Increased Patient Exposure Research Articles

Safety of Secukinumab from 1Million Patient-Years of Exposure: Experience from Post-Marketing Setting and Clinical Trials.

Secukinumab is an anti-interleukin (IL)-17A monoclonal antibody indicated for multiple immunological disorders. Here, we aim to summarize secukinumab safety in clinical trials (CTs) and post-marketing setting (PMS) until 25June2022. Adverse events (AEs) were summarized with crude reporting rate (RR) per 100 patient-years (PY) in PMS for all reported indications and with exposure-adjusted incident rates (EAIR) per 100 PY in pooled 47 CTs for approved indications. Secukinumab exposure totaled 1,159,260 PY in PMS and 27,765 PY in CTs. AEs were mostly (> 80%) non-serious in PMS. EAIR for serious AEs was 7.0/100 PY. Nasopharyngitis (RR 0.59/100 PY, EAIR 16.08/100 PY) and pneumonia (RR 0.14/100 PY, EAIR 0.17/100 PY) were the most common infection and serious infection, respectively. Candida infections (RR 0.20/100 PY, EAIR 2.16/100 PY) were the most common fungal infections. Inflammatory bowel disease (IBD) was observed in PMS (0.14/100 PY) and CTs (0.26/100 PY). Most (76%) patients with prior IBD did not report IBD flare during CTs. PMS monitoring identified paradoxical skin reactions including dyshidrotic eczema (RR 0.006/100 PY) and pyoderma gangrenosum (RR 0.003/100 PY). Secukinumab safety profile with increased patient exposure remained favorable. Paradoxical skin reactions were identified in post-marketing monitoring.

Regional Differences in Education: Can We Bridge that Gap with Simulation-Based Training?

AbstractInterventional radiology (IR) training is not uniform throughout the world with clear limitations to education, training, and procedural exposure based on regions within different countries and the world. Varying technical exposure can lead to limitations in technical and therapeutic opportunities for patients. Since hands-on exposure to specific procedural skills may not occur in some locations, high fidelity endovascular simulation training can provide an opportunity for technical skills to be learned with an effort to increase patient exposure to care as well as improve technical procedural skill learning.

Case Report: Diabetic ketoacidosis after co-administration of empagliflozin and probenecid

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are filtered and secreted to their primary site of action in the proximal tubule of the kidney. Many commonly used medications have potential to diminish renal elimination of SGLT2 inhibitors by inhibiting their tubular secretion. We present a case of severe diabetic ketoacidosis (DKA) in a patient with type 2 diabetes occurring several days after co-prescription of empagliflozin and probenecid. Other than the recent introduction of empagliflozin, no cause for the DKA episode was apparent. A pharmacokinetic interaction between probenecid and empagliflozin, involving organic anion transporter 3 (OAT3), reduces proximal tubular secretion of empagliflozin. Co-administration of an OAT3 inhibitor, such as probenecid, with empagliflozin may increase patient exposure and diminish glucosuric response to the SGLT2 inhibitor, thereby increasing the risk of DKA. We suggest that clinicians exercise caution when prescribing empagliflozin alongside inhibitors of OAT3 in patients with type 2 diabetes.

Evaluation of rural general practice experiences for pre-vocational medical graduates.

