Pub Date : 2025-03-20DOI: 10.1002/14651858.CD014796.pub2
Isolde Sommer, Julia Harlfinger, Ana Toromanova, Lisa Affengruber, Andreea Dobrescu, Irma Klerings, Ursula Griebler, Christina Kien
<p><strong>Background: </strong>General health checks are integral to preventive services in many healthcare systems. They are offered, for example, through national programmes or commercial providers. Usually, general health checks consist of several screening tests to assess the overall health of clients who present without symptoms, aiming to reduce the population's morbidity and mortality. A 2019 Cochrane review of effectiveness studies suggested that general health checks have little or no effect on either all-cause mortality, cancer or cardiovascular mortality or cardiovascular morbidity. These findings emphasise the need to explore the values of different stakeholder groups associated with general health checks.</p><p><strong>Objectives: </strong>To identify how stakeholders (i.e. healthcare managers or policymakers, healthcare providers, and clients) perceive and experience general health checks and experience influencing factors relevant to the commissioning, delivery and uptake of general health checks. Also, to supplement and contextualise the findings and conclusions of a 2019 Cochrane effectiveness review by Krogsbøll and colleagues.</p><p><strong>Search methods: </strong>We searched MEDLINE (Ovid) and CINAHL (EBSCO) and conducted citation-based searches (e.g. reference lists, effectiveness review-associated studies and cited references in our included studies). The original searches cover the period from inception to August 2022. The results from the update search in September 2023 have not yet been incorporated.</p><p><strong>Selection criteria: </strong>We included primary studies that utilised qualitative methods for data collection and analysis. Included studies explored perceptions and experiences of commissioning, delivery and uptake of general health checks. Stakeholders of interest were healthcare managers, policymakers, healthcare providers and adults who participate (clients) or do not participate (potential clients) in general health checks. The general health check had to include screening tests for at least two diseases or risk factors. We considered studies conducted in any country, setting, and language.</p><p><strong>Data collection and analysis: </strong>We applied a prespecified sampling frame to purposefully sample a variety of eligible studies. This sampling approach allowed us to capture conceptually rich studies that described the viewpoints of different stakeholder groups from diverse geographical regions and different settings. Using the framework synthesis approach, we developed a framework representing individual, intervention and contextual factors, which guided data extraction and synthesis. We assessed the methodological limitations of each study using an adapted version of the Critical Appraisals Skills Programme (CASP) tool. We applied the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative Research) approach to assess our confidence in each finding.</p><p><strong>Main results: </stro
{"title":"Stakeholders' perceptions and experiences of factors influencing the commissioning, delivery, and uptake of general health checks: a qualitative evidence synthesis.","authors":"Isolde Sommer, Julia Harlfinger, Ana Toromanova, Lisa Affengruber, Andreea Dobrescu, Irma Klerings, Ursula Griebler, Christina Kien","doi":"10.1002/14651858.CD014796.pub2","DOIUrl":"https://doi.org/10.1002/14651858.CD014796.pub2","url":null,"abstract":"<p><strong>Background: </strong>General health checks are integral to preventive services in many healthcare systems. They are offered, for example, through national programmes or commercial providers. Usually, general health checks consist of several screening tests to assess the overall health of clients who present without symptoms, aiming to reduce the population's morbidity and mortality. A 2019 Cochrane review of effectiveness studies suggested that general health checks have little or no effect on either all-cause mortality, cancer or cardiovascular mortality or cardiovascular morbidity. These findings emphasise the need to explore the values of different stakeholder groups associated with general health checks.</p><p><strong>Objectives: </strong>To identify how stakeholders (i.e. healthcare managers or policymakers, healthcare providers, and clients) perceive and experience general health checks and experience influencing factors relevant to the commissioning, delivery and uptake of general health checks. Also, to supplement and contextualise the findings and conclusions of a 2019 Cochrane effectiveness review by Krogsbøll and colleagues.</p><p><strong>Search methods: </strong>We searched MEDLINE (Ovid) and CINAHL (EBSCO) and conducted citation-based searches (e.g. reference lists, effectiveness review-associated studies and cited references in our included studies). The original searches cover the period from inception to August 2022. The results from the update search in September 2023 have not yet been incorporated.</p><p><strong>Selection criteria: </strong>We included primary studies that utilised qualitative methods for data collection and analysis. Included studies explored perceptions and experiences of commissioning, delivery and uptake of general health checks. Stakeholders of interest were healthcare managers, policymakers, healthcare providers and adults who participate (clients) or do not participate (potential clients) in general health checks. The general health check had to include screening tests for at least two diseases or risk factors. We considered studies conducted in any country, setting, and language.</p><p><strong>Data collection and analysis: </strong>We applied a prespecified sampling frame to purposefully sample a variety of eligible studies. This sampling approach allowed us to capture conceptually rich studies that described the viewpoints of different stakeholder groups from diverse geographical regions and different settings. Using the framework synthesis approach, we developed a framework representing individual, intervention and contextual factors, which guided data extraction and synthesis. We assessed the methodological limitations of each study using an adapted version of the Critical Appraisals Skills Programme (CASP) tool. We applied the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative Research) approach to assess our confidence in each finding.</p><p><strong>Main results: </stro","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD014796"},"PeriodicalIF":8.8,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-20DOI: 10.1002/14651858.CD015673.pub2
