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Microsurgery Nov 2016Reconstruction of the distal radius in children is cumbersome, requiring simultaneous restoration of joint function and axial growth. Vascularized proximal fibular... (Review)
Review
PURPOSE
Reconstruction of the distal radius in children is cumbersome, requiring simultaneous restoration of joint function and axial growth. Vascularized proximal fibular epiphyseal transfers (VFET) have been popularized over non-vascularized transfers and prosthesis. This systematic review aims to evaluate the effectiveness of VFET and its associated complications.
METHODS
Electronic database of PubMed MEDLINE was searched between 1970 and 2014. Studies reporting VFET for distal radius reconstruction in children (<15 years old) with clear reporting of technique (vascular pedicle) and objective outcome measures were included. Outcomes of interest were rate of graft growth, bone union and complications. A one-way Analysis of Variance (ANOVA) test was used to compare growth rates between pedicle types.
RESULTS
Fourteen studies met the inclusion criteria, representing 25 patients. Pedicles used were anterior tibial (44%), peroneal (16%), or bi-pedicled (40%) anastomosed in antegrade (64%) or reverse flow (36%) fashion. Among all pedicle types, best results were achieved using anterior tibial artery with reversed flow, yielding average growth rate of 0.83 cm/year (P = 0.01). Recipient complications included four premature epiphyseal plate closures, a flap loss, and six wrist radial deviations. Donor complications included six common peroneal nerve palsies (five temporary, a permanent), and a talocalcaneal instability. Overall complication rates between pedicle types were comparable (P = 0.062).
CONCLUSION
VFET may be a surgical option capable of restoring joint function and axial growth potential in select patients. The reverse flow technique based on the anterior tibial artery may result in superior outcomes. However, the overall complication rate is high and permanent peroneal nerve palsy may result.
LEVEL OF EVIDENCE
IV © 2015 Wiley Periodicals, Inc. Microsurgery 36:705-711, 2016.
Topics: Bone Transplantation; Child; Epiphyses; Fibula; Free Tissue Flaps; Humans; Postoperative Complications; Radius; Plastic Surgery Procedures
PubMed: 26497641
DOI: 10.1002/micr.22521 -
British Journal of Cancer Jul 2014Erythropoiesis-stimulating agents (ESAs) reduce the need for red blood cell transfusions; however, they increase the risk of thromboembolic events and mortality. The... (Meta-Analysis)
Meta-Analysis Review
Effects of erythropoiesis-stimulating agents on fatigue- and anaemia-related symptoms in cancer patients: systematic review and meta-analyses of published and unpublished data.
BACKGROUND
Erythropoiesis-stimulating agents (ESAs) reduce the need for red blood cell transfusions; however, they increase the risk of thromboembolic events and mortality. The impact of ESAs on quality of life (QoL) is controversial and led to different recommendations of medical societies and authorities in the USA and Europe. We aimed to critically evaluate and quantify the effects of ESAs on QoL in cancer patients.
METHODS
We included data from randomised controlled trials (RCTs) on the effects of ESAs on QoL in cancer patients. Randomised controlled trials were identified by searching electronic data bases and other sources up to January 2011. To reduce publication and outcome reporting biases, we included unreported results from clinical study reports. We conducted meta-analyses on fatigue- and anaemia-related symptoms measured with the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) and FACT-Anaemia (FACT-An) subscales (primary outcomes) or other validated instruments.
