Patient-based Approach Research Articles

A Novel Dry Simulator Model for Learning Comprehensive Endoscopic Retrograde Cholangiopancreatography/Endoscopic Sphincterotomy Procedures while Minimizing Adverse Bleeding Events (with Video).

Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are essential skills for performing endoscopic cholangiopancreatic procedures. However, these procedures have a high incidence of adverse events, and current training predominantly relies on patient-based approaches. Herein, we aimed to develop an ERCP/EST simulator model to address the need for safer training alternatives, especially for learners with limited ERCP experience. The model was designed to facilitate the use of actual endoscopic devices, supporting learning objectives that align with the components of the validated Bethesda ERCP Skill Assessment Tool (BESAT). BESAT focuses on skills, such as papillary alignment, maintenance of duodenoscope position, gentle and efficient cannulation, controlled sphincterotomy in the correct trajectory, and guidewire manipulation. Thirty gastroenterology trainees used the simulator between May 2022 and March 2023, and their satisfaction was assessed using a visual analog scale (VAS) and pre- and post-training questionnaires. The novel simulator model comprised a disposable duodenal papillary section, suitable for incision with an electrosurgical knife, alongside washable upper gastrointestinal tract and bile duct sections for repeated use. The duodenal papillary section enabled reproduction of a realistic endoscope position and the adverse bleeding events due to improper incisions. The bile duct section allowed for the reproduction of fluoroscopic-like images, enabling learners to practice guidewire guidance and insertion of other devices. Following training, the median VAS score reflecting the expectation for model learning significantly increased from 69.5 (interquartile range [IQR]: 55.5-76.5) to 85.5 (IQR: 78.0-92.0) (p < 0.01). All participants expressed a desire for repeated simulator training sessions. This innovative simulator could serve as a practical educational tool, particularly beneficial for novices in ERCP. It could facilitate hands-on practice with actual devices, enhancing procedural fluency and understanding of precise incisions to minimize the risk of bleeding complications during EST.

The Evolution of Current Concept of the Reconstructive Ladder in Plastic Surgery: The Emerging Role of Translational Medicine.

Plastic surgeons have used the reconstructive ladder for many decades as a standard directory for complex trauma reconstruction with the goal of repairing body structures and restoring functionality. This consists of different surgical maneuvers, such as secondary intention and direct tissue closure, as well as more complex methods such as local tissue transfer and free flap. The reconstructive ladder represents widely known options achievable for tissue reconstruction and wound closure that puts at the bottom rung the simplest methods of reconstruction and strengthens the complexity by moving upward. Regenerative medicine and surgery constitute a quickly spreading area of translational research that can be employed by minimally invasive surgical strategies, with the aim of regenerating cells and tissues in vivo in order to reestablish normal function through the intrinsic potential of cells, in combination with biomaterials and appropriate biochemical stimuli. These translational procedures have the aim of creating an appropriate microenvironment capable of supporting the physiological cellular function to generate the desired cells or tissues and to generate parenchymal, stromal, and vascular components on demand, and above all to produce intelligent materials capable of determining the fate of cells. Smart technologies have been grown that give extra "rungs" on the classic reconstructive ladder to integrate a more holistic, patient-based approach with improved outcomes. This commentary presents the evolution of the traditional concept of the reconstructive ladder in the field of plastic surgery into a new course with the aim of achieving excellent results for soft tissue reconstruction by applying innovative technologies and biologically active molecules for a wide range of surgical diseases.

When should contralateral testicular fixation be performed in postpubertal patients with testicular torsion: A comparative study

