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BMC Psychiatry Apr 2008Systematic reviews based on efficacy trials are inconclusive about which second generation antipsychotic drug (SGA) should be preferred in normal clinical practice, and... (Review)
Review
BACKGROUND
Systematic reviews based on efficacy trials are inconclusive about which second generation antipsychotic drug (SGA) should be preferred in normal clinical practice, and studies with longer duration and more pragmatic designs are called for. Effectiveness studies, also known as naturalistic, pragmatic, practical or real life studies, adhere to these principles as they aim to mimic daily clinical practice and have longer follow-up.
OBJECTIVE
To review the head-to-head effectiveness of SGAs in the domains of global outcomes, symptoms of disease, and tolerability.
METHODS
Searches were made in Embase, PubMED, and the Cochrane central register of controlled trials for effectiveness studies published from 1980 to 2008, week 1. Different combinations of the keywords antipsychotic*, neuroleptic* AND open, pragmatic, practical, naturalistic, real life, effectiveness, side effect*, unwanted effect*, tolera* AND compar* AND random* were used.
RESULTS
Sixteen different reports of randomized head-to-head comparisons of SGA effectiveness were located. There were differences regarding sample sizes, inclusion criteria and follow-up periods, as well as sources of financial sponsorship. In acute-phase and first-episode patients no differences between the SGAs were disclosed regarding alleviating symptoms of disease. Olanzapine was associated with more weight gain and adverse effects on serum lipids. In the chronic phase patients olanzapine groups had longer time to discontinuation of treatment and better treatment adherence compared to other SGAs. The majority of studies found no differences between the SGAs in alleviating symptoms of psychosis in chronically ill patients. Olanzapine was associated with more metabolic adverse effects compared to the others SGAs. There were surprisingly few between-drug differences regarding side effects. First generation antipsychotics were associated with lower total mental health care costs in 2 of 3 studies on chronically ill patients, but were also associated with more extrapyramidal side effects compared to the SGAs in several studies.
CONCLUSION
In chronically ill patients olanzapine may have an advantage over other SGAs regarding longer time to treatment discontinuation and better drug adherence, but the drug is also associated with more metabolic side effects. More effectiveness studies on first-episode psychosis are needed.
Topics: Adolescent; Adult; Antipsychotic Agents; Humans; Placebos; Randomized Controlled Trials as Topic; Research Design; Schizophrenia; Treatment Outcome
PubMed: 18439263
DOI: 10.1186/1471-244X-8-31 -
Antimicrobial Resistance and Infection... Jan 2022Despite clear evidence of benefits in acute-care hospitals, controversy over the effectiveness of IPC measures for MDROs is perceptible and evidence-based practice has... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Despite clear evidence of benefits in acute-care hospitals, controversy over the effectiveness of IPC measures for MDROs is perceptible and evidence-based practice has not been established.
OBJECTIVE
To investigate the effects of IPC interventions on MDRO colonization and infections in LTCFs.
DATA SOURCES
Ovid MEDLINE, EMBASE, and CINAHL from inception to September 2020.
ELIGIBILITY CRITERIA
Original and peer-reviewed articles examining the post-intervention effects on MDRO colonization and infections in LTCFs.
INTERVENTIONS
(i) Horizontal interventions: administrative engagement, barrier precautions, education, environmental cleaning, hand hygiene, performance improvement, and source control; and (ii) vertical intervention: active surveillance plus decolonization.
STUDY APPRAISAL AND SYNTHESIS
We employed a random-effects meta-analysis to estimate the pooled risk ratios (pRRs) for methicillin-resistant Staphylococcus aureus (MRSA) colonization by intervention duration; and conducted subgroup analyses on different intervention components. Study quality was assessed using Cochrane risk of bias tools.