Despite substantial investment in rural workforce support, sustaining the necessary recruitment and retention of general practitioners (GPs) in rural areas remains a challenge. Insufficient medical graduates are choosing a general/rural practice career. Medical training at postgraduate level, particularly for those 'between' undergraduate medical education and specialty training, remains strongly reliant on hospital experience in larger hospitals, potentially diverting interest away from general/rural practice. The Rural Junior Doctor Training Innovation Fund (RJDTIF) program offered junior hospital doctors (interns) an experience of 10 weeks in a rural general practice, aiming to increase their consideration of general/rural practice careers This study aimed to evaluate the educational and potential workforce impact of the RJDTIF program. Up to 110 places were established during 2019-2020 for Queensland's interns to undertake an 8-12-week rotation (depending on individual hospital rosters) out of regional hospitals to work in a rural general practice. Participants were surveyed before and after the placement, although only 86 were invited due to the disruption caused by the COVID-19 pandemic. Descriptive quantitative statistics were applied to the survey data. Four semi-structured interviews were conducted to further explore the experiences post-placement, with audio-recordings transcribed verbatim. Semi-structured interview data were analysed using inductive, reflexive thematic analysis. In total, 60 interns completed either survey, although only 25 were matched as completing both surveys. About half (48%) indicated they had preferenced the rural GP term and 48% indicated strong enthusiasm for the experience. General practice was indicated as the most likely career option for 50%, other general specialty 28% and subspecialty 22%. Likelihood to be working in a regional/rural location in 10 years was indicated as 'likely' or 'very likely' for 40%, 'unlikely' for 24% and 'unsure' for 36%. The two most common reasons for preferencing a rural GP term were experiencing training in a primary care setting (50%) and gaining more clinical skills through increased patient exposure (22%). The overall impact on pursuing a primary care career was self-assessed as much more likely by 41%, but much less by 15%. Interest in a rural location was less influenced. Those rating the term poor or average had low pre-placement enthusiasm for the term. The qualitative analysis of interview data produced two themes: importance of the rural GP term for interns (hands-on learning, skills improvement, influence on future career choice and engagement with the local community), and potential improvements to rural intern GP rotations. Most participants reported a positive experience from their rural GP rotation, which was recognised as a sound learning experience at an important time with respect to choosing a specialty. Despite the challenges posed by the pandemic, this evidence supports the investment in programs that provide opportunities for junior doctors to experience rural general practice in these formative postgraduate years to stimulate interest in this much-needed career pathway. Focusing resources on those who have at least some interest and enthusiasm may improve its workforce impact.

How Real Are Computed Tomography Low Dose Simulations? An Investigational In-Vivo Large Animal Study

CT low-dose simulation methods have gained significant traction in protocol development, as they lack the risk of increased patient exposure. However, in-vivo validations of low-dose simulations are as uncommon as prospective low-dose image acquisition itself. Therefore, we investigated the extent to which simulated low-dose CT datasets resemble their real-dose counterparts. Fourteen veterinarian-sedated alive pigs underwent three CT scans on the same third generation dual-source scanner with 2 months between each scan. At each time, three additional scans ensued, with mAs reduced to 50%, 25%, and 10%. All scans were reconstructed using wFBP and ADMIRE levels 1-5. Matching low-dose datasets were generated from the 100% scans using reconstruction-based and DICOM-based simulations. Objective image quality (CT numbers stability, noise, and signal-to-noise ratio) was measured via consistent regions of interest. Three radiologists independently rated all possible dataset combinations per time point for subjective image quality (-1=inferior, 0=equal, 1=superior). The points were averaged for a semiquantitative score, and inter-rater-agreement was measured using Spearman's correlation coefficient. A structural similarity index (SSIM) analyzed the voxel-wise similarity of the volumes. Adequately corrected mixed-effects analysis compared objective and subjective image quality. Multiple linear regression with three-way interactions measured the contribution of dose, reconstruction mode, simulation method, and rater to subjective image quality. There were no significant differences between objective and subjective image quality of reconstruction-based and DICOM-based simulation on all dose levels (p≥0.137). However, both simulation methods produced significantly lower objective image quality than real-dose images below 25% mAs due to noise overestimation (p<0.001; SSIM≤89±3). Overall, inter-rater-agreement was strong (r≥0.68, mean 0.93±0.05, 95% CI 0.92-0.94; each p<0.001). In regression analysis, significant decreases in subjective image quality were observed for lower radiation doses (b ≤ -0.387, 95%CI -0.399 to -0.358; p<0.001) but not for reconstruction modes, simulation methods, raters, or three-way interactions (p≥0.103). Simulated low-dose CT datasets are subjectively and objectively indistinguishable from their real-dose counterparts down to 25% mAs, making them an invaluable tool for efficient low-dose protocol development.

