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The Lancet. Gastroenterology &... May 2017Acute upper gastrointestinal bleeding is a leading indication for red blood cell (RBC) transfusion worldwide, although optimal thresholds for transfusion are debated. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Acute upper gastrointestinal bleeding is a leading indication for red blood cell (RBC) transfusion worldwide, although optimal thresholds for transfusion are debated.
METHODS
We searched MEDLINE, Embase, CENTRAL, CINAHL, and the Transfusion Evidence Library from inception to Oct 20, 2016, for randomised controlled trials comparing restrictive and liberal RBC transfusion strategies for acute upper gastrointestinal bleeding. Main outcomes were mortality, rebleeding, ischaemic events, and mean RBC transfusion. We computed pooled estimates for each outcome by random effects meta-analysis, and individual participant data for a cluster randomised trial were re-analysed to facilitate meta-analysis. We compared treatment effects between patient subgroups, including patients with liver cirrhosis, patients with non-variceal upper gastrointestinal bleeding, and patients with ischaemic heart disease at baseline.
FINDINGS
We included four published and one unpublished randomised controlled trial, totalling 1965 participants. The number of RBC units transfused was lower in the restrictive transfusion group than in the liberal transfusion group (mean difference -1·73 units, 95% CI -2·36 to -1·11, p<0·0001). Restrictive transfusion was associated with lower risk of all-cause mortality (relative risk [RR] 0·65, 95% CI 0·44-0·97, p=0·03) and rebleeding overall (0·58, 0·40-0·84, p=0·004). We detected no difference in risk of ischaemic events. There were no statistically significant differences in the subgroups.
INTERPRETATION
These results support more widespread implementation of restrictive transfusion policies for adults with acute upper gastrointestinal bleeding.
FUNDING
None.
Topics: Acute Disease; Erythrocyte Transfusion; Gastrointestinal Hemorrhage; Humans; Ischemia; Liver Cirrhosis; Myocardial Ischemia; Randomized Controlled Trials as Topic; Recurrence
PubMed: 28397699
DOI: 10.1016/S2468-1253(17)30054-7 -
Paediatrics and International Child... Nov 2018Background Pneumonia is the most common cause of death in children worldwide, accounting for 15% of all deaths of children under 5 years of age. This review summarises...
Background Pneumonia is the most common cause of death in children worldwide, accounting for 15% of all deaths of children under 5 years of age. This review summarises the evidence for the empirical antibiotic treatment of community-acquired pneumonia in neonates and children and puts emphasis on publications since the release of the previous WHO Evidence Summary report published in 2014. Methods A systematic search for systematic reviews and meta-analyses of antibiotic therapy for community-acquired pneumonia was conducted between 1 January 2013 and 10 November 2016. Results The optimal dosing recommendation for amoxicillin remains unclear with limited pharmacological and clinical evidence. There is limited evidence from surveillance to indicate whether amoxicillin or broader spectrum antibiotics (e.g. third-generation cephalosporins) are being used most commonly for paediatric CAP in different WHO regions. Data are lacking on clinical efficacy in the context of pneumococcal, staphylococcal and mycoplasma disease and the relative contributions of varying first-line and step-down options to the selection of such resistance. Conclusion Further pragmatic trials are required to optimise management of hospitalised children with severe and very severe pneumonia.
Topics: Adolescent; Amoxicillin; Anti-Bacterial Agents; Cephalosporins; Child; Child, Preschool; Community-Acquired Infections; Guidelines as Topic; Humans; Infant; Infant, Newborn; Pneumonia, Bacterial; World Health Organization
PubMed: 29790844
DOI: 10.1080/20469047.2017.1409455 -
Journal of the American Academy of... Oct 2021Actinic keratoses (AK) are rough scaly patches that arise on chronically ultraviolet-exposed skin and can progress to keratinocyte carcinoma.
BACKGROUND
Actinic keratoses (AK) are rough scaly patches that arise on chronically ultraviolet-exposed skin and can progress to keratinocyte carcinoma.
OBJECTIVE
This analysis examined the literature related to the management of AK to provide evidence-based recommendations for treatment. Grading, histologic classification, natural history, risk of progression, and dermatologic surveillance of AKs are also discussed.
METHODS
A multidisciplinary Work Group conducted a systematic review to address 5 clinical questions on the management of AKs and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of the evidence and formulating and grading clinical recommendations. Graded recommendations were voted on to achieve consensus.
