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The Cochrane Database of Systematic... Nov 2013In sickle cell disease, a common inherited haemoglobin disorder, abnormal haemoglobin distorts red blood cells, causing anaemia, vaso-occlusion and dysfunction in most... (Review)
Review
BACKGROUND
In sickle cell disease, a common inherited haemoglobin disorder, abnormal haemoglobin distorts red blood cells, causing anaemia, vaso-occlusion and dysfunction in most body organs. Without intervention, stroke affects around 10% of children with sickle cell anaemia (HbSS) and recurrence is likely. Chronic blood transfusion dilutes the sickled red blood cells, reducing the risk of vaso-occlusion and stroke. However, side effects can be severe.
OBJECTIVES
To assess risks and benefits of chronic blood transfusion regimens in people with sickle cell disease to prevent first stroke or recurrences.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and conference proceedings.Date of the latest search of the Group's Haemoglobinopathies Trials Register: 28 January 2013.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials comparing blood transfusion as prophylaxis for stroke in people with sickle cell disease to alternative or no treatment.
DATA COLLECTION AND ANALYSIS
Both authors independently assessed the risk of bias of the included trials and extracted data.
MAIN RESULTS
Searches identified three eligible randomised trials (n = 342). The first two trials addressed the use of chronic transfusion to prevent primary stroke; the third utilized the drug hydroxycarbamide (hydroxyurea) and phlebotomy to prevent both recurrent (secondary) stroke and iron overload in patients who had already experienced an initial stroke. In the first trial (STOP) a chronic transfusion regimen for maintaining sickle haemoglobin lower than 30% was compared with standard care in 130 children with sickle cell disease judged (through transcranial Doppler ultrasonography) as high-risk for first stroke. During the trial, 11 children in the standard care group suffered a stroke compared to one in the transfusion group, odds ratio 0.08 (95% confidence interval 0.01 to 0.66). This meant the trial was terminated early. The transfusion group had a high complications rate, including iron overload, alloimmunisation, and transfusion reactions. The second trial (STOP II) investigated risk of stroke when transfusion was stopped after at least 30 months in this population. The trial closed early due to a significant difference in risk of stroke between participants who stopped transfusion and those who continued as measured by reoccurrence of abnormal velocities on Doppler examination or the occurrence of overt stroke in the group that stopped transfusion. The third trial (SWiTCH) was a non-inferiority trial comparing transfusion and iron chelation (standard management) with hydroxyurea and phlebotomy (alternative treatment) with the combination endpoint of prevention of stroke recurrence and reduction of iron overload. This trial was stopped early after enrolment and follow up of 133 children because of analysis showing futility in reaching the composite primary endpoint. The stroke rate (seven strokes on hydroxyurea and phlebotomy, none on transfusion and chelation, odds ratio 16.49 (95% confidence interval 0.92 to 294.84)) was within the non-inferiority margin, but the liver iron content was not better in the alternative arm.
AUTHORS' CONCLUSIONS
The STOP trial demonstrated a significantly reduced risk of stroke in participants with abnormal transcranial Doppler ultrasonography velocities receiving regular blood transfusions. The follow-up trial (STOP 2) indicated that individuals may revert to former risk status if transfusion is discontinued. The degree of risk must be balanced against the burden of chronic transfusions. The combination of hydroxyurea and phlebotomy is not as effective as "standard" transfusion and chelation in preventing secondary stroke and iron overload. Ongoing multicentre trials are investigating the use of chronic transfusion to prevent silent infarcts, the use of hydroxyurea as an alternative to transfusion in children with abnormal transcranial Doppler ultrasonography velocities, and the use of hydroxyurea to prevent conversion of transcranial Doppler ultrasonography velocities from conditional (borderline) to abnormal values.
