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1.
Asian Pac J Cancer Prev ; 25(4): 1425-1432, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38680004

RESUMO

AIM: This study comprehensively investigated pre-treatment quality assurance (QA) for 100 cancer patients undergoing stereotactic treatments (SRS/SRT) using various detectors. METHODS: The study conducted QA for SRS/SRT treatments planned with a 6MV SRS beam at a dose rate of 1,000 MU/min, utilizing Eclipse v13.6 Treatment Planning System (TPS). Point dose measurements employed 0.01cm3 and 0.13cm3 cylindrical ionization chambers, while planar dose verification utilized Gafchromic EBT-XD Film and Portal Imager (aS1000). Plans were categorized by target volume, and a thorough analysis compared point dose agreements, planar dose gamma pass rates, and their correlations with chamber volume mean dose, detector type, and point dose agreement. Additionally, the consistency between different ionization chambers was assessed. RESULTS: Point dose agreement generally improved with increasing target volume, except for volumes over 10cm3 with 0.01cm3 chambers, showing a contrary trend. Significant differences (p<0.05) were observed between TPS and measured doses for both chambers. Gamma pass rate improved with increasing target volume in EBT XD and aS1000 analyses, except for the >10cm3 group in EBT XD. EBT XD demonstrated better agreement with TPS for target volumes up to 10cm3 compared to aS1000, with a statistically significant difference (p<0.05) between the detectors. Strong correlations were found between chamber point dose and chamber volume mean dose agreement, as well as between the two gamma criteria analyses of the same detector type in the planar dose correlation analysis. However, weak correlations were discovered for other analyses. CONCLUSION: This study found weak correlation between different detector types in pre-treatment QA for point dose and planar dose evaluation. However, within a specific detector type, strong correlation was observed for different point dose evaluation methods and gamma criteria. This highlights the importance of cautious interpretation of QA results, particularly for SRS QA, due to the lack of correlation between detector types.


Assuntos
Neoplasias , Garantia da Qualidade dos Cuidados de Saúde , Radiocirurgia , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador , Humanos , Radiocirurgia/métodos , Planejamento da Radioterapia Assistida por Computador/métodos , Planejamento da Radioterapia Assistida por Computador/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Neoplasias/radioterapia , Radiometria/métodos , Radioterapia de Intensidade Modulada/métodos
2.
J Appl Clin Med Phys ; 25(5): e14343, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38569013

RESUMO

PURPOSE: Single-isocenter multi-target intracranial stereotactic radiotherapy (SIMT) is an effective treatment for brain metastases with complex treatment plans and delivery optimization necessitating rigorous quality assurance. This work aims to assess five methods for quality assurance of SIMT treatment plans in terms of their suitability and sensitivity to delivery errors. METHODS: Sun Nuclear ArcCHECK and SRS MapCHECK, GafChromic EBT Radiochromic Film, machine log files, and Varian Portal Dosimetry were all used to measure 15 variations of a single SIMT plan. Variations of the original plan were created with Python. They comprised various degrees of systematic MLC offsets per leaf up to 2 mm, random per-leaf variations with differing minimum and maximum magnitudes, simulated collimator, and dose miscalibrations (MU scaling). The erroneous plans were re-imported into Eclipse and plan-quality degradation was assessed by comparing each plan variation to the original clinical plan in terms of the percentage of clinical goals passing relative to the original plan. Each erroneous plan could be then ranked by the plan-quality degradation percentage following recalculation in the TPS so that the effects of each variation could be correlated with γ pass rates and detector suitability. RESULTS & CONCLUSIONS: It was found that 2%/1 mm is a good starting point for the ArcCHECK, Portal Dosimetry, and the SRS MapCHECK methods, respectively, and provides clinically relevant error detection sensitivity. Looser dose criteria of 5%/1 mm or 5%/1.5 mm are suitable for film dosimetry and log-file-based methods. The statistical methods explored can be expanded to other areas of patient-specific QA and detector assessment.


Assuntos
Neoplasias Encefálicas , Garantia da Qualidade dos Cuidados de Saúde , Radiocirurgia , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador , Radioterapia de Intensidade Modulada , Humanos , Planejamento da Radioterapia Assistida por Computador/métodos , Neoplasias Encefálicas/radioterapia , Radiocirurgia/métodos , Radiocirurgia/instrumentação , Garantia da Qualidade dos Cuidados de Saúde/normas , Radioterapia de Intensidade Modulada/métodos , Aceleradores de Partículas/instrumentação , Radiometria/métodos , Radiometria/instrumentação , Algoritmos
3.
J Appl Clin Med Phys ; 25(5): e14337, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38576183

