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JAMA Otolaryngology-- Head & Neck... Mar 2017Head and neck cancers often require complex, labor-intensive surgeries, especially when free flap reconstruction is required. Enhanced recovery is important in this... (Review)
Review
Optimal Perioperative Care in Major Head and Neck Cancer Surgery With Free Flap Reconstruction: A Consensus Review and Recommendations From the Enhanced Recovery After Surgery Society.
IMPORTANCE
Head and neck cancers often require complex, labor-intensive surgeries, especially when free flap reconstruction is required. Enhanced recovery is important in this patient population but evidence-based protocols on perioperative care for this population are lacking.
OBJECTIVE
To provide a consensus-based protocol for optimal perioperative care of patients undergoing head and neck cancer surgery with free flap reconstruction.
EVIDENCE REVIEW
Following endorsement by the Enhanced Recovery After Surgery (ERAS) Society to develop this protocol, a systematic review was conducted for each topic. The PubMed and Cochrane databases were initially searched to identify relevant publications on head and neck cancer surgery from 1965 through April 2015. Consistent key words for each topic included "head and neck surgery," "pharyngectomy," "laryngectomy," "laryngopharyngectomy," "neck dissection," "parotid lymphadenectomy," "thyroidectomy," "oral cavity resection," "glossectomy," and "head and neck." The final selection of literature included meta-analyses and systematic reviews as well as randomized controlled trials where available. In the absence of high-level data, case series and nonrandomized studies in head and neck cancer surgery patients or randomized controlled trials and systematic reviews in non-head and neck cancer surgery patients, were considered. An international panel of experts in major head and neck cancer surgery and enhanced recovery after surgery reviewed and assessed the literature for quality and developed recommendations for each topic based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. All recommendations were graded following a consensus discussion among the expert panel.
FINDINGS
The literature search, including a hand search of reference lists, identified 215 relevant publications that were considered to be the best evidence for the topic areas. A total of 17 topic areas were identified for inclusion in the protocol for the perioperative care of patients undergoing major head and neck cancer surgery with free flap reconstruction. Best practice includes several elements of perioperative care. Among these elements are the provision of preoperative carbohydrate treatment, pharmacologic thromboprophylaxis, perioperative antibiotics in clean-contaminated procedures, corticosteroid and antiemetic medications, short acting anxiolytics, goal-directed fluid management, opioid-sparing multimodal analgesia, frequent flap monitoring, early mobilization, and the avoidance of preoperative fasting.
CONCLUSIONS AND RELEVANCE
The evidence base for specific perioperative care elements in head and neck cancer surgery is variable and in many cases information from different surgerical procedures form the basis for these recommendations. Clinical evaluation of these recommendations is a logical next step and further research in this patient population is warranted.
Topics: Free Tissue Flaps; Head and Neck Neoplasms; Humans; Nutritional Support; Patient Education as Topic; Perioperative Care; Plastic Surgery Procedures
PubMed: 27737447
DOI: 10.1001/jamaoto.2016.2981 -
Anaesthesia May 2021Caesarean section is associated with moderate-to-severe postoperative pain, which can influence postoperative recovery and patient satisfaction as well as breastfeeding...
Caesarean section is associated with moderate-to-severe postoperative pain, which can influence postoperative recovery and patient satisfaction as well as breastfeeding success and mother-child bonding. The aim of this systematic review was to update the available literature and develop recommendations for optimal pain management after elective caesarean section under neuraxial anaesthesia. A systematic review utilising procedure-specific postoperative pain management (PROSPECT) methodology was undertaken. Randomised controlled trials published in the English language between 1 May 2014 and 22 October 2020 evaluating the effects of analgesic, anaesthetic and surgical interventions were retrieved from MEDLINE, Embase and Cochrane databases. Studies evaluating pain management for emergency or unplanned operative deliveries or caesarean section performed under general anaesthesia were excluded. A total of 145 studies met the inclusion criteria. For patients undergoing elective caesarean section performed under neuraxial anaesthesia, recommendations include intrathecal morphine 50-100 µg or diamorphine 300 µg administered pre-operatively; paracetamol; non-steroidal anti-inflammatory drugs; and intravenous dexamethasone administered after delivery. If intrathecal opioid was not administered, single-injection local anaesthetic wound infiltration; continuous wound local anaesthetic infusion; and/or fascial plane blocks such as transversus abdominis plane or quadratus lumborum blocks are recommended. The postoperative regimen should include regular paracetamol and non-steroidal anti-inflammatory drugs with opioids used for rescue. The surgical technique should include a Joel-Cohen incision; non-closure of the peritoneum; and abdominal binders. Transcutaneous electrical nerve stimulation could be used as analgesic adjunct. Some of the interventions, although effective, carry risks, and consequentially were omitted from the recommendations. Some interventions were not recommended due to insufficient, inconsistent or lack of evidence. Of note, these recommendations may not be applicable to unplanned deliveries or caesarean section performed under general anaesthesia.