RESULTS
Of 3877 studies identified, 19 were eligible for inclusion (eight randomized controlled trials (RCTs)). Studies reported outcomes associated with MRSA (15 studies), vancomycin-resistant Enterococci (VRE) (four studies), Clostridium difficile (two studies), and Gram-negative bacteria (GNB) (two studies). Eleven studies were included in the meta-analysis. The pRRs were close to unity regardless of intervention duration (long: RR 0.81 [95% CI 0.60-1.10]; medium: RR 0.81 [95% CI 0.25-2.68]; short: RR 0.95 [95% CI 0.53-1.69]). Vertical interventions in studies with a small sample size showed significant reductions in MRSA colonization while horizontal interventions did not. All studies involving active administrative engagement reported reductions. The risk of bias was high in all but two studies.
CONCLUSIONS
Our meta-analysis did not show any beneficial effects from IPC interventions on MRSA reductions in LTCFs. Our findings highlight that the effectiveness of interventions in these facilities is likely conditional on resource availability-particularly decolonization and barrier precautions, due to their potential adverse events and uncertain effectiveness. Hence, administrative engagement is crucial for all effective IPC programmes. LTCFs should consider a pragmatic approach to reinforce standard precautions as routine practice and implement barrier precautions and decolonization to outbreak responses only.
Topics: Drug Resistance, Multiple, Bacterial; Humans; Infection Control; Methicillin-Resistant Staphylococcus aureus; Staphylococcal Infections
PubMed: 35033198
DOI: 10.1186/s13756-021-01044-0 -
BMC Complementary Medicine and Therapies May 2024Pragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting. This study aimed to provide a...
BACKGROUND
Pragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting. This study aimed to provide a comprehensive methodological analysis of PATs using the PRECIS-2(PRagmatic Explanatory Continuum Indicator Summary-2) tool to determine their pragmatism.
METHODS
The MEDLINE, EMBASE, Cochrane Central Register for Controlled Trials, CINAHL, Allied and Complementary Medicine Database, China National Knowledge Infrastructure, VIP, WANFANG, Taiwan Periodical Literature Database, KoreaMed, KMbase, Research Information Service System, Oriental Medicine Advanced Searching Integrated System, CiNii and ClinicalTrials.gov were searched. The search included randomised controlled trials (RCTs) and protocols of RCTs that investigated all types of acupuncture and used self-declared pragmatic design. Two authors independently collected the basic information and characteristics of the studies and assessed their pragmatism using the nine PRECIS-2 domains and the additional domain of control.
RESULTS
A total of 93 studies were included. The means of eligibility, recruitment, organisation, primary outcome, primary analysis, and control domains were statistically larger than three and were shown to be pragmatic. The means of setting, flexibility:delivery, and follow-up domains were not greater than three and were shown to be non-pragmatic. For flexibility:adherence domain was inappropriate for assessment owing to insufficient information in the studies.
CONCLUSIONS
PATs were pragmatic in the domain of eligibility, recruitment, organisation, primary outcome, primary analysis, and control and were not pragmatic in the domain of setting, flexibility:delivery, and follow-up. Future PATs need to strengthen the pragmatism in the setting, flexibility:delivery, and follow-up domains and to describe the flexibility:adherence domain in more detail.
TRIAL REGISTRATION
CRD42021236975.
Topics: Humans; Acupuncture Therapy; Pragmatic Clinical Trials as Topic; Randomized Controlled Trials as Topic; Research Design
PubMed: 38702632
DOI: 10.1186/s12906-024-04473-7 -
The Cochrane Database of Systematic... Mar 2021Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published Cochrane Review.
OBJECTIVES
To determine whether the timing of dornase alfa inhalation (in relation to airway clearance techniques or morning versus evening inhalation) has an impact on objective and subjective measures of clinical efficacy in people with cystic fibrosis.
SEARCH METHODS
Relevant randomised and quasi-randomised controlled trials were identified from the Cochrane Cystic Fibrosis Trials Register, the Physiotherapy Evidence Database (PEDro), clinical trial registries and international cystic fibrosis conference proceedings. Date of the most recent search: 12 October 2020.
