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ObjectiveThe Accelerator Program for Discovery in Brain Disorders using Stem Cells (ADBS) is a longitudinal study focused on collecting and analysing clinical, neuropsychological, neurophysiological, and multimodal neuroimaging data from five cohorts of patients with major psychiatric disorders from genetically high-risk families, their unaffected first-degree relatives, and healthy subjects. Here, we present a complete description of the acquisition of multimodal MRI data along with the quality assurance (QA) and quality check (QC) procedures that we are following in this study.MethodsThe QA procedure consists of monitoring of different quantitative measurements using an agar gel and a geometrical phantom. For the already acquired data from human subjects, we describe QC steps for each imaging modality. To quantify reliability of outcome measurements, we perform test-retest reliability on human volunteers.ResultsWe have presented results from analysis of phantom data and test-retest reliability on a human volunteer. Results show consistency in data acquisition and reliable quantification of different outcome measurements.ConclusionThe acquisition protocol and QA-QC procedures described here can yield consistent and reliable outcome measures. We hope to acquire and eventually release high quality longitudinal neuroimaging dataset that will serve the scientific community and pave the way for interesting discoveries.

Clinician-reported outcome measures (ClinRO measures) play a fundamental role in quality assurance throughout healthcare systems. With commissioners turning ever more frequently to ClinRO data to evaluate and compare individual hospital performance and casemix, and funding decisions increasingly relying on these data, agreed core outcome sets (COS) are essential for the collection of standardised specialty-specific outcomes. Beyond their role in service commissioning, COS enable standardisation of outcomes in clinical studies, allowing comparisons to be drawn between similar trials as well as pooling of data for systematic reviews and metaanalyses. This review explores those ClinRO measures most commonly reported in the third molar literature, highlighting inconsistencies in ClinRO selection, measurement and reporting among researchers. We recognise here a prime opportunity for the specialty to address this lag in COS relative to other surgical specialties. With the Quality Outcomes in Maxillofacial Surgery (QOMS) overseeing the institution of many subspecialty-specific national databases in recent years, OMFS is well placed to develop a series of COS for each subspecialty domain for the benefit of researchers, clinicians and ultimately, patients.

Background Given the complexity of living donor hepatectomy, it is expected that high hospital volume will better outcomes. This study aims to evaluate post-operative outcomes for living donor hepatectomy in a medium volume liver transplant centre and compare to outcomes in high volume centres. Also, it serves as a validation tool for framework of structure-process-outcome model for safe living donor hepatectomy program. Methods 204 donors who underwent donor hepatectomy between June 1996 to September 2019 were reviewed retrospectively and compared to outcomes in high volume centres. Results At 6 months, overall donor morbidity rate was 20/204 (9.8%). Wound complications were most common at 5/204 (2.5%). Majority of complications were either Clavien grade 1 or 2 and only 3 donors had Clavien grade 3 complications. There was zero donor mortality. Discussion Our centre's donor morbidity rate of 9.8% is the one of the lowest reported in the published literature. With increased experience, stringent donor selection and enhanced perioperative care by a multi-disciplinary team, outcomes in a medium volume centre can match the outcomes reported in high volume centres. The framework for quality in terms of structure, process and outcomes is presented which can be adopted for developing programs.

This study aimed to highlight the value and key findings of on-site proton audits.The authors performed 38 on-site measurement-based peer reviews of proton centers participating in National Cancer Institute-funded clinical trials. The reviews covered beam calibration, lateral and depth measurements, mechanical checks, treatment planning and clinical practice, and quality assurance (QA) practices. Program deficiencies were noted, and recommendations were made about ways institutions could improve their practices.Institutions received an average of 3 (range, 1-8) recommendations for practice improvements. The number of deficiencies did not decrease over time, highlighting the continued need for this type of peer review. The most common deficiencies were for Task Group-recommended QA compliance (97% of centers), computed tomography number (CTN) to relative linear stopping power conversion (59%), and QA procedures (53%). In addition, 32% of institutions assessed failed at least 1 lateral beam profile measurement (90% of pixels passing 3% [global]/3 mm; 10% threshold), despite passing internal QA measurements. These failures occurred for several different plan configurations (large, small, shallow, and deep targets) and at different depths in the beam path (proximal to target, central, and distal). CTN to relative linear stopping power conversion curves showed deviations at low, mid, and high CTNs and highlighted areas of inconsistency between proton centers, with many centers falling outside of 2 sigma of the mean curve of their peers. All deficiencies from the peer review were discussed with the institutions, and many implemented dosimetric treatment planning and practice changes to improve the accuracy of their system and consistency with other institutions.This peer review program has been integral in confirming and promoting consistency and best practice across proton centers for clinical trials, minimizing deviations for outcomes data.

Research Question Which classification criteria of sperm normality were used after the publication of the WHO 5th Edition manual (WHO5), and how did the laboratories perform? Design Semen samples were sent to enrolled laboratories over a 10-year period for the determination of the proportion of sperm with normal morphology. The coefficient of variation (CV) was used to indicate the level of precision between laboratories. Results Prior to the publication of WHO5, there were at least 6 different classification criteria in use. After 2010, WHO5 was quickly adopted, with 50% of laboratories using WHO5 criteria after the first 2 years, rising to 93.7% after 10 years. Reported normal forms by WHO3 and WHO4 users remained consistent, however the morphology results for each distribution declined significantly over time for WHO5 users, suggesting laboratories were becoming more strict in their identification of normal sperm. The precision of WHO5 users improved over time as shown by a steady decline in the CVs. Conclusions Whilst the introduction of WHO5 resulted in the effective adoption of its morphology classification system with laboratories showing improved between-laboratory variation over time, the identification of normal forms by WHO5 users over time was inconsistent, as laboratories became more strict. Given the reduction in reported normal forms by WHO5 users, it appears that increased training of laboratory personnel or the consideration of validated objective automated analysers in the assessment of sperm morphology would seem warranted.

PURPOSE: The purpose of this planning study was to develop an acceptable technique for highly hypofractionated intensity-modulated radiation therapy using simultaneous integrated boost technique (SIB-hHF-RT) for nonmetastatic National Comprehensive Cancer Network high-risk prostate cancer. MATERIALS AND METHODS: We created SIB-hHF-RT plans for 14 nonmetastatic prostate cancer patients with MRI-detectable intraprostatic lesions (IPLs) and without intestines locating close to the seminal vesicle and prostate. We prescribed 57Gy for IPLs and 54Gy for the remainder of planning target volume (PTV) in 15 fractions. The IPLs were contoured based on magnetic resonance imaging, and PTV was generated by adding 6-8-mm margins to the clinical target volume. For the dose-volume constraints of organs at risk (OARs), the same constraints as 54Gy plans were used so as not to increase the toxicity. RESULTS: All created plans fulfilled the dose-volume constraints of all targets and OARs. The median estimated beam-on time was 108.5s. For patient-specific quality assurance, the global gamma passing rates (3%/2mm) with 10% dose threshold criteria were greater than 93% in all cases and greater than 95% in 11 cases. CONCLUSION: SIB-hHF-RT plans were developed that fulfill the acceptable dose-volume constraints and pass patient-specific quality assurance. We believe these plans can be applied to selected patients with nonmetastatic prostate cancer.

Objectives : We implemented a project named MENINGSTOP in three countries of North Africa (Algeria, Morocco and Tunisia). The main objective was to use real-time PCR to detect, identify and type the three main agents (Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae) responsible for invasive bacterial infections (IBI). Methods : The protocol of WHO and US CDC for real-time PCR was used to detect and type the three bacterial agents in clinical samples. We also designated two quality exercises using an external interlaboratory study and cross-testing of 10% of randomly selected samples. Results : Among the 752 samples tested, 18% were positive for one of the three agents. N. meningitidis was the most frequent globally reaching 9% of all samples (7% to 17% range) followed by S. pneumoniae 8% of all samples (6% to 15%). Group B meningococci was the most frequent (74% of all positive samples for meningococci and ranging from 50% to 90%). Quality assurance showed >85% correlation scores. Conclusions : Real-time PCR can help improving epidemiological surveillance. Data confirm the prevalence of meningococci B. Our project add a reliable tool to enhance surveillance and to help decision making in vaccination strategies against IBI.

