Individual Case Review Research Articles

Impact of a clinical pharmacist-led, artificial intelligence–supported medication adherence program on medication adherence performance, chronic disease control measures, and cost savings

BackgroundChronic diseases are the leading cause of disability and death in the United States. Clinical pharmacists have been shown to optimize health outcomes and reduce health care expenditures in patients with chronic diseases through improving medication adherence. ObjectiveThe primary objective of this study was to evaluate a pharmacist-led, artificial intelligence (AI)–supported medication adherence program on medication adherence, select disease control measures, and health care expenditures. MethodsThis was a multicenter, retrospective, quasi-experimental evaluation from January 2019 to December 2019 (preimplementation) and January 2021 to December 2021 (postimplementation). This pharmacy-driven service focuses on improving medication adherence and patient outcomes through AI-supported analytics, individual patient case review, and pharmacist-led individual patient outreach. The primary end point was to determine whether implementation improved medication adherence in 3 medication-related measures: medication adherence for hypertension (MAH), medication adherence for cholesterol (MAC), and medication adherence for diabetes (MAD). Secondary outcomes were to evaluate reductions in select chronic diseases control measures and cost savings of this service after implementation of this service. ResultsThis medication adherence service was deployed across 10,477 patients: 60.6% of patients were in at least 1 medication-related measure, generating 2762 actionable medication adherence gaps. After the implementation of this pharmacist-led program, medication adherence improved in all 3 disease state measures (MAH 5.9% improvement, MAC 7.9% improvement, MAD, 6.4% improvement), and Medicare Star ratings also improved. The percentage of patients with diabetes who reached their A1c goal also increased (75.5%-81.7%). Furthermore, reductions in overall health care expenditures were seen per member per month in patients who were adherent in comparison with those who were nonadherent (hypertension 31% cost savings, hyperlipidemia 25% cost savings, diabetes 32% cost savings). ConclusionThis clinical pharmacist–driven service leveraged technology and patient connection to increase medication adherence in patients with chronic disease states and led to improvement in select disease control measures and substantial health care cost savings.

Identifying high-risk medications and error types in Danish patient safety database using disproportionality analysis.

Medication error (ME) surveillance in Danish healthcare relies on the mandatory national incident reporting system, the Danish Patient Safety Database (DPSD). Individual case reviews and descriptive statistics with frequency counts are the most often used approaches when analyzing MEs in incident reporting systems, including the DPSD. However, incident reporting systems often generate a large number of reports and may suffer from underreporting; consequently, additional approaches are needed to overcome these challenges. Disproportionality analysis (DPA) is a statistical tool used for signal detection of adverse drug reactions in pharmacovigilance reports, but the evidence for using DPA on ME analysis in safety reporting systems is limited. We aimed to test the feasibility of DPA by analysing harmful MEs reported to DPSD 2014-2018. We utilized proportional reporting ratios (PRR) to identify signals of diproportionality. We identified well-known high-risk medicines, including anticoagulants, opioids, insulins, antiepileptic, and antipsychotic drugs, and their association with several ME types and stages in a medication process. DPA might be suggested as an additional tool for screening MEs and identifying priority areas for further investigation in safety reporting systems.

CTNI-70. RADIOTHERAPY QUALITY ASSURANCE IN THE ROAM/EORTC1308 ATYPICAL MENINGIOMA RANDOMISED CONTROLLED TRIAL: PROSPECTIVE REVIEW IMPROVES RADIOTHERAPY QUALITY AND CONSISTENCY

