Pub Date : 2025-01-27DOI: 10.1002/14651858.CD016119
Teesta Dey, Maia G Cole, Daisy Brown, Ruaraidh A Hill, Marty Chaplin, Hanna E Huffstetler, Ffion Curtis
<p><strong>Rationale: </strong>Postpartum haemorrhage, defined as a blood loss of 500 mL or more within 24 hours of birth, is the leading global cause of maternal morbidity and mortality. Uterine fibroids are non-cancerous growths that develop in or around the uterus, and affect an increasing number of women. Caesarean myomectomy is the surgical removal of fibroids during a caesarean section. Traditionally, obstetricians have avoided this procedure given the risk of uncontrollable haemorrhage. There is also the risk of longer operating time and more days in the hospital. However, there could be potential benefits in removing uterine fibroids for improved fertility, and caesarean section may provide an effective and efficient opportunity to perform this procedure. Given the link between removal of uterine fibroids and postpartum haemorrhage, it is prudent to evaluate current literature and assess the benefits and harms of caesarean myomectomy in pregnant women with uterine fibroids.</p><p><strong>Objectives: </strong>To assess the benefits and harms of caesarean myomectomy in pregnant women with uterine fibroids undergoing caesarean section.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Global Index Medicus, ICTRP portal, and ClinicalTrials.gov; performed supplementary searches of references and citations; and contacted study authors on 2 February 2024.</p><p><strong>Eligibility criteria: </strong>We included published randomised and quasi-randomised controlled trials, and observational controlled studies that assessed the impact of myomectomy on maternal health outcomes in pregnant women with fibroids undergoing caesarean birth. We excluded qualitative studies, case reports or series, conference abstracts, opinion papers, letters, and book chapters. There were no restrictions on ethnicity, race, socioeconomic status, education level, or place of residence.</p><p><strong>Outcomes: </strong>Critical outcomes were requirement for blood transfusion, risk of haemorrhage, change in haemoglobin, length of hospitalisation, length of operation, major surgery at time of procedure, fertility outcome, and postpartum fever.</p><p><strong>Risk of bias: </strong>We assessed risk of bias for non-randomised controlled studies using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool.</p><p><strong>Synthesis methods: </strong>We conducted a meta-analysis for each outcome when more than one study provided data. If it was not possible to analyse data via meta-analysis, we synthesised results narratively using Synthesis Without Meta-analysis (SWiM) guidance. We used GRADE to assess certainty of evidence for each critical and important outcome.</p><p><strong>Included studies: </strong>We included 23 non-randomised studies with 7504 women. Most studies were conducted in high-income or upper-middle-income countries. Five studies enrolled women with singleton pregnancies and one study was restricted to women with a t
{"title":"Caesarean myomectomy in pregnant women with uterine fibroids.","authors":"Teesta Dey, Maia G Cole, Daisy Brown, Ruaraidh A Hill, Marty Chaplin, Hanna E Huffstetler, Ffion Curtis","doi":"10.1002/14651858.CD016119","DOIUrl":"10.1002/14651858.CD016119","url":null,"abstract":"<p><strong>Rationale: </strong>Postpartum haemorrhage, defined as a blood loss of 500 mL or more within 24 hours of birth, is the leading global cause of maternal morbidity and mortality. Uterine fibroids are non-cancerous growths that develop in or around the uterus, and affect an increasing number of women. Caesarean myomectomy is the surgical removal of fibroids during a caesarean section. Traditionally, obstetricians have avoided this procedure given the risk of uncontrollable haemorrhage. There is also the risk of longer operating time and more days in the hospital. However, there could be potential benefits in removing uterine fibroids for improved fertility, and caesarean section may provide an effective and efficient opportunity to perform this procedure. Given the link between removal of uterine fibroids and postpartum haemorrhage, it is prudent to evaluate current literature and assess the benefits and harms of caesarean myomectomy in pregnant women with uterine fibroids.</p><p><strong>Objectives: </strong>To assess the benefits and harms of caesarean myomectomy in pregnant women with uterine fibroids undergoing caesarean section.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Global Index Medicus, ICTRP portal, and ClinicalTrials.gov; performed supplementary searches of references and citations; and contacted study authors on 2 February 2024.</p><p><strong>Eligibility criteria: </strong>We included published randomised and quasi-randomised controlled trials, and observational controlled studies that assessed the impact of myomectomy on maternal health outcomes in pregnant women with fibroids undergoing caesarean birth. We excluded qualitative studies, case reports or series, conference abstracts, opinion papers, letters, and book chapters. There were no restrictions on ethnicity, race, socioeconomic status, education level, or place of residence.</p><p><strong>Outcomes: </strong>Critical outcomes were requirement for blood transfusion, risk of haemorrhage, change in haemoglobin, length of hospitalisation, length of operation, major surgery at time of procedure, fertility outcome, and postpartum fever.</p><p><strong>Risk of bias: </strong>We assessed risk of bias for non-randomised controlled studies using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool.</p><p><strong>Synthesis methods: </strong>We conducted a meta-analysis for each outcome when more than one study provided data. If it was not possible to analyse data via meta-analysis, we synthesised results narratively using Synthesis Without Meta-analysis (SWiM) guidance. We used GRADE to assess certainty of evidence for each critical and important outcome.</p><p><strong>Included studies: </strong>We included 23 non-randomised studies with 7504 women. Most studies were conducted in high-income or upper-middle-income countries. Five studies enrolled women with singleton pregnancies and one study was restricted to women with a t","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD016119"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045436","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 : 2025-01-27DOI: 10.1002/14651858.CD011762.pub2
Carlos A Salazar, Juan E Basilio Flores, German Malaga, Giuliana N Malasquez, Roberto Bernardo
