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Journal of Clinical Medicine May 2019Breast density, a measure of dense fibroglandular tissue relative to non-dense fatty tissue, is confirmed as an independent risk factor of breast cancer. Although there... (Review)
Review
Breast density, a measure of dense fibroglandular tissue relative to non-dense fatty tissue, is confirmed as an independent risk factor of breast cancer. Although there has been an increasing interest in the quantitative assessment of breast density, no research has investigated the optimal technical approach of breast MRI in this aspect. Therefore, we performed a systematic review and meta-analysis to analyze the current studies on quantitative assessment of breast density using MRI and to determine the most appropriate technical/operational protocol. Databases (PubMed, EMBASE, ScienceDirect, and Web of Science) were searched systematically for eligible studies. Single arm meta-analysis was conducted to determine quantitative values of MRI in breast density assessments. Combined means with their 95% confidence interval (CI) were calculated using a fixed-effect model. In addition, subgroup meta-analyses were performed with stratification by breast density segmentation/measurement method. Furthermore, alternative groupings based on statistical similarities were identified via a cluster analysis employing study means and standard deviations in a Nearest Neighbor/Single Linkage. A total of 38 studies matched the inclusion criteria for this systematic review. Twenty-one of these studies were judged to be eligible for meta-analysis. The results indicated, generally, high levels of heterogeneity between study means within groups and high levels of heterogeneity between study variances within groups. The studies in two main clusters identified by the cluster analysis were also subjected to meta-analyses. The review confirmed high levels of heterogeneity within the breast density studies, considered to be due mainly to the applications of MR breast-imaging protocols and the use of breast density segmentation/measurement methods. Further research should be performed to determine the most appropriate protocol and method for quantifying breast density using MRI.
PubMed: 31137728
DOI: 10.3390/jcm8050745 -
Journal of the American Heart... May 2022Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not... (Clinical Trial)
Clinical Trial
Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention-to-treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention-to-treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per-protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time-varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years. At 2-year follow-up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per-protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75-1.03; =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79-1.26; =0.99). The per-protocol and intention-to-treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.
Topics: Aspirin; Drug Therapy, Combination; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Ticagrelor; Treatment Outcome
PubMed: 35229616
DOI: 10.1161/JAHA.121.024291 -
International Journal of Environmental... Jun 2021The aim of this human cadaver study was to assess the accuracy of zygomatic/pterygoid implant placement using custom-made bone-supported laser sintered titanium...
The aim of this human cadaver study was to assess the accuracy of zygomatic/pterygoid implant placement using custom-made bone-supported laser sintered titanium templates. For this purpose, pre-surgical planning was done on computed tomography scans of each cadaver. Surgical guides were printed using direct metal laser sintering technology. Four zygomatic and two pterygoid implants were inserted in each case using the guided protocol and related tools. Post-operative computed tomography (CT) scans were obtained to evaluate deviations between the planned and inserted implants. Accuracy was measured by overlaying the real position in the post-operative CT on the virtual presurgical placement of the implant in a CT image. Descriptive and bivariate analyses of the data were performed. As a result, a total of 40 zygomatic and 20 pterygoid implants were inserted in 10 cadavers. The mean deviations between the planned and the placed zygomatic and pterygoid implants were respectively (mean ± SD): 1.69° ± 1.12° and 4.15° ± 3.53° for angular deviation. Linear distance deviations: 0.93 mm ± 1.23 mm and 1.35 mm ± 1.45 mm at platform depth, 1.35 mm ± 0.78 mm and 1.81 mm ± 1.47 mm at apical plane, 1.07 mm ± 1.47 mm and 1.22 mm ± 1.44 mm for apical depth. In conclusion, the surgical guide system showed accuracy for all the variables studied and allowed acceptable and accurate implant placement regardless of the case complexity.
Topics: Cadaver; Computer-Aided Design; Humans; Prostheses and Implants; Surgery, Computer-Assisted; Tomography, X-Ray Computed
PubMed: 34200143
DOI: 10.3390/ijerph18116142 -
Fully automated image quality evaluation on patient CT: Multi-vendor and multi-reconstruction study.PloS One 2022While the recent advancements of computed tomography (CT) technology have contributed in reducing radiation dose and image noise, an objective evaluation of image...
