Retrospective Review Research Articles

Expanding the phenotype of neurofibromatosis type 1 microdeletion syndrome.

Neurofibromatosis type 1 (NF-1) microdeletion syndrome accounts for 5 to 11% of individuals with NF-1. The aim of our study was to characterize a large cohort of individuals with NF-1 microdeletion syndrome and expand its natural history. We conducted a retrospective chart review from 1994 to 2024 of individuals with NF-1 microdeletion syndrome followed at two large Neurofibromatosis Clinics. This cohort consists of 57 individuals with NF-1 microdeletion syndrome (28 type-1, 4 type-2, 2 type-3, 9 atypical deletions, and 14 indeterminate). We note 38/56 (67.9%) with describable facial features, 25/57 (43.8%) with plexiform neurofibromas, and 3/57 (5.2%) with malignant peripheral nerve sheath tumors within the observed period. The most reported neurodevelopmental manifestations from school-age or older individuals included 39/49 (79.6%) with developmental delays, 35/49 (71.4%) with expressive and/or receptive speech delays, 33/41 (80.5%) with learning difficulties, and 23/42 (54.8%) with attention-deficit/hyperactivity disorder. Full-scale IQ testing data was available for 22 individuals (range: 50-96). Of the 21 adults in this cohort, 14/21 (66.7%) graduated from high school, and 4/21 (19.0%) had some college experience. Many individuals received academic support (i.e., special education, individual education plan). In this cohort, neurocognitive outcomes in adults varied more than typically reported in the literature.

Individual placement and support in mental health services: evaluation of routine clinical data using aretrospective chart review

People with severe mental illnesses are often excluded from working life and would like support to (re)enter the general labor market as part of the psychiatric treatment. Individual placement and support (IPS) is an effective method of finding and retaining work in the general labor market. The aim of the study was to determine the integration rates of IPS into the general labor market in acute and postacute psychiatric settings, identifying patient, setting and program characteristics associated with (re)entering work. A retrospective chart review (RCR) of routine clinical data between 2016 and 2021 was carried out. The IPS program adherence was rated using the IPS fidelity scale. A total of 375 patients participated in the IPS with at least 4 appointments. The (re)integration rate into the general labor market was 51.7%. A shorter time period to the last working day, diagnosis of F1, F2, F3 (vs. F4), change of treatment setting and IPS in the psychiatric institute outpatient department (PIA), IPS fidelity and the number of IPS coaching sessions were positively correlated with (re)integration into work. The implementation of IPS in clinical mental healthcare is possible and leads to high integration rates in the open labor market. An early start of IPS during the clinical treatment can promote social inclusion.

Australia's first cardiac emergency department: Patient profile, activity and performance in the initial 6 months.

To profile the initial 6-month experience at the Victorian Heart Hospital (VHH) cardiac emergency (CE). The primary objective was to describe VHH CE patient characteristics, including presenting complaint, final diagnosis and disposition. Secondary objectives were to report on patient numbers, patient source and quality indicator performance including ambulance off-load by 40 min, waiting time and length of stay (LOS). A retrospective review included all patients who presented to the VHH CE from 9 March 2023 to 8 September 2023. Patient reports containing the relevant clinical information were generated from the CE electronic medical record system. Diagnoses of MI were checked for accuracy by full record review. There were 3303 CE presentations in the first 6 months of operation, of which 6% were transferred from other sites. Median age was 65 years (interquartile range [IQR]: 53-77), 56% were males; the most common presenting complaints were presumed cardiac chest pain (67%) and arrhythmia (17%). The admission, discharge and transfer rates were 38%, 54% and 8%, respectively. In total, 15% were diagnosed with MI. The most common diagnoses for discharged and admitted patients were non-specific chest pain (57%) and ST-elevation MI (22%), respectively. Ambulance off-load by 40 min was met for 96%. Median waiting time was 6 min (IQR: 3-10). Median CE LOS for discharged and admitted patients was 3.2 h (IQR: 2.5-4.0) and 3.7 h (IQR: 1.8-6.0), with 75% and 56% being <4 h, respectively. The population predominantly had cardiovascular disease as expected. Some performance indicators, including ED LOS, were identified as requiring intervention.

