Pub Date : 2025-02-27DOI: 10.1002/14651858.CD005187.pub6
Roger E Thomas, Tom Jefferson, Toby J Lasserson, Stan Earnshaw
<p><strong>Rationale: </strong>People who work in long-term care institutions (LTCIs), such as doctors, nurses, other health professionals, cleaners and porters (and also family visitors), may have substantial rates of influenza during influenza seasons. They often continue to work when infected with influenza, increasing the likelihood of transmitting influenza to those in their care. The immune systems of care home residents may be weaker than those of the general population; vaccinating care home workers could reduce transmission of influenza within LTCIs.</p><p><strong>Objectives: </strong>To assess the effects of vaccinating healthcare workers in long-term care institutions against influenza on influenza-related outcomes in residents aged 60 years or older.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (via Cochrane Library), MEDLINE (via Ovid), Embase (via Elsevier), Web of Science (Science Citation Index-Expanded and Conference Proceedings Citation Index - Science), and two clinical trials registries up to 22 August 2024.</p><p><strong>Eligibility criteria: </strong>In this version of the review we restricted eligibility to randomised controlled trials (RCTs) of influenza vaccination of healthcare workers (HCWs) caring for residents aged 60 years or older in LTCIs. Previously we included cohort or case-control studies.</p><p><strong>Outcomes: </strong>Outcomes of interest were: influenza (confirmed by laboratory tests) and its complications (lower respiratory tract infection; hospitalisation or death due to lower respiratory tract infection), all-cause mortality, and adverse events.</p><p><strong>Risk of bias: </strong>We used version one of the Cochrane risk of bias tool for RCTs.</p><p><strong>Synthesis methods: </strong>Two review authors independently extracted data and assessed the risk of bias. We used risk ratios (RRs) with 95% confidence intervals (CIs) to summarise the effects of vaccination on our outcomes of interest. We accounted for clustering by dividing events and sample sizes for each study by an assumed design effect as part of a sensitivity analysis. We used GRADE to assess the certainty of evidence for our outcomes of interest.</p><p><strong>Included studies: </strong>We did not identify any new trials for inclusion in this update. Four cluster-RCTs from Europe (8468 residents) of interventions to offer influenza vaccination for HCWs caring for residents ≥ 60 years in LTCIs provided outcome data that addressed the objectives of our review. The average age of the residents was between 77 and 86 years, and most were female (70% to 77%). The studies were comparable in their intervention and outcome measures. The studies did not report adverse events. The principal sources of bias in the studies related to attrition, lack of blinding, contamination in the control groups, and low rates of vaccination coverage in the intervention arms, leading us to downgrade the certaint
{"title":"Influenza vaccination for healthcare workers who care for people aged 60 or older living in long-term care institutions.","authors":"Roger E Thomas, Tom Jefferson, Toby J Lasserson, Stan Earnshaw","doi":"10.1002/14651858.CD005187.pub6","DOIUrl":"10.1002/14651858.CD005187.pub6","url":null,"abstract":"<p><strong>Rationale: </strong>People who work in long-term care institutions (LTCIs), such as doctors, nurses, other health professionals, cleaners and porters (and also family visitors), may have substantial rates of influenza during influenza seasons. They often continue to work when infected with influenza, increasing the likelihood of transmitting influenza to those in their care. The immune systems of care home residents may be weaker than those of the general population; vaccinating care home workers could reduce transmission of influenza within LTCIs.</p><p><strong>Objectives: </strong>To assess the effects of vaccinating healthcare workers in long-term care institutions against influenza on influenza-related outcomes in residents aged 60 years or older.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (via Cochrane Library), MEDLINE (via Ovid), Embase (via Elsevier), Web of Science (Science Citation Index-Expanded and Conference Proceedings Citation Index - Science), and two clinical trials registries up to 22 August 2024.</p><p><strong>Eligibility criteria: </strong>In this version of the review we restricted eligibility to randomised controlled trials (RCTs) of influenza vaccination of healthcare workers (HCWs) caring for residents aged 60 years or older in LTCIs. Previously we included cohort or case-control studies.</p><p><strong>Outcomes: </strong>Outcomes of interest were: influenza (confirmed by laboratory tests) and its complications (lower respiratory tract infection; hospitalisation or death due to lower respiratory tract infection), all-cause mortality, and adverse events.</p><p><strong>Risk of bias: </strong>We used version one of the Cochrane risk of bias tool for RCTs.</p><p><strong>Synthesis methods: </strong>Two review authors independently extracted data and assessed the risk of bias. We used risk ratios (RRs) with 95% confidence intervals (CIs) to summarise the effects of vaccination on our outcomes of interest. We accounted for clustering by dividing events and sample sizes for each study by an assumed design effect as part of a sensitivity analysis. We used GRADE to assess the certainty of evidence for our outcomes of interest.</p><p><strong>Included studies: </strong>We did not identify any new trials for inclusion in this update. Four cluster-RCTs from Europe (8468 residents) of interventions to offer influenza vaccination for HCWs caring for residents ≥ 60 years in LTCIs provided outcome data that addressed the objectives of our review. The average age of the residents was between 77 and 86 years, and most were female (70% to 77%). The studies were comparable in their intervention and outcome measures. The studies did not report adverse events. The principal sources of bias in the studies related to attrition, lack of blinding, contamination in the control groups, and low rates of vaccination coverage in the intervention arms, leading us to downgrade the certaint","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD005187"},"PeriodicalIF":8.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866472/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143514874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-27DOI: 10.1002/14651858.CD012570.pub2
Gan Mi Wang, Liang Jin Li, Linyi Fan, Meng Xu, Wen Lu Tang, James M Wright