Allogeneic Hematopoietic Stem Cell Transplantation in the Outpatient Setting: The Mayo Clinic Experience

Hematopoietic stem cell transplantations (HSCT) are intensive and potentially curative modalities available for a variety of hematological diseases. Although alloHSCTs are typically performed in an inpatient setting, there has been increasing interest in moving them to the outpatient setting. AlloHSCTs are associated with a median length of hospital stay of 30 days. AlloHSCTs in the inpatient setting may increase patient exposure to nosocomial infections, drug-resistant organisms, rapid deconditioning with time spent in hospital beds, and loss of muscle mass. In this study, we aim to share outcomes of 856 consecutive alloHSCTs done in our institute over the past 2 decades. This is a single-center retrospective chart review encompassing 856 patients who underwent outpatient alloHSCTs between 2000 and 2017. Reduced-intensity conditioning, stem cell infusion, and much of the immediate follow-up in the early alloHSCT period was performed on an outpatient basis with daily evaluation, laboratory assessment, and intervention as needed. Rate of non-routine hospital admission was our primary outcome of interest. We also looked at various secondary outcomes, including causes of admission, median length of stay, and in-hospital mortality rate. Data analysis was performed using STATA statistical software Version 15. Descriptive statistics were used to summarize baseline demographic data and outcomes. Logistic regression modeling was used to identify predictors of hospital admission. We observed that about one third of our cohort never required admission to the hospital throughout the first 100 days after HSCT. Among those admitted, 6.6% experienced a direct admission to the intensive care unit, and the overall in hospital mortality was low at 5%. Furthermore, the median length of stay was noted to be decreased at 6 days compared to a median reported 30 days in existing literature. Overall, we observed favorable safety profile and outcomes with outpatient management of HSCTs.

Factors contributing to uncertainty in decision making and strategies to reduce this uncertainty in undergraduate medical students.

Objectives: This study aims to identify the common factors that contribute towards uncertainty in decision making in undergraduate medical students and highlights the strategies that can be used to reduce this uncertainty. Study Design: Qualitative Study. Setting: Riphah International University, Avicenna Medical and Dental College, Lahore. Period: July 2020 to September 2020. Material &amp; Methods: Four focus groups were conducted with a total of 26 participants (2 with faculty members, 2 with final year students). Data was transcribed and analyzed using ATLAS. ti software. Thematic analysis was done. Results: Two main themes were identified: faculty related and student related reasons and strategies. The most common reason for uncertainty in decision making was a lack of knowledge while the most common strategy to reduce this uncertainty was increased patient exposure and enhancing medical knowledge. Conclusion: Uncertainty is ingrained in medical education and is commonly experienced by medical students during their interaction with patients. It is essential to identify the reasons that contribute to this uncertainty in decision making and highlight strategies that reduce it in order to foster competent and confident physicians.

Design of placebo-controlled randomized trials of anticancer agents: Ethical considerations based on a review of published trials.

Limited information exists about the design of placebo-controlled cancer trials. Through a systematic review of trials published in 2013, we describe placebo use in randomized trials testing anticancer agents and analyze strategies that increase exposure to the experimental regimen. Trials were classified as add-on (placebo in combination with standard treatment) or placebo-only. Strategies to allow more than half of the participants to receive the experimental regimen were reviewed. The risk-benefit ratio of receiving the experimental agent was considered favorable if the difference in primary outcome was significant (p ≤ 0.05), neutral if there was no significant difference in the primary outcome and the experimental agent did not add substantial toxicity, and unfavorable otherwise. Eighty trials were included (32,694 participants). Most trials were add-on (69%). The risk-benefit outcome was favorable, neutral, and unfavorable to the experimental agent in 52%, 32%, and 16% of placebo-only trials and 25%, 53%, and 22%, respectively, of add-on trials. Four strategies increased exposure to the experimental regimen: one-way crossover (23%), uneven randomization (21%), three-arms (13%), and randomized discontinuation design (4%); these strategies were used more often in placebo-only trials. A minority of participants received placebo alone and strategies to increase experimental exposure were used commonly. Fewer than half of the studies had favorable outcomes, thus defending the use of placebo controls, when there is no established treatment. Strategies that increase patient exposure to experimental agents rather than placebo may expose them to non-beneficial, sometimes toxic, experimental agents.

