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Quality Assurance for Patients with Breast Cancer - the Impact of Clinical Cancer Registries.

ABSTRACT: Introduction: Since 2000 all service providers in the German healthcare system are legally obliged to take part in quality assurance (QA) procedures as stipulated in Book Five of the German Social Code. Clinical cancer registries provide methodological tools to assess the quality of structures, processes and outcomes. The aim of this study was to analyze the consequences of guideline-concordant treatment using two examples of quality indicators: endocrine therapy (adjuvant hormonal therapy, AHT) to treat patients with steroid hormone receptor (SHR)-positive breast cancer and trastuzumab therapy to treat patients with HER2-positive breast cancer. Material and Methods: Data from the Tumor Center Regensburg (Bavaria, Germany) included all female patients listed in the registry with primary, non-metastatic invasive breast cancer diagnosed between 2000 and 2012. Results: A total of 6164 patients with invasive breast cancer and known HER2 status were analyzed. 1134 patients (18.4 %) had HER2-positive and 5346 patients (86.7 %) had SHR-positive breast cancer. Premenopausal patients with HER2-positive breast cancer receiving trastuzumab had a 7-year OS rate of 93.8 % compared to 86.8 % of patients who did not receive trastuzumab (p = 0.079). Similarly, postmenopausal patients with HER2-positive breast cancer treated with trastuzumab had better 7-year OS rates (87.3 %) than patients who did not receive the antibody (76.7 %) (p < 0.001). Premenopausal patients with SHR-positive breast cancer receiving AHT had a 7-year OS rate of 95.2 % compared to 75.9 % of patients who did not receive AHT (p < 0.001). Equally, postmenopausal patients treated with AHT had a 7-year OS rate of 83.8 % compared to 64.1 % without AHT (p < 0.001). Conclusion: Clinical cancer registries depend on the cooperation of the various health service providers to generate data that are essential for QA for breast cancer patients.

SUBMITTER: Inwald EC

PROVIDER: S-EPMC4175129 | biostudies-other | 2014 Sep

REPOSITORIES: biostudies-other

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Project description:BackgroundThis research reviewed major Clinical Trial Registries (CTRs) and assessed the availability of fields on quality assurance for approved medicines used as Investigational Medicinal Products (IMPs) in phase IV clinical trials.MethodsTwo reviewers independently assessed CTRs of the International Committee of Medical Journal Editors (ICJME) and of World Health Organization (WHO) platforms. Each CTR was checked by two reviewers on availability of fields on brand name, manufacturer's name, approval status, approving authority, compliance with Good Manufacturing Practices, and quality testing. In case of discrepancy, consensus was sought between the two reviewers.ResultsOf 19 identified CTRs, 8 and 6 belonged to WHO and ICMJE, respectively, while 5 were equally part of both platforms. All CTRs had an 'intervention' field where data on IMPs and IMP comparators are captured. The Canadian CTR used 'drug name' rather than 'intervention'. The EU, Peruvian, and UK CTRs had fields for 'brand name'. However, only the EU CTR had fields for 'manufacturer's name', 'approval status', and 'approving authority'. None of the CTRs had fields on 'compliance with Good Manufacturing Practices' or 'quality testing'.ConclusionThis study demonstrates that none of the CTRs of ICMJE and WHO platforms has adequate fields to establish that the source of post-marketing IMPs is of assured quality. This is astonishing given the lengthy requirements in WHO and ICMJE guidelines. Considering the relation between IMP quality and safety of clinical trial participants, the gap of quality assurance fields should be bridged at CTRs concurrently to adjustments of WHO and ICMJE guidelines on CTRs. Specifically, IMP quality testing addressing issues on IMP appearance, impurities, microbial contamination, and dosing should be conducted and reported before, during, and after clinical trial conduct. Until adoption of these measures, the EU CTR should be preferred for registration of phase IV clinical trials conducted in countries lacking stringent regulatory capacities.

