A quality assurance study of the development of quality of care in outpatient clinics for treatment of addiction in Greenland.

INTRODUCTION: In 2016, a new addiction treatment service, Allorfik, was introduced in Greenland. Allorfik has, throughout the implementation and after, used auditing of patient records with feedback to develop the quality of care in treatment. Audits and feedback are routinely done in each treatment center. This study wishes to investigate the development of the quality of treatment through the case notes from the journal audits. METHODOLOGY: This study is based on case notes audits from 2019, 2020 and 2021. In the audits, the focus has been on the quality of documentation and content for ten specific areas in each patient record. Each area was scored on a Likert scale of 0-4 for both outcomes. Statistical analyses were done using Stata 17, and P-values < 0.05 were considered statistically significant. We present baseline characteristics for patients and illustrate the development of quality for both outcomes as time trends with scatter plots. RESULTS: The analysis was based on data from 454 patients and audits of their case notes. The mean number of weeks in treatment is 12.72, and the mean age for the people in the audited case notes is 39. Time had a positive effect on both outcomes, and so each month, documentation increased by 0.21 points (p-value = <0.001), and content increased by 0.27 points (p-value = <0.001). CONCLUSION: For documentation and content, the quality level has increased significantly with time, and the quality of case notes is at an excellent level at the final audits of all treatment centers.

Repurposing DailyQA3 for an efficient and spot position sensitive daily quality assurance tool for proton therapy.

INTRODUCTION: Daily quality assurance is an integral part of a radiotherapy workflow to ensure the dose is delivered safely and accurately to the patient. It is performed before the first treatment of the day and needs to be time and cost efficient for a multiple gantries proton center. In this study, we introduced an efficient method to perform QA for output constancy, range verification, spot positioning accuracy and imaging and proton beam isocenter coincidence with DailyQA3. METHODS: A stepped acrylic block of specific dimensions is fabricated and placed on top of the DailyQA3 device. Treatment plans comprising of two different spread-out Bragg peaks and five individual spots of 1.0 MU each are designed to be delivered to the device. A mathematical framework to measure the 2D distance between the detectors and individual spot is introduced and play an important role in realizing the spot positioning and centering QA. Lastly, a 5 months trends of the QA for two gantries are presented. RESULTS: The outputs are monitored by two ion chambers in the DailyQA3 and a tolerance of ± 3 % $ \pm 3\% $ are used. The range of the SOBPs are monitored by the ratio of ion chamber signals and a tolerance of ± 1 mm $ \pm 1\ {\mathrm{mm}}$ is used. Four diodes at ± 10 cm $ \pm 10\ {\mathrm{cm}}$ from the central ion chambers are used for spot positioning QA, while the central ion chamber is used for imaging and proton beam isocenter coincidence QA. Using the framework, we determined the absolute signal threshold corresponding to the offset tolerance between the individual proton spot and the detector. A 1.5 mm $1.5\ {\mathrm{mm}}$ tolerances are used for both the positioning and centering QA. No violation of the tolerances is observed in the 5 months trends for both gantries. CONCLUSION: With the proposed approach, we can perform four QA items in the TG224 within 10 min.

An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium.

Accurate and timely reporting of adverse events (AEs) in clinical trials is crucial to ensuring data integrity and patient safety. However, AE under-reporting remains a challenge, often highlighted in Good Clinical Practice (GCP) audits and inspections. Traditional detection methods, such as on-site investigator audits via manual source data verification (SDV), have limitations. Addressing this, the open-source R package {simaerep} was developed to facilitate rapid, comprehensive, and near-real-time detection of AE under-reporting at each clinical trial site. This package leverages patient-level AE and visit data for its analyses. To validate its efficacy, three member companies from the Inter coMPany quALity Analytics (IMPALA) consortium independently assessed the package. Results showed that {simaerep} consistently and effectively identified AE under-reporting across all three companies, particularly when there were significant differences in AE rates between compliant and non-compliant sites. Furthermore, {simaerep}'s detection rates surpassed heuristic methods, and it identified 50% of all detectable sites as early as 25% into the designated study duration. The open-source package can be embedded into audits to enable fast, holistic, and repeatable quality oversight of clinical trials.

Developing the Workforce of the Digital Future: mHealth Competency and Fidelity Measurement in Community-Based Care.