Silvia Minozzi, Giusy Rita Maria La Rosa, Francesco Salis, Antonella Camposeragna, Rosella Saulle, Lorenzo Leggio, Roberta Agabio
<p><strong>Background: </strong>Alcohol use disorder (AUD) is a mental disorder characterised by a strong desire to consume alcohol and impaired control of alcohol use, with devastating consequences. Many people with AUD do not respond to psychosocial or pharmacological interventions when these are provided alone. Combining these interventions may improve the response to treatment, though evidence remains limited.</p><p><strong>Objectives: </strong>To assess the effects of combined pharmacological and psychosocial interventions for the treatment of AUD in adults.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers in November 2023, without language restrictions.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing combined pharmacological and psychosocial interventions versus pharmacological or psychosocial interventions alone, or no intervention/treatment as usual (TAU), in adults with AUD. Our primary outcomes were continuous abstinent participants, frequency of use (measured as heavy drinkers, percentages of abstinent days, heavy-drinking days), amount of use (number of drinks per drinking day), adverse events, serious adverse events, dropouts from treatment, and dropouts due to adverse events.</p><p><strong>Data collection and analysis: </strong>We assessed risk of bias using Cochrane's RoB 1 tool, performed random-effects meta-analyses, and evaluated the certainty of evidence according to the GRADE approach.</p><p><strong>Main results: </strong>We included 21 RCTs (4746 participants). The most studied pharmacological and psychosocial interventions were naltrexone (81.0%) and cognitive behavioural therapy (66.7%), respectively. Most participants were men (74%), aged about 44 years, with AUD, without comorbid mental disorders or other substance use disorders; 15 RCTs detoxified participants before treatment. We judged 28.5% of the studies as at low risk of bias for random sequence generation, allocation concealment, performance bias for objective and subjective outcomes, and detection bias for subjective outcomes; all studies were at low risk of detection bias for objective outcomes; 85.7% of studies were at low risk of attrition bias; 14.2% of studies were at low risk of reporting bias. 1) Compared to psychosocial intervention alone, combined pharmacological and psychosocial interventions probably reduce the number of heavy drinkers (above the clinically meaningful threshold (MID) of 2%; absolute difference (AD) -10%, 95% confidence interval (CI) -18% to -2%; risk ratio (RR) 0.86, 95% CI 0.76 to 0.97; 8 studies, 1609 participants; moderate-certainty evidence). They may increase continuous abstinent participants (MID 5%; AD 5%, 95% CI 1% to 11%; RR 1.17, 95% CI 1.02 to 1.34; 6 studies, 1184 participants; low-certainty evidence). They probably have little to no effect on: • the rate of abstinent days (MID 8%; mean difference
{"title":"Combined pharmacological and psychosocial interventions for alcohol use disorder.","authors":"Silvia Minozzi, Giusy Rita Maria La Rosa, Francesco Salis, Antonella Camposeragna, Rosella Saulle, Lorenzo Leggio, Roberta Agabio","doi":"10.1002/14651858.CD015673.pub2","DOIUrl":"https://doi.org/10.1002/14651858.CD015673.pub2","url":null,"abstract":"<p><strong>Background: </strong>Alcohol use disorder (AUD) is a mental disorder characterised by a strong desire to consume alcohol and impaired control of alcohol use, with devastating consequences. Many people with AUD do not respond to psychosocial or pharmacological interventions when these are provided alone. Combining these interventions may improve the response to treatment, though evidence remains limited.</p><p><strong>Objectives: </strong>To assess the effects of combined pharmacological and psychosocial interventions for the treatment of AUD in adults.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers in November 2023, without language restrictions.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing combined pharmacological and psychosocial interventions versus pharmacological or psychosocial interventions alone, or no intervention/treatment as usual (TAU), in adults with AUD. Our primary outcomes were continuous abstinent participants, frequency of use (measured as heavy drinkers, percentages of abstinent days, heavy-drinking days), amount of use (number of drinks per drinking day), adverse events, serious adverse events, dropouts from treatment, and dropouts due to adverse events.</p><p><strong>Data collection and analysis: </strong>We assessed risk of bias using Cochrane's RoB 1 tool, performed random-effects meta-analyses, and evaluated the certainty of evidence according to the GRADE approach.</p><p><strong>Main results: </strong>We included 21 RCTs (4746 participants). The most studied pharmacological and psychosocial interventions were naltrexone (81.0%) and cognitive behavioural therapy (66.7%), respectively. Most participants were men (74%), aged about 44 years, with AUD, without comorbid mental disorders or other substance use disorders; 15 RCTs detoxified participants before treatment. We judged 28.5% of the studies as at low risk of bias for random sequence generation, allocation concealment, performance bias for objective and subjective outcomes, and detection bias for subjective outcomes; all studies were at low risk of detection bias for objective outcomes; 85.7% of studies were at low risk of attrition bias; 14.2% of studies were at low risk of reporting bias. 1) Compared to psychosocial intervention alone, combined pharmacological and psychosocial interventions probably reduce the number of heavy drinkers (above the clinically meaningful threshold (MID) of 2%; absolute difference (AD) -10%, 95% confidence interval (CI) -18% to -2%; risk ratio (RR) 0.86, 95% CI 0.76 to 0.97; 8 studies, 1609 participants; moderate-certainty evidence). They may increase continuous abstinent participants (MID 5%; AD 5%, 95% CI 1% to 11%; RR 1.17, 95% CI 1.02 to 1.34; 6 studies, 1184 participants; low-certainty evidence). They probably have little to no effect on: • the rate of abstinent days (MID 8%; mean difference ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD015673"},"PeriodicalIF":8.8,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-20DOI: 10.1002/14651858.CD013835.pub2
Elena Jimenez Tejero, Jesús Lopez-Alcalde, Andrea Correa-Pérez, Elena Stallings, Andrea Gaetano Gil, Laura Del Campo Albendea, Miriam Mateos-Haro, Borja Manuel Fernandez-Felix, Raymond Stallings, Noelia Alvarez-Diaz, Eduardo García Laredo, Aurora Solier, Elia Fernández-Martínez, Raquel Morillo Guerrero, Marcos de Miguel, Raquel Perez, Alba Antequera, Alfonso Muriel, David Jimenez, Javier Zamora