Project description:BackgroundClinical quality registries (CQRs) are playing an increasingly important role in improving health outcomes and reducing health care costs. CQRs are established with the purpose of monitoring quality of care, providing feedback, benchmarking performance, describing pattern of treatment, reducing variation and as a tool for conducting research.ObjectivesTo synthesise the impact of clinical quality registries (CQRs) as an 'intervention' on (I) mortality/survival; (II) measures of outcome that reflect a process or outcome of health care; (III) health care utilisation; and (IV) healthcare-related costs.MethodsThe following electronic databases were searched: MEDLINE, EMBASE, CENTRAL, CINAHL and Google Scholar. In addition, a review of the grey literature and a reference check of citations and reference lists within articles was undertaken to identify relevant studies in English covering the period January 1980 to December 2016. The PRISMA-P methodology, checklist and standard search strategy using pre-defined inclusion and exclusion criteria and structured data extraction tools were used. Data on study design and methods, participant characteristics attributes of included registries and impact of the registry on outcome measures and/or processes of care were extracted.ResultsWe identified 30102 abstracts from which 75 full text articles were assessed and finally 17 articles were selected for synthesis. Out of 17 studies, six focused on diabetes care, two on cardiac diseases, two on lung diseases and others on organ transplantations, rheumatoid arthritis, ulcer healing, surgical complications and kidney disease. The majority of studies were "before after" design (#11) followed by cohort design (#2), randomised controlled trial (#2), experimental non randomised study and one cross sectional comparison. The measures of impact of registries were multifarious and included change in processes of care, quality of care, treatment outcomes, adherence to guidelines and survival. Sixteen of 17 studies demonstrated positive findings in their outcomes after implementation of the registry.ConclusionsDespite the large number of published articles using data derived from CQRs, few have rigorously evaluated the impact of the registry as an intervention on improving health outcomes. Those that have evaluated this impact have mostly found a positive impact on healthcare processes and outcomes.Trial registrationPROSPERO CRD42015017319.

Project description:Purpose: More and more automatic segmentation tools are being introduced in routine clinical practice. However, physicians need to spend a considerable amount of time in examining the generated contours slice by slice. This greatly reduces the benefit of the tool's automaticity. In order to overcome this shortcoming, we developed an automatic quality assurance (QA) method for automatic segmentation using convolutional neural networks (CNNs). Materials and Methods: The study cohort comprised 680 patients with early-stage breast cancer who received whole breast radiation. The overall architecture of the automatic QA method for deep learning-based segmentation included the following two main parts: a segmentation CNN model and a QA network that was established based on ResNet-101. The inputs were from computed tomography, segmentation probability maps, and uncertainty maps. Two kinds of Dice similarity coefficient (DSC) outputs were tested. One predicted the DSC quality level of each slice ([0.95, 1] for "good," [0.8, 0.95] for "medium," and [0, 0.8] for "bad" quality), and the other predicted the DSC value of each slice directly. The performances of the method to predict the quality levels were evaluated with quantitative metrics: balanced accuracy, F score, and the area under the receiving operator characteristic curve (AUC). The mean absolute error (MAE) was used to evaluate the DSC value outputs. Results: The proposed methods involved two types of output, both of which achieved promising accuracy in terms of predicting the quality level. For the good, medium, and bad quality level prediction, the balanced accuracy was 0.97, 0.94, and 0.89, respectively; the F score was 0.98, 0.91, and 0.81, respectively; and the AUC was 0.96, 0.93, and 0.88, respectively. For the DSC value prediction, the MAE was 0.06 ± 0.19. The prediction time was approximately 2 s per patient. Conclusions: Our method could predict the segmentation quality automatically. It can provide useful information for physicians regarding further verification and revision of automatic contours. The integration of our method into current automatic segmentation pipelines can improve the efficiency of radiotherapy contouring.

Project description:ObjectivesThe objective of this systematic review was to examine the existing evidence base for the cost-effectiveness or cost-benefit of clinical quality registries (CQRs).DesignSystematic review and narrative synthesis.Data sourcesNine electronic bibliographic databases, including MEDLINE, EMBASE and CENTRAL, in the period from January 2000 to August 2019.Eligibility criteriaAny peer-reviewed published study or grey literature in English which had reported on an economic evaluation of one or more CQRs.Data extraction and synthesisData were screened, extracted and appraised by two independent reviewers. A narrative synthesis was performed around key attributes of each CQR and on key patient outcomes or changes to healthcare processes or utilisation. A narrative synthesis of the cost-effectiveness associated with CQRs was also conducted. The primary outcome was cost-effectiveness, in terms of the estimated incremental cost-effectiveness ratio (ICER), cost savings or return-on-investment (ROI) attributed to CQR implementation.ResultsThree studies and one government report met the inclusion criteria for the review. A study of the National Surgical Quality Improvement Programme (NSQIP) in the USA found that the cost-effectiveness of this registry improved over time, based on an ICER of US$8312 per postoperative event avoided. A separate study in Canada estimated the ROI to be US$3.43 per US$1.00 invested in the NSQIP. An evaluation of a post-splenectomy CQR in Australia estimated that registry cost-effectiveness improved from US$234?329 to US$18?358 per life year gained when considering the benefits accrued over the lifetime of the population. The government report evaluating five Australian CQRs estimated an overall return of 1.6-5.5 times the cost of investment.ConclusionsAvailable data indicate that CQRs can be cost-effective and can lead to significant returns on investment. It is clear that further studies that evaluate the economic and clinical impacts of CQRs are necessary.Prospero registration numberCRD42018116807.

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Quality Assurance for Patients with Breast Cancer - the Impact of Clinical Cancer Registries.

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