<p><strong>Background: </strong>People undergoing major orthopaedic surgery are at increased risk of postoperative thromboembolic events. Low molecular weight heparins (LMWHs) are recommended for thromboprophylaxis in this population. New oral anticoagulants, including direct factor Xa inhibitors, are recommended as alternatives. They may have more advantages than disadvantages compared to LMWHs and vitamin K antagonists (VKAs, another type of anticoagulant).</p><p><strong>Objectives: </strong>To assess the benefits and harms of prophylactic anticoagulation with direct factor Xa inhibitors compared with low molecular weight heparins and vitamin K antagonists in people undergoing major orthopaedic surgery for elective total hip or knee replacement or hip fracture surgery.</p><p><strong>Search methods: </strong>We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, two other databases, and two trial registers to 11 November 2023. We conducted reference checks to identify additional studies.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing the effects of direct factor Xa inhibitors to LMWHs or VKAs in people undergoing major orthopaedic surgery.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were all-cause mortality, major venous thromboembolism (VTE), symptomatic VTE, major bleeding, and serious hepatic and non-hepatic adverse events. We evaluated the risk of bias in the included studies using Cochrane's risk of bias 1 tool. We calculated estimates of treatment effects using risk ratios (RR) with 95% confidence intervals (CIs), and used GRADE criteria to assess the certainty of the evidence.</p><p><strong>Main results: </strong>We included 53 RCTs (44,371 participants). Participants' average age was 64 years (range: 18 to 93 years). Only one RCT compared a VKA with direct factor Xa inhibitors. All 53 RCTs compared direct factor Xa inhibitors with LMWHs. Twenty-three studies included participants undergoing total hip replacement; 21 studies, total knee replacement; and three studies included people having hip fracture surgery. The studies' average duration was approximately 42 days (range: two to 720 days). Compared to LMWHs, direct factor Xa inhibitors may have little to no effect on all-cause mortality, but the evidence is very uncertain (RR 0.83, 95% CI 0.52 to 1.31; I<sup>2</sup> = 0%; 28 studies, 29,698 participants; very low-certainty evidence). Direct factor Xa inhibitors may make little to no difference to major venous thromboembolic events compared to LMWHs, but the evidence is very uncertain (RR 0.51, 95% CI 0.37 to 0.71; absolute risk difference: 12 fewer major VTE events per 1000 participants, 95% CI 16 fewer to 7 fewer; I<sup>2</sup> = 48%; 28 studies, 24,574 participants; very low-certainty evidence). Compared to LMWHs, direct factor Xa inhibitors may reduce symptomatic VTE (RR 0.64, 95% CI 0.50 t
{"title":"Direct factor Xa inhibitors versus low molecular weight heparins or vitamin K antagonists for prevention of venous thromboembolism in elective primary hip or knee replacement or hip fracture repair.","authors":"Carlos A Salazar, Juan E Basilio Flores, German Malaga, Giuliana N Malasquez, Roberto Bernardo","doi":"10.1002/14651858.CD011762.pub2","DOIUrl":"10.1002/14651858.CD011762.pub2","url":null,"abstract":"<p><strong>Background: </strong>People undergoing major orthopaedic surgery are at increased risk of postoperative thromboembolic events. Low molecular weight heparins (LMWHs) are recommended for thromboprophylaxis in this population. New oral anticoagulants, including direct factor Xa inhibitors, are recommended as alternatives. They may have more advantages than disadvantages compared to LMWHs and vitamin K antagonists (VKAs, another type of anticoagulant).</p><p><strong>Objectives: </strong>To assess the benefits and harms of prophylactic anticoagulation with direct factor Xa inhibitors compared with low molecular weight heparins and vitamin K antagonists in people undergoing major orthopaedic surgery for elective total hip or knee replacement or hip fracture surgery.</p><p><strong>Search methods: </strong>We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, two other databases, and two trial registers to 11 November 2023. We conducted reference checks to identify additional studies.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing the effects of direct factor Xa inhibitors to LMWHs or VKAs in people undergoing major orthopaedic surgery.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were all-cause mortality, major venous thromboembolism (VTE), symptomatic VTE, major bleeding, and serious hepatic and non-hepatic adverse events. We evaluated the risk of bias in the included studies using Cochrane's risk of bias 1 tool. We calculated estimates of treatment effects using risk ratios (RR) with 95% confidence intervals (CIs), and used GRADE criteria to assess the certainty of the evidence.</p><p><strong>Main results: </strong>We included 53 RCTs (44,371 participants). Participants' average age was 64 years (range: 18 to 93 years). Only one RCT compared a VKA with direct factor Xa inhibitors. All 53 RCTs compared direct factor Xa inhibitors with LMWHs. Twenty-three studies included participants undergoing total hip replacement; 21 studies, total knee replacement; and three studies included people having hip fracture surgery. The studies' average duration was approximately 42 days (range: two to 720 days). Compared to LMWHs, direct factor Xa inhibitors may have little to no effect on all-cause mortality, but the evidence is very uncertain (RR 0.83, 95% CI 0.52 to 1.31; I<sup>2</sup> = 0%; 28 studies, 29,698 participants; very low-certainty evidence). Direct factor Xa inhibitors may make little to no difference to major venous thromboembolic events compared to LMWHs, but the evidence is very uncertain (RR 0.51, 95% CI 0.37 to 0.71; absolute risk difference: 12 fewer major VTE events per 1000 participants, 95% CI 16 fewer to 7 fewer; I<sup>2</sup> = 48%; 28 studies, 24,574 participants; very low-certainty evidence). Compared to LMWHs, direct factor Xa inhibitors may reduce symptomatic VTE (RR 0.64, 95% CI 0.50 t","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD011762"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045705","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 : 2025-01-27DOI: 10.1002/14651858.CD016026
Emma Olsson, Marcus G Prescott, Kristine B Titlestad, Michelle Fiander, Roger F Soll, Matteo Bruschettini
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of individualized developmental care interventions for promoting development and preventing morbidity in preterm infants.
{"title":"Individualized developmental care interventions for promoting development and preventing morbidity in preterm infants.","authors":"Emma Olsson, Marcus G Prescott, Kristine B Titlestad, Michelle Fiander, Roger F Soll, Matteo Bruschettini","doi":"10.1002/14651858.CD016026","DOIUrl":"10.1002/14651858.CD016026","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of individualized developmental care interventions for promoting development and preventing morbidity in preterm infants.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD016026"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045734","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 : 2025-01-27DOI: 10.1002/14651858.CD015120.pub2
Annika Theodoulou, Thomas R Fanshawe, Eleanor Leavens, Effie Theodoulou, Angela Difeng Wu, Laura Heath, Cristina Stewart, Nicole Nollen, Jasjit S Ahluwalia, Ailsa R Butler, Anisa Hajizadeh, James Thomas, Nicola Lindson, Jamie Hartmann-Boyce
<p><strong>Background: </strong>People from lower socioeconomic groups are more likely to smoke and less likely to succeed in achieving abstinence, making tobacco smoking a leading driver of health inequalities. Contextual factors affecting subpopulations may moderate the efficacy of individual-level smoking cessation interventions. It is not known whether any intervention performs differently across socioeconomically-diverse populations and contexts.</p><p><strong>Objectives: </strong>To assess whether the effects of individual-level smoking cessation interventions on combustible tobacco cigarette use differ by socioeconomic groups, and their potential impact on health equalities.</p><p><strong>Search methods: </strong>We searched the Cochrane Database of Systematic Reviews from inception to 1 May 2023 for Cochrane reviews investigating individual-level smoking cessation interventions. We selected studies included in these reviews that met our criteria. We contacted study authors to identify further eligible studies.