ObjectiveIn this study, we aimed to describe the timing of contralateral testicular fixation with our ten year results in postpubertal patients with testicular torsion with a patient-based approach. MethodsPostpubertal patients diagnosed with testicular torsion in a tertiary hospital between January-2012 and September-2022 were divided into 2 groups according to the "patient-based approach" criteria we adopted in our clinic. Group 1 in whom the contralateral teste was fixed in the same surgical act and group 2 in whom the fixation was deferred. Both groups, were retrospectively examined, statistically analyzed and compared. ResultsA total of 41 patients were included in the study. Among those, 19 (46.3%) were fixed in the same act, and 22 (53.7%) underwent postponed elective contralateral testicular fixation. Early term wound dehiscence was observed in one patient in each group (4.5% Group 1 vs. 5.3% Group 2). In the postoperative period, no contralateral testicular atrophy or torsion was detected in the study groups during 1-year follow-up. ConclusionThere is no algorithm for when contralateral testicular fixation should be performed in postpubertal patients with testicular torsion. Patient-based approaches, in which the clinical characteristics of the patient are prioritized in determining the timing of contralateral testicular fixation, can produce more effective and safe results.

Cancer-associated thrombosis and drug-drug interactions of antithrombotic and antineoplastic agents.

Venous thromboembolism (VTE) is often associated with malignant diseases and notably contributes to morbidity and mortality in patients with cancer. Cancer-associated thrombosis (CAT) brings additional costs to health expenditures and has a negative impact on oncological outcomes. Either the recurrence rate of VTE or bleeding complications are also higher in patients with cancer. Prophylactic anticoagulation has been recommended in peri-surgical periods, inpatient settings, and high-risk ambulatory patients. Although various risk stratification scores are used, none are ideal for identifying patients who can benefit from anticoagulant prophylaxis. New risk scoring systems or biomarkers are needed to identify patients who are more likely to benefit from prophylaxis with low bleeding risk. The questions about the patients who will be given prophylaxis and those who develop thromboembolism, with which drug, and how long they will be treated are still not fully answered. Anticoagulation is the cornerstone of the treatment, but management of CAT remains complex. Low molecular weight heparins and direct oral anticoagulants are effective and safe options for the treatment of CAT. Recognizing adverse effects, drug-drug interactions, and accompanying conditions that cause dose adjustment is crucial. Prevention and treatment of VTE in patients with cancer require a multidisciplinary and patient-based approach. PLAIN LANGUAGE SUMMARY: Cancer-associated thrombosis is a significant cause of mortality and morbidity in patients with cancer. Chemotherapy, surgery, and/or use of central venous access remarkably increase the risk of thrombosis. Prophylactic anticoagulation should be considered not only in inpatient follow-up and during peri-surgical period but also ambulatory patients with a high risk of thrombosis. Many parameters, such as drug-drug interactions, primary side of cancer, and comorbidities of patients should be considered when selecting anticoagulant drugs. More accurate risk stratification scores or biomarkers are still an unmet need.

¿Cuándo se debe realizar la fijación testicular contralateral en pacientes pospuberales con torsión testicular? Estudio comparativo

ObjectiveIn this study, we aimed to describe the timing of contralateral testicular fixation with our ten year results in postpubertal patients with testicular torsion with a patient-based approach. MethodsPostpubertal patients diagnosed with testicular torsion in a tertiary hospital between January-2012 and September-2022 were divided into two groups according to the «patient-based approach» criteria we adopted in our clinic. Group1 in whom the contralateral teste was fixed in the same surgical act and group2 in whom the fixation was deferred. Both groups, were retrospectively examined, statistically analyzed and compared. ResultsA total of 41 patients were included in the study. Among those, 19 (46.3%) were fixed in the same act, and 22 (53.7%) underwent postponed elective contralateral testicular fixation. Early term wound dehiscence was observed in one patient in each group (4.5% group1 vs. 5.3% group2). In the postoperative period, no contralateral testicular atrophy or torsion was detected in the study groups during 1-year follow-up. ConclusionThere is no algorithm for when contralateral testicular fixation should be performed in postpubertal patients with testicular torsion. Patient-based approaches, in which the clinical characteristics of the patient are prioritized in determining the timing of contralateral testicular fixation, can produce more effective and safe results.

Venous balloon test occlusion for pulsatile tinnitus assessment: A clinical feasibility study.