SELECTION CRITERIA
Any trial of dornase alfa in people with cystic fibrosis where timing of inhalation was the randomised element in the trial with either: inhalation before compared to after airway clearance techniques; or morning compared to evening inhalation. DATA COLLECTION AND ANALYSIS: Both authors independently selected trials, assessed risk of bias and extracted data with disagreements resolved by discussion. Relevant data were extracted and, where possible, meta-analysed. We assessed the quality of the evidence using GRADE.
MAIN RESULTS
We identified 115 trial reports representing 55 trials, of which five trials (providing data on 122 participants) met our inclusion criteria. All five trials used a cross-over design. Intervention periods ranged from two to eight weeks. Four trials (98 participants) compared dornase alfa inhalation before versus after airway clearance techniques. Inhalation after instead of before airway clearance did not significantly change forced expiratory volume at one second (very-low quality evidence). Similarly, forced vital capacity (low-quality evidence) and quality of life (very-low quality evidence) were not significantly affected; forced expiratory flow at 25% was significantly worse with dornase alfa inhalation after airway clearance, mean difference -0.17 litres (95% confidence interval -0.28 to -0.05), based on the pooled data from two small trials in children (7 to 19 years) with well-preserved lung function. All other secondary outcomes were statistically non-significant. In one trial (25 participants), morning versus evening inhalation had no impact on lung function or symptoms (low-quality evidence).
AUTHORS' CONCLUSIONS
The current evidence derived from a small number of participants does not indicate that inhalation of dornase alfa after airway clearance techniques is more or less effective than the traditional recommendation to inhale nebulised dornase alfa 30 minutes prior to airway clearance techniques, for most outcomes. For children with well-preserved lung function, inhalation before airway clearance may be more beneficial for small airway function than inhalation after. However, this result relied on a measure with high variability and trials with variable follow-up. In the absence of strong evidence to indicate that one timing regimen is better than another, the timing of dornase alfa inhalation can be largely based on pragmatic reasons or individual preference with respect to the time of airway clearance and time of day. Further research is warranted.
Topics: Administration, Inhalation; Adolescent; Child; Combined Modality Therapy; Cystic Fibrosis; Deoxyribonuclease I; Drug Administration Schedule; Forced Expiratory Volume; Humans; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Respiratory Therapy; Time Factors; Vital Capacity; Young Adult
PubMed: 33686652
DOI: 10.1002/14651858.CD007923.pub6 -
Plastic and Reconstructive Surgery.... Jan 2020Nail bed and fingertip injuries are the commonest hand injuries in children and can lead to profound functional and cosmetic impairments if not appropriately managed.... (Review)
Review
UNLABELLED
Nail bed and fingertip injuries are the commonest hand injuries in children and can lead to profound functional and cosmetic impairments if not appropriately managed. Fingertip injuries can present with subungual hematomas, simple or stellate lacerations, crush, or avulsion injuries, often with associated fractures or tip amputations. The fundamentals of managing nail bed injuries concern restoring the form and function of a painless fingertip. However, there are controversies surrounding the optimal management of each of these injuries, which has led to nonuniformity of clinical practice.
METHODS
The PubMed database was searched from March 2001 to March 2019, using a combination of MeSH terms and keywords. Studies evaluating children (<18 years of age) and the fingertip (defined as distal to the distal interphalangeal joint) were included following screening by the authors.
RESULTS AND CONCLUSION
The evidence base for the diverse clinical management strategies currently employed for fingertip injuries in the pediatric population is limited. Further studies yielding level I data in this field are warranted.