</p><p><strong>Selection criteria: </strong>We included parallel, cluster or factorial randomised controlled trials (RCTs) investigating any individual-level smoking cessation intervention which encouraged complete cessation of combustible tobacco cigarette use compared to no intervention, placebo, or another intervention in adults. Studies must have assessed or reported smoking quit rates, split by any measure of socioeconomic status (SES) at longest follow-up (≥ six months), and been published in 2000 or later.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methods for screening, data extraction, and risk of bias assessment. We assessed the availability of smoking abstinence data by SES in lieu of selective reporting. The primary outcome was smoking cessation quit rates, split by lower and higher SES, at the longest follow-up (≥ six months). Where possible, we calculated ratios of odds ratios (ROR) with 95% confidence intervals (CIs) for each study, comparing lower to higher SES. We pooled RORs by intervention type in random-effects meta-analyses, using the generic inverse-variance method. We subgrouped by type of SES indicator and economic classification of the study country. We summarised all evidence in effect direction plots and categorised the intervention impact on health equality as: positive (evidence that the relative effect of the intervention on quit rates was greater in lower rather than higher SES groups), possibly positive, neutral, possibly neutral, possibly negative, negative, no reported statistically significant difference, or unclear. We evaluated certainty using GRADE.</p><p><strong>Main results: </strong>We included 77 studies (73 from high-income countries), representing 127,791 participants. We deemed 12 studies at low overall risk of bias, 13 at unclear risk, and the remaining 52 at high risk. Included studies investigated a range of pharmacological interventions, behaviou
{"title":"Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status.","authors":"Annika Theodoulou, Thomas R Fanshawe, Eleanor Leavens, Effie Theodoulou, Angela Difeng Wu, Laura Heath, Cristina Stewart, Nicole Nollen, Jasjit S Ahluwalia, Ailsa R Butler, Anisa Hajizadeh, James Thomas, Nicola Lindson, Jamie Hartmann-Boyce","doi":"10.1002/14651858.CD015120.pub2","DOIUrl":"10.1002/14651858.CD015120.pub2","url":null,"abstract":"<p><strong>Background: </strong>People from lower socioeconomic groups are more likely to smoke and less likely to succeed in achieving abstinence, making tobacco smoking a leading driver of health inequalities. Contextual factors affecting subpopulations may moderate the efficacy of individual-level smoking cessation interventions. It is not known whether any intervention performs differently across socioeconomically-diverse populations and contexts.</p><p><strong>Objectives: </strong>To assess whether the effects of individual-level smoking cessation interventions on combustible tobacco cigarette use differ by socioeconomic groups, and their potential impact on health equalities.</p><p><strong>Search methods: </strong>We searched the Cochrane Database of Systematic Reviews from inception to 1 May 2023 for Cochrane reviews investigating individual-level smoking cessation interventions. We selected studies included in these reviews that met our criteria. We contacted study authors to identify further eligible studies.</p><p><strong>Selection criteria: </strong>We included parallel, cluster or factorial randomised controlled trials (RCTs) investigating any individual-level smoking cessation intervention which encouraged complete cessation of combustible tobacco cigarette use compared to no intervention, placebo, or another intervention in adults. Studies must have assessed or reported smoking quit rates, split by any measure of socioeconomic status (SES) at longest follow-up (≥ six months), and been published in 2000 or later.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methods for screening, data extraction, and risk of bias assessment. We assessed the availability of smoking abstinence data by SES in lieu of selective reporting. The primary outcome was smoking cessation quit rates, split by lower and higher SES, at the longest follow-up (≥ six months). Where possible, we calculated ratios of odds ratios (ROR) with 95% confidence intervals (CIs) for each study, comparing lower to higher SES. We pooled RORs by intervention type in random-effects meta-analyses, using the generic inverse-variance method. We subgrouped by type of SES indicator and economic classification of the study country. We summarised all evidence in effect direction plots and categorised the intervention impact on health equality as: positive (evidence that the relative effect of the intervention on quit rates was greater in lower rather than higher SES groups), possibly positive, neutral, possibly neutral, possibly negative, negative, no reported statistically significant difference, or unclear. We evaluated certainty using GRADE.</p><p><strong>Main results: </strong>We included 77 studies (73 from high-income countries), representing 127,791 participants. We deemed 12 studies at low overall risk of bias, 13 at unclear risk, and the remaining 52 at high risk. Included studies investigated a range of pharmacological interventions, behaviou","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD015120"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045507","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 : 2025-01-27DOI: 10.1002/14651858.CD001155.pub3
George A Wells, Shu-Ching Hsieh, Joan Peterson, Carine Zheng, Shannon E Kelly, Beverley Shea, Peter Tugwell
<p><strong>Rationale: </strong>Osteoporosis is an abnormal reduction in bone mass and bone deterioration, leading to increased fracture risk. Alendronate belongs to the bisphosphonate class of drugs, which inhibit bone resorption by interfering with the activity of osteoclasts (bone cells that break down bone tissue). This is an update of a Cochrane review first published in 2008.</p><p><strong>Objectives: </strong>To assess the benefits and harms of alendronate in the primary and secondary prevention of osteoporotic fractures in postmenopausal women at lower and higher risk of fracture, respectively.</p><p><strong>Search methods: </strong>We searched Evidence-Based Medicine Reviews (which includes CENTRAL), MEDLINE, Embase, two trial registers, drug approval agency websites, and the bibliographies of relevant systematic reviews to identify the studies included in this review. The latest search date was 01 February 2023. We imposed no restrictions on language, date, form of publication, or reported outcomes.</p><p><strong>Eligibility criteria: </strong>We included only randomized controlled trials that assessed the effects of alendronate on postmenopausal women. Targeted participants must have received at least one year of alendronate. We classified a study as secondary prevention if its population met one or more of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, a low bone mineral density T-score (-2.5 or lower), and 75 years old or older. If a study population met none of those criteria, we classified it as a primary prevention study.</p><p><strong>Outcomes: </strong>Our major outcomes were clinical vertebral, non-vertebral, hip, and wrist fractures, withdrawals due to adverse events, and serious adverse events.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias 1 tool.</p><p><strong>Synthesis methods: </strong>We used standard methodological procedures expected by Cochrane. Based on the previous review experience, in which the clinical and methodological characteristics in the primary and secondary prevention studies were homogeneous, we used a fixed-effect model for meta-analysis and estimated effects using the risk ratio (RR) for dichotomous outcomes. Our base case analyses included all eligible placebo-controlled studies with usable data. We selected the data available for the longest treatment period. We consider a relative change exceeding 15% as clinically important.</p><p><strong>Included studies: </strong>We included 119 studies, of which 102 studies provided data for quantitative synthesis. Of these, we classified 34 studies (15,188 participants) as primary prevention and 68 studies (29,577 participants) as secondary prevention. We had concerns about risks of bias in most studies. Selection bias was the most frequently overlooked domain, with only 20 studies (19%) describing appropriate methods for both sequence generation and allocation concealment. Eight studie