RESULTS
We identified 58 eligible RCTs. Clinical study reports were available for 27% (4 out of 15) of the investigator-initiated trials and 95% (41 out of 43) of the industry-initiated trials. We excluded 21 RTCs as we could not use their QoL data for meta-analyses, either because of incomplete reporting (17 RCTs) or because of premature closure of the trial (4 RCTs). We included 37 RCTs with 10581 patients; 21 RCTs were placebo controlled. Chemotherapy was given in 27 of the 37 RCTs. The median baseline haemoglobin (Hb) level was 10.1 g dl(-1); in 8 studies ESAs were stopped at Hb levels below 13 g dl(-1) and in 27 above 13 g dl(-1). For FACT-F, the mean difference (MD) was 2.41 (95% confidence interval (95% CI) 1.39-3.43; P<0.0001; 23 studies, n=6108) in all cancer patients and 2.81 (95% CI 1.73-3.90; P<0.0001; 19 RCTs, n=4697) in patients receiving chemotherapy, which was below the threshold (≥ 3) for a clinically important difference (CID). Erythropoiesis-stimulating agents had a positive effect on anaemia-related symptoms (MD 4.09; 95% CI 2.37-5.80; P=0.001; 14 studies, n=2765) in all cancer patients and 4.50 (95% CI 2.55-6.45; P<0.0001; 11 RCTs, n=2436) in patients receiving chemotherapy, which was above the threshold (≥ 4) for a CID. Of note, this effect persisted when we restricted the analysis to placebo-controlled RCTs in patients receiving chemotherapy. There was some evidence that the MDs for FACT-F were above the threshold for a CID in RCTs including cancer patients receiving chemotherapy with Hb levels below 12 g dl(-1) at baseline and in RCTs stopping ESAs at Hb levels above 13 g dl(-1). However, these findings for FACT-F were not confirmed when we restricted the analysis to placebo-controlled RCTs in patients receiving chemotherapy.
CONCLUSIONS
In cancer patients, particularly those receiving chemotherapy, we found that ESAs provide a small but clinically important improvement in anaemia-related symptoms (FACT-An). For fatigue-related symptoms (FACT-F), the overall effect did not reach the threshold for a CID.
Topics: Anemia; Erythropoiesis; Fatigue; Hematinics; Humans; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 24743705
DOI: 10.1038/bjc.2014.171 -
Journal of Pediatric Orthopedics Aug 2021Fractures involving the distal tibia growth plate are common in children. Injury or treatment that damages the growth plate may result in progressive angular deformity...
BACKGROUND
Fractures involving the distal tibia growth plate are common in children. Injury or treatment that damages the growth plate may result in progressive angular deformity or leg length discrepancy. There is no consensus on treatment and follow-up of these injuries. This study aims to describe which factors increase the risk of premature physeal closure (PPC).
MATERIAL AND METHODS
A systematic review and meta-analysis were performed. Altogether 395 articles were reviewed, and ultimately 12 of them were found eligible, comprising 1997 patients. The most usual type of fracture was Salter-Harris (SH) II (n=855, 49%) followed by SH III (n=296, 17%) and SH I (n=261, 15%). The risk of PPC according to number of reduction attempts, method of treatment, and residual displacement was the primary outcome.
RESULTS
The total rate of PPC was 13% (n=245). The PPC rate varied from 0.2% to 42% across the studies. Patients with SH IV fractures were most likely to develop PPC (20%), followed by those with SH II (12%) (P<0.05) and repeated (>2) reduction maneuvers were associated with a higher risk of PPC (pooled odds ratio, 8.5; 95% confidence interval, 6.3-12.17; P<0.05). Open reduction was associated with a lower risk of PPC when analyzing only displaced fractures (odds ratio, 0.63; 95% confidence interval, 0.38-0.91; P<0.05).
INTERPRETATION
This meta-analysis implies that residual displacement after reduction is the most significant factor in predicting PPC. It seems that open reduction might reduce the PPC rate among patients with dislocated fractures. In addition, there is some evidence that a higher number of reduction attempts correlates positively with the risk of PPC.
PubMed: 33843787
DOI: 10.1097/BPO.0000000000001833 -
Frontiers in Pediatrics 2023Endotypes leading to very and extremely preterm birth are clustered into two groups: infection/inflammation and dysfunctional placentation. We conducted a systematic...
INTRODUCTION
Endotypes leading to very and extremely preterm birth are clustered into two groups: infection/inflammation and dysfunctional placentation. We conducted a systematic review of observational studies exploring the association between these two endotypes and the pharmacological closure of patent ductus arteriosus (PDA) induced by cyclooxygenase (COX) inhibitors. Chorioamnionitis represented the infectious-inflammatory endotype, while dysfunctional placentation proxies were hypertensive disorders of pregnancy (HDP) and small for gestational age (SGA) or intrauterine growth restriction.
METHODS
PubMed/Medline and Embase databases were searched. The random-effects odds ratio (OR) and 95% confidence interval (CI) were calculated for each association. We included 30 studies (12,639 infants).
