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The Cochrane Database of Systematic... Apr 2016Midwives are primary providers of care for childbearing women around the world. However, there is a lack of synthesised information to establish whether there are... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Midwives are primary providers of care for childbearing women around the world. However, there is a lack of synthesised information to establish whether there are differences in morbidity and mortality, effectiveness and psychosocial outcomes between midwife-led continuity models and other models of care.
OBJECTIVES
To compare midwife-led continuity models of care with other models of care for childbearing women and their infants.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (25 January 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
All published and unpublished trials in which pregnant women are randomly allocated to midwife-led continuity models of care or other models of care during pregnancy and birth.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. The quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS
We included 15 trials involving 17,674 women. We assessed the quality of the trial evidence for all primary outcomes (i.e. regional analgesia (epidural/spinal), caesarean birth, instrumental vaginal birth (forceps/vacuum), spontaneous vaginal birth, intact perineum, preterm birth (less than 37 weeks) and all fetal loss before and after 24 weeks plus neonatal death using the GRADE methodology: all primary outcomes were graded as of high quality.For the primary outcomes, women who had midwife-led continuity models of care were less likely to experience regional analgesia (average risk ratio (RR) 0.85, 95% confidence interval (CI) 0.78 to 0.92; participants = 17,674; studies = 14; high quality), instrumental vaginal birth (average RR 0.90, 95% CI 0.83 to 0.97; participants = 17,501; studies = 13; high quality), preterm birth less than 37 weeks (average RR 0.76, 95% CI 0.64 to 0.91; participants = 13,238; studies = eight; high quality) and less all fetal loss before and after 24 weeks plus neonatal death (average RR 0.84, 95% CI 0.71 to 0.99; participants = 17,561; studies = 13; high quality evidence). Women who had midwife-led continuity models of care were more likely to experience spontaneous vaginal birth (average RR 1.05, 95% CI 1.03 to 1.07; participants = 16,687; studies = 12; high quality). There were no differences between groups for caesarean births or intact perineum.For the secondary outcomes, women who had midwife-led continuity models of care were less likely to experience amniotomy (average RR 0.80, 95% CI 0.66 to 0.98; participants = 3253; studies = four), episiotomy (average RR 0.84, 95% CI 0.77 to 0.92; participants = 17,674; studies = 14) and fetal loss less than 24 weeks and neonatal death (average RR 0.81, 95% CI 0.67 to 0.98; participants = 15,645; studies = 11). Women who had midwife-led continuity models of care were more likely to experience no intrapartum analgesia/anaesthesia (average RR 1.21, 95% CI 1.06 to 1.37; participants = 10,499; studies = seven), have a longer mean length of labour (hours) (mean difference (MD) 0.50, 95% CI 0.27 to 0.74; participants = 3328; studies = three) and more likely to be attended at birth by a known midwife (average RR 7.04, 95% CI 4.48 to 11.08; participants = 6917; studies = seven). There were no differences between groups for fetal loss equal to/after 24 weeks and neonatal death, induction of labour, antenatal hospitalisation, antepartum haemorrhage, augmentation/artificial oxytocin during labour, opiate analgesia, perineal laceration requiring suturing, postpartum haemorrhage, breastfeeding initiation, low birthweight infant, five-minute Apgar score less than or equal to seven, neonatal convulsions, admission of infant to special care or neonatal intensive care unit(s) or in mean length of neonatal hospital stay (days).Due to a lack of consistency in measuring women's satisfaction and assessing the cost of various maternity models, these outcomes were reported narratively. The majority of included studies reported a higher rate of maternal satisfaction in midwife-led continuity models of care. Similarly, there was a trend towards a cost-saving effect for midwife-led continuity care compared to other care models.
AUTHORS' CONCLUSIONS
This review suggests that women who received midwife-led continuity models of care were less likely to experience intervention and more likely to be satisfied with their care with at least comparable adverse outcomes for women or their infants than women who received other models of care.Further research is needed to explore findings of fewer preterm births and fewer fetal deaths less than 24 weeks, and all fetal loss/neonatal death associated with midwife-led continuity models of care.