Integrating mobile health (mHealth) interventions into settings that serve diverse patient populations requires that prerequisite professional competencies are delineated and that standards for clinical quality assurance can be pragmatically assessed. Heretofore, proposed mHealth competencies have been broad and have lacked a framework to support specific applications. We outline the meta-competencies identified in the literature relevant to mHealth interventions and demonstrate how these meta-competencies can be integrated with population- and intervention-related competencies to help guide a pragmatic approach to competency assessment. We present a use case based on FOCUS-an evidence-based mHealth intervention designed for individuals with serious mental illness and currently being implemented in geographically and demographically diverse community behavioral health settings. Subsequent to identifying the cross-cutting competencies relevant to the target population (outpatients experiencing psychotic symptoms), substratal intervention (Cognitive Behavioral Therapy for psychosis), and treatment modality (mHealth), we detail the development process of an mHealth fidelity monitoring system (mHealth-FMS). We adhered to a published sequential 5-step process to design a fidelity monitoring system that aligns with our integrated mHealth competency framework and that was guided by best practices prescribed by the Treatment Fidelity Workgroup of the National Institutes of Health Behavior Change Consortium. The mHealth-FMS is intended to enhance both clinical and implementation outcomes by grounding the mHealth interventionist and the system of care in which they operate in the core functions, tasks, knowledge, and competencies associated with system-integrated mHealth delivery. Future research will explore acceptability and feasibility of the mHealth-FMS.

Image quality characterization of an ultra-high-speed kilovoltage cone-beam computed tomography imaging system on an O-ring linear accelerator.

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.

Fluorescence Spectroscopy Based Characterization of Flaxseed Oil.

Fluorescence spectroscopy has been employed for the compositional analysis of flaxseed oil, detection of its adulteration and investigation of the thermal effects on its molecular composition. Excitation wavelengths from 320 to 420 nm have been used to explore the valued ingredients in flaxseed oil. The emission bands of flaxseed oil centred at 390, 414, 441, 475, 515 and 673/720 nm represent vitamin K, isomers of vitamin E, carotenoids and chlorophylls, which can be used as a marker for quality analysis. Due to its high quality, it is highly prone to adulteration and in this study, detection of its adulteration with canola oil is demonstrated by applying principal component analysis. Moreover, the effects of temperature on the molecular composition of cold pressed flaxseed oil has been explored by heating them at cooking temperatures of 100, 110, 120, 130, 140, 150, 160, 170 and 180 °C, each for 30 min. On heating, the deterioration of vitamin E, carotenoids and chlorophylls occurred with an increase in the oxidation products. However, it was found that up to 140 °C, flaxseed oil retains much of its natural composition whereas up to 180 oC, it loses much of its valuable ingredients along with increase of oxidized products.

Technical note: Radiological clinical equivalence for phantom materials in carbon ion therapy.

PURPOSE: As carbon ion radiotherapy increases in use, there are limited phantom materials for heterogeneous or anthropomorphic phantom measurements. This work characterized the radiological clinical equivalence of several phantom materials in a therapeutic carbon ion beam. METHODS: Eight materials were tested for radiological material-equivalence in a carbon ion beam. The materials were computed tomography (CT)-scanned to obtain Hounsfield unit (HU) values, then irradiated in a monoenergetic carbon ion beam to determine relative linear stopping power (RLSP). The corresponding HU and RLSP for each phantom material were compared to clinical carbon ion calibration curves. For absorbed dose comparison, ion chamber measurements were made in the center of a carbon ion spread-out Bragg peak (SOBP) in water and in the phantom material, evaluating whether the material perturbed the absorbed dose measurement beyond what was predicted by the HU-RLSP relationship. RESULTS: Polyethylene, solid water (Gammex and Sun Nuclear), Blue Water (Standard Imaging), and Techtron HPV had measured RLSP values that agreed within ±4.2% of RLSP values predicted by the clinical calibration curve. Measured RLSP for acrylic was 7.2% different from predicted. The agreement for balsa wood and cork varied between samples. Ion chamber measurements in the phantom materials were within 0.1% of ion chamber measurements in water for most materials (solid water, Blue Water, polyethylene, and acrylic), and within 1.9% for the rest of the materials (balsa wood, cork, and Techtron HPV). CONCLUSIONS: Several phantom materials (Blue Water, polyethylene, solid water [Gammex and Sun Nuclear], and Techtron HPV) are suitable for heterogeneous phantom measurements for carbon ion therapy. Low density materials should be carefully characterized due to inconsistencies between samples.