RESUMO

PURPOSE: The quality of on-board imaging systems, including cone-beam computed tomography (CBCT), plays a vital role in image-guided radiation therapy (IGRT) and adaptive radiotherapy. Recently, there has been an upgrade of the CBCT systems fused in the O-ring linear accelerators called HyperSight, featuring a high imaging performance. As the characterization of a new imaging system is essential, we evaluated the image quality of the HyperSight system by comparing it with Halcyon 3.0 CBCT and providing benchmark data for routine imaging quality assurance. METHODS: The HyperSight features ultra-fast scan time, a larger kilovoltage (kV) detector, a more substantial kV tube, and an advanced reconstruction algorithm. Imaging protocols in the two modes of operation, treatment mode with IGRT and the CBCT for planning (CBCTp) mode were evaluated and compared with Halcyon 3.0 CBCT. Image quality metrics, including spatial resolution, contrast resolution, uniformity, noise, computed tomography (CT) number linearity, and calibration error, were assessed using a Catphan and an electron density phantom and analyzed with TotalQA software. RESULTS: HyperSight demonstrated substantial improvements in contrast-to-noise ratio and noise in both IGRT and CBCTp modes compared to Halcyon 3.0 CBCT. CT number calibration error of HyperSight CBCTp mode (1.06%) closely matches that of a full CT scanner (0.72%), making it suitable for adaptive planning. In addition, the advanced hardware of HyperSight, such as ultra-fast scan time (5.9 s) or 2.5 times larger heat unit capacity, enhanced the clinical efficiency in our experience. CONCLUSIONS: HyperSight represented a significant advancement in CBCT imaging. With its image quality, CT number accuracy, and ultra-fast scans, HyperSight has a potential to transform patient care and treatment outcomes. The enhanced scan speed and image quality of HyperSight are expected to significantly improve the quality and efficiency of treatment, particularly benefiting patients.


Assuntos
Algoritmos , Tomografia Computadorizada de Feixe Cônico , Processamento de Imagem Assistida por Computador , Aceleradores de Partículas , Imagens de Fantasmas , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador , Radioterapia Guiada por Imagem , Tomografia Computadorizada de Feixe Cônico/métodos , Aceleradores de Partículas/instrumentação , Humanos , Planejamento da Radioterapia Assistida por Computador/métodos , Processamento de Imagem Assistida por Computador/métodos , Radioterapia Guiada por Imagem/métodos , Radioterapia de Intensidade Modulada/métodos , Garantia da Qualidade dos Cuidados de Saúde/normas , Interpretação de Imagem Radiográfica Assistida por Computador/métodos
4.
J Appl Clin Med Phys ; 25(5): e14313, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38650177

RESUMO

BACKGROUND: This study utilizes interviews of clinical medical physicists to investigate self-reported shortcomings of the current weekly chart check workflow and opportunities for improvement. METHODS: Nineteen medical physicists were recruited for a 30-minute semi-structured interview, with a particular focus placed on image review and the use of automated tools for image review in weekly checks. Survey-type questions were used to gather quantitative information about chart check practices and importance placed on reducing chart check workloads versus increasing chart check effectiveness. Open-ended questions were used to probe respondents about their current weekly chart check workflow, opinions of the value of weekly chart checks and perceived shortcomings, and barriers and facilitators to the implementation of automated chart check tools. Thematic analysis was used to develop common themes across the interviews. RESULTS: Physicists ranked highly the value of reducing the time spent on weekly chart checks (average 6.3 on a scale from 1 to 10), but placed more value on increasing the effectiveness of checks with an average of 9.2 on a 1-10 scale. Four major themes were identified: (1) weekly chart checks need to adapt to an electronic record-and-verify chart environment, (2) physicists could add value to patient care by analyzing images without duplicating the work done by physicians, (3) greater support for trending analysis is needed in weekly checks, and (4) automation has the potential to increase the value of physics checks. CONCLUSION: This study identified several key shortcomings of the current weekly chart check process from the perspective of the clinical medical physicist. Our results show strong support for automating components of the weekly check workflow in order to allow for more effective checks that emphasize follow-up, trending, failure modes and effects analysis, and allow time to be spent on other higher value tasks that improve patient safety.


Assuntos
Fluxo de Trabalho , Humanos , Física Médica , Inquéritos e Questionários , Processamento de Imagem Assistida por Computador/métodos , Automação , Garantia da Qualidade dos Cuidados de Saúde/normas , Entrevistas como Assunto/métodos
5.
J Appl Clin Med Phys ; 25(5): e14328, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38553788

RESUMO

PURPOSE: Experimental patient-specific QA (PSQA) is a time and resource-intensive process, with a poor sensitivity in detecting errors. Radiation therapy facilities aim to substitute it by means of independent dose calculation (IDC) in combination with a comprehensive beam delivery QA program. This paper reports on the commissioning of the IDC software tool myQA iON (IBA Dosimetry) for proton therapy and its clinical implementation at the MedAustron Ion Therapy Center. METHODS: The IDC commissioning work included the validation of the beam model, the implementation and validation of clinical CT protocols, and the evaluation of patient treatment data. Dose difference maps, gamma index distributions, and pass rates (GPR) have been reviewed. The performance of the IDC tool has been assessed and clinical workflows, simulation settings, and GPR tolerances have been defined. RESULTS: Beam model validation showed agreement of ranges within ± 0.2 mm, Bragg-Peak widths within ± 0.1 mm, and spot sizes at various air gaps within ± 5% compared to physical measurements. Simulated dose in 2D reference fields deviated by -0.3% ± 0.5%, while 3D dose distributions differed by 1.8% on average to measurements. Validation of the CT calibration resulted in systematic differences of 2.0% between IDC and experimental data for tissue like samples. GPRs of 99.4 ± 0.6% were found for head, head and neck, and pediatric CT protocols on a 2%/2 mm gamma criterion. GPRs for the adult abdomen protocol were at 98.9% on average with 3%/3 mm. Root causes of GPR outliers, for example, implants were identified and evaluated. CONCLUSION: IDC has been successfully commissioned and integrated into the MedAustron clinical workflow for protons in 2021. IDC has been stepwise and safely substituting experimental PSQA since February 2021. The initial reduction of proton experimental PSQA was about 25% and reached up to 90% after 1 year.