Optimizing hemostasis in HoLEP surgery: retrospective review of selective bipolar plasmakinetic technology guided by bladder irrigation fluid color.

To evaluate the effectiveness of selective bipolar plasmakinetic technology based on bladder irrigation fluid color on hemostasis in HoLEP surgwery METHODS: A total of 209 patients who underwent HoLEP surgery from October 2021 to July 2023 were included and divided into Hemostasis Management Group and control group. the color of the irrigation fluid was categorized into 5 levels and the bipolar plasmakinetic technology was applied when the color came to level 4 or up. The following was analyzed: postoperative use of balloon compression, blood loss, irrigation time, length of hospital stay, and the number of a second operation. Only 4 patients in Hemostasis Management Group required postoperative urinary catheter balloon compression, while there are 15 in the control group(p=0.03). The average irrigation time for patients in the HM Group with bipolar plasmakinetic hemostasis was 21.88±13.76 hours, compared to that in patients with catheter balloon compression(p=0.007). Based on the bladder irrigation color chart, the selective application of bipolar plasmakinetic hemostasis led to a significant reduction in the number of patients requiring postoperative bladder catheter balloon compression. Secondly, the irrigation time of patients who underwent bipolar plasmakinetic hemostasis also decreased.

Reducing recurrence rates in hiatal hernia repair: Results of a quality improvement study.

Patient and procedure factors are considered in the decision-making process for surgical repair of hiatal hernias. Recurrence is multi-factorial and has been shown to be related to size, type, BMI and age. This study examined recurrence rates in a single institution, identified areas for improved surgical technique, and re-assessed recurrence following implantation of a quality improvement initiative. A retrospective review of patients undergoing hiatal hernia repair surgery between 2018 and 2022 was conducted. Demographics, pre-operative characteristics, intra-operative procedures and recurrence rates were reviewed. Seventy-five patients from 2018 to 2020 and 34 patients from 2021 to 2022 were identified. The recurrence rate was 21% in 2018-2020, with 14% requiring a revisional procedure. Recurrence and re-operation were subsequently reduced to 6% in 2021 and 2022, which was statistically significant (p = 0.043). There was an increase in gastropexy from 21% to 41% following the review (p = 0.032), which wasmainly reserved for large and giant hernias. Procedural and literature review, alongside gastropexy, can be attributed to recurrence rate reduction. It is important to educate patients on the likelihood and risk factors of recurrence. A comprehensive review of procedures and a quality improvement program in our facility for hiatal hernia repair is shown to reduce recurrence.

Closing the Loop on Revision: The Impact of Emotional Well-Being on Elective Revision After Breast Reconstruction.

A diagnosis of breast cancer has a significant impact on a patient's physical and emotional health. Breast reconstruction improves quality of life and self-esteem following mastectomy. However, many patients undergo additional elective revision procedures after reconstruction. This study aims to assess the relationship between perioperative emotional well-being and elective revisions in breast reconstruction. A retrospective review was performed of patients who underwent breast reconstruction with a single surgeon from January 2007- December 2017. Revision procedures were defined as additional operations that fall outside the index reconstructive plan. Medical records were reviewed for a history of generalized anxiety disorder (GAD) and/or major depressive disorder (MDD). Multivariate analysis was performed to identify factors associated with revision. A total of 775 patients undergoing breast reconstruction were included, of which 121 (15.6%) underwent elective revision. Overall, a history of any psychiatric history (p<0.001), depression alone (p=0.001%), and GAD and depression together (p=0.003) were significantly associated with revision surgery. On multivariate logistic regression controlling for comorbidities and reconstruction modality, depression alone and GAD and depression together were significantly associated with increased likelihood of revision surgery (OR 3.20, p<0.001; OR 2.63, p<0.001). Peri-operative emotional well-being and reconstruction modality impact the rate of secondary revision surgery. An understanding of the surgical and patient-related risk factors for revision can provide more informed patient-decision making and improve surgical planning.