BACKGROUND In 2018, an innovative, State government funded cannabis medicines drug information service was established for health professionals in New South Wales (NSW). The NSW Cannabis Medicines Advisory Service (CMAS) provides expert clinical guidance and support to medical practitioners considering prescribing a cannabis medicine to their patient(s). AIMS This research examines quality assurance and patient outcomes related to enquirers' experience with NSW CMAS. METHODS Data collection involved an online, anonymous survey with two components. Following a health professional enquiry, quality assurance data was collected about the enquirers' experience with NSW CMAS. The second survey focused on patient outcomes and provides real-world observational data about cannabis medicines safety and effectiveness across a wide range of indications. RESULTS Data collection occurred between January 2020 and June 2021. Preliminary analyses were based on 68 quality assurance and 50 patient outcomes survey responses. General practitioners represented the highest proportion of survey responses (n = 33, 49%). The most common enquiry involved 'patient-specific advice' (n = 50, 74%). Patient-specific information provided by the service was mainly used for prescribing decision support (n = 45, 90%). CONCLUSIONS Preliminary findings highlight the impact of an innovative cannabis medicines drug information service in supporting health professional clinical practice in an area of rapid knowledge translation. Quality assurance data indicates that the service is perceived well by the majority of enquirers. Patient outcomes data across a wide range of indications suggest some effectiveness and a reasonable safety profile for prescribed cannabis medicines for most patients. This article is protected by copyright. All rights reserved.

Purpose Quality assurance (QA) practices improve the quality level of oncology trials by ensuring that the protocol is followed and the results are valid and reproducible. This study investigated the utilization of QA among randomized controlled trials that involve radiotherapy (RT). Methods and Materials We searched ClinicalTrials.gov in February 2020 for all phase III oncology randomized clinical trials (RCTs). These trials were screened for RT-specific RCTs that had published primary trial results. Information regarding QA in each trial was collected from the study publications and trial protocol if available. Two individuals independently performed trial screening and data collection. Pearson’s Chi-square tests analyses were used to assess factors that were associated with QA inclusion in RT trials. Results Forty-two RCTs with RT as the primary intervention or as a mandatory component of the protocol were analyzed; the earliest was started in 1994 and one trial was still active though not recruiting. Twenty-nine (69%) trials mandated RT quality assurance (RTQA) practices as part of the trial protocol, with 19 (45%) trials requiring institutional credentialing. Twenty-one (50%) trials published protocol deviation outcomes. Clinical trials involving advanced radiation techniques (IMRT, VMAT, SRS, SBRT) did not include more RTQA than trials without these advanced techniques (73% vs. 65%, p=0.55). Trials that reported protocol deviation outcomes were associated with mandating RTQA in their protocols as compared to trials that did not report these outcomes (100% vs. 38%, p Conclusions There is a lack of RTQA utilization and transparency in RT clinical trials. It is imperative for RT trials to include increased QA for safe, consistent, and high-quality RT planning and delivery.

Purpose Brachytherapy is an essential technique to deliver radiation therapy and is involved in the treatment of multiple disease sites as monotherapy or as an adjunct to external beam radiation therapy. With a growing focus on the cost and value of cancer treatments as well new payment models, it is essential that standardized quality measures and metrics exist to allow for straightforward assessment of brachytherapy quality and for the development of clinically significant and relevant clinical data elements. We present the American Brachytherapy Society consensus statement on quality measures and metrics for brachytherapy as well as suggested clinical data elements. Methods and Materials Members of the American Brachytherapy Society with expertise in disease site specific brachytherapy created a consensus statement based on a literature review and clinical experience. Results Key quality measures (ex. workup, clinical indications), dosimetric metrics, and clinical data elements for brachytherapy were evaluated for each modality including breast cancer, cervical cancer, endometrial cancer, prostate cancer, keratinocyte carcinoma, soft tissue sarcoma, and uveal melanoma. Conclusions This consensus statement provides standardized quality measures and dosimetric quality metrics as well as clinical data elements for each disease site to allow for standardized assessments of brachytherapy quality. Moving forward, a similar paradigm can be considered for external beam radiation therapy as well, providing comprehensive radiation therapy quality measures, metrics, and clinical data elements that can be incorporated into new payment models.

Semen analysis is a basic test for evaluating male fertility potential, as it plays an essential role in driving the future management and treatment of infertility in couples. Manual semen analysis includes the evaluation of both macroscopic and microscopic parameters, whereas automated semen analysis is conducted through a computer-aided sperm analysis system and can include additional parameters that are not evaluated by manual analysis. Both quality control (QC) and quality assurance (QA) are important to ensure reproducible results for semen analysis, and represent fundamental checks and balances of all stages (pre-analytical, analytical, and post-analytical) of semen analysis. To ensure accuracy and precision, the laboratory technicians' performance should be evaluated biannually. This narrative review aims to describe standardized laboratory procedures for an accurate assessment of semen parameters that incorporate both QC and QA practices.

Background Haemolysis, icterus and lipaemia (HIL) are common interferants in laboratory medicine, potentially impacting patient care. This survey investigates HIL management in medical laboratories across the UK and Republic of Ireland (ROI). Methods A survey was sent to members of key professional organisations for laboratory medicine in the UK and ROI. Questions related to the detection, monitoring, quality control, and management of HIL. Results In total, responses from 124 laboratories were analysed, predominantly from England (52%) and ROI (36%). Most responses were from public hospitals with biochemistry services (90%), serving primary care (91%), inpatients (91%), and outpatients (89%). Most laboratories monitored H (98%), I (88%), and L (96%) using automated indices (93%), alone or in combination with visual inspection. Manufacturer-stated cut-offs were used by 83% and were applied to general chemistries in 79%, and immunoassays in 50%. Where HIL cut-offs are breached, 64% withheld results, while 96% reported interference to users. HIL were defined using numeric scales (70%) and ordinal scales (26%). HIL targets exist in 35% of laboratories, and 54% have attempted to reduce HIL. Internal Quality Control for HIL was lacking in 62% of laboratories, and just 18% of respondents have participated in External Quality Assurance. Laboratories agree manufacturers should: standardise HIL reporting (94%), ensure comparability between platforms (94%), and provide information on HIL cross-reactivity (99%). Respondents (99%) showed interest in evidence-based, standardised HIL cut-offs. Conclusions Most respondents monitor HIL, although the wide variation in practice may differentially affect clinical care. Laboratories seem receptive to education and advice on HIL management.

Recent successful trials of thrombectomy launched a shift to imaging-based patient selection for stroke intervention. Many centers have adopted CT perfusion imaging (CTP) as a routine part of stroke workflow, and the demand for emergent CTP interpretation is growing. Fully automated CTP postprocessing software that rapidly generates standardized color-coded CTP summary maps with minimal user input and with easy accessibility of the software output is increasingly being adopted. Such automated postprocessing greatly streamlines clinical workflow and CTP interpretation for radiologists and other frontline physicians. However, the straightforward interface overshadows the computational complexity of the underlying postprocessing workflow, which, if not carefully examined, predisposes the interpreting physician to diagnostic errors. Using case examples, this article aims to familiarize the general radiologist with interpreting automated CTP software data output in the context of contemporary stroke management, providing a discussion of CTP acquisition and postprocessing, a stepwise guide for CTP quality assurance and troubleshooting, and a framework for avoiding clinically significant pitfalls of CTP interpretation in commonly encountered clinical scenarios. Interpreting radiologists should apply the outlined approach for quality assurance and develop a comprehensive search pattern for the identified pitfalls, to ensure accurate CTP interpretation and optimize patient selection for reperfusion.

Purpose A Benchmark Case (BC) was performed as part of the quality assurance process of the randomized phase 2 GORTEC 2014-14 OMET study, testing the possibility of multisite stereotactic radiation therapy (SBRT) alone in oligometastatic head and neck squamous cell carcinoma (HNSCC) as an alternative to systemic treatment and SBRT. Material and methods Compliance of the investigating centers with the prescription, delineation, planning and evaluation recommendations available in the research protocol was assessed. In addition, classical dosimetric analysis was supplemented by quantitative geometric analysis using conformation indices. Results Twenty centers participated in the BC analysis. Among them, four major deviations (MaD) were reported in two centers. Two (10%) centers in MaD had omitted the satellite tumor nodule and secondarily validated after revision. Their respective DICE indexes were 0.37 and 0 and use of extracranial SBRT devices suboptimal There were significant residual heterogeneities between participating centers, including those with a similar SBRT equipment, with impact of plan quality using standard indicators and geometric indices. Conclusion A priori QA using a BC conditioning the participation of the clinical investigation centers showed deviations from good SBRT practice and led to the exclusion of one out of the twenty participating centers. The majority of centers have demonstrated rigorous compliance with the research protocol. The use of quality indexes adds a complementary approach to improve assessment of plan quality.