Topics: Amnion; Analgesia, Obstetrical; Cesarean Section; Continuity of Patient Care; Episiotomy; Female; Humans; Infant; Infant Mortality; Infant, Newborn; Midwifery; Models, Organizational; Patient Satisfaction; Perinatal Care; Postnatal Care; Pregnancy; Prenatal Care; Randomized Controlled Trials as Topic
PubMed: 27121907
DOI: 10.1002/14651858.CD004667.pub5 -
Journal of Pediatric Nursing 2021Effective pain management is the key to improving not only patient outcomes but also patient satisfaction. Patient controlled analgesia (PCA) is a pain management method...
PROBLEM
Effective pain management is the key to improving not only patient outcomes but also patient satisfaction. Patient controlled analgesia (PCA) is a pain management method that allows the patient to self-administer their medication. Because of the great variety of physical and cognitive abilities in the pediatric population, involvement of a nurse or parent proxy is necessary.
PURPOSE
The purpose of this study was to ascertain the most effective approaches to PCA in pediatric settings.
ELIGIBILITY CRITERIA
Criteria for articles selection were as follows: (a) published in a peer-review journal, (b) between 2014 and 2019, (c) in English, (d) directly addressing the issues of safety and efficacy of patient-controlled analgesia by proxy in the pediatric patient population.
SAMPLE
Databases used in the search included CINAHL Plus with Full Text, DynaMed, MedLine with Full Text, and ScienceDirect. Combinations of the following keywords were used to search each database: "nurse controlled analgesia", "parent controlled analgesia", "patient controlled analgesia by proxy", "NCA", "P/NCA", "PCA by proxy", "pediatrics", "children", "pediatric patients". Database searches yielded 172 results. Articles that were duplicated, missing inclusion criteria or did not directly address the issues of safety and efficacy of PCA by proxy were removed. Eleven articles fit the selection criteria.
RESULTS
Eleven articles were included in the final report. The themes that emerged from the analysis included pain management of neonates and infants, children with developmental disabilities, children with cancer, as well as the sources and possible solutions to errors in medication preparation.
CONCLUSIONS
It was concluded that PCA by proxy remains a safe and efficient method of pain administration for the pediatric population, with the exception of children suffering from developmental and neurological disabilities.
IMPLICATIONS
PCA by proxy, although presenting challenges, remains a safe and efficient way of pain management across different pediatric populations, such as infants and neonates or children with cancer, both inpatient and outpatient, and new technologies could positively influence the safety of this method of pain management. Conversely, children with developmental and neurological disabilities do not benefit from this method of pain management and are more prone to experiencing adverse effects.
Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Child; Humans; Infant; Infant, Newborn; Pain Management; Pain, Postoperative; Parents; Patient Satisfaction; Pediatrics
PubMed: 34139608
DOI: 10.1016/j.pedn.2021.06.002 -
The Journal of Trauma and Acute Care... Dec 2023Patient-controlled analgesia (PCA) has potential as a form of analgesia for trauma patients in the emergency department (ED). The objective of this review was to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Patient-controlled analgesia (PCA) has potential as a form of analgesia for trauma patients in the emergency department (ED). The objective of this review was to evaluate the effectiveness and safety of PCA for the management of adults with acute traumatic pain in the ED. The hypothesis was that PCA can effectively treat acute trauma pain in adults in the ED, with minimal adverse outcomes and better patient satisfaction compared with non-PCA modalities.
METHODS
MEDLINE (PubMed), Embase, SCOPUS, ClinicalTrials.gov , and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched from inception date to December 13, 2022. Randomized controlled trials involving adults presenting to the ED with acute traumatic pain who received intravenous (IV) analgesia via PCA compared with other modalities were included. The Cochrane Risk of Bias tool and the Grading of Recommendation, Assessment, Development, and Evaluation approach were used to assess the quality of included studies.