<p><strong>Background: </strong>Renin inhibitors, which inhibit the first and rate-limiting step in the renin angiotensin system (RAS), are thought to be more effective than other RAS inhibitors in blocking the RAS. Previous meta-analyses have shown that renin inhibitors have a favourable tolerability profile in people with mild-to-moderate hypertension and a blood-pressure-lowering magnitude that is similar to that of angiotensin receptor blockers (ARBs). ARBs inhibit the RAS by interfering with the binding of angiotensin II with its receptors. ARBs are widely prescribed and recommended as first-line therapy by some hypertension guidelines. However, a drug's efficacy in lowering blood pressure cannot be considered as a definitive indicator of its effectiveness in reducing mortality and morbidity. The benefits and harms of renin inhibitors compared to ARBs in treating hypertension are unknown.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of renin inhibitors compared to angiotensin receptor blockers in people with primary hypertension.</p><p><strong>Search methods: </strong>On 26 January 2024, the Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials: Cochrane Hypertension's Specialised Register, Cochrane Central Register of Controlled Trials, Ovid MEDLINE, and Ovid Embase. The World Health Organization International Clinical Trials Registry Platform and the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) were also searched for ongoing trials. We contacted authors of relevant papers regarding further published and unpublished work and checked the bibliographies of included studies and relevant systematic reviews. The searches had no language restrictions.</p><p><strong>Selection criteria: </strong>We included randomised, double-blind, parallel-design clinical trials comparing renin inhibitors and ARBs for people with primary hypertension. Studies recruiting people with proven secondary hypertension were excluded.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected the included trials, evaluated the risks of bias using the RoB 1 tool, and entered the data for analysis. We reported dichotomous outcomes as a risk ratio (RR) with a 95% confidence interval (CI) and continuous variables as mean difference (MD) with a 95% CI. The primary outcomes were all-cause mortality, total cardiovascular events, end-stage renal disease (ESRD), withdrawal due to adverse effects (WDAE), serious adverse events (SAE), and adverse events. The secondary outcomes were fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, fatal heart failure or hospitalisation for heart failure, systolic and diastolic blood pressure (SBP and DBP), and heart rate. We used the GRADE approach to rate our confidence in the evidence.</p><p><strong>Main results: </strong>We included 11 double-blind RCTs involving 6780 participa
{"title":"Renin inhibitors versus angiotensin receptor blockers for primary hypertension.","authors":"Gan Mi Wang, Liang Jin Li, Linyi Fan, Meng Xu, Wen Lu Tang, James M Wright","doi":"10.1002/14651858.CD012570.pub2","DOIUrl":"10.1002/14651858.CD012570.pub2","url":null,"abstract":"<p><strong>Background: </strong>Renin inhibitors, which inhibit the first and rate-limiting step in the renin angiotensin system (RAS), are thought to be more effective than other RAS inhibitors in blocking the RAS. Previous meta-analyses have shown that renin inhibitors have a favourable tolerability profile in people with mild-to-moderate hypertension and a blood-pressure-lowering magnitude that is similar to that of angiotensin receptor blockers (ARBs). ARBs inhibit the RAS by interfering with the binding of angiotensin II with its receptors. ARBs are widely prescribed and recommended as first-line therapy by some hypertension guidelines. However, a drug's efficacy in lowering blood pressure cannot be considered as a definitive indicator of its effectiveness in reducing mortality and morbidity. The benefits and harms of renin inhibitors compared to ARBs in treating hypertension are unknown.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of renin inhibitors compared to angiotensin receptor blockers in people with primary hypertension.</p><p><strong>Search methods: </strong>On 26 January 2024, the Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials: Cochrane Hypertension's Specialised Register, Cochrane Central Register of Controlled Trials, Ovid MEDLINE, and Ovid Embase. The World Health Organization International Clinical Trials Registry Platform and the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) were also searched for ongoing trials. We contacted authors of relevant papers regarding further published and unpublished work and checked the bibliographies of included studies and relevant systematic reviews. The searches had no language restrictions.</p><p><strong>Selection criteria: </strong>We included randomised, double-blind, parallel-design clinical trials comparing renin inhibitors and ARBs for people with primary hypertension. Studies recruiting people with proven secondary hypertension were excluded.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected the included trials, evaluated the risks of bias using the RoB 1 tool, and entered the data for analysis. We reported dichotomous outcomes as a risk ratio (RR) with a 95% confidence interval (CI) and continuous variables as mean difference (MD) with a 95% CI. The primary outcomes were all-cause mortality, total cardiovascular events, end-stage renal disease (ESRD), withdrawal due to adverse effects (WDAE), serious adverse events (SAE), and adverse events. The secondary outcomes were fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, fatal heart failure or hospitalisation for heart failure, systolic and diastolic blood pressure (SBP and DBP), and heart rate. We used the GRADE approach to rate our confidence in the evidence.</p><p><strong>Main results: </strong>We included 11 double-blind RCTs involving 6780 participa","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD012570"},"PeriodicalIF":8.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866471/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143514875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-27DOI: 10.1002/14651858.CD000478.pub5
Johannes Hasskamp, Christian Meinhardt, Petrease H Patton, Antje Timmer
<p><strong>Background: </strong>Maintenance of remission is essential in inflammatory bowel disease (IBD) in terms of disease course and long-term prognosis. The thiopurines azathioprine and 6-mercaptopurine have longstanding merit in ulcerative colitis, but more therapeutic options have been developed. This review is an update and extension of a review last published in 2016.</p><p><strong>Objectives: </strong>To assess the effectiveness and safety of azathioprine and 6-mercaptopurine in monotherapy or combined therapy regimens compared to placebo or active controls for the maintenance of remission in ulcerative colitis.</p><p><strong>Search methods: </strong>We searched Cochrane Central Register of Controlled Trials (until May 2023), ClinicalTrials.gov (until May 2023), Embase (until August 2022), MEDLINE (until May 2023), and WHO ICTRP (until May 2023). We checked reference lists of the included studies and, if needed, contacted the authors to request more data or information.