RESULTS
Meta-analysis showed a significant association between exposure to HDP and increased rate of pharmacological closure of PDA (17 studies, OR 1.41, 95% CI 1.10-1.81, p = 0.006). In contrast, neither chorioamnionitis (13 studies, OR 0.75, 95% CI 0.47-1.18, = 0.211) nor SGA (17 studies, OR 1.20, 95% CI 0.96-1.50, = 0.115) were significantly associated with the response to therapy. Subgroup analyses showed that the higher response to COX inhibitors in the HDP group was significant for indomethacin (OR 1.568, 95% CI 1.147-2.141, = 0.005) but not for ibuprofen (OR 1.107, 95% CI 0.248-4.392, = 0.894) or for the studies using both drugs (OR 1.280, 95% CI 0.935-1.751, = 0.124). However, meta-regression showed that this difference between the drugs was not statistically significant ( = 0.404).
DISCUSSION/CONCLUSION
Our data suggest that the pathologic condition that triggers prematurity may alter the response to pharmacological treatment of PDA. The DA of infants exposed to HDP appears to be more responsive to COX inhibitors.
PubMed: 36937978
DOI: 10.3389/fped.2023.1078506 -
Journal of Neonatal-perinatal Medicine 2022Several small randomized controlled trials (RCTs) and observational studies have compared high (15-20/7.5-10/7.5-10 mg/kg/dose) versus standard dose... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Several small randomized controlled trials (RCTs) and observational studies have compared high (15-20/7.5-10/7.5-10 mg/kg/dose) versus standard dose (10/5/5 mg/kg/dose) ibuprofen for patent ductus arteriosus (PDA) closure, with limited evidence on efficacy and safety.
OBJECTIVE
To systematically review and meta-analyze studies of high versus standard dose ibuprofen for the closure of PDA in preterm infants.
METHODS
Databases were searched for RCTs and observational studies assessing high compared to standard dose of ibuprofen for PDA closure for preterm infants until August 2021. The primary outcome was failure of PDA closure after the first course of ibuprofen. The secondary outcomes were the failure of PDA closure after a second course of ibuprofen, rates of PDA ligation, all-cause mortality prior to hospital discharge, bronchopulmonary dysplasia, necrotizing enterocolitis, bleeding disorders, oliguria, and serum creatinine after treatment.
RESULTS
There were 6 studies with 369 patients (3 RCT, N = 190; 3 observational studies, N = 179). Compared to standard dose, high dose ibuprofen did not significantly decrease the failure rate of PDA closure in preterm infants after the first course (Relative risk (RR) 0.74, 95% confidence interval (CI) 0.53 -1.03, 6 studies, N = 369). High dose ibuprofen significantly decreased the rates of PDA ligation compared to standard dose (RR 0.33, 95% CI 0.16 -0.70, 5 studies, N = 309).
INTERPRETATION
Based on low-grade evidence, high dose ibuprofen may more effectively reduce rates of PDA ligation compared to standard dose with no increase in adverse effects, neonatal morbidities and mortality.
Topics: Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Humans; Ibuprofen; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature
PubMed: 35404294
DOI: 10.3233/NPM-210968 -
Frontiers in Pediatrics 2019Indomethacin and ibuprofen, two commonly used prostaglandin inhibitors, are the drugs of choice for patent ductus arteriosus. However, paracetamol is an alternative...
Indomethacin and ibuprofen, two commonly used prostaglandin inhibitors, are the drugs of choice for patent ductus arteriosus. However, paracetamol is an alternative choice when these drugs are ineffective or contraindicated. This study aimed to confirm paracetamol's efficacy and safety compared with those of other drugs or placebos for patent ductus arteriosus closure in premature infants. We conducted a literature search using the Cochrane Library, PubMed, CINAHL, and EMBASE databases for randomized controlled trials and quasi-randomized controlled trials. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to direct the process and PICO (P, population; I, intervention/interest; C, comparator; O, outcome) principle to constitute the theme. We combined the research data through qualitative summaries or meta-analyses. The final analyses included 15 trials ( = 1,313). No significant differences were noted between paracetamol and ibuprofen except for shorter mean days needed for patent ductus arteriosus closure, lower risk of gastrointestinal bleeding, and hyperbilirubinemia. No significant difference existed between paracetamol and indomethacin. Oral paracetamol was more effective than placebo in infants weighing 1,501-2,500 g. Our study findings tentatively conclude that paracetamol can induce early patent ductus arteriosus closure without significant side effects but that its efficacy is not superior to that of indomethacin.