RESULTS
A total of 1,368 publications were screened, with 3 studies involving 382 patients meeting the eligibility criteria. All three studies compared PCA IV morphine with clinician-titrated IV morphine boluses. For the primary outcome of pain relief, the pooled estimate was in favor of PCA with a standard mean difference of -0.36 (95% confidence interval, -0.87 to 0.16). There were mixed results concerning patient satisfaction. Adverse event rates were low overall. The evidence from all three studies was graded as low-quality because of a high risk of bias from lack of blinding.
CONCLUSION
This study did not demonstrate a significant improvement in pain relief or patient satisfaction using PCA for trauma in the ED. Clinicians wishing to use PCA to treat acute trauma pain in adult patients in the ED are advised to consider the available resources in their own practice settings and to implement protocols for monitoring and responding to potential adverse events.
LEVEL OF EVIDENCE
Systematic Review/Meta-Analyses; Level III.
Topics: Humans; Adult; Analgesia, Patient-Controlled; Pain Management; Acute Pain; Emergency Service, Hospital; Morphine
PubMed: 37335181
DOI: 10.1097/TA.0000000000004004 -
Anesthesia and Analgesia Oct 2016Bolus administration of opioids via a patient-controlled analgesia (PCA) device is widely used in the postoperative pediatric population. PCA devices have been shown to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Bolus administration of opioids via a patient-controlled analgesia (PCA) device is widely used in the postoperative pediatric population. PCA devices have been shown to provide superior analgesia and greater patient satisfaction compared with intermittent administration. Studies comparing the efficacy of PCA with and without a background infusion for postoperative analgesia in children vary considerably in terms of dosing and methodologic quality, making it difficult for practitioners to derive clinically useful information. The purpose of this meta-analysis was to assess whether the addition of a background infusion to PCA bolus administration of an opioid analgesic is more effective (defined as lower pain scores) than PCA bolus alone in the postoperative population specific to children.
METHODS
We searched Medline, Embase, and CENTRAL from inception to January 2015 for registered and ongoing trials included in the meta-Register of Controlled Trials and ClinicalTrials.gov, and reference lists of review articles and included articles. Study selection was randomized controlled studies comparing PCA bolus with PCA bolus plus background infusion for postoperative analgesia in children aged 0 to 18 years and adolescents aged 13 to 21 years undergoing any form of surgery that used patient-reported pain scores as an outcome measure. Two reviewers independently extracted data on patient and study characteristics, interventions, and outcomes from included studies using standardized data extraction forms. Seven trials met our eligibility criteria. Data were analyzed using Review Manager version 5.3. Meta-analyses were performed for outcomes that were defined similarly and reported in 2 or more studies, including patient-reported pain scores, nausea and/or vomiting, sedation, and opioid consumption. We independently assessed the risk of bias for each outcome and the certainty in the estimates of effect for critically important outcomes (pain scores, nausea and/or vomiting, excessive sedation) using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Subgroup analyses based on dose of background infusion (high versus low dose) and risk of bias (low versus high/unclear) were performed.
RESULTS
There were no significant differences found with respect to pain scores 12 and 24 hours after surgery, opioid consumption, or risk of adverse events with the addition of a background opioid infusion to PCA opioid bolus doses. The quality of the evidence was deemed to be low to very low.
CONCLUSIONS
There was no significant difference in outcomes with the addition of an opioid background infusion to PCA bolus doses of opioid. Further high-quality studies are required.
Topics: Adolescent; Analgesia, Patient-Controlled; Analgesics, Opioid; Child; Child, Preschool; Drug Therapy, Combination; Humans; Pain, Postoperative; Randomized Controlled Trials as Topic
PubMed: 27065359
DOI: 10.1213/ANE.0000000000001244 -
The Cochrane Database of Systematic... Jul 2017Historically, women have generally been attended and supported by other women during labour. However, in hospitals worldwide, continuous support during labour has often...
BACKGROUND
Historically, women have generally been attended and supported by other women during labour. However, in hospitals worldwide, continuous support during labour has often become the exception rather than the routine.