Abstract OBJECTIVE ROAM/1308 is an international randomised controlled phase III trial comparing radiotherapy (60Gy in 30 fractions) to observation following complete surgical resection of atypical meningioma. We embedded prospective radiotherapy quality assurance (RTQA) within the trial with the aim of ensuring consistent radiotherapy planning and delivery. METHODS The radiotherapy protocol described the consensus contouring/planning guidelines. Pre-trial assessment included benchmark cases (outlining/planning) and a technology ‘Dummy Run’. Individual case reviews were undertaken. Non-conformities were classed as ‘major’ (undertreatment of dural margins/over treatment of brain or organs at risk) or ‘minor’ (for education). Resubmissions were mandated for all major non-conformities. All plans were approved before radiotherapy delivery. RESULTS The UK RTQA group coordinated European sites. The Australian RTQA group (TROG) reviewed their sites and provided all data to the UK for review. Four radiation oncologists reviewed contours and physicists/dosimetrists reviewed plans. All sites (20 UK, 25 EORTC, 11 TROG) undertook the benchmark/’Dummy Run’ cases prior to opening. Resubmissions were: UK (1 contour, 0 plans), EORTC (2 contours, 6 plans) and TROG (1 contour, 3 plans). Trial communications and outlining workshops were used to provide feedback. Radiotherapy was delivered to 30, 26 and 7 patients at 11 UK, 12 EORTC and 5 TROG sites, respectively. Overall, 25 (40%) patient cases needed resubmitting: 23 (37%) sets of outlines (2 cases twice) and 9 (14%) treatment plans (1 plan twice). CONCLUSIONS Prospective quality assurance and case review are essential to ensure consistent high-quality radiotherapy and benchmark/’Dummy Run’ alone is not sufficient. RTQA should be used for future trials in rare tumours where centres may only treat a few patients. The consistent high-quality radiotherapy in ROAM/EORTC1308 ensures the primary outcome (progression free survival: to report 2026) will be a robust assessment and any difference between treatment arms cannot be attributed to variation in radiotherapy planning or delivery.

Dose Escalation in Esophageal Cancer: Comparing Pre-Accrual and On-Trial Target Volume Delineation in the UK SCOPE2 Trial

The ongoing UK SCOPE2 trial evaluates radiotherapy (RT) dose escalation and PET-guided systemic therapy in esophageal cancer, and has an accompanying RT trials quality assurance (RTTQA) program, evolved through the preceding SCOPE trials. We compare pre-accrual with on-trial individual case review (ICR) target volume delineation (TVD). Prior to recruitment, centers were required to undertake TVD exercises using 3D/4D DICOM datasets with relevant clinical details and a RT planning guidance document (RPGD) provided. Contours were then compared against the RTTQA team-defined gold standard. Exceptions were those who had satisfied QA requirements for a previous esophageal RT trial (NeoSCOPE). For ICRs, prospective reviews (prior RT start, PRs) were undertaken for each center's first submission, plus high-dose cases submitted pending formal safety review. Additional PRs were undertaken at the RTTQA team's discretion. Timely retrospective reviews (within 2 weeks of RT start, TRR) were also undertaken for a random 10% sample. TVDs were assessed for compliance using predefined criteria and the RPGD. Resubmission was requested at reviewer's discretion, usually due to unacceptable variation (UV) from protocol. Clarification was sought before contour approval/resubmission request if appropriate. Review outcomes were then evaluated. PTV6000 was new to SCOPE2, along with a greater emphasis on use of 4DCT than in prior SCOPE trials. A total of 85 pre-accrual cases from 33 UK centers were reviewed, of which 20 (24%) were resubmissions, and 50 (59%) were accepted. 99 TVD UVs were observed in 49 cases, most commonly in CTVB (42/99, 42%), which included editing for normal structures and elective lymph node regions, followed by ITV (4D cases only, 14/52, 27%) and PTV6000 (13/99, 13%). 121 ICRs from 31 UK centers were available for review. 87 (72%) were PRs and 34 (28%) TRRs. 43 (36%) completed the relevant SCOPE2 exercise. 19 (16%) were resubmissions, and 82 (68%) were accepted. 72 UVs were observed in 45 ICRs; again, most commonly in CTVB (34/72, 48%), PTV6000 (high dose arm only, 11/46, 24%) and ITV (4D only, 5/26, 19%). Of the 45 cases where a UV was recorded, 16 (36%) had completed the relevant SCOPE2 pre-accrual. Comparing area of UV on SCOPE2 pre-accrual cases and ICRs, 3 (19%) contours contained the same (2 = CTVB, 1 = PTV6000), 5 (31%) contained different and 8 (50%) had no UVs at pre-accrual. The rate of UV was significantly lower for ICR than for pre-accrual submissions (0.60 and 1.16 respectively, p = 0.001). Significantly fewer UVs in ICR compared with pre-accrual supports a robust, educational RTTQA program through national collaboration and evolving trial series. CTVB, along with newer volumes of ITV and PTV6000, were recurring UV domains and should inform RPGD development and RTTQA for ongoing recruitment and future trials.