Purpose A new target autocrop function was introduced in the Varian Eclipse™ treatment planning software (version 15.5 above). The study aimed to evaluate this new target autocrop impact on nasopharyngeal carcinoma (NPC) plan quality and delivery efficiency. Methods Randomly 66 approved NPC simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) treatment plans were retrospectively studied. The manual cropping-based plans served as reference and were designed using sliding-window IMRT. Reference plans were re-optimized with identical planning parameters following the institutional clinical protocol except for the optimization objective of the manual cropping targets deleted. Additionally, each target within 5mm of another had one lower objective at 100% volume and one upper objective at 0% volume for the autocrop plans. Plan quality was assessed based on selected parameters, including TCP (tumor control probability), NTCP (normal tissue complication probability), conformality index (CI), homogeneity index (HI), and dose-volume characteristics. Additionally, the delivery efficiency, the total plan treatment time defined as a sum of monitor units (MUs) for each treated field, and delivery accuracy, γ passing rate of treatment plan quality assurance (QA) also were compared. Results Both the manual cropping plans and the autocrop plans could be approved by an experienced oncologist. Overall, the autocrop plans could provide approximately a 13% reduction in linac MU while maintaining comparable plan quality, radiobiological ranking, and accuracy to that of the manual cropping plans. Conclusions The new target autocrop tip facilitated the SIB IMRT plans for nasopharyngeal cancer patients. The autocrop could guarantee the quality and delivery accuracy of the radiotherapy plan, improved the planning efficiency, treatment efficiency, and reduced machine wear and tear. It was a promising tool for optimal plan selection for NPC SIB IMRT.

Purpose To describe a guidance on the management of post-acute COVID 19 patients in geriatric rehabilitation. Methods The guidance is based on guidelines for post-acute COVID-19 geriatric rehabilitation developed in the Netherlands, updated with recent insights from literature, related guidance from other countries and disciplines, and combined with experiences from experts in countries participating in the Geriatric Rehabilitation Special Interest Group of the European Geriatric Medicine Society. Results This guidance for post-acute COVID-19 rehabilitation is divided into a section addressing general recommendations for geriatric rehabilitation and a section addressing specific processes and procedures. The Sect. "General recommendations for geriatric rehabilitation" addresses: (1) general requirements for post-acute COVID-19 rehabilitation and (2) critical aspects for quality assurance during COVID-19 pandemic. The Sect. "Specific processes and procedures", addresses the following topics: (1) patient selection; (2) admission; (3) treatment; (4) discharge; and (5) follow-up and monitoring. Conclusion Providing tailored geriatric rehabilitation treatment to post-acute COVID-19 patients is a challenge for which the guidance is designed to provide support. There is a strong need for additional evidence on COVID-19 geriatric rehabilitation including developing an understanding of risk profiles of older patients living with frailty to develop individualised treatment regimes. The present guidance will be regularly updated based on additional evidence from practice and research. Key summary pointsAim To describe a guidance on the management of post-acute COVID 19 patients in geriatric rehabilitation. Findings This guidance addresses general requirements for post-acute COVID-19 geriatric rehabilitation and critical aspects for quality assurance during the COVID-19 pandemic. Furthermore, the guidance describes relevant care processes and procedures divided in five topics: patient selection; admission; treatment; discharge; and follow-up and monitoring. Message This guidance is designed to provide support to care professionals involved in the geriatric rehabilitation treatment of post-acute COVID-19 patients.

Transthoracic echocardiography (TTE) is a standard procedure for emergency physicians (EPs). Transesophageal echocardiography (TEE) is known to have great utility in patients who are critically ill or in cardiac arrest and has been used by some EPs with specialized ultrasound (US) training, but it is generally considered outside the reach of the majority of EPs. We surmised that all of our EPs could learn to perform focused TEE (F-TEE), so we trained and credentialed all of the physicians in our group.We trained 52 EPs to perform and interpret F-TEEs using a 4-h simulator-based course. We kept a database of all F-TEE examinations for quality assurance and continuous quality feedback. Data are reported using descriptive statistics.Emergency physicians attempted 557 total F-TEE examinations (median = 10, interquartile range = 5-15) during the 42-month period following training. Clinically relevant images were obtained in 99% of patients. EPs without fellowship or other advanced US training performed the majority of F-TEEs (417, 74.9%) and 94.3% (95% confidence interval [CI] = 91.4%-96.3%) had interpretable images recorded. When TTE and TEE were both performed (n = 410), image quality of TEE was superior in 378 (93.3%, 95% CI = 89.7%-95%). Indications for F-TEE included periarrest states (55.7%), cardiac arrest (32.1%), and shock (12.2%). There was one case of endotracheal tube dislodgement during TEE placement, but this was immediately identified and replaced without complication.After initiating a mandatory group F-TEE training and credentialing program, we report the largest series to date of EP-performed resuscitative F-TEE. The majority of F-TEE examinations (75%) were performed by EPs without advanced US training beyond residency.

Results of medical interventions must be documented and evaluated. In studies, this is done with clinical outcomes data (clinician/clinical reported outcome measure, CROM). In the past, less weight has been given to patient surveys with questionnaires (patient reported outcome measure, PROM).This retrospective study included 104 eyes from 53 patients. Of these, 35 patients had cataract surgery and 15 patients had a refractive lens exchange. The implanted lenses included 62 trifocal IOLs (Asphina trifiocal 839, Zeiss), 34 trifocal toric IOLs (Asphina trifocal toric 939, Zeiss) and 8 bifocal IOLs (Asphina 808, Zeiss) with the same IOL platform. Patients completed a modified questionnaire before surgery and one year after surgery. We made changes to the CatQuest-9SF questionnaire so as to also document side effects.The effort required by the patients to answer the questionnaire was a burden. Transcribing the data into electronic files so as they could be saved and analyzed was a lot of work for the staff. Among the patients, 88.7% were spectacle-independent in everyday life, and 77.5% for reading. 44.4% had a halo problem. 92% reported the operation as a success. 100% had a prediction error of ≤ ± 0.75 dpt.There is a high rate of patient satisfaction with the outcome of the intervention. New questionnaires are needed for new IOLs. The Catquest-9SF is from 2009. Accordingly, revisions and new validation is necessary. Beyond that, only automatic data transfer will reduce the amount of work involved in data input.Die Ergebnisse von medizinischen Interventionen müssen dokumentiert und bewertet werden. Das erfolgte zumeist in Studien mit klinischen Daten über die Resultate (clinician/clinical reported outcome measure, CROM). Bisher weniger gewichtet waren die Ergebnisberichte von Patienten (patient reported outcome measure, PROM).In dieser retrospektiven Studie wurden 104 Augen von 53 Patienten eingeschlossen. 36 Patienten erhielten eine Kataraktoperation und 15 Patienten einen refraktiven Linsenaustausch. Implantiert wurden 62 trifokale IOL (Asphina trifokal 839, Zeiss), 34 triofokal-torische (Asphina trifokal torisch 939, Zeiss) sowie 8 bifokale IOL (Asphina 808, Zeiss). Die Patienten füllten vor und 1 Jahr nach der OP einen modifizierten Fragebogen aus. Wir haben Modifikationen des oft eingesetzten CatQuest-9SF-Fragebogens vorgenommen, um bei den Patientenbeurteilungen auch evtl. Nebenwirkungen dokumentieren zu können.Belastend auch für die Patienten war der Aufwand für die Beantwortung der Fragen. Hoher Aufwand für die Praxis bedeutet, die Studiendaten zu erheben, zu speichern und auszuwerten. Es kamen 88,7% der Patienten nach der OP im Alltag und 77,5% beim Lesen ohne Brille aus. 44,4% bejahten eine Blendung bei Gegenlicht. 92% bewerteten die OP als Erfolg. 100% lagen innerhalb einer Restrefraktion von ≤ 0,75 dpt.Es besteht eine hohe Zufriedenheit mit dem OP-Ergebnis. Aufgrund geänderter Fragen an die Patienten, der CatQuest-9SF-Fragebogen stammt von 2009, sind weitere Modifikationen und eine Validierung für einen breiten Einsatz erforderlich. Außerdem müssen zukünftig digital automatisch extrahierte Daten die Bearbeitungslast reduzieren.