{"title":"Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women.","authors":"George A Wells, Shu-Ching Hsieh, Joan Peterson, Carine Zheng, Shannon E Kelly, Beverley Shea, Peter Tugwell","doi":"10.1002/14651858.CD001155.pub3","DOIUrl":"10.1002/14651858.CD001155.pub3","url":null,"abstract":"<p><strong>Rationale: </strong>Osteoporosis is an abnormal reduction in bone mass and bone deterioration, leading to increased fracture risk. Alendronate belongs to the bisphosphonate class of drugs, which inhibit bone resorption by interfering with the activity of osteoclasts (bone cells that break down bone tissue). This is an update of a Cochrane review first published in 2008.</p><p><strong>Objectives: </strong>To assess the benefits and harms of alendronate in the primary and secondary prevention of osteoporotic fractures in postmenopausal women at lower and higher risk of fracture, respectively.</p><p><strong>Search methods: </strong>We searched Evidence-Based Medicine Reviews (which includes CENTRAL), MEDLINE, Embase, two trial registers, drug approval agency websites, and the bibliographies of relevant systematic reviews to identify the studies included in this review. The latest search date was 01 February 2023. We imposed no restrictions on language, date, form of publication, or reported outcomes.</p><p><strong>Eligibility criteria: </strong>We included only randomized controlled trials that assessed the effects of alendronate on postmenopausal women. Targeted participants must have received at least one year of alendronate. We classified a study as secondary prevention if its population met one or more of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, a low bone mineral density T-score (-2.5 or lower), and 75 years old or older. If a study population met none of those criteria, we classified it as a primary prevention study.</p><p><strong>Outcomes: </strong>Our major outcomes were clinical vertebral, non-vertebral, hip, and wrist fractures, withdrawals due to adverse events, and serious adverse events.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias 1 tool.</p><p><strong>Synthesis methods: </strong>We used standard methodological procedures expected by Cochrane. Based on the previous review experience, in which the clinical and methodological characteristics in the primary and secondary prevention studies were homogeneous, we used a fixed-effect model for meta-analysis and estimated effects using the risk ratio (RR) for dichotomous outcomes. Our base case analyses included all eligible placebo-controlled studies with usable data. We selected the data available for the longest treatment period. We consider a relative change exceeding 15% as clinically important.</p><p><strong>Included studies: </strong>We included 119 studies, of which 102 studies provided data for quantitative synthesis. Of these, we classified 34 studies (15,188 participants) as primary prevention and 68 studies (29,577 participants) as secondary prevention. We had concerns about risks of bias in most studies. Selection bias was the most frequently overlooked domain, with only 20 studies (19%) describing appropriate methods for both sequence generation and allocation concealment. Eight studie","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD001155"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045295","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 : 2025-01-20DOI: 10.1002/14651858.CD009730.pub3
Matthew N Hurley, Sherie Smith, Patrick Flume, Nikki Jahnke, Andrew P Prayle
<p><strong>Background: </strong>Cystic fibrosis is a multisystem disease characterised by the production of thick secretions causing recurrent pulmonary infection, often with unusual bacteria. Intravenous (IV) antibiotics are commonly used in the treatment of acute deteriorations in symptoms (pulmonary exacerbations); however, recently the assumption that exacerbations are due to increases in bacterial burden has been questioned. This is an update of a previously published review.</p><p><strong>Objectives: </strong>To establish whether IV antibiotics for the treatment of pulmonary exacerbations in people with cystic fibrosis improve short-term and long-term clinical outcomes.</p><p><strong>Search methods: </strong>We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews and ongoing trials registers. Date of last search of Cochrane Trials Register: 19 June 2024.</p><p><strong>Selection criteria: </strong>Randomised controlled trials and the first treatment cycle of cross-over studies comparing IV antibiotics (given alone or in an antibiotic combination) with placebo, or inhaled or oral antibiotics for people with cystic fibrosis experiencing a pulmonary exacerbation. Studies comparing different IV antibiotic regimens were also eligible.</p><p><strong>Data collection and analysis: </strong>We assessed studies for eligibility and risk of bias, and extracted data. Using GRADE, we assessed the certainty of the evidence for the outcomes lung function % predicted (forced expiratory volume in one second (FEV<sub>1</sub>) and forced vital capacity (FVC)), time to next exacerbation and quality of life.</p><p><strong>Main results: </strong>We included 45 studies involving 2810 participants. The included studies were mostly small, and inadequately reported, many of which were quite old. The certainty of the evidence was mostly low. Combined intravenous antibiotics versus placebo Data reported for absolute change in % predicted FEV<sub>1</sub> and FVC suggested a possible improvement in favour of IV antibiotics, but the evidence is very uncertain (1 study, 12 participants; very low-certainty evidence). The study did not measure time to next exacerbation or quality of life. Intravenous versus nebulised antibiotics Five studies (122 participants) reported FEV<sub>1</sub>, with analysable data only from one study (16 participants). We found no difference between groups (moderate-certainty evidence). Three studies (91 participants) reported on FVC, with analysable data from only one study (54 participants). We are very uncertain on the effect of nebulised antibiotics (very low-certainty evidence). In one study, the 16 participants on nebulised plus IV antibiotics had a lower mean number of days to next exacerbation than those on combined IV antibiotics (low-certainty evidence), but we found