Cloud Computing based Influenza Virus Prevention and Control for Bio-Medical Applications

Aims: To improve the flexibility and efficiency of measurement of influenza virus prevention and control, and realize the combination of modern Internet technology and medical technology, in this article, the cases of influenza virus outbreaks in the past five years will be retrieved from various websites. Background: A total of 5087 articles including clinical case analysis literature, individual infection case reports, review literature, Chinese and English literature, outbreak cases, and duplicate literature of non-human infection cases should be excluded Method: Natural Development of Influenza Virus Infection in Individuals Result: The results show that in the influenza virus epidemic database, the longest course of influenza virus infection is 10 days, the shortest is 2 days, the average course is 5.6 (5.6 ± 1.7) days, and the proportion of cases with the course of 5 days is the largest, and the proportion of cases with the course of 8 days is the smallest. Conclusion: In the international common mathematical modelling research, it is found that the latency of influenza viruses is 1-7 days, most of them are 2-4 days, the average latency is 1.9 days, and the course of the disease is 3-6 days. In this study, through the medical information sensor system based on cloud computing, the SEIAR model of the influenza virus outbreak database is built, and the average latency of all outbreaks is calculated. The average latency of the influenza virus is 2.0 days, which is very close to the international research data, and the difference between the two is only 0.1 days. Compared with non-interventional outbreaks, influenza virus control measures push the peak period from 145 days (no intervention) to 169 days (i.e. 24 days later). The infection rate of the influenza virus decreases from 74.75% untreated to 26.41%, that is to say, 48.34

A Quality Control Study on Involved Node Radiation Therapy in the European Organisation for Research and Treatment of Cancer/Lymphoma Study Association/Fondazione Italiana Linfomi H10 Trial on Stages I and II Hodgkin Lymphoma: Lessons Learned

Involved node radiation therapy (INRT) was introduced in the European Organisation for Research and Treatment of Cancer/Lymphoma Study Association/Fondazione Italiana Linfomi H10 trial, a large multicenter trial in early-stage Hodgkin Lymphoma. The present study aimed to evaluate the quality of INRT in this trial. A retrospective, descriptive study was initiated to evaluate INRT in a representative sample encompassing approximately 10% of all irradiated patients in the H10 trial. Sampling was stratified by academic group, year of treatment, size of the treatment center, and treatment arm, and it was done proportional to the size of the strata. The sample was completed for all patients with known recurrences to enable future research on relapse patterns. Radiation therapy principle, target volume delineation and coverage, and applied technique and dose were evaluated using the EORTC Radiation Therapy Quality Assurance platform. Each case was reviewed by 2 reviewers and, in case of disagreement also by an adjudicator for a consensus evaluation. Data were retrieved for 66 of 1294 irradiated patients (5.1%). Data collection and analysis were hampered more than anticipated by changes in archiving of diagnostic imaging and treatment planning systems during the running period of the trial. A review could be performed on 61 patients. The INRT principle was applied in 86.6%. Overall, 88.5% of cases were treated according to protocol. Unacceptable variations were predominately due to geographic misses of the target volume delineations. The rate of unacceptable variations decreased during trial recruitment. The principle of INRT was applied in most of the reviewed patients. Almost 90% of the evaluated patients were treated according to the protocol. The present results should, however, be interpreted with caution because the number of patients evaluated was limited. Individual case reviews should be done in a prospective fashion in future trials. Radiation therapy Quality Assurance tailored to the clinical trial objectives is strongly recommended.