Pulsatile tinnitus (PT) can have huge impact on the patients' quality of life and can be associated with curable vascular anomalies. In the present study, we aim firstly to describe our protocol for venous BTO and secondly to report possible predictors for a positive BTO test. All consecutive PT patients undergoing BTO for the purpose of determining eligibility for venous neuro-intervention were included. We recommend BTO for patients when there is uncertainty in the association of the venous pathology identified on non-invasive cross-sectional imaging (CTV or MRV) and the patient's symptoms. Between May 2016 and October 2022, we recorded 29 venous balloon test occlusions fulfilling our inclusions criteria. Over the 29 procedures scheduled, 8 finally did not lead to a successful balloon test occlusion. The main reason was that the patient did not hear the PT on the day the angiogram was performed. Two patients could not have the BTO due to difficulties in venous navigation. After BTO, only four patients of our cohort were scheduled for an endovascular treatment. We describe a technique and present a single cohort of venous BTO in severe PT patients with unclear anatomical cause. This angiographic test was useful to exclude patients from endovascular surgery and discuss the most probable cause of the PT. Complexity of vascular PT should support a patient-based approach when discussing interventional treatment.

Multicomponent provider–patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes: clinical trial protocol for the ACHIEVE study

IntroductionType 2 diabetes (T2D) is one of the most frequent comorbid medical conditions in pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the pregnant individual and infant....

Diagnostic factors for recurrent pregnancy loss: an expanded workup

PurposeThere is limited information on the risk factors for recurrent pregnancy loss (RPL).MethodsIn this study, a patient-based approach was used to investigate the possible involvement and relative relevance of a large number of diagnostic factors in 843 women with RPL who underwent an extensive diagnostic workup including 44 diagnostic factors divided into 7 major categories.ResultsThe rates of abnormalities found were: (1) genital infections: 11.74%; (2) uterine anatomic defects: 23.72%; (3) endocrine disorders: 29.42%; (4) thrombophilias: 62%; (5) autoimmune abnormalities: 39.2%; (6) parental karyotype abnormalities 2.25%; (7) clinical factors: 87.78%. Six hundred and fifty-nine out of eight hundred and forty-three women (78.17%) had more than one abnormality. The mean number of pregnancy losses increased by increasing the number of the abnormalities found (r = 0.86949, P < 0.02). The factors associated with the highest mean number of pregnancy losses were cervical isthmic incompetence, anti-beta-2-glycoprotein-1 antibodies, unicornuate uterus, anti-prothrombin A antibodies, protein C deficiency, and lupus anticoagulant. The majority of the considered abnormalities had similar, non-significant prevalence between women with 2 versus ≥ 3 pregnancy losses with the exception of age ≥ 35 years and MTHFR A1298C heterozygote mutation. No difference was found between women with primary and secondary RPL stratified according to the number of abnormalities detected (Chi-square: 8.55, P = 0.07). In these women, the only factors found to be present with statistically different rates were age ≥ 35 years, cigarette smoking, and genital infection by Ureaplasma.ConclusionA patient-based diagnostic approach in women with RPL could be clinically useful and could represent a basis for future research.

Gender-Dependent Comparison of Coronary Computed Tomography Angiographic Characteristics among Patients with Suspected Atherosclerosis: A Single-Center Experience.

In this study, we aimed to examine gender-based differences in coronary artery disease (CAD) risk factors, the presence and severity of atherosclerosis, and the distribution of plaque type in patients presenting with chest pain. A total of 1496 patients who applied to our cardiology outpatient clinic with chest pain and underwent computed coronary tomographic angiography (CTA) between August 2020 and October 2021 were included in the study. Plaque characteristics, Agatston score, and Coronary Artery Disease-Reporting and Data System (CAD-RADS) score obtained from the patients' CTAs were compared by gender. Of the 1496 patients evaluated, 47.9% were female. Coronary atherosclerosis was detected in 35.4% of females and 52.9% of males (P <0.001). Diabetes mellitus [155 (21.8%) vs. 123 (15.7%); P <0.001] and hypertension [271 (38.1%) vs. 249 (32%); P <0.001] rates were higher in females than in males. Plaque burden and high-risk plaque rate were found to be higher in males (P <0.001). Next, the rate of moderate-to-high coronary artery stenosis (CAD-RADS ≥3) was observed at 21.6% in men and 12.2% in women (P <0.001). Agatston score was found to be higher in males than in females for all age groups (P <0.001). The severity of CAD increased sharply with age in females (P interaction = 0.003). Although female patients demonstrated higher rates of traditional risk factors, the male gender was associated with increased coronary plaque burden, high-risk plaque, CADRADS, and Agatston scores. Therefore, patient-based approaches that consider gender-related differences could provide effective treatment and follow-up.