<p><strong>Background: </strong>Pulmonary embolism (PE) is relatively common worldwide. It is a serious condition that can be life-threatening. Studies on the relationship between adverse outcomes of this condition and whether a patient is male or female have yielded inconsistent results. Determining whether there is an association between sex and short-term mortality in patients with acute PE is important as this information may help guide different approaches to PE monitoring and treatment.</p><p><strong>Objectives: </strong>To determine whether sex (i.e. being a male or a female patient) is an independent prognostic factor for predicting mortality in adults with acute symptomatic pulmonary embolism.</p><p><strong>Search methods: </strong>The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register up to 17 February 2023. We scanned conference abstracts and reference lists of included studies and systematic reviews. We also contacted experts to identify additional studies. There were no restrictions with respect to language or date of publication.</p><p><strong>Selection criteria: </strong>We included phase 2-confirmatory prognostic studies, that is, any longitudinal study (prospective or retrospective) evaluating the independent association between sex (male or female) and mortality in adults with acute PE.</p><p><strong>Data collection and analysis: </strong>We followed the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of prognostic factor studies (CHARMS-PF) and the Cochrane Prognosis Methods Group template for prognosis reviews. Two review authors independently screened the studies, extracted data, assessed the risk of bias according to the Quality in Prognosis Studies (QUIPS) tool, and assessed the certainty of the evidence (GRADE). Meta-analyses were performed by pooling adjusted estimates. When meta-analysis was not possible, we reported the main results narratively.</p><p><strong>Main results: </strong>We included seven studies (726,293 participants), all of which were retrospective cohort studies with participants recruited and managed in hospitals between 2000 and 2018. Studies took place in the USA, Spain, and Japan. Most studies were multicentre. None were conducted in low- or middle-income countries. The participants' mean age ranged from 62 to 69 years, and the proportion of females was higher in six of the seven studies, ranging from 46% to 60%. Sex and gender terms were used inconsistently. Participants received different PE treatments: reperfusion, inferior vena cava filter, anticoagulation, and haemodynamic/respiratory support. The prognostication time (the point from which the outcome was predicted) was frequently omitted. The included studies provided data for three of our outcomes of interest
{"title":"Sex as a prognostic factor for mortality in adults with acute symptomatic pulmonary embolism.","authors":"Elena Jimenez Tejero, Jesús Lopez-Alcalde, Andrea Correa-Pérez, Elena Stallings, Andrea Gaetano Gil, Laura Del Campo Albendea, Miriam Mateos-Haro, Borja Manuel Fernandez-Felix, Raymond Stallings, Noelia Alvarez-Diaz, Eduardo García Laredo, Aurora Solier, Elia Fernández-Martínez, Raquel Morillo Guerrero, Marcos de Miguel, Raquel Perez, Alba Antequera, Alfonso Muriel, David Jimenez, Javier Zamora","doi":"10.1002/14651858.CD013835.pub2","DOIUrl":"https://doi.org/10.1002/14651858.CD013835.pub2","url":null,"abstract":"<p><strong>Background: </strong>Pulmonary embolism (PE) is relatively common worldwide. It is a serious condition that can be life-threatening. Studies on the relationship between adverse outcomes of this condition and whether a patient is male or female have yielded inconsistent results. Determining whether there is an association between sex and short-term mortality in patients with acute PE is important as this information may help guide different approaches to PE monitoring and treatment.</p><p><strong>Objectives: </strong>To determine whether sex (i.e. being a male or a female patient) is an independent prognostic factor for predicting mortality in adults with acute symptomatic pulmonary embolism.</p><p><strong>Search methods: </strong>The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register up to 17 February 2023. We scanned conference abstracts and reference lists of included studies and systematic reviews. We also contacted experts to identify additional studies. There were no restrictions with respect to language or date of publication.</p><p><strong>Selection criteria: </strong>We included phase 2-confirmatory prognostic studies, that is, any longitudinal study (prospective or retrospective) evaluating the independent association between sex (male or female) and mortality in adults with acute PE.</p><p><strong>Data collection and analysis: </strong>We followed the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of prognostic factor studies (CHARMS-PF) and the Cochrane Prognosis Methods Group template for prognosis reviews. Two review authors independently screened the studies, extracted data, assessed the risk of bias according to the Quality in Prognosis Studies (QUIPS) tool, and assessed the certainty of the evidence (GRADE). Meta-analyses were performed by pooling adjusted estimates. When meta-analysis was not possible, we reported the main results narratively.</p><p><strong>Main results: </strong>We included seven studies (726,293 participants), all of which were retrospective cohort studies with participants recruited and managed in hospitals between 2000 and 2018. Studies took place in the USA, Spain, and Japan. Most studies were multicentre. None were conducted in low- or middle-income countries. The participants' mean age ranged from 62 to 69 years, and the proportion of females was higher in six of the seven studies, ranging from 46% to 60%. Sex and gender terms were used inconsistently. Participants received different PE treatments: reperfusion, inferior vena cava filter, anticoagulation, and haemodynamic/respiratory support. The prognostication time (the point from which the outcome was predicted) was frequently omitted. The included studies provided data for three of our outcomes of interest","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD013835"},"PeriodicalIF":8.8,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: This is a protocol for a Cochrane Review (prognosis). The objectives are as follows: To quantify the risk of tumour relapse/recurrence after a surgical resection of stage 1A non-small cell lung cancer (NSCLC) as manifested on computed tomography (CT) imaging as a subsolid nodule.