Plan quality association between dummy run and individual case review in a prospective multi-institutional clinical trial of postoperative cervical cancer patients treated with intensity-modulated radiotherapy: Japan clinical Oncology Group study (JCOG1402)

Background and purposeThe Japan Clinical Oncology Group (JCOG) 1402 conducted a multicenter clinical trial of postoperative intensity-modulated radiotherapy (IMRT) for high-risk uterine cervical cancer patients. We assess effectiveness of the quality assurance (QA) program in central review through dummy runs (DRs) performed before patient enrollment and post-treatment individual case review (ICR), and clarify the pitfalls in treatment planning. Material and methodsThe ICRs were conducted using the same QA program as the DR for 214 plans. The deviations were compared with those demonstrated in the DRs, and the pitfalls were clarified. Fifteen face-to-face meetings were held with physicians at participating institutions to provide feedback. ResultsTwo-hundred and eighty-eight deviations and nine violations were detected in the 214 plans. The patterns of the deviations observed in the ICRs were similar to that in the DR. Frequent deviations were observed in clinical target volume (CTV) delineations, 50% in the DRs and 37% in the ICRs, respectively. In the ICRs, approximately 1.4 deviations/violations were observed per plan, which was lower than DR. Nine violations included inaccurate CTV delineation and improper PTV (planning target volume) margin, which had risks in loco-regional failures by inadequate dose coverage. ConclusionsOur developed QA program commonly used in DR and ICR clarified the pitfalls in treatment plans. Although the frequent deviations in CTV delineations were observed in the ICR, the deviations decreased compared to that in the DR. More specified face-to-face meetings with participating institutions will be necessary to maintain the quality of IMRT in the clinical protocol.

Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials

Background and PurposeSIOP Europe’s QUARTET project launched in 2016; aiming to improve access to high-quality radiotherapy for children and adolescents treated within clinical trials across Europe. The aim of this report is to present the profile of institutions participating in six QUARTET-affiliated trials and a description of the initial individual case review (ICR) outcomes. MethodsThis is a two-part analysis. Firstly, using facility questionnaires, beam output audit certificates, and advanced technique credentialing records to create a profile of approved institutions, and secondly, collating trial records for ICRs submitted prior to 31/10/2022. Trials included are: SIOPEN HR-NBL1, SIOPEN-LINES, SIOPEN- VERITAS, SIOP-BTG HRMB, EpSSG-FaR-RMS, and SIOPEN HR-NBL2. ResultsBy 31/10/2022, a total of 103 institutions had commenced QUARTET site approval procedures to participate in QUARTET-affiliated trials; 66 sites across 20 countries were approved. These participating institutions were often paediatric referral sites with intensity modulated radiotherapy or proton beam therapy, designated paediatric radiation oncologists, and paediatric adapted facilities and imaging protocols available. In total, 263 patient plans were submitted for ICR, 254 ICRs from 15 countries were completed. ICRs had a rejection rate of 39.8%, taking an average of 1.4 submissions until approval was achieved. Target delineation was the most frequent reason for rejection. ConclusionThe QUARTET facility questionnaire is a valuable tool for mapping resources, personnel, and technology available to children and adolescents receiving radiotherapy. Prospective ICR is essential for paediatric oncology clinical trials and should be prioritised to reduce protocol violations.

Automated analysis of FDG-PET/CT imaging to monitor heterogeneous disease response in metastatic castration-resistant prostate cancer.

251 Background: The heterogeneity of individual sites of disease in prostate cancer is well recognized and increases over time as the therapies administered promote divergent evolution. In clinical practice, this is often depicted in radiology reports as a mixed response, wherein some lesions improve and others progress or emerge, for which individualizing management is challenging. The problem is exacerbated in patients with high volume disease by the inability to concisely and effectively assess overall disease status which may mask the presence of emerging resistance that could benefit from early intervention and/or a change in therapy. Methods: Thirty-one sets of serial baseline and on-treatment FDG-PET/CT images done for the clinical management of patients with progressing mCRPC were analyzed using TRAQinform IQ software (AIQ Solutions). Individual regions of interest (ROI) identified and tracked across imaging time-points were analyzed for a range of features. The univariate prognostic weight of each feature was assessed with Cox regression models. Imaging features from single timepoints, heterogeneity of response features, and PSA values/dynamics were input into the separate TRAQinform Profile software, which was calculated to predict either time on treatment or overall survival using 3-fold cross-validation of a random survival forest. Individual case reviews were performed on select patients including TRAQinform IQ analytics, PSA trends, radiology reports, and physician notes to evaluate the potential additive benefit of the TRAQinform IQ output. Results: In general, imaging features were more strongly correlated with overall survival than PSA dynamics. After iterative feature selection, only imaging features were selected for TRAQinform Profile scores. In the case of predicting OS, the most important features were baseline total lesion glycolysis (TLG), and the number of new/progressing lesions. Patients with high TRAQinform Profile scores had shorter median survival times than those with low scores (630 vs 1326 days, p<0.01, c-index = 0.744). Of particular value was the finding that the software could identify indicators of oligo-progression for which directed radiotherapy could be considered. Also detected were early indications of widespread disease progression represented as changes in total SUV uptake and TRAQinform Profile scores, which could indicate that the patient was no longer benefitting from treatment and a change in therapy was needed. Conclusions: In pilot analysis, the TRAQinform Profile scores generated from baseline and early on-treatment FDG-PET images had treatment-agnostic prognostic value in mCRPC. Further validation is on-going. The TRAQinform IQ software can aid in identifying the presence of resistant lesions in the setting of otherwise grossly stable disease as determined by the treating physician.