OBJECTIVES
The primary objective was to assess the effects, on women and their babies, of continuous, one-to-one intrapartum support compared with usual care, in any setting. Secondary objectives were to determine whether the effects of continuous support are influenced by:1. Routine practices and policies in the birth environment that may affect a woman's autonomy, freedom of movement and ability to cope with labour, including: policies about the presence of support people of the woman's own choosing; epidural analgesia; and continuous electronic fetal monitoring.2. The provider's relationship to the woman and to the facility: staff member of the facility (and thus has additional loyalties or responsibilities); not a staff member and not part of the woman's social network (present solely for the purpose of providing continuous support, e.g. a doula); or a person chosen by the woman from family members and friends;3. Timing of onset (early or later in labour);4. Model of support (support provided only around the time of childbirth or extended to include support during the antenatal and postpartum periods);5. Country income level (high-income compared to low- and middle-income).
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2016), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 June 2017) and reference lists of retrieved studies.
SELECTION CRITERIA
All published and unpublished randomised controlled trials, cluster-randomised trials comparing continuous support during labour with usual care. Quasi-randomised and cross-over designs were not eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We sought additional information from the trial authors. The quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS
We included a total of 27 trials, and 26 trials involving 15,858 women provided usable outcome data for analysis. These trials were conducted in 17 different countries: 13 trials were conducted in high-income settings; 13 trials in middle-income settings; and no studies in low-income settings. Women allocated to continuous support were more likely to have a spontaneous vaginal birth (average RR 1.08, 95% confidence interval (CI) 1.04 to 1.12; 21 trials, 14,369 women; low-quality evidence) and less likely to report negative ratings of or feelings about their childbirth experience (average RR 0.69, 95% CI 0.59 to 0.79; 11 trials, 11,133 women; low-quality evidence) and to use any intrapartum analgesia (average RR 0.90, 95% CI 0.84 to 0.96; 15 trials, 12,433 women). In addition, their labours were shorter (MD -0.69 hours, 95% CI -1.04 to -0.34; 13 trials, 5429 women; low-quality evidence), they were less likely to have a caesarean birth (average RR 0.75, 95% CI 0.64 to 0.88; 24 trials, 15,347 women; low-quality evidence) or instrumental vaginal birth (RR 0.90, 95% CI 0.85 to 0.96; 19 trials, 14,118 women), regional analgesia (average RR 0.93, 95% CI 0.88 to 0.99; 9 trials, 11,444 women), or a baby with a low five-minute Apgar score (RR 0.62, 95% CI 0.46 to 0.85; 14 trials, 12,615 women). Data from two trials for postpartum depression were not combined due to differences in women, hospitals and care providers included; both trials found fewer women developed depressive symptomatology if they had been supported in birth, although this may have been a chance result in one of the studies (low-quality evidence). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, such as admission to special care nursery (average RR 0.97, 95% CI 0.76 to 1.25; 7 trials, 8897 women; low-quality evidence), and exclusive or any breastfeeding at any time point (average RR 1.05, 95% CI 0.96 to 1.16; 4 trials, 5584 women; low-quality evidence).Subgroup analyses suggested that continuous support was most effective at reducing caesarean birth, when the provider was present in a doula role, and in settings in which epidural analgesia was not routinely available. Continuous labour support in settings where women were not permitted to have companions of their choosing with them in labour, was associated with greater likelihood of spontaneous vaginal birth and lower likelihood of a caesarean birth. Subgroup analysis of trials conducted in high-income compared with trials in middle-income countries suggests that continuous labour support offers similar benefits to women and babies for most outcomes, with the exception of caesarean birth, where studies from middle-income countries showed a larger reduction in caesarean birth. No conclusions could be drawn about low-income settings, electronic fetal monitoring, the timing of onset of continuous support or model of support.Risk of bias varied in included studies: no study clearly blinded women and personnel; only one study sufficiently blinded outcome assessors. All other domains were of varying degrees of risk of bias. The quality of evidence was downgraded for lack of blinding in studies and other limitations in study designs, inconsistency, or imprecision of effect estimates.
