain. The included studies provided data for a total of 2470 participants with a mean age ranging from 37.3 to 52.8 years. Seventeen studies included participants with lumbosacral radicular pain with a diagnosis based on clinical assessment and 15 studies included participants with mixed duration of symptoms. The included studies were conducted mainly in North America and Europe. Fifteen studies did not report funding sources, five studies reported not receiving funding, and five reported receiving funding from a non-profit or government source. Eight trials reported data on pain intensity, 12 reported data on disability, and eight studies reported data on adverse events. The duration of the follow-up assessments ranged from 12 hours to 1 year. We considered eight trials to be of high quality because we judged them as having low risk of bias in four out of the five bias domains. We identified one ongoing trial in a trial registry. Epidural corticosteroid injections were probably slightly more effective compared to placebo in reducing leg pain at short-term follow-up (mean difference (MD) -4.93, 95% confidence interval (CI) -8.77 to -1.09 on a 0 to 100 scale; 8 trials, n = 949; moderate-quality evidence (downgraded for risk of bias)). For disability, epidural corticosteroid injections were probably slightly more effective compared to placebo in reducing disability at short-term follow-up (MD -4.18, 95% CI -6.04 to -2.17, on a 0 to 100 scale; 12 trials, n = 1367; moderate-quality evidence (downgraded for risk of bias)). The treatment effects are small, however, and may not be considered clinically important by patients and clinicians (i.e. MD lower than 10%). Most trials provided insufficient information on how or when adverse events were assessed (immediate or short-term follow-up) and only reported adverse drug reactions - that is, adverse events that the trialists attributed to the study treatment. We are very uncertain that epidural corticosteroid injections make no difference compared to placebo injection in the frequency of minor adverse events (risk ratio (RR) 1.14, 95% CI 0.91 to 1.42; 8 trials, n = 877; very low quality evidence (downgraded for risk of bias, inconsistency and imprecision)). Minor adverse events included increased pain during or after the injection, non-specific headache, post-dural puncture headache, irregular periods, accidental dural puncture, thoracic pain, non-local rash, sinusitis, vasovagal response, hypotension, nausea, and tinnitus. One study reported a major drug reaction for one patient on anticoagulant therapy who had a retroperitoneal haematoma as a complication of the corticosteroid injection.
AUTHORS' CONCLUSIONS
This study found that epidural corticosteroid injections probably slightly reduced leg pain and disability at short-term follow-up in people with lumbosacral radicular pain. In addition, no minor or major adverse events were reported at short-term follow-up after epidural corticosteroid injections or placebo injection. Although the current review identified additional clinical trials, the available evidence still provides only limited support for the use of epidural corticosteroid injections in people with lumbosacral radicular pain as the treatment effects are small, mainly evident at short-term follow-up and may not be considered clinically important by patients and clinicians (i.e. mean difference lower than 10%). According to GRADE, the quality of the evidence ranged from very low to moderate, suggesting that further studies are likely to play an important role in clarifying the efficacy and tolerability of this treatment. We recommend that further trials should attend to methodological features such as appropriate allocation concealment and blinding of care providers to minimise the potential for biased estimates of treatment and harmful effects.