The new French kidney allocation system for donations after brain death: Rationale, implementation, and evaluation

In recent decades, the allocation policies of many countries have moved from center-based to patient-based approaches. The new French kidney allocation system (KAS) of donations after brain death for adult recipients, implemented in 2015, was principally designed to introduce a unified allocation score (UAS) to be applied locally for one kidney and nationally for the other and to replace regional borders by a new geographical model. The new KAS balances dialysis duration and waiting time to compensate for listing delays and provides more effective longevity matching between donors and recipients with better HLA and age matching. We report these changes, with their rationale and main results. Results show improved HLA matching for young recipients and more rapid access to transplant for older recipients. Young recipients also had better access to transplantation. Transplant access decreased for recipients aged 60-69 and required tuning of KAS parameters. In conclusion, our results strongly indicate that national or adequately broad geographic allocation areas, combined with multiplicative interactions between allocation criteria, permit multivariate optimization of organ allocation and thus improve national kidney sharing and balance HLA matching and age matching, at the price of longer cold ischemic times and more logistical constraints than with local allocation.

Imaging or Adrenal Vein Sampling Approach in Primary Aldosteronism? A Patient-Based Approach.

Primary aldosteronism (PA) is the most frequent cause of secondary hypertension, associated with an increased risk of cardiovascular and cerebral disease, compared to essential hypertension. Therefore, it is mandatory to promptly recognize the disease and offer to the patient the correct diagnostic-therapeutic process in order to reduce new-onset cardiovascular events. It is fundamental to define subtype classification (unilateral or bilateral disease), in order to provide the best treatment (surgery for unilateral and medical treatment for bilateral disease). Here, we report five clinical cases of different subtypes of PA (patients with monolateral or bilateral PA, nondiagnostic AVS, allergy to iodinated contrast, and patients not suitable for surgery), with particular attention to the diagnostic-therapeutic process and the different approaches tailored to a single case. Since PA is a spectrum of various diseases, it needs a personalized diagnostic-therapeutic process, customized for the individual patient, depending on previous medical history, suitability for the surgery and patient's preferences.

Distinction of Lymphoma from Sarcoidosis on 18F-FDG PET/CT: Evaluation of Radiomics-Feature-Guided Machine Learning Versus Human Reader Performance.