Assuntos
Órgãos em Risco , Terapia com Prótons , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador , Software , Humanos , Terapia com Prótons/métodos , Planejamento da Radioterapia Assistida por Computador/métodos , Órgãos em Risco/efeitos da radiação , Garantia da Qualidade dos Cuidados de Saúde/normas , Imagens de Fantasmas , Radioterapia de Intensidade Modulada/métodos , Calibragem , Neoplasias/radioterapia , Tomografia Computadorizada por Raios X/métodos , Algoritmos
6.
J Appl Clin Med Phys ; 25(5): e14264, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38252813

RESUMO

Create a virtual ArcCHECK-MR phantom, customized for a 1.5T MR-linac, with consideration of the different density regions within the quality assurance (QA) phantom, aiming to streamline the utilization of this specialized QA device. A virtual phantom was constructed in the treatment planning system (TPS) to replicate the ArcCHECK-MR's composition, consisting of five distinct layers: "Outer" (representing the outer PMMA ring), "Complex" (simulating the printed circuit boards), "Detectors" (encompassing the detector area), "Inner" (signifying the inner PMMA ring) and "Insert" (representing the PMMA insert). These layers were defined based on geometric data and represented as contour points on a set of dummy CT images. Additionally, a setup platform was integrated as contoured structures. To determine the relative electron density (RED) values of the external and internal PMMA components, measurements were taken at 25 points in the insert using an ion chamber. A novel method for establishing the exit/entrance dose ratio (EEDR) for ArcCHECK-MR was introduced. The RED of higher density region was derived by evaluating the local gamma index passing rate results with criteria of 2% dose difference and 2 mm distance-to-agreement. The performance of the virtual phantom was assessed for Unity 7 FFF beams with a 1.5T magnetic field. The radii of the five ring structures within the virtual phantom measured 133.0 mm, 110.0 mm, 103.4 mm, 100.0 mm, and 75.0 mm for the "Outer," "Complex," "Detectors," "Inner" and "Insert" regions, respectively. The RED values were as follows: ArcCHECK-MR PMMA had a RED of 1.130, "Detectors" were assumed to have a RED of 1.000, "Complex" had a RED of 1.200, and the setup QA phantom justified a RED of 1.350. Early validation results demonstrate that the 5-layer virtual phantom, when compared to the commonly used bulk overridden phantom, offers improved capability in MR-linac environments. This enhancement led to an increase in passing rates for the local gamma index by approximately 5 ∼ 6%, when applying the criteria of 2%, 2 mm. We have successfully generated a virtual representation of the distinct regions within the ArcCHECK-MR using a TPS, addressing the challenges associated with its use in conjunction with a 1.5T MR-linac. We consistently observed favorable local gamma index passing rates across two 1.5T MR-linac and ArcCHECK-MR unit combinations. This approach has the potential to minimize uncertainties in the creation of the QA phantom for ArcCHECK-MR across various institutions.


Assuntos
Imageamento por Ressonância Magnética , Aceleradores de Partículas , Imagens de Fantasmas , Garantia da Qualidade dos Cuidados de Saúde , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador , Humanos , Garantia da Qualidade dos Cuidados de Saúde/normas , Planejamento da Radioterapia Assistida por Computador/métodos , Aceleradores de Partículas/instrumentação , Imageamento por Ressonância Magnética/métodos , Imageamento por Ressonância Magnética/normas , Radioterapia de Intensidade Modulada/métodos , Neoplasias/radioterapia , Neoplasias/diagnóstico por imagem
7.
Pract Radiat Oncol ; 14(3): e205-e213, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38237893