{"title":"Intravenous antibiotics for pulmonary exacerbations in people with cystic fibrosis.","authors":"Matthew N Hurley, Sherie Smith, Patrick Flume, Nikki Jahnke, Andrew P Prayle","doi":"10.1002/14651858.CD009730.pub3","DOIUrl":"10.1002/14651858.CD009730.pub3","url":null,"abstract":"<p><strong>Background: </strong>Cystic fibrosis is a multisystem disease characterised by the production of thick secretions causing recurrent pulmonary infection, often with unusual bacteria. Intravenous (IV) antibiotics are commonly used in the treatment of acute deteriorations in symptoms (pulmonary exacerbations); however, recently the assumption that exacerbations are due to increases in bacterial burden has been questioned. This is an update of a previously published review.</p><p><strong>Objectives: </strong>To establish whether IV antibiotics for the treatment of pulmonary exacerbations in people with cystic fibrosis improve short-term and long-term clinical outcomes.</p><p><strong>Search methods: </strong>We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews and ongoing trials registers. Date of last search of Cochrane Trials Register: 19 June 2024.</p><p><strong>Selection criteria: </strong>Randomised controlled trials and the first treatment cycle of cross-over studies comparing IV antibiotics (given alone or in an antibiotic combination) with placebo, or inhaled or oral antibiotics for people with cystic fibrosis experiencing a pulmonary exacerbation. Studies comparing different IV antibiotic regimens were also eligible.</p><p><strong>Data collection and analysis: </strong>We assessed studies for eligibility and risk of bias, and extracted data. Using GRADE, we assessed the certainty of the evidence for the outcomes lung function % predicted (forced expiratory volume in one second (FEV<sub>1</sub>) and forced vital capacity (FVC)), time to next exacerbation and quality of life.</p><p><strong>Main results: </strong>We included 45 studies involving 2810 participants. The included studies were mostly small, and inadequately reported, many of which were quite old. The certainty of the evidence was mostly low. Combined intravenous antibiotics versus placebo Data reported for absolute change in % predicted FEV<sub>1</sub> and FVC suggested a possible improvement in favour of IV antibiotics, but the evidence is very uncertain (1 study, 12 participants; very low-certainty evidence). The study did not measure time to next exacerbation or quality of life. Intravenous versus nebulised antibiotics Five studies (122 participants) reported FEV<sub>1</sub>, with analysable data only from one study (16 participants). We found no difference between groups (moderate-certainty evidence). Three studies (91 participants) reported on FVC, with analysable data from only one study (54 participants). We are very uncertain on the effect of nebulised antibiotics (very low-certainty evidence). In one study, the 16 participants on nebulised plus IV antibiotics had a lower mean number of days to next exacerbation than those on combined IV antibiotics (low-certainty evidence), but we found ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD009730"},"PeriodicalIF":8.8,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001388","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 : 2025-01-20DOI: 10.1002/14651858.CD012429.pub2
Dawid Storman, Magdalena Koperny, Krzysztof Styczeñ, Wojciech Datka, Rafal R Jaeschke
<p><strong>Background: </strong>Antipsychotic drugs are the mainstay of treatment for schizophrenia. Even though several novel second-generation antipsychotics (i.e. lurasidone, iloperidone and cariprazine) have been approved in recent years, typical antipsychotics (e.g. chlorpromazine, haloperidol, and fluphenazine) remain a crucial therapeutic option for the condition around the world. Little is known about the relative risk-to-benefit ratio of the 'latest' second-generation antipsychotics compared to the typical agents of 'established stature'.</p><p><strong>Objectives: </strong>To systematically review the efficacy and safety of lurasidone versus typical antipsychotics for adults with schizophrenia or schizophrenia-related disorders.</p><p><strong>Search methods: </strong>We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials on 5 June 2019. We also ran an update search in CENTRAL, MEDLINE, Embase, and three additional databases as well as two trial registers and the US Food and Drug Administration database on 1 April 2024.</p><p><strong>Selection criteria: </strong>We searched for randomized controlled trials (RCTs) comparing lurasidonewith typical antipsychotic drugs (such as chlorpromazine, fluphenazine, haloperidol, loxapine, mesoridazine, molindone, perphenazine, thioridazine, thiothixene, zuclopenthixol) for adults with schizophrenia. No additional search restrictions were applied.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methodological procedures. We extracted information on participant characteristics, interventions, study outcomes, study design, trial methods, and funding sources. Two review authors independently extracted data and assessed the risk of bias. We assessed the certainty of evidence with GRADE for these key outcomes: change in mental state, death by suicide or natural cause, quality of life, total serious adverse events and severe adverse events (as defined by study authors).</p><p><strong>Main results: </strong>We included two studies with a total of 308 individuals diagnosed with schizophrenia (220 men and 85 women). A total of 223 participants received lurasidone (20, 40, or 80 mg/day), and 82 received haloperidol (up to 10 mg/day) or perphenazine (up to 32 mg/day); three people did not receive any study medication. Both studies were performed in the US. The duration of the follow-up was four to six weeks. Death by suicide/natural causes and quality of life were not reported by the two included studies. The evidence is very uncertain about the effects of lurasidone on change in mental state: the Brief Psychiatric Rating Scale (BPRS) (MD 3.74, 95% CI 0.57 to 6.90; 1 RCT, 281 participants; very low-certainty evidence); and the Positive and Negative Syndrome Scale (PANSS) (MD 6.68, 95% CI 2.45 to 10.91; 1 RCT, 281 participants; very low-certainty evidence). The evidence is also very uncertain about the effects of lurasidone on total serious adverse events (
背景:抗精神病药物是治疗精神分裂症的主要药物。尽管近年来已经批准了几种新的第二代抗精神病药物(如鲁拉西酮、依哌啶酮和卡吡嗪),但典型的抗精神病药物(如氯丙嗪、氟哌啶醇和氟非那嗪)仍然是世界各地治疗该病的关键选择。关于“最新”的第二代抗精神病药物与“成熟”的典型药物的相对风险-收益比,我们知之甚少。目的:系统回顾鲁拉西酮与典型抗精神病药物对成人精神分裂症或精神分裂症相关疾病的疗效和安全性。检索方法:我们于2019年6月5日检索了Cochrane精神分裂症组的基于研究的试验登记册。我们还于2024年4月1日在CENTRAL、MEDLINE、Embase和另外三个数据库以及两个试验注册库和美国食品和药物管理局数据库中进行了更新检索。选择标准:我们检索了鲁拉西酮与典型抗精神病药物(如氯丙嗪、氟非那嗪、氟哌啶醇、洛沙平、美索里嗪、莫林酮、奋那嗪、硫硝嗪、硫噻吩、zuclopenthxol)治疗成人精神分裂症的随机对照试验(rct)。没有施加额外的搜索限制。数据收集和分析:我们遵循标准的Cochrane方法程序。我们提取了参与者特征、干预措施、研究结果、研究设计、试验方法和资金来源的信息。两位综述作者独立提取数据并评估偏倚风险。我们用GRADE评估这些关键结局的证据确定性:精神状态改变、自杀或自然原因死亡、生活质量、总严重不良事件和严重不良事件(由研究作者定义)。主要结果:我们纳入了两项研究,共308名被诊断为精神分裂症的个体(220名男性和85名女性)。共有223名参与者接受鲁拉西酮(20,40或80mg /天),82名接受氟哌啶醇(高达10mg /天)或奋那嗪(高达32mg /天);其中三人没有接受任何研究药物。两项研究都是在美国进行的。随访时间为4至6周。这两项纳入的研究未报告自杀/自然原因死亡和生活质量。关于鲁拉西酮对精神状态改变的影响的证据非常不确定:简短精神病学评定量表(BPRS) (MD 3.74, 95% CI 0.57至6.90;1项随机对照试验,281名受试者;极低确定性证据);阳性和阴性综合征量表(PANSS) (MD 6.68, 95% CI 2.45 ~ 10.91;1项随机对照试验,281名受试者;非常低确定性证据)。关于鲁拉西酮对总严重不良事件的影响,证据也非常不确定(RR 0.98, 95% CI 0.37 ~ 2.60;2项随机对照试验,303名受试者;证据确定性极低)和严重不良事件(RR 1.70, 95% CI 0.46 ~ 6.32;1项随机对照试验,281名受试者;证据的确定性非常低)。作者的结论:我们非常不确定鲁拉西酮是否对精神分裂症患者的精神状态有益,总的严重不良事件,或者与典型的抗精神病药物相比,严重的不良事件。本综述中纳入的证据的确定性非常低,来自两个小型试验。研究的局限性(偏倚风险)和不精确的结果影响了我们对证据的信心。此外,关于死亡率(由于自杀或自然原因)或生活质量的数据也没有。需要进一步的大规模随机研究来更清楚地了解鲁拉西酮与典型抗精神病药物治疗精神分裂症的利弊。