Revisiting oligodendroglioma grading in the 2021 WHO classification: calcification and larger contrast-enhancing tumor volume may predict higher oligodendroglioma grade.

To investigate whether qualitative and quantitative imaging phenotypes can predict the grade of oligodendroglioma. Retrospective chart and imaging reviews were conducted on 180 adults with oligodendroglioma (IDH-mutant and 1p/19q codeleted) between 2005 and 2021. Qualitative imaging characteristics including tumor location, calcification, gliomatosis cerebri, cystic change, necrosis, and infiltrative pattern were analyzed. Quantitative imaging assessment was performed from the tumor mask via automatic segmentation to calculate total, contrast-enhancing (CE), non-enhancing (NE), and necrotic tumor volumes. Logistic analyses were conducted to determine predictors of oligodendroglioma grade. This study included 180 patients (84 [46.7%] with grade 2 and 96 [53.3%] with grade 3 oligodendrogliomas), with a median age of 42 years (range 23-76 years), comprising 91 females and 89 males. On univariable analysis, calcification (odds ratio [OR] = 6.00, P < 0.001), necrosis (OR = 21.84, P = 0.003), presence of CE tumor (OR = 7.86, P < 0.001), larger total (OR = 1.01, P < 0.001), larger CE (OR = 2.22, P = 0.010), and larger NE (OR = 1.01, P < 0.001) tumor volumes were predictors of grade 3 oligodendroglioma. On multivariable analysis, calcification (OR = 3.79, P < 0.001) and larger CE tumor volume (OR = 2.70, P = 0.043) remained as independent predictors of grade 3 oligodendroglioma. The multivariable model exhibited an AUC, accuracy, sensitivity, specificity of 0.78 (95% confidence interval 0.72-0.84), 72.8%, 79.2%, 69.1%, respectively. Presence of calcification and larger CE tumor volume may serve as useful imaging biomarkers for prediction of oligodendroglioma grade. Assessment of intratumoral calcification and CE tumor volume may facilitate accurate preoperative estimation of oligodendroglioma grade. Presence of intratumoral calcification and larger contrast-enhancing tumor volume were the significant predictors of higher grade oligodendroglioma based on the 2021 WHO classification.

Diagnostic Discrepancies in the Emergency Department: A Retrospective Study.

Diagnostic errors contribute substantially to preventable medical errors. Especially, the emergency department (ED) is a high-risk environment. Previous research showed that in 15%-30% of the ED patients, there is a difference between the primary diagnosis assigned by the emergency physician and the discharge diagnosis. This study aimed to determine the number and types of diagnostic discrepancies and to explore factors predicting discrepancies. A retrospective record review was conducted in an academic medical center. The primary diagnosis assigned in the ED was compared with the discharge diagnosis after hospital admission. For each patient, we gathered additional information about the diagnostic process to identify possible predictors of diagnostic discrepancies. The electronic health records of 200 patients were reviewed. The primary diagnosis assigned in the ED was substantially different from the discharge diagnosis in 16.0%. These diagnostic discrepancies were associated with a higher number of additional diagnostics applied for (2.4 versus 2.0 diagnostics; P = 0.002) and longer stay in the ED (5.9 versus 4.7 hours; P = 0.008). A difference between the diagnosis assigned by the emergency physician and the discharge diagnosis was found in almost 1 in 6 patients. The increased number of additional diagnostics and the longer stay at the ED in the group of patients with a diagnostic discrepancy suggests that these cases reflect the more difficult cases. More research should be done on predictive factors of diagnostic discrepancies.

Long-Term Plate Complications in Patient-Specific Plates Utilizing Computer-Aided Design.