Topics: Anemia, Sickle Cell; Blood Transfusion; Child; Early Termination of Clinical Trials; Humans; Hydroxyurea; Phlebotomy; Randomized Controlled Trials as Topic; Secondary Prevention; Stroke; Transfusion Reaction
PubMed: 24226646
DOI: 10.1002/14651858.CD003146.pub2 -
The American Journal of Clinical... Aug 2013Hereditary hemochromatosis (HH) leads to iron loading because of a disturbance in the negative-feedback mechanism between dietary iron absorption and iron status. The... (Review)
Review
BACKGROUND
Hereditary hemochromatosis (HH) leads to iron loading because of a disturbance in the negative-feedback mechanism between dietary iron absorption and iron status. The management of HH is achieved by repeated phlebotomies.
OBJECTIVE
We investigated whether HH patients would benefit from a diet with low iron intake and bioavailability.
DESIGN
We performed a systematic review of studies that linked iron bioavailability and status with dietary factors in subjects with diagnosed HH. Studies on heterozygotes for the HFE mutation were excluded.
RESULTS
No prospective, randomized study was reported. Nine studies that directly measured iron bioavailability from test meals in HH patients have been described as well as 3 small, prospective, longitudinal studies in HH patients. Eight cross-sectional studies were identified that investigated the effect of dietary composition on iron status. Calculations of iron bioavailability in HH were made by extrapolating data on hepcidin concentrations and their association with iron bioavailability. The potential reduction in the yearly amount of blood to be phlebotomized when restricting dietary iron absorbed was estimated in the 3 longitudinal studies and ranged between 0.5 and 1.5 L. This amount would be dependent on individual disease penetrance as well as the dietary intervention.
CONCLUSIONS
Despite the limited quantitative evidence and the lack of randomized, prospective trials, dietary interventions that modify iron intake and bioavailability may affect iron accumulation in HH patients. Although this measure may be welcome in patients willing to contribute to their disease management, limited data exist on the clinical and quality-of-life benefit.
Topics: Absorption; Antimicrobial Cationic Peptides; Biological Availability; Diet; Hemochromatosis; Hepcidins; Heterozygote; Humans; Iron, Dietary; Mutation; Penetrance
PubMed: 23803887
DOI: 10.3945/ajcn.112.048264 -
The Cochrane Database of Systematic... Dec 2012Physiological changes brought about by pain may contribute to the development of morbidity in neonates. Clinical studies have shown reduction in changes in physiological... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Physiological changes brought about by pain may contribute to the development of morbidity in neonates. Clinical studies have shown reduction in changes in physiological parameters and pain score measurements following pre-emptive analgesic administration in situations where the neonate is experiencing pain or stress. Non-pharmacological measures (such as holding, swaddling and breastfeeding) and pharmacological measures (such as acetaminophen, sucrose and opioids) have been used for this purpose.
OBJECTIVES
The primary objective was to evaluate the effectiveness of breastfeeding or supplemental breast milk in reducing procedural pain in neonates. The secondary objective was to conduct subgroup analyses based on the type of control intervention, gestational age and the amount of supplemental breast milk given.
SEARCH METHODS
We performed a literature search using the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 10), MEDLINE (1966 to February 2011), EMBASE (1980 to February 2011), CINAHL (1982 to February 2011), abstracts from the annual meetings of the Society for Pediatric Research (1994 to 2011), and major paediatric pain conference proceedings. We did not apply any language restrictions.
SELECTION CRITERIA
Randomised controlled trials (RCTs) or quasi-RCTs of breastfeeding or supplemental breast milk versus no treatment/other measures in neonates were eligible for inclusion in this review. The study must have reported on either physiologic markers of pain or validated pain scores.
DATA COLLECTION AND ANALYSIS
We assessed the methodological quality of the trials using the information provided in the studies and by personal communication with the authors. We extracted data on relevant outcomes, estimated the effect size and reported this as a risk ratio (RR), risk difference (RD) and weighted mean difference (MD) as appropriate.