Topics: Adrenal Cortex Hormones; Adult; Anesthetics, Local; Humans; Injections, Epidural; Lumbosacral Region; Middle Aged; Randomized Controlled Trials as Topic; Sciatica
PubMed: 32271952
DOI: 10.1002/14651858.CD013577 -
Cardiovascular and Interventional... Jan 2021Objective To systematically review the published literature on genicular artery embolization (GAE) for osteoarthritis (OA) related knee pain. Materials and Methods Using... (Meta-Analysis)
Meta-Analysis
Objective To systematically review the published literature on genicular artery embolization (GAE) for osteoarthritis (OA) related knee pain. Materials and Methods Using three databases, a systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Outcome measures included the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results Three single-arm studies were included from an initial search yielding 305 results. One hundred and eighty-six knees in 133 patients with either mild-to-moderate (174/186, 94%) or severe (12/186, 6%) OA underwent embolization with either imipenem/cilastatin sodium (159/186, 85%) or embozene (27/186, 15%). Technical success was 100%. Average VAS improved from baseline at 1 day, 1 week, 1 month, 3 months, 4 months, 6 months, 1 year and 2 years (66.5 at baseline vs 33.5, 32.7, 33.8, 28.9, 29.0, 22.3, 14.8 and 14.0, respectively). Average WOMAC scores improved from baseline at 1, 3, 4, 6, 12 and 24 months (45.7 at baseline vs 24.0, 31.0, 14.8, 14.6, 8.2 and 6.2). Severe OA in 12 cases showed initially improved VAS, but was not sustained. Minor adverse events such as erythema in the region of embolization (21/186, 11%), puncture-site hematoma (18/186, 10%), paresthesia (2/186, 1%) and fever (1/186, 0.5%) were reported. Conclusion Limited single-arm studies report GAE is promising for treating OA-related pain. Most treatments performed for mild-to-moderate OA demonstrated durable clinical responses from 6 months to 4 years. Limited data for severe OA suggest a non-durable response. Future studies should be standardized to facilitate comparison and control for placebo effect.
Topics: Arthralgia; Embolization, Therapeutic; Humans; Leg; Osteoarthritis, Knee; Pain Management; Pain Measurement; Treatment Outcome
PubMed: 33135117
DOI: 10.1007/s00270-020-02687-z -
ERJ Open Research Jul 2023Biologics have proven efficacy for patients with severe asthma but there is lack of consensus on defining response. We systematically reviewed and appraised... (Review)
Review
BACKGROUND
Biologics have proven efficacy for patients with severe asthma but there is lack of consensus on defining response. We systematically reviewed and appraised methodologically developed, defined and evaluated definitions of non-response and response to biologics for severe asthma.
METHODS
We searched four bibliographic databases from inception to 15 March 2021 Two reviewers screened references, extracted data, and assessed methodological quality of development, measurement properties of outcome measures and definitions of response based on COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). A modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach and narrative synthesis were undertaken.
RESULTS
13 studies reported three composite outcome measures, three asthma symptoms measures, one asthma control measure and one quality of life measure. Only four measures were developed with patient input; none were composite measures. Studies utilised 17 definitions of response: 10 out of 17 (58.8%) were based on minimal clinically important difference (MCID) or minimal important difference (MID) and 16 out of 17 (94.1%) had high-quality evidence. Results were limited by poor methodology for the development process and incomplete reporting of psychometric properties. Most measures rated "very low" to "low" for quality of measurement properties and none met all quality standards.
CONCLUSIONS
This is the first review to synthesise evidence about definitions of response to biologics for severe asthma. While high-quality definitions are available, most are MCIDs or MIDs, which may be insufficient to justify continuation of biologics in terms of cost-effectiveness. There remains an unmet need for universally accepted, patient-centred, composite definitions to aid clinical decision making and comparability of responses to biologics.
PubMed: 37143849
DOI: 10.1183/23120541.00444-2022 -
The European Respiratory Journal Jan 2021Use of electronic cigarettes (e-cigarettes) is prevalent among adolescents and young adults, but there has been limited knowledge about health consequences in human... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Use of electronic cigarettes (e-cigarettes) is prevalent among adolescents and young adults, but there has been limited knowledge about health consequences in human populations. We conduct a systematic review and meta-analysis of results on respiratory disorders from studies of general-population samples and consider the mapping of these results to findings about biological processes linked to e-cigarettes in controlled laboratory studies.
METHOD
We conducted a literature search and meta-analysis of epidemiological studies on the association of e-cigarette use with asthma and with COPD. We discuss findings from laboratory studies about effects of e-cigarettes on four biological processes: cytotoxicity, oxidative stress/inflammation, susceptibility to infection and genetic expression.