RESULTS
Analysis of the evidence resulted in 18 recommendations.
LIMITATIONS
This analysis is based on the best available evidence at the time it was conducted. The pragmatic decision to limit the literature review to English language randomized trials may have excluded data published in other languages or limited identification of relevant long-term follow-up data.
CONCLUSIONS
Strong recommendations are made for using ultraviolet protection, topical imiquimod, topical 5-fluorouracil, and cryosurgery. Conditional recommendations are made for the use of photodynamic therapy and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens.
Topics: Diclofenac; Fluorouracil; Humans; Imiquimod; Keratosis, Actinic; Photochemotherapy
PubMed: 33820677
DOI: 10.1016/j.jaad.2021.02.082 -
CNS Drugs May 2021Long-acting injectable (LAI) antipsychotics, compared with oral antipsychotics (OA), have been found to significantly improve patient outcomes, including reduced... (Comparative Study)
Comparative Study Meta-Analysis
Real-World Evidence of the Clinical and Economic Impact of Long-Acting Injectable Versus Oral Antipsychotics Among Patients with Schizophrenia in the United States: A Systematic Review and Meta-Analysis.
BACKGROUND
Long-acting injectable (LAI) antipsychotics, compared with oral antipsychotics (OA), have been found to significantly improve patient outcomes, including reduced hospitalizations and emergency room (ER) admissions and increased medication adherence among adult patients with schizophrenia. In turn, the clinical benefits achieved may translate into lower economic burden. Real-world evidence of the comparative effectiveness of LAI is needed to understand the potential benefits of LAI outside of the context of clinical trials. This study aimed to provide a comprehensive synthesis of recent published real-world studies comparing healthcare utilization, costs, and adherence between patients with schizophrenia treated with LAI versus OA in the United States.
METHODS
In this systematic literature review, MEDLINE was searched for peer-reviewed, real-world studies (i.e., retrospective or pragmatic designs) published in English between January 1, 2010 and February 10, 2020. Comparative studies reporting hospitalizations, ER admissions, healthcare costs, or medication adherence (measured by proportion of days covered [PDC]) in adults with schizophrenia treated with LAI versus OA (or pre- vs post-LAI initiation) in the United States were retained. Random effects meta-analyses were conducted among eligible studies to evaluate the association of LAI versus OA use on hospitalizations, ER admissions, healthcare costs, and treatment adherence. A sensitivity analysis among the subset of studies that compared OA with paliperidone palmitate once monthly (PP1M), specifically, was conducted.
RESULTS
A total of 1083 articles were identified by the electronic literature search, and two publications were manually added subsequently. Among the 57 publications meeting the inclusion criteria, 25 provided sufficient information for inclusion in the meta-analyses. Compared with patients treated with OA, patients initiated on LAI had lower odds of hospitalization (odds ratio [OR] 0.62, 95% confidence interval [CI] 0.54-0.71, n = 7), fewer hospitalizations (incidence rate ratio [IRR] [95% CI] 0.75 [0.65-0.88], n = 9), and fewer ER admissions (IRR [95% CI] 0.86 [0.77-0.97], n = 6). The initiation of LAI was associated with higher per-patient-per-year (PPPY) pharmacy costs (mean difference [MD] [95% CI] $5603 [3799-7407], n = 6), which was offset by lower PPPY medical costs (MD [95% CI] - $5404 [- 7745 to - 3064], n = 6), resulting in no significant net difference in PPPY total all-cause healthcare costs between patients treated with LAI and those treated with OA (MD [95% CI] $327 [- 1565 to 2219], n = 7). Patients initiated on LAI also had higher odds of being adherent to their medication (PDC ≥ 80%; OR [95% CI] 1.89 [1.52-2.35], n = 9). A sensitivity analysis on a subset of publications evaluating PP1M found results similar to those of the main analysis conducted at the LAI class level.
CONCLUSIONS
Based on multiple studies with varying sub-types of patient populations with schizophrenia in the United States published in the last decade, this meta-analysis demonstrated that LAI antipsychotics were associated with improved medication adherence and significant clinical benefit such as reduced hospitalizations and ER admissions compared with OA. The lower medical costs offset the higher pharmacy costs, resulting in a non-significant difference in total healthcare costs. Taken together, these findings provide strong evidence on the clinical and economic benefits of LAI compared with OA for the treatment of schizophrenia in the real world.