{"title":"Prognosis of surgically resected clinical stage 1A non-small cell lung cancers manifesting as a subsolid nodule on computed tomography including pure ground glass nodules.","authors":"Renée Manser, Reem Malouf, Corynne Marchal, Diane Pascoe, Gavin M Wright, Asha Bonney","doi":"10.1002/14651858.CD016091","DOIUrl":"https://doi.org/10.1002/14651858.CD016091","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (prognosis). The objectives are as follows: To quantify the risk of tumour relapse/recurrence after a surgical resection of stage 1A non-small cell lung cancer (NSCLC) as manifested on computed tomography (CT) imaging as a subsolid nodule.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD016091"},"PeriodicalIF":8.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143655953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-19DOI: 10.1002/14651858.CD011926.pub3
Thomas H Dierikx, Douwe H Visser, Tim de Meij, James Versalovic, Mariska Mg Leeflang, Chris Cooper, Mohan Pammi
Background: Microbial cultures for diagnosis of neonatal sepsis have low sensitivity and reporting delay. Advances in molecular microbiology have fostered new molecular assays that are rapid and may improve neonatal outcomes.
Objectives: To assess the diagnostic accuracy of various molecular methods for the diagnosis of culture-positive bacterial and fungal sepsis in neonates and to explore heterogeneity among studies by analyzing subgroups classified by gestational age and type of sepsis onset and compare molecular tests with one another.
Search methods: We searched CENTRAL, MEDLINE, Embase and trial registries in August 2023. We checked reference lists of included studies and systematic reviews where subject matter related to the intervention or population examined in this review.
Selection criteria: We included studies that were prospective or retrospective, cohort or cross-sectional design, which evaluated molecular assays (index test) in neonates with suspected sepsis in comparison with microbial cultures (reference standard).
Data collection and analysis: Two review authors independently screened studies, extracted data and assessed the methodological quality of the studies. We performed meta-analyses using the bivariate model and entered data into Review Manager.
Main results: Seventy-four studies were eligible for inclusion, of which 68 studies provided data for meta-analysis. The total number of participants was 14,309 (1328 infants who were culture-positive and 12,981 infants who were culture-negative) from 68 studies that were included in the meta-analysis. The summary estimate of sensitivity was 0.91 (95% confidence interval (CI) 0.85 to 0.95) and of specificity was 0.88 (95% CI 0.83 to 0.92) (low-certainty evidence). We explored heterogeneity by subgroup analyses of type of test, gestational age, type of sepsis onset and prevalence of sepsis. We found insufficient explanations for the heterogeneity (low- to very low-certainty evidence). Sensitivity analyses including studies that analyzed blood samples, using good methodology and those that did not use multiple samples from the same participant revealed similar results (low-certainty evidence).
Authors' conclusions: Molecular assays have the advantage of producing rapid results and have moderate diagnostic accuracy. Molecular assays may prevent overuse of antibiotics in neonates with suspected sepsis. The efficacy and cost-effectiveness of these molecular assays should be evaluated using randomized trials comparing molecular assays as an add-on test versus conventional methods without the add-on test in neonates with suspected sepsis.
{"title":"Molecular assays for the diagnosis of sepsis in neonates: a diagnostic test accuracy review.","authors":"Thomas H Dierikx, Douwe H Visser, Tim de Meij, James Versalovic, Mariska Mg Leeflang, Chris Cooper, Mohan Pammi","doi":"10.1002/14651858.CD011926.pub3","DOIUrl":"https://doi.org/10.1002/14651858.CD011926.pub3","url":null,"abstract":"<p><strong>Background: </strong>Microbial cultures for diagnosis of neonatal sepsis have low sensitivity and reporting delay. Advances in molecular microbiology have fostered new molecular assays that are rapid and may improve neonatal outcomes.</p><p><strong>Objectives: </strong>To assess the diagnostic accuracy of various molecular methods for the diagnosis of culture-positive bacterial and fungal sepsis in neonates and to explore heterogeneity among studies by analyzing subgroups classified by gestational age and type of sepsis onset and compare molecular tests with one another.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase and trial registries in August 2023. We checked reference lists of included studies and systematic reviews where subject matter related to the intervention or population examined in this review.</p><p><strong>Selection criteria: </strong>We included studies that were prospective or retrospective, cohort or cross-sectional design, which evaluated molecular assays (index test) in neonates with suspected sepsis in comparison with microbial cultures (reference standard).</p><p><strong>Data collection and analysis: </strong>Two review authors independently screened studies, extracted data and assessed the methodological quality of the studies. We performed meta-analyses using the bivariate model and entered data into Review Manager.</p><p><strong>Main results: </strong>Seventy-four studies were eligible for inclusion, of which 68 studies provided data for meta-analysis. The total number of participants was 14,309 (1328 infants who were culture-positive and 12,981 infants who were culture-negative) from 68 studies that were included in the meta-analysis. The summary estimate of sensitivity was 0.91 (95% confidence interval (CI) 0.85 to 0.95) and of specificity was 0.88 (95% CI 0.83 to 0.92) (low-certainty evidence). We explored heterogeneity by subgroup analyses of type of test, gestational age, type of sepsis onset and prevalence of sepsis. We found insufficient explanations for the heterogeneity (low- to very low-certainty evidence). Sensitivity analyses including studies that analyzed blood samples, using good methodology and those that did not use multiple samples from the same participant revealed similar results (low-certainty evidence).</p><p><strong>Authors' conclusions: </strong>Molecular assays have the advantage of producing rapid results and have moderate diagnostic accuracy. Molecular assays may prevent overuse of antibiotics in neonates with suspected sepsis. The efficacy and cost-effectiveness of these molecular assays should be evaluated using randomized trials comparing molecular assays as an add-on test versus conventional methods without the add-on test in neonates with suspected sepsis.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD011926"},"PeriodicalIF":8.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-19DOI: 10.1002/14651858.CD009752.pub3