Assess the long-term plate complications with patient-specific plates (PSPs) created with computer-aided design (CAD) and computer-aided manufacturing (CAM) for fibula free flap reconstructions for mandibular defects. Retrospective chart review from January 2010 to July 2022 of patients who underwent mandibular reconstruction with a fibula free flap and PSP. Primary outcome was plating-related complications, defined as plate exposure, fracture, loose screws, and plate removal. A total of 221 patients underwent PSP fibula reconstruction. Average age was 59.8 + 14.3 years old with male to female ratio of 2:1. Squamous cell carcinoma of the mandible was the most common reason for resection, 47.5%, n = 105. Plate removal occurred in 11% of patients (n = 25) about 17.4 months after the initial surgery. Plates were removed due to exposure (76%, n = 19) or screw loosening (24%, n = 6). Malignancy was associated with an increased risk of plate complications when compared to benign tumor (odds ratio [OR] 9.04, confidence interval [CI] 1.36-3.85), osteonecrosis (OR 1.38, CI 0.59-3.48), and trauma (OR 1.26, CI 0.23-12.8). Postoperative radiation therapy (OR 2.27, CI 1.07-4.82, p = 0.026) and surgical site infection (OR 9.22, CI 4.11-21.88, p = 0.001) were associated with more plate complications. CAD creates PSPs that remain stable in the majority of patients over the long term. Plate removal is less compared to non-PSP reconstruction. Consideration of the soft tissue envelope over the plate and management of perioperative infection at the time of surgery should be entertained. Level 4 Laryngoscope, 2024.

Reporting of Incidental Thrombotic Arteriopathy in Lung Resection Specimens: Examination of Clinical Impact.

Pulmonary thrombotic arteriopathy (PTA) can be an incidental finding in lung resections performed for various indications. Historic studies largely examined PTA in autopsies. Thus, the prevalence in surgical samples, particularly in the modern era of lung cancer screening, is poorly defined. Detection of PTA in surgical samples may provide an opportunity for therapeutic intervention, but the impact of this finding on clinical management is unknown. We retrospectively examined consecutive lung surgical resections containing a report of incidental PTA between 2019 and 2022 in our institution. A retrospective chart review was performed to determine the history of systemic thromboembolism and clinical and radiographic follow-up. All slides were reviewed to morphologically characterize the vascular changes. Among 2930 pulmonary resections, 66 (2.3%) reportedly contained PTA. Twenty-four (36.4%) patients had a clinically recognized thromboembolic event either before or after surgical resection. Patients with clinically recognized thromboembolic disease were significantly more likely to have both acute and organized thrombi affecting large arteries. The presence of infarct, chronic hypertensive vasculopathy, or number of vessels with thrombi were not significantly associated with a clinically detected event. Reporting of incidental PTA led to clinical intervention in six patients and confirmed systemic thromboembolic disease in 2. Moreover, 2 patients with no further workup based on the incidental pathology findings subsequently developed pulmonary embolism. PTA is incidentally detected in 2.3% of surgical lung resections, and in two-thirds of cases, there is no clinical suspicion of thromboembolic disease. Pathologic reporting of PTA rarely led to clinical intervention, suggesting a need for improved communication of incidental pathology findings.

Impact of a new state law and electronic health record prompt on naloxone prescribing in an academic medical center.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. To evaluate the impact of a best-practice advisory (BPA) and South Carolina legislation on naloxone prescribing patterns. The primary objective was to assess the change in naloxone prescription rates following BPA implementation. The secondary objective was to analyze the performance of the BPA. Naloxone prescriptions generated before (July 28, 2020, through July 27, 2021) and after (July 28, 2021, through July 28, 2022) BPA implementation were analyzed via retrospective chart review. Lists of patients at risk for opioid overdose and patients for whom the BPA fired were generated for March 2022. The BPA's effectiveness was evaluated based on the proportion of at-risk patients missed by the alert, the frequency with which the BPA resulted in a naloxone prescription, and the reasons for not prescribing naloxone when the BPA fired. Following BPA implementation, there was a significant increase in the average monthly naloxone prescribing rate from 66.1 to 625.5 prescriptions per month. Overall, 2,086 patients were considered at risk for opioid overdose and 1,101 had a BPA alert during March 2022, with 32.7% of BPA alerts resulting in naloxone prescribing. The most common reasons selected for not prescribing naloxone were "patient refusal" and "criteria not met." Only 354 patients (17.1%) at risk for opioid overdose also had a BPA alert. State legislation and implementation of the BPA significantly increased naloxone prescribing rates. However, a significant proportion of patients identified as being at risk did not have a BPA alert and most BPA alerts did not result in naloxone prescribing, suggesting a need for improvement of the BPA.