MAIN RESULTS
Of twenty eligible studies, ten evaluated breastfeeding and ten evaluated supplemental breast milk. Sixteen studies analysed used heel lance and four used venepuncture as procedure. We noted marked heterogeneity in control intervention and pain assessment measures among the studies. Neonates in the breastfeeding group had statistically a significantly lower increase in heart rate, reduced proportion of crying time and reduced duration of first cry and total crying time compared to positioning (swaddled and placed in a crib), holding by mother, placebo, pacifier use, no intervention or oral sucrose group, or both.Premature Infant Pain Profile (PIPP) scores were significantly lower in the breastfeeding group compared to positioning, placebo or oral sucrose group, or both. However, there was no statistically significant difference in PIPP scores when compared to no intervention. Douleur Aigue Nouveau-ne scores (DAN) were significantly lower in the breastfeeding group compared to the placebo group and the group held in mother's arms, but not when compared to the glucose group. Neonatal Infant Pain Scale (NIPS) was significantly lower in the breastfeeding group compared to the no intervention group, but there was no difference when compared to the oral sucrose group. The Neonatal Facial Coding System (NFCS) was significantly lower in the breastfeeding group when compared to oral glucose, pacifier use, holding by mother and no intervention, but no difference was found when compared to formula feeding.Supplemental breast milk yielded variable results. Neonates in the supplemental breast milk group had a significantly lower increase in heart rate, a reduction in duration of crying and a lower NFCS compared to the placebo group. Neonates in the supplemental breast milk group had a significantly higher increase in heart rate changes when compared to the sucrose group. Sucrose (in any concentration, i.e. 12.5%, 20%, 25%) was found to reduce the duration of cry when compared to breast milk, as did glycine, pacifier use, rocking, or no intervention. Breast milk was found not to be effective in reducing validated and non-validated pain scores such as NIPS, NFCS, and DAN; only being significantly better when compared to placebo (water) or massage. We did not identify any study that has evaluated safety/effectiveness of repeated administration of breastfeeding or supplemental breast milk for pain relief.
AUTHORS' CONCLUSIONS
If available, breastfeeding or breast milk should be used to alleviate procedural pain in neonates undergoing a single painful procedure rather than placebo, positioning or no intervention. Administration of glucose/sucrose had similar effectiveness as breastfeeding for reducing pain. The effectiveness of breast milk for painful procedure should be studied in the preterm population, as there are currently a limited number of studies in the literature that have assessed it's effectiveness in this population.
Topics: Breast Feeding; Crying; Hemodynamics; Humans; Infant Care; Infant, Newborn; Milk, Human; Pacifiers; Pain; Phlebotomy; Punctures; Randomized Controlled Trials as Topic
PubMed: 23235618
DOI: 10.1002/14651858.CD004950.pub3 -
Medical Education Online 2012The objective was to systematically review the literature to identify and grade tools used for the end point assessment of procedural skills (e.g., phlebotomy, IV... (Review)
Review
The objective was to systematically review the literature to identify and grade tools used for the end point assessment of procedural skills (e.g., phlebotomy, IV cannulation, suturing) competence in medical students prior to certification. The authors searched eight bibliographic databases electronically - ERIC, Medline, CINAHL, EMBASE, Psychinfo, PsychLIT, EBM Reviews and the Cochrane databases. Two reviewers independently reviewed the literature to identify procedural assessment tools used specifically for assessing medical students within the PRISMA framework, the inclusion/exclusion criteria and search period. Papers on OSATS and DOPS were excluded as they focused on post-registration assessment and clinical rather than simulated competence. Of 659 abstracted articles 56 identified procedural assessment tools. Only 11 specifically assessed medical students. The final 11 studies consisted of 1 randomised controlled trial, 4 comparative and 6 descriptive studies yielding 12 heterogeneous procedural assessment tools for analysis. Seven tools addressed four discrete pre-certification skills, basic suture (3), airway management (2), nasogastric tube insertion (1) and intravenous cannulation (1). One tool used a generic assessment of procedural skills. Two tools focused on postgraduate laparoscopic skills and one on osteopathic students and thus were not included in this review. The levels of evidence are low with regard to reliability - κ = 0.65-0.71 and minimum validity is achieved - face and content. In conclusion, there are no tools designed specifically to assess competence of procedural skills in a final certification examination. There is a need to develop standardised tools with proven reliability and validity for assessment of procedural skills competence at the end of medical training. Medicine graduates must have comparable levels of procedural skills acquisition entering the clinical workforce irrespective of the country of training.