PubMed: 32095403
DOI: 10.1097/GOX.0000000000002595 -
The Cochrane Database of Systematic... Jun 2015Major depression and other depressive conditions are common in people with cancer. These conditions are not easily detectable in clinical practice, due to the overlap... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Major depression and other depressive conditions are common in people with cancer. These conditions are not easily detectable in clinical practice, due to the overlap between medical and psychiatric symptoms, as described by diagnostic manuals such as the Diagnostic and Statistical Manual of Mental Disorders (DSM) and International Classification of Diseases (ICD). Moreover, it is particularly challenging to distinguish between pathological and normal reactions to such a severe illness. Depressive symptoms, even in subthreshold manifestations, have been shown to have a negative impact in terms of quality of life, compliance with anti-cancer treatment, suicide risk and likely even the mortality rate for the cancer itself. Randomised controlled trials (RCTs) on the efficacy and tolerability of antidepressants in this population group are few and often report conflicting results.
OBJECTIVES
To assess the effects and acceptability of antidepressants for treating depressive symptoms in adults (18 years or older) with cancer (any site and stage).
SEARCH METHODS
We searched the following electronic bibliographic databases: the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 3), MEDLINE Ovid (1946 to April week 3, 2014), EMBASE Ovid (1980 to 2014 week 17) and PsycINFO Ovid (1987 to April week 4, 2014). We additionally handsearched the trial databases of the most relevant national, international and pharmaceutical company trial registers and drug-approving agencies for published, unpublished and ongoing controlled trials.
SELECTION CRITERIA
We included RCTs allocating adults (18 years or above) with any primary diagnosis of cancer and depression (including major depressive disorder, adjustment disorder, dysthymic disorder or depressive symptoms in the absence of a formal diagnosis) comparing antidepressants versus placebo, or antidepressants versus other antidepressants.
DATA COLLECTION AND ANALYSIS
Two review authors independently checked eligibility and extracted data using a form specifically designed for the aims of this review. The two authors compared the data extracted and then entered data into RevMan 5 with a double-entry procedure. Information extracted included study and participant characteristics, intervention details, outcome measures for each time point of interest, cost analysis and sponsorship by a drug company. We used the standard methodological procedures expected by The Cochrane Collaboration.
MAIN RESULTS
We retrieved a total of nine studies (861 participants), with seven studies contributing to the meta-analysis for the primary outcome. Four of these compared antidepressants and placebo, two compared two antidepressants and one-three armed study compared two antidepressants and a placebo arm. For the acute phase treatment response (6 to 12 weeks), we found very low quality evidence for the effect of antidepressants as a class on symptoms of depression compared with placebo when measured as a continuous outcome (standardised mean difference (SMD) -0.45, 95% confidence interval (CI) -1.01 to 0.11, five RCTs, 266 participants) or as a proportion of people who had depression (risk ratio (RR) 0.82, 95% CI 0.62 to 1.08, five RCTs, 417 participants). No trials reported data on the follow-up response (more than 12 weeks). In head-to-head comparisons we only retrieved data for selective serotonin reuptake inhibitors (SSRIs) versus tricyclic antidepressants, providing very low quality evidence for the difference between these two classes (SMD -0.08, 95% CI -0.34 to 0.18, three RCTs, 237 participants). No clear evidence of an effect of antidepressants versus either placebo or other antidepressants emerged from the analyses of the secondary efficacy outcomes (dichotomous outcome, response at 6 to 12 weeks, very low quality evidence). We found very low quality evidence for the effect of antidepressants as a class in terms of dropouts due to any cause compared with placebo (RR 0.87, 95% CI 0.49 to 1.53, six RCTs, 455 participants), as well as between SSRIs and tricyclic antidepressants (RR 0.83, 95% CI 0.53 to 1.30, three RCTs, 237 participants). We downgraded the quality of the evidence because the included studies were at an unclear or high risk of bias due to poor reporting, imprecision arising from small sample sizes and wide confidence intervals, and inconsistency due to statistical or clinical heterogeneity.