AUTHORS' CONCLUSIONS
Continuous support during labour may improve outcomes for women and infants, including increased spontaneous vaginal birth, shorter duration of labour, and decreased caesarean birth, instrumental vaginal birth, use of any analgesia, use of regional analgesia, low five-minute Apgar score and negative feelings about childbirth experiences. We found no evidence of harms of continuous labour support. Subgroup analyses should be interpreted with caution, and considered as exploratory and hypothesis-generating, but evidence suggests continuous support with certain provider characteristics, in settings where epidural analgesia was not routinely available, in settings where women were not permitted to have companions of their choosing in labour, and in middle-income country settings, may have a favourable impact on outcomes such as caesarean birth. Future research on continuous support during labour could focus on longer-term outcomes (breastfeeding, mother-infant interactions, postpartum depression, self-esteem, difficulty mothering) and include more woman-centred outcomes in low-income settings.
Topics: Cesarean Section; Delivery, Obstetric; Doulas; Female; Humans; Labor, Obstetric; Personal Autonomy; Pregnancy; Pregnancy Outcome; Professional-Patient Relations
PubMed: 28681500
DOI: 10.1002/14651858.CD003766.pub6 -
Lancet (London, England) Oct 2015Music is a non-invasive, safe, and inexpensive intervention that can be delivered easily and successfully. We did a systematic review and meta-analysis to assess whether... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Music is a non-invasive, safe, and inexpensive intervention that can be delivered easily and successfully. We did a systematic review and meta-analysis to assess whether music improves recovery after surgical procedures.
METHODS
We included randomised controlled trials (RCTs) of adult patients undergoing surgical procedures, excluding those involving the central nervous system or head and neck, published in any language. We included RCTs in which any form of music initiated before, during, or after surgery was compared with standard care or other non-drug interventions. We searched MEDLINE, Embase, CINAHL, and Cochrane Central. We did meta-analysis with RevMan (version 5.2), with standardised mean differences (SMD) and random-effects models, and used Stata (version 12) for meta-regression. This study is registered with PROSPERO, number CRD42013005220.
FINDINGS
We identified 4261 titles and abstracts, and included 73 RCTs in the systematic review, with size varying between 20 and 458 participants. Choice of music, timing, and duration varied. Comparators included routine care, headphones with no music, white noise, and undisturbed bed rest. Music reduced postoperative pain (SMD -0·77 [95% CI -0·99 to -0·56]), anxiety (-0·68 [-0·95 to -0·41]), and analgesia use (-0·37 [-0·54 to -0·20]), and increased patient satisfaction (1·09 [0·51 to 1·68]), but length of stay did not differ (SMD -0·11 [-0·35 to 0·12]). Subgroup analyses showed that choice of music and timing of delivery made little difference to outcomes. Meta-regression identified no causes of heterogeneity in eight variables assessed. Music was effective even when patients were under general anaesthetic.
INTERPRETATION
Music could be offered as a way to help patients reduce pain and anxiety during the postoperative period. Timing and delivery can be adapted to individual clinical settings and medical teams.
FUNDING
None.
Topics: Adult; Analgesia; Anxiety; Humans; Length of Stay; Music; Music Therapy; Pain, Postoperative; Patient Satisfaction; Postoperative Period
PubMed: 26277246
DOI: 10.1016/S0140-6736(15)60169-6 -
Frontiers in Pharmacology 2022To investigate the efficacy and safety of dexmedetomidine (DEX) for postoperative patient controlled intravenous analgesia (PCIA). Two investigators independently...