PURPOSE To describe the quality assurance (QA) program and early toxicities in the phase III randomized trial BONBIS (NCT00907868) on the role of a localized radiation boost in ductal carcinoma in situ (DCIS). MATERIALS AND METHODS From November 2008 to July 2014, 2004 patients were randomized in arm A (only whole breast radiotherapy, WBRT) and arm B (WBRT + boost). The QA program involved 44 participant centers that performed the dummy run (DR). Compliance and uniformity of clinical target volume (CTV) delineations, and dose prescription and delivery according to the BONBIS trial radiotherapy guidelines were analyzed. Acute toxicities (during and up to 3 months after radiotherapy completion, NCI-CTCAE v3.0 classification) were evaluated in 1929 patients. RESULTS The differences in whole breast CTV (CTV1) and planning target volume (PTV1) were ≤10%, and the differences in boost CTV (CTV2) and PTV (PTV2) were ≥20% compared with the reference DR values; 95% of the prescribed dose encompassed 98.7% and 100% of the median CTV1 and CTV2. Grade ≥2 breast erythema (38.3% vs. 22.4% of grade 2 and 5.4% vs. 2.1% of grade 3, p

The paper considers an algorithm for the diagnostic study of patients with cancer of different localization, the possibility and feasibility of involving imaging techniques in radiation therapy and brachytherapy (BT) planning. The most widely used ultrasound in BT planning does not exclude a subjective assessment of the boundaries of the tumor and organs at risk, as well as the inaccuracies caused by endostatic devices. Magnetic resonance imaging (MRI) provides a high level of achievement of the criteria necessary for BT planning, but it has financial constraints and the need for individual selection of research conditions. Computed tomography (CT) is the most effective technique for visualizing the tumor, endostatic devices, and organs at risk for BT 3D planning. The involvement of MRI and positron emission tomography with CT in BT planning is a promising area that requires equipping with a mathematical tool for double and triple contouring of the tumor and organs at risk and for defining protection priorities. The prescribed and used focal dose should be controlled by direct dosimetry methods to ensure quality assurance.

purpose This practice parameter aims to detail the processes, qualifications of personnel, patient selection, equipment, patient and personnel safety, documentation, and quality control and improvement necessary for an HDR brachytherapy program. Methods and Materials This practice parameter was revised collaboratively by the American College of Radiology (ACR), the American Brachytherapy Society (ABS), and the American Society for Radiation Oncology (ASTRO). Results Brachytherapy is a radiotherapeutic modality in which radionuclide or electronic sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application. Brachytherapy alone or combined with external beam radiotherapy plays an important role in the management and treatment of patients with cancer. High-dose-rate (HDR) brachytherapy uses radionuclides, such as iridium-192, at dose rates of ≥12 Gy/hr to a designated target point or volume, and it is an important treatment for a variety of malignant and benign conditions. Its use allows for application of high doses of radiation to defined target volumes with relative sparing of adjacent critical structures. Conclusions HDR brachytherapy requires detailed attention to personnel, equipment, patient and personnel safety, and continuing staff education. Coordination between the radiation oncologist and treatment planning staff and effective quality assurance procedures are important components of successful HDR brachytherapy programs.

OBJECTIVE: To improve safety and efficiency of radiotherapy process by customizing a Varian ARIA oncology information system following the guidelines provided in AAPM TG-100 report. METHODS: First, failure mode and effects analysis (FMEA) and quality management program were implemented for radiotherapy process. We have customized the visual care path in the ARIA system and set up a series of templates for simulation, prescription, contouring, treatment planning, and multiple checklists. Average time of activities’ completion and amount of planning errors were compared before and after the use of the customized ARIA to evaluate its impact on the efficiency and safety of radiotherapy. RESULTS: Completion time and on-time completion rate of the key activities in the care path are improved. The time of OAR/targets contouring decreases from (1.94±1.51) days to (1.64±1.07) days (p = 0.003), with the on-time completion rate increases from 77.4%to 83.3%(p = 0.048). Treatment planning time decreases from (0.81±0.65) days to (0.55±0.51) days (p

Amaç: Kan kültürü, sepsise neden olan mikroorganizmaların üretilmesini ve tanımlanmasını sağladığı, antibiyotik tedavisini zamanında başlamayı ve mortalite ve morbiditeyi azalttığı için hasta takibinde hayati öneme sahiptir. Bu çalışmada hastanemiz mikrobiyoloji laboratuvarında otomatik kan kültür sisteminde üretilen mikroorganizmaların kalite göstergeleri açısından değerlendirilmesi amaçlanmıştır.Metod: Bu çalışmada, XXX Üniversitesi Tıbbi Mikrobiyoloji Laboratuvarına gönderilen kan kültürü örneklerinden otomatize kan kültürü BACTEC-9120 (Becton Dickinson, ABD) sisteminde üreyen mikroorganizmalar retrospektif değerlendirilmiştir. Bu amaçla kan kültürü istemi yapılan örneklerin reddedilme ve kontaminasyon oranı, Gram boyama sonucu-son identifikasyon uyum oranı, tek şişe gönderilen örnek sayısı ve inkübasyon sonrası mikroorganizmaların üreme süreleri belirlenmiştir.Bulgular: Laboratuvara çeşitli kliniklerden gönderilen 5037 kan kültür örneği dahil edilmiştir. Bu örneklerden %1.7’si uygunsuz numune olarak reddedilmiştir. Gram boyama -son identifikasyon uyumu araştırılmış ve %97,8 olarak saptanmıştır. Gönderilen örneklerin tek şişe sayısı 511 olarak bulunmuştur. Çalışmaya alınan 5037 örneğin, %20.7’sinde üreme saptanmış, bunların %10.2’si kontaminant olarak kabul edilmiştir. Araştırmamızda üreme süresi incelenen etkenlerin ortalama üreme süresi 30,29 saat olarak saptanmıştır.Sonuç: Sonuç olarak, kan kültürlerinde gerçek patojenleri kontaminant ajanlardan ayırt etmek için altın standart yoktur., Objective: Blood culture are of vital importance in patient follow-up, as they enable the identification and production of sepsis causative microorganisms, initiate antibiotic treatment in a timely manner and reduce mortality and morbidity. In this study, it is aimed to evaluate the microorganisms grown in the automated blood culture in the microbiology laboratory of the hospital in terms of quality indicators.Method: In this study, microorganisms grown from automated blood culture BACTEC-9120 (Becton Dickinson, USA) system from the blood culture samples sent to XXX University Medical Microbiology Laboratory were evaluated retrospectively. For this purpose, the rejection and contamination rate of the samples for which blood culture was requested, the result of Gram staining-final identification compliance, the number of samples sent from a single bottle, and the growth times of microorganisms after incubation were determined. Result: 5037 blood culture samples were sent to the laboratory from various clinics. 1.7% of these samples were rejected as inappropriate samples. Gram stain-final identification compatibility of blood cultures was investigated and it was determined as 97.8%. The single bottle number of the samples sent was found to be 511. For the 5037 samples included in the study, growth was detected in 20.7%, of which 10.2% were considered as contaminants. In our study, the average breeding time of the factors examined for breeding time was determined to be 30.29 hours.Conclusion: As conclusion, there is no gold standard to distinguish true pathogens from contaminant agents in blood cultures.

Background and Purpose: Rapid access to acute stroke treatment improves clinical outcomes in patients with ischemic stroke. We aimed to shorten the time to admission and to acute stroke treatment for patients with acute stroke in the Hamburg metropolitan area by collaborative multilevel measures involving all hospitals with stroke units, the Emergency Medical Services (EMS), and health-care authorities. Methods: In 2007, an area-wide stroke care quality project was initiated. The project included mandatory admission of all stroke patients in Hamburg exclusively to hospitals with stroke units, harmonized acute treatment algorithms among all hospitals, repeated training of the EMS staff, a multimedia educational campaign, and a mandatory stroke care quality monitoring system based on structured data assessment and quality indicators for procedural measures. We analyzed data of all patients with acute stroke who received inhospital treatment in the city of Hamburg during the evaluation period from the quality assurance database data and evaluated trends of key quality indicators over time. Results: From 2007 to 2016, a total of 83,395 patients with acute stroke were registered. During this period, the proportion of patients admitted within ≤3 h from symptom onset increased over time from 27.8% in 2007 to 35.2% in 2016 (p < 0.001). The proportion of patients who received rapid thrombolysis (within ≤30 min after admission) increased from 7.7 to 54.1% (p < 0.001). Conclusions: Collaborative stroke care quality projects are suitable and effective to improve acute stroke care.