Topics: Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Cesarean Section; Dexamethasone; Female; Humans; Injections, Spinal; Pain Management; Pain, Postoperative; Pregnancy
PubMed: 33370462
DOI: 10.1111/anae.15339 -
The Cochrane Database of Systematic... May 2018Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain, and is widely used as a form... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain, and is widely used as a form of pain relief in labour. However, there are concerns about unintended adverse effects on the mother and infant. This is an update of an existing Cochrane Review (Epidural versus non-epidural or no analgesia in labour), last published in 2011.
OBJECTIVES
To assess the effectiveness and safety of all types of epidural analgesia, including combined-spinal-epidural (CSE) on the mother and the baby, when compared with non-epidural or no pain relief during labour.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (ClinicalTrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) (30 April 2017), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials comparing all types of epidural with any form of pain relief not involving regional blockade, or no pain relief in labour. We have not included cluster-randomised or quasi-randomised trials in this update.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risks of bias, extracted data and checked them for accuracy. We assessed selected outcomes using the GRADE approach.
MAIN RESULTS
Fifty-two trials met the inclusion criteria and we have included data from 40 trials, involving over 11,000 women. Four trials included more than two arms. Thirty-four trials compared epidural with opioids, seven compared epidural with no analgesia, one trial compared epidural with acu-stimulation, one trial compared epidural with inhaled analgesia, and one trial compared epidural with continuous midwifery support and other analgesia. Risks of bias varied throughout the included studies; six out of 40 studies were at high or unclear risk of bias for every bias domain, while most studies were at high or unclear risk of detection bias. Quality of the evidence assessed using GRADE ranged from moderate to low quality.Pain intensity as measured using pain scores was lower in women with epidural analgesia when compared to women who received opioids (standardised mean difference -2.64, 95% confidence interval (CI) -4.56 to -0.73; 1133 women; studies = 5; I = 98%; low-quality evidence) and a higher proportion were satisfied with their pain relief, reporting it to be "excellent or very good" (average risk ratio (RR) 1.47, 95% CI 1.03 to 2.08; 1911 women; studies = 7; I = 97%; low-quality evidence). There was substantial statistical heterogeneity in both these outcomes. There was a substantial decrease in the need for additional pain relief in women receiving epidural analgesia compared with opioid analgesia (average RR 0.10, 95% CI 0.04 to 0.25; 5099 women; studies = 16; I = 73%; Tau = 1.89; Chi = 52.07 (P < 0.00001)). More women in the epidural group experienced assisted vaginal birth (RR 1.44, 95% CI 1.29 to 1.60; 9948 women; studies = 30; low-quality evidence). A post hoc subgroup analysis of trials conducted after 2005 showed that this effect is negated when trials before 2005 are excluded from this analysis (RR 1.19, 95% CI 0.97 to 1.46). There was no difference between caesarean section rates (RR 1.07, 95% CI 0.96 to 1.18; 10,350 women; studies = 33; moderate-quality evidence), and maternal long-term backache (RR 1.00, 95% CI 0.89 to 1.12; 814 women; studies = 2; moderate-quality evidence). There were also no clear differences between groups for the neonatal outcomes, admission to neonatal intensive care unit (RR 1.03, 95% CI 0.95 to 1.12; 4488 babies; studies = 8; moderate-quality evidence) and Apgar score less than seven at five minutes (RR 0.73, 95% CI 0.52 to 1.02; 8752 babies; studies = 22; low-quality evidence). We downgraded the evidence for study design limitations, inconsistency, imprecision in effect estimates, and possible publication bias.Side effects were reported in both epidural and opioid groups. Women with epidural experienced more hypotension, motor blockade, fever, and urinary retention. They also had longer first and second stages of labour, and were more likely to have oxytocin augmentation than the women in the opioid group. Women receiving epidurals had less risk of respiratory depression requiring oxygen, and were less likely to experience nausea and vomiting than women receiving opioids. Babies born to women in the epidural group were less likely to have received naloxone. There was no clear difference between groups for postnatal depression, headache, itching, shivering, or drowsiness. Maternal morbidity and long-term neonatal outcomes were not reported.Epidural analgesia resulted in less reported pain when compared with placebo or no treatment, and with acu-stimulation. Pain intensity was not reported in the trials that compared epidural with inhaled analgesia, or continuous support. Few trials reported on serious maternal side effects.