While the recent advancements of computed tomography (CT) technology have contributed in reducing radiation dose and image noise, an objective evaluation of image quality in patient scans has not yet been established. In this study, we present a patient-specific CT image quality evaluation method that includes fully automated measurements of noise level, structure sharpness, and alteration of structure. This study used the CT images of 120 patients from four different CT scanners reconstructed with three types of algorithm: filtered back projection (FBP), vendor-specific iterative reconstruction (IR), and a vendor-agnostic deep learning model (DLM, ClariCT.AI, ClariPi Inc.). The structure coherence feature (SCF) was used to divide an image into the homogeneous (RH) and structure edge (RS) regions, which in turn were used to localize the regions of interests (ROIs) for subsequent analysis of image quality indices. The noise level was calculated by averaging the standard deviations from five randomly selected ROIs on RH, and the mean SCFs on RS was used to estimate the structure sharpness. The structure alteration was defined by the standard deviation ratio between RS and RH on the subtraction image between FBP and IR or DLM, in which lower structure alterations indicate successful noise reduction without degradation of structure details. The estimated structure sharpness showed a high correlation of 0.793 with manually measured edge slopes. Compared to FBP, IR and DLM showed 34.38% and 51.30% noise reduction, 2.87% and 0.59% lower structure sharpness, and 2.20% and -12.03% structure alteration, respectively, on an average. DLM showed statistically superior performance to IR in all three image quality metrics. This study is expected to contribute to enhance the CT protocol optimization process by allowing a high throughput and quantitative image quality evaluation during the introduction or adjustment of lower-dose CT protocol into routine practice.
Topics: Algorithms; Humans; Radiation Dosage; Radiographic Image Interpretation, Computer-Assisted; Tomography, X-Ray Computed
PubMed: 35857804
DOI: 10.1371/journal.pone.0271724 -
International Journal of Radiation... Apr 2015A phase 3 trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma mandated real-time central review of involved field radiation therapy (IFRT) and... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
A phase 3 trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma mandated real-time central review of involved field radiation therapy (IFRT) and imaging records by a centralized review center to maximize protocol compliance. We report the impact of centralized radiation therapy review on protocol compliance.
METHODS AND MATERIALS
Review of simulation films, port films, and dosimetry records was required before and after treatment. Records were reviewed by study-affiliated or review center-affiliated radiation oncologists. A deviation of 6% to 10% from protocol-specified dose was scored as "minor"; a deviation of >10% was "major." A volume deviation was scored as "minor" if margins were less than specified or "major" if fields transected disease-bearing areas. Interventional review and final compliance review scores were assigned to each radiation therapy case and compared.
RESULTS
Of 1712 patients enrolled, 1173 underwent IFRT at 256 institutions in 7 countries. An interventional review was performed in 88% of patients and a final review in 98%. Overall, minor and major deviations were found in 12% and 6% of patients, respectively. Among the cases for which ≥1 pre-IFRT modification was requested by the Quality Assurance Review Center and subsequently made by the treating institution, 100% were made compliant on final review. By contrast, among the cases for which ≥1 modification was requested but not made by the treating institution, 10% were deemed compliant on final review.
CONCLUSIONS
In a large trial with complex treatment pathways and heterogeneous radiation therapy fields, central review was performed in a large percentage of cases before IFRT and identified frequent potential deviations in a timely manner. When suggested modifications were performed by the institutions, deviations were almost eliminated.
Topics: Adolescent; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Child; Child, Preschool; Cyclophosphamide; Doxorubicin; Etoposide; Guideline Adherence; Hodgkin Disease; Humans; Infant; Infant, Newborn; Prednisone; Quality Assurance, Health Care; Radiography; Vincristine; Young Adult
PubMed: 25670539
DOI: 10.1016/j.ijrobp.2014.11.034 -
Trials Nov 2022Retention remains a major challenge for many clinical trials. The SPIRIT guidelines state the following information on retention should be included in the trial protocol...
BACKGROUND
Retention remains a major challenge for many clinical trials. The SPIRIT guidelines state the following information on retention should be included in the trial protocol "Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols". This guidance shows the importance of planning retention methods and handling missing data as this can impact how the results of the trial are interpreted. The most recent Cochrane review of strategies to improve retention in clinical trials highlighted that some trials implemented multiple retention strategies and we questioned whether the use of multiple strategies was planned at the design stage and included in the protocol or are strategies implemented when retention becomes an issue within the trial. The purpose of our scoping review is to establish if and how trial teams prepare for retention at the design phase of clinical trials.