Results of Pivotal Phase 2 Trial of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

BackgroundSL-401 is a novel targeted therapy, comprised of recombinant IL-3 genetically fused to a truncated diphtheria toxin payload, directed to the interleukin-3 receptor α (CD123), a target highly expressed on blastic plasmacytoid dendritic cell neoplasm (BPDCN). SL-401 has been granted breakthrough therapy designation (BTD) for the treatment of patients with BPDCN. BPDCN is an aggressive hematologic malignancy with poor outcomes, including ~12 month overall survival (OS) from diagnosis, and no approved therapies or standard of care, highlighting the need for novel therapeutic approaches. Detailed results from the pivotal Phase 2 trial of SL-401 in BPDCN will be presented for the first time.MethodsThis pivotal Phase 2 trial of SL-401 is a multicenter, open label, non-randomized, single-arm trial. In Stage 1, first line (1L) and relapsed/refractory (r/r) BPDCN patients received SL-401 as a daily IV infusion at 7, 9, or 12 mcg/kg/day on days 1-5 of a 21-day cycle. Patients with BPDCN enrolled in subsequent stages received SL-401 at the dose determined in Stage 1 (12mcg/kg). Stage 2 enrolled 1L and r/r BPDCN patients, and Stage 3 enrolled only 1L BPDCN patients. Stage 3 was prospectively designed with a pre-specified analysis plan to support potential registration. Enrollment in Stages 1-3 has been completed. To ensure ongoing patient access, a Stage 4 cohort is currently open for enrollment of both 1L and r/r BPDCN patients.Results45 patients with BPDCN (Stages 1 and 2: n=32; Stage 3: n=13) were enrolled at 7 sites in the US. The following results are from Stages 1 and 2; Stage 3 data will be presented at the conference. Median age was 72 years (range, 29-85 years); 81% were male. In Stage 1, 12 mcg/kg was the highest tested dose for BPDCN; MTD was not reached. Across all patients and doses, there was an 84% (27/32) overall response rate (ORR), and 59% (19/32) rate of complete response (CR), which includes CR with incomplete hematologic recovery (CRi) (n=1) and clinical CR (CRc; CR with minimal residual skin abnormality) (n=4). ORR was 95% (18/19), with a CR rate of 79% (15/19), in 1L patients. In r/r patients, ORR was 69% (9/13) with a 31% (4/13) CR rate. Eight patients with BPDCN (28%: 8/29) were bridged to stem cell transplant (SCT) following remission with SL-401 (12 mcg/kg), including 1 r/r patient; no cases of post-SCT veno-occlusive disease (VOD) have been reported in these patients. In first-line patients (SL-401: 12 mcg/kg), median OS has not been reached; PFS: 9.5 months. In r/r patients, median OS was 8.5 months; PFS: 3.6 months. Median follow-up was 4.5 months (range 0.5 to 22.9).The most common treatment-related adverse events (TRAEs) with SL-401 across BPDCN and other indications (acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), and multiple myeloma) (n=134 patients) were hypoalbuminemia (43%), transaminitis (43%), and thrombocytopenia (26%). Capillary leak syndrome (CLS), a well-documented side effect, occurred in 18% (24/134) of patients, and has been generally manageable and reversible; 2.2% (3/134) of cases resulted in deaths.ConclusionsSL-401 continues to demonstrate notable single agent activity, including multiple CRs, in Stages 1 and 2 of the pivotal Phase 2 BPDCN trial. In 1L patients (SL-401: 12 mcg/kg), 44% (7/16) were bridged to SCT after a durable response from SL-401, and median OS has not been reached. SL-401 side effect profile has remained generally consistent and manageable over increased patient exposure and experience. Analysis of Stage 3 data is ongoing and detailed pivotal efficacy data from this cohort, along with updated Stage 1 and 2 results, will be presented at the conference for the first time. DisclosuresPemmaraju:LFB: Consultancy, Honoraria; Incyte Corporation: Consultancy, Honoraria; stemline: Consultancy, Honoraria, Research Funding; novartis: Consultancy, Honoraria, Research Funding; cellectis: Research Funding; affymetrix: Research Funding; roche diagnostics: Consultancy, Honoraria; abbvie: Research Funding. Lane:Stemline Therapeutics: Research Funding; N-of-one: Consultancy. Stein:Stemline: Consultancy; Amgen: Consultancy, Speakers Bureau. Vasu:Stemline Therapeutics: Research Funding; Boehringer-Ingelheim: Research Funding. Rizzieri:Erytech: Research Funding; Shire: Research Funding. Duvic:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Membership on an entity's Board of Directors or advisory committees, Other: Research funding (paid to institution); . Shubert:Stemline Therapeutics: Employment. Spence:Stemline Therapeutics: Consultancy. Shemesh:Stemline Therapeutics: Employment. Chen:Stemline Therapeutics: Employment. Brooks:Stemline Therapeutics: Employment, Equity Ownership, Patents & Royalties. Bergstein:Stemline Therapeutics: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties. McDonald:Stemline Therapeutics: Employment, Equity Ownership. Goswami:Stemline Therapeutics: Employment. Sloan:Stemline Pharmaceuticals: Consultancy; Molecular Templates, Inc.: Consultancy. Lancet:Biopath, Biosight, Boehringer Ingelheim, Celator/Jazz, Celgene, Janssen, Karyopharm Therapeutics, and Novartis: Consultancy; Pfizer: Other: Institutional research funding. Kantarjian:Pfizer: Research Funding; Amgen: Research Funding; Bristol-Meyers Squibb: Research Funding; ARIAD: Research Funding; Novartis: Research Funding; Delta-Fly Pharma: Research Funding.