RESULTS
Epidemiological studies, both cross-sectional and longitudinal, show a significant association of e-cigarette use with asthma and COPD, controlling for cigarette smoking and other covariates. For asthma (n=15 studies), the pooled adjusted odds ratio (aOR) was 1.39 (95% CI 1.28-1.51); for COPD (n=9 studies) the aOR was 1.49 (95% CI 1.36-1.65). Laboratory studies consistently show an effect of e-cigarettes on biological processes related to respiratory harm and susceptibility to illness, with e-cigarette conditions differing significantly from clean-air controls, although sometimes less than for cigarettes.
CONCLUSIONS
The evidence from epidemiological studies meets established criteria for consistency, strength of effect, temporality, and in some cases a dose-response gradient. Biological plausibility is indicated by evidence from multiple laboratory studies. We conclude that e-cigarette use has consequences for asthma and COPD, which is of concern for respirology and public health.
Topics: Adolescent; Cross-Sectional Studies; Electronic Nicotine Delivery Systems; Humans; Laboratories; Tobacco Products; Vaping; Young Adult
PubMed: 33154031
DOI: 10.1183/13993003.01815-2019 -
The Cochrane Database of Systematic... Aug 2022Acute pulmonary embolism (APE) is a major cause of acute morbidity and mortality. APE results in long-term morbidity in up to 50% of survivors, known as post-pulmonary... (Review)
Review
BACKGROUND
Acute pulmonary embolism (APE) is a major cause of acute morbidity and mortality. APE results in long-term morbidity in up to 50% of survivors, known as post-pulmonary embolism (post-PE) syndrome. APE can be classified according to the short-term (30-day) risk of mortality, based on a variety of clinical, imaging and laboratory findings. Most mortality and morbidity is concentrated in high-risk (massive) and intermediate-risk (submassive) APE. The first-line treatment for APE is systemic anticoagulation. High-risk (massive) APE accounts for less than 10% of APE cases and is a life-threatening medical emergency, requiring immediate reperfusion treatment to prevent death. Systemic thrombolysis is the recommended treatment for high-risk (massive) APE. However, only a minority of the people affected receive systemic thrombolysis, due to comorbidities or the 10% risk of major haemorrhagic side effects. Of those who do receive systemic thrombolysis, 8% do not respond in a timely manner. Surgical pulmonary embolectomy is an alternative reperfusion treatment, but is not widely available. Intermediate-risk (submassive) APE represents 45% to 65% of APE cases, with a short-term mortality rate of around 3%. Systemic thrombolysis is not recommended for this group, as major haemorrhagic complications outweigh the benefit. However, the people at higher risk within this group have a short-term mortality of around 12%, suggesting that anticoagulation alone is not an adequate treatment. Identification and more aggressive treatment of people at intermediate to high risk, who have a more favourable risk profile for reperfusion treatments, could reduce short-term mortality and potentially reduce post-PE syndrome. Catheter-directed treatments (catheter-directed thrombolysis and catheter embolectomy) are minimally invasive reperfusion treatments for high- and intermediate-risk APE. Catheter-directed treatments can be used either as the primary treatment or as salvage treatment after failure of systemic thrombolysis. Catheter-directed thrombolysis administers 10% to 20% of the systemic thrombolysis dose directly into the thrombus in the lungs, potentially reducing the risks of haemorrhagic side effects. Catheter embolectomy mechanically removes the thrombus without the need for thrombolysis, and may be useful for people with contraindications for thrombolysis. Currently, the benefits of catheter-based APE treatments compared with existing medical and surgical treatment are unclear despite increasing adoption of catheter treatments by PE response teams. This review examines the evidence for the use of catheter-directed treatments in high- and intermediate-risk APE. This evidence could help guide the optimal treatment strategy for people affected by this common and life-threatening condition.