AUTHORS' CONCLUSIONS
Low-quality evidence shows that epidural analgesia may be more effective in reducing pain during labour and increasing maternal satisfaction with pain relief than non-epidural methods. Although overall there appears to be an increase in assisted vaginal birth when women have epidural analgesia, a post hoc subgroup analysis showed this effect is not seen in recent studies (after 2005), suggesting that modern approaches to epidural analgesia in labour do not affect this outcome. Epidural analgesia had no impact on the risk of caesarean section or long-term backache, and did not appear to have an immediate effect on neonatal status as determined by Apgar scores or in admissions to neonatal intensive care. Further research may be helpful to evaluate rare but potentially severe adverse effects of epidural analgesia and non-epidural analgesia on women in labour and long-term neonatal outcomes.
Topics: Analgesia, Epidural; Analgesia, Obstetrical; Cesarean Section; Delivery, Obstetric; Female; Humans; Infant, Newborn; Intensive Care Units, Neonatal; Labor Pain; Labor, Obstetric; Patient Satisfaction; Pregnancy; Randomized Controlled Trials as Topic; Risk
PubMed: 29781504
DOI: 10.1002/14651858.CD000331.pub4 -
Pain Physician Nov 2017Music is increasingly used as an adjuvant for the management of chronic pain (CP), as it is non-invasive, inexpensive, and patients usually report positive experiences... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Music is increasingly used as an adjuvant for the management of chronic pain (CP), as it is non-invasive, inexpensive, and patients usually report positive experiences with it. However, little is known about its clinical efficacy in chronic pain patients.
OBJECTIVES
We aimed to determine the effect of music as an adjuvant for chronic pain, as well as to identify characteristics of music interventions associated with positive clinical outcomes.
STUDY DESIGN
In this systematic review and meta-analysis, we investigated randomized controlled trials (RCTs) of adult patients that reported any type of music intervention for chronic pain, chosen by the researcher or patient, lasting for any duration. Searches were performed using PsycINFO, Scopus, and PubMed for RCTs published until the end of May 2016. The primary outcome was reduction in self-reported pain using a standardized pain measurement instrument, reported post-intervention. The secondary outcomes were: quality of life measures, depression, anxiety, and related measures.
METHODS
The study was pre-registered with PROSPERO (CRD42016039837), and the meta-analysis was performed using RevMan 5.3 (The Nordic Cochrane Centre for The Cochrane Collaboration, Copenhagen, Denmark). We identified 768 titles and abstracts, and we included 14 RTCs that fulfilled our criteria. The sample size of the studies varied between 25 and 200 patients.
RESULTS
We found that music reduced self-reported chronic pain and depressive symptoms. We also found that music had a greater effect when the patient chose the music, compared to when the researcher chose it.
LIMITATIONS
The sample size of RCTs was small and sometimes with different outcome measures. There was high heterogeneity associated with pooled estimates.
CONCLUSIONS
Our analysis suggests that music may be beneficial as an adjuvant for chronic pain patients, as it reduces self-reported pain and its common comorbidities. Importantly, the analgesic effect of music appears higher with self-chosen over researcher-chosen music.
KEY WORDS
Pain, music, analgesia, music-induced analgesia, chronic pain, meta-analysis, systematic review, therapy.
Topics: Analgesia; Chronic Pain; Humans; Music; Music Therapy; Pain Management
PubMed: 29149141
DOI: No ID Found -
The Cochrane Database of Systematic... Mar 2018Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute to the popularity of complementary methods of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute to the popularity of complementary methods of pain management. This review examined currently available evidence on the use of relaxation therapies for pain management in labour. This is an update of a review first published in 2011.