{"title":"Lurasidone versus typical antipsychotics for schizophrenia.","authors":"Dawid Storman, Magdalena Koperny, Krzysztof Styczeñ, Wojciech Datka, Rafal R Jaeschke","doi":"10.1002/14651858.CD012429.pub2","DOIUrl":"10.1002/14651858.CD012429.pub2","url":null,"abstract":"<p><strong>Background: </strong>Antipsychotic drugs are the mainstay of treatment for schizophrenia. Even though several novel second-generation antipsychotics (i.e. lurasidone, iloperidone and cariprazine) have been approved in recent years, typical antipsychotics (e.g. chlorpromazine, haloperidol, and fluphenazine) remain a crucial therapeutic option for the condition around the world. Little is known about the relative risk-to-benefit ratio of the 'latest' second-generation antipsychotics compared to the typical agents of 'established stature'.</p><p><strong>Objectives: </strong>To systematically review the efficacy and safety of lurasidone versus typical antipsychotics for adults with schizophrenia or schizophrenia-related disorders.</p><p><strong>Search methods: </strong>We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials on 5 June 2019. We also ran an update search in CENTRAL, MEDLINE, Embase, and three additional databases as well as two trial registers and the US Food and Drug Administration database on 1 April 2024.</p><p><strong>Selection criteria: </strong>We searched for randomized controlled trials (RCTs) comparing lurasidonewith typical antipsychotic drugs (such as chlorpromazine, fluphenazine, haloperidol, loxapine, mesoridazine, molindone, perphenazine, thioridazine, thiothixene, zuclopenthixol) for adults with schizophrenia. No additional search restrictions were applied.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methodological procedures. We extracted information on participant characteristics, interventions, study outcomes, study design, trial methods, and funding sources. Two review authors independently extracted data and assessed the risk of bias. We assessed the certainty of evidence with GRADE for these key outcomes: change in mental state, death by suicide or natural cause, quality of life, total serious adverse events and severe adverse events (as defined by study authors).</p><p><strong>Main results: </strong>We included two studies with a total of 308 individuals diagnosed with schizophrenia (220 men and 85 women). A total of 223 participants received lurasidone (20, 40, or 80 mg/day), and 82 received haloperidol (up to 10 mg/day) or perphenazine (up to 32 mg/day); three people did not receive any study medication. Both studies were performed in the US. The duration of the follow-up was four to six weeks. Death by suicide/natural causes and quality of life were not reported by the two included studies. The evidence is very uncertain about the effects of lurasidone on change in mental state: the Brief Psychiatric Rating Scale (BPRS) (MD 3.74, 95% CI 0.57 to 6.90; 1 RCT, 281 participants; very low-certainty evidence); and the Positive and Negative Syndrome Scale (PANSS) (MD 6.68, 95% CI 2.45 to 10.91; 1 RCT, 281 participants; very low-certainty evidence). The evidence is also very uncertain about the effects of lurasidone on total serious adverse events (","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD012429"},"PeriodicalIF":8.8,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001406","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 : 2025-01-17DOI: 10.1002/14651858.CD014845.pub2
Natasha Clarke, Emily Pechey, Ian Shemilt, Mark Pilling, Nia W Roberts, Theresa M Marteau, Susan A Jebb, Gareth J Hollands
<p><strong>Background: </strong>Overconsumption of food and consumption of any amount of alcohol increases the risk of non-communicable diseases. Calorie (energy) labelling is advocated as a means to reduce energy intake from food and alcoholic drinks. However, there is continued uncertainty about these potential impacts, with a 2018 Cochrane review identifying only a small body of low-certainty evidence. This review updates and extends the 2018 Cochrane review to provide a timely reassessment of evidence for the effects of calorie labelling on people's selection and consumption of food or alcoholic drinks.</p><p><strong>Objectives: </strong>- To estimate the effect of calorie labelling for food (including non-alcoholic drinks) and alcoholic drinks on selection (with or without purchasing) and consumption. - To assess possible modifiers - label type, setting, and socioeconomic status - of the effect of calorie labelling on selection (with or without purchasing) and consumption of food and alcohol.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, PsycINFO, five other published or grey literature databases, trial registries, and key websites, followed by backwards and forwards citation searches. Using a semi-automated workflow, we searched for and selected records and corresponding reports of eligible studies, with these searches current to 2 August 2021. Updated searches were conducted in September 2023 but their results are not fully integrated into this version of the review.</p><p><strong>Selection criteria: </strong>Eligible studies were randomised controlled trials (RCTs) or quasi-RCTs with between-subjects (parallel group) or within-subjects (cross-over) designs, interrupted time series studies, or controlled before-after studies comparing calorie labelling with no calorie labelling, applied to food (including non-alcoholic drinks) or alcoholic drinks. Eligible studies also needed to objectively measure participants' selection (with or without purchasing) or consumption, in real-world, naturalistic laboratory, or laboratory settings.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion and extracted study data. We applied the Cochrane RoB 2 tool and ROBINS-I to assess risk of bias in included studies. Where possible, we used (random-effects) meta-analyses to estimate summary effect sizes as standardised mean differences (SMDs) with 95% confidence intervals (CIs), and subgroup analyses to investigate potential effect modifiers, including study, intervention, and participant characteristics. We synthesised data from other studies in a narrative summary. We rated the certainty of evidence using GRADE.</p><p><strong>Main results: </strong>We included 25 studies (23 food, 2 alcohol and food), comprising 18 RCTs, one quasi-RCT, two interrupted time series studies, and four controlled before-after studies. Most studies were conducted in real-world field sett
背景:过度食用食物和摄入任何数量的酒精都会增加非传染性疾病的风险。提倡将卡路里(能量)标签作为减少从食物和酒精饮料中摄入能量的一种手段。然而,这些潜在的影响仍然存在不确定性,2018年的Cochrane综述只发现了一小部分低确定性的证据。本综述更新并扩展了2018年Cochrane综述,及时重新评估了卡路里标签对人们选择和消费食物或酒精饮料的影响的证据。目标:-评估食品(包括非酒精饮料)和酒精饮料的卡路里标签对选择(购买或不购买)和消费的影响。-评估卡路里标签对食品和酒精的选择(有或没有购买)和消费的影响的可能修饰因素——标签类型、设置和社会经济地位。检索方法:检索了CENTRAL、MEDLINE、Embase、PsycINFO、其他5个已发表或灰色文献数据库、试验注册库和关键网站,然后进行了前后引文检索。使用半自动化的工作流程,我们检索并选择了符合条件的研究的记录和相应的报告,这些检索截止到2021年8月2日。2023年9月进行了更新搜索,但其结果并未完全纳入本版本的综述。入选标准:适用于食品(包括非酒精饮料)或酒精饮料的随机对照试验(rct)或准rct,采用受试者间(平行组)或受试者内(交叉)设计、中断时间序列研究或对照卡路里标签与无卡路里标签的前后对照研究。合格的研究还需要客观地衡量参与者在现实世界、自然主义实验室或实验室环境中的选择(有或没有购买)或消费。资料收集和分析:两位综述作者独立选择研究纳入并提取研究数据。我们应用Cochrane RoB 2工具和ROBINS-I评估纳入研究的偏倚风险。在可能的情况下,我们使用(随机效应)荟萃分析来估计95%置信区间(ci)的标准化平均差异(smd)的总效应大小,并使用亚组分析来调查潜在的效应调节因素,包括研究、干预和参与者特征。我们综合了其他研究的数据,形成了一个叙述性的摘要。我们使用GRADE对证据的确定性进行评级。主要结果:我们纳入了25项研究(23项食物研究,2项酒精和食物研究),包括18项随机对照试验,1项准随机对照试验,2项中断时间序列研究和4项前后对照研究。大多数研究是在现实世界的实地环境中进行的(16/25,其中13个在餐馆或自助餐厅,3个在超市);六项研究在自然主义实验室进行,试图模仿现实世界的环境;三个研究是在实验室环境下进行的。大多数研究评估了菜单或菜单板上的卡路里标签的影响(18/25);六项研究评估了直接贴在产品或其包装上或贴在产品或其包装旁边的卡路里标签的影响;一项研究评估了菜单和产品包装上的标签。最常被评估的标签类型是简单的卡路里标签(20/25),还有其他研究评估卡路里标签上至少有一种其他营养素的信息,或者卡路里标签上有身体活动卡路里当量(PACE)的标签(或两者都有)。24项研究在高收入国家进行,其中15项在美国,6项在英国,1项在爱尔兰,1项在法国,1项在加拿大。大多数研究(18/25)是在高社会经济地位人群中进行的,而6项研究同时包括低社会经济群体和高社会经济群体,一项研究仅包括低社会经济群体的参与者。24项研究包括对食物选择(有或没有购买)的测量,其中大多数测量了购买的选择(17/24),8项研究包括对食物消费的测量。食物的卡路里标签导致能量选择的小幅减少(SMD -0.06, 95% CI -0.08至-0.03;16项随机研究,19项比较,9850名受试者;高确定性证据),当只包括低偏倚风险的研究和只包括选择与购买的研究时,效果几乎相同。可能有更大的消耗减少(SMD -0.19, 95% CI -0.33至-0.05;8项随机研究,10项比较,2134名受试者;确定性的证据)。这些效应量表明,对于平均600千卡的一餐,接触到卡路里标签的成年人会少选择11千卡(相当于减少1.8%),并少摄入35千卡(相当于减少5.9%)。