OBJECTIVES
To assess the effects of catheter-directed therapies versus alternative treatments for high-risk (massive) and intermediate-risk (submassive) APE.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search was 15 March 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of catheter-directed therapies for the treatment of high-risk (massive) and intermediate-risk (submassive) APE. We excluded catheter-directed treatments for non-PE. We applied no restrictions on participant age or on the date, language or publication status of RCTs.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. The main outcomes were all-cause mortality, treatment-associated major and minor haemorrhage rates based on two established clinical definitions, recurrent APE requiring retreatment or change to a different APE treatment, length of hospital stay, and quality of life. We used GRADE to assess certainty of evidence for each outcome.
MAIN RESULTS
We identified one RCT (59 participants) of (ultrasound-augmented) catheter-directed thrombolysis for intermediate-risk (submassive) APE. We found no trials of any catheter-directed treatments (thrombectomy or thrombolysis) in people with high-risk (massive) APE or of catheter-based embolectomy in people with intermediate-risk (submassive) APE. The included trial compared ultrasound-augmented catheter-directed thrombolysis with alteplase and systemic heparinisation versus systemic heparinisation alone. In the treatment group, each participant received an infusion of alteplase 10 mg or 20 mg over 15 hours. We identified a high risk of selection and performance bias, low risk of detection and reporting bias, and unclear risk of attrition and other bias. Certainty of evidence was very low because of risk of bias and imprecision. By 90 days, there was no clear difference in all-cause mortality between the treatment group and control group. A single death occurred in the control group at 20 days after randomisation, but it was unrelated to the treatment or to APE (odds ratio (OR) 0.31, 95% confidence interval (CI) 0.01 to 7.96; 59 participants). By 90 days, there were no episodes of treatment-associated major haemorrhage in either the treatment or control group. There was no clear difference in treatment-associated minor haemorrhage between the treatment and control group by 90 days (OR 3.11, 95% CI 0.30 to 31.79; 59 participants). By 90 days, there were no episodes of recurrent APE requiring retreatment or change to a different APE treatment in the treatment or control group. There was no clear difference in the length of mean total hospital stay between the treatment and control groups. Mean stay was 8.9 (standard deviation (SD) 3.4) days in the treatment group versus 8.6 (SD 3.9) days in the control group (mean difference 0.30, 95% CI -1.57 to 2.17; 59 participants). The included trial did not investigate quality of life measures. AUTHORS' CONCLUSIONS: There is a lack of evidence to support widespread adoption of catheter-based interventional therapies for APE. We identified one small trial showing no clear differences between ultrasound-augmented catheter-directed thrombolysis with alteplase plus systemic heparinisation versus systemic heparinisation alone in all-cause mortality, major and minor haemorrhage rates, recurrent APE and length of hospital stay. Quality of life was not assessed. Multiple small retrospective case series, prospective patient registries and single-arm studies suggest potential benefits of catheter-based treatments, but they provide insufficient evidence to recommend this approach over other evidence-based treatments. Researchers should consider clinically relevant primary outcomes (e.g. mortality and exercise tolerance), rather than surrogate markers (e.g. right ventricular to left ventricular (RV:LV) ratio or thrombus burden), which have limited clinical utility. Trials must include a control group to determine if the effects are specific to the treatment.
Topics: Acute Disease; Anticoagulants; Hemorrhage; Humans; Pulmonary Embolism; Thrombolytic Therapy; Tissue Plasminogen Activator
PubMed: 35938605
DOI: 10.1002/14651858.CD013083.pub2 -
The Cochrane Database of Systematic... Mar 2020Ulcerative colitis is an inflammatory condition affecting the colon, with an annual incidence of approximately 10 to 20 per 100,000 people. The majority of people with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Ulcerative colitis is an inflammatory condition affecting the colon, with an annual incidence of approximately 10 to 20 per 100,000 people. The majority of people with ulcerative colitis can be put into remission, leaving a group who do not respond to first- or second-line therapies. There is a significant proportion of people who experience adverse effects with current therapies. Consequently, new alternatives for the treatment of ulcerative colitis are constantly being sought. Probiotics are live microbial feed supplements that may beneficially affect the host by improving intestinal microbial balance, enhancing gut barrier function and improving local immune response.