INCREASED EXPOSURE TO X-RAYS DURING CORONARY ANGIOGRAPHY AND PERCUTANEOUS CORONARY INTERVENTIONS ASSOCIATED WITH FRACTIONAL FLOW RESERVE MEASUREMENT AND ENDOCORONARY IMAGING TECHNIQUES.

Growing use of fractional flow reserve (FFR) and intracoronary imaging techniques by optical coherence tomography or intravascular ultrasound has raised concerns about additional exposure during coronary angiography and percutaneous coronary interventions (PCIs). Using data from the prospective CRAC-France PCI Prospective Multicentre registry, we sought to evaluate the effect of these new techniques on the radiation dose to patients undergoing coronary procedures. Data on Kerma Area Product (PKA), total air kerma (KAr) and fluoroscopy time from 42182 coronary procedures were retrospectively compared, using multivariable linear regression, according to whether they included FFR and intracoronary imaging. In coronary angiography, FFR was associated with longer fluoroscopy time and higher PKA (21.0 vs. 18.9Gy.cm2) and KAr (372 vs. 299mGy) (all p<0.001). Intracoronary imaging was associated with longer fluoroscopy time, higher contrast volume (both p<0.001), lower PKA (18.3 vs. 19.0Gy.cm2, p=0.02) and similar KAr. In PCI, FFR was associated with a moderate increase in KAr (682 vs. 626mGy, p<0.01) but not PKA (35.9 vs. 33.7Gy.cm2, p=0.34). For intracoronary imaging, there were no differences between groups, except for contrast volume. Increased patient exposure associated with FFR and intracoronary imaging is moderate in diagnostic coronary angiography and minimal or none in PCI, provided optimization techniques are used. It should not be a limitation on the use of these techniques given the important additional information they provide.

Typical values related to the complexity of interventional treatment of acute ischemic stroke.

Interventional Neuroradiology (INR) procedures are often complex, requiring prolonged high-dose exposures. This leads to increased radiation exposure to both patient and operating staff. The purpose of this study is to identify parameters related to the complexity of acute ischemic stroke (AIS) procedures that increase patient exposure and derive DRLs according to ICRP 135. Data from 145 patients treated for AIS between 2017 and 2019 in a Hub Stroke center were retrospectively analyzed. Dosimetric parameters, demographic and clinical data were collected for each patient. The INR operator and the fluoroscopy system used were included. A multivariable analysis was performed to identify which parameters significantly influence the dosimetric data. Thrombus location and the use of stent retriever were noted as the most likely parameters of complex INR procedures. Male sex is an indicator of complex procedure only with regards to the Kerma area product and the air kerma. Patient age significantly affects the exposure time alone. Senior or more experienced operator's data demonstrated reduced patient's exposure time and therefore the KAP and Kar values. The type of X-ray equipment influenced the outcome of the procedure in terms of number of images acquired. Typical values obtained are 168 Gycm2, 0.68Gy, 19min and 181 images. Typical values derived in this study promote patient dose optimization, when considering the complexity of INR procedures. The clinical variables related to the complexity of procedure that mainly affect the dosimetric data in our experience are thrombus location and use of stent retrievers.