OBJECTIVES
To examine the effects of mind-body relaxation techniques for pain management in labour on maternal and neonatal well-being during and after labour.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (9 May 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 5 2017), MEDLINE (1966 to 24 May 2017), CINAHL (1980 to 24 May 2017), the Australian New Zealand Clinical Trials Registry (18 May 2017), ClinicalTrials.gov (18 May 2017), the ISRCTN Register (18 May 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (18 May 2017), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (including quasi randomised and cluster trials) comparing relaxation methods with standard care, no treatment, other non-pharmacological forms of pain management in labour or placebo.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We attempted to contact study authors for additional information. We assessed evidence quality with GRADE methodology.
MAIN RESULTS
This review update includes 19 studies (2519 women), 15 of which (1731 women) contribute data. Interventions examined included relaxation, yoga, music and mindfulness. Approximately half of the studies had a low risk of bias for random sequence generation and attrition bias. The majority of studies had a high risk of bias for performance and detection bias, and unclear risk of bias for, allocation concealment, reporting bias and other bias. We assessed the evidence from these studies as ranging from low to very low quality, and therefore the effects below should be interpreted with caution.RelaxationWe found that relaxation compared to usual care provided lowered the intensity of pain (measured on a scale of 0 to 10 with low scores indicating less pain) during the latent phase of labour (mean difference (MD) -1.25, 95% confidence interval (CI) -1.97 to -0.53, one trial, 40 women). Four trials reported pain intensity in the active phase; there was high heterogeneity between trials and very low-quality evidence suggested that there was no strong evidence that the effects were any different between groups for this outcome (MD -1.08, 95% CI -2.57 to 0.41, four trials, 271 women, random-effects analysis). Very low-quality evidence showed that women receiving relaxation reported greater satisfaction with pain relief during labour (risk ratio (RR) 8.00, 95% CI 1.10 to 58.19, one trial, 40 women), and showed no clear benefit for satisfaction with childbirth experience (assessed using different scales) (standard mean difference (SMD) -0.03, 95% CI -0.37 to 0.31, three trials, 1176 women). For safety outcomes there was very low-quality evidence of no clear reduction in assisted vaginal birth (average RR 0.61, 95% CI 0.20 to 1.84, four trials, 1122 women) or in caesarean section rates (average RR 0.73, 95% CI 0.26 to 2.01, four trials, 1122 women). Sense of control in labour, and breastfeeding were not reported under this comparison.YogaWhen comparing yoga to control interventions there was low-quality evidence that yoga lowered pain intensity (measured on a scale of 0 to 10) with low scores indicating less pain) (MD -6.12, 95% CI -11.77 to -0.47, one trial, 66 women), greater satisfaction with pain relief (MD 7.88, 95% CI 1.51 to 14.25, one trial, 66 women) and greater satisfaction with childbirth experience (MD 6.34, 95% CI 0.26 to 12.42 one trial, 66 women (assessed using the Maternal Comfort Scale with higher score indicating greater comfort). Sense of control in labour, breastfeeding, assisted vaginal birth, and caesarean section were not reported under this comparison.MusicWhen comparing music to control interventions there was evidence of lower pain intensity in the latent phase for women receiving music (measured on a scale of 0 to 10 with low scores indicating less pain) (MD -0.73, 95% CI -1.01 to -0.45, random-effects analysis, two trials, 192 women) and very low-quality evidence of no clear benefit in the active phase (MD -0.51, 95% CI -1.10 to 0.07, three trials, 217 women). Very low-quality evidence suggested no clear benefit in terms of reducing assisted vaginal birth (RR 0.41, 95% CI 0.08 to 2.05, one trial, 156 women) or caesarean section rate (RR 0.78, 95% CI 0.36 to 1.70, two trials, 216 women). Satisfaction with pain relief, sense of control in labour, satisfaction with childbirth experience, and breastfeeding were not reported under this comparison.Audio analgesiaOne trial evaluating audio analgesia versus control only reported one outcome and showed no evidence of benefit in satisfaction with pain relief.MindfulnessOne trial evaluating mindfulness versus usual care found an increase in sense of control for the mindfulness group (using the Childbirth Self-Efficacy Inventory) (MD 31.30, 95% CI 1.61 to 60.99, 26 women). There is no strong evidence that the effects were any different between groups for satisfaction in childbirth, or for caesarean section rate, need for assisted vaginal delivery or need for pharmacological pain relief. No other outcomes were reported in this trial.
