Mammography in combination with breast ultrasonography versus mammography for breast cancer screening in women at average risk.

BACKGROUND: Screening mammography can detect breast cancer at an early stage. Supporters of adding ultrasonography to the screening regimen consider it a safe and inexpensive approach to reduce false-negative rates during screening. However, those opposed to it argue that performing supplemental ultrasonography will also increase the rate of false-positive findings and can lead to unnecessary biopsies and treatments. OBJECTIVES: To assess the comparative effectiveness and safety of mammography in combination with breast ultrasonography versus mammography alone for breast cancer screening for women at average risk of breast cancer. SEARCH METHODS: We searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov up until 3 May 2021. SELECTION CRITERIA: For efficacy and harms, we considered randomised controlled trials (RCTs) and controlled non-randomised studies enrolling at least 500 women at average risk for breast cancer between the ages of 40 and 75. We also included studies where 80% of the population met our age and breast cancer risk inclusion criteria. DATA COLLECTION AND ANALYSIS: Two review authors screened abstracts and full texts, assessed risk of bias, and applied the GRADE approach. We calculated the risk ratio (RR) with 95% confidence intervals (CI) based on available event rates. We conducted a random-effects meta-analysis. MAIN RESULTS: We included eight studies: one RCT, two prospective cohort studies, and five retrospective cohort studies, enrolling 209,207 women with a follow-up duration from one to three years. The proportion of women with dense breasts ranged from 48% to 100%. Five studies used digital mammography; one study used breast tomosynthesis; and two studies used automated breast ultrasonography (ABUS) in addition to mammography screening. One study used digital mammography alone or in combination with breast tomosynthesis and ABUS or handheld ultrasonography. Six of the eight studies evaluated the rate of cancer cases detected after one screening round, whilst two studies screened women once, twice, or more. None of the studies assessed whether mammography screening in combination with ultrasonography led to lower mortality from breast cancer or all-cause mortality. High certainty evidence from one trial showed that screening with a combination of mammography and ultrasonography detects more breast cancer than mammography alone. The J-START (Japan Strategic Anti-cancer Randomised Trial), enrolling 72,717 asymptomatic women, had a low risk of bias and found that two additional breast cancers per 1000 women were detected over two years with one additional ultrasonography than with mammography alone (5 versus 3 per 1000; RR 1.54, 95% CI 1.22 to 1.94). Low certainty evidence showed that the percentage of invasive tumours was similar, with no statistically significant difference between the two groups (69.6% (128 of 184) versus 73.5% (86 of 117); RR 0.95, 95% CI 0.82 to 1.09). However, positive lymph node status was detected less frequently in women with invasive cancer who underwent mammography screening in combination with ultrasonography than in women who underwent mammography alone (18% (23 of 128) versus 34% (29 of 86); RR 0.53, 95% CI 0.33 to 0.86; moderate certainty evidence). Further, interval carcinomas occurred less frequently in the group screened by mammography and ultrasonography compared with mammography alone (5 versus 10 in 10,000 women; RR 0.50, 95% CI 0.29 to 0.89; 72,717 participants; high certainty evidence). False-negative results were less common when ultrasonography was used in addition to mammography than with mammography alone: 9% (18 of 202) versus 23% (35 of 152; RR 0.39, 95% CI 0.23 to 0.66; moderate certainty evidence). However, the number of false-positive results and necessary biopsies were higher in the group with additional ultrasonography screening. Amongst 1000 women who do not have cancer, 37 more received a false-positive result when they participated in screening with a combination of mammography and ultrasonography than with mammography alone (RR 1.43, 95% CI 1.37 to 1.50; high certainty evidence). Compared to mammography alone, for every 1000 women participating in screening with a combination of mammography and ultrasonography, 27 more women will have a biopsy (RR 2.49, 95% CI 2.28 to 2.72; high certainty evidence). Results from cohort studies with methodological limitations confirmed these findings. A secondary analysis of the J-START provided results from 19,213 women with dense and non-dense breasts. In women with dense breasts, the combination of mammography and ultrasonography detected three more cancer cases (0 fewer to 7 more) per 1000 women screened than mammography alone (RR 1.65, 95% CI 1.0 to 2.72; 11,390 participants; high certainty evidence). A meta-analysis of three cohort studies with data from 50,327 women with dense breasts supported this finding, showing that mammography and ultrasonography combined led to statistically significantly more diagnosed cancer cases compared to mammography alone (RR 1.78, 95% CI 1.23 to 2.56; 50,327 participants; moderate certainty evidence). For women with non-dense breasts, the secondary analysis of the J-START study demonstrated that more cancer cases were detected when adding ultrasound to mammography screening compared to mammography alone (RR 1.93, 95% CI 1.01 to 3.68; 7823 participants; moderate certainty evidence), whilst two cohort studies with data from 40,636 women found no statistically significant difference between the two screening methods (RR 1.13, 95% CI 0.85 to 1.49; low certainty evidence). AUTHORS' CONCLUSIONS: Based on one study in women at average risk of breast cancer, ultrasonography in addition to mammography leads to more screening-detected breast cancer cases. For women with dense breasts, cohort studies more in line with real-life clinical practice confirmed this finding, whilst cohort studies for women with non-dense breasts showed no statistically significant difference between the two screening interventions. However, the number of false-positive results and biopsy rates were higher in women receiving additional ultrasonography for breast cancer screening. None of the included studies analysed whether the higher number of screen-detected cancers in the intervention group resulted in a lower mortality rate compared to mammography alone. Randomised controlled trials or prospective cohort studies with a longer observation period are needed to assess the effects of the two screening interventions on morbidity and mortality.