AUTHORS' CONCLUSIONS
Despite the impact of depression on people with cancer, available studies were very few and of low quality. This review found very low quality evidence for the effects of these drugs compared with placebo. On the basis of these results clear implications for practice cannot be made. The use of antidepressants in people with cancer should be considered on an individual basis and, considering the lack of head-to-head data, the choice of which agent should be prescribed may be based on the data on antidepressant efficacy in the general population of individuals with major depression, also taking into account that data on medically ill patients suggest a positive safety profile for the SSRIs. Large, simple, randomised, pragmatic trials comparing commonly used antidepressants versus placebo in people with cancer with depressive symptoms, with or without a formal diagnosis of a depressive disorder, are urgently needed to better inform clinical practice.
Topics: Adjustment Disorders; Adult; Antidepressive Agents; Antidepressive Agents, Tricyclic; Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder; Humans; Neoplasms; Randomized Controlled Trials as Topic; Selective Serotonin Reuptake Inhibitors
PubMed: 26029972
DOI: 10.1002/14651858.CD011006.pub2 -
Pain Physician Sep 2023Extensive research into potential sources of thoracic pain with or without referred pain into the chest wall has demonstrated that thoracic facet joints can be a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Extensive research into potential sources of thoracic pain with or without referred pain into the chest wall has demonstrated that thoracic facet joints can be a potential source of pain confirmed by precise, diagnostic blocks.The objective of this systematic review and meta-analysis is to evaluate the effectiveness of medial branch blocks and radiofrequency neurotomy as a therapeutic thoracic facet joint intervention.
METHODS
Systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies of medial branch blocks and the radiofrequency neurotomy in managing thoracic pain utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was performed. A comprehensive literature search of multiple databases of RCTs and observational studies of medial branch blocks and radiofrequency neurotomy in managing chronic thoracic pain were identified from 1996 to December 2022 with inclusion of manual searches of the bibliography of known review articles and multiple databases. Methodologic quality and risk of bias assessment was also conducted. Evidence was synthesized utilizing principles of quality assessment and best evidence synthesis, with conventional and single meta-analysis. The primary outcome measure of success was 3 months of pain reduction for medial branch blocks and 6 months for radiofrequency thermoneurolysis for a single treatment. Short-term success was defined as up to 6 months and long-term was more than 6 months.
RESULTS
This literature search yielded 11 studies meeting the inclusion criteria, of which 3 were RCTs and 8 were observational studies. Of the 3 RCTs, 2 of them assessed medial branch blocks and one trial assessed radiofrequency for thoracic pain. The evidence for managing thoracic pain with qualitative analysis and single-arm meta-analysis and GRADE system of appraisal, with the inclusion of 2 RCTs and 3 observational studies for medial branch blocks was Level II. For radiofrequency neurotomy, with the inclusion of one RCT of 20 patients in the treatment group and 5 observational studies, the evidence was Level III in managing thoracic pain.
LIMITATIONS
There was a paucity of literature with RCTs and real-world pragmatic controlled trials. Even observational studies had small sample sizes providing inadequate clinically applicable results. In addition, there was heterogeneity of the available studies in terms of their inclusion and exclusion criteria, defining their endpoints and the effectiveness of the procedures.
CONCLUSION
This systematic review and meta-analysis show Level II evidence of medial branch blocks and Level III evidence for radiofrequency neurotomy on a long-term basis in managing chronic thoracic pain.
KEY WORDS
Chronic spinal pain, thoracic facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks, diagnostic accuracy, radiofrequency neurotomy.
Topics: Humans; Nerve Block; Pain Management; Chronic Pain; Denervation; Anesthesia, Local; Chest Pain; Zygapophyseal Joint; Treatment Outcome
PubMed: 37774177
DOI: No ID Found -
Journal of Medical Internet Research Aug 2023Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video... (Review)
Review
BACKGROUND
Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video recording patients for direct care purposes.
OBJECTIVE
We aimed to synthesize empirical studies published internationally to explore the extent to which video recording patients is acceptable and effective in supporting direct care and, for the United Kingdom, to summarize the relevant guidance of professional and regulatory bodies.