AIM Room service is a patient-focused foodservice model gaining interest in Australian hospitals following demonstrated patient and organisational benefits. This study aimed to compare nutritional intake, waste, patient satisfaction, meal costs and meal quality between a bought-in, thaw-retherm foodservice model and a cook-fresh, on-demand room service model at a large tertiary public hospital. METHODS A retrospective analysis of quality assurance data compared thaw-retherm to room service. Nutritional intake and plate waste were measured using a visual intake analysis tool; production waste was measured using weighted analysis methodology; patient satisfaction was measured using a validated patient satisfaction survey; meal quality was assessed using a validated meal quality audit tool, and meal costs were obtained from hospital finance reports. Independent sample t-tests or nonparametric equivalent (Mann-Whitney U-test) for continuous variables and Pearson's Chi-square for categorical data were applied for comparative purposes. RESULTS Average energy and protein intake, as well as percentage requirements met, improved between thaw-retherm and room service (4320 kJ/day vs 7265 kJ/day; 42.4 g/day vs 82.5 g/day; and 46% vs 80.7%; 49.9% vs 98.4%; all P

Background Intraoperative consultation (IOC) of axillary sentinel lymph node (SLN) biopsy continues to play a role in selected breast cancer patients. The reported sensitivity rates for intraoperative SLN evaluation in breast cancer range from 47% to 80%. We study a center where the majority of SLN IOC is performed by imprint cytology, and a protocol was established to limit microscopic examination to three slides for a reporting TAT goal of 30 min. Methods Approval to conduct this study was obtained from the REB. A retrospective review was performed on all consecutive SLN cases sent for IOC. Reported IOC assessments of all cases were compared with the final pathology. Results Of 164 patients, there were 22 (13%) false negative IOC events, including 15 missed macro‐metastasis and 7 missed micro‐metastasis. The overall sensitivity for touch imprint in detecting SLNs macro‐metastasis was 70.9%. Reporting total turnaround time was on average 3 min longer, whereas sensitivity and specificity were not significantly different in the two protocol periods. Conclusion Implementation of an IOC policy for a maximum of three slides for imprint cytology did not result in a significant impact on the sensitivity, specificity, or total turnaround time for SLN in breast cancer patients. False negative IOC events were mainly due to sampling error. Quality review was made difficult by limited documentation related to the gross handling of the specimens at IOC. System factors identified include insufficient space for the IOC report on the pathology requisition, and the lack of clearly communicated expectations for documentation., The sensitivity of touch imprint cytology during intra‐operative consultation in sentinel lymph nodes of breast cancer is not affected by the number of lymph nodes assessed. False negative intra‐operative consultation events were mainly due to sampling error. Quality review was made difficult by limited documentation related to the gross handling of the specimens at intra‐operative consultation. Factors identified include insufficient space for the IOC report on the pathology requisition, and the lack of clearly communicated expectations for documentation.

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 70 years) had more well-differentiated, estrogen receptor (ER)-positive and HER2-negative carcinomas, whereas younger women ( 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.

Introduction Paraspinal stereotactic body radiotherapy (SBRT) involves risks of severe complications. We evaluated the safety of the paraspinal SBRT program in a large academic hospital by applying failure modes and effects analysis. Methods The analysis was conducted by a multidisciplinary committee (two therapists, one dosimetrist, four physicists, and two radiation oncologists). The paraspinal SBRT workflow was segmented into four phases (simulation, treatment planning, delivery, and machine quality assurance (QA)). Each phase was further divided into a sequence of sub‐processes. Potential failure modes (PFM) were identified from each subprocess and scored in terms of the frequency of occurrence, severity and detectability, and a risk priority number (RPN). High‐risk PFMs were identified based on RPN and were studied for root causes using fault tree analysis. Results Our paraspinal SBRT process was characterized by eight simulations, 11 treatment planning, nine delivery, and two machine QA sub‐processes. There were 18, 29, 19, and eight PFMs identified from simulation, planning, treatment, and machine QA, respectively. The median RPN of the PFMs was 62.9 for simulation, 68.3 for planning, 52.9 for delivery, and 22.0 for machine QA. The three PFMs with the highest RPN were: previous radiotherapy outside the institution is not accurately evaluated (RPN: 293.3), incorrect registration between diagnostic magnetic resonance imaging and simulation computed tomography causing incorrect contours (273.0), and undetected patient movement before ExacTrac baseline (217.8). Remedies to the high RPN failures were implemented, including staff education, standardized magnetic resonance imaging acquisition parameters, and an image fusion process, and additional QA on beam steering. Conclusions A paraspinal SBRT workflow in a large clinic was evaluated using a multidisciplinary and systematic risk analysis, which led to feasible solutions to key root causes. Treatment planning was a major source of PFMs that systematically affect the safety and quality of treatments. Accurate evaluation of external treatment records remains a challenge.

3d printing is capable of providing dose individualization for pediatric medicines and translating the precision medicine approach into practical application. In pediatrics, dose individualization and preparation of small dosage forms is a requirement for successful therapy, which is frequently not possible due to the lack of suitable dosage forms. For precision medicine, individual characteristics of patients are considered for the selection of the best possible API in the most suitable dose with the most effective release profile to improve therapeutic outcome. 3d printing is inherently suitable for manufacturing of individualized medicines with varying dosages, sizes, release profiles and drug combinations in small batch sizes, which cannot be manufactured with traditional technologies. However, understanding of critical quality attributes and process parameters still needs to be significantly improved for this new technology. To ensure health and safety of patients, cleaning and process validation needs to be established. Additionally, adequate analytical methods for the in-process control of intermediates, regarding their printability as well as control of the final 3d printed tablets considering any risk of this new technology will be required. The PolyPrint consortium is actively working on developing novel polymers for fused deposition modeling (FDM) 3d printing, filament formulation and manufacturing development as well as optimization of the printing process, and the design of a GMP-capable FDM 3d printer. In this manuscript, the consortium shares its views on quality aspects and measures for 3d printing from drug-loaded filaments, including formulation development, the printing process, and the printed dosage forms. Additionally, engineering approaches for quality assurance during the printing process and for the final dosage form will be presented together with considerations for a GMP-capable printer design.

Introduction Point-of-care ultrasound (POCUS) is an integral aspect of critical care and emergency medicine curriculums throughout the country, but it has been slow to integrate into internal medicine residency programs. POCUS has many benefits for internal medicine providers, guiding diagnostic decisions and aiding in procedures. Additionally, POCUS is a convenient and portable resource specifically for internal medicine providers in the military when practicing in deployed or critical care settings. Critical care and emergency medicine clinicians are excellent resources to lead these courses. We sought to develop a new POCUS curriculum for internal medicine residents within the Naval Medical Center Portsmouth Internal Medicine Residency program with the support of emergency medicine and critical care medicine staff to lead and oversee the training. The project’s aim was to increase internal medicine resident confidence with POCUS by 20% and proficiency with POCUS as evidenced by pretest and posttest analysis by 10%. Materials and Methods The program consisted of a 2-day, 9-hour, introductory course, combining lecture with hands-on scanning taught by emergency medicine physicians who had completed emergency ultrasound fellowship-level training. This was followed by a longitudinal component of hands-on scanning throughout the academic year built into the residents’ schedules. Emergency and critical care medicine ultrasound staff reviewed all studies for quality assurance (QA). The residents were given both precourse and post-course knowledge tests and confidence surveys, which utilized a 5-point Likert scale. The knowledge assessments were analyzed with a paired t-test, and the Likert scale data were analyzed using the Wilcoxon signed-rank test. The Naval Medical Center Portsmouth Institutional Review Board deemed this project nonhuman subjects’ research. Results Twenty participants were enrolled, with 10 (50%) of those enrolled completing all course requirements. The average precourse knowledge assessment score was 76.60%, and postcourse assessment score was 80.95% (+4.35%, P = .33). The confidence survey scores were initially 73.33% and improved to 77.67% (+4.34%, P = .74). Conclusions A curriculum comprised of a 9-hour workshop followed by a longitudinal hands-on experience can provide improvement in internal medicine resident POCUS knowledge and confidence. This model emphasizes the benefit of emergency and critical care cooperation for ultrasound training and provides an emphasis on medicine-relevant scans and longitudinal training.