Nursing perspectives on care delivery during the early stages of the covid-19 pandemic: A qualitative study.

BackgroundResearch examining RNs’ experiences during the COVID-19 pandemic is lacking, thus inhibiting efforts to optimize nursing care delivery and patient outcomes during the current pandemic and future public health emergencies.ObjectiveTo explore the experience of being a registered nurse caring for patients with COVID-19 at an urban academic medical center during the early stages of the pandemicDesignQualitative descriptive study, guided by Donabedian's Quality Framework for Evaluation of Healthcare Delivery which focuses on structures, processes, and outcomes of care deliverySettingUrban academic medical center in the northeast United StatesParticipantsRegistered nurses cared for or caring for patients with COVID-19, age ≥18 years old, and English-speakingMethodsParticipants were recruited for individual in-person semi-structured interviews. Interviews occurred during March and April 2020 and were recorded and transcribed. Transcripts were analyzed by two researchers using emergent qualitative content analysis to identify themes.ResultsTwenty-one registered nurses participated in the study. Three themes emerged from the data, included one relevant to structures and two relevant to processes of care during the pandemic. Registered nurses perceived the clinical context as highly dynamic, but quickly adapted to pandemic-related care delivery. They felt a “sense of duty” to care for patients with COVID-19, despite being fearful of acquiring or spreading infection. Compared to clinical colleagues, registered nurses reported increased patient exposure and performed tasks previously assigned to other clinical team members.ConclusionRoles and nursing practice processes evolved to meet the demand for care despite challenges. Registered nurses require adequate protection for their frontline role which may consist of increased patient exposure compared to clinical colleagues, emotional support, and clear clinical guidance. A deeper understanding of how a public health emergency, such as the COVID-19 pandemic, affects nursing practice can guide future efforts to optimize healthcare structures, nursing care processes, and patient outcomes. Our study can inform strategies for providing registered nurses with adequate communication, protection, and resources during the COVID-19 pandemic and future similar public health emergencies.

A Prospective Observational Study of Air Burden in Intravenous Tubing: Factors that Increase Patient Exposure

An observational prospective trial was conducted in operating room settings across multiple study sites. A total of 120 surgical patients undergoing a variety of interventional and surgical procedures were included, representing multiple patient populations, case types and anesthesia setups. The ClearLine IV, a device that detects and removes air from IV tubing, was inserted into the IV circuit. Clinicians followed standard protocols. Blood warmers were used at the practitioner's discretion. IV fluid was administered at a constant flow rate or through a bolus given over 30-60 seconds per standard of care. The volume and duration of fluid administration was recorded, along with the frequency, duration and amount of air captured by ClearLine IV.

Patient perceptions and preferences of biologic therapies in SLE

ObjectiveTo evaluate patient perceptions of biologic therapies from a large, population-based cohort of patients with SLE with significant numbers of blacks and whites and across the full spectrum of socioeconomic...

Transitioning From a Level II to Level I Trauma Center Increases Resident Patient Exposure

Increased patient exposure has been shown to improve residency training as determined by better patient outcomes. The transition of John Peter Smith Hospital from a level II to a level I trauma center in 2009 provided a unique opportunity to investigate the direct effects of increased patient exposure on residency training in a relatively controlled setting. We evaluated the effect of the transition to a level I trauma center on residency training. In 2014, we examined the annual facility reports and separated the data into 2 groups: level II (2001 to 2008) and level I (2010 to 2013). The primary outcome measures were patient volume, surgical volume, patient acuity, and scholarly activity by the residents. The patient volume in all units increased significantly (p < .05 for all) after the transition to a level I center. The surgical volume increased significantly for the general surgery, orthopedics, and podiatry departments (p < .05 for all) but remained unchanged in the gynecology and oral maxillofacial surgery departments. The volume measures were performed on all 98 residents (100%). Patient acuity and scholarly activity increased by 17% and 52%, respectively; however, the differences in these data were not statistically significant. The scholarly activity per resident was measured for the orthopedic and podiatry departments. For those departments, the total number of residents was 30, and scholarly activity was measured for 100% of them. Overall, resident education improved when the hospital transitioned to a level I trauma center, although certain subspecialties benefited more than did others from this transition.