PubMed: 32133328
DOI: 10.3389/fped.2019.00568 -
JAMA Network Open Mar 2024Platform trials have become increasingly common, and evidence is needed to determine how this trial design is actually applied in current research practice.
IMPORTANCE
Platform trials have become increasingly common, and evidence is needed to determine how this trial design is actually applied in current research practice.
OBJECTIVE
To determine the characteristics, progression, and output of randomized platform trials.
EVIDENCE REVIEW
In this systematic review of randomized platform trials, Medline, Embase, Scopus, trial registries, gray literature, and preprint servers were searched, and citation tracking was performed in July 2022. Investigators were contacted in February 2023 to confirm data accuracy and to provide updated information on the status of platform trial arms. Randomized platform trials were eligible if they explicitly planned to add or drop arms. Data were extracted in duplicate from protocols, publications, websites, and registry entries. For each platform trial, design features such as the use of a common control arm, use of nonconcurrent control data, statistical framework, adjustment for multiplicity, and use of additional adaptive design features were collected. Progression and output of each platform trial were determined by the recruitment status of individual arms, the number of arms added or dropped, and the availability of results for each intervention arm.
FINDINGS
The search identified 127 randomized platform trials with a total of 823 arms; most trials were conducted in the field of oncology (57 [44.9%]) and COVID-19 (45 [35.4%]). After a more than twofold increase in the initiation of new platform trials at the beginning of the COVID-19 pandemic, the number of platform trials has since declined. Platform trial features were often not reported (not reported: nonconcurrent control, 61 of 127 [48.0%]; multiplicity adjustment for arms, 98 of 127 [77.2%]; statistical framework, 37 of 127 [29.1%]). Adaptive design features were only used by half the studies (63 of 127 [49.6%]). Results were available for 65.2% of closed arms (230 of 353). Premature closure of platform trial arms due to recruitment problems was infrequent (5 of 353 [1.4%]).
CONCLUSIONS AND RELEVANCE
This systematic review found that platform trials were initiated most frequently during the COVID-19 pandemic and declined thereafter. The reporting of platform features and the availability of results were insufficient. Premature arm closure for poor recruitment was rare.
Topics: Humans; Pandemics; COVID-19; Cognition; Data Accuracy; Medical Oncology
PubMed: 38506807
DOI: 10.1001/jamanetworkopen.2024.3109 -
Cardiology in the Young Apr 2024The optimal management of a patent ductus arteriosus in a population of preterm infants is controversial. Traditionally, when the patent ductus arteriosus does not close... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
The optimal management of a patent ductus arteriosus in a population of preterm infants is controversial. Traditionally, when the patent ductus arteriosus does not close either with conservative treatment or in response to pharmacological therapy, the only option is surgical closure. However, transcatheter occlusion might provide a therapeutic alternative.
METHODS
We searched PubMed, Embase, and Cochrane databases for non-randomised and randomised controlled trials that compared transcatheter percutaneous closure of patent ductus arteriosus with surgical ligation in low-birth-weight preterm infants (<2,500 g). A random-effects model was used for outcomes with high heterogeneity.
RESULTS
We included twelve studies comprising 4,668 low-birth-weight preterm infants, of whom 966 (20.7%) were in the transcatheter percutaneous closure group, and 3,702 (79.3%) patients were included in the surgical group. All-cause mortality (OR 0.28; 95% confidence interval 0.18-0.423; p < 0.00001; I = 0%) and haemodynamic instability (OR 0.10; 95% confidence interval 0.05-0.21; p < 0.001; I = 14%) were significantly lower in the transcatheter percutaneous closure group. There was no significant difference between transcatheter and surgical patent ductus arteriosus closure for the outcomes of bronchopulmonary dysplasia (0.93; 95% confidence interval 0.46-1.87; p = 0.83; I = 0%) and major complications (OR 0.76; 95% confidence interval 0.34-1.69; p = 0.51; I = 43%).
CONCLUSION
These findings suggest that transcatheter patent ductus arteriosus closure in preterm infants under 2,500 g is a safe and effective alternative to surgical treatment. There was a substantial reduction in all-cause mortality and haemodynamic instability with transcatheter intervention compared to surgical closure.