AUTHORS' CONCLUSIONS
Relaxation, yoga and music may have a role with reducing pain, and increasing satisfaction with pain relief, although the quality of evidence varies between very low to low. There was insufficient evidence for the role of mindfulness and audio-analgesia. The majority of trials did not report on the safety of the interventions. Further randomised controlled trials of relaxation modalities for pain management in labour are needed. Trials should be adequately powered and include clinically relevant outcomes such as those described in this review.
Topics: Analgesia, Obstetrical; Cesarean Section; Female; Humans; Labor Pain; Mindfulness; Music Therapy; Pain Management; Pain Measurement; Patient Satisfaction; Pregnancy; Randomized Controlled Trials as Topic; Relaxation Therapy; Supine Position; Yoga
PubMed: 29589650
DOI: 10.1002/14651858.CD009514.pub2 -
The Cochrane Database of Systematic... Mar 2017Empyema refers to pus in the pleural space, commonly due to adjacent pneumonia, chest wall injury, or a complication of thoracic surgery. A range of therapeutic options... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Empyema refers to pus in the pleural space, commonly due to adjacent pneumonia, chest wall injury, or a complication of thoracic surgery. A range of therapeutic options are available for its management, ranging from percutaneous aspiration and intercostal drainage to video-assisted thoracoscopic surgery (VATS) or thoracotomy drainage. Intrapleural fibrinolytics may also be administered following intercostal drain insertion to facilitate pleural drainage. There is currently a lack of consensus regarding optimal treatment.
OBJECTIVES
To assess the effectiveness and safety of surgical versus non-surgical treatments for complicated parapneumonic effusion or pleural empyema.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 9), MEDLINE (Ebscohost) (1946 to July week 3 2013, July 2015 to October 2016) and MEDLINE (Ovid) (1 May 2013 to July week 1 2015), Embase (2010 to October 2016), CINAHL (1981 to October 2016) and LILACS (1982 to October 2016) on 20 October 2016. We searched ClinicalTrials.gov and WHO International Clinical Trials Registry Platform for ongoing studies (December 2016).
SELECTION CRITERIA
Randomised controlled trials that compared a surgical with a non-surgical method of management for all age groups with pleural empyema.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked the data for accuracy. We contacted trial authors for additional information. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
We included eight randomised controlled trials with a total of 391 participants. Six trials focused on children and two on adults. Trials compared tube thoracostomy drainage (non-surgical), with or without intrapleural fibrinolytics, to either VATS or thoracotomy (surgical) for the management of pleural empyema. Assessment of risk of bias for the included studies was generally unclear for selection and blinding but low for attrition and reporting bias. Data analyses compared thoracotomy versus tube thoracostomy and VATS versus tube thoracostomy. We pooled data for meta-analysis where appropriate. We performed a subgroup analysis for children along with a sensitivity analysis for studies that used fibrinolysis in non-surgical treatment arms.The comparison of open thoracotomy versus thoracostomy drainage included only one study in children, which reported no deaths in either treatment arm. However, the trial showed a statistically significant reduction in mean hospital stay of 5.90 days for those treated with primary thoracotomy. It also showed a statistically significant reduction in procedural complications for those treated with thoracotomy compared to thoracostomy drainage. We downgraded the quality of the evidence for length of hospital stay and procedural complications outcomes to moderate due to the small sample size.The comparison of VATS versus thoracostomy drainage included seven studies, which we pooled in a meta-analysis. There was no statistically significant difference in mortality or procedural complications between groups. This was true for both adults and children with or without fibrinolysis. However, mortality data were limited: one study reported one death in each treatment arm, and seven studies reported no deaths. There was a statistically significant reduction in mean length of hospital stay for those treated with VATS. The subgroup analysis showed the same result in adults, but there was insufficient evidence to estimate an effect for children. We could not perform a separate analysis for fibrinolysis for this outcome because all included studies used fibrinolysis in the non-surgical arms. We downgraded the quality of the evidence to low for mortality (due to wide confidence intervals and indirectness), and moderate for other outcomes in this comparison due to either high heterogeneity or wide confidence intervals.