METHODS
Five electronic databases (MEDLINE, Embase, APA PsycINFO, CENTRAL, and HMIC) were searched from 2012 to 2022. Eligible studies evaluated an intervention involving video recording of adult patients (≥18 years) to support diagnosis, care, or treatment. All study designs and countries of publication were included. Websites of UK professional and regulatory bodies were searched to identify relevant guidance. The acceptability of video recording patients was evaluated using study recruitment and retention rates and a framework synthesis of patients' and clinical staff's perspectives based on the Theoretical Framework of Acceptability by Sekhon. Clinically relevant measures of impact were extracted and tabulated according to the study design. The framework approach was used to synthesize the reported ethico-legal considerations, and recommendations of professional and regulatory bodies were extracted and tabulated.
RESULTS
Of the 14,221 abstracts screened, 27 studies met the inclusion criteria. Overall, 13 guidance documents were retrieved, of which 7 were retained for review. The views of patients and clinical staff (16 studies) were predominantly positive, although concerns were expressed about privacy, technical considerations, and integrating video recording into clinical workflows; some patients were anxious about their physical appearance. The mean recruitment rate was 68.2% (SD 22.5%; range 34.2%-100%; 12 studies), and the mean retention rate was 73.3% (SD 28.6%; range 16.7%-100%; 17 studies). Regarding effectiveness (10 studies), patients and clinical staff considered video recordings to be valuable in supporting assessment, care, and treatment; in promoting patient engagement; and in enhancing communication and recall of information. Observational studies (n=5) favored video recording, but randomized controlled trials (n=5) did not demonstrate that video recording was superior to the controls. UK guidelines are consistent in their recommendations around consent, privacy, and storage of recordings but lack detailed guidance on how to operationalize these recommendations in clinical practice.
CONCLUSIONS
Video recording patients for direct care purposes appears to be acceptable, despite concerns about privacy, technical considerations, and how to incorporate recording into clinical workflows. Methodological quality prevents firm conclusions from being drawn; therefore, pragmatic trials (particularly in older adult care and the movement disorders field) should evaluate the impact of video recording on diagnosis, treatment monitoring, patient-clinician communication, and patient safety. Professional and regulatory documents should signpost to practical guidance on the implementation of video recording in routine practice.
TRIAL REGISTRATION
PROSPERO CRD42022331825: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=331825.
Topics: Humans; Aged; Patient Participation; Empirical Research; Communication; Narration; Clinical Decision-Making
PubMed: 37585249
DOI: 10.2196/46478 -
The Cochrane Database of Systematic... Sep 2017Breast milk alone, given at standard recommended volumes (150 to 180 mL/kg/d), is not adequate to meet the protein, energy, and other nutrient requirements of growing... (Review)
Review
BACKGROUND
Breast milk alone, given at standard recommended volumes (150 to 180 mL/kg/d), is not adequate to meet the protein, energy, and other nutrient requirements of growing preterm or low birth weight infants. One strategy that may be used to address these potential nutrient deficits is to give infants enteral feeds in excess of 200 mL/kg/d ('high-volume' feeds). This approach may increase nutrient uptake and growth rates, but concerns include that high-volume enteral feeds may cause feed intolerance, gastro-oesophageal reflux, aspiration pneumonia, necrotising enterocolitis, or complications related to fluid overload, including patent ductus arteriosus and bronchopulmonary dysplasia.
OBJECTIVES
To assess the effect on growth and safety of feeding preterm or low birth weight infants with high (> 200 mL/kg/d) versus standard (≤ 200 mL/kg/d) volume of enteral feeds. Infants in intervention and control groups should have received the same type of milk (breast milk, formula, or both), the same fortification or micronutrient supplements, and the same enteral feeding regimen (bolus, continuous) and rate of feed volume advancement.To conduct subgroup analyses based on type of milk (breast milk vs formula), gestational age or birth weight category of included infants (very preterm or VLBW vs preterm or LBW), presence of intrauterine growth restriction (using birth weight relative to the reference population as a surrogate), and income level of the country in which the trial was conducted (low or middle income vs high income) (see 'Subgroup analysis and investigation of heterogeneity').