Quality Assurance of a Multicenter Prospective Phase III Randomized Controlled Trial Investigating the Role of Internal Mammary Lymph Node (IMN) in Node-Positive Breast Cancer: Individual Case Review

<h3>Purpose/Objective(s)</h3> Postmastectomy radiotherapy in Node-positive breast cancer with or without Internal mammary nodal irradiation (POTENTIAL) study is an ongoing study investigates the role of IMN irradiation in breast cancer patients. This study reported the result of the dosimetric quality assurance regarding individual case review of target coverage and doses to heart and lungs. <h3>Materials/Methods</h3> Real-time central reviews were performed for the first ten enrolled patients in each center regarding contouring and planning. The target coverage, including planning target volume of all targets and IMN (PTVall, PTVim), clinical target volume of IMN (CTVim), and doses to heart and lungs were evaluated. <h3>Results</h3> Among the 117 patients who were enrolled at 14 centers, 62 (53.0%) patients were randomly assigned to the IMN irradiation group (IMNI) and 55 (47.0%) patients to no IMN group (no IMNI group). Sixty (51.3%) patients received HFRT at dose of 43.5 Gy/15f/2.9 Gy, and 57 (48.7%) patients received CFRT at dose of 50 Gy/25f/2 Gy. A total of 108 (92.3%) patients were irradiated with intensity-modulated radiotherapy (IMRT) technique to the supra/infraclavicular nodal region (SNR) and chest wall (CW) +/- IMN. In 9 (7.6%) patients, the CW +/-IMN were irradiated by electrons, and the SNR was irradiated with IMRT technique. The D95 and D90 of PTVall reached the prescribed dose in 36.8% and 81.2% of the patients, respectively. In the IMN group who were irradiated with IMRT technique, the D95 and D90 of PTVim reached the prescribed dose in 29.8% and 78.9% of the patients, respectively. When the IMN was irradiated with electrons, the mean D95 and D90 of CTVim was 31.1 Gy and 37.1 Gy, significantly lower than that of patients treated with IMRT (P = 0.008). In the no IMNI group, the mean D95 of PTVim was 12.6 Gy and 20.2 Gy for patients treated with HFRT and CFRT, respectively, which was both significantly lower than that of the IMNI group (P < 0.001). For patients treated with HFRT, the Dmean and V5 of the heart was significantly higher in IMNI group compared to those in no IMNI group (5.2 vs 3.4 Gy, p = 0.001; 26.2% vs 14.4%, p< 0.001). The differences were significant in Dmean (12.9 vs 11.3 Gy, p = 0.001), V20 (26.0% vs 22.4%, p = 0.002), and V5 (50.2% vs 46.6%, p=0.009) of the ipsilateral lung, but not in V5 (6.2% vs 4.8%, p = 0.367) of contralateral lung, between IMN and no IMN group. For patients treated with CFRT, there were no significant differences in Dmean (5.4 vs 4.8 Gy, p = 0.366) and V5 (32.1% vs 26.7%, p = 0.169) of the heart between IMNI and no IMNI group. There were significant differences in Dmean (15.1 vs 14.0 Gy, p = 0.004), V20 (28.7% vs 26.0%, p=0.002), and V5 (56.9% vs 52.5%, p=0.001) of the ipsilateral lung, and V5 (12.7% vs 5.5%, p < 0.001) of contralateral lung between IMN and no IMN group. <h3>Conclusion</h3> Individual case review of POTENTIAL study showed that the target coverage was acceptable, and doses to the heart and lung increased in IMNI group compared to no IMNI group.