Topics: Antipsychotic Agents; Delayed-Action Preparations; Emergency Service, Hospital; Health Care Costs; Hospitalization; Humans; Injections; Medication Adherence; Schizophrenia; United States
PubMed: 33909272
DOI: 10.1007/s40263-021-00815-y -
Health Technology Assessment... Mar 2023We aimed to compare the clinical effectiveness, cost-effectiveness and complication rates of total ankle replacement with those of arthrodesis (i.e. ankle fusion) in the...
BACKGROUND
We aimed to compare the clinical effectiveness, cost-effectiveness and complication rates of total ankle replacement with those of arthrodesis (i.e. ankle fusion) in the treatment of end-stage ankle osteoarthritis.
METHODS
This was a pragmatic, multicentre, parallel-group, non-blinded randomised controlled trial. Patients with end-stage ankle osteoarthritis who were aged 50-85 years and were suitable for both procedures were recruited from 17 UK hospitals and randomised using minimisation. The primary outcome was the change in the Manchester-Oxford Foot Questionnaire walking/standing domain scores between the preoperative baseline and 52 weeks post surgery.
RESULTS
Between March 2015 and January 2019, 303 participants were randomised using a minimisation algorithm: 152 to total ankle replacement and 151 to ankle fusion. At 52 weeks, the mean (standard deviation) Manchester-Oxford Foot Questionnaire walking/standing domain score was 31.4 (30.4) in the total ankle replacement arm ( = 136) and 36.8 (30.6) in the ankle fusion arm ( = 140); the adjusted difference in the change was -5.6 (95% confidence interval -12.5 to 1.4; = 0.12) in the intention-to-treat analysis. By week 52, one patient in the total ankle replacement arm required revision. Rates of wound-healing issues (13.4% vs. 5.7%) and nerve injuries (4.2% vs. < 1%) were higher and the rate of thromboembolic events was lower (2.9% vs. 4.9%) in the total ankle replacement arm than in the ankle fusion arm. The bone non-union rate (based on plain radiographs) in the ankle fusion arm was 12.1%, but only 7.1% of patients had symptoms. A post hoc analysis of fixed-bearing total ankle replacement showed a statistically significant improvement over ankle fusion in Manchester-Oxford Foot Questionnaire walking/standing domain score (-11.1, 95% confidence interval -19.3 to -2.9; = 0.008). We estimate a 69% likelihood that total ankle replacement is cost-effective compared with ankle fusion at the National Institute for Health and Care Excellence's cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained over the patient's lifetime.
LIMITATIONS
This initial report contains only 52-week data, which must therefore be interpreted with caution. In addition, the pragmatic nature of the study means that there was heterogeneity between surgical implants and techniques. The trial was run across 17 NHS centres to ensure that decision-making streams reflected the standard of care in the NHS as closely as possible.
CONCLUSIONS
Both total ankle replacement and ankle fusion improved patients' quality of life at 1 year, and both appear to be safe. When total ankle replacement was compared with ankle fusion overall, we were unable to show a statistically significant difference between the two arms in terms of our primary outcome measure. The total ankle replacement versus ankle arthrodesis (TARVA) trial is inconclusive in terms of superiority of total ankle replacement, as the 95% confidence interval for the adjusted treatment effect includes both a difference of zero and the minimal important difference of 12, but it can rule out the superiority of ankle fusion. A post hoc analysis comparing fixed-bearing total ankle replacement with ankle fusion showed a statistically significant improvement of total ankle replacement over ankle fusion in Manchester-Oxford Foot Questionnaire walking/standing domain score. Total ankle replacement appears to be cost-effective compared with ankle fusion at the National Institute for Health and Care Excellence's cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained over a patient's lifetime based on long-term economic modelling.
FUTURE WORK
We recommend long-term follow-up of this important cohort, in particular radiological and clinical progress. We also recommend studies to explore the sensitivity of clinical scores to detect clinically important differences between arms when both have already achieved a significant improvement from baseline.
TRIAL REGISTRATION
This trial is registered as ISRCTN60672307 and ClinicalTrials.gov NCT02128555.
FUNDING
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 27, No. 5. See the NIHR Journals Library website for further project information.
Topics: Humans; Arthroplasty, Replacement, Ankle; Ankle; Quality of Life; Osteoarthritis; Cost-Benefit Analysis; Arthrodesis; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 37022932
DOI: 10.3310/PTYJ1146 -
The Cochrane Database of Systematic... May 2021The World Health Organization (WHO) recommends that people of all ages take regular and adequate physical activity. If unable to meet the recommendations due to health...