A non-interventional, multicenter study to characterize the socio-demographics, clinical characteristics, and management of Generalized Pustular Psoriasis (GPP) patients in Spain: IMPULSE study.

Generalized pustular psoriasis (GPP) is a chronic, rare, and potentially life-threatening skin condition characterized by flares comprising widespread sterile pustules and systemic inflammation. Both the rarity and heterogeneity of the disease have made GPP classification and standardization of clinical criteria challenging. Before the approval of spesolimab (IL-36R antibody) in 2022 there were no approved treatments in the USA or Europe for GPP flares. Treatment for GPP has amounted to off-label use of medicines approved to treat plaque psoriasis. Our aim was to describe the socio-demographics, clinical characteristics, and treatment patterns of patients with GPP in Spain. Non-interventional, descriptive, multi-center, retrospective chart review of patients diagnosed with GPP in Spain. 56 patients (50% women) were included, with a mean (SD) age at diagnosis of 53.7 (20.5) and a mean (SD) time of follow-up of 3.7 (3.1) years. In 80% of patients, GPP diagnosis was associated with a flare and 67.3% had known risk factors for GPP [such as previous diagnosis or family history of plaque psoriasis, comorbidities, smoking or stress. Hypertension and plaque psoriasis were the most frequent comorbidities (44.6% each). The number of GPP flares per patient-year was 0.55 with (range 0-4) a mean (SD) body surface area involvement of 21.3% (19.1). The most frequent manifestations of GPP flares were pustules (88.5%), erythema (76.9%) and scaling (76.9%). Additionally, 65.4% of patients had plaque psoriasis, 53.8% had unspecified skin lesions, and 30.8% experienced pain. The treatments used for GPP flares were off-label conventional systemic drugs (75%), mostly corticosteroids, cyclosporine and acitretin. In the periods between flares, off-label biologics were used in 56.5% of patients. During the study period, 9 patients (16.1%) had at least one complication, and 5 of them required hospitalization. This is the first multi-center study in Spanish GPP patients. Most patients were in their fifties, with personal or family history of plaque psoriasis, stress, smoking and a wide range of comorbidities and complications. Even though the number of flares per patient/year was 0.55, there was variability between patients. Both off-label conventional systemics and off-label biologics were used for flare management without a clear treatment pattern.

Myringoplasty Using Human Birth Tissue Allografts to Repair Large Tympanic Membrane Perforations.

Examine outcomes among a series of pediatric patients who underwent myringoplasty using human birth tissue (BT) for repair of large tympanic membrane (TM) perforations. Case series. Single-institution pediatric hospital. Retrospective chart review of patients treated with BT during a 4-year study period. Subjects who underwent myringoplasty for large (size 40% or greater) TM perforations were included for this study. Patients with a stable perforation of at least 1 month's duration preoperatively who then followed up for at least 3 months postoperatively met inclusion criteria. Six subjects were included in this study. One subject underwent bilateral repair; thus, this series includes a total of 7 perforations. TM perforations ranged from 40% to 70% of the TM. At initial follow-up (median of 2 months), 5 of the 7 perforations had healed. One of these 5 had evidence of a 10% recurrent perforation at 5 months, which subsequently healed. Of the 2 patients not healed at initial follow-up, 1 had only a residual pinpoint perforation that subsequently healed; the other had a persistent 30% perforation that was possibly related to their postoperative recovery period, which was complicated by a respiratory viral illness. For large TM perforations, myringoplasty with BT grafts may be a viable alternative to longer, more invasive procedures like tympanoplasty. Larger, randomized, prospective studies are needed.