RESUMO

PURPOSE: Significant heterogeneity exists in clinical quality assurance (QA) practices within radiation oncology departments, with most chart rounds lacking prospective peer-reviewed contour evaluation. This has the potential to significantly affect patient outcomes, particularly for head and neck cancers (HNC) given the large variance in target volume delineation. With this understanding, we incorporated a prospective systematic peer contour-review process into our workflow for all patients with HNC. This study aims to assess the effectiveness of implementing prospective peer review into practice for our National Cancer Institute Designated Cancer Center and to report factors associated with contour modifications. METHODS AND MATERIALS: Starting in November 2020, our department adopted a systematic QA process with real-time metrics, in which contours for all patients with HNC treated with radiation therapy were prospectively peer reviewed and graded. Contours were graded with green (unnecessary), yellow (minor), or red (major) colors based on the degree of peer-recommended modifications. Contours from November 2020 through September 2021 were included for analysis. RESULTS: Three hundred sixty contours were included. Contour grades were made up of 89.7% green, 8.9% yellow, and 1.4% red grades. Physicians with >12 months of clinical experience were less likely to have contour changes requested than those with <12 months (8.3% vs 40.9%; P < .001). Contour grades were significantly associated with physician case load, with physicians presenting more than the median number of 50 cases having significantly less modifications requested than those presenting <50 (6.7% vs 13.3%; P = .013). Physicians working with a resident or fellow were less likely to have contour changes requested than those without a trainee (5.2% vs 12.6%; P = .039). Frequency of major modification requests significantly decreased over time after adoption of prospective peer contour review, with no red grades occurring >6 months after adoption. CONCLUSIONS: This study highlights the importance of prospective peer contour-review implementation into systematic clinical QA processes for HNC. Physician experience proved to be the highest predictor of approved contours. A growth curve was demonstrated, with major modifications declining after prospective contour review implementation. Even within a high-volume academic practice with subspecialist attendings, >10% of patients had contour changes made as a direct result of prospective peer review.


Assuntos
Neoplasias de Cabeça e Pescoço , Garantia da Qualidade dos Cuidados de Saúde , Humanos , Neoplasias de Cabeça e Pescoço/radioterapia , Garantia da Qualidade dos Cuidados de Saúde/normas , Planejamento da Radioterapia Assistida por Computador/métodos , Planejamento da Radioterapia Assistida por Computador/normas , Estudos Prospectivos , Feminino , Radioterapia (Especialidade)/normas , Radioterapia (Especialidade)/métodos , Masculino
8.
Pract Radiat Oncol ; 14(3): e173-e179, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38176466

RESUMO

PURPOSE: With expansion of academic cancer center networks across geographically-dispersed sites, ensuring high-quality delivery of care across all network affiliates is essential. We report on the characteristics and efficacy of a radiation oncology peer-review quality assurance (QA) system implemented across a large-scale multinational cancer network. METHODS AND MATERIALS: Since 2014, weekly case-based peer-review QA meetings have been standard for network radiation oncologists with radiation oncology faculty at a major academic center. This radiotherapy (RT) QA program involves pre-treatment peer-review of cases by disease site, with disease-site subspecialized main campus faculty members. This virtual QA platform involves direct review of the proposed RT plan as well as supporting data, including relevant pathology and imaging studies for each patient. Network RT plans were scored as being concordant or nonconcordant based on national guidelines, institutional recommendations, and/or expert judgment when considering individual patient-specific factors for a given case. Data from January 1, 2014, through December 31, 2019, were aggregated for analysis. RESULTS: Between 2014 and 2019, across 8 network centers, a total of 16,601 RT plans underwent peer-review. The network-based peer-review case volume increased over the study period, from 958 cases in 2014 to 4,487 in 2019. A combined global nonconcordance rate of 4.5% was noted, with the highest nonconcordance rates among head-and-neck cases (11.0%). For centers that joined the network during the study period, we observed a significant decrease in the nonconcordance rate over time (3.1% average annual decrease in nonconcordance, P = 0.01); among centers that joined the network prior to the study period, nonconcordance rates remained stable over time. CONCLUSIONS: Through a standardized QA platform, network-based multinational peer-review of RT plans can be achieved. Improved concordance rates among newly added network affiliates over time are noted, suggesting a positive impact of network membership on the quality of delivered cancer care.


Assuntos
Garantia da Qualidade dos Cuidados de Saúde , Radioterapia (Especialidade) , Humanos , Radioterapia (Especialidade)/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Revisão por Pares/métodos , Neoplasias/radioterapia
9.
Radiother Oncol ; 195: 110060, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38122852

RESUMO

The European Society for Radiotherapy and Oncology (ESTRO) has advocated the establishment of guidelines to optimise precision radiotherapy (RT) in conjunction with contemporary therapeutics for cancer care. Quality assurance in RT (QART) plays a pivotal role in influencing treatment outcomes. Clinical trials incorporating QART protocols have demonstrated improved survival rates with minimal associated toxicity. Nonetheless, in routine clinical practice, there can be variability in the indications for RT, dosage, fractionation, and treatment planning, leading to uncertainty. In pivotal trials reporting outcomes of systemic therapy for breast cancer, there is limited information available regarding RT, and the potential interaction between modern systemic therapy and RT remains largely uncharted. This article is grounded in a consensus recommendation endorsed by ESTRO, formulated by international breast cancer experts. The consensus was reached through a modified Delphi process and was presented at an international meeting convened in Florence, Italy, in June 2023. These recommendations are regarded as both optimal and essential standards, with the latter aiming to define the minimum requirements. A template for a case report form (CRF) has been devised, which can be utilised by all clinical breast cancer trials involving RT. Optimal requirements include adherence to predefined RT planning protocols and centralised QART. Essential requirements aim to reduce variations and deviations from the guidelines in RT, even when RT is not the primary focus of the trial. These recommendations underscore the significance of implementing these practices in both clinical trials and daily clinical routines to generate high-quality data.