Using analytical performance specifications in a medical laboratory.

Analytical performance specifications (APS) are used for the quantitative assessment of assay analytical performance, with the aim of providing information appropriate for clinical care of patients. One of the major locations where APS are used is in the routine clinical laboratory. These may be used to assess and monitor assays in a range of settings including method selection, method verification or validation, external quality assurance, internal quality control and assessment of measurement uncertainty. The aspects of assays that may be assessed include imprecision, bias, selectivity, sample type, analyte stability and interferences. This paper reviews the practical use of APS in a routine clinical laboratory, using the laboratory I supervise as an example.

Assessing the sensitivity and suitability of a range of detectors for SIMT PSQA.

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.

Clinical pharmacy key performance indicators for hospital inpatient setting: a systematic review.

BACKGROUND: Key performance indicators (KPIs) are quantifiable measures used to monitor the quality of health services. Implementation guidelines for clinical pharmacy services (CPS) do not specify KPIs. AIM: To assess the quality of the studies that have developed KPIs for CPS in inpatient hospital settings. METHOD: A systematic review was conducted by searching in Web of Science, Scopus, and PubMed, supplemented with citation analyses and grey literature searches, to retrieve studies addressing the development of KPIs in CPS for hospital inpatients. Exclusions comprised drug- or disease-specific studies and those not written in English, French, Portuguese, or Spanish. The Appraisal of Indicators through Research and Evaluation (AIRE) instrument assessed methodological quality. Domain scores and an overall score were calculated using an equal-weight principle. KPIs were classified into structure, process, and outcome categories. The protocol is available at https://doi.org/10.17605/OSF.IO/KS2G3 . RESULTS: We included thirteen studies that collectively developed 225 KPIs. Merely five studies scored over 50% on the AIRE instrument, with domains #3 (scientific evidence) and #4 (formulation and usage) displaying low scores. Among the KPIs, 8.4% were classified as structure, 85.8% as process, and 5.8% as outcome indicators. The overall methodological quality did not exhibit a clear association with a major focus on outcomes. None of the studies provided benchmarking reference values. CONCLUSION: The KPIs formulated for evaluating CPS in hospital settings primarily comprised process measures, predominantly suggested by pharmacists, with inadequate evidence support, lacked piloting or validation, and consequently, were devoid of benchmarking reference values.

Establishing an External Quality Assessment (EQA) Program for Urinalysis in Medical Laboratories of Thailand.

Thailand Association of Clinical Biochemists (TACB) introduced External Quality Assurance schemes (EQAs) for urinalysis (UA) using urine strips in medical laboratories of Thailand. The few available External Quality Assessment (EQA) programs on urinary microalbumin rarely include an evaluation of clinical cases. The aim of the present study was to assess a descriptive analysis of biochemical urinalysis including urine microalbumin in the Thailand laboratory practice. From January 2021 to December 2021, four surveys were organized. EQA urine samples were distributed to the participants by mail. The participants measured the UA of 2 samples quarterly and returned the results together with the information about their instruments and suggestion for the performance of the laboratory report quarterly. Moreover, summary of the situation of each laboratory performance was feedbacked by online system. Fifty-eight laboratories participated in the survey. The EQA panels included positive and negative samples. The analytical results for passed parameters of urine chemical test range from 79.3-100%. All special tests; microalbumin, creatinine, and beta-HCG showed correct result from 85.1-96.1%. The overall accuracy, specificity, and sensitivity were 92.6, 85.7, and 75,4%, respectively. The major issues were observed: the low sensitivity for the detection of low-concentration samples and the incapacity of several methods to detect the positive sample. The assessment is needed to continuously evaluate the improvement proficiency of laboratories in Thailand.

An artificial neural network based approach for predicting the proton beam spot dosimetric characteristics of a pencil beam scanning technique.