BACKGROUND
The World Health Organization (WHO) recommends that people of all ages take regular and adequate physical activity. If unable to meet the recommendations due to health conditions, international guidance advises being as physically active as possible. Evidence from community interventions of physical activity indicate that people living with medical conditions are sometimes excluded from participation in studies. In this review, we considered the effects of activity-promoting interventions on physical activity and well-being in studies, as well as any adverse events experienced by participants living with inherited or acquired neuromuscular diseases (NMDs). OBJECTIVES: To assess the effects of interventions designed to promote physical activity in people with NMD compared with no intervention or alternative interventions.
SEARCH METHODS
On 30 April 2020, we searched Cochrane Neuromuscular Specialised Register, CENTRAL, Embase, MEDLINE, and ClinicalTrials.Gov. WHO ICTRP was not accessible at the time.
SELECTION CRITERIA
We considered randomised or quasi-randomised trials, including cross-over trials, of interventions designed to promote physical activity in people with NMD compared to no intervention or alternative interventions. We specifically included studies that reported physical activity as an outcome measure. Our main focus was studies in which promoting physical activity was a stated aim but we also included studies in which physical activity was assessed as a secondary or exploratory outcome.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane procedures.
MAIN RESULTS
The review included 13 studies (795 randomised participants from 12 studies; number of participants unclear in one study) of different interventions to promote physical activity. Most studies randomised a minority of invited participants. No study involved children or adolescents and nine studies reported minimal entry criteria for walking. Participants had one of nine inherited or acquired NMDs. Types of intervention included structured physical activity support, exercise support (as a specific form of physical activity), and behaviour change support that included physical activity or exercise. Only one included study clearly reported that the aim of intervention was to increase physical activity. Other studies reported or planned to analyse the effects of intervention on physical activity as a secondary or exploratory outcome measure. Six studies did not report results for physical activity outcomes, or the data were not usable. We judged 10 of the 13 included studies at high or unclear risk of bias from incomplete physical activity outcome reporting. We did not perform a meta-analysis for any comparison because of differences in interventions and in usual care. We also found considerable variation in how studies reported physical activity as an outcome measure. The studies that reported physical activity measurement did not always clearly report intention-to-treat (ITT) analysis or whether final assessments occurred during or after intervention. Based on prespecified measures, we included three comparisons in our summary of findings. A physical activity programme (weight-bearing) compared to no physical activity programme One study involved adults with diabetic peripheral neuropathy (DPN) and reported weekly duration of walking during and at the end of a one-year intervention using a StepWatch ankle accelerometer. Based on the point estimate and low-certainty evidence, intervention may have led to an important increase in physical activity per week; however, the 95% confidence interval (CI) included the possibility of no difference or an effect in either direction at three months (mean difference (MD) 34 minutes per week, 95% CI -92.19 to 160.19; 69 participants), six months (MD 68 minutes per week, 95% CI -55.35 to 191.35; 74 participants), and 12 months (MD 49 minutes per week, 95% CI -75.73 to 173.73; 70 participants). Study-reported effect estimates for foot lesions and full-thickness ulcers also included the possibility of no difference, a higher, or lower risk with intervention. A sensor-based, interactive exercise programme compared to no sensor-based, interactive exercise programme One study involved adults with DPN and reported duration of walking over 48 hours at the end of four weeks' intervention using a t-shirt embedded PAMSys sensor. It was not possible to draw conclusions about the effectiveness of the intervention from the very low-certainty evidence (MD -0.64 hours per 48 hours, 95% CI -2.42 to 1.13; 25 participants). We were also unable to draw conclusions about impact on the Physical Component Score (PCS) for quality of life (MD 0.24 points, 95% CI -5.98 to 6.46; 35 participants; very low-certainty evidence), although intervention may have made little or no difference to the Mental Component Score (MCS) for quality of life (MD 5.10 points, 95% CI -0.58 to 10.78; 35 participants; low-certainty evidence). A functional exercise programme compared to a stretching exercise programme One study involved adults with spinal and bulbar muscular atrophy and reported a daily physical activity count at the end of 12 weeks' intervention using an Actical accelerometer. It was not possible to draw conclusions about the effectiveness of either intervention (requiring compliance) due to low-certainty evidence and unconfirmed measurement units (MD -8701, 95% CI -38,293.30 to 20,891.30; 43 participants). Functional exercise may have made little or no difference to quality of life compared to stretching (PCS: MD -1.10 points, 95% CI -5.22 to 3.02; MCS: MD -1.10 points, 95% CI -6.79 to 4.59; 49 participants; low-certainty evidence). Although studies reported adverse events incompletely, we found no evidence of supported activity increasing the risk of serious adverse events.