Assuntos
Neoplasias da Mama , Ensaios Clínicos como Assunto , Consenso , Humanos , Neoplasias da Mama/radioterapia , Feminino , Ensaios Clínicos como Assunto/normas , Europa (Continente) , Radioterapia (Especialidade)/normas , Sociedades Médicas , Garantia da Qualidade dos Cuidados de Saúde/normas
10.
JAMA ; 331(3): 245-249, 2024 01 16.
Artigo em Inglês | MEDLINE | ID: mdl-38117493

RESUMO

Importance: Given the importance of rigorous development and evaluation standards needed of artificial intelligence (AI) models used in health care, nationwide accepted procedures to provide assurance that the use of AI is fair, appropriate, valid, effective, and safe are urgently needed. Observations: While there are several efforts to develop standards and best practices to evaluate AI, there is a gap between having such guidance and the application of such guidance to both existing and new AI models being developed. As of now, there is no publicly available, nationwide mechanism that enables objective evaluation and ongoing assessment of the consequences of using health AI models in clinical care settings. Conclusion and Relevance: The need to create a public-private partnership to support a nationwide health AI assurance labs network is outlined here. In this network, community best practices could be applied for testing health AI models to produce reports on their performance that can be widely shared for managing the lifecycle of AI models over time and across populations and sites where these models are deployed.


Assuntos
Inteligência Artificial , Atenção à Saúde , Laboratórios , Garantia da Qualidade dos Cuidados de Saúde , Qualidade da Assistência à Saúde , Inteligência Artificial/normas , Instalações de Saúde/normas , Laboratórios/normas , Parcerias Público-Privadas , Garantia da Qualidade dos Cuidados de Saúde/normas , Atenção à Saúde/normas , Qualidade da Assistência à Saúde/normas , Estados Unidos
12.
J Med Internet Res ; 24(7): e39590, 2022 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-35788102

RESUMO

BACKGROUND: In 2020, more than 250 eHealth solutions were added to app stores each day, or 90,000 in the year; however, the vast majority of these solutions have not undergone clinical validation, their quality is unknown, and the user does not know if they are effective and safe. We sought to develop a simple prescreening scoring method that would assess the quality and clinical relevance of each app. We designed this tool with 3 health care stakeholder groups in mind: eHealth solution designers seeking to evaluate a potential competitor or their own tool, investors considering a fundraising candidate, and a hospital clinician or IT department wishing to evaluate a current or potential eHealth solution. OBJECTIVE: We built and tested a novel prescreening scoring tool (the Medical Digital Solution scoring tool). The tool, which consists of 26 questions that enable the quick assessment and comparison of the clinical relevance and quality of eHealth apps, was tested on 68 eHealth solutions. METHODS: The Medical Digital Solution scoring tool is based on the 2021 evaluation criteria of the French National Health Authority, the 2022 European Society of Medical Oncology recommendations, and other provided scores. We built the scoring tool with patient association and eHealth experts and submitted it to eHealth app creators, who evaluated their apps via the web-based form in January 2022. After completing the evaluation criteria, their apps obtained an overall score and 4 categories of subscores. These criteria evaluated the type of solution and domain, the solution's targeted population size, the level of clinical assessment, and information about the provider. RESULTS: In total, 68 eHealth solutions were evaluated with the scoring tool. Oncology apps (22%, 20/90) and general health solutions (23%, 21/90) were the most represented. Of the 68 apps, 32 (47%) were involved in remote monitoring by health professionals. Regarding clinical outcomes, 5% (9/169) of the apps assessed overall survival. Randomized studies had been conducted for 21% (23/110) of the apps to assess their benefit. Of the 68 providers, 38 (56%) declared the objective of obtaining reimbursement, and 7 (18%) out of the 38 solutions seeking reimbursement were assessed as having a high probability of reimbursement. The median global score was 11.2 (range 4.7-17.4) out of 20 and the distribution of the scores followed a normal distribution pattern (Shapiro-Wilk test: P=.33). CONCLUSIONS: This multidomain prescreening scoring tool is simple, fast, and can be deployed on a large scale to initiate an assessment of the clinical relevance and quality of a clinical eHealth app. This simple tool can help a decision-maker determine which aspects of the app require further analysis and improvement.