Topics: Airway Management; Catheterization; Clinical Competence; Educational Measurement; Humans; Internship and Residency; Intubation, Gastrointestinal; Reproducibility of Results; Students, Medical; Suture Techniques
PubMed: 22927716
DOI: 10.3402/meo.v17i0.18398 -
Clinical Biochemistry Sep 2012This article is a systematic review of the effectiveness of three practices for reducing blood culture contamination rates: venipuncture, phlebotomy teams, and... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
This article is a systematic review of the effectiveness of three practices for reducing blood culture contamination rates: venipuncture, phlebotomy teams, and prepackaged preparation/collection (prep) kits.
DESIGN AND METHODS
The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used.
RESULTS
Studies included as evidence were: 9 venipuncture (vs. versus intravenous catheter), 5 phlebotomy team; and 7 prep kit. All studies for venipuncture and phlebotomy teams favored these practices, with meta-analysis mean odds ratios for venipuncture of 2.69 and phlebotomy teams of 2.58. For prep kits 6 studies' effect sizes were not statistically significantly different from no effect (meta-analysis mean odds ratio 1.12).
CONCLUSIONS
Venipuncture and the use of phlebotomy teams are effective practices for reducing blood culture contamination rates in diverse hospital settings and are recommended as evidence-based "best practices" with high overall strength of evidence and substantial effect size ratings. No recommendation is made for or against prep kits based on uncertain improvement.
Topics: Bacteria; Blood; Cell Culture Techniques; Centers for Disease Control and Prevention, U.S.; Diagnostic Errors; Equipment Contamination; False Positive Reactions; Humans; Odds Ratio; Phlebotomy; Practice Guidelines as Topic; Program Evaluation; Quality Improvement; Reagent Kits, Diagnostic; United States
PubMed: 22709932
DOI: 10.1016/j.clinbiochem.2012.06.007 -
Journal of Hepatology Nov 2012Hemochromatosis is a disorder of the iron metabolism, characterized by high body iron content, necessitating frequent phlebotomies to remove excess iron. In some... (Review)
Review
Hemochromatosis is a disorder of the iron metabolism, characterized by high body iron content, necessitating frequent phlebotomies to remove excess iron. In some countries, this blood is discarded and not used for blood transfusion because of the non-voluntary character of this donation, and because a potential risk of microbial contamination of the donor blood is assumed. A systematic review was performed in order to collect and critically examine solid evidence with regard to the effectiveness and safety of blood for transfusion when derived from hemochromatosis patients who do not suffer from complications or organ damage. Using three databases (The Cochrane Library, MEDLINE, and Embase) we searched for studies from date of inception until January 2012. Out of 3470 articles, 80 references that were relevant to our question were selected, including many opinion pieces, comments, letters, and narrative reviews. Based on our selection criteria, we finally retained only six observational studies, so evidence on this subject is scarce and furthermore, the strength of the available evidence is low to very low, due to poor study designs. We found no evidence that red blood cell concentrates from hemochromatosis patients without complications of iron overload do not comply with the physiological quality requirements for transfusion, nor that their blood would present a greater risk to recipient safety than blood from non-hemochromatosis donors. However, in vitro findings from two studies suggest that iron-overloaded patients would be more susceptible to bacterial growth, but future in vivo studies are warranted to confirm this. Based on this, we call for harmonization of the blood donor selection policy among countries allowing hemochromatosis patients who do not suffer from complications of iron overload to donate blood, once iron levels are normalized.