OBJECTIVES
To assess the efficacy of probiotics compared with placebo or standard medical treatment (5-aminosalicylates, sulphasalazine or corticosteroids) for the induction of remission in people with active ulcerative colitis.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, and two other databases on 31 October 2019. We contacted authors of relevant studies and manufacturers of probiotics regarding ongoing or unpublished trials that may be relevant to the review, and we searched ClinicalTrials.gov. We also searched references of trials for any additional trials.
SELECTION CRITERIA
Randomised controlled trials (RCTs) investigating the effectiveness of probiotics compared to standard treatments or placebo in the induction of remission of active ulcerative colitis. We considered both adults and children, with studies reporting outcomes of clinical, endoscopic, histologic or surgical remission as defined by study authors DATA COLLECTION AND ANALYSIS: Two review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We analysed data using Review Manager 5. We expressed dichotomous and continuous outcomes as risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE methodology.
MAIN RESULTS
In this review, we included 14 studies (865 randomised participants) that met the inclusion criteria. Twelve of the studies looked at adult participants and two studies looked at paediatric participants with mild to moderate ulcerative colitis, the average age was between 12.5 and 47.7 years. The studies compared probiotics to placebo, probiotics to 5-ASA and a combination of probiotics plus 5-ASA compared to 5-ASA alone. Seven studies used a single probiotic strain and seven used a mixture of strains. The studies ranged from two weeks to 52 weeks. The risk of bias was high for all except two studies due to allocation concealment, blinding of participants, incomplete reports of outcome data and selective reporting. This led to GRADE ratings of the evidence ranging from moderate to very low. Probiotics versus placebo Probiotics may induce clinical remission when compared to placebo (RR 1.73, 95% CI 1.19 to 2.54; 9 studies, 594 participants; low-certainty evidence; downgraded due to imprecision and risk of bias, number needed to treat for an additional beneficial outcome (NNTB) 5). Probiotics may lead to an improvement in clinical disease scores (RR 2.29, 95% CI 1.13 to 4.63; 2 studies, 54 participants; downgraded due to risk of bias and imprecision). There may be little or no difference in minor adverse events, but the evidence is of very low certainty (RR 1.04, 95% CI 0.42 to 2.59; 7 studies, 520 participants). Reported adverse events included abdominal bloating and discomfort. Probiotics did not lead to any serious adverse events in any of the seven studies that reported on it, however five adverse events were reported in the placebo arm of one study (RR 0.09, CI 0.01 to 1.66; 1 study, 526 participants; very low-certainty evidence; downgraded due to high risk of bias and imprecision). Probiotics may make little or no difference to withdrawals due to adverse events (RR 0.85, 95% CI 0.42 to 1.72; 4 studies, 401 participants; low-certainty evidence). Probiotics versus 5-ASA There may be little or no difference in the induction of remission with probiotics when compared to 5-ASA (RR 0.92, 95% CI 0.73 to 1.16; 1 study, 116 participants; low-certainty evidence; downgraded due to risk of bias and imprecision). There may be little or no difference in minor adverse events, but the evidence is of very low certainty (RR 1.33, 95% CI 0.53 to 3.33; 1 study, 116 participants). Reported adverse events included abdominal pain, nausea, headache and mouth ulcers. There were no serious adverse events with probiotics, however perforated sigmoid diverticulum and respiratory failure in a patient with severe emphysema were reported in the 5-ASA arm (RR 0.21, 95% CI 0.01 to 4.22; 1 study, 116 participants; very low-certainty evidence). Probiotics combined with 5-ASA versus 5-ASA alone Low-certainty evidence from a single study shows that when combined with 5-ASA, probiotics may slightly improve the induction of remission (based on the Sunderland disease activity index) compared to 5-ASA alone (RR 1.22 CI 1.01 to 1.47; 1 study, 84 participants; low-certainty evidence; downgraded due to unclear risk of bias and imprecision). No information about adverse events was reported. Time to remission, histological and biochemical outcomes were sparsely reported in the studies. None of the other secondary outcomes (progression to surgery, need for additional therapy, quality of life scores, or steroid withdrawal) were reported in any of the studies.