Sarcoidosis and lymphoma often share common features on 18F-FDG PET/CT, such as intense hypermetabolic lesions in lymph nodes and multiple organs. We aimed at developing and validating radiomics signatures to differentiate sarcoidosis from Hodgkin lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL). Methods: We retrospectively collected 420 patients (169 sarcoidosis, 140 HL, and 111 DLBCL) who underwent pretreatment 18F-FDG PET/CT at the University Hospital of Liege. The studies were randomly distributed to 4 physicians, who gave their diagnostic suggestion among the 3 diseases. The individual and pooled performance of the physicians was then calculated. Interobserver variability was evaluated using a sample of 34 studies interpreted by all physicians. Volumes of interest were delineated over the lesions and the liver using MIM software, and 215 radiomics features were extracted using the RadiomiX Toolbox. Models were developed combining clinical data (age, sex, and weight) and radiomics (original and tumor-to-liver TLR radiomics), with 7 different feature selection approaches and 4 different machine-learning (ML) classifiers, to differentiate sarcoidosis and lymphomas on both lesion-based and patient-based approaches. Results: For identifying lymphoma versus sarcoidosis, physicians' pooled sensitivity, specificity, area under the receiver-operating-characteristic curve (AUC), and accuracy were 0.99 (95% CI, 0.97-1.00), 0.75 (95% CI, 0.68-0.81), 0.87 (95% CI, 0.84-0.90), and 89.3%, respectively, whereas for identifying HL in the tumor population, it was 0.58 (95% CI, 0.49-0.66), 0.82 (95% CI, 0.74-0.89), 0.70 (95% CI, 0.64-0.75) and 68.5%, respectively. Moderate agreement was found among observers for the diagnosis of lymphoma versus sarcoidosis and HL versus DLBCL, with Fleiss κ-values of 0.66 (95% CI, 0.45-0.87) and 0.69 (95% CI, 0.45-0.93), respectively. The best ML models for identifying lymphoma versus sarcoidosis showed an AUC of 0.94 (95% CI, 0.93-0.95) and 0.85 (95% CI, 0.82-0.88) in lesion- and patient-based approaches, respectively, using TLR radiomics (plus age for the second). To differentiate HL from DLBCL, we obtained an AUC of 0.95 (95% CI, 0.93-0.96) in the lesion-based approach using TLR radiomics and 0.86 (95% CI, 0.80-0.91) in the patient-based approach using original radiomics and age. Conclusion: Characterization of sarcoidosis and lymphoma lesions is feasible using ML and radiomics, with very good to excellent performance, equivalent to or better than that of physicians, who showed significant interobserver variability in their assessment.

Osteopathic Manipulative Medicine: A Brief Review of the Hands-On Treatment Approaches and Their Therapeutic Uses.

Osteopathic manipulative medicine (OMM) is an emerging practice in the healthcare field with increasing popularity and evidence-based therapy. Osteopathic manipulative treatments (OMT) include hands-on manipulations of different body structures to increase systemic homeostasis and total patient well-being. Indeed, this new realm of the whole patient-based approach is being taught in osteopathic schools around the country, and the osteopathic principles of a mind-body-spirit-based treatment are being instilled in many new Doctor of Osteopathy (D.O.) students. However, despite their proven therapeutic value, there are still many individuals, both in and outside the medical profession, who are unaware (or misinformed) of the therapeutic uses and potential benefits of OMT. Here, we provide a brief introduction to this osteopathic therapeutic approach, focusing on the hands-on techniques that are regularly implemented in the clinical setting. It is becoming increasingly evident that different OMTs can be implemented to enhance patient recovery, both alone and in conjunction with the targeted therapies used in allopathic regimens. Therefore, it may be beneficial to inform the general medical community and educate the public and those associated with the healthcare field about the benefits of using OMT as a treatment modality. OMT is lower-cost, noninvasive, and highly effective in promoting full-body healing by targeting the nervous, lymphatic, immune, and vascular systems. There is a growing body of literature related to osteopathic research and the possible molecular pathways involved in the healing process, and this burgeoning field of medicine is expected to increase in value in the healthcare field. This brief review article explains the frequently utilized OMT modalities and their recognized therapeutic benefits, which underscore the need to understand the possible molecular mechanisms and circulating biomarkers linked to the systemic benefits of osteopathic medicine.

Focal cortical dysplasia classification for refractory epilepsy detection using artificial neural network

ABSTRACT Refractory epilepsy is a condition characterised by epileptic seizure occurrence, which cannot be controlled with antiepileptic drugs. Focal Cortical Dysplasia (FCD) was detected as one of the main causes of refractory epilepsy. Surgical intervention is necessary to minimise or eliminate seizure occurrences, although it is only indicated in cases where there is complete certainty of the FCD region. Therefore, this paper addresses the development of a classification method to detect FCD on MRI based on morphological and textural features from a voxel-level perspective. The experiments were based on a voxel classification assessment as well as on a patient-based assessment. Multiple classifiers were tested using both voxel-based and patient-based approaches, and the best results were achieved using Multi-Layer Perceptron, AdaBoost and Support Vector Machine classifiers, which yielded close accuracy values. For voxel-based assessment, the best accuracy was 96.81% by Multi-Layer Perceptron and for patient-based assessment, the best accuracy was 90.64% by Support Vector Machine.