AUTHORS' CONCLUSIONS
We found a lack of evidence relating to children, adolescents, and non-ambulant people of any age. Many people living with NMD did not meet randomised controlled trial eligibility criteria. There was variation in the components of supported activity intervention and usual care, such as physical therapy provision. We identified variation among studies in how physical activity was monitored, analysed, and reported. We remain uncertain of the effectiveness of promotional intervention for physical activity and its impact on quality of life and adverse events. More information is needed on the ITT population, as well as more complete reporting of outcomes. While there may be no single objective measure of physical activity, the study of qualitative and dichotomous change in self-reported overall physical activity might offer a pragmatic approach to capturing important change at an individual and population level.
Topics: Bias; Exercise; Health Promotion; Humans; Muscle Stretching Exercises; Neuromuscular Diseases; Outcome Assessment, Health Care; Quality of Life; Randomized Controlled Trials as Topic; Resistance Training; Time Factors; Walking
PubMed: 34027632
DOI: 10.1002/14651858.CD013544.pub2 -
The Cochrane Database of Systematic... Jun 2019Inhaled corticosteroids (ICS) are the most effective treatment for children with persistent asthma. Although treatment with ICS is generally considered to be safe in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Inhaled corticosteroids (ICS) are the most effective treatment for children with persistent asthma. Although treatment with ICS is generally considered to be safe in children, the potential adverse effects of these drugs on growth remains a matter of concern for parents and physicians.
OBJECTIVES
To assess the impact of different inhaled corticosteroid drugs and delivery devices on the linear growth of children with persistent asthma.
SEARCH METHODS
We searched the Cochrane Airways Trials Register, which is derived from systematic searches of bibliographic databases including CENTRAL, MEDLINE, Embase, CINAHL, AMED and PsycINFO. We handsearched respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov and manufacturers' clinical trial databases, or contacted the manufacturer, to search for potential relevant unpublished studies. The literature search was initially conducted in September 2014, and updated in November 2015, September 2018, and April 2019.
SELECTION CRITERIA
We selected parallel-group randomized controlled trials of at least three months' duration. To be included, trials had to compare linear growth between different inhaled corticosteroid molecules at equivalent doses, delivered by the same type of device, or between different devices used to deliver the same inhaled corticosteroid molecule at the same dose, in children up to 18 years of age with persistent asthma.
DATA COLLECTION AND ANALYSIS
At least two review authors independently selected studies and assessed risk of bias in included studies. The data were extracted by one author and checked by another. The primary outcome was linear growth velocity. We conducted meta-analyses using Review Manager 5.3 software. We used mean differences (MDs) and 95% confidence intervals (CIs ) as the metrics for treatment effects, and the random-effects model for meta-analyses. We did not perform planned subgroup analyses due to there being too few included trials.
MAIN RESULTS
We included six randomized trials involving 1199 children aged from 4 to 12 years (per-protocol population: 1008), with mild-to-moderate persistent asthma. Two trials were from single hospitals, and the remaining four trials were multicentre studies. The duration of trials varied from six to 20 months.One trial with 23 participants compared fluticasone with beclomethasone, and showed that fluticasone given at an equivalent dose was associated with a significant greater linear growth velocity (MD 0.81 cm/year, 95% CI 0.46 to 1.16, low certainty evidence). Three trials compared fluticasone with budesonide. Fluticasone given at an equivalent dose had a less suppressive effect than budesonide on growth, as measured by change in height over a period from 20 weeks to 12 months (MD 0.97 cm, 95% CI 0.62 to 1.32; 2 trials, 359 participants; moderate certainty evidence). However, we observed no significant difference in linear growth velocity between fluticasone and budesonide at equivalent doses (MD 0.39 cm/year, 95% CI -0.94 to 1.73; 2 trials, 236 participants; very low certainty evidence).Two trials compared inhalation devices. One trial with 212 participants revealed a comparable linear growth velocity between beclomethasone administered via hydrofluoroalkane-metered dose inhaler (HFA-MDI) and beclomethasone administered via chlorofluorocarbon-metered dose inhaler (CFC-MDI) at an equivalent dose (MD -0.44 cm/year, 95% CI -1.00 to 0.12; low certainty evidence). Another trial with 229 participants showed a small but statistically significant greater increase in height over a period of six months in favour of budesonide via Easyhaler, compared to budesonide given at the same dose via Turbuhaler (MD 0.37 cm, 95% CI 0.12 to 0.62; low certainty evidence).