Rational use of brain CT scans at Al-Shifa Hospital in Gaza Strip: an analysis of hospital records

BackgroundThe use of CT scans has increased substantially in the Gaza Strip, occupied Palestinian territory. Although this technique has improved diagnostic capability, it has increased patient exposure to radiation and contributed to high costs. We aimed to assess the need for neurological CT scans at the Al-Shifa Hospital, Gaza Strip, occupied Palestinian territory, with a view to restrict patient exposure to radiation and minimise the financial burden of CT scanning on the Palestinian Ministry of Health. MethodsWe reviewed all neurological CT scan requests between June 1, 2011, and Aug 31, 2011, in the Al-Shifa Hospital using a checklist that included availability and completeness of requests, previous examination, clinical data, medical data, and the results of examinations. We used SPSS to analyse the data and χ2 to assess the association between the study variables. This study was approved by the Helsinki Committee, Gaza Strip. We used we used SPSS (version 13) for the analyses. Findings4132 CT scans were done in the study period, of which 1578 (38%) were brain CT scans. We identified and reviewed 1129 (72%) scan requests: 616 (55%) of the requests were urgent, 420 (37%) were for patients younger than 20 years, and 642 (57%) were for male patients. In 1023 (91%) requests the referring physicians did not note if the patient had undergone previous examinations. In 501 (44%) of scans the medical history was not provided, in 348 (31%) CT scans clinical assessment was not provided, and in 536 (47%) of requests no tentative diagnosis was stated. No abnormalities were noted in 660 (58%) of the brain CT scan assessments (260 [42%] of the urgent examinations and 400 [78%] of elective examinations, 356 [56%] of male examinations, and 304 [62%] of female examinations). The differences in results between urgent and elective examinations were significant (χ2=97·06 and p=0·0001), as were the difference in results between male and female examinations (χ2=1·52 and p=0·10). InterpretationBrain CT is frequently requested by physicians without documentation of previous tests, clinical examination, and patients' medical history. More than 58% of brain CT scans are normal in Gaza public hospitals. The Palestinian Ministry of Health has restricted funds, therefore, CT requests for patients should be better justified. FundingNone.

Prevention of contrast-induced acute kidney injury in patients undergoing cardiovascular procedures-a systematic review and network meta-analysis.

BackgroundInterventional diagnostic and therapeutic procedures requiring intravascular iodinated contrast steadily increase patient exposure to the risks of contrast-induced acute kidney injury (CIAKI), which is associated with death, nonfatal cardiovascular events, and prolonged hospitalization. The aim of this study was to investigate the efficacy of pharmacological and non-pharmacological treatments for CIAKI prevention in patients undergoing cardiovascular invasive procedures with iodinated contrast.Methods and findingsMEDLINE, Google Scholar, EMBASE and Cochrane databases as well as abstracts and presentations from major cardiovascular and nephrology meetings were searched, up to 22 April 2016. Eligible studies were randomized trials comparing strategies to prevent CIAKI (alone or in combination) when added to saline versus each other, saline, placebo, or no treatment in patients undergoing cardiovascular invasive procedures with administration of iodinated contrast. Two reviewers independently extracted trial-level data including number of patients, duration of follow-up, and outcomes. Eighteen strategies aimed at CIAKI prevention were identified. The primary outcome was the occurrence of CIAKI. Secondary outcomes were mortality, myocardial infarction, dialysis and heart failure. The data were pooled using network meta-analysis. Treatment estimates were calculated as odds ratios (ORs) with 95% credible intervals (CrI). 147 RCTs involving 33,463 patients were eligible. Saline plus N-acetylcysteine (OR 0.72, 95%CrI 0.57–0.88), ascorbic acid (0.59, 0.34–0.95), sodium bicarbonate plus N-acetylcysteine (0.59, 0.36–0.89), probucol (0.42, 0.15–0.91), methylxanthines (0.39, 0.20–0.66), statin (0.36, 0.21–0.59), device-guided matched hydration (0.35, 0.12–0.79), prostaglandins (0.26, 0.08–0.62) and trimetazidine (0.26, 0.09–0.59) were associated with lower odds of CIAKI compared to saline. Methylxanthines (0.12, 0.01–0.94) or left ventricular end-diastolic pressure-guided hydration (0.09, 0.01–0.59) were associated with lower mortality compared to saline.ConclusionsCurrently recommended treatment with saline as the only measure to prevent CIAKI during cardiovascular procedures may not represent the optimal strategy. Vasodilators, when added to saline, may significantly reduce the odds of CIAKI following cardiovascular procedures.

