| 1. |
- Houssami, Nehmat, et al.
(författare)
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Effectiveness of digital breast tomosynthesis (3D-mammography) in population breast cancer screening : A protocol for a collaborative individual participant data (IPD) meta-analysis
- 2017
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Ingår i: Translational Cancer Research. - : AME Publishing Company. - 2218-676X .- 2219-6803. ; 6:4, s. 869-877
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Tidskriftsartikel (refereegranskat)abstract
- Background: There is accumulating evidence that digital breast tomosynthesis, referred to as 3D-mammography in this protocol, improves screen-detection measures compared to standard 2D-mammography in the context of population screening for breast cancer. However, the effect of 3D-mammography at follow-up of screened women is not yet known: it is unknown whether additional cancer detection from 3D-mammography leads to incremental screening benefit through a reduction of interval cancers, or whether it is mostly over-detecting indolent cancers. Methods: The aim of this study is to examine whether 3D-mammography population screening improves breast cancer screening effectiveness by reducing interval cancer rates compared to standard digital (2D) mammography screening, using individual participant data (IPD) meta-analysis. In this protocol, we outline the research plan which includes systematic identification of studies eligible to contribute data into the IPD meta-analysis, and sourcing and assembling IPD for participants screened with 3D-mammography (3D alone or integrated 2D/3D or integrated 2Dsynthetic/3D) and comparison participants screened with 2D-mammography (standard of care in breast screening). The primary end-point of this work is the interval breast cancer rate per 10,000 screens for 3D-mammography versus 2D-mammography screening. The IPD meta-analysis will also assess secondary outcomes including: screening sensitivity, cancer detection rates, cancer (prognostic) characteristics, and recall rates, for 3D-mammography versus 2D-mammography screening. The use of IPD meta-analysis will allow stratification of results by age and breast density, and will also facilitate analysis of cancer histological (prognostic) characteristics. Discussion: Finalization of data collection procedures and analysis plans will be complete by the end of 2017. Data collection will occur from late 2017 to late 2018 (screen-detection measures: cancer detection and recall data) and from mid-2018 to mid-2019 (interval cancer data). Results of detection measures should be available by 2019, and interval cancer results in 2020. By addressing the critical evidence gap on whether 3D-mammography screening reduces interval cancer rates (compared to 2D-mammography), we expect that our findings will inform timely translation of 3D-mammography technology into breast screening practice in population-based health programs.
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| 2. |
- Houssami, Nehmat, et al.
(författare)
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Interval breast cancer rates for digital breast tomosynthesis versus digital mammography population screening : An individual participant data meta-analysis
- 2021
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Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 34
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Tidskriftsartikel (refereegranskat)abstract
- Background: Digital breast tomosynthesis (DBT) improves breast cancer (BC) detection compared to mammography, however, it is unknown whether this reduces interval cancer rate (ICR) at follow-up. Methods: Using individual participant data (IPD) from DBT screening studies (identified via periodic literature searches July 2016 to November 2019) we performed an IPD meta-analysis. We estimated ICR for DBT-screened participants and the difference in pooled ICR for DBT and mammography-only screening, and compared interval BC characteristics. Two-stage meta-analysis (study-specific estimation, pooled synthesis) of ICR included random-effects, adjusting for study and age, and was estimated in age and density subgroups. Comparative screening sensitivity was calculated using screen-detected and interval BC data. Findings: Four prospective DBT studies, from European population-based programs, contributed IPD for 66,451 DBT-screened participants: age-adjusted pooled ICR was 13.17/10,000 (95%CI: 8.25–21.02). Pooled ICR was higher in the high-density (21.08/10,000; 95%CI: 6.71–66.27) than the low-density (8.63/10,000; 95%CI: 5.25–14.192) groups (P = 0.03) however estimates did not differ across age-groups (P = 0.32). Based on two studies that also provided data for 153,800 mammography screens (age-adjusted ICR 17.69/10,000; 95%CI: 13.22–23.66), DBT's pooled ICR was 16.83/10,000 (95%CI: 11.89–23.82). Comparative meta-analysis showed a non-significant difference in ICR (-0.44/10,000; 95%CI: -11.00–10.11) and non-significant difference in screening sensitivity (6.79%; 95%CI: -0.73–14.87%) between DBT and DM but a significant pooled difference in cancer detection rate of 33.49/10,000 (95%CI: 23.88–43.10). Distribution of interval BC prognostic characteristics did not differ between screening modalities except that those occurring in DBT-screened participants were significantly more likely to be negative for axillary-node metastases (P = 0.005). Interpretation: Although heterogeneity in ICR estimates and few datasets limit recommendations, there was no difference between DBT and mammography in pooled ICR despite DBT increasing cancer detection.