Assuntos
Indicadores de Qualidade em Assistência à Saúde , Software , Telemedicina , Humanos , Garantia da Qualidade dos Cuidados de Saúde/métodos , Garantia da Qualidade dos Cuidados de Saúde/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Qualidade da Assistência à Saúde/normas , Software/normas , Telemedicina/normas
13.
Plast Reconstr Surg ; 149(3): 453e-464e, 2022 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-35196683

RESUMO

BACKGROUND: Economic evaluations can inform decision-making; however, previous publications have identified poor quality of economic evaluations in surgical specialties. METHODS: Study periods were from January 1, 2006, to April 20, 2020 (methodologic quality) and January 1, 2014, to April 20, 2020 (reporting quality). Primary outcomes were methodologic quality [Guidelines for Authors and Peer Reviewers of Economic Submissions to The BMJ (Drummond's checklist), 33 points; Quality of Health Economic Studies (QHES), 100 points; Consensus on Health Economic Criteria (CHEC), 19 points] and reporting quality (Consolidated Health Economic Evaluation Standards (CHEERS) statement, 24 points). RESULTS: Forty-seven hand economic evaluations were included. Partial economic analyses (i.e., cost analysis) were the most common (n = 34; 72 percent). Average scores of full economic evaluations (i.e., cost-utility analysis and cost-effectiveness analysis) were: Drummond's checklist, 27.08 of 33 (82.05 percent); QHES, 79.76 of 100 (79.76 percent); CHEC, 15.54 of 19 (81.78 percent); and CHEERS, 20.25 of 24 (84.38 percent). Cost utility analyses had the highest methodologic and reporting quality scores: Drummond's checklist, 28.89 of 35 (82.54 percent); QHES, 86.56 of 100 (86.56 percent); CHEC, 16.78 of 19 (88.30 percent); and CHEERS, 20.8 of 24 (86.67 percent). The association (multiple R) between CHEC and CHEERS was strongest: CHEC, 0.953; Drummond's checklist, 0.907; and QHES, 0.909. CONCLUSIONS: Partial economic evaluations in hand surgery are prevalent but not very useful. The Consensus on Health Economic Criteria and Consolidated Health Economic Evaluation Standards should be used in tandem when undertaking and evaluating economic evaluation in hand surgery.


Assuntos
Análise Custo-Benefício/métodos , Mãos/cirurgia , Procedimentos de Cirurgia Plástica/economia , Garantia da Qualidade dos Cuidados de Saúde/métodos , Punho/cirurgia , Análise Custo-Benefício/normas , Humanos , Garantia da Qualidade dos Cuidados de Saúde/normas , Procedimentos de Cirurgia Plástica/normas
14.
PLoS One ; 17(2): e0263736, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35134089

RESUMO

Sudden emergence and rapid spread of COVID-19 created an inevitable need for expansion of the COVID-19 laboratory testing network across the world. The strategy to test-track-treat was advocated for quick detection and containment of the disease. Being the second most populous country in the world, India was challenged to make COVID-19 testing available and accessible in all parts of the country. The molecular laboratory testing network was augmented expeditiously, and number of laboratories was increased from one in January 2020 to 2951 till mid-September, 2021. This rapid expansion warranted the need to have inbuilt systems of quality control/ quality assurance. In addition to the ongoing inter-laboratory quality control (ILQC), India implemented an External Quality Assurance Program (EQAP) with assistance from World Health Organization (WHO) and Royal College of Pathologists, Australasia. Out of the 953 open system rRTPCR laboratories in both public and private sector who participated in the first round of EQAP, 891(93.4%) laboratories obtained a passing score of > = 80%. The satisfactory performance of Indian COVID-19 testing laboratories has boosted the confidence of the public and policy makers in the quality of testing. ILQC and EQAP need to continue to ensure adherence of the testing laboratories to the desired quality standards.


Assuntos
Teste para COVID-19/normas , COVID-19/diagnóstico , Técnicas de Laboratório Clínico/normas , Laboratórios/normas , Programas de Rastreamento/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Reação em Cadeia da Polimerase Via Transcriptase Reversa/normas , COVID-19/epidemiologia , COVID-19/genética , COVID-19/virologia , Humanos , Índia/epidemiologia , Controle de Qualidade , SARS-CoV-2/genética , SARS-CoV-2/isolamento & purificação , Manejo de Espécimes/métodos
15.
Fertil Steril ; 117(2): 246-251, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34986984

RESUMO

A basic semen investigation has established principles that are necessary for ascertaining reliable and internationally comparable results. Although these principles have been present in the WHO manual since its inception, the baseline issue across most published studies and practice in reproductive medicine (in which the male is considered) is repetitive failure to adhere to these principles, thereby leading to relevant comparable data and accuracy. To address this failure, the sixth edition of the WHO manual includes revised basic methods, and a complementary formal standard of the International Standards Organization (ISO23162:2021) for basic semen examination has been published. Perhaps the most significant change in the sixth edition is the reintroduction of the four-category distinction of sperm motility, which causes additional work for laboratories in changing reporting parameters but is clinically important. Another essential change is the widened focus from mainly a prognostic tool for medically assisted reproduction to additionally raising awareness of semen examination as a measure of male reproductive functions and general male health.