</p><p><strong>Selection criteria: </strong>Randomized controlled trials (RCTs) of at least 24 weeks' duration comparing azathioprine or 6-mercaptopurine with placebo or any other medication, or comparing different treatment modalities of azathioprine or 6-mercaptopurine, in persons of any age with quiescent ulcerative colitis were eligible. We only considered studies with mixed IBD populations or with a preceding induction period if separate results on participants with ulcerative colitis in remission were available or could be calculated. The primary outcome was failure to maintain clinical or endoscopic remission (relapse). Secondary outcomes included change in disease activity, quality of life, hospitalization, need for surgery, days off work, adverse events, and withdrawal due to adverse events.</p><p><strong>Data collection and analysis: </strong>Two authors independently extracted data using standard forms, resolved any disagreements by consensus, and assessed study quality using the Cochrane risk of bias tool (RoB 2). We conducted separate analyses by type of control, calculated pooled risk ratios (RRs) or risk differences (RDs) using the fixed-effect model unless heterogeneity was likely, and assessed the certainty of evidence using the GRADE approach.</p><p><strong>Main results: </strong>We included 10 studies in the review, including 468 adult participants with ulcerative colitis. The risk of bias across these was low for most outcomes, but we considered some outcomes to have some concerns or high risk of bias due to insufficient information on concealment of allocation and outcome measurement. Based on five placebo-controlled studies, azathioprine or 6-mercaptopurine may reduce the risk of failing to maintain remission. In the thiopurine group, 45% (64/143) of participants failed to maintain remission compared to 67% (96/143) of participants receiving placebo (RR 0.66, 95% confidence interval (CI) 0.54 to 0.82; 5 studies, 286 participants; low-certainty eviden
{"title":"Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis.","authors":"Johannes Hasskamp, Christian Meinhardt, Petrease H Patton, Antje Timmer","doi":"10.1002/14651858.CD000478.pub5","DOIUrl":"10.1002/14651858.CD000478.pub5","url":null,"abstract":"<p><strong>Background: </strong>Maintenance of remission is essential in inflammatory bowel disease (IBD) in terms of disease course and long-term prognosis. The thiopurines azathioprine and 6-mercaptopurine have longstanding merit in ulcerative colitis, but more therapeutic options have been developed. This review is an update and extension of a review last published in 2016.</p><p><strong>Objectives: </strong>To assess the effectiveness and safety of azathioprine and 6-mercaptopurine in monotherapy or combined therapy regimens compared to placebo or active controls for the maintenance of remission in ulcerative colitis.</p><p><strong>Search methods: </strong>We searched Cochrane Central Register of Controlled Trials (until May 2023), ClinicalTrials.gov (until May 2023), Embase (until August 2022), MEDLINE (until May 2023), and WHO ICTRP (until May 2023). We checked reference lists of the included studies and, if needed, contacted the authors to request more data or information.</p><p><strong>Selection criteria: </strong>Randomized controlled trials (RCTs) of at least 24 weeks' duration comparing azathioprine or 6-mercaptopurine with placebo or any other medication, or comparing different treatment modalities of azathioprine or 6-mercaptopurine, in persons of any age with quiescent ulcerative colitis were eligible. We only considered studies with mixed IBD populations or with a preceding induction period if separate results on participants with ulcerative colitis in remission were available or could be calculated. The primary outcome was failure to maintain clinical or endoscopic remission (relapse). Secondary outcomes included change in disease activity, quality of life, hospitalization, need for surgery, days off work, adverse events, and withdrawal due to adverse events.</p><p><strong>Data collection and analysis: </strong>Two authors independently extracted data using standard forms, resolved any disagreements by consensus, and assessed study quality using the Cochrane risk of bias tool (RoB 2). We conducted separate analyses by type of control, calculated pooled risk ratios (RRs) or risk differences (RDs) using the fixed-effect model unless heterogeneity was likely, and assessed the certainty of evidence using the GRADE approach.</p><p><strong>Main results: </strong>We included 10 studies in the review, including 468 adult participants with ulcerative colitis. The risk of bias across these was low for most outcomes, but we considered some outcomes to have some concerns or high risk of bias due to insufficient information on concealment of allocation and outcome measurement. Based on five placebo-controlled studies, azathioprine or 6-mercaptopurine may reduce the risk of failing to maintain remission. In the thiopurine group, 45% (64/143) of participants failed to maintain remission compared to 67% (96/143) of participants receiving placebo (RR 0.66, 95% confidence interval (CI) 0.54 to 0.82; 5 studies, 286 participants; low-certainty eviden","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD000478"},"PeriodicalIF":8.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866470/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143514872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-26DOI: 10.1002/14651858.CD016223
Katherine Semrau, Ethan Litman, Rose L Molina, Megan Marx Delaney, Leslie Choi, Lindsay Robertson, Anna H Noel-Storr, Jeanne-Marie Guise
<p><strong>Rationale: </strong>Despite World Health Organization (WHO) guidelines for preventing, detecting, and treating postpartum hemorrhage (PPH), effective implementation has lagged.</p><p><strong>Objectives: </strong>To evaluate the clinical benefits and harms of implementation strategies used to promote adherence to WHO clinical guidelines for the prevention, detection, and treatment of PPH.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and two trial registries, along with reference checking, citation searching, and contact with study authors. The latest search date was 25 April 2024.</p><p><strong>Eligibility criteria: </strong>We included randomized controlled trials (RCTs), including cluster, pragmatic, and stepped-wedge designs, and non-randomized studies of interventions (NRSIs), including interrupted time series (ITS) studies, controlled before-after (CBA) studies, and follow-up (cohort) studies containing concurrent controls that focused on or described implementation strategies of WHO guidelines for the prevention, detection, and treatment of PPH. Participants were birth attendants and people giving birth in a hospital or healthcare facility. We excluded studies that did not implement a WHO PPH recommendation, had no comparator group, or did not report clinical/implementation outcomes.</p><p><strong>Outcomes: </strong>Our critical outcomes were: adherence to WHO-recommended guidelines for PPH prevention, detection, and treatment; PPH ≥ 500 mL; PPH ≥ 1000 mL; additional uterotonics within 24 hours after birth; blood transfusions; maternal death; severe morbidities (major surgery; admission to intensive care unit [ICU]); and adverse effects (variable and related to the clinical intervention) during hospitalization for birth. Our important outcomes were: breastfeeding at discharge; implementation outcomes such as acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability of the implementation strategy; and health professional outcomes such as knowledge and skill.</p><p><strong>Risk of bias: </strong>We used the RoB 2 and ROBINS-I tools to assess risk of bias in RCTs and NRSIs, respectively.</p><p><strong>Synthesis methods: </strong>Two review authors independently selected studies, performed data extraction, and assessed risk of bias and trustworthiness. Due to the nature of the data, we reported relevant results for each comparison and outcome but did not attempt quantitative synthesis. We used GRADE to assess the certainty of evidence.</p><p><strong>Included studies: </strong>We included 13 studies (9 cluster-RCTs and 4 NRSIs) with a total of 1,027,273 births and more than 4373 birth attendants. The included studies were conducted in 17 different countries. Most trials were conducted in resource-limited settings. None of the included studies reported data on the use of additional uter