The effectiveness of interventions to prevent loneliness and social isolation in the community-dwelling and old population: an overview of systematic reviews and meta-analysis.

BACKGROUND: Loneliness and social isolation have comparable health effects to widely acknowledged and established risk factors. Although old people are particularly affected, the effectiveness of interventions to prevent and/or mitigate social isolation and loneliness in the community-dwelling older adults is unclear. The aim of this review of reviews was to pool the findings of systematic reviews (SRs) addressing the question of effectiveness. METHODS: Ovid MEDLINE®, Health Evidence, Epistemonikos and Global Health (EBSCO) were searched from January 2017 to November 2021. Two reviewers independently assessed each SR in two consecutive steps based on previously defined eligibility criteria and appraised the methodological quality using a measurement tool to assess SRs 2, AMSTAR 2. One author extracted data from both SRs and eligible studies; another checked this. We conducted meta-analyses to pool the study results. We report the results of the random-effects and common-effect models. RESULTS: We identified five SRs containing a total of 30 eligible studies, 16 with a low or moderate risk of bias. Our random-effects meta-analysis indicates an overall SMD effect of 0.63 [95% confidence interval (CI): -0.10 to 1.36] for loneliness and was unable to detect an overall effect of the interventions on social support [SMD: 0.00; 95% CI: -0.11 to 0.12]. DISCUSSION: The results show interventions can potentially reduce loneliness in the non-institutionalized, community-dwelling and older population living at home. As confidence in the evidence is low, rigorous evaluation is recommended. REGISTRATION: International Prospective Register of SRs (PROSPERO): Registration number: CRD42021255625.

Evidence-based occupational health and safety interventions: a comprehensive overview of reviews.

OBJECTIVES: Occupational injuries and diseases are a huge public health problem and cause extensive suffering and loss of productivity. Nevertheless, many occupational health and safety (OHS) guidelines are still not based on the best available evidence. In the last decade, numerous systematic reviews on behavioural, relational and mixed interventions to reduce occupational injuries and diseases have been carried out, but a comprehensive synopsis is yet missing. The aim of this overview of reviews is to provide a comprehensive basis to inform evidence-based decision-making about interventions in the field of OHS. METHODS: We conducted an overview of reviews. We searched MEDLINE (Ovid), the Cochrane Library (Wiley), epistemonikos.org and Scopus (Elsevier) for relevant systematic reviews published between January 2008 and June 2018. Two authors independently screened abstracts and full-text publications and determined the risk of bias of the included systematic reviews with the ROBIS (Risk of Bias in Systematic Reviews) tool. RESULTS: We screened 2287 abstracts and 200 full-texts for eligibility. Finally, we included 25 systematic reviews with a low risk of bias for data synthesis and analysis. We identified systematic reviews on the prevention of occupational injuries, musculoskeletal, skin and lung diseases, occupational hearing impairment and interventions without specific target diseases. Several interventions led to consistently positive results on individual diseases; other interventions did not show any effects, or the studies are contradictory. We provide detailed results on all included interventions. DISCUSSION: To our knowledge, this is the first comprehensive overview of behavioural, relational and mixed interventions and their effectiveness in preventing occupational injuries and diseases. It provides policymakers with an important basis for making evidence-based decisions on interventions in this field. PROSPERO REGISTRATION NUMBER: CRD42018100341.

Pathways leading to success and non-success: a process evaluation of a cluster randomized physical activity health promotion program applying fuzzy-set qualitative comparative analysis.