To investigate the efficacy and safety of dexmedetomidine (DEX) for postoperative patient controlled intravenous analgesia (PCIA). Two investigators independently searched Pubmed, Embase, Scopus, Cochrane Library and CBM for randomized controlled trials of DEX for PCIA. Thirty-seven studies with a total of 5,409 patients were included in this meta-analysis. Compared with analgesics alone, DEX for PCIA reduced pain score at 24 h [mean difference (MD) = -0.70; 95% confidence interval (CI): -0.85, -0.54; < 0.00001, = 90%] and 48 h postoperatively (MD = -0.43; 95% CI: -0.52, -0.34; < 0.00001, = 96%). Moreover, DEX reduced analgesics consumption during the first 24 h [standardized mean difference (SMD) = -0.25; 95% CI: -0.34, -0.16; < 0.00001, = 91%] and the number of resuscitation analgesics administered [odds ratio (OR) = 0.54; 95% CI: 0.44, 0.66; < 0.00001, = 72%]. Furthermore, DEX improved patient satisfaction (OR = 3.55; 95% CI: 2.36, 5.35; < 0.00001, = 60%), and reduced incidence of side effects, such as postoperative nausea and vomiting (PONV) (OR = 0.47; 95% CI: 0.39, 0.57; < 0.00001, = 59%) and pruritus after surgery (OR = 0.45; 95% CI: 0.30, 0.68; = 0.0001, = 0%). Besides, DEX attenuates inflammatory cytokine levels, such as IL-6 (MD = -5.73; 95% CI: -8.34, -3.12; < 0.00001, = 91%) and TNF-α (MD = -0.63; 95% CI: -0.76, -0.50; < 0.00001, = 89%). Finally, DEX increased the risk of bradycardia (OR = 1.66; 95% CI: 1.12, 2.45; = 0.01, = 15%), but the complication of hypotension did not differ between the two groups (OR = 1.30; 95% CI: 0.84, 2.04; = 0.25, = 0%). DEX is used for postoperative PCIA analgesia, which can significantly improve the analgesic effect, effectively control postoperative inflammatory response, reduce the dosage and adverse reactions of analgesics, and improve postoperative patient satisfaction. Of course, the impact of the immunosuppressive effect of DEX on the prognosis of patients needs further study. CRD42022340933, https://www.crd.york.ac.uk/prospero/.
PubMed: 36578546
DOI: 10.3389/fphar.2022.1028704 -
PloS One 2022Remifentanil patient-controlled analgesia (rPCA) and epidural analgesia (EA) has been used for pain relief in labor. We aimed to evaluate the efficacy and safety of rPCA... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Remifentanil patient-controlled analgesia (rPCA) and epidural analgesia (EA) has been used for pain relief in labor. We aimed to evaluate the efficacy and safety of rPCA versus EA in labor, to provide evidence support for clinical analgesia and pain care.
METHODS
We searched PubMed, EMBASE, ScienceDirect, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang and Weipu databases for RCTs comparing rPCA and EA in labor until February 15, 2022. Two researchers independently screened literature and extracted data. RevMan 5.3 software was used for data analysis.
RESULTS
A total of 10 RCTs involving 3086 parturients were enrolled, 1549 parturients received rPCA and 1537 received EA. Meta-analysis indicated that the incidence of intrapartum maternal fever within 1 hour of labor analgesia (OR = 0.43, 95%CI: 0.30~0.62), after 1 hour of labor analgesia (OR = 0.42, 95%CI: 0.20~0.90) in the rPCA was significantly less than that of EA (all P<0.05). The incidence of respiratory depression (OR = 3.56, 95%CI: 2.45~5.16, P<0.001) in the rPCA was significantly higher than that of EA. There were no significant differences in the incidence of Apgar scores<7 at 5 minutes (OR = 1.18, 95%CI: 0.71~1.96, P = 0.53), the patients' satisfaction of pain relief during labor analgesia (SMD = 0.03, 95%CI: -0.40~0.46, P = 0.90) between rPCA and EA (all P>0.05).
CONCLUSION
rPCA can be an optional alternative to EA with similar pain relief and less risk of intrapartum maternal fever. However, rPCA was associated with increased risk of respiratory depression. Future studies with rigorous design and larger sample size are needed to provide more reliable evidences for clinical rPCA and EA use.