Effect of combined rapid access point-of-care intestinal ultrasound clinic on the management of inflammatory bowel disease

BackgroundIntestinal ultrasound (IUS), although less widely practiced in the UK, offers several advantages in inflammatory bowel disease (IBD), particularly with regard to the accessibility of the test and immediate availability...

Health markers, depressive symptoms, and community deprivation in a type 2 diabetes multidisciplinary care clinic for youth

IntroductionType 2 diabetes disproportionately affects non-Hispanic/Latino Black and Hispanic/Latino youth. The purpose of this study was to examine whether differences in metabolic risk factors and depressive symptoms exist by race/ethnicity and socioeconomic deprivation and whether these impact clinic attendance and health markers over 1 year in a multidisciplinary type 2 diabetes clinic for youth.MethodsThis study was a retrospective chart review of 54 youth with type 2 diabetes who had both an initial and follow-up visit. Demographic information, metabolic health markers [body mass index (BMI), hemoglobin A1C, liver enzymes, lipid panel, and urine microalbumin], depressive symptoms, and clinic attendance data were obtained from the medical record. Patient address was geocoded to the census tract level to calculate community socioeconomic deprivation.ResultsLiver enzymes (ALT and AST) were significantly higher in patients identifying as Hispanic/Latino (ALT M = 97.0 ± 40.6, AST M = 53.6 ± 21.4) and lowest in patients identifying as non-Hispanic/Latino Black (ALT M = 23.1 ± 11.3, F = 10.6 p < .001; AST M = 23.1 ± 11.4, F = 8.1; p < .001) at initial visit. From initial visit to follow-up, there were significant improvements in ALT (F = 13.43, p < .001), AST (F = 6.58, p < .05), and BMIz (F = 18.39, p < .001). Patients identifying as Black or Hispanic showed an increase in depressive symptoms over time, while patients identifying as non-Hispanic White showed a decrease (F = 11.08; p < .05). Unexpectedly, patients living in areas with higher socioeconomic deprivation showed a decrease in hemoglobin A1C over time, while patients living in lower socioeconomic deprivation showed an increase (F = 5.15, p < .05).ConclusionsDifferences exist in metabolic health parameters by race/ethnicity and by socioeconomic deprivation. Multidisciplinary care for youth with type 2 diabetes needs to consider and work to address the systems of inequity experienced by patients that drive disparities in health outcomes.

Neurological manifestations of ehrlichiosis among a cohort of patients: prevalence and clinical symptoms

BackgroundEhrlichiosis is a potentially fatal tick-borne disease that can progress to involve the central nervous system (CNS) (i.e., neuro-ehrlichiosis), particularly in cases where diagnosis and treatment are delayed. Despite a six-fold national increase in the incidence of ehrlichiosis over the past 20 years, recent data on the prevalence and manifestations of neuro-ehrlichiosis are lacking.MethodsWe conducted a retrospective chart review of all patients tested for ehrlichiosis at University of North Carolina Health facilities between 2018 and 2021 and identified patients who met epidemiological criteria for ehrlichiosis as established by the Council of State and Territorial Epidemiologists and employed by the Centers for Disease Control and Prevention. We estimated the prevalence of neurological symptoms and described the spectrum of neurological manifestations in acute ehrlichiosis, documenting select patient cases in more detail in a case series.ResultsOut of 55 patients with confirmed or probable ehrlichiosis, five patients (9.1%) had neurologic symptoms, which is notably lower than previous estimates. Neurological presentations were highly variable and included confusion, amnesia, seizures, focal neurological deficits mimicking ischemic vascular events, and an isolated cranial nerve palsy, though all patients had unremarkable neuroimaging at time of presentation. All but one patient had risk factors for severe ehrlichiosis (i.e., older age, immunosuppression).ConclusionsNeuro-ehrlichiosis may lack unifying patterns in clinical presentation that would otherwise aid in diagnosis. Clinicians should maintain a high index of suspicion for neuro-ehrlichiosis in patients with acute febrile illness, diverse neurological symptoms, and negative neuroimaging in lone star tick endemic regions.

Using Machine Learning for Endoscopic Detection of Low-Grade Subglottic Stenosis: A Proof of Principle.