{"title":"Implementation strategies for WHO guidelines to prevent, detect, and treat postpartum hemorrhage.","authors":"Katherine Semrau, Ethan Litman, Rose L Molina, Megan Marx Delaney, Leslie Choi, Lindsay Robertson, Anna H Noel-Storr, Jeanne-Marie Guise","doi":"10.1002/14651858.CD016223","DOIUrl":"10.1002/14651858.CD016223","url":null,"abstract":"<p><strong>Rationale: </strong>Despite World Health Organization (WHO) guidelines for preventing, detecting, and treating postpartum hemorrhage (PPH), effective implementation has lagged.</p><p><strong>Objectives: </strong>To evaluate the clinical benefits and harms of implementation strategies used to promote adherence to WHO clinical guidelines for the prevention, detection, and treatment of PPH.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and two trial registries, along with reference checking, citation searching, and contact with study authors. The latest search date was 25 April 2024.</p><p><strong>Eligibility criteria: </strong>We included randomized controlled trials (RCTs), including cluster, pragmatic, and stepped-wedge designs, and non-randomized studies of interventions (NRSIs), including interrupted time series (ITS) studies, controlled before-after (CBA) studies, and follow-up (cohort) studies containing concurrent controls that focused on or described implementation strategies of WHO guidelines for the prevention, detection, and treatment of PPH. Participants were birth attendants and people giving birth in a hospital or healthcare facility. We excluded studies that did not implement a WHO PPH recommendation, had no comparator group, or did not report clinical/implementation outcomes.</p><p><strong>Outcomes: </strong>Our critical outcomes were: adherence to WHO-recommended guidelines for PPH prevention, detection, and treatment; PPH ≥ 500 mL; PPH ≥ 1000 mL; additional uterotonics within 24 hours after birth; blood transfusions; maternal death; severe morbidities (major surgery; admission to intensive care unit [ICU]); and adverse effects (variable and related to the clinical intervention) during hospitalization for birth. Our important outcomes were: breastfeeding at discharge; implementation outcomes such as acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability of the implementation strategy; and health professional outcomes such as knowledge and skill.</p><p><strong>Risk of bias: </strong>We used the RoB 2 and ROBINS-I tools to assess risk of bias in RCTs and NRSIs, respectively.</p><p><strong>Synthesis methods: </strong>Two review authors independently selected studies, performed data extraction, and assessed risk of bias and trustworthiness. Due to the nature of the data, we reported relevant results for each comparison and outcome but did not attempt quantitative synthesis. We used GRADE to assess the certainty of evidence.</p><p><strong>Included studies: </strong>We included 13 studies (9 cluster-RCTs and 4 NRSIs) with a total of 1,027,273 births and more than 4373 birth attendants. The included studies were conducted in 17 different countries. Most trials were conducted in resource-limited settings. None of the included studies reported data on the use of additional uter","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD016223"},"PeriodicalIF":8.8,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11863301/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143499626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-26DOI: 10.1002/14651858.CD015785
Odette de Bruin, Emily Wem Phijffer, Fariba Ahmadizar, Nicoline At Van der Maas, Joanne G Wildenbeest, Miriam Cjm Sturkenboom, Louis J Bont, Carlos E Durán, Kitty Wm Bloemenkamp
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of SARS-CoV-2 vaccination during pregnancy, versus placebo or no vaccination during pregnancy, for preventing COVID-19 disease in mothers and infants.
{"title":"Efficacy and safety of SARS-CoV-2 vaccination in pregnancy to prevent COVID-19 in mothers and early infancy.","authors":"Odette de Bruin, Emily Wem Phijffer, Fariba Ahmadizar, Nicoline At Van der Maas, Joanne G Wildenbeest, Miriam Cjm Sturkenboom, Louis J Bont, Carlos E Durán, Kitty Wm Bloemenkamp","doi":"10.1002/14651858.CD015785","DOIUrl":"10.1002/14651858.CD015785","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of SARS-CoV-2 vaccination during pregnancy, versus placebo or no vaccination during pregnancy, for preventing COVID-19 disease in mothers and infants.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD015785"},"PeriodicalIF":8.8,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11863297/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143499682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-26DOI: 10.1002/14651858.CD013429.pub2
Chloe Swords, Matthew E Smith, Anant Patel, Gill Norman, Alexis Llewellyn, James R Tysome
<p><strong>Background: </strong>Eustachian tube dysfunction (ETD) causes symptoms and signs of pressure dysregulation in the middle ear, and is associated with tympanic membrane retraction, otitis media with effusion, and chronic otitis media. Interventions aiming to improve symptoms can be non-surgical or surgical, including balloon dilatation of the Eustachian tube, also known as balloon eustachian tuboplasty (BET) for obstructive ETD. However, existing published evidence for the effectiveness and safety of BET remains unclear.</p><p><strong>Objectives: </strong>To evaluate the effects of balloon dilatation of the Eustachian tube in adults with obstructive Eustachian tube dysfunction.</p><p><strong>Search methods: </strong>The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid M>DLINE; Ovid Embase; Web of Science; Clinicaltrials.gov; ICTRP and additional sources for published and unpublished trials. The final search was updated on 18th January 2024. There were no restrictions on language, publication date or study setting.</p><p><strong>Selection criteria: </strong>Randomised controlled trials were included if they allocated adult participants with chronic obstructive ETD to treatment randomly and compared BET with non-surgical treatment, no treatment, or other surgical treatment. Studies with other designs were excluded.