Kirstin L Wilkinson, Catherine Kimber, Alisha Allana, Carolyn Dorée, Rita Champaneria, Susan J Brunskill, Michael F Murphy
<p><strong>Background: </strong>Congenital heart disease is the most common neonatal congenital condition. Surgery is often necessary. Patients with congenital heart disease are potentially exposed to red cell transfusion preoperatively, intraoperatively and postoperatively when admitted for cardiac surgery. There are a number of risks associated with red cell transfusion that may increase morbidity and mortality.</p><p><strong>Objectives: </strong>To evaluate the association of red blood cell transfusion management with mortality and morbidity in people with congenital heart disease who are undergoing cardiac surgery.</p><p><strong>Search methods: </strong>We searched multiple bibliographic databases and trials registries, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), Transfusion Evidence Library, ClinicalTrials.gov and the World Health Organization (WHO) ICTRP. The most recent search was on 2 January 2024, with no limitation by language of publication.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing red blood cell transfusion interventions in patients undergoing cardiac surgery for congenital heart disease. Participants of any age (neonates, paediatrics and adults) and with any type of congenital heart disease (cyanotic or acyanotic) were eligible for inclusion. No comorbidities were excluded.</p><p><strong>Data collection and analysis: </strong>Two of five (AA, CK, KW, SB, SF) review authors independently extracted data and assessed the risk of bias in the trials. We contacted study authors for additional information. Two review authors (CK, KW) used GRADE methodology to assess evidence certainty for critical outcomes and comparisons.</p><p><strong>Main results: </strong>We identified 19 relevant trials. The trials had 1606 participants, all of whom were neonates or children. No trials were conducted in the preoperative period or with adults. The trials compared different types of red blood cell transfusions. No trial compared red blood cell transfusion versus no red blood cell transfusion. None of the trials was at low risk of bias overall. Eight trials had a high risk of bias in at least one domain, most commonly, blinding of participants and personnel. For our critical outcomes, we judged the certainty of the evidence based on GRADE criteria to be low or very low. Five trials (497 participants) compared a restrictive versus a liberal transfusion-trigger. It is very uncertain whether a restrictive transfusion-trigger has an effect on all-cause mortality in the short-term (0 to 30 days post-surgery) (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.42 to 3.00; 3 RCTs, 347 participants; very low certainty evidence) or long term (31 days to two years post-surgery) (RR 0.33, 95% CI 0.01 to 7.87; 1 RCT, 60 participants; very low certainty evidence). The evidence is also very uncertain on the incidence of severe adv
{"title":"Red blood cell transfusion management for people undergoing cardiac surgery for congenital heart disease.","authors":"Kirstin L Wilkinson, Catherine Kimber, Alisha Allana, Carolyn Dorée, Rita Champaneria, Susan J Brunskill, Michael F Murphy","doi":"10.1002/14651858.CD009752.pub3","DOIUrl":"https://doi.org/10.1002/14651858.CD009752.pub3","url":null,"abstract":"<p><strong>Background: </strong>Congenital heart disease is the most common neonatal congenital condition. Surgery is often necessary. Patients with congenital heart disease are potentially exposed to red cell transfusion preoperatively, intraoperatively and postoperatively when admitted for cardiac surgery. There are a number of risks associated with red cell transfusion that may increase morbidity and mortality.</p><p><strong>Objectives: </strong>To evaluate the association of red blood cell transfusion management with mortality and morbidity in people with congenital heart disease who are undergoing cardiac surgery.</p><p><strong>Search methods: </strong>We searched multiple bibliographic databases and trials registries, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), Transfusion Evidence Library, ClinicalTrials.gov and the World Health Organization (WHO) ICTRP. The most recent search was on 2 January 2024, with no limitation by language of publication.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing red blood cell transfusion interventions in patients undergoing cardiac surgery for congenital heart disease. Participants of any age (neonates, paediatrics and adults) and with any type of congenital heart disease (cyanotic or acyanotic) were eligible for inclusion. No comorbidities were excluded.</p><p><strong>Data collection and analysis: </strong>Two of five (AA, CK, KW, SB, SF) review authors independently extracted data and assessed the risk of bias in the trials. We contacted study authors for additional information. Two review authors (CK, KW) used GRADE methodology to assess evidence certainty for critical outcomes and comparisons.</p><p><strong>Main results: </strong>We identified 19 relevant trials. The trials had 1606 participants, all of whom were neonates or children. No trials were conducted in the preoperative period or with adults. The trials compared different types of red blood cell transfusions. No trial compared red blood cell transfusion versus no red blood cell transfusion. None of the trials was at low risk of bias overall. Eight trials had a high risk of bias in at least one domain, most commonly, blinding of participants and personnel. For our critical outcomes, we judged the certainty of the evidence based on GRADE criteria to be low or very low. Five trials (497 participants) compared a restrictive versus a liberal transfusion-trigger. It is very uncertain whether a restrictive transfusion-trigger has an effect on all-cause mortality in the short-term (0 to 30 days post-surgery) (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.42 to 3.00; 3 RCTs, 347 participants; very low certainty evidence) or long term (31 days to two years post-surgery) (RR 0.33, 95% CI 0.01 to 7.87; 1 RCT, 60 participants; very low certainty evidence). The evidence is also very uncertain on the incidence of severe adv","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD009752"},"PeriodicalIF":8.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-18DOI: 10.1002/14651858.CD016133
Themistoklis Paraskevas, Georgios Gakis, Michail Papapanou, Theodoros N Sergentanis, Alexandros Sotiriadis, Charalampos S Siristatidis
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the relative benefits and harms of statins for preeclampsia prevention in pregnant women.