Topics: Belgium; Blood Donors; Blood Transfusion; Hemochromatosis; Humans; Iron; Risk Factors
PubMed: 22659521
DOI: 10.1016/j.jhep.2012.04.040 -
The Cochrane Database of Systematic... Oct 2011Heel lance has been the conventional method of blood sampling in neonates for screening tests. Neonates undergoing heel lance experience pain which cannot be completely... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Heel lance has been the conventional method of blood sampling in neonates for screening tests. Neonates undergoing heel lance experience pain which cannot be completely alleviated.
OBJECTIVES
To determine whether venepuncture or heel lance is less painful and more effective for blood sampling in term neonates.
SEARCH STRATEGY
Randomized or quasi-randomised controlled trials comparing pain response to venepuncture versus heel lance were identified by searching the Cochrane Central Regsiter of Controlled Trials (CENTRAL, The Cochrane Library), MEDLINE, EMBASE, CINAHL, and clinical trials registries in May 2011.
SELECTION CRITERIA
Trials comparing pain response to venepuncture versus heel lance with or with out the use of a sweet tasting solution as a co-intervention in term neonates.
DATA COLLECTION AND ANALYSIS
Outcomes included pain response to venepuncture versus heel lance with or without the use of a sweet tasting solution using validated pain measures, the need of repeat sampling and cry characteristics. Analyses included typical relative risk (RR), risk difference (RD), number needed to treat (NNT), weighted mean difference (WMD) and standardized mean difference (SMD) with their 95% confidence intervals (CI). Between study heterogeneity was reported including the I squared (I(2)) test.
MAIN RESULTS
Six studies (n = 478) of variable quality were included. A composite outcome of Infant Pain Scale (NIPS), Neonatal Facial Action Coding System (NFCS) and/or Premature Infant Pain Profile (PIPP) score was reported in 288 infants, who did not receive a sweet tasting solution. Meta-analysis showed a significant reduction in the venepuncture versus the heel lance group (SMD -0.76, 95% CI -1.00 to -0.52; I(2) = 0%). When a sweet tasting solution was provided the SMD remained significant favouring the venepuncture group (SMD - 0.38, 95% CI -0.69 to -0.07). The typical RD for requiring more than one skin puncture for venepuncture versus heel lance (reported in 4 studies; n = 254) was -0.34 (95% CI -0.43 to -0.25; I(2) = 97%). The NNT to avoid one repeat skin puncture was 3 (95% CI 2 to 4). Cry characteristics favoured the venepuncture group but the differences were reduced by the provision of sweet tasting solutions prior to either procedure.
AUTHORS' CONCLUSIONS
Venepuncture, when performed by a skilled phlebotomist, appears to be the method of choice for blood sampling in term neonates. The use of a sweet tasting solution further reduces the pain.Further well designed randomised controlled trials should be conducted in settings where several individuals perform the procedures.
Topics: Blood Specimen Collection; Heel; Humans; Infant, Newborn; Pain; Phlebotomy; Punctures; Randomized Controlled Trials as Topic
PubMed: 21975734
DOI: 10.1002/14651858.CD001452.pub4 -
BMJ Clinical Evidence Apr 2011Preterm or ill neonates may undergo 1 to 21 heel punctures or venepunctures a day. These punctures are likely to be painful. Heel punctures comprise 61% to 87% and... (Review)
Review
INTRODUCTION
Preterm or ill neonates may undergo 1 to 21 heel punctures or venepunctures a day. These punctures are likely to be painful. Heel punctures comprise 61% to 87% and venepunctures comprise 8% to 13% of the invasive procedures performed on ill infants. Analgesics are rarely given specifically for blood sampling procedures, but 5% to 19% of infants receive analgesia for other indications.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to reduce pain-related distress and morbidity during venepuncture in preterm or term babies aged under 12 months in a neonatal unit? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 20 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: oral sweet solutions; pacifiers; and topical anaesthetics (lidocaine-prilocaine cream, tetracaine).