Background:The complexity associated with the treatment planning and delivery of stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) volumetric modulated arc therapy (VMAT) plans which employs continuous dynamic modulation of dose rate, field aperture and gantry speed necessitates diligent pre-treatment patient-specific quality assurance (QA). Numerous techniques for pre-treatment VMAT treatment plans QA are currently available with the aid of several different devices including the electronic portal imager (EPID). Although several studies have provided recommendations for gamma criteria for VMAT pre-treatment QA, there are no specifics for SRS/SRT VMAT QA. Thus, we conducted a study to evaluate intracranial SRS/SRT VMAT QA to determine clinical action levels for gamma criteria based on the institutional estimated means and standard deviations.Materials and methods:We conducted a retrospective analysis of 118 EPID patient-specific pre-treatment QA dosimetric measurements of 47 brain SRS/SRT VMAT treatment plans using the integrated Varian solution (RapidArcTM planning, EPID and Portal dosimetry system) for planning, delivery and EPID QA analysis. We evaluated the maximum gamma (γmax), average gamma (γave) and percentage gamma passing rate (%GP) for different distance-to-agreement/dose difference (DTA/DD) criteria and low-dose thresholds.Results:The gamma index analysis shows that for patient-specific SRS/SRT VMAT QA with the portal dosimetry, the mean %GP is ≥98% for 2–3 mm/1–3% and Field+0%, +5% and +10% low-dose thresholds. When applying stricter spatial criteria of 1 mm, the mean %GP is >90% for DD of 2–3% and ≥88% for DD of 1%. The mean γmax ranges: 1·32 ± 1·33–2·63 ± 2·35 for 3 mm/1–3%, 1·57 ± 1·36–2·87 ± 2·29 for 2 mm/1–3% and 2·36 ± 1·83–3·58 ± 2·23 for 1 mm/1–3%. Similarly the mean γave ranges: 0·16 ± 0·06–0·19 ± 0·07 for 3 mm/1–3%, 0·21 ± 0·08–0·27 ± 0·10 for 2 mm/1–3% and 0·34 ± 0·14–0·49 ± 0·17 for 1 mm/1–3%. The mean γmax and mean γave increase with increased DTA and increased DD for all low-dose thresholds.Conclusions:The establishment of gamma criteria local action levels for SRS/SRT VMAT pre-treatment QA based on institutional resources is imperative as a useful tool for standardising the evaluation of EPID-based patient-specific SRS/SRT VMAT QA. Our data suggest that for intracranial SRS/SRT VMAT QA measured with the EPID, a stricter gamma criterion of 1 mm/2% or 1 mm/3% with ≥90% %GP could be used while still maintaining an in-control QA process with no extra burden on resources and time constraints.

Dementia presents a major public health challenge to healthcare providers globally. When older people with dementia need inpatient mental healthcare, they can be cared for in one of two different types of older adult ward. These patients can either be admitted to an organic inpatient ward for people with dementia or the subtypes of dementia, or they can be admitted to a mixed inpatient ward for older people who have either functional or organic conditions. Using a quality assurance pilot study, the authors aimed to investigate whether the quality of care for patients with dementia differed between mixed and organic inpatient wards in units exclusively serving older people. The quality of care on both types of ward was compared by analysing observed interactions between patients and staff, patient well-being and patient environment and mealtimes. The quality of care was measured with a specially developed instrument and against evidence-based standards of care. The ratings of both types of ward showed high levels of quality interactions between patients and staff. There were minimal differences in the quality of patient and staff interactions, patient well-being, and patient environment and mealtimes between the two types of ward. Further work on outcomes and carer experiences needs to be undertaken to establish the optimal care environment for people with dementia.

Background:Microbiological surveillance of bronchoscopes and automatic endoscope reprocessors (AERs)/washer disinfectors as a quality control measure is controversial. Experts also are divided on the infection risks associated with bronchoscopic procedures.Objective:We evaluated the impact of routine microbiological surveillance and audits of cleaning/disinfection practices on contamination rates of reprocessed bronchoscopes.Design:Audits were conducted of reprocessing procedures and microbiological surveillance on all flexible bronchoscopes used from January 2007 to June 2020 at a teaching hospital in France. Contamination rates per year were calculated and analyzed using a Poisson regression model. The risk factors for microbiological contamination were analyzed using a multivariable logistical regression model.Results:In total, 478 microbiological tests were conducted on 91 different bronchoscopes and 57 on AERs. The rate of bronchoscope contamination significantly decreased between 2007 and 2020, varying from 30.2 to 0% (P < .0001). Multivariate analysis confirmed that retesting after a previous contaminated test was significantly associated with higher risk of bronchoscope contamination (OR, 2.58; P = .015). This finding was explained by the persistence of microorganisms in bronchoscopes despite repeated disinfections. However, the risk of persistent contamination was not associated with the age of the bronchoscope.Conclusions:Our results confirm that bronchoscopes can remain contaminated despite repeated reprocessing. Routine microbial testing of bronchoscopes for quality assurance and audit of decontamination and disinfection procedures can improve the reprocessing of bronchoscopes and minimize the rate of persistent contamination.

Based on new trial data regarding immune checkpoint inhibitors (ICIs), the detection of high-grade microsatellite instability (MSI-H) or underlying deficient mismatch repair protein (dMMR) is now becoming increasingly important for predicting treatment response. For the first time, a PD‑1 ICI (pembrolizumab) has been approved by the European Medicines Agency (EMA) for first-line treatment of advanced (stage IV) dMMR/MSI‑H colorectal cancer (CRC). Further indications, such as dMMR/MSI‑H endometrial carcinoma (EC), have already succeeded (Dostarlimab, 2nd line treatment) and others are expected to follow before the end of 2021. The question of optimal testing in routine diagnostics should therefore be re-evaluated. Based on a consideration of the strengths and weaknesses of the widely available methods (immunohistochemistry and PCR), a test algorithm is proposed that allows quality assured, reliable, and cost-effective dMMR/MSI‑H testing. For CRC and EC, testing is therefore already possible at the primary diagnosis stage, in line with international recommendations (NICE, NCCN). The clinician is therefore enabled from the outset to consider not only the predictive but also the prognostic and predispositional implications of such a test when counseling patients and formulating treatment recommendations. As a basis for quality assurance, participation in interlaboratory comparisons and continuous documentation of results (e.g., QuIP Monitor) are strongly recommended.

ObjectivesTo analyze the effectiveness and quality of stroke clinical practice guidelines (CPGs) published in recent years in order to guide future guideline developers to develop better guidelines.ParticipantsNo patient involvedMethodPubMed, China Biology Medicine (CBM), Wanfang, CNKI, and CPG-relevant websites were searched from January 2015 to December 2019 by two researchers independently. The RIGHT (Reporting Items for Practice Guidelines in Healthcare) checklist was used to assess the reporting quality in terms of domains and items. Then, a subgroup analysis of the results was performed.Primary and secondary outcome measuresRIGHT checklist reporting rateResultsA total of 66 CPGs were included. Twice as many CPGs were published internationally as were published in China. More than half were updated. Most CPGs are published in journals, developed by societies or associations, and were evidence-based grading. The average reporting rate for all included CPGs was 47.6%. Basic information got the highest (71.7% ± 19.7%) reporting rate, while review and quality assurance got the lowest (22.0% ± 24.6%). Then, a cluster analysis between countries, publishing channels, and institutions was performed. There were no statistically significant differences in the reporting quality on the CPGs between publishing countries (China vs. international), publishing channels (journals vs. websites), and institutions (associations vs. non-associations).ConclusionsCurrent stroke CPGs reports are of low quality. We recommend that guideline developers improve the quality of reporting of key information and improve the management of conflicts of interest. We recommend that guideline developers consider the RIGHT checklist as an important tool for guideline development.Trial registration10.17605/OSF.IO/PBWUX.