Utilising Machine Learning (ML) models to predict dosimetric parameters in pencil beam scanning proton therapy presents a promising and practical approach. The study developed Artificial Neural Network (ANN) models to predict proton beam spot size and relative positional errors using 9000 proton spot data. The irradiation log files as input variables and corresponding scintillation detector measurements as the label values. The ANN models were developed to predict six variables: spot size in thex-axis,y-axis, major axis, minor axis, and relative positional errors in thex-axis andy-axis. All ANN models used a Multi-layer perception (MLP) network using one input layer, three hidden layers, and one output layer. Model performance was validated using various statistical tools. The log file recorded spot size and relative positional errors, which were compared with scintillator-measured data. The Root Mean Squared Error (RMSE) values for the x-spot and y-spot sizes were 0.356 mm and 0.362 mm, respectively. Additionally, the maximum variation for the x-spot relative positional error was 0.910 mm, while for the y-spot, it was 1.610 mm. The ANN models exhibit lower prediction errors. Specifically, the RMSE values for spot size prediction in the x, y, major, and minor axes are 0.053 mm, 0.049 mm, 0.053 mm, and 0.052 mm, respectively. Additionally, the relative spot positional error prediction model for the x and y axes yielded maximum errors of 0.160 mm and 0.170 mm, respectively. The normality of models was validated using the residual histogram and Q-Q plot. The data over fit, and bias were tested using K (k = 5) fold cross-validation, and the maximum RMSE value of the K fold cross-validation among all the six ML models was less than 0.150 mm (R-Square 0.960). All the models showed excellent prediction accuracy. Accurately predicting beam spot size and positional errors enhances efficiency in routine dosimetric checks.

Test facility management: Responsibilities and paradigms of a new era.

GLP test facility management refers to the proper management and organization of a facility that conducts studies according to GLP regulations. Compliance with GLP regulations is necessary for data generated in such facilities to be accepted by regulatory authorities. According to GLP Principles, Test facility management (TFM) is responsible for a wide range of tasks and responsibilities to ensure the smooth and efficient operation of the facility. The framework in which the TFM operates within the Test Facility is certainly much more complex than in the early days of the GLP, and moreover it is unlikely that anything will change from a scientific and technological point of view in the years to come. Several aspects have changed from a scientific and technological point of view, and we know that innovation is very rapid. From the above considerations emerges the need for a major change in the performance of the TFM's role.

Individualized center-based analysis of urinary and sexual functional outcome after radical prostatectomy based on the prostate cancer outcome study: a post hoc pathway to patient outcome measurement analysis for quality improvement.

PURPOSE: We evaluate differences of patient-reported outcome measurements (PROM) based urinary continence and sexual function 12 months after radical prostatectomy (RPE) based on perioperative, surgical, and patient-specific characteristics in a large European academic urology center. MATERIALS AND METHODS: All men enrolled in the Prostate Cancer Outcome Study (PCO) study who were treated with RPE between 2017 and 2021 completed EPIC-26 information surveys before and 12 months after RPE. Survey data were linked to clinical data of our institution. Logistic regression analyses were performed to examine the correlation between individual surgeons, patient characteristics, patient clinical data, and their urinary continence and sexual function. RESULTS: In total, data of 429 men were analyzed: unstratified mean (SD) EPIC-26 domain score for urinary function decreased from 93.3 (0.7) to 60.4 (1.5) one year after RPE, respectively for sexual function from 64.95 (1.6) to 23.24 (1.1). Patients with preoperative adequate urinary function (EPIC-26 score > 80) reported significantly different mean urinary function scores between 53.35 (28.88) and 66.25 (25.15), p= 0.001, stratified by surgeons experience. On binary logistic regression analyses, only nerve sparing techniques (OR: 1,83, 95% CI: 1.01;3.21; p = 0.045) and low body mass index (OR: 0.91, CI: 0.85;0.99, p= 0.032) predicted adequate postoperative urinary function. CONCLUSIONS: The results show how using provider-specific data from a larger cohort study enables to develop institution-specific analysis for functional outcomes after RPE. These models can be used for internal quality improvement as well as enhanced and provider-specific patient communication and shared decision making.

Methods and reagent-lot comparisons by regression analysis: sample size considerations.

BACKGROUND: Parametric regression analysis is widely used in methods comparisons and more recently in checking the concordance of test results following receipt of new reagent lots. The greater frequency of reagent-lot evaluations increases pressure to detect bias with smallest possible sample sizes (i.e. smallest consumption of time and resources). This study revisits bias detection using the joint slope, intercept confidence region as an alternative to slope and intercept confidence intervals. METHODS: Four cases were considered representing constant errors, proportional errors (constant CV) and two more complicated error patterns typical of immunoassays. Maximum:minimum range ratios varied from 2:1 to 2000:1. After setting a maximum tolerable difference a series of slope, intercept combinations, each of which predicted the critical difference, were systematically evaluated in simulations which determined the minimum sample size required to detect the difference, firstly using slope, intercept confidence intervals and secondly using the joint slope, intercept confidence region. RESULTS: At small to moderate range ratios, bias detection by joint confidence region required greatly reduced sample sizes to the extent that it should encourage reagent-lot evaluations or, alternatively, transform those already routinely performed into considerably less costly exercises. CONCLUSIONS: While some software is available to calculate joint confidence regions in real-life analyses, shifting this testing method into the mainstream will require a greater number of software developers incorporating the necessary code into their regression programs. The computer program used to conduct this study is freely available and can be used to model any laboratory test.