Prognostic significance of 68Ga-Pentixafor PET/CT in multiple myeloma recurrence: a comparison to 18F-FDG PET/CT and laboratory results.

This study investigates the prognostic value of 68Ga-Pentixafor PET/CT using PET-derived quantitative in multiple myeloma (MM) patients with suspected recurrence in comparison to 18F-FDG PET/CT and clinical data. Twenty-four MM patients with suspicion for relapse who underwent 68Ga-Pentixafor and 18F-FDG PET/CT were retrospectively evaluated. Total bone marrow glycolysis for 18F-FDG (TBMFDG) and total bone marrow uptake for 68Ga-Pentixafor PET/CT (TBMCXCR4) were calculated using whole-body metabolic tumor burden obtained by dedicated software (MIM 7.0.6). The patients were followed for 19-24months, and the association of PET-derived quantitative data with overall survival (OS) was analyzed. 68Ga-Pentixafor PET/CT was positive in 17 patients, of which 13 were also positive on 18F-FDG PET/CT, whereas 7 patients were negative on both scans. The positive rate of 68Ga-Pentixafor and 18F-FDG PET/CT on a patient-based approach was 70.8% and 54.1%, respectively. 68Ga-Pentixafor positivity was significantly associated with OS (p = 0.009), and 18F-FDG positivity was at the margin of statistical significance (p = 0.056). TBMCXCR4 and TBMFDG were negatively correlated with OS (r = -0.457, p = 0.025 and r = -0.617, p = 0.001, respectively). The OS was negatively correlated with beta-2-microglobulin levels (r = -0.511, p = 0.01) and CRAB score (r = -0.592, p = 0.002) as an indicator of the end-organ disease, which confirmed these results. Serum beta-2-microglobulin levels and CRAB score were also correlated with TBMCXCR4 (r = 0.442, p = 0.039 and r = 0.573, p = 0.003, respectively) and TBMFDG (r = 0.543, p = 0.009 and r = -0.424, p = 0.003, respectively). 68Ga-Pentixafor PET/CT positivity is a negative prognostic factor in the survival outcome of MM patients. Complementary 68Ga-Pentixafor PET/CT has the potential to overcome 18F-FDG PET/CT limitations and helps a more precise risk stratification.

Basic psychometric markers of post-traumatic stress disorder in combatants

In the study, the authors determined psychometric markers of post-traumatic stress disorder (PTSD) in combatants. The study was conducted during 2016—2018, 150 military personnel were examined. The sample was formed by the criterion of the PTSD presence/absence in combatants. Two groups of comparison were formed: the group 1 consisted of 93 persons with diagnosis of PTSD (F43.1) according to the ICD-10 criteria; the group 2 consisted of 57 conditionally healthy persons (without signs of PTSD). All the examined persons were men, their average age was 33.71 ± 1.34 years old. They were mainly sergeants and privates of the Armed Forces of Ukraine (AFU), who served under the contract, the average duration of their participation in military actions was 214.7 ± 41.55 days. Research methods: clinical-psychopathological, clinical-anamnestic, psychodiagnostics ones: Mississippian Scale of Post-traumatic Stress Disorder (military version) (T. M. Keane et al., 1987); Questionnaire for the Severity of Psychopathological Symptoms (SCL- 90-R) (L. R. Derogatis et al., 1977, adapted by V. Starcevic et al., 2000); Hospital Anxiety and Depression Scale (HADS) (A. S. Zigmond, R. P. Snaith, 1983); The Scale of the Clinical Assessment of the Severity of Violations by Y. I. Levin (1995). The results of the investigation expanded the information on the mental status of the AFU combatants who took part in the military actions in the East of Ukraine, by means of quantified assessment of PTSD symptoms. An important component of the rehabilitation of combatants with PTSD is the establishment of an appropriate therapeutic environment the against patient-based approach in order to potentiate the psychological, psychotherapeutic work aimed at restoring the interrelations of combatants at the level of micro- and macroenvironment. Key words: combatants, post-traumatic stress disorder, post-stress mental disorder, combat mental trauma

The management of lower limb arteriovenous grafts in the perioperative period following renal transplantation.