Introduction: The aim of this study was to propose a dosimetric audit of the CyberKnife system. Dosimetry audit is an important part of the quality assurance process in radiotherapy. Most of the proposed dosimetric audits are dedicated to classical medical accelerators. Currently, there is no commonly implemented scheme for conducting a dosimetric audit of the CyberKnife accelerator. Material and methods: To verify the dosimetric and geometric parameters of the entire radiotherapy process, as is required in E2E test procedure, the CIRS SHANE anthropomorphic phantom was used. A tomography with a resolution of 1.5 mm was prepared, five PTVs (Planning Target Volume) of different volumes were drawn; approximately: 88 cm3, 44 cm3, 15 cm3, 7 cm3, 1.5 cm3. Five treatment plans were made using the 6D Skull tracking method, FIXED collimators, RayTracing algorithm. Each treatment plan was verified in a slab Phantom, with a PinPoint chamber. The dose was measured by an ionization chamber type TM31010 Semiflex, placed in the center area of the target. Results: The result of the QA verification in slab phantom was up to 5,0%. The percentage difference for the measurement in the SHANE phantom was: 4.29%, -1.42%, -0.70%, 1.37%, -1.88% respectively for the targets: 88 cm3, 44 cm3, 15 cm3, 7 cm3, 1.5 cm3. Conclusions: By analyzing various approaches to small-field dosimetry audits in the literature, it can be assumed that the proposed CyberKnife dosimetric audit using the SHANE phantom is an appropriate method of verification of the radiotherapy process. Particular attention should be paid to the target volume, adjusting it to the system capabilities.

Introduction Mammography is one of the most technically demanding radiographic processes, and mammography quality assurance initiatives are priorities in the implementation of public health screening services. In the optimisation of image quality (IQ), radiographers play a major role. Between 1998 and 2009, the steering committee for mammography of a large population‐based screening service in northern Italy undertook several audit checks of the imaging facilities. In 2009, the target age range of the screening service was extended. The mammogram volume was projected to increase steeply but with no substantial increase in the radiographer workforce. Methods In view of the potential impact on mammographic IQ, the passive audit approach was abandoned in favour of an active radiographer‐oriented IQ review programme. Its technical basis consists of regularly repeated rounds of review of random samples of digital mammograms performed by each first‐level radiographer and by more experienced local reference radiographers, with IQ classification, followed by a training effort and a monitoring work. Results The mammogram volume grew from 140,822 in 2008 to 319,394 in 2014 (+127%) and then stabilised. In 2012, the proportion of mammograms with a poor IQ rose from 0.6% to 19.3%, paralleled by a substantial decrease of mammograms interpreted to have a moderate and perfect IQ. Conversely, a generalised improvement occurred in both rounds of 2016 and in the first round of 2018. Conclusion In the new challenging scenario, the programme proved to be effective. A successful IQ review initiative is one that encourages radiographers to participate with a positive and confident attitude., A regional multicentre image quality review programme for mammography was developed consisting of a process of review of a sample of mammograms with image quality classification, independently performed by all first‐level radiographers and by more experienced local reference radiographers, followed by a training effort and a monitoring work. The programme places emphasis on motivating and training the radiographers and not on testing them. Its results demonstrate that a successful image quality review initiative for radiographers is one that encourages them to participate with a positive and confident attitude.

Appendicitis is the most common pediatric emergent surgical condition, with 77,000 American pediatric admissions costing $680 million US annually. Diagnosing appendicitis can be challenging. The prospective Quality Assurance and performance improvement project for suspected aPPEndicitis (QAPPE) study implemented a standardized appendicitis assessment pathway. This current study aims to assess the cost-effectiveness of the QAPPE pathway.QAPPE data (February 2018-January 2019) were compared to retrospective data from the year prior (January-December 2017). Patients aged18, presenting with suspicion of appendicitis were identified using the emergency department patient database. Patients were excluded if they were transferred from an outside center or if appendicitis was not suspected. Study arms were compared using Student's t-test and assessed with standard costing techniques. The Incremental Cost-Effectiveness Ratio (ICER) was determined. Deterministic and probabilistic sensitivity analyses of the model were performed. Effectiveness was assessed by percent of negative appendectomies where alternate diagnosis was made intraoperatively or histologically. Significance was set at p 0.05.QAPPE (n = 247) and traditional care (n = 234) patients were compared. Traditional care had higher admission frequency and lower pediatric appendicitis score. Demographics between all included patients and those admitted were similar overall. Patient costs were $3656.32 (95% CI $2407-$5250) Canadian (CAD) for QAPPE and $3823.56 (95% CI $2604-$5451) CAD for traditional care. QAPPE was the dominant strategy in the base model and probabilistic simulation found it favored in 64.7% of model iterations with a willingness to pay of $70,000 CAD.Using the QAPPE pathway to assess patients with suspected appendicitis reduced costs and improved effectiveness of patient care.2.

Usability and cognitive workload (CWL) are multidimensional constructs that describe user experience, predict performance, and inform system design. The relationship between the subjective measures of these constructs has not been adequately explored, especially in healthcare delivery settings where suboptimal usability of electronic health records and CWL of healthcare professionals are among the major contributing factors to medical errors. This study quantifies the perceived usability of a dosimetry quality assurance (QA) checklist and the perceived CWL of dosimetrists in radiation oncology clinical settings of an academic medical center and investigates the association between perceived usability and perceived CWL. Findings suggest that our institutional dosimetry QA checklist has suboptimal usability, but the associated CWL is acceptable. Further, the correlation analysis reveals that perceived usability and perceived CWL are non-overlapping constructs and may be jointly employed to reduce the risk of healthcare professionals committing medical errors.

Background and aims Over the last decade, regulators have taken significant steps towards tackling perceptions that regulatory systems are burdensome. There has been much international research activity in the regulation of health and care professionals. This article reports a review of studies on health professions regulation between January 2011 and March 2020. Its chief object was to provide robust and up-to-date evidence to assist regulators in policy development and implementation. The main objectives of this study were to: Identify and retrieve research in the field of health and care professions regulation in English since 2011; Evaluate the published research, exploring its utility to regulators and practitioners, and drawing out any key messages; Draw conclusions concerning the scope and limitations of the research literature and identify areas for further research. Methods We undertook a rapid evidence assessment (REA) of the international literature on health and care professions regulation, including reviewing ten UK regulators’ websites to identify issues of concern and strategic priorities. We retrieved 3833 references, using a four-stage screening process to select the 81 most relevant. Results Results are reported within six key themes: harm prevention and patient safety; fitness to practise; quality assurance of education and training; registration including maintenance of registers; guidelines and standards and relations with regulatory bodies. Conclusions Regulation of professionals in health and care is comparatively undeveloped as a field of academic study. Consequently, the published evidence is diffuse and small-scale. Most work presents relatively weak data of low relevance to regulators, mainly reporting or describing the current position. Few studies are able to show the impact of regulation or demonstrate a causal link between regulation and its effects. To inform their research and policy agendas health and social care regulators need to commission, interpret and apply the scholarly literature more effectively; academics need to engage with regulators to ensure that their research provides high-quality evidence with practical relevance to the regulators’ agendas. Further study is needed to explore how effective academic collaborations between regulators and researchers may be created and sustained.

Purpose The goal of the study is to determine the inter-rater agreement on multiple factors that were utilized to evaluate the quality of pediatric chest X-ray exams from different levels of healthcare provision in an African setting. Methods The image quality of pediatric chest X-rays from 3 South African medical centers of varying level of healthcare service were retrospectively assessed by 3 raters for 12 quality factors including: (1) absent body parts; (2) under inspiration; (3) patient rotation; (4) scapula in the way; (5) patient kyphosis/lordosis; (6) artefact/foreign body; (7) central vessel visualization; (8) peripheral vessels visualization; (9) poor collimation; and (10) trachea and bronchi visualization; (11) post-cardiac vessel visualization; and (12) absent or wrong image orientation. Analysis was performed using the Brennan-–Prediger coefficient of agreement for inter-rater reliability and Cochran's Q statistic and McNemar's test for inter-rater bias. Results 1077 X-rays were reviewed. The least difference between observers in the frequency of the errors was noticed for factors (1) absent body parts and (12) absent or wrong image orientation with almost perfect agreement between raters. κ score for these two factors among all raters and between each pair of raters was more than 0.95 with no significant inter-rater bias. Conversely, there was poor agreement for the remaining factors with the least agreed on being factor (3) patient rotation with a κ score of 0.23. This was followed by factors (2) under inspiration (κ score of 0.32) and factors (4) scapula in the way (κ score of 0.35) respectively. There was significant inter-rater bias for all these three factors. Conclusion Many of the factors used to assess the quality of a chest X-ray in children demonstrate poor reliability despite mitigation against variations in training, standard quality definitions and level of healthcare service provision. New definitions, objective measures and recording tools for assessing pediatric chest radiographic quality are required.