AUTHORS' CONCLUSIONS
This review suggests that the drug molecule and delivery device may impact the effect size of ICS on growth in children with persistent asthma. Fluticasone at an equivalent dose seems to inhibit growth less than beclomethasone and budesonide. Easyhaler is likely to have less adverse effect on growth than Turbuhaler when used for delivery of budesonide. However, the evidence from this systematic review of head-to-head trials is not certain enough to inform the selection of inhaled corticosteroid or inhalation device for the treatment of children with persistent asthma. Further studies are needed, and pragmatic trials and real-life observational studies seem more attractive and feasible.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Budesonide; Child; Child, Preschool; Fluticasone; Growth; Humans; Metered Dose Inhalers; Randomized Controlled Trials as Topic; Time Factors
PubMed: 31194879
DOI: 10.1002/14651858.CD010126.pub2 -
Pain Physician Oct 2022Epidural injections are among the most commonly performed procedures for managing low back and lower extremity pain. Pinto et al and Chou et al previously performed... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Epidural injections are among the most commonly performed procedures for managing low back and lower extremity pain. Pinto et al and Chou et al previously performed systematic reviews and meta-analyses, which, along with a recent update from Oliveira et al showing the lack of effectiveness of epidural steroid injections in managing lumbar disc herniation, spinal stenosis, and radiculopathy. In contrast to these papers, multiple other systematic reviews and meta-analyses have supported the effectiveness and use of epidural injections utilizing fluoroscopically guided techniques. A major flaw in the review can be related to attributing active-controlled trials to placebo-controlled trials. The assumption that local anesthetics do not provide sustained benefit, despite extensive evidence that local anesthetics provide long-term relief, similar to a combination of local anesthetic with steroids is flawed.
STUDY DESIGN
The Cochrane Review of randomized controlled trials (RCTs) of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy were reanalyzed using systematic methodology and meta-analysis.
OBJECTIVES
To re-evaluate Cochrane data on RCTs of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy utilizing qualitative and quantitative techniques with dual-arm and single-arm analysis.
METHODS
In this systematic review, we have used the same RCTs from the Cochrane Review of a minimum of 20% change in pain scale or significant pain relief of >= 50%. The outcome measures were pain relief and functional status improvement. Significant improvement was defined as 50% or greater pain relief and functional status improvement. Our review was performed utilizing the Cochrane Review methodologic quality assessment and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Evidence was summarized utilizing the principles of best evidence synthesis and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system. Clinical relevance of the pragmatic nature of each study was assessed.
RESULTS
In evaluating the RCTs in the Cochrane Review, 10 trials were performed with fluoroscopic guidance. Utilizing conventional dual-arm and single-arm meta-analysis, the evidence is vastly different from the interpretation of the data within the Cochrane Review. The overall combined evidence is Level I, or strong evidence, at one and 3 months, and Level II, or moderate evidence, at 6 and 12 months.
LIMITATIONS
The limitation of this study is that only data contained in the Cochrane Review were analyzed.
CONCLUSION
A comparative systematic review and meta-analysis of the Cochrane Review of randomized controlled trials (RCTs) of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy yielded different results. This review, based on the evidence derived from placebo-controlled trials and active-controlled trials showed Level I, or strong evidence, at one and 3 months and Level II at 6 and 12 months. This review once again emphasizes the importance of the allocation of studies to placebo-control and active-control groups, utilizing standards of practice with inclusion of only the studies performed under fluoroscopic guidance.
Topics: Humans; Radiculopathy; Anesthetics, Local; Sciatica; Low Back Pain; Injections, Epidural; Steroids
PubMed: 36288577
DOI: No ID Found -
PEC Innovation Dec 2023Informal caregivers (ICs) are vital to supportive cancer care and assisting cancer patients, but this caregiving burden is associated with significant distress. While... (Review)
Review
OBJECTIVE
Informal caregivers (ICs) are vital to supportive cancer care and assisting cancer patients, but this caregiving burden is associated with significant distress. While addressing caregiving, it is important to explore if the caregivers are receiving care they need. Evaluating interventions that address burden and distress is integral to targeting ICs needs. This study evaluated interventions addressing IC burden and distress.