The presence of a lower limb arteriovenous graft (LL-AVG) is indicative of a group of complex hemodialysis patients who have precarious long-term vascular access. The aim of this study is to describe our experience of the clinical decisions and interactions between LL-AVG and renal transplantation. The records of 23 patients who received a transplant in the presence of a LL-AVG between 2010 and 2018 were analyzed: firstly, to determine whether patients with a LL-AVG received extended criteria transplants, the implantation procedure, and the management of the LL-AVG in the post-operative period. Seventeen patients (74%) had "end-stage access" and were thus considered for all offer stratified by the kidney donor profile index (KDPI) and donor type (DBD or DCD). In eleven patients (48%), a kidney with a high risk of delayed graft function was transplanted. Same-sided renal transplantation occurred in only 35% of cases, and of these, only one LL-AVG was ligated immediately to improve transplant perfusion. A patient-based approach applied in decision-making on management of the LL-AVG post-transplantation should include (a) the likelihood of delayed graft function, (b) the need for post-operative hemodialysis, (c) the side of proposed transplant compared to the LL-AVG, and (d) local complications.

Standardized cardiovascular magnetic resonance imaging (CMR) protocols: 2020 update

This document is an update to the 2013 publication of the Society for Cardiovascular Magnetic Resonance (SCMR) Board of Trustees Task Force on Standardized Protocols. Concurrent with this publication, 3 additional task forces will publish documents that should be referred to in conjunction with the present document. The first is a document on the Clinical Indications for CMR, an update of the 2004 document. The second task force will be updating the document on Reporting published by that SCMR Task Force in 2010. The 3rd task force will be updating the 2013 document on Post-Processing. All protocols relative to congenital heart disease are covered in a separate document.The section on general principles and techniques has been expanded as more of the techniques common to CMR have been standardized. A section on imaging in patients with devices has been added as this is increasingly seen in day-to-day clinical practice. The authors hope that this document continues to standardize and simplify the patient-based approach to clinical CMR. It will be updated at regular intervals as the field of CMR advances.

Acceptability of a theory-based adherence intervention for adults with asthma – a person-based approach

Objective: Nonadherence to inhaled corticosteroids contributes to poor asthma control. This study evaluated two different theory-based intervention approaches to address nonadherence in adults with asthma using a person-based, qualitative approach to investigate comprehensibility, coherence and acceptability.Methods: The two intervention approaches addressed treatment beliefs and misconceptions in asthma, aiming to provide a common-sense rationale for medication adherence. Approach one reframed asthma using a concept of balance, the second approach was more traditional presenting medical consequences of nonadherence. We ran three focus group interviews involving 19 adults with asthma to investigate patient acceptability of the intervention approaches and their influence on perceptions of asthma and medication.Results: Approach one was perceived as novel compared to current practice, logical and easily understandable. Its use of non-medical jargon was perceived as representing information more positively, moving away from stigmatizing people with asthma. Approach two was perceived as not sufficiently novel, not applicable to everyone’s illness experience and triggering fear.Conclusions: Patient feedback allowed us to refine our intervention strategy prior to running costly feasibility trials. Patient-based approaches for intervention planning may facilitate implementation and acceptability of interventions in practice.

Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this Study Within A Trial (SWAT) is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-based approach to receiving trial results for participants in the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST), a trial of thyroxine versus placebo in people aged 65 years and older. Methods: Mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-based approach using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-based approach) and control group (standard approach developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two groups. Results: Participants want to receive results of clinical trials, with qualitative findings indicating three key themes including ‘acknowledgement of individual contribution’, ‘contributing for a collective benefit’ and ‘receiving accessible and easy to understand results’. Building on these findings, the patient-based approachwas developed. TRUST participants (n=101) were randomised to the intervention (n=51) or control group (n=50). The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two approaches. Conclusions: We have demonstrated that it is feasible to involve trial participants in the development of result dissemination materials. Although, in this study PPI did not influence patients’ understanding of results, it documents the process of conducting PPI within the clinical trial setting.