AUTHORS' CONCLUSIONS
Low-certainty evidence suggests that probiotics may induce clinical remission in active ulcerative colitis when compared to placebo. There may be little or no difference in clinical remission with probiotics alone compared to 5-ASA. There is limited evidence from a single study which failed to provide a definition of remission, that probiotics may slightly improve the induction of remission when used in combination with 5-ASA. There was no evidence to assess whether probiotics are effective in people with severe and more extensive disease, or if specific preparations are superior to others. Further targeted and appropriately designed RCTs are needed to address the gaps in the evidence base. In particular, appropriate powering of studies and the use of standardised participant groups and outcome measures in line with the wider field are needed, as well as reporting to minimise risk of bias.
Topics: Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Bias; Child; Colitis, Ulcerative; Combined Modality Therapy; Humans; Mesalamine; Middle Aged; Numbers Needed To Treat; Probiotics; Randomized Controlled Trials as Topic; Remission Induction; Sample Size; Sulfasalazine
PubMed: 32128795
DOI: 10.1002/14651858.CD005573.pub3 -
JAMA Network Open Dec 2023Prosocial interventions encourage voluntary actions that benefit others. Community solidarity in response to the COVID-19 pandemic, expanding mutual aid programs, and... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Prosocial interventions encourage voluntary actions that benefit others. Community solidarity in response to the COVID-19 pandemic, expanding mutual aid programs, and health workforce issues have accelerated prosocial health interventions.
OBJECTIVE
To investigate the association of prosocial interventions with health outcomes in clinical trials and observational studies.
DATA SOURCES
In this systematic review and meta-analysis informed by the Cochrane Handbook for Systematic Reviews of Interventions, 5 databases (MEDLINE [via PubMed], Embase, CINAHL, PsycInfo, and Scopus) were searched from database inception through February 23, 2023. The search included terms for altruism and prosocial behaviors, health outcomes, and study type.
STUDY SELECTION
Included studies, determined by multiple reviewers, compared health outcomes in a prosocial intervention group with a nonintervention group.
DATA EXTRACTION AND SYNTHESIS
Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline, data extraction and synthesis captured quantitative and qualitative data. To pool data from quantitative studies, random-effects meta-analyses were used to estimate the impact of prosocial interventions. To combine data from quantitative and qualitive studies, data were transformed into qualitative narratives using meta-aggregation.
MAIN OUTCOMES AND MEASURES
The main outcome was whether prosocial interventions were associated with improved health outcomes. Barriers to and facilitators of implementation of these interventions were assessed.
RESULTS
The search identified 5229 citations; 30 studies were included in the synthesis. Studies indicated that prosocial interventions were associated with positive health outcomes for givers (17 studies [56.7]) and recipients (8 [26.7%]). Prosocial interventions included acts of kindness (12 studies [40.0%]), cash gifts (7 [23.3%]), pay-it-forward approaches (6 [20.0%]), and expressions of kindness (5 [16.7%]). Improvements were reported in depression, testing for sexually transmitted diseases, vaccine uptake, physical activity, and individual biomarkers. Data from 6 studies (20.0%) demonstrated that pay-it-forward approaches were associated with increased uptake of diagnostic tests or vaccines among vulnerable groups (moderate certainty of evidence). Data from 14 studies (46.7%) suggested that community connectedness facilitated prosocial interventions. Shared vulnerabilities among groups (eg, sexual minority individuals, older adults) may provide a context for collective mobilization to improve health in local communities.
CONCLUSIONS AND RELEVANCE
This systematic review and meta-analysis found that prosocial interventions were associated with improved health outcomes among vulnerable groups and have been useful for addressing health disparities. Further research is needed to develop and evaluate prosocial interventions.
Topics: Humans; Aged; Pandemics; COVID-19
PubMed: 38064214
DOI: 10.1001/jamanetworkopen.2023.46789