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| 3. |
- Houssami, Nehmat, et al.
(författare)
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Meta-analysis of prospective studies evaluating breast cancer detection and interval cancer rates for digital breast tomosynthesis versus mammography population screening
- 2021
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Ingår i: European Journal of Cancer. - : Elsevier BV. - 0959-8049. ; 148, s. 14-23
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Forskningsöversikt (refereegranskat)abstract
- Introduction: Breast cancer (BC) screening using digital breast tomosynthesis (DBT) has been shown to increase cancer detection compared with mammography; however, it is unknown whether DBT impacts interval cancer rate (ICR). Methods: We systematically identified prospective DBT studies reporting data on screen-detected and interval BCs to perform a study-level meta-analysis of the comparative effect of DBT on ICR in population screening. Meta-analysis of cancer detection rate (CDR), ICR, and the differences between DBT and mammography in CDR and ICR pooled estimates, included random-effects. Sensitivity analysis examined whether study methods (imaging used, comparison group design, interval BC ascertainment) affected pooled estimates. Results: Five eligible prospective (non-randomised) studies of DBT population screening reported on 129,969 DBT-screened participants and 227,882 mammography-only screens, including follow-up publications reporting interval BC data. Pooled CDR was 9.03/1000 (95% confidence interval [CI] 8.53–9.56) for DBT, and 5.95/1000 (95% CI 5.65–6.28) for mammography: the pooled difference in CDR was 3.15/1000 (95% CI 2.53–3.77), and was evident for the detection of invasive and in-situ malignancy. Pooled ICR was 1.56/1000 DBT screens (95% CI 1.22–2.00), and 1.75/1000 mammography screens (95% CI 1.46–2.11): the estimated pooled difference in ICR was −0.15/1000 (95% CI –0.59 to 0.29) and was not substantially altered in several sensitivity analyses. Conclusions: Meta-analysis shows consistent evidence that DBT significantly increased CDR compared with mammography screening; however, there was little difference between DBT and mammography in pooled ICR. This could suggest, but does not demonstrate, some over-detection. Meta-analysis using individual participant data, randomised trials and comparative studies quantifying cumulative detection and ICR over repeat DBT screen-rounds would provide valuable evidence to inform screening programs.
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| 4. |
- Seidler, Anna Lene, et al.
(författare)
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Deferred cord clamping, cord milking, and immediate cord clamping at preterm birth: a systematic review and individual participant data meta-analysis.