AUTHORS' CONCLUSIONS
Our findings suggest there is no statistically significant difference in mortality between primary surgical and non-surgical management of pleural empyema for all age groups. Video-assisted thoracoscopic surgery may reduce length of hospital stay compared to thoracostomy drainage alone.There was insufficient evidence to assess the impact of fibrinolytic therapy.A number of common outcomes were reported in the included studies that were not directly examined in our primary and secondary outcomes. These included duration of chest tube drainage, duration of fever, analgesia requirement, and total cost of treatment. Future studies focusing on patient-centred outcomes, such as patient functional scores, and other clinically relevant outcomes, such as radiographic improvement, treatment failure rates, and amount of fluid drainage, are needed to inform clinical decisions.
Topics: Adult; Child; Drainage; Empyema, Pleural; Humans; Length of Stay; Randomized Controlled Trials as Topic; Selection Bias; Thoracic Surgery, Video-Assisted; Thoracostomy; Thrombolytic Therapy
PubMed: 28304084
DOI: 10.1002/14651858.CD010651.pub2 -
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 -
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 -
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 -
JAMA Surgery Oct 2017There is increased interest in nonpharmacological treatments to reduce pain after total knee arthroplasty. Yet, little consensus supports the effectiveness of these... (Meta-Analysis)
Meta-Analysis Review
IMPORTANCE
There is increased interest in nonpharmacological treatments to reduce pain after total knee arthroplasty. Yet, little consensus supports the effectiveness of these interventions.
OBJECTIVE
To systematically review and meta-analyze evidence of nonpharmacological interventions for postoperative pain management after total knee arthroplasty.
DATA SOURCES
Database searches of MEDLINE (PubMed), EMBASE (OVID), Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, Web of Science (ISI database), Physiotherapy Evidence (PEDRO) database, and ClinicalTrials.gov for the period between January 1946 and April 2016.
STUDY SELECTION
Randomized clinical trials comparing nonpharmacological interventions with other interventions in combination with standard care were included.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently extracted the data from selected articles using a standardized form and assessed the risk of bias. A random-effects model was used for the analyses.
MAIN OUTCOMES AND MEASURES
Postoperative pain and consumption of opioids and analgesics.
RESULTS
Of 5509 studies, 39 randomized clinical trials were included in the meta-analysis (2391 patients). The most commonly performed interventions included continuous passive motion, preoperative exercise, cryotherapy, electrotherapy, and acupuncture. Moderate-certainty evidence showed that electrotherapy reduced the use of opioids (mean difference, -3.50; 95% CI, -5.90 to -1.10 morphine equivalents in milligrams per kilogram per 48 hours; P = .004; I2 = 17%) and that acupuncture delayed opioid use (mean difference, 46.17; 95% CI, 20.84 to 71.50 minutes to the first patient-controlled analgesia; P < .001; I2 = 19%). There was low-certainty evidence that acupuncture improved pain (mean difference, -1.14; 95% CI, -1.90 to -0.38 on a visual analog scale at 2 days; P = .003; I2 = 0%). Very low-certainty evidence showed that cryotherapy was associated with a reduction in opioid consumption (mean difference, -0.13; 95% CI, -0.26 to -0.01 morphine equivalents in milligrams per kilogram per 48 hours; P = .03; I2 = 86%) and in pain improvement (mean difference, -0.51; 95% CI, -1.00 to -0.02 on the visual analog scale; P < .05; I2 = 62%). Low-certainty or very low-certainty evidence showed that continuous passive motion and preoperative exercise had no pain improvement and reduction in opioid consumption: for continuous passive motion, the mean differences were -0.05 (95% CI, -0.35 to 0.25) on the visual analog scale (P = .74; I2 = 52%) and 6.58 (95% CI, -6.33 to 19.49) opioid consumption at 1 and 2 weeks (P = .32, I2 = 87%), and for preoperative exercise, the mean difference was -0.14 (95% CI, -1.11 to 0.84) on the Western Ontario and McMaster Universities Arthritis Index Scale (P = .78, I2 = 65%).
CONCLUSIONS AND RELEVANCE
In this meta-analysis, electrotherapy and acupuncture after total knee arthroplasty were associated with reduced and delayed opioid consumption.
Topics: Analgesics, Opioid; Arthroplasty, Replacement, Knee; Humans; Pain Management; Pain, Postoperative
PubMed: 28813550
DOI: 10.1001/jamasurg.2017.2872