A Systematic Review on the Impact of Quality Assurance Programs on Outcomes after Radical Prostatectomy.

BACKGROUND AND OBJECTIVE: The implementation of quality assurance programs (QAPs) within urological practice has gained prominence; yet, their impact on outcomes after radical prostatectomy (RP) remains uncertain. This paper aims to systematically review the current literature regarding the implementation of QAPs and their impact on outcomes after robot-assisted RP, laparoscopic RP, and open prostatectomy, collectively referred to as RP. METHODS: A systematic Embase, Medline (OvidSP), and Scopus search was conducted, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) process, on January 12, 2024. Studies were identified and included if these covered implementation of QAPs and their impact on outcomes after RP. QAPs were defined as any intervention seeking quality improvement through critically reviewing, analyzing, and discussing outcomes. Included studies were assessed critically using the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool, with results summarized narratively. KEY FINDINGS AND LIMITATIONS: Ten included studies revealed two methodological strategies: periodic performance feedback and surgical video assessments. Despite conceptual variability, QAPs improved outcomes consistently (ie, surgical margins, urine continence, erectile function, and hospital readmissions). Of the two strategies, video assessments better identified suboptimal surgical practice and technical errors. Although the extent of quality improvements did not appear to correlate with the frequency of QAPs, there was an apparent correlation with whether or not outcomes were evaluated collectively. CONCLUSIONS AND CLINICAL IMPLICATIONS: Current findings suggest that QAPs have a positive impact on outcomes after RP. Caution in interpretation due to limited data is advised. More extensive research is required to explore how conceptual differences impact the extent of quality improvements. PATIENT SUMMARY: In this paper, we review the available scientific literature regarding the implementation of quality assurance programs and their impact on outcomes after radical prostatectomy. The included studies offered substantial support for the implementation of quality assurance programs as an incentive to improve the quality of care continuously.

Diagnostic interobserver agreement for thyroid fine-needle aspirates: Effects of reviewer experience and molecular diagnostics.

OBJECTIVES: Few cytologically indeterminate thyroid fine-needle aspirations (FNAs) harbor BRAF V600E. Here, we assess interobserver agreement for The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC) category III (atypia of undetermined significance [AUS]) FNAs harboring BRAF V600E and contrast their features with those harboring non-BRAF V600E alterations, with attention to cytopathology experience. METHODS: Seven reviewers evaluated 5 AUS thyroid FNAs harboring BRAF V600E. To blind reviewers, cases were intermixed with 19 FNAs falling within other TBSRTC categories and in which genetic alterations other than BRAF V600E had been identified (24 FNAs total). Interobserver agreement against both "index" and most popular ("mode") diagnoses was calculated. Four additional BRAF V600E cases were independently reviewed. RESULTS: Reviewers included 3 trainees and 3 American Board of Pathology (board)-certified cytopathologists. Board-certified cytopathologists, whose experience ranged from 2 to more than 15 subspecialty practice years, had known AUS rates. BRAF V600E was identified in 5 of 260 (2%) AUS FNAs. Interobserver agreement was higher among cytopathologists with more experience. Mode diagnosis differed from index diagnosis in 6 of 11 cases harboring RAS-like alterations; mode diagnosis was AUS in 4 of 5 BRAF V600E FNAs. CONCLUSIONS: Atypia of undetermined significance of thyroid FNAs harboring BRAF V600E is uncommon yet relatively reproducible, particularly among pathologists with experience. It is advisable to sequence BRAF across V600 in such cases.

Spread-out Bragg peak measurements using a compact quality assurance range calorimeter at the Clatterbridge Cancer Centre.