BACKGROUND: Health promotion programs can only lead to improvements in health outcomes if they are effectively implemented. However, most studies assessing implementation success focus on only one condition, although more conditions influence this process. Therefore, evidence is scarce on what conditions play a role in successful implementation and how they interact. Hence, we aimed to identify which combinations of teacher and implementation process characteristics affected the emotional and social school experience (SCE) of pupils participating in a school-based health promotion program. METHODS: This study was part of an effectiveness and process evaluation including 24 intervention and 27 control classes. We used fuzzy-set qualitative comparative analysis (fsQCA) to identify combinations of conditions that were associated with either an increase or no increase in the outcome SCE in comparison to the control group at 20 months post intervention. We deductively selected five conditions based on the Consolidated Framework for Implementation Research: teachers' perceived self-efficacy, teachers' expectations of the benefits of the intervention, teachers' previous knowledge about the intervention, dosage of physical activity breaks, and quality of the implementation. RESULTS: We identified five different pathways that led to no increase in the pupils' outcome (parameters of fit: consistency 94%, coverage 66%). The combination of an unsatisfying quality of implementing the intervention and a low previous knowledge about the intervention showed the highest empirical relevance. Similarly, fewer physical activity breaks in combination with other conditions impeded the program's success. Furthermore, we identified two different pathways characterizing ways to success (consistency: 81%, coverage: 52%). The most relevant combination was good quality implementation of physical activity breaks, implemented by teachers with a high self-efficacy, and a good previous knowledge about the intervention. CONCLUSIONS: QCA has potential for an in-depth analysis of complex interventions as it can rely on small to medium sample sizes and analyze pathways to success and non-success separately. The investigated program can be improved by considering the following suggestions: The quality of the implementation process should be monitored during the implementation phase, and regular feedback loops and learning opportunities for teachers should accompany a program. Clear recommendations regarding the dosage should be established. TRIAL REGISTRATION: German register of clinical studies: DRKS00000622 . Retrospectively registered: December 3, 2010, ( http://www.drks.de/drks_web/setLocale_EN.do ). Approved by the Ethics Committee of Lower Austria (GS4-EK-4/107-2010).

[GRADE: Evidence to Decision (EtD) frameworks - a systematic and transparent approach to making well informed healthcare choices. 1: Introduction]. / GRADE: Von der Evidenz zur Empfehlung oder Entscheidung - ein systematischer und transparenter Ansatz, um gut informierte Entscheidungen im Gesundheitswesen zu treffen. 1: Einleitung.

In healthcare, the processes, criteria, and evidence that decision makers use to reach their judgments often remain unclear. Decision makers sometimes neglect important criteria, give undue weight to criteria, or do not use the best available evidence to inform their judgments. Thus, the GRADE (Grading of Recommendations Assessment, Development and Evaluation) working group developed a system to support transparent decision making. The purpose of the Evidence-to-Decision (EtD) framework is to help people use evidence in a structured and transparent way to inform decisions in the context of clinical recommendations, coverage decisions, and health system, or public health recommendations and decisions. EtD frameworks include the formulation of the question, an assessment of the evidence, and drawing conclusions. EtD frameworks inform users of recommendations about judgments that were made and the evidence supporting these judgments by making the basis for decisions transparent to target audiences. EtD frameworks also facilitate dissemination of recommendations.

Effectiveness evaluation of a health promotion programme in primary schools: a cluster randomised controlled trial.

BACKGROUND: Programmes based on the World Health Organization's Health Promoting Schools framework (HPS) have been implemented in several countries but for evidence-based policy-making more research is required to determine the effectiveness of the HPS approach. METHODS: We conducted a cluster randomised controlled trial. The units of randomisation were primary school classes recruited in May 2010. Eligible participants were Year 3 primary school classes in Lower Austria that had not participated in a similar programme during the last two years. After baseline assessment in September 2010, 53 classes from 45 primary schools in Lower Austria were randomly assigned to an intervention (n = 26 classes, 432 children) or waiting control arm (n = 27 classes, 493 children aged 8.7 years +/- 4 months). Over the course of 1.5 academic years, participating teachers received on-the-job training (20 h) and two workshops (8 h) to promote health related behaviour in students such as physical activity during the school day and to improve the quality of regular physical education classes. We assessed 15 outcomes grouped into five categories: Emotional and Social Experience in School, Physical Activity, Well-being, and Attention Performance measured by validated and standardised questionnaire and Motor Skills measured by validated and standardised motoric and coordination tests in the school gym. The primary outcome was Classroom Climate and part of the outcomecategory Emotional and Social Experience in School. The final assessment took place in April 2012. All assessors were blinded to the allocation of classes. Multilevel growth modelling was used to investigate programme effectiveness. RESULTS: We could not detect any statistically significant differences between groups for the outcomecategories Emotional and Social Experience in school (p = 0.22 to 0.78), Physical Activity, Well-being, and Attention Performance. Significant differences between groups were limited to the outcomecategory Motor Skills (Complex Reaction Ability, Spatial Orientation Skills, Coordination with Precision) which were higher in the intervention group (P < .05). CONCLUSIONS: Despite small statistically significant differences in Motor Skills, our study could not detect any clinically relevant improvements in the Emotional and Social Experience at School (including the primary outcome ClassroomClimate), Physical Activity, Well-being, Motor Skills and Attention Performance of students. TRIAL REGISTRATION: German register of clinical studies: DRKS00000622 . Retrospectively registered: 03.12.2010. Approved by the Ethics Committee of Lower Austria (GS4-EK-4/107-2010).