Immune-Mediated Association Between Celiac Disease and Sensorineural Hearing Loss: A Systematic Narrative Review.

The auto-immune correlation between sensorineural hearing loss and celiac disease has previously been hypothesized. This review describes available evidence and offers insights for future perspectives. We searched the PubMed database. Studies in the review included children and adults with celiac disease evaluated for hearing loss. Individual case reports and review articles were excluded. The various searches turned in 32 results, of which 10 met the inclusion criteria. Auto-immune hearing loss has been proposed as extra- intestinal symptoms of celiac disease, despite the pathogenetic mechanisms being not entirely clear. Several studies postulated that subclinical hearing loss may be present in children with celiac disease. Despite existing literature not clarifying the link between celiac disease and sensorineural hearing loss, some authors proposed hearing screening in younger patients with celiac disease, to prevent the behavioral, cognitive, and sensorimotor impairment of hearing loss. Further rigorous studies are strongly recommended to better explore the relationship between hearing loss and celiac disease.

OC-0609 Radiotherapy quality assurance of the PEACE-1 trial: Initial results of individual case reviews

OC-0609 Radiotherapy quality assurance of the PEACE-1 trial: Initial results of individual case reviews

The Impact of Radiotherapy Protocol Adherence on the Treatment Outcome in Patients With Locally Advanced NSCLC Treated With Concurrent Chemoradiation: Results From the Radiotherapy Quality Assurance of the International Randomized PET-Plan Trial

The success of intensification and personalization of the curative treatment of non-small cell lung cancer (NSCLC) is strongly associated with the precision in radiotherapy (RT) treatment, which must therefore follow high standards. Herein we evaluate the impact of RT protocol adherence in the prospective international multicenter trial on curative treatment of NSCLC.In the open-label, randomized, controlled PET-Plan trial, patients with inoperable NSCLC were randomized at a 1:1 ratio regarding the target volume delineation informed by ¹⁸F-FDG PET and CT plus elective nodal irradiation (Arm A) or target volumes informed by PET alone (Arm B) and received iso-toxically dose-escalated concurrent chemoradiation. The prospectively organized quality assurance program (RTQA) included individual case review by predefined criteria. 24 items (arm A) and 20 items (arm B) were scored as per protocol (pP), minor (miD), intermediate (inD) and major (maD) deviation by a multicenter panel of radiation oncologists and medical physicists.Between 05/2009 and 11/2016, 205 patients were randomized, (one patient was excluded after randomization), 173 were treated per-RT protocol and 31 (15%) patients had maD. Patients with maD had an inferior overall survival (OS) (HR 2.9, 95% CI 1.8-4.4, P < .0001) as well as a higher risk of loco-regional progression (HR 5.7, 95% CI 2.7-11.1, P < .0001). Especially, patients with maD concerning normal tissue delineation and/or dose constraints had a worse OS (HR 3.6, 95% CI 1.5-7.3, P = 0.006) although there was no impact on the incidence of toxicities. Adjusting for the UICC stadium and the gross tumor volume as prognostic factors, the effects remained similar.Non-adherence to the RT protocol was associated with an inferior OS and loco-regional control. These results underline the importance of RTQA.

Types of deviation and review criteria in pretreatment central quality control of tumor bed boost in medulloblastoma\u2014an analysis of the German Radiotherapy Quality Control Panel in the SIOP PNET5 MB trial

PurposeIn 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 methodsA 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.ResultsOf 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.ConclusionIn 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.