SEARCH METHODS
We used the Cochrane Neonatal standard search strategy, which included searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2) in the Cochrane Library; MEDLINE (1946 to November 2016); Embase (1974 to November 2016); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to November 2016), as well as conference proceedings, previous reviews, and trial registries.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that compared high-volume versus standard-volume enteral feeds for preterm or low birth weight infants.
DATA COLLECTION AND ANALYSIS
Two review authors assessed trial eligibility and risk of bias and independently extracted data. We analysed treatment effects in individual trials and reported the risk ratio and risk difference for dichotomous data, and the mean difference for continuous data, with respective 95% confidence intervals. . We assessed the quality of evidence at the outcome level via the GRADE approach.
MAIN RESULTS
We found one eligible trial that included 64 infants. This trial was not blinded. Analysis showed a higher rate of weight gain in the high-volume feeds group: mean difference 6.20 g/kg/d (95% confidence interval 2.71 to 9.69). There was no increase in the risk of feed intolerance or necrotising enterocolitis with high-volume feeds, but 95% confidence intervals around these estimates were wide. We assessed the quality of evidence for these outcomes as 'low' or 'very low' because of imprecision of the estimates of effect and concern about risk of bias due to lack of blinding in the included trial. Trial authors provided no data on other outcomes, including gastro-oesophageal reflux, aspiration pneumonia, necrotising enterocolitis, patent ductus arteriosus, bronchopulmonary dysplasia, or long-term growth and neurodevelopment.
AUTHORS' CONCLUSIONS
We found only very limited data from one small unblinded trial on the effects of high-volume feeds on important outcomes for preterm or low birth weight infants. The quality of evidence is low to very low. Hence, available evidence is insufficient to support or refute high-volume enteral feeds in preterm or low birth weight infants. A large, pragmatic randomised controlled trial is needed to provide data of sufficient quality and precision to inform policy and practice.
PubMed: 28898404
DOI: 10.1002/14651858.CD012413.pub2 -
The Cochrane Database of Systematic... Apr 2016Uncertainty exists regarding the management of newborn infants with a bloodstream infection and a central venous catheter in place. The central venous catheter may act... (Review)
Review
BACKGROUND
Uncertainty exists regarding the management of newborn infants with a bloodstream infection and a central venous catheter in place. The central venous catheter may act as a nidus for infecting organisms and observational studies have suggested that early removal of the catheter is associated with a lower incidence of persistent or complicated infection. However, since central venous catheters provide secure vascular access to deliver nutrition and medications, the possible harms of early removal versus expectant management also need to be considered.
OBJECTIVES
To determine the effect of early removal versus expectant management of central venous catheters on morbidity and mortality in newborn infants with bloodstream infections.
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 11), MEDLINE (1966 to October 2015), EMBASE (1980 to October 2015), CINAHL (1982 to October 2015), conference proceedings and previous reviews.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials that compared early removal versus expectant management of central venous catheters in neonates with bloodstream infections.
DATA COLLECTION AND ANALYSIS
We used the standard methods of the Cochrane Neonatal Review Group.
MAIN RESULTS
We did not identify any eligible randomised controlled trials.
AUTHORS' CONCLUSIONS
There are no trial data to guide practice regarding early removal versus expectant management of central venous catheters in newborn infants with bloodstream infections. A simple and pragmatic randomised controlled trial is needed to resolve the uncertainty about optimal management in this common and important clinical scenario.
Topics: Bacteremia; Catheter-Related Infections; Catheterization, Central Venous; Catheters, Indwelling; Device Removal; Humans; Infant, Newborn; Time Factors; Watchful Waiting
PubMed: 27095103
DOI: 10.1002/14651858.CD008436.pub3