- 2023
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Ingår i: Lancet (London, England). - 1474-547X. ; 402:10418, s. 2209-2222
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Forskningsöversikt (refereegranskat)abstract
- Umbilical cord clamping strategies at preterm birth have the potential to affect important health outcomes. The aim of this study was to compare the effectiveness of deferred cord clamping, umbilical cord milking, and immediate cord clamping in reducing neonatal mortality and morbidity at preterm birth.We conducted a systematic review and individual participant data meta-analysis. We searched medical databases and trial registries (from database inception until Feb 24, 2022; updated June 6, 2023) for randomised controlled trials comparing deferred (also known as delayed) cord clamping, cord milking, and immediate cord clamping for preterm births (<37 weeks' gestation). Quasi-randomised or cluster-randomised trials were excluded. Authors of eligible studies were invited to join the iCOMP collaboration and share individual participant data. All data were checked, harmonised, re-coded, and assessed for risk of bias following prespecified criteria. The primary outcome was death before hospital discharge. We performed intention-to-treat one-stage individual participant data meta-analyses accounting for heterogeneity to examine treatment effects overall and in prespecified subgroup analyses. Certainty of evidence was assessed with Grading of Recommendations Assessment, Development, and Evaluation. This study is registered with PROSPERO, CRD42019136640.We identified 2369 records, of which 48 randomised trials provided individual participant data and were eligible for our primary analysis. We included individual participant data on 6367 infants (3303 [55%] male, 2667 [45%] female, two intersex, and 395 missing data). Deferred cord clamping, compared with immediate cord clamping, reduced death before discharge (odds ratio [OR] 0·68 [95% CI 0·51-0·91], high-certainty evidence, 20 studies, n=3260, 232 deaths). For umbilical cord milking compared with immediate cord clamping, no clear evidence was found of a difference in death before discharge (OR 0·73 [0·44-1·20], low certainty, 18 studies, n=1561, 74 deaths). Similarly, for umbilical cord milking compared with deferred cord clamping, no clear evidence was found of a difference in death before discharge (0·95 [0·59-1·53], low certainty, 12 studies, n=1303, 93 deaths). We found no evidence of subgroup differences for the primary outcome, including by gestational age, type of delivery, multiple birth, study year, and perinatal mortality.This study provides high-certainty evidence that deferred cord clamping, compared with immediate cord clamping, reduces death before discharge in preterm infants. This effect appears to be consistent across several participant-level and trial-level subgroups. These results will inform international treatment recommendations.Australian National Health and Medical Research Council.
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| 5. |
- Seidler, Anna Lene, et al.
(författare)
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Short, medium, and long deferral of umbilical cord clamping compared with umbilical cord milking and immediate clamping at preterm birth: a systematic review and network meta-analysis with individual participant data.
- 2023
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Ingår i: Lancet (London, England). - 1474-547X. ; 402:10418, s. 2223-2234
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Forskningsöversikt (refereegranskat)abstract
- Deferred (also known as delayed) cord clamping can improve survival of infants born preterm (before 37 weeks of gestation), but the optimal duration of deferral remains unclear. We conducted a systematic review and individual participant data network meta-analysis with the aim of comparing the effectiveness of umbilical cord clamping strategies with different timings of clamping or with cord milking for preterm infants.We searched medical databases and trial registries from inception until Feb 24, 2022 (updated June 6, 2023) for randomised controlled trials comparing cord clamping strategies for preterm infants. Individual participant data were harmonised and assessed for risk of bias and quality. Interventions were grouped into immediate clamping, short deferral (≥15 s to <45 s), medium deferral (≥45 s to <120 s), long deferral (≥120 s), and intact cord milking. The primary outcome was death before hospital discharge. We calculated one-stage, intention-to-treat Bayesian random-effects individual participant data network meta-analysis. This study was registered with PROSPERO, CRD42019136640.We included individual participant data from 47 trials with 6094 participants. Of all interventions, long deferral reduced death before discharge the most (compared with immediate clamping; odds ratio 0·31 [95% credibility interval] 0·11-0·80; moderate certainty). The risk of bias was low for 10 (33%) of 30 trials, 14 (47%) had some concerns, and 6 (20%) were rated as having a high risk of bias. Heterogeneity was low, with no indication of inconsistency.This study found that long deferral of clamping leads to reduced odds of death before discharge in preterm infants. In infants assessed as requiring immediate resuscitation, this finding might only be generalisable if there are provisions for such care with the cord intact. These results are based on thoroughly cleaned and checked individual participant data and can inform future guidelines and practice.Australian National Health and Medical Research Council.
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| 6. |
- Seidler, Anna Lene, et al.
(författare)
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Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP) : Study protocol
- 2020
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 10:3
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Forskningsöversikt (refereegranskat)abstract
- Introduction: Timing of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. Objectives: (1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. Methods and analysis: Systematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks' gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. Ethics and dissemination: Ethics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases.
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| 7. |
- Wilkinson, Jack, et al.
(författare)
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Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions
- 2024
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 14:3
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.Methods and analysis The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.Ethics and dissemination The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.
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| 8. |
- Abbafati, Cristiana, et al.
(författare)
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- 2020
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Tidskriftsartikel (refereegranskat)
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| 9. |
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- 2019
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Tidskriftsartikel (refereegranskat)
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