Background and purpose The efficacy of clinical trials and the outcome of patient treatment are dependent on the quality assurance (QA) of radiation therapy (RT) plans. There are two widely utilized approaches that include plan optimization guidance created based on patient‐specific anatomy. This study examined these two techniques for dose‐volume histogram predictions, RT plan optimizations, and prospective QA processes, namely the knowledge‐based planning (KBP) technique and another first principle (FP) technique. Methods This analysis included 60, 44, and 10 RT plans from three Radiation Therapy Oncology Group (RTOG) multi‐institutional trials: RTOG 0631 (Spine SRS), RTOG 1308 (NSCLC), and RTOG 0522 (H&N), respectively. Both approaches were compared in terms of dose prediction and plan optimization. The dose predictions were also compared to the original plan submitted to the trials for the QA procedure. Results For the RTOG 0631 (Spine SRS) and RTOG 0522 (H&N) plans, the dose predictions from both techniques have correlation coefficients of >0.9. The RT plans that were re‐optimized based on the predictions from both techniques showed similar quality, with no statistically significant differences in target coverage or organ‐at‐risk sparing. The predictions of mean lung and heart doses from both methods for RTOG1308 patients, on the other hand, have a discrepancy of up to 14 Gy. Conclusions Both methods are valuable tools for optimization guidance of RT plans for Spine SRS and Head and Neck cases, as well as for QA purposes. On the other hand, the findings suggest that KBP may be more feasible in the case of inoperable lung cancer patients who are treated with IMRT plans that have spatially unevenly distributed beam angles.

We wished to document the prevalence and quantitative effects of compromised 82Rb PET data acquisitions on myocardial flow reserve (MFR). Data were analyzed retrospectively for 246 rest and regadenoson-stress studies of 123 patients evaluated for known or suspected CAD. An automated injector delivered pre-determined activities of 82Rb. Automated quality assurance algorithms identified technical problems for 7% (9/123) of patients. Stress data exhibited 2 instances of scanner saturation, 1 blood peak detection, 1 blood peak width, 1 gradual patient motion, and 2 abrupt patient motion problems. Rest data showed 1 instance of blood peak width and 2 abrupt patient motion problems. MFR was lower for patients with technical problems flagged by the quality assurance algorithms than those without technical problems (1.5 ± 0.5 versus 2.1 ± 0.7, P = 0.01), even though rest and stress ejection fraction, asynchrony and relative myocardial perfusion measures were similar for these two groups (P > 0.05), suggesting that MFR accuracy was adversely affected by technical errors. It is important to verify integrity of 82Rb data to ensure MFR computation quality.

Introduction. The paper presents an original, used in our Institute, method of lung volume irradiation in patients with pneumonia during COVID-19 infection. Material and methods. Procedures such as the simulation of treatment and radiotherapy are performed in a treatment room. Real time radiation treatment planning is realized as 2D planning (Irreg Planning VMS) in a separate room, and the 3D (eclipse VMS) dose distribution is calculated after the treatment. During radiation exposure, a fluence map is measured. Results. A method of irradiating the lungs of patients with COVID-19 was developed, which allows to shorten the time the patient is on the treatment table and minimize contacts between the patient and staff. Conclusions. The presented procedure made it possible to minimize the time of patient’s stay in the radiotherapy department and at the same time, it retains all the required quality assurance procedures in radiotherapy treatment.

Introduction: High-quality pediatric gastrointestinal procedures are performed when clinically indicated and defined by their successful performance by skilled providers in a safe, comfortable, child-oriented, and expeditious manner. The process of pediatric endoscopy begins when a plan to perform the procedure is first made and ends when all appropriate patient follow-up has occurred. Procedure-related standards and indicators developed to date for endoscopy in adults emphasize cancer screening and are thus unsuitable for pediatric medicine. Methods: With support from the North American and European Societies of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN and ESPGHAN), an international working group of the Pediatric Endoscopy Quality Improvement Network (PEnQuIN) used the methodological strategy of the Appraisal of Guidelines for REsearch and Evaluation (AGREE) II instrument to develop standards and indicators relevant for assessing the quality of endoscopic procedures. Consensus was sought via an iterative online Delphi process and finalized at an in- person conference. The quality of evidence and strength of recommendations were rated according to the GRADE (Grading of Recommendation Assessment, Development, and Evaluation) approach. Results: The PEnQuIN working group achieved consensus on 14 standards for pediatric endoscopic procedures, as well as 30 indicators that can be used to identify high-quality procedures. These were subcategorized into three subdomains: Preprocedural (3 standards, 7 indicators), Intraprocedural (8 standards, 18 indicators), and Postprocedural (3 standards, 5 indicators). A minimum target for the key indicator, “rate of adequate bowel preparation, ” was set at ≥80%. Discussion: It is recommended that all facilities and individual providers performing pediatric endoscopy worldwide initiate and engage with the procedure-related standards and indicators developed by PEnQuIN to identify gaps in quality and drive improvement.

Purpose In Germany, Austria, and Switzerland, pretreatment radiotherapy quality control (RT-QC) for tumor bed boost (TB) in non-metastatic medulloblastoma (MB) was not mandatory but was recommended for patients enrolled in the SIOP PNET5 MB trial between 2014 and 2018. This individual case review (ICR) analysis aimed to evaluate types of deviations in the initial plan proposals and develop uniform review criteria for TB boost. Patients and methods A total of 78 patients were registered in this trial, of whom a subgroup of 65 patients were available for evaluation of the TB treatment plans. Dose uniformity was evaluated according to the definitions of the protocol. Additional RT-QC criteria for standardized review of target contours were elaborated and data evaluated accordingly. Results Of 65 initial TB plan proposals, 27 (41.5%) revealed deviations of target volume delineation. Deviations according to the dose uniformity criteria were present in 14 (21.5%) TB plans. In 25 (38.5%) cases a modification of the RT plan was recommended. Rejection of the TB plans was rather related to unacceptable target volume delineation than to insufficient dose uniformity. Conclusion In this analysis of pretreatment RT-QC, protocol deviations were present in a high proportion of initial TB plan proposals. These findings emphasize the importance of pretreatment RT-QC in clinical trials for MB. Based on these data, a proposal for RT-QC criteria for tumor bed boost in non-metastatic MB was developed.

There is wide variation in the recommendations for photodocumentation at colonoscopy. The British Society of Gastroenterology (BSG) quality assurance standard suggests ‘photographic proof of ileocaecal valve, terminal ileum, anastomosis or appendix orifice [is] required in all cases’.1 Like the American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology (ACG) guidelines,2 documentation of any other part of the colon is not currently mandated. Although caecal photographs serve to confirm that the colonoscope has been passed the full length of the colon, they do not document whether the colonic mucosa has been adequately visualised. Photodocumentation is a relatively simple ‘push button’ process, and most endoscopists now have access to reporting systems that can automatically integrate multiple images in real time. A pertinent question therefore is, should we perform more comprehensive photodocumentation and will this lead to improvements in the quality and reliability of the examination? One approach to overcoming the limitations of static photodocumentation would be to video record the entire procedure, and with improvements in data storage, this is now technically possible. Video-recording has been found to increase mean inspection time by 49% and quality of mucosal inspection technique (measured by blinded assessment) by up to 30%.3 However, there are still significant data storage costs and issues arise around sharing of information with colleagues and manipulation of large data files. Given that endoscopists are familiar with photodocumentation and files are smaller and easy to embed in current software records, enhancing current practice with specific emphasis on quality and training in photodocumentation may be a more acceptable and realistic way of enhancing quality. An example of where enhanced photodocumentation has been recommended is the BSG standards for upper gastrointestinal (GI) endoscopy.4 Eight photos of anatomical landmarks are now advised. The impetus for this approach was a recognition that …