A study for determination of various positioning errors in digital panoramic radiography for evaluation of diagnostic image quality.

Our study aims to determine the various positioning errors and their relative frequency and to identify those errors directly responsible for diagnostically inadequate images. Five hundred panoramic radiographs taken serially (from the year 2007) were retrospectively assessed for the positioning errors by three oral and maxillofacial radiology specialists using a performa enlisting the errors. The three specialists had different duration of clinical experience and they evaluated the orthopantograms as diagnostically acceptable or unacceptable. They also observed the relative frequency of all the positioning errors. The kappa value for intraobserver agreement was calculated, which suggested that the agreement among the observers was fair. Of the 500 panoramic radiographs viewed by the three observers, 25 (5%) had no errors, while 475 (95%) showed one or more positioning errors. The most common error in our study was found to be head turned to one side (33.8%) and the least common error was patient movement during exposure (1.8%). Positioning errors are very common in digital panoramic radiography, and they lead to production of poor-quality radiographs. The operator should take this fact into consideration and spend more time in patient positioning, thereby reducing the repetition of radiographs and unwanted patient exposure.

Development and implementation of a pharmacist-run comprehensive medication review program in Wisconsin.

The development and implementation of a centralized, pharmacist-run population health program were pursued within a health system to increase patient exposure to comprehensive medication reviews (CMRs) and improve visit processes. Program implementation included choosing appropriate pilot pharmacy locations, developing a feasible staffing model, standardizing the workflow, and creating a patient referral process. The impact on patient exposure, specific interventions, and the sustainability of the program were evaluated over a seven-month period. A total of 96 CMRs were scheduled during the data collection period. Attendance at scheduled CMRs was 54% (52 visits); there were 25 cancellations (26%) and 19 no-shows (20%). Since program implementation, there has been more than a twofold increase (2.08) in the number of CMRs completed within the health system. On average, all aspects of each patient visit took 1.78 hours to complete. Pharmacists spent 28% of scheduled time on CMR tasks and 72% of time on telephone calls and technical tasks to maintain appointments. A pharmacist-run CMR program helped to elevate the role of the community pharmacist in a health system and to improve patient exposure to CMRs. Sustaining a centralized CMR program requires support from other members of the health-system team so that pharmacists can spend more time providing patient care and less time on the technical tasks involved.

A novel radiation detector for removing scattered radiation in chest radiography: Monte Carlo simulation-based performance evaluation

Scattered radiation is the main reason for the degradation of image quality and the increased patient exposure dose in diagnostic radiology. In an effort to reduce scattered radiation, a novel structure of an indirect flat panel detector has been proposed. In this study, a performance evaluation of the novel system in terms of image contrast as well as an estimation of the number of photons incident on the detector and the grid exposure factor were conducted using Monte Carlo simulations. The image contrast of the proposed system was superior to that of the no-grid system but slightly inferior to that of the parallel-grid system. The number of photons incident on the detector and the grid exposure factor of the novel system were higher than those of the parallel-grid system but lower than those of the no-grid system. The proposed system exhibited the potential for reduced exposure dose without image quality degradation; additionally, can be further improved by a structural optimization considering the manufacturer's specifications of its lead contents.