Assuntos
Ejaculação , Infertilidade Masculina/diagnóstico , Manuais como Assunto/normas , Análise do Sêmen/normas , Espermatozoides/patologia , Organização Mundial da Saúde , Fertilidade , Humanos , Infertilidade Masculina/patologia , Infertilidade Masculina/fisiopatologia , Masculino , Valor Preditivo dos Testes , Garantia da Qualidade dos Cuidados de Saúde/normas , Controle de Qualidade , Indicadores de Qualidade em Assistência à Saúde/normas , Reprodutibilidade dos Testes
16.
J Cancer Res Clin Oncol ; 148(2): 387-400, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34705105

RESUMO

BACKGROUND: We explored the hypothesis that high-quality standards in diagnostic mammography can lead to an early diagnosis of breast cancers and identifies at risk populations outside screening programs. The histopathological features and distribution of the TNM classification were examined in relation to patient age in a large group of women with breast cancers participating in the Quality Assured Mamma Diagnostic (QuaMaDi) program of the state of Schleswig-Holstein. PATIENTS AND METHODS: Surgical pathological reports were studied for clinicopathological characteristics, receptor status, molecular subtype and tumor stage. The analysis was conducted by dividing the study population into three age groups: women under 50 years (pre-screening), 50-69 years (peri-screening) and over 70 years (post-screening). RESULTS: 7.111 biopsies and 2.887 resection specimens were included. Breast cancer was diagnosed in 4.241 (59.7%) cases, one fourth of them in women < 50 years. Elderly women (> 70 years) had more well-differentiated, estrogen receptor (ER)-positive and HER2-negative carcinomas, whereas younger women (< 50 years) tended to have more poorly differentiated, ER negative, and HER2-positive carcinomas. 47% of breast carcinoma were luminal B tumors and were most common regardless of age. 70.4% of resected specimen had pT1 stage. Nodal negative were 71.2%. CONCLUSION: In QuaMaDi breast cancer was diagnosed at an early and potentially curable stage of the disease due to high-quality standards in diagnostic mammography. In addition, regardless of age, an increased number of prognostically unfavorable molecular subtypes were detected. Thus, QuaMaDi helps to identify at risk populations. QuaMaDi significantly improves diagnostic mammography and complements mammography screening programs.


Assuntos
Neoplasias da Mama/diagnóstico , Neoplasias da Mama/epidemiologia , Carcinoma/diagnóstico , Carcinoma/epidemiologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/patologia , Carcinoma/patologia , Detecção Precoce de Câncer/métodos , Detecção Precoce de Câncer/normas , Feminino , Alemanha/epidemiologia , Humanos , Mamografia/normas , Mamografia/estatística & dados numéricos , Programas de Rastreamento/organização & administração , Programas de Rastreamento/normas , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Garantia da Qualidade dos Cuidados de Saúde/normas , Sistema de Registros
17.
J Pediatr ; 241: 141-146.e2, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34626669

RESUMO

OBJECTIVE: To develop and face-validate population-level indicators for potential appropriateness of end-of-life care, for children with cancer, neurologic conditions, and genetic/congenital conditions, to be applied to administrative health data containing medication and treatment variables. STUDY DESIGN: Modified RAND/University of California at Los Angeles appropriateness method. We identified potential indicators per illness group through systematic literature review, scoping review, and expert interviews. Three unique expert panels, a cancer (n = 19), neurology (n = 21), and genetic/congenital (n = 17) panel, participated in interviews and rated indicators in individual ratings, group discussions, and second individual ratings. Each indicator was rated on a scale from 1 to 9 for suitability. Consensus was calculated with the interpercentile range adjusted for symmetry formula. Indicators with consensus about unsuitability were removed, those with consensus about suitability were retained, and those with lack of consensus deliberated in the group discussion. Experts included pediatricians, nurses, psychologists, physiotherapists, pharmacologists, care coordinators, general practitioners, social workers from hospitals, care teams, and general practice. RESULTS: Literature review and expert interviews yielded 115 potential indicators for cancer, 111 for neurologic conditions, and 99 for genetic/congenital conditions. We combined similar indicators, resulting in respectively 36, 32, and 33 indicators per group. Expert scoring approved 21 indicators for cancer, 24 for neurologic conditions, and 23 for genetic/congenital conditions. CONCLUSIONS: Our indicators can be applied to administrative data to evaluate appropriateness of children's end-of-life care. Differences from adults' indicators stress the specificity of children's end-of-life care. Individual care and remaining aspects, such as family support, can be evaluated with complementary tools.


Assuntos
Garantia da Qualidade dos Cuidados de Saúde/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Assistência Terminal/normas , Adolescente , Criança , Pré-Escolar , Consenso , Humanos , Lactente , Recém-Nascido , Garantia da Qualidade dos Cuidados de Saúde/métodos , Reprodutibilidade dos Testes
18.
PLoS One ; 16(12): e0261018, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34882705