Topics: Infant; Female; Infant, Newborn; Humans; Infant, Premature; Ductus Arteriosus, Patent; Ibuprofen; Infant, Low Birth Weight; Premature Birth
PubMed: 38329109
DOI: 10.1017/S1047951123004353 -
Environmental Pollution (Barking, Essex... Jan 2019Little is known about the impacts of maternal exposure to acute episodes of outdoor air pollution, such as that resulting from wildfires, on obstetric and neonatal...
BACKGROUND
Little is known about the impacts of maternal exposure to acute episodes of outdoor air pollution, such as that resulting from wildfires, on obstetric and neonatal outcomes. This systematic review aims to synthesise the existing literature exploring the relationship between maternal exposure to short-to medium-term changes in outdoor air quality and obstetric and neonatal outcomes.
METHODS
A systematic search of peer-reviewed articles using PubMed, Cochrane Library, EMBASE, ScienceDirect, Web of Science, ProQuest, GreenFILE and Scopus was conducted in January 2018 using selected search terms. Quality of included studies were assessed using the Newcastle Ottawa Scale.
RESULTS
Eleven studies were included; eight assessed the impact of maternal exposure to air pollution exacerbation events, such as wildfires, oil well fires and volcanic eruptions, and three assessed the impact of improvement events, such as the 2018 Beijing Olympics and closure of industrial activities, on obstetric and neonatal outcomes. Studies were highly heterogenous in methodology. Six studies found a significant association between acute changes in air quality and markers of fetal growth restriction, while two did not. Three studies found an adverse association between acute changes in air quality and markers of gestational maturity, and one did not.
CONCLUSION
Overall, there is some evidence that maternal exposure to acute changes in air quality of short-to medium-term duration increases the risk of fetal growth restriction and preterm birth. The relationship for other adverse obstetric or neonatal outcomes is less clear.
Topics: Air Pollution; Beijing; Female; Fetal Growth Retardation; Fires; Humans; Industry; Infant, Newborn; Maternal Exposure; Pregnancy; Pregnancy Outcome; Premature Birth; Volcanic Eruptions
PubMed: 30469286
DOI: 10.1016/j.envpol.2018.10.086 -
Indian Heart Journal 2020This systematic review and meta-analysis aimed to synthesize the latest evidence on the efficacy and safety of oral acetaminophen compared to oral ibuprofen for patent... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review and meta-analysis aimed to synthesize the latest evidence on the efficacy and safety of oral acetaminophen compared to oral ibuprofen for patent ductus arteriosus (PDA) in preterm infants.
METHODS
We performed a systematic literature search on topics that assesses the use of oral paracetamol compared to oral ibuprofen in preterm neonates diagnosed with PDA from PubMed, EuropePMC, Cochrane Central Database, ScienceDirect, ProQuest, ClinicalTrials.gov, and hand-sampling from potential articles.
RESULTS
There were 1547 subjects from 10 selected studies. Primary closure rate was similar in both groups. Subgroup analysis on studies enrolling neonates with ≤30 weeks gestational age showed that ibuprofen was superior (OR 0.52 [0.31, 0.90], I: 0%). On the other hand, paracetamol was superior neonates with ≤34 weeks gestational age (OR 1.73 [1.01, 2.94], I: 30%). Reopening rate, surgical closure rate, mortality, intraventricular hemorrhage, and necrotizing enterocolitis were similar in both groups. Rate of renal dysfunction (OR 0.27 [0.10, 0.77], I: 0%) and gastrointestinal bleeding (OR 0.31 [0.11, 0.88], I: 0%) were lower in paracetamol group. Subgroup analysis of randomized controlled studies (RCTs) showed similar results. Meta-regression analysis showed that the primary closure rate was not influenced by gestational age, birth weight, and gender. GRADE demonstrates a low level of certainty for primary closure and mortality. Renal dysfunction and gastrointestinal bleeding havea moderate level of certainty.
CONCLUSION
There was no significant difference between the efficacy of oral paracetamol and oral ibuprofen. However, the rate of renal dysfunction and gastrointestinal bleeding were higher in oral ibuprofen.
Topics: Acetaminophen; Administration, Oral; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Cardiac Surgical Procedures; Ductus Arteriosus, Patent; Gestational Age; Humans; Ibuprofen; Infant, Newborn; Infant, Premature; Treatment Outcome
PubMed: 32768013
DOI: 10.1016/j.ihj.2020.05.012