</p><p><strong>Data collection and analysis: </strong>At least two review authors independently selected trials using predetermined inclusion criteria, assessed the risk of bias, extracted data, and rated the certainty of evidence (CoE) according to GRADEpro. Statistical analyses were performed using a random-effects model and interpreted according to the most recent version of the Cochrane Handbook. Predefined primary outcomes were obstructive ETD symptoms, Eustachian tube function (objective or semi-objective tests), or serious adverse events. Secondary outcomes were hearing, tympanic membrane abnormalities, quality of life, and other adverse events.</p><p><strong>Main results: </strong>Nine trials were identified with 684 randomised participants across three comparisons: BET versus non-surgical treatment (five trials, 422 participants), BET versus no treatment (sham surgery; one trial, 17 participants), and BET versus other surgery (four trials, 275 participants). None of the studies were rated with an overall low risk of bias. Comparing BET to non-surgical treatment up to three months, there is low-certainty evidence showing that BET may reduce patient-reported ETD symptoms (change in ETDQ-7: mean difference (MD) -1.66 (95% CI -2.16 to -1.16; I<sup>2</sup> = 63%; 4 RCTs, 362 participants)). There is very low-certainty evidence that BET may improve ETD as assessed by objective or semi-objective measures (improvement in tympanometry: RR 2.51 (95% CI 1.82 to 3.48; I<sup>2</sup> = 0%; 3 RCTs, 369 participants). Between three and 12 months, the evidence i
{"title":"Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults.","authors":"Chloe Swords, Matthew E Smith, Anant Patel, Gill Norman, Alexis Llewellyn, James R Tysome","doi":"10.1002/14651858.CD013429.pub2","DOIUrl":"10.1002/14651858.CD013429.pub2","url":null,"abstract":"<p><strong>Background: </strong>Eustachian tube dysfunction (ETD) causes symptoms and signs of pressure dysregulation in the middle ear, and is associated with tympanic membrane retraction, otitis media with effusion, and chronic otitis media. Interventions aiming to improve symptoms can be non-surgical or surgical, including balloon dilatation of the Eustachian tube, also known as balloon eustachian tuboplasty (BET) for obstructive ETD. However, existing published evidence for the effectiveness and safety of BET remains unclear.</p><p><strong>Objectives: </strong>To evaluate the effects of balloon dilatation of the Eustachian tube in adults with obstructive Eustachian tube dysfunction.</p><p><strong>Search methods: </strong>The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid M>DLINE; Ovid Embase; Web of Science; Clinicaltrials.gov; ICTRP and additional sources for published and unpublished trials. The final search was updated on 18th January 2024. There were no restrictions on language, publication date or study setting.</p><p><strong>Selection criteria: </strong>Randomised controlled trials were included if they allocated adult participants with chronic obstructive ETD to treatment randomly and compared BET with non-surgical treatment, no treatment, or other surgical treatment. Studies with other designs were excluded.</p><p><strong>Data collection and analysis: </strong>At least two review authors independently selected trials using predetermined inclusion criteria, assessed the risk of bias, extracted data, and rated the certainty of evidence (CoE) according to GRADEpro. Statistical analyses were performed using a random-effects model and interpreted according to the most recent version of the Cochrane Handbook. Predefined primary outcomes were obstructive ETD symptoms, Eustachian tube function (objective or semi-objective tests), or serious adverse events. Secondary outcomes were hearing, tympanic membrane abnormalities, quality of life, and other adverse events.</p><p><strong>Main results: </strong>Nine trials were identified with 684 randomised participants across three comparisons: BET versus non-surgical treatment (five trials, 422 participants), BET versus no treatment (sham surgery; one trial, 17 participants), and BET versus other surgery (four trials, 275 participants). None of the studies were rated with an overall low risk of bias. Comparing BET to non-surgical treatment up to three months, there is low-certainty evidence showing that BET may reduce patient-reported ETD symptoms (change in ETDQ-7: mean difference (MD) -1.66 (95% CI -2.16 to -1.16; I<sup>2</sup> = 63%; 4 RCTs, 362 participants)). There is very low-certainty evidence that BET may improve ETD as assessed by objective or semi-objective measures (improvement in tympanometry: RR 2.51 (95% CI 1.82 to 3.48; I<sup>2</sup> = 0%; 3 RCTs, 369 participants). Between three and 12 months, the evidence i","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD013429"},"PeriodicalIF":8.8,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11863300/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143499681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-24DOI: 10.1002/14651858.CD013745.pub2
Samer Al Said, Klaus Kaier, Edris Nury, Dima Alsaid, C Michael Gibson, Jeroen Bax, Dirk Westermann, Joerg J Meerpohl
<p><strong>Background: </strong>Balancing the risk of thromboembolism and bleeding after transcatheter aortic valve replacement (TAVR) remains clinically challenging. Questions regarding the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) after TAVR still need to be definitively answered.</p><p><strong>Objectives: </strong>To evaluate the efficacy and safety of NOACs after TAVR in individuals with and without indication for anticoagulation.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Web of Science, ClinicalTrials.gov, and WHO ICTRP on 7 October 2023 together with reference checking and citation searching to identify additional studies.</p><p><strong>Selection criteria: </strong>We searched for randomised controlled trials (RCTs) that compared NOACs versus antiplatelet therapy or vitamin K antagonists (VKAs) after TAVR in adults with or without an indication for anticoagulation.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods and conducted random-effects pair-wise analyses and network meta-analyses (NMAs). Our primary outcomes were all-cause mortality, cardiovascular mortality, stroke, and major bleeding. We used GRADE to assess the certainty of evidence.</p><p><strong>Main results: </strong>We included four RCTs with 4808 participants in the NMA. Of these, one compared rivaroxaban versus antiplatelet therapy in people without an indication for anticoagulation after TAVR; one compared apixaban versus antiplatelet therapy in people without an indication for anticoagulation or versus VKA in people with an indication for anticoagulation after TAVR; one compared edoxaban versus VKA in people with an indication for anticoagulation after TAVR; and one compared edoxaban with antiplatelet therapy in people without an indication for anticoagulation after TAVR. The mean age of trial participants was 81 years. Follow-up duration ranged from 6 to 18 months. Overall, we judged the risk of bias in the included trials to be low in all domains except for blinding, which was assessed as high in all four studies. No studies evaluated dabigatran. In people without an indication for anticoagulation, rivaroxaban and apixaban may increase all-cause mortality after TAVR as compared to antiplatelet therapy (rivaroxaban: risk ratio (RR) 1.67, 95% confidence interval (CI) 1.13 to 2.46; studies = 1, participants = 1644; moderate-certainty evidence; apixaban: RR 1.71, 95% CI 0.97 to 3.02; studies = 1, participants = 1049; low-certainty evidence), while edoxaban may result in little or no difference (RR 1.59, 95% CI 0.27 to 9.36; studies = 1, participants = 229; low-certainty evidence). Low-certainty evidence suggests little or no difference between rivaroxaban, apixaban, or edoxaban and antiplatelet therapy in cardiovascular mortality (rivaroxaban: RR 1.28, 95% CI 0.78 to 2.10; studies = 1, participants = 1644; apixaban: RR 1.30, 95% CI 0.64 to 2.65; studies = 1, participants = 1049; ed