Topics: Pregnancy; Female; Humans; Remifentanil; Analgesia, Epidural; Analgesics, Opioid; Labor Pain; Analgesia, Obstetrical; Analgesia, Patient-Controlled
PubMed: 36534641
DOI: 10.1371/journal.pone.0275716 -
The International Journal of... Apr 2021Transcranial direct current stimulation has shown promising clinical results, leading to increased demand for an evidence-based review on its clinical effects. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Transcranial direct current stimulation has shown promising clinical results, leading to increased demand for an evidence-based review on its clinical effects.
OBJECTIVE
We convened a team of transcranial direct current stimulation experts to conduct a systematic review of clinical trials with more than 1 session of stimulation testing: pain, Parkinson's disease motor function and cognition, stroke motor function and language, epilepsy, major depressive disorder, obsessive compulsive disorder, Tourette syndrome, schizophrenia, and drug addiction.
METHODS
Experts were asked to conduct this systematic review according to the search methodology from PRISMA guidelines. Recommendations on efficacy were categorized into Levels A (definitely effective), B (probably effective), C (possibly effective), or no recommendation. We assessed risk of bias for all included studies to confirm whether results were driven by potentially biased studies.
RESULTS
Although most of the clinical trials have been designed as proof-of-concept trials, some of the indications analyzed in this review can be considered as definitely effective (Level A), such as depression, and probably effective (Level B), such as neuropathic pain, fibromyalgia, migraine, post-operative patient-controlled analgesia and pain, Parkinson's disease (motor and cognition), stroke (motor), epilepsy, schizophrenia, and alcohol addiction. Assessment of bias showed that most of the studies had low risk of biases, and sensitivity analysis for bias did not change these results. Effect sizes vary from 0.01 to 0.70 and were significant in about 8 conditions, with the largest effect size being in postoperative acute pain and smaller in stroke motor recovery (nonsignificant when combined with robotic therapy).
CONCLUSION
All recommendations listed here are based on current published PubMed-indexed data. Despite high levels of evidence in some conditions, it must be underscored that effect sizes and duration of effects are often limited; thus, real clinical impact needs to be further determined with different study designs.
Topics: Brain Diseases; Evidence-Based Medicine; Humans; Mental Disorders; Pain; Practice Guidelines as Topic; Transcranial Direct Current Stimulation
PubMed: 32710772
DOI: 10.1093/ijnp/pyaa051 -
The Cochrane Database of Systematic... Sep 2023Total knee replacement (TKR) is a common intervention for people with end-stage symptomatic knee osteoarthritis, resulting in significant improvements in pain, function... (Review)
Review
BACKGROUND
Total knee replacement (TKR) is a common intervention for people with end-stage symptomatic knee osteoarthritis, resulting in significant improvements in pain, function and quality of life within three to six months. It is, however, acutely associated with pain, local oedema and blood loss. Post-operative management may include cryotherapy. This is the application of low temperatures to the skin surrounding the surgical site, through ice or cooled water, often delivered using specialised devices. This is an update of a review published in 2012.
OBJECTIVES
To evaluate the effect of cryotherapy in the acute phase after TKR (within 48 hours after surgery) on blood loss, pain, transfusion rate, range of motion, knee function, adverse events and withdrawals due to adverse events.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, as well as reference lists, related links and conference proceedings on 27 May 2022.
SELECTION CRITERIA
We included randomised controlled trials or controlled clinical trials comparing cryotherapy with or without other treatments (such as compression, regional nerve block or continuous passive motion) to no treatment, or the other treatment alone, following TKR for osteoarthritis.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies for inclusion, extracted data and assessed risk of bias and certainty of evidence using GRADE. We discussed any disagreements and consulted another review author to resolve them, if required. Major outcomes were blood loss, pain, transfusion rate, knee range of motion, knee function, total adverse events and withdrawals from adverse events. Minor outcomes were analgesia use, knee swelling, length of stay, quality of life, activity level and participant-reported global assessment of success.