METHODS
Randomized control trials (RCT) assessing interventions for IC burden and distress and exploring supportive care as an adjunct to the intervention were included. Six electronic databases were searched in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analyses guidelines through October 2021. Effect sizes were estimated, and risk of bias was assessed.
RESULTS
Of 678 studies, 11 were included. Most ICs were spouses, females, and white. Interventions included educational programs, cognitive behavioral treatment, and a telephone support program. Five studies utilized behavioral theories and seven included supportive care. Pooled results showed no significant effect on reducing caregiver distress (ES, -0.26, p<0.001).
CONCLUSIONS
Caring for the caregiver with interventions for reducing burden and distress are not efficacious. Innovative, well-designed, more pragmatic RCTs are needed.
INNOVATION
This study exclusively focused on interventions and supportive care needs for reducing distress and burden among cancer ICs.
PubMed: 37214528
DOI: 10.1016/j.pecinn.2023.100145 -
JMIR MHealth and UHealth May 2023Mobile health (mHealth) apps can promote physical activity; however, the pragmatic nature (ie, how well research translates into real-world settings) of these studies is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Mobile health (mHealth) apps can promote physical activity; however, the pragmatic nature (ie, how well research translates into real-world settings) of these studies is unknown. The impact of study design choices, for example, intervention duration, on intervention effect sizes is also understudied.
OBJECTIVE
This review and meta-analysis aims to describe the pragmatic nature of recent mHealth interventions for promoting physical activity and examine the associations between study effect size and pragmatic study design choices.
METHODS
The PubMed, Scopus, Web of Science, and PsycINFO databases were searched until April 2020. Studies were eligible if they incorporated apps as the primary intervention, were conducted in health promotion or preventive care settings, included a device-based physical activity outcome, and used randomized study designs. Studies were assessed using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) frameworks. Study effect sizes were summarized using random effect models, and meta-regression was used to examine treatment effect heterogeneity by study characteristics.
RESULTS
Overall, 3555 participants were included across 22 interventions, with sample sizes ranging from 27 to 833 (mean 161.6, SD 193.9, median 93) participants. The study populations' mean age ranged from 10.6 to 61.5 (mean 39.6, SD 6.5) years, and the proportion of males included across all studies was 42.8% (1521/3555). Additionally, intervention lengths varied from 2 weeks to 6 months (mean 60.9, SD 34.9 days). The primary app- or device-based physical activity outcome differed among interventions: most interventions (17/22, 77%) used activity monitors or fitness trackers, whereas the rest (5/22, 23%) used app-based accelerometry measures. Data reporting across the RE-AIM framework was low (5.64/31, 18%) and varied within specific dimensions (Reach=44%; Effectiveness=52%; Adoption=3%; Implementation=10%; Maintenance=12.4%). PRECIS-2 results indicated that most study designs (14/22, 63%) were equally explanatory and pragmatic, with an overall PRECIS-2 score across all interventions of 2.93/5 (SD 0.54). The most pragmatic dimension was flexibility (adherence), with an average score of 3.73 (SD 0.92), whereas follow-up, organization, and flexibility (delivery) appeared more explanatory with means of 2.18 (SD 0.75), 2.36 (SD 1.07), and 2.41 (SD 0.72), respectively. An overall positive treatment effect was observed (Cohen d=0.29, 95% CI 0.13-0.46). Meta-regression analyses revealed that more pragmatic studies (-0.81, 95% CI -1.36 to -0.25) were associated with smaller increases in physical activity. Treatment effect sizes were homogenous across study duration, participants' age and gender, and RE-AIM scores.
CONCLUSIONS
App-based mHealth physical activity studies continue to underreport several key study characteristics and have limited pragmatic use and generalizability. In addition, more pragmatic interventions observe smaller treatment effects, whereas study duration appears to be unrelated to the effect size. Future app-based studies should more comprehensively report real-world applicability, and more pragmatic approaches are needed for maximal population health impacts.
TRIAL REGISTRATION
PROSPERO CRD42020169102; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=169102.
Topics: Male; Humans; Child; Adolescent; Young Adult; Adult; Middle Aged; Exercise; Mobile Applications; Health Promotion; Telemedicine; Research Design
PubMed: 37140972
DOI: 10.2196/43162