背景：平衡经导管主动脉瓣置换术（TAVR）后血栓栓塞和出血的风险在临床上仍具有挑战性。有关经导管主动脉瓣置换术（TAVR）后非维生素 K 口服抗凝剂（NOACs）的疗效和安全性问题仍有待明确回答：目的：评估有抗凝适应症和无抗凝适应症的患者在TAVR术后使用NOACs的疗效和安全性：我们于2023年10月7日检索了CENTRAL、MEDLINE、Embase、Web of Science、ClinicalTrials.gov和WHO ICTRP，并进行了参考文献检查和引文检索，以确定其他研究：我们搜索了在有或没有抗凝适应症的成人中，比较 TAVR 后 NOAC 与抗血小板疗法或维生素 K 拮抗剂 (VKAs) 的随机对照试验 (RCT)：我们采用标准的 Cochrane 方法，进行了随机效应配对分析和网络荟萃分析 (NMA)。我们的主要结果是全因死亡率、心血管死亡率、中风和大出血。我们使用 GRADE 评估证据的确定性：我们在 NMA 中纳入了四项 RCT，共有 4808 名参与者。其中，一项研究比较了利伐沙班与抗血小板疗法在TAVR后无抗凝指征人群中的应用；一项研究比较了阿哌沙班与抗血小板疗法在TAVR后无抗凝指征人群中的应用或与VKA在TAVR后有抗凝指征人群中的应用；一项研究比较了依多沙班与VKA在TAVR后有抗凝指征人群中的应用；一项研究比较了依多沙班与抗血小板疗法在TAVR后无抗凝指征人群中的应用。试验参与者的平均年龄为 81 岁。随访时间从 6 个月到 18 个月不等。总体而言，我们认为纳入的试验在所有方面的偏倚风险都较低，但盲法除外，所有四项研究的盲法均被评估为较高。没有研究对达比加群进行评估。对于无抗凝指征的患者，与抗血小板疗法相比，利伐沙班和阿哌沙班可能会增加TAVR术后的全因死亡率（利伐沙班：风险比（RR）1.67，95%置信区间（CI）1.13~2.46；研究=1，参与者=1644；中度确定性证据；阿哌沙班：RR 1.71，95%置信区间（CI）1.13~2.46；研究=1，参与者=1644；中度确定性证据）：RR为1.71，95% CI为0.97至3.02；研究=1，参与者=1049；低度确定性证据），而依多沙班可能导致的差异很小或没有差异（RR为1.59，95% CI为0.27至9.36；研究=1，参与者=229；低度确定性证据）。低确定性证据表明，利伐沙班、阿哌沙班或依度沙班与抗血小板疗法在心血管死亡率方面几乎没有差异（利伐沙班：RR 1.28，95% CI 0.27 至 9.36；研究 = 1；参与者 = 229；低确定性证据）：RR为1.28，95% CI为0.78至2.10；研究=1，参与者=1644；阿哌沙班：RR为1.30，95% CI为0.64至2.65；研究=1，参与者=1049；埃多沙班：RR7.44，95% CI 0.39至142.38；研究=1，参与者=229），以及利伐沙班或埃多沙班与抗血小板药物在中风中的作用（利伐沙班：RR为1.19，95% CI为0.71至2.00；研究=1，参与者=1644；依度沙班：RR为1.06，95% CI为0.15至7.42；研究=1，参与者=229）。利伐沙班与抗血小板治疗相比可能会增加TAVR后的大出血（RR 1.98，95% CI 1.07至3.65；研究=1，参与者=1644；中度确定性证据），而阿哌沙班与抗血小板治疗之间可能差异很小或没有差异（RR 1.07，95% CI 0.70至1.64；研究=1，参与者=1049；低度确定性证据）。目前尚不清楚埃多沙班是否对大出血有影响，尽管点估计值表明出血会增加（与抗血小板疗法相比，RR 2.13，95% CI 0.70 至 1.64；研究 = 1；参与者 = 1049；低确定性证据）：RR 2.13，95% CI 0.54 至 8.30；研究 = 1，参与者 = 229；低确定性证据）。对于有抗凝适应症的患者，低确定性证据表明，与 VKA 相比，阿哌沙班或埃多沙班可能会导致 TAVR 后我们预先定义的主要疗效结果几乎没有差异（全因死亡率：阿哌沙班：RR 1.02，95% CI 0.54 至 8.30；研究 = 1；参与者 = 229；低确定性证据）：RR为1.02，95% CI为0.59至1.77；研究=1，参与者=451；埃多沙班：RR为0.91，95% CI为0.69至1.20；研究=1，参与者=1426；心血管死亡率：阿哌沙班：RR为1.43，95% CI为0.76至2.70；研究=1，参与者=451；埃多沙班：RR 1.07，95% CI 0.72 至 1.57；研究 = 1，参与者 = 1426；中风：阿哌沙班：RR 1.28，95% CI 0.35 至 4.70；研究 = 1，参与者 = 451；依度沙班：RR为0.83，95% CI为0.51至1.34；研究=1，参与者=1426）。在这一人群中，阿哌沙班可能会导致与VKA相似的出血率，而在有抗凝适应症的人群中，依多沙班可能会增加TAVR后的大出血（阿哌沙班：RR 0.90，95% CI 0.51至1.34；研究=1，参与者=1426）：RR为0.90，95% CI为0.53至1.54；研究=1，参与者=451；低确定性证据；埃多沙班：RR为1.44，95% CI为1.08至1.93；研究=1，参与者=1426；中等确定性证据）。
{"title":"Non-vitamin K antagonist oral anticoagulants (NOACs) after transcatheter aortic valve replacement (TAVR): a network meta-analysis.","authors":"Samer Al Said, Klaus Kaier, Edris Nury, Dima Alsaid, C Michael Gibson, Jeroen Bax, Dirk Westermann, Joerg J Meerpohl","doi":"10.1002/14651858.CD013745.pub2","DOIUrl":"10.1002/14651858.CD013745.pub2","url":null,"abstract":"<p><strong>Background: </strong>Balancing the risk of thromboembolism and bleeding after transcatheter aortic valve replacement (TAVR) remains clinically challenging. Questions regarding the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) after TAVR still need to be definitively answered.</p><p><strong>Objectives: </strong>To evaluate the efficacy and safety of NOACs after TAVR in individuals with and without indication for anticoagulation.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Web of Science, ClinicalTrials.gov, and WHO ICTRP on 7 October 2023 together with reference checking and citation searching to identify additional studies.</p><p><strong>Selection criteria: </strong>We searched for randomised controlled trials (RCTs) that compared NOACs versus antiplatelet therapy or vitamin K antagonists (VKAs) after TAVR in adults with or without an indication for anticoagulation.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods and conducted random-effects pair-wise analyses and network meta-analyses (NMAs). Our primary outcomes were all-cause mortality, cardiovascular mortality, stroke, and major bleeding. We used GRADE to assess the certainty of evidence.</p><p><strong>Main results: </strong>We included four RCTs with 4808 participants in the NMA. Of these, one compared rivaroxaban versus antiplatelet therapy in people without an indication for anticoagulation after TAVR; one compared apixaban versus antiplatelet therapy in people without an indication for anticoagulation or versus VKA in people with an indication for anticoagulation after TAVR; one compared edoxaban versus VKA in people with an indication for anticoagulation after TAVR; and one compared edoxaban with antiplatelet therapy in people without an indication for anticoagulation after TAVR. The mean age of trial participants was 81 years. Follow-up duration ranged from 6 to 18 months. Overall, we judged the risk of bias in the included trials to be low in all domains except for blinding, which was assessed as high in all four studies. No studies evaluated dabigatran. In people without an indication for anticoagulation, rivaroxaban and apixaban may increase all-cause mortality after TAVR as compared to antiplatelet therapy (rivaroxaban: risk ratio (RR) 1.67, 95% confidence interval (CI) 1.13 to 2.46; studies = 1, participants = 1644; moderate-certainty evidence; apixaban: RR 1.71, 95% CI 0.97 to 3.02; studies = 1, participants = 1049; low-certainty evidence), while edoxaban may result in little or no difference (RR 1.59, 95% CI 0.27 to 9.36; studies = 1, participants = 229; low-certainty evidence). Low-certainty evidence suggests little or no difference between rivaroxaban, apixaban, or edoxaban and antiplatelet therapy in cardiovascular mortality (rivaroxaban: RR 1.28, 95% CI 0.78 to 2.10; studies = 1, participants = 1644; apixaban: RR 1.30, 95% CI 0.64 to 2.65; studies = 1, participants = 1049; ed","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD013745"},"PeriodicalIF":8.8,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11848970/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-24DOI: 10.1002/14651858.CD016192
K M Saif-Ur-Rahman, Nadra Nurdin, Ani Movsisyan, Kavita Kothari, Thomas Conway, Marie Tierney, Petek Eylul Taneri, Deirdre Mulholland, Andrea C Tricco, Jacqueline Dinnes, Declan Devane
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effectiveness of different SARS-CoV-2 testing strategies in reducing COVID-19 cases, hospitalisations, and deaths among suspected cases and asymptomatic individuals.