Impact of radiotherapy protocol adherence in NSCLC patients treated with concurrent chemoradiation: RTQA results of the PET-Plan trial

IntroductionThe success of intensification and personalisation of the curative treatment of non-small cell lung cancer (NSCLC) is strongly associated with the precision in radiotherapy. Here, we evaluate the impact of radiotherapy protocol adherence in a prospective multicentre trial. MethodsIn the open-label, randomised, controlled PET-Plan trial, patients with inoperable NSCLC were randomized at a 1:1 ratio regarding the target volume delineation informed by 1F-FDG PET and CT plus elective nodal irradiation (arm A) or target volumes informed by PET alone (arm B) and received iso-toxically dose-escalated concurrent chemoradiation. The prospectively organised quality assurance program (RTQA) included individual case review by predefined criteria. For evaluation, protocol adherence was scored as per protocol (pP), with minor (miD), intermediate (inD) and major (maD) deviations. In order to exclude biases through patients who discontinued treatment, patients who received ≥60 Gy were additionally analysed. ResultsBetween 05/2009–11/2016, 205 patients were randomized, 204 patients started treatment according to protocol of which 31 (15%) patients had maD. Patients with maD had an inferior overall survival (OS) (HR 2.9, 95% CI 1.8–4.4, p < 0.0001) and a higher risk of loco-regional progression (HR 5.7, 95% CI 2.7–11.1, p < 0.0001). These results were significant also in the subgroup of patients receiving ≥ 60 Gy. Patients with maD concerning normal tissue delineation and/or dose constraints had a worse OS (p = 0.006) although no higher incidence of grade ≥ 3 toxicities. ConclusionsNon-adherence to the radiotherapy protocol was associated with an inferior OS and loco-regional control. These results underline the importance of RTQA.

From the Reading Room to Operating Room: Retrospective Data and Pictorial Review After 806 SCOUT Placements

ObjectiveNon-wire localization techniques are becoming more common. SCOUT surgical guidance system has been shown to increase flexibility in scheduling patients for surgery. The objective of this article is to provide institutional experiences with pictorial review after placement of 806 SCOUT devices. Materials and methodsRadiology procedure reports of SCOUT device placements from January 11, 2018 to May 19, 2020 were reviewed to assess demographics of patient population, imaging method of placement, size of reflector delivery system used, placement approach, and time spent in the radiology suite or Turn Around Time (TAT). TAT was compared to that of wire placement using a Two-tailed Mann-Whitney U Test. Reports were assessed for those with absent signal at time of placement. In cases where signal was absent, migration was found, or complications noted, further case review was performed using the Electronic Medical Record to assess whether the devices were successfully retrieved. ResultsThere were 806 total SCOUT placements identified from radiology procedure reports in patients aged 12-92 with 64.3% (518/806) placed using ultrasound-guidance and 35.7% (288/806) by mammographic-guidance. The most common delivery device was a 7.5 cm needle. Only 0.9% (7/806) of SCOUT reflectors were >1cm from target, all of which were successfully excised. After radiology placement, signal was not heard in 1.4% (9/806) of cases and individual case review revealed that all were successfully excised. In 2019, TATs of SCOUT procedures were significantly lower than TATs from wire localizations (P = 0.00024). ConclusionsSCOUT localization for breast surgery can provide solutions to problems encountered by patients and providers. A year after implementation, SCOUT use was found to result in shorter TATs in radiology. In addition, 100% of devices that were either migrated or inaudible at the time of radiology placement were successfully excised.

A Holistic Approach to Pathology Education During the Coronavirus Disease 2019 (COVID-19) Pandemic

A Holistic Approach to Pathology Education During the Coronavirus Disease 2019 (COVID-19) Pandemic

Use of prescribing safety quality improvement reports in UK general practices: a qualitative assessment

BackgroundQuality improvement (QI) initiatives are increasingly used to improve the quality of care and reduce prescribing errors. The Royal College of General Practitioners (RCGP) and Clinical Practice Research Datalink (CPRD) QI initiative uses routinely collected electronic primary care data to provide bespoke practice-level reports on prescribing safety. The aim of this study was to explore how the QI reports were used, barriers and facilitators to use, long-term culture change and perceived impact on patient care and practices systems as a result of receiving the reports.MethodsA qualitative study using purposive sampling of practices contributing to the CPRD, semi-structured interviews and inductive thematic analysis. We interviewed general practitioners, pharmacists, practice managers and research nurses.ResultsWe conducted 18 interviews, and organised themes summarising the use of QI reports in practice: receiving the report, facilitators and barriers to acting upon the reports, acting upon the report, and how the reports contribute to a quality culture. Effective dissemination of reports, and a positive attitude to audit and the perceived relevance of the clinical topic facilitated use. Lack of time and failure to see or act upon the reports meant they were not used. Factors influencing use of the reports included the structure of the report, ease of identifying cases, and perceptions about coding accuracy. GPs and pharmacists used the reports to conduct case reviews and directly contact patients to discuss unsafe prescribing and patient medication preferences. Finally, the reports contributed to the development of a quality culture within practices through promoting audit activity and acting as a reminder of good prescribing behaviours, promoting future patient safety initiatives, contributing to continuing professional development and improving local networks.ConclusionsThis study found the reports facilitated individual case review leading to an enhanced sense of quality culture in practices where they were utilised. Our findings demonstrate that the reports were generally considered useful and have been used to support patient safety and clinical practice in specific cases.