RESUMO

INTRODUCTION: Clinical record (CR) is the primary tool used by healthcare workers (HCWs) to record clinical information and its completeness can help achieve safer practices. CR is the most appropriate source in order to measure and evaluate the quality of care. In order to achieve a safety climate is fundamental to involve a responsive healthcare workforce thorough peer-review and feedbacks. This study aims to develop a peer-review tool for clinical records quality assurance, presenting the seven-year experience in the evolution of it; secondary aims are to describe the CR completeness and HCWs' diligence toward recording information in it. METHODS: To assess the completeness of CRs a peer-review tool was developed in a large Academic Hospital of Northern Italy. This tool included measurable items that examined different themes, moments and levels of the clinical process. Data were collected every three months between 2010 and 2016 by appointed and trained HCWs from 42 Units; the hospital Quality Unit was responsible for of processing and validating them. Variations in the proportion of CR completeness were assessed using Cochran-Armitage test for trends. RESULTS: A total of 9,408 CRs were evaluated. Overall CR completeness improved significantly from 79.6% in 2010 to 86.5% in 2016 (p<0.001). Doctors' attitude showed a trend similar to the overall completeness, while nurses improved more consistently (p<0.001). Most items exploring themes, moments and levels registered a significant improvement in the early years, then flattened in last years. Results of the validation process were always above the cut-off of 75%. CONCLUSIONS: This peer-review tool enabled the Quality Unit and hospital leadership to obtain a reliable picture of CRs completeness, while involving the HCWs in the quality evaluation. The completeness of CR showed an overall positive and significant trend during these seven years.


Assuntos
Centros Médicos Acadêmicos/normas , Documentação/normas , Registros Eletrônicos de Saúde/normas , Sistemas de Informação Hospitalar/normas , Manejo da Dor/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Melhoria de Qualidade/normas , Anestesia/normas , Humanos
19.
Radiat Oncol ; 16(1): 226, 2021 Nov 22.
Artigo em Inglês | MEDLINE | ID: mdl-34809645

RESUMO

PURPOSE: This study presents patient-specific quality assurance (QA) results from the first 395 clinical cases for the new helical TomoTherapy® platform (Radixact) coupled with dedicated Precision TPS. METHODS: The passing rate of the Gamma Index (GP%) of 395 helical QA of patient-specific tomotherapy, acquired with ArcCHECK, is presented, analysed and correlated to various parameters of the plan. Following TG-218 recommendations, the clinic specific action limit (ALcs) and tolerance limit (TLcs) were calculated for our clinic and monitored during the analysed period. RESULTS: The mean values ​​(± 1 standard deviation) of GP% (3%/2 mm) (both global and local normalization) are: 97.6% and 90.9%, respectively. The proposed ALcs and TLcs, after a period of two years' process monitoring are 89.4% and 91.1% respectively. CONCLUSIONS: The phantom measurements closely match the planned dose distributions, demonstrating that the calculation accuracy of the new Precision TPS and the delivery accuracy of the Radixact unit are adequate, with respect to international guidelines and reports. Furthermore, a first correlation with the planning parameters was made. Action and tolerance limits have been set for the new Radixact Linac.


Assuntos
Neoplasias/radioterapia , Aceleradores de Partículas/instrumentação , Imagens de Fantasmas , Garantia da Qualidade dos Cuidados de Saúde/normas , Planejamento da Radioterapia Assistida por Computador/métodos , Radioterapia de Intensidade Modulada/métodos , Raios gama , Humanos , Órgãos em Risco/efeitos da radiação , Dosagem Radioterapêutica
20.
Radiat Oncol ; 16(1): 217, 2021 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-34775998

RESUMO

BACKGROUND: Main purpose was to describe procedures and identify challenges in the implementation process of adaptive and non-adaptive MR-guided radiotherapy (MRgRT), especially new risks in workflow due to the new technique. We herein report the single center experience for the implementation of (MRgRT) and present an overview on our treatment practice. METHODS: Descriptive statistics were used to summarize clinical and technical characteristics of treatment and patient characteristics including sites treated between April 2019 and end of March 2020 after ethical approval. A risk analysis was performed to identify risks of the online adaptive workflow. RESULTS: A summary of the processes on the MR-Linac including workflows, quality assurance and possible pitfalls is presented. 111 patients with 124 courses were treated during the first year of MR-guided radiotherapy. The most commonly treated site was the abdomen (42% of all treatment courses). 73% of the courses were daily online adapted and a high number of treatment courses (75%) were treated with stereotactic body irradiation. Only 4/382 fractions could not be treated due to a failing online adaptive quality assurance. In the risk analysis for errors, the two risks with the highest risk priority number were both in the contouring category, making it the most critical step in the workflow. CONCLUSION: Although challenging, establishment of MRgRT as a routinely used technique at our department was successful for all sites and daily o-ART was feasible from the first day on. However, ongoing research and reports will have to inform us on the optimal indications for MRgRT because careful patient selection is necessary as it continues to be a time-consuming treatment technique with restricted availability. After risk analysis, the most critical workflow category was the contouring process, which resembles the need of experienced staff and safety check paths.


Assuntos
Implementação de Plano de Saúde , Neoplasias/patologia , Seleção de Pacientes , Garantia da Qualidade dos Cuidados de Saúde/normas , Radiocirurgia/métodos , Planejamento da Radioterapia Assistida por Computador/métodos , Radioterapia Guiada por Imagem/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/radioterapia , Neoplasias/cirurgia , Órgãos em Risco/efeitos da radiação , Prognóstico , Dosagem Radioterapêutica , Radioterapia de Intensidade Modulada/métodos , Reirradiação , Estudos Retrospectivos , Gestão de Riscos
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