{"title":"Calorie (energy) labelling for changing selection and consumption of food or alcohol.","authors":"Natasha Clarke, Emily Pechey, Ian Shemilt, Mark Pilling, Nia W Roberts, Theresa M Marteau, Susan A Jebb, Gareth J Hollands","doi":"10.1002/14651858.CD014845.pub2","DOIUrl":"10.1002/14651858.CD014845.pub2","url":null,"abstract":"<p><strong>Background: </strong>Overconsumption of food and consumption of any amount of alcohol increases the risk of non-communicable diseases. Calorie (energy) labelling is advocated as a means to reduce energy intake from food and alcoholic drinks. However, there is continued uncertainty about these potential impacts, with a 2018 Cochrane review identifying only a small body of low-certainty evidence. This review updates and extends the 2018 Cochrane review to provide a timely reassessment of evidence for the effects of calorie labelling on people's selection and consumption of food or alcoholic drinks.</p><p><strong>Objectives: </strong>- To estimate the effect of calorie labelling for food (including non-alcoholic drinks) and alcoholic drinks on selection (with or without purchasing) and consumption. - To assess possible modifiers - label type, setting, and socioeconomic status - of the effect of calorie labelling on selection (with or without purchasing) and consumption of food and alcohol.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, PsycINFO, five other published or grey literature databases, trial registries, and key websites, followed by backwards and forwards citation searches. Using a semi-automated workflow, we searched for and selected records and corresponding reports of eligible studies, with these searches current to 2 August 2021. Updated searches were conducted in September 2023 but their results are not fully integrated into this version of the review.</p><p><strong>Selection criteria: </strong>Eligible studies were randomised controlled trials (RCTs) or quasi-RCTs with between-subjects (parallel group) or within-subjects (cross-over) designs, interrupted time series studies, or controlled before-after studies comparing calorie labelling with no calorie labelling, applied to food (including non-alcoholic drinks) or alcoholic drinks. Eligible studies also needed to objectively measure participants' selection (with or without purchasing) or consumption, in real-world, naturalistic laboratory, or laboratory settings.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion and extracted study data. We applied the Cochrane RoB 2 tool and ROBINS-I to assess risk of bias in included studies. Where possible, we used (random-effects) meta-analyses to estimate summary effect sizes as standardised mean differences (SMDs) with 95% confidence intervals (CIs), and subgroup analyses to investigate potential effect modifiers, including study, intervention, and participant characteristics. We synthesised data from other studies in a narrative summary. We rated the certainty of evidence using GRADE.</p><p><strong>Main results: </strong>We included 25 studies (23 food, 2 alcohol and food), comprising 18 RCTs, one quasi-RCT, two interrupted time series studies, and four controlled before-after studies. Most studies were conducted in real-world field sett","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD014845"},"PeriodicalIF":8.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11738108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001386","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 : 2025-01-17DOI: 10.1002/14651858.CD016134
Idnan Yunas, Ioannis D Gallos, Adam J Devall, Marcelina Podesek, John Allotey, Yemisi Takwoingi, Arri Coomarasamy
<p><strong>Background: </strong>Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Accurate diagnosis of PPH can prevent adverse outcomes by enabling early treatment.</p><p><strong>Objectives: </strong>What is the accuracy of methods (index tests) for diagnosing primary PPH (blood loss ≥ 500 mL in the first 24 hours after birth) and severe primary PPH (blood loss ≥ 1000 mL in the first 24 hours after birth) (target conditions) in women giving birth vaginally (participants) compared to weighed blood loss measurement or other objective measurements of blood loss (reference standards)?</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Web of Science Core Collection, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform to 24 May 2024.</p><p><strong>Selection criteria: </strong>We included women who gave birth vaginally in any setting. Study types included diagnostic cohort studies and cross-sectional studies that reported 2 x 2 data (number of true positive, false positive, false negative, and true negative results) or where the 2 x 2 data could be derived from test accuracy estimates. Eligible index tests included: visual estimation; calibrated blood collection devices; approach with calibrated drape and observations; blood loss estimation using the SAPHE (Signalling a Postpartum Hemorrhage Emergency) Mat; blood loss field image analysis and other technologies; uterine atony assessment; clinical variables (e.g. heart rate, blood pressure, shock index); early warning charts; haemoglobin levels; and predelivery fibrinogen levels. Eligible reference standards included objective methods such as: gravimetric blood loss measurement, which involves weighing collected blood, as well as weighing blood-soaked pads, gauze and sheets, and subtracting their dry weight; calibrated devices to measure blood volume (volumetric blood loss measurement); the alkaline-haematin method of blood loss estimation; and blood extracted using machine-extraction and measured spectrometrically as oxyhaemoglobin.</p><p><strong>Data collection and analysis: </strong>At least two review authors, working independently, undertook study screening, selection, data extraction, assessment of risk of bias, and assessment of the certainty of the evidence. We resolved any differences through consensus or with input from another author. We generated 2 x 2 tables of the true positives, true negatives, false positives, and false negatives to calculate the sensitivity, specificity, and 95% confidence intervals for each index test. We presented sensitivity and specificity estimates from studies in forest plots. Where possible, we conducted meta-analyses for each index test and reference standard combination for each target condition. We examined heterogeneity by visual inspection of the forest plots.</p><p><strong>Main results: </strong>Our review included 18 studies with a total of 291,040
背景:产后出血(PPH)是全世界孕产妇死亡的主要原因。PPH的准确诊断可以通过早期治疗来预防不良后果。目的:与称重失血量测量或其他客观失血量测量(参考标准)相比,阴道分娩妇女(参与者)诊断原发性PPH(出生后24小时失血量≥500 mL)和重度原发性PPH(出生后24小时失血量≥1000 mL)(目标条件)的方法(指标试验)的准确性如何?检索方法:检索截止到2024年5月24日的CENTRAL、MEDLINE、Embase、Web of Science Core Collection、ClinicalTrials.gov和世界卫生组织国际临床试验注册平台。选择标准:我们包括在任何环境下顺产的妇女。研究类型包括诊断队列研究和报告2 × 2数据(真阳性、假阳性、假阴性和真阴性结果的数量)的横断面研究,或者2 × 2数据可以从测试准确性估计中得出的研究。合格的指标测试包括:目测;经校准的采血装置;标定垂度和观测方法;使用SAPHE(产后出血紧急信号)Mat进行失血估计;失血现场图像分析等技术;子宫张力评估;临床变量(如心率、血压、休克指数);预警图;血红蛋白水平;产前纤维蛋白原水平。合格的参考标准包括客观方法,如:重量法失血量测量,包括称重采集的血液,以及称重血浸垫、纱布和床单,并减去它们的干重;经校准的血量测量设备(容量失血量测量);血量测定的碱-血素法用机器提取的血液用光谱法测量氧合血红蛋白。数据收集和分析:至少有两名综述作者独立工作,进行研究筛选、选择、数据提取、偏倚风险评估和证据确定性评估。我们通过达成共识或听取其他作者的意见来解决任何分歧。我们生成了2 × 2的真阳性、真阴性、假阳性和假阴性表,以计算每个指标检验的敏感性、特异性和95%置信区间。我们提出了森林样地研究的敏感性和特异性估计。在可能的情况下,我们对每个指标测试和每个目标条件的参考标准组合进行了荟萃分析。我们通过对森林样地的目视检查来检验异质性。主要结果:我们的综述包括18项研究,共有291,040名参与者。14项研究评估PPH, 7项研究评估重度PPH。大多数研究是在医院环境中进行的(18项研究中有16项)。在患者选择领域有4项研究存在高偏倚风险,14项研究存在低风险。对于指数检验域,10项研究为低偏倚风险,7项研究为高风险,1项研究为不确定风险。在参考标准领域,1项研究存在高偏倚风险,17项研究存在低偏倚风险。对于流量和时间域,有3项研究存在高偏倚风险,15项研究存在低偏倚风险。跨领域的所有研究的适用性问题都很低。在摘要中,我们优先报告了指数测试中常见的、重要的阈值或敏感性估计证据的确定性至少为中等的结果。完整的结果在评论的主体部分。PPH(失血量≥500 mL)对于PPH,以重量计失血量作为参考标准的目测灵敏度为48%(95%置信区间(CI) 44% ~ 53%;中等确定性)和97%特异性(95% CI 95%至99%;高确定性)(4项研究,196,305名参与者)。以体积失血量作为参考标准的目视估计灵敏度为22% (95% CI 12% ~ 37%;中等确定性)和99%的特异性(95% CI 97%至100%;中等确定性)(2项研究,514名参与者)。采用校准的悬垂加观察的诊断方法,以重量失血量测量作为PPH的参考标准,灵敏度为93% (95% CI为92%至94%;高确定性)和95%特异性(95% CI 95%至96%;高确定性)(2项研究,53,762名参与者)。当血红蛋白水平低于10 g/dL时,以重力失血量作为参考标准,其灵敏度为37% (95% CI为30% ~ 44%;高确定性)和79%的特异性(95% CI 76%至82%;高确定性)(1项研究,1058名参与者)。
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Pub Date : 2025-01-17DOI: 10.1002/14651858.CD013748.pub2
Edward R Bader, Mazen M Allam, Thomas Gw Harris, Neena Suchdev, Yoon Kong Loke, Raphae Barlas