Pretreatment central quality control for craniospinal irradiation in non-metastatic medulloblastoma

PurposeSeveral studies have demonstrated the negative impact of radiotherapy protocol deviations on tumor control in medulloblastoma. In the SIOP PNET5 MB trial, a pretreatment radiotherapy quality control (RT-QC) program was introduced. A first analysis for patients enrolled in Germany, Switzerland and Austria with focus on types of deviations in the initial plan proposals and review criteria for modern radiation technologies was performed.Methods and patientsSixty-nine craniospinal irradiation (CSI) plans were available for detailed analyses. RT-QC was performed according to protocol definitions on dose uniformity. Because of the lack of definitions for high-precision 3D conformal radiotherapy within the protocol, additional criteria for RT-QC on delineation and coverage of clinical target volume (CTV) and planning target volume (PTV) were defined and evaluated.ResultsTarget volume (CTV/PTV) deviations occurred in 49.3% of initial CSI plan proposals (33.3% minor, 15.9% major). Dose uniformity deviations were less frequent (43.5%). Modification of the RT plan was recommended in 43.5% of CSI plans. Unacceptable RT plans were predominantly related to incorrect target delineation rather than dose uniformity. Unacceptable plans were negatively correlated to the number of enrolled patients per institution with a cutoff of 5 patients (p = 0.001).ConclusionThis prospective pretreatment individual case review study revealed a high rate of deviations and emphasizes the strong need of pretreatment RT-QC in clinical trials for medulloblastoma. Furthermore, the experiences point out the necessity of new RT-QC criteria for high-precision CSI techniques.

Understanding maternal mortality in women with obesity and the role of care they receive: a national case-control study

ObjectiveObesity has significant implications for the health of pregnant women. However, few studies have quantified its association with maternal mortality or examined the relevant underlying causes and the role of care, although this remains the most severe maternal outcome. Our objectives were to quantify the risk of maternal death by prepregnancy body mass index and to determine whether obesity affected the quality of care of the women who died.DesingThis is a national population-based case–control study in France. Cases were 364 maternal deaths from the 2007–2012 National Confidential Enquiry. Controls were 14,681 parturients from the nationally representative 2010 perinatal survey. We studied the association between categories of prepregnancy BMI and maternal death by multivariable logistic regression, estimating adjusted odds ratios and 95% confidence intervals, overall and by specific causes of death. Individual case reviews assessed the quality of care provided to the women who died, by obesity status.ResultsCompared with women with normal BMI, underweight women (<18.5 kg/m2) had an adjusted OR of death of 0.75 (95% CI, 0.42–1.33), overweight women (25–29.9 kg/m2) 1.65 (95% CI, 1.24–2.19), women with class 1 obesity (30–34.9 kg/m2) 2.22 (95% CI, 1.55–3.19) and those with class 2–3 obesity (≥35 kg/m2) 3.40 (95% CI, 2.17–5.33). Analysis by cause showed significant excess risk of maternal death due to cardiovascular diseases, venous thromboembolism, hypertensive complications and stroke in women with obesity. Suboptimal care was as frequent among women with (35/62, 57%) as without obesity (136/244, 56%), but this inadequate management was directly related to obesity among 14/35 (40%) obese women with suboptimal care. Several opportunities for improvement were identified.ConclusionsThe risk of maternal death increases with BMI; it multiplied by 1.6 in overweight women and more than tripled in pregnant women with severe obesity. Training clinicians in the specificities of care for pregnant women with obesity could improve their outcomes.