METHODS AND ANALYSIS
We will follow the methodological framework and guidelines for scoping reviews outlined by the Joanna Briggs Institute. We will search MEDLINE/PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science. A comprehensive search strategy for PubMed was developed in collaboration with an experienced research librarian. We will include protocols for phase 2, 3, and 4 RCTs as well as pilot and feasibility studies. The screening process will involve two reviewers. EM will independently screen all titles and abstracts. FS will screen 10% of the overall search output, and where necessary full protocol texts will be screened to determine eligibility. We will randomly sample eligible protocols to ensure the protocols represent a variety of trial and intervention types. Data will be extracted from each protocol and the results will be synthesised. The analysis will be qualitative using a narrative summary and descriptive statistics where appropriate.
DISCUSSION
The scoping review will help trial methodologists better understand if retention strategies are planned for during the design stage of the trial contributing to the PRioRiTy II unanswered question "How should people who run trials plan for retention during their funding application and creation of the trial (protocol development)?".
Topics: Humans; Research Design; Review Literature as Topic; Clinical Trials as Topic
PubMed: 36397085
DOI: 10.1186/s13063-022-06866-w -
MethodsX 2018Sugar and organic acid contents are major factors for tomato fruit flavour and are important breeding traits. Here we provide an improved protocol for accurate...
Sugar and organic acid contents are major factors for tomato fruit flavour and are important breeding traits. Here we provide an improved protocol for accurate quantification of the main sugars, glucose and fructose, and the organic acids, citric acid and malic acid, present in tomato. The tomato extract is spiked with lactose and tricarballylic acid as internal standards and loaded onto a NH2 solid phase extraction (SPE) column. The sugars appear in the flow-through and are subsequently analysed by HPLC using a Nucleodur NH2 column and a refractive index detector. The organic acids bind to the SPE column and are eluted with 400 mM phosphoric acid. For analysis, the organic acids are separated by HPLC using a Nucleodur C18ec column and detected by UV absorption at 210 nm. The method shows excellent inter-day and intra-day reproducibility for glucose, fructose and citric acid with standard deviations of 1-5%. Quantification of citric acid by HPLC and GC-MS showed perfect agreement with a deviation of less than 3%. •Simple method for quantification of glucose, fructose, citric acid and malic acid in tomato.•Efficient removal of interfering compounds by solid phase extraction.•High intra and inter-day reproducibility.
PubMed: 30023316
DOI: 10.1016/j.mex.2018.05.014 -
Journal of Eating Disorders Sep 2023No guidelines currently exist that represent a standardization of care for Avoidant/Restrictive Food Intake Disorder (ARFID) on an inpatient service. Unique features of...
BACKGROUND
No guidelines currently exist that represent a standardization of care for Avoidant/Restrictive Food Intake Disorder (ARFID) on an inpatient service. Unique features of this diagnosis (e.g., sensory sensitivity contributing to involuntary emesis) suggest that established protocols that were developed for anorexia nervosa might be less effective for adolescents with ARFID. To inform improved inpatient medical stabilization and care for these patients, we first provide an overview of clinical characteristics for patients with ARFID who presented to a pediatric hospital for inpatient eating disorder care. We use these descriptives to outline the rationale for, and executions of, modifications to an inpatient protocol designed to flexibly meet the needs of this clinical population.
METHODS
Chart review with descriptive statistics were conducted for patients who had received an ARFID diagnosis from March 2019 to March 2023 (N = 32, aged 9-23). We then present a case series (n = 3) of adolescents who either transitioned to a novel adjusted protocol from an original standard of care on the inpatient service, or who received only the standard protocol.
RESULTS
The sample was aged M(SD) = 15.6 (3.3) years, 53% male, and a majority (69%) presented with the ARFID presentation specific to fear of negative consequences. On average, patients had deviated from their growth curve for just over two years and presented with mean 76% of their estimated body weight. Of those requiring nasogastric tube insertion during admission (n = 8, 25%), average duration of tube placement was 15 days. From within this sample, case series data suggest that the adjusted protocol will continue to have a positive impact on care trajectory among adolescents admitted for ARFID including improved weight gain, reduction of emesis, and improved food intake.
CONCLUSIONS
Findings demonstrate the likely need to tailor established medical inpatient protocols for those with ARFID given different symptom presentation and maintenance factors compared to patients with anorexia nervosa. Further research is warranted to explore the longer-term impact of protocol changes and to inform standardization of care for this high priority clinical population across care sites.
PubMed: 37737186
DOI: 10.1186/s40337-023-00895-9 -
Orthopaedic Journal of Sports Medicine May 2023Posterior shoulder instability is being identified and treated more frequently by orthopaedic providers. After posterior shoulder stabilization, long-term outcomes in...