<p><strong>Background: </strong>Aneurysmal subarachnoid haemorrhage continues to cause a significant burden of morbidity and mortality despite advances in care. Trials investigating local administration of thrombolytics have reported promising results.</p><p><strong>Objectives: </strong>- To assess the effect of thrombolysis on improving functional outcome and case fatality following aneurysmal subarachnoid haemorrhage - To determine the effect of thrombolysis on the risk of cerebral artery vasospasm, delayed cerebral ischaemia, and hydrocephalus following subarachnoid haemorrhage - To determine the risk of complications of local thrombolysis in aneurysmal subarachnoid haemorrhage SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (last searched 9 March 2023), MEDLINE Ovid (1946 to 9 March 2023), and Embase Ovid (1974 to 9 March 2023). We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). We performed forward and reverse citation tracking of included studies using Google Scholar.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials comparing subarachnoid thrombolysis via any route of administration into any anatomical site continuous with the subarachnoid space versus placebo, sham thrombolysis, or standard treatment.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion in the review. We extracted study data and used version 2 of the Cochrane risk-of-bias tool for randomised trials to assess the risk of bias in the studies. We resolved any disagreement through discussion with a third author. Our primary outcome was poor functional outcome. Secondary outcomes were case fatality, haemorrhagic complications, cerebral artery vasospasm, delayed cerebral ischaemia, cerebral infarction, and hydrocephalus. We performed meta-analyses for each outcome and performed sensitivity analysis excluding studies at high risk of bias. We presented results as risk ratios (RRs) with 95% confidence intervals (CIs). We performed further sensitivity analysis by including all intervention groups from studies reporting more than one intervention group. For each outcome, we used the GRADE criteria to determine the certainty of the evidence.</p><p><strong>Main results: </strong>We included eight studies from six countries in this review. The studies had a total of 410 participants, of whom 205 received thrombolysis. We identified three ongoing trials. We assessed one trial as having a high risk of bias for all outcomes; we assessed the remainder as having a low risk of bias or some concerns. Thrombolysis likely results in a reduction in poor functional outcome when compared to placebo or standard care (29.4% versus 39.7%, RR 0.73, 95% CI 0.56 to 0.94; 8 studies, 408 participants; moderate-certainty evidence). Thrombolysis likely results in little to no difference in case fatality (12.8% versus 17.7%, RR
背景:尽管治疗取得了进步,动脉瘤性蛛网膜下腔出血仍然是发病率和死亡率的重要负担。研究溶栓药物局部管理的试验报告了有希望的结果。目的:评估溶栓对改善动脉瘤性蛛网膜下腔出血后功能结局和病死率的影响;确定溶栓对动脉瘤性蛛网膜下腔出血后脑动脉痉挛、迟发性脑缺血和脑积水风险的影响;确定动脉瘤性蛛网膜下腔出血局部溶栓并发症的风险。我们检索了Cochrane中央对照试验注册库(最后检索日期为2023年3月9日)、MEDLINE Ovid(1946年至2023年3月9日)和Embase Ovid(1974年至2023年3月9日)。我们还检索了ClinicalTrials.gov和WHO国际临床试验注册平台(ICTRP)。我们使用谷歌Scholar对纳入的研究进行了正向和反向引文跟踪。选择标准:我们纳入了随机对照试验,比较蛛网膜下腔溶栓通过任何给药途径进入蛛网膜下腔的任何解剖部位与安慰剂、假溶栓或标准治疗。资料收集和分析:两位综述作者独立选择研究纳入综述。我们提取研究数据,并使用Cochrane随机试验风险偏倚工具第2版来评估研究的偏倚风险。我们通过与第三作者讨论来解决任何分歧。我们的主要结果是功能不良。次要结局是病死率、出血性并发症、脑动脉血管痉挛、迟发性脑缺血、脑梗死和脑积水。我们对每个结果进行了荟萃分析,并进行了敏感性分析,排除了高偏倚风险的研究。我们以95%置信区间(ci)的风险比(rr)来呈现结果。我们通过纳入来自多个干预组的研究的所有干预组,进行了进一步的敏感性分析。对于每个结果,我们使用GRADE标准来确定证据的确定性。主要结果:我们纳入了来自6个国家的8项研究。这些研究共有410名参与者,其中205人接受了溶栓治疗。我们确定了三个正在进行的试验。我们将一项试验评估为所有结果具有高偏倚风险;我们将其余的评估为低偏倚风险或存在一些问题。与安慰剂或标准治疗相比,溶栓可能导致功能不良结局的减少(29.4%对39.7%,RR 0.73, 95% CI 0.56 ~ 0.94;8项研究,408名参与者;moderate-certainty证据)。溶栓可能导致病死率几乎没有差异(12.8%对17.7%,RR 0.71, 95% CI 0.46 ~ 1.10;8项研究,408名参与者;moderate-certainty证据)。溶栓可能导致出血性并发症的差异很小或没有差异(10.3%对7.2%,RR 1.40, 95% CI 0.73至2.68;6项研究,341名参与者;确定性的证据)。溶栓可能导致脑动脉血管痉挛减少(32.9%对47.6%,RR 0.70, 95% CI 0.54 ~ 0.91;研究中,参与者;中度确定性证据),并可能导致迟发性脑缺血减少(23.8%对38.2%,RR 0.62, 95% CI 0.45 ~ 0.88;研究中,参与者;确定性的证据)。溶栓可能导致脑梗死几乎没有差异(28.6%对37.5%,RR 0.76, 95% CI 0.44 ~ 1.31;研究中,参与者;低确定性证据),并且可能导致脑积水的风险几乎没有差异(18.3%对24.1%,RR 0.77, 95% CI 0.54至1.10;研究中,参与者;moderate-certainty证据)。作者的结论:有证据表明溶栓可能改善动脉瘤性蛛网膜下腔出血后的预后,而不会增加出血并发症的风险。溶栓可能降低功能预后不良和脑动脉痉挛的风险,并可能降低迟发性脑缺血的风险,但可能对病死率或脑积水几乎没有影响,对脑梗死的风险几乎没有影响。然而,目前的证据仍然不确定。不确定性主要是由于参与者和结果事件的总数较少。需要进一步的研究数据来证实溶栓对改善动脉瘤性蛛网膜下腔出血后预后的有效性。
{"title":"Thrombolysis for aneurysmal subarachnoid haemorrhage.","authors":"Edward R Bader, Mazen M Allam, Thomas Gw Harris, Neena Suchdev, Yoon Kong Loke, Raphae Barlas","doi":"10.1002/14651858.CD013748.pub2","DOIUrl":"10.1002/14651858.CD013748.pub2","url":null,"abstract":"<p><strong>Background: </strong>Aneurysmal subarachnoid haemorrhage continues to cause a significant burden of morbidity and mortality despite advances in care. Trials investigating local administration of thrombolytics have reported promising results.</p><p><strong>Objectives: </strong>- To assess the effect of thrombolysis on improving functional outcome and case fatality following aneurysmal subarachnoid haemorrhage - To determine the effect of thrombolysis on the risk of cerebral artery vasospasm, delayed cerebral ischaemia, and hydrocephalus following subarachnoid haemorrhage - To determine the risk of complications of local thrombolysis in aneurysmal subarachnoid haemorrhage SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (last searched 9 March 2023), MEDLINE Ovid (1946 to 9 March 2023), and Embase Ovid (1974 to 9 March 2023). We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). We performed forward and reverse citation tracking of included studies using Google Scholar.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials comparing subarachnoid thrombolysis via any route of administration into any anatomical site continuous with the subarachnoid space versus placebo, sham thrombolysis, or standard treatment.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion in the review. We extracted study data and used version 2 of the Cochrane risk-of-bias tool for randomised trials to assess the risk of bias in the studies. We resolved any disagreement through discussion with a third author. Our primary outcome was poor functional outcome. Secondary outcomes were case fatality, haemorrhagic complications, cerebral artery vasospasm, delayed cerebral ischaemia, cerebral infarction, and hydrocephalus. We performed meta-analyses for each outcome and performed sensitivity analysis excluding studies at high risk of bias. We presented results as risk ratios (RRs) with 95% confidence intervals (CIs). We performed further sensitivity analysis by including all intervention groups from studies reporting more than one intervention group. For each outcome, we used the GRADE criteria to determine the certainty of the evidence.</p><p><strong>Main results: </strong>We included eight studies from six countries in this review. The studies had a total of 410 participants, of whom 205 received thrombolysis. We identified three ongoing trials. We assessed one trial as having a high risk of bias for all outcomes; we assessed the remainder as having a low risk of bias or some concerns. Thrombolysis likely results in a reduction in poor functional outcome when compared to placebo or standard care (29.4% versus 39.7%, RR 0.73, 95% CI 0.56 to 0.94; 8 studies, 408 participants; moderate-certainty evidence). Thrombolysis likely results in little to no difference in case fatality (12.8% versus 17.7%, RR ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD013748"},"PeriodicalIF":8.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11740285/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001414","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}