OBJECTIVE: The superior dose conformity provided by proton therapy relative to conventional X-ray radiotherapy necessitates more rigorous Quality Assurance (QA) procedures to ensure optimal patient safety. Practically however, time-constraints prevent comprehensive measurements to be made of the proton range in water: a key parameter in ensuring accurate treatment delivery. APPROACH: A novel scintillator-based device for fast, accurate water-equivalent proton range QA measurements for ocular proton therapy is presented. Experiments were conducted using a compact detector prototype, the Quality Assurance Range Calorimeter (QuARC), at the Clatterbridge Cancer Centre (CCC) in Wirral, UK for the measurement of pristine and spread-out Bragg peaks (SOBPs). The QuARC uses a series of 14 optically-isolated 100 x 100 x 2.85 mm polystyrene scintillator sheets, read out by a series of photodiodes. The detector system is housed in a custom 3D-printed enclosure mounted directly to the nozzle and a numerical model was used to fit measured depth-light curves and correct for scintillator light quenching. MAIN RESULTS: Measurements of the pristine 60 MeV proton Bragg curve found the QuARC able to measure proton ranges accurate to 0.2 mm and reduced QA measurement times from several minutes down to a few seconds. A new framework of the quenching model was deployed to successfully fit depth-light curves of SOBPs with similar range accuracy. SIGNIFICANCE: The speed, range accuracy and simplicity of the QuARC make the device a promising candidate for ocular proton range QA. Further work to investigate the performance of SOBP fitting at higher energies/greater depths is warranted.

Ten steps to transform ideas into product innovations: An interdisciplinary collaboration between nursing and engineering.

AIMS: To describe the development process of a device from the conception of the idea to the first contact with the commercial environment, and to demonstrate its practical application through an interdisciplinary collaboration between nursing and engineering for the design of a protective device for peripheral venous catheters. BACKGROUND: Nurses are key agents for identifying unresolved needs or problems related to nursing care. To address these needs, creative ideation processes are often triggered among nurses to seek technological answers to these challenges. RESULTS: The ten steps to develop a device are presented: (1) detecting an unsatisfied clinical need; (2) searching for preexisting marketed products; (3) searching for patents; (4) maintaining confidentiality throughout the process; (5) obtaining institutional support; (6) forming a multidisciplinary team; (7) developing the idea; (8) applying for a patent; (9) building the prototype; (10) marketing the device. This methodology was applied to design a protective device for peripheral venous catheters in hospitalized patients. CONCLUSIONS: Nurses can play a key role in the promotion of healthcare innovation in their field to improve procedures, thanks to their direct contact with patients, and by providing their insight on devices that can enhance patient care. The successful interdisciplinary collaboration between nurses and engineers can provide a response to relevant clinical problems such as the manipulation or removal of peripheral venous catheters. IMPLICATIONS FOR NURSING AND/OR HEALTH POLICY: A hospital policy is required to encourage the participation of nurses in innovative actions. Furthermore, it is important to support nurse leaders who can play a pivotal role in incorporating creativity into work environments and empowering other nurses to innovatively address clinical issues. NO PATIENT OR PUBLIC CONTRIBUTION: This article describes the process for developing a health device.

Systematic evaluation of Merkel cell carcinoma clinical practice guidelines using the AGREE II instrument.

Merkel cell carcinoma (MCC) is a rare type of skin cancer that requires a multidisciplinary approach with a variety of specialists for management and treatment. Clinical practice guidelines (CPGs) have recently been established to standardize management algorithms. The objective of this study was to appraise such CPGs via the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Eight CPGs were identified via systematic literature search following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. Four appraisers trained in AGREE II protocols evaluated each CPG and deemed two CPGs as high quality, five as moderate quality, and one as low quality. Intraclass correlation coefficients (ICCs) were calculated to verify reviewer consistency as excellent, good, and moderate across four, one, and one domain, respectively. The majority of MCC CPGs are lacking in specifying stakeholder involvement, applicability, and rigor of development. The two high quality CPGs are from the Alberta Health Services (AHS) and the collaboration between the European Dermatology Forum, the European Association of Dermato-Oncology, and the European Organization of Research and Treatment of Cancer (EDF/EADO/EORTC). The EDF/EADO/EORTC CPG had the highest overall score with no significant deficiencies across any domain. An important limitation is that the AGREE II instrument is not designed to evaluate the validity of each CPG's recommendations; conclusions therefore can only be drawn about each CPG's developmental quality. Future MCC CPGs may benefit from garnering public perspectives, inviting external expert review, and considering available resources and implementation barriers during their developmental stages.