{"title":"Statins for preventing preeclampsia.","authors":"Themistoklis Paraskevas, Georgios Gakis, Michail Papapanou, Theodoros N Sergentanis, Alexandros Sotiriadis, Charalampos S Siristatidis","doi":"10.1002/14651858.CD016133","DOIUrl":"10.1002/14651858.CD016133","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the relative benefits and harms of statins for preeclampsia prevention in pregnant women.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD016133"},"PeriodicalIF":8.8,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11915783/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656021","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}
<p><strong>Background: </strong>Urolithiasis (urinary stones) is a common disease with an increasing incidence globally. It often presents with renal colic, which is characterised by acute and intense abdominal pain. The first step in the management of renal colic is pain control. Various medications, including narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), antispasmodics, and others, have been used for this condition. NSAIDs are amongst the most commonly used drugs for renal colic. They act by reducing inflammation and lowering the pressure inside the urinary collecting system. This review updates a previous Cochrane Systematic Review (Afshar 2015), focusing exclusively on NSAIDs.</p><p><strong>Objectives: </strong>To assess the benefits and harms of different nonsteroidal anti-inflammatory drugs (NSAIDs) for the management of pain in adults with acute renal colic.</p><p><strong>Search methods: </strong>We performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, Google Scholar, trial registries, and conference proceedings up to 25 August 2023. We applied no restrictions on publication language or status.</p><p><strong>Selection criteria: </strong>We included randomised (or quasi-randomised) controlled trials (RCTs) assessing the effects of NSAIDs in the management of renal colic adult patients (i.e. study participants over 16 years of age). We included studies that compared NSAIDs versus placebo, one NSAID versus another, or different doses or routes of administration of the same NSAID.</p><p><strong>Data collection and analysis: </strong>Two review authors independently classified studies and abstracted data from the included studies. Primary outcomes included pain up to one hour after treatment as measured by a validated patient-reported tool, the need for rescue medication up to six hours after treatment, and serious adverse events up to one week after treatment. Secondary outcomes included pain recurrence, significant pain relief, and minor adverse events. We performed meta-analysis using the random-effects model. We rated the certainty of evidence according to the GRADE approach.</p><p><strong>Main results: </strong>Our search identified 29 RCTs for inclusion in the review. The 29 studies involved a total of 3593 participants who were randomly allocated to treatment with an NSAID or placebo. The mean age of participants ranged from 27 to 47 years across the studies. Participants used a 10 cm visual analogue scale (VAS) to indicate the extent of their pain. NSAIDs versus placebo NSAIDs may reduce renal colic pain in 30 minutes compared to placebo (mean difference (MD) -3.84 cm, 95% confidence interval (CI) -6.41 to -1.27; I<sup>2</sup> = 95%; 3 studies, 250 participants; low-certainty evidence). The evidence is very uncertain about the effect of NSAIDs on the need for rescue medication (risk ratio (RR) 0.24, 95% CI 0.11 to 0.53; I<sup>2</sup> = 73%; 4 studies, 280 participants; very low-certainty evidence). NSAID
{"title":"Nonsteroidal anti-inflammatory drugs (NSAIDs) for acute renal colic.","authors":"Kourosh Afshar, Jagdeep Gill, Hanan Mostafa, Maryam Noparast","doi":"10.1002/14651858.CD006027.pub3","DOIUrl":"10.1002/14651858.CD006027.pub3","url":null,"abstract":"<p><strong>Background: </strong>Urolithiasis (urinary stones) is a common disease with an increasing incidence globally. It often presents with renal colic, which is characterised by acute and intense abdominal pain. The first step in the management of renal colic is pain control. Various medications, including narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), antispasmodics, and others, have been used for this condition. NSAIDs are amongst the most commonly used drugs for renal colic. They act by reducing inflammation and lowering the pressure inside the urinary collecting system. This review updates a previous Cochrane Systematic Review (Afshar 2015), focusing exclusively on NSAIDs.</p><p><strong>Objectives: </strong>To assess the benefits and harms of different nonsteroidal anti-inflammatory drugs (NSAIDs) for the management of pain in adults with acute renal colic.</p><p><strong>Search methods: </strong>We performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, Google Scholar, trial registries, and conference proceedings up to 25 August 2023. We applied no restrictions on publication language or status.</p><p><strong>Selection criteria: </strong>We included randomised (or quasi-randomised) controlled trials (RCTs) assessing the effects of NSAIDs in the management of renal colic adult patients (i.e. study participants over 16 years of age). We included studies that compared NSAIDs versus placebo, one NSAID versus another, or different doses or routes of administration of the same NSAID.</p><p><strong>Data collection and analysis: </strong>Two review authors independently classified studies and abstracted data from the included studies. Primary outcomes included pain up to one hour after treatment as measured by a validated patient-reported tool, the need for rescue medication up to six hours after treatment, and serious adverse events up to one week after treatment. Secondary outcomes included pain recurrence, significant pain relief, and minor adverse events. We performed meta-analysis using the random-effects model. We rated the certainty of evidence according to the GRADE approach.</p><p><strong>Main results: </strong>Our search identified 29 RCTs for inclusion in the review. The 29 studies involved a total of 3593 participants who were randomly allocated to treatment with an NSAID or placebo. The mean age of participants ranged from 27 to 47 years across the studies. Participants used a 10 cm visual analogue scale (VAS) to indicate the extent of their pain. NSAIDs versus placebo NSAIDs may reduce renal colic pain in 30 minutes compared to placebo (mean difference (MD) -3.84 cm, 95% confidence interval (CI) -6.41 to -1.27; I<sup>2</sup> = 95%; 3 studies, 250 participants; low-certainty evidence). The evidence is very uncertain about the effect of NSAIDs on the need for rescue medication (risk ratio (RR) 0.24, 95% CI 0.11 to 0.53; I<sup>2</sup> = 73%; 4 studies, 280 participants; very low-certainty evidence). NSAID","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD006027"},"PeriodicalIF":8.8,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907407/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623880","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 : 2025-03-14DOI: 10.1002/14651858.CD014792.pub2