BACKGROUND
Posterior shoulder instability is being identified and treated more frequently by orthopaedic providers. After posterior shoulder stabilization, long-term outcomes in function and mobility are largely dependent on the postoperative rehabilitation period. Thus, it is important to assess the consistency between protocols at different institutions.
PURPOSE/HYPOTHESIS
The purpose of this study was to investigate the variability among rehabilitation protocols published by academic orthopaedic programs and their affiliates. It was hypothesized that there would be little consistency in the duration of immobilization, timing of functional milestones, and start dates of various exercises.
STUDY DESIGN
Cross-sectional study.
METHODS
Rehabilitation protocols after posterior shoulder stabilization that were published online from Accreditation Council for Graduate Medical Education (ACGME)-accredited orthopaedic surgery programs and their affiliates were evaluated for recommendations on immobilization, exercises, activities, range of motion (ROM), and return-to-sport goals.
RESULTS
Of the 204 ACGME-accredited orthopaedic surgery programs, 22 programs and 17 program affiliates had publicly available rehabilitation protocols that were included for review. There were 37 programs (94.9%) that recommended the use of sling immobilization for a mean of 4.7 ± 1.8 weeks postoperatively. Active ROM of the elbow, wrist, and hand was the most common early ROM exercise to be recommended (36 programs; 92.3%). The goal of 90° passive external rotation demonstrated the widest range of recommended start dates (0-12 weeks postoperatively). Late ROM exercises and start dates varied between protocols, with the largest standard deviation found in achieving full active ROM (13.5 ± 3.6 weeks). Resistance exercises showed a wide range of recommended start dates. Bench presses and push-ups began, on average, at 13.1 ± 3.4 and 15.3 ± 3.2 weeks, respectively. Return to sport was recommended at 21.7 ± 3.6 weeks.
CONCLUSION
There was a high level of variability in postoperative rehabilitation protocols after posterior shoulder stabilization among orthopaedic programs and their affiliates, suggesting that a standard protocol for rehabilitation has yet to be established.
PubMed: 37162762
DOI: 10.1177/23259671231161589 -
BMJ Open Dec 2021Gentamicin is the aminoglycoside antibiotic of choice in the UK. It has a narrow therapeutic index: underdosing results in inefficacy while overdosing is characterised...
OBJECTIVES
Gentamicin is the aminoglycoside antibiotic of choice in the UK. It has a narrow therapeutic index: underdosing results in inefficacy while overdosing is characterised by nephrotoxicity and ototoxicity. To improve patient safety, hospitals have protocols for the prescription of gentamicin, which vary in complexity and approach. This study aimed to explore two distinct protocols for prescribing gentamicin in hospital settings, in order to understand the mechanisms they trigger and the outcomes they achieve.
SETTING
A mixed-methods realist evaluation explored gentamicin prescribing protocols in two hospital surgical admissions units in South West England between January and August 2018. Site 1 had a traditional, complex protocol, while site 2 took a simplified protocol.
PARTICIPANTS
Testing the initial programme theory (IPT) involved semi-structured audio-recorded interviews of a volunteer sample of healthcare professionals (HCPs) involved in the prescribing and administering process, alongside a clinical audit reviewing accuracy of gentamicin prescribing.
OUTCOME MEASURES
Three sequential phases were used to identify factors in a successful protocol: IPT generation; testing; refinement of the IPT. The IPT was generated by literature search and analysis of existing protocols of sites 1 and 2. Refinement of the IPT synthesised the results of the quantitative and qualitative research to identify the key characteristics of a successful protocol.
RESULTS
One hundred gentamicin prescriptions were reviewed, with a mean accuracy of gentamicin prescribing at site 1 of 65.67% and at site 2 of 78.79% (p<0.01). Thirty HCPs were interviewed. Key contexts were identified including prescriptiveness, experience and availability of patient information. These triggered hidden mechanisms including uncertainty, fear, confidence and frustration leading to both intended outcomes but also unintended outcomes such as deviation from protocol and unnecessary gentamicin levels.
CONCLUSIONS
A simplified prescribing protocol for gentamicin is better accepted by prescribers, leading to better adherence to protocol and more accurate prescribing.
Topics: Gentamicins; Health Personnel; Hospitals; Humans; Qualitative Research; United Kingdom
PubMed: 34949620
DOI: 10.1136/bmjopen-2021-052697