Topics: Administration, Oral; Analgesics; Blood Specimen Collection; Double-Blind Method; Humans; Infant; Pain; Pain Measurement; Phlebotomy; Punctures; Tetracaine
PubMed: 21463539
DOI: No ID Found -
Alternative Therapies in Health and... 2010Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have beneficial effect on herpes zoster compared with Western medication.
METHODS
We included randomized controlled trials (RCTs) on wet cupping for herpes zoster. We searched PubMed, the Cochrane Library (Issue 3, 2008), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journals Fulltext Database VIP, and Wan Fang Database. All searches ended in February 2009. Two authors extracted data and assessed the trials' quality independently. RevMan 5.0.18 software (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark) was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI).
RESULTS
Eight RCTs involving 651 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding, and intention-to-treat analysis. Meta-analyses showed wet cupping was superior to medication in the number of cured patients (RR 2.49, 95% CI 1.91 to 3.24, P < .00001), the number of patients with improved symptoms (RR 1.15, 95% CI 1.05 to 1.26, P = .003), and reducing the incidence rate of postherpetic neuralgia (RR 0.06, 95% CI 0.02 to 0.25, P = .0001). Wet cupping plus medication was significantly better than medication alone on number of cured patients (RR 1.93, 95% CI 1.23 to 3.04, P = .005) but demonstrated no difference in symptom improvement (RR 1.00, 95% CI 0.92 to 1.08, P = .98). There were no serious adverse effects related to wet cupping therapy in the included trials.
CONCLUSION
Wet cupping appears to be effective in the treatment of herpes zoster. However, further large, rigorously designed
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Bloodletting; Child; China; Denmark; Female; Herpes Zoster; Humans; Male; Medicine, Chinese Traditional; Middle Aged; Outcome Assessment, Health Care; Phytotherapy; Randomized Controlled Trials as Topic; Risk; Treatment Outcome; Young Adult
PubMed: 21280462
DOI: No ID Found -
Annals of Hematology Aug 2009Polycythemia vera (PV) in children and adolescents is very rare. Data on clinical and laboratory evaluations as well as on treatment modalities are sparse. Here, we... (Review)
Review
Polycythemia vera (PV) in children and adolescents is very rare. Data on clinical and laboratory evaluations as well as on treatment modalities are sparse. Here, we report the long-term clinical course of a PV patient first diagnosed more than 40 years ago at age 12. In addition, after a systematic review of the scientific medical literature, clinical and hematological data of 35 patients (19 female and 17 male) from 25 previous reports are summarized. Three patients developed PV following antecedent hematological malignancies. Budd-Chiari syndrome was diagnosed in seven patients indicating a particular risk of young patients of developing this disorder. One patient presented with ischemic stroke, one patient with gangrene, and three patients with severe hemorrhage. Three patients died from disease-related complications. Hematocrit levels and platelet counts were not correlated with disease severity. Leukocytosis >15 x 10(9)/L was present in 9/35 patients and associated with a thromboembolic or hemorrhagic complication in seven patients. The few available data on molecular genetics and endogenous erythroid colony growth indicate changes comparable to those detectable in adult patients. Treatment varied enormously. It included aspirin, phlebotomy, hydroxycarbamide, busulfan, melphalan, pyrimethamine, and interferon-alpha. Two patients successfully underwent stem cell transplantation. Currently, it is impossible to treat an individual pediatric PV patient with an evidence-based regimen.
Topics: Adolescent; Budd-Chiari Syndrome; Child; Erythropoiesis; Hematologic Neoplasms; Hematologic Tests; Humans; Middle Aged; Polycythemia; Polycythemia Vera
PubMed: 19468728
DOI: 10.1007/s00277-009-0758-y