Rachel H Robertson, Kylie Russell, Vanessa Jordan, Sanjay Pandanaboyana, Dong Wu, John Windsor
<p><strong>Background: </strong>Resection of the head of the pancreas is most commonly done by a pancreaticoduodenectomy, known as a Whipple procedure. The most common indication for pancreaticoduodenectomy is malignancy, but can include benign tumours and chronic pancreatitis. Complete surgical resection, with negative margins, provides the best prospect of long-term survival. Pancreaticoduodenectomy involves specific and unique alterations to the digestive system and maintaining nutritional status (optimising outcomes and achieving resumption of a normal diet) in patients with cancer after major surgery is a challenge. Malnutrition is a risk factor following pancreaticoduodenectomy, due to the magnitude of the operation and the frequency of complications. Postoperatively, patients are fed either orally, enterally or parenterally. Oral intake may start with fluids and then progress to solid food, or may be ad libitum. Enteral feeding may be via a nasojejunal tube or feeding tube jejunostomy. Parenteral nutrition can be delivered via a central or peripheral intravenous line, and may provide full nutrition (TPN) or partial nutrition (supplemental PN).</p><p><strong>Objectives: </strong>To assess the effects of postoperative nutritional support strategies on complications and recovery in adults after pancreaticoduodenectomy.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, LILACS and CINAHL (from inception to October 2022), ongoing trials registers and other internet databases. We searched previous systematic reviews, relevant publications on the same topic and the references of included studies.</p><p><strong>Selection criteria: </strong>Randomised controlled trials of postoperative nutritional interventions in an inpatient setting for patients undergoing pancreaticoduodenectomy. We specifically looked for studies comparing route or timing rather than nutritional content.</p><p><strong>Data collection and analysis: </strong>Two review authors independently assessed studies for inclusion, judged the risk of bias and extracted data. Studies requiring translation were assessed for inclusion, risk of bias and data extraction by an external translator and another author. We used GRADE to evaluate the certainty of the evidence.</p><p><strong>Main results: </strong>We included 17 studies (1897 participants). Of these, eight studies could be included in a meta-analysis. The route, timing and target of nutritional support varied widely between studies. Enteral feeding (jejunostomy, nasojejunal or gastrojejunostomy) was used in at least 13 studies (one study did not specify the method of enteral route), parenteral nutrition (PN) was used in at least 10 studies (two studies had a control of 'surgeon's preference' and no further details were given) and oral intake was used in seven studies. Overall, the evidence presented in this review is of low to very low certainty. Four studies compared jejunostomy feeding with total parenteral
{"title":"Postoperative nutritional support after pancreaticoduodenectomy in adults.","authors":"Rachel H Robertson, Kylie Russell, Vanessa Jordan, Sanjay Pandanaboyana, Dong Wu, John Windsor","doi":"10.1002/14651858.CD014792.pub2","DOIUrl":"10.1002/14651858.CD014792.pub2","url":null,"abstract":"<p><strong>Background: </strong>Resection of the head of the pancreas is most commonly done by a pancreaticoduodenectomy, known as a Whipple procedure. The most common indication for pancreaticoduodenectomy is malignancy, but can include benign tumours and chronic pancreatitis. Complete surgical resection, with negative margins, provides the best prospect of long-term survival. Pancreaticoduodenectomy involves specific and unique alterations to the digestive system and maintaining nutritional status (optimising outcomes and achieving resumption of a normal diet) in patients with cancer after major surgery is a challenge. Malnutrition is a risk factor following pancreaticoduodenectomy, due to the magnitude of the operation and the frequency of complications. Postoperatively, patients are fed either orally, enterally or parenterally. Oral intake may start with fluids and then progress to solid food, or may be ad libitum. Enteral feeding may be via a nasojejunal tube or feeding tube jejunostomy. Parenteral nutrition can be delivered via a central or peripheral intravenous line, and may provide full nutrition (TPN) or partial nutrition (supplemental PN).</p><p><strong>Objectives: </strong>To assess the effects of postoperative nutritional support strategies on complications and recovery in adults after pancreaticoduodenectomy.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, LILACS and CINAHL (from inception to October 2022), ongoing trials registers and other internet databases. We searched previous systematic reviews, relevant publications on the same topic and the references of included studies.</p><p><strong>Selection criteria: </strong>Randomised controlled trials of postoperative nutritional interventions in an inpatient setting for patients undergoing pancreaticoduodenectomy. We specifically looked for studies comparing route or timing rather than nutritional content.</p><p><strong>Data collection and analysis: </strong>Two review authors independently assessed studies for inclusion, judged the risk of bias and extracted data. Studies requiring translation were assessed for inclusion, risk of bias and data extraction by an external translator and another author. We used GRADE to evaluate the certainty of the evidence.</p><p><strong>Main results: </strong>We included 17 studies (1897 participants). Of these, eight studies could be included in a meta-analysis. The route, timing and target of nutritional support varied widely between studies. Enteral feeding (jejunostomy, nasojejunal or gastrojejunostomy) was used in at least 13 studies (one study did not specify the method of enteral route), parenteral nutrition (PN) was used in at least 10 studies (two studies had a control of 'surgeon's preference' and no further details were given) and oral intake was used in seven studies. Overall, the evidence presented in this review is of low to very low certainty. Four studies compared jejunostomy feeding with total parenteral","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD014792"},"PeriodicalIF":8.8,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623895","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 : 2025-03-11DOI: 10.1002/14651858.CD009252.pub2