{"title":"Effectiveness of SARS-CoV-2 testing strategies.","authors":"K M Saif-Ur-Rahman, Nadra Nurdin, Ani Movsisyan, Kavita Kothari, Thomas Conway, Marie Tierney, Petek Eylul Taneri, Deirdre Mulholland, Andrea C Tricco, Jacqueline Dinnes, Declan Devane","doi":"10.1002/14651858.CD016192","DOIUrl":"10.1002/14651858.CD016192","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effectiveness of different SARS-CoV-2 testing strategies in reducing COVID-19 cases, hospitalisations, and deaths among suspected cases and asymptomatic individuals.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD016192"},"PeriodicalIF":8.8,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11848964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-21DOI: 10.1002/14651858.CD014160.pub2
Berndt Urlesberger, Rita Cabano, Greg Soll, Adrienne Pahl, Ju Lee Oei, Georg M Schmölzer, Wolfgang Raith, Matteo Bruschettini
<p><strong>Background: </strong>Neonatal abstinence syndrome (NAS) is a drug-withdrawal syndrome, mostly occurring after antenatal exposure to opioids. A neonate may be born physically dependent on opioid medications, which causes withdrawal symptoms (such as high-pitched crying, disruptions in the sleep-wake cycle and tremors) after birth. This is diagnosed with a standardised withdrawal assessment, such as the Finnegan score. Newborns developing NAS require medical treatment and longer hospital stays after birth than neonates without this condition. Treatments for NAS include multiple multimodal treatments to ease symptoms of withdrawal, such as swaddling, 'rooming in' and breastfeeding. If the standardised assessment exceeds a certain threshold, newborns are treated pharmacologically with an orally administered opioid. However, optimal NAS management continues to be debated. Acupuncture has been proposed as a potential intervention. Acupuncture involves stimulation of specific points on the body, either through the insertion of thin metal needles or with techniques that do not penetrate the skin, such as acupressure and laser.</p><p><strong>Objectives: </strong>To assess if acupuncture (acupressure, needle, laser) reduces the treatment duration of neonatal abstinence syndrome (NAS) in newborn infants, reduces adverse events and reduces length of hospital stay.</p><p><strong>Search methods: </strong>We used bibliographic databases (CENTRAL, PubMed, Embase) and trial registries, together with reference checking, citation searching and contact with study authors, to identify the studies that are included in the review. The latest search date was 25 August 2023.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) or quasi-RCTs, and cluster-randomised trials. We included infants born at full term and late preterm who were diagnosed with NAS within the first 72 hours after birth (i.e. showing significant signs as assessed using a standardised NAS assessment tool, e.g. presenting with withdrawal syndrome and Finnegan score > 8). We included studies where acupuncture (using invasive or non-invasive techniques) was compared with: 1) no intervention; 2) placebo or sham treatment; 3) any pharmacological treatment; or 4) another type of acupuncture (e.g. penetration of the skin with a needle versus acupressure). Acupuncture could be given alone or in combination with conventional medical treatment for NAS ('standard care'), as long as the latter was administered to the control group as well.</p><p><strong>Data collection and analysis: </strong>We used the standard methodological procedures expected by Cochrane. Our primary outcomes were duration of any pharmacological treatment for NAS, adverse events and length of hospital stay. We used GRADE to assess the certainty of evidence.</p><p><strong>Main results: </strong>We included two single-centre RCTs (104 infants). Both studies compared non-invasive acupuncture added
{"title":"Acupuncture for neonatal abstinence syndrome in newborn infants.","authors":"Berndt Urlesberger, Rita Cabano, Greg Soll, Adrienne Pahl, Ju Lee Oei, Georg M Schmölzer, Wolfgang Raith, Matteo Bruschettini","doi":"10.1002/14651858.CD014160.pub2","DOIUrl":"10.1002/14651858.CD014160.pub2","url":null,"abstract":"<p><strong>Background: </strong>Neonatal abstinence syndrome (NAS) is a drug-withdrawal syndrome, mostly occurring after antenatal exposure to opioids. A neonate may be born physically dependent on opioid medications, which causes withdrawal symptoms (such as high-pitched crying, disruptions in the sleep-wake cycle and tremors) after birth. This is diagnosed with a standardised withdrawal assessment, such as the Finnegan score. Newborns developing NAS require medical treatment and longer hospital stays after birth than neonates without this condition. Treatments for NAS include multiple multimodal treatments to ease symptoms of withdrawal, such as swaddling, 'rooming in' and breastfeeding. If the standardised assessment exceeds a certain threshold, newborns are treated pharmacologically with an orally administered opioid. However, optimal NAS management continues to be debated. Acupuncture has been proposed as a potential intervention. Acupuncture involves stimulation of specific points on the body, either through the insertion of thin metal needles or with techniques that do not penetrate the skin, such as acupressure and laser.</p><p><strong>Objectives: </strong>To assess if acupuncture (acupressure, needle, laser) reduces the treatment duration of neonatal abstinence syndrome (NAS) in newborn infants, reduces adverse events and reduces length of hospital stay.</p><p><strong>Search methods: </strong>We used bibliographic databases (CENTRAL, PubMed, Embase) and trial registries, together with reference checking, citation searching and contact with study authors, to identify the studies that are included in the review. The latest search date was 25 August 2023.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) or quasi-RCTs, and cluster-randomised trials. We included infants born at full term and late preterm who were diagnosed with NAS within the first 72 hours after birth (i.e. showing significant signs as assessed using a standardised NAS assessment tool, e.g. presenting with withdrawal syndrome and Finnegan score > 8). We included studies where acupuncture (using invasive or non-invasive techniques) was compared with: 1) no intervention; 2) placebo or sham treatment; 3) any pharmacological treatment; or 4) another type of acupuncture (e.g. penetration of the skin with a needle versus acupressure). Acupuncture could be given alone or in combination with conventional medical treatment for NAS ('standard care'), as long as the latter was administered to the control group as well.</p><p><strong>Data collection and analysis: </strong>We used the standard methodological procedures expected by Cochrane. Our primary outcomes were duration of any pharmacological treatment for NAS, adverse events and length of hospital stay. We used GRADE to assess the certainty of evidence.</p><p><strong>Main results: </strong>We included two single-centre RCTs (104 infants). Both studies compared non-invasive acupuncture added","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD014160"},"PeriodicalIF":8.8,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11843615/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-20DOI: 10.1002/14651858.CD015517