MAIN RESULTS
We included 22 trials (20 randomised trials and two controlled clinical trials), with 1839 total participants. The mean ages reflected the TKR population, ranging from 64 to 74 years. Cryotherapy with compression was compared to no treatment in four studies, and to compression alone in nine studies. Cryotherapy without compression was compared to no treatment in eight studies. One study compared cryotherapy without compression to control with compression alone. We combined all control interventions in the primary analysis. Certainty of evidence was low for blood loss (downgraded for bias and inconsistency), pain (downgraded twice for bias) and range of motion (downgraded for bias and indirectness). It was very low for transfusion rate (downgraded for bias, inconsistency and imprecision), function (downgraded twice for bias and once for inconsistency), total adverse events (downgraded for bias, indirectness and imprecision) and withdrawals from adverse events (downgraded for bias, indirectness and imprecision). The nature of cryotherapy made blinding difficult and most studies had a high risk of performance and detection bias. Low-certainty evidence from 12 trials (956 participants) shows that cryotherapy may reduce blood loss at one to 13 days after surgery. Blood loss was 825 mL with no cryotherapy and 561 mL with cryotherapy: mean difference (MD) 264 mL less (95% confidence interval (CI) 7 mL less to 516 mL less). Low-certainty evidence from six trials (530 participants) shows that cryotherapy may slightly improve pain at 48 hours on a 0- to 10-point visual analogue scale (lower scores indicate less pain). Pain was 4.8 points with no cryotherapy and 3.16 points with cryotherapy: MD 1.6 points lower (95% CI 2.3 lower to 1.0 lower). We are uncertain whether cryotherapy improves transfusion rate at zero to 13 days after surgery. The transfusion rate was 37% with no cryotherapy and 79% with cryotherapy (risk ratio (RR) 2.13, 95% CI 0.04 to 109.63; 2 trials, 91 participants; very low-certainty evidence). Low-certainty evidence from three trials (174 participants) indicates cryotherapy may improve range of motion at discharge: it was 62.9 degrees with no cryotherapy and 71.2 degrees with cryotherapy: MD 8.3 degrees greater (95% CI 3.6 degrees more to 13.1 degrees more). We are uncertain whether cryotherapy improves function two weeks after surgery. Function was 75.4 points on the 0- to 100-point Dutch Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale (lower score indicates worse function) in the control group and 88.6 points with cryotherapy (MD 13.2 points better, 95% CI 0.5 worse to 27.1 improved; 4 trials, 296 participants; very low-certainty evidence). We are uncertain whether cryotherapy reduces total adverse events: the risk ratio was 1.30 (95% CI 0.53 to 3.20; 16 trials, 1199 participants; very low-certainty evidence). Adverse events included discomfort, local skin reactions, superficial infections, cold-induced injuries and thrombolytic events. We are uncertain whether cryotherapy reduces withdrawals from adverse events (RR 2.71, 95% CI 0.42 to 17.38; 19 trials, 1347 participants; very low-certainty evidence). No significant benefit was found for secondary outcomes of analgesia use, length of stay, activity level or quality of life. Evidence from seven studies (403 participants) showed improved mid-patella swelling between two and six days after surgery (MD 7.32 mm less, 95% CI 11.79 to 2.84 lower), though not at six weeks and three months after surgery. The included studies did not assess participant-reported global assessment of success.
AUTHORS' CONCLUSIONS
The certainty of evidence was low for blood loss, pain and range of motion, and very low for transfusion rate, function, total adverse events and withdrawals from adverse events. We are uncertain whether cryotherapy improves transfusion rate, function, total adverse events or withdrawals from adverse events. We downgraded evidence for bias, indirectness, imprecision and inconsistency. Hence, the potential benefits of cryotherapy on blood loss, pain and range of motion may be too small to justify its use. More well-designed randomised controlled trials focusing especially on clinically meaningful outcomes, such as blood transfusion, and patient-reported outcomes, such as knee function, quality of life, activity level and participant-reported global assessment of success, are required.
Topics: Humans; Middle Aged; Aged; Arthroplasty, Replacement, Knee; Quality of Life; Cryotherapy; Knee Joint; Pain
PubMed: 37706609
DOI: 10.1002/14651858.CD007911.pub3