Ana Carolina Nl Fernandes, Cristine H Jorge, Mark Weatherall, Isadora V Ribeiro, Sheila A Wallace, E Jean C Hay-Smith
<p><strong>Background: </strong>Pelvic floor muscle training (PFMT), compared to no treatment, is effective for treating urinary incontinence (UI) in women. Feedback and biofeedback are additional resources that give women more information about their pelvic floor muscle contraction. The extra information could improve training performance by increasing capability or motivation for PFMT. The Committee on Conservative Management from the 7th International Consultation on Incontinence states that the benefit of adding biofeedback to PFMT is unclear. This review is an update of a Cochrane review last published in 2011.</p><p><strong>Objectives: </strong>The primary objective was to assess the effects of PFMT with feedback or biofeedback, or both, for UI in women. We considered the following research questions. Are there differences in the effects of PFMT with feedback, biofeedback, or both versus PFMT without these adjuncts in the management of stress, urgency or mixed UI in women? Are there differences in the effects of feedback versus biofeedback as adjuncts to PFMT for women with UI? Are there differences in the effects of different types of biofeedback?</p><p><strong>Search methods: </strong>We searched the Cochrane Incontinence Specialised Register (searched 27 September 2023), which includes searches of CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP as well as handsearching of journals and conference proceedings, and the reference lists of relevant articles.</p><p><strong>Selection criteria: </strong>We included only randomised controlled trials (RCTs), cluster-RCTs and quasi-RCTs in women with UI. We excluded studies that recruited women with neurological conditions, who were pregnant or less than six months postpartum. Eligible studies made one of the following comparisons: PFMT plus feedback versus PFMT alone, PFMT plus biofeedback versus PFMT alone, PFMT plus feedback or biofeedback versus PFMT alone, PFMT plus feedback versus PFMT plus biofeedback, and one type of biofeedback versus another.</p><p><strong>Data collection and analysis: </strong>Two review authors independently assessed studies for eligibility, extracted data onto a prepiloted form, and assessed risk of bias using RoB 1. We used the GRADE approach to assess the certainty of evidence in each comparison by outcome. Our primary outcome was lower urinary tract symptom-specific quality of life. We pooled data using a standardised mean difference (SMD). Secondary outcomes were leakage episodes in 24 hours (mean difference (MD)), leakage severity (MD), subjective cure or improvement (odds ratio (OR)), satisfaction (OR), and adverse events (descriptive summary).</p><p><strong>Main results: </strong>We included 41 completed studies with 3483 women. Most (33 studies, 3031 women) investigated the effect of PFMT with biofeedback versus PFMT alone. Eleven studies were at low risk of bias overall, 27 at unclear risk of bias, and three at
{"title":"Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women.","authors":"Ana Carolina Nl Fernandes, Cristine H Jorge, Mark Weatherall, Isadora V Ribeiro, Sheila A Wallace, E Jean C Hay-Smith","doi":"10.1002/14651858.CD009252.pub2","DOIUrl":"10.1002/14651858.CD009252.pub2","url":null,"abstract":"<p><strong>Background: </strong>Pelvic floor muscle training (PFMT), compared to no treatment, is effective for treating urinary incontinence (UI) in women. Feedback and biofeedback are additional resources that give women more information about their pelvic floor muscle contraction. The extra information could improve training performance by increasing capability or motivation for PFMT. The Committee on Conservative Management from the 7th International Consultation on Incontinence states that the benefit of adding biofeedback to PFMT is unclear. This review is an update of a Cochrane review last published in 2011.</p><p><strong>Objectives: </strong>The primary objective was to assess the effects of PFMT with feedback or biofeedback, or both, for UI in women. We considered the following research questions. Are there differences in the effects of PFMT with feedback, biofeedback, or both versus PFMT without these adjuncts in the management of stress, urgency or mixed UI in women? Are there differences in the effects of feedback versus biofeedback as adjuncts to PFMT for women with UI? Are there differences in the effects of different types of biofeedback?</p><p><strong>Search methods: </strong>We searched the Cochrane Incontinence Specialised Register (searched 27 September 2023), which includes searches of CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP as well as handsearching of journals and conference proceedings, and the reference lists of relevant articles.</p><p><strong>Selection criteria: </strong>We included only randomised controlled trials (RCTs), cluster-RCTs and quasi-RCTs in women with UI. We excluded studies that recruited women with neurological conditions, who were pregnant or less than six months postpartum. Eligible studies made one of the following comparisons: PFMT plus feedback versus PFMT alone, PFMT plus biofeedback versus PFMT alone, PFMT plus feedback or biofeedback versus PFMT alone, PFMT plus feedback versus PFMT plus biofeedback, and one type of biofeedback versus another.</p><p><strong>Data collection and analysis: </strong>Two review authors independently assessed studies for eligibility, extracted data onto a prepiloted form, and assessed risk of bias using RoB 1. We used the GRADE approach to assess the certainty of evidence in each comparison by outcome. Our primary outcome was lower urinary tract symptom-specific quality of life. We pooled data using a standardised mean difference (SMD). Secondary outcomes were leakage episodes in 24 hours (mean difference (MD)), leakage severity (MD), subjective cure or improvement (odds ratio (OR)), satisfaction (OR), and adverse events (descriptive summary).</p><p><strong>Main results: </strong>We included 41 completed studies with 3483 women. Most (33 studies, 3031 women) investigated the effect of PFMT with biofeedback versus PFMT alone. Eleven studies were at low risk of bias overall, 27 at unclear risk of bias, and three at ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD009252"},"PeriodicalIF":8.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603752","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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