Carina Wagner, Moritz Ernst, Nora Cryns, Annika Oeser, Sarah Messer, Andreas Wender, Joachim Wiskemann, Freerk T Baumann, Ina Monsef, Paul J Bröckelmann, Ulrike Holtkamp, Roberta W Scherer, Shiraz I Mishra, Nicole Skoetz
<p><strong>Rationale: </strong>Cancer-related fatigue (CRF) is the most prevalent and severe symptom among people with cancer. It can be attributed to the cancer itself or to anticancer therapies. CRF affects the individual physically and mentally, and cannot be alleviated by rest. Studies show a positive effect of exercise on CRF.</p><p><strong>Objectives: </strong>To evaluate the effects of cardiovascular training on cancer-related fatigue (CRF), quality of life (QoL), adverse events, anxiety, and depression in people with cancer, with regard to their stage of anticancer therapy (before, during, or after), up to 12 weeks, up to six months, or longer, postintervention.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and World Health Organization ICTRP to identify studies that are included in the review. The latest search date was October 2023.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) evaluating cardiovascular training for CRF or QoL, or both, in people with cancer. Trials were eligible if training was structured, included at least five sessions, and instruction was face-to-face (via video tools or in person). We excluded studies with fewer than 20 randomised participants per group and where only an abstract was available.</p><p><strong>Outcomes: </strong>Our critical outcomes were: short-, medium-, long-term CRF and QoL. Important outcomes were adverse events, and short-, medium-, long-term anxiety and depression.</p><p><strong>Risk of bias: </strong>We used the Cochrane RoB 1 tool to assess bias in RCTs.</p><p><strong>Synthesis methods: </strong>We used standard Cochrane methodology. We synthesised results for each outcome using meta-analysis where possible (inverse variance or Mantel-Haenszel; random-effects model). We pooled data for the respective assessment periods above. We used GRADE to assess certainty of evidence for each outcome.</p><p><strong>Included studies: </strong>We included 23 RCTs with 2135 participants, of whom 96.6% originated from high-income countries; 1101 participants were randomised to cardiovascular training and 1034 to no training. Studies included mostly females who were diagnosed with breast cancer. We also identified 36 ongoing and 12 completed studies that have not yet published (awaiting assessment). We only present findings on CRF, QoL and adverse events. For details regarding anxiety and depression, see full text.</p><p><strong>Synthesis of results: </strong>Cardiovascular training before anticancer therapy versus no training for people with cancer We identified no studies for inclusion in this comparison. Cardiovascular training during anticancer therapy versus no training for people with cancer We included 10 studies (1026 participants); eight studies contributed data to quantitative analyses (860 participants). Cardiovascular training probably reduces short-term CRF slightly (mean difference (MD) 2.85, 95% con
{"title":"Cardiovascular training for fatigue in people with cancer.","authors":"Carina Wagner, Moritz Ernst, Nora Cryns, Annika Oeser, Sarah Messer, Andreas Wender, Joachim Wiskemann, Freerk T Baumann, Ina Monsef, Paul J Bröckelmann, Ulrike Holtkamp, Roberta W Scherer, Shiraz I Mishra, Nicole Skoetz","doi":"10.1002/14651858.CD015517","DOIUrl":"10.1002/14651858.CD015517","url":null,"abstract":"<p><strong>Rationale: </strong>Cancer-related fatigue (CRF) is the most prevalent and severe symptom among people with cancer. It can be attributed to the cancer itself or to anticancer therapies. CRF affects the individual physically and mentally, and cannot be alleviated by rest. Studies show a positive effect of exercise on CRF.</p><p><strong>Objectives: </strong>To evaluate the effects of cardiovascular training on cancer-related fatigue (CRF), quality of life (QoL), adverse events, anxiety, and depression in people with cancer, with regard to their stage of anticancer therapy (before, during, or after), up to 12 weeks, up to six months, or longer, postintervention.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and World Health Organization ICTRP to identify studies that are included in the review. The latest search date was October 2023.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) evaluating cardiovascular training for CRF or QoL, or both, in people with cancer. Trials were eligible if training was structured, included at least five sessions, and instruction was face-to-face (via video tools or in person). We excluded studies with fewer than 20 randomised participants per group and where only an abstract was available.</p><p><strong>Outcomes: </strong>Our critical outcomes were: short-, medium-, long-term CRF and QoL. Important outcomes were adverse events, and short-, medium-, long-term anxiety and depression.</p><p><strong>Risk of bias: </strong>We used the Cochrane RoB 1 tool to assess bias in RCTs.</p><p><strong>Synthesis methods: </strong>We used standard Cochrane methodology. We synthesised results for each outcome using meta-analysis where possible (inverse variance or Mantel-Haenszel; random-effects model). We pooled data for the respective assessment periods above. We used GRADE to assess certainty of evidence for each outcome.</p><p><strong>Included studies: </strong>We included 23 RCTs with 2135 participants, of whom 96.6% originated from high-income countries; 1101 participants were randomised to cardiovascular training and 1034 to no training. Studies included mostly females who were diagnosed with breast cancer. We also identified 36 ongoing and 12 completed studies that have not yet published (awaiting assessment). We only present findings on CRF, QoL and adverse events. For details regarding anxiety and depression, see full text.</p><p><strong>Synthesis of results: </strong>Cardiovascular training before anticancer therapy versus no training for people with cancer We identified no studies for inclusion in this comparison. Cardiovascular training during anticancer therapy versus no training for people with cancer We included 10 studies (1026 participants); eight studies contributed data to quantitative analyses (860 participants). Cardiovascular training probably reduces short-term CRF slightly (mean difference (MD) 2.85, 95% con","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD015517"},"PeriodicalIF":8.8,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11840886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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