The current study trains, tests, and evaluates a deep learning algorithm to detect subglottic stenosis (SGS) on endoscopy. A retrospective review of patients undergoing microlaryngoscopy-bronchoscopy was performed. A pretrained image classifier (Resnet50) was retrained and tested on 159 images of airways taken at the glottis, 106 normal-sized airways, and 122 with SGS. Data augmentation was performed given the small sample size to prevent overfitting. Overall model accuracy was 73.3% (SD: 3.8). Precision and recall for stenosis were 77.3% (SD: 4.0) and 72.7 (SD: 4.0). F1 score for the detection of stenosis was 0.75 (SD: 0.04). Precision and recall for normal-sized images were lower at 69% (SD: 4.35) and 74% (SD: 4), with an F1 score of 0.71 (SD: 0.04). This study demonstrates that an image classification algorithm can identify SGS on endoscopic images. Work is needed to improve diagnostic accuracy for eventual deployment of the algorithm into clinical care.

Reflections on the challenges of conducting an international multicentre randomized controlled trial of balance training in addition to pulmonary rehabilitation and its impact on fall incidence in people with COPD

BackgroundPulmonary rehabilitation (PR) is accepted as standard care for individuals with COPD. We conducted an international, multi-centred randomized controlled trial (RCT) to determine if adding balance training to PR would reduce the incidence of falls in people with COPD. While there have been many trials investigating the effectiveness of PR, few have involved international collaboration. Successful execution of rehabilitation trials requires a significant investment of time, staffing, and resources. With the recent completion of the Balance Training for Fall Reduction in COPD RCT, we report on the design, implementation, and execution of our trial using project management phases. We also highlight our lessons learned for consideration in future multi-centre rehabilitation trials.MethodsThis was a retrospective review of the planning, preparation, timelines, and personnel training involved in the execution of this study using four of the five project management phases described by Farrell et al. in 2010: (1) initiation, (2) planning, (3) execution, and (4) monitoring and controlling. We report descriptive statistics as percentages and counts and summarize our lessons learned.ResultsTen outpatient PR programs in three continents participated. Thirty-one personnel worked on the trial across all sites. Enrolment began in January 2017 and was suspended in March 2020 due to the COVID-19 pandemic. Approximately 1275 patients were screened, 455 (36%) were eligible, 258 (57%) consented, 243 (53%) participated, and 130 (61%) completed the 12-month follow-up assessment. Lessons learned through our experience included (1) ensuring awareness of funder policies and considering the impact on collaborating sites; (2) preparing for the possibility of human resource and program disruptions; (3) anticipating site dropout and having a contingency plan in place; (4) planning and monitoring process measure data before, during, and after trial initiation; (5) ensuring frequent and consistent communication with and between collaborating sites; (6) maximizing features of database platform to ensure data set completeness and controlled data access; and (7) identifying strategies for increasing patient engagement in a high-demand study.ConclusionsWe identify seven lessons learned through our experience conducting an international, multicentre rehabilitation-based RCT. These lessons can provide guidance to other trialists conducting studies with similar logistics and may assist with future trial planning and implementation.

A multimodal approach to diagnosis of neuromuscular neosporosis in dogs.

Early diagnosis of neosporosis in dogs is challenging. To evaluate the feasibility of a compound multimodal testing approach for diagnosing in dogs neuromuscular and combined forms of neosporosis. A total of 16 dogs diagnosed with solely neuromuscular neosporosis or with a combination of neuromuscular and central nervous system neosporosis. Retrospective review of clinical signs, laboratory findings, treatment, and outcome with focus on the diagnostic utility of different tests. Development of a chromogenic in situ hybridization (ISH) assay for the identification of Neospora caninum in paraffin-embedded muscle samples. 13/16 dogs had only neuromuscular signs of neosporosis, 3/16 had disease signs with concomitant central nervous system (CNS) involvement. Serology was performed in 15/16, with 10/15 showing titers >1 : 160 at admission. PCR on muscle samples detected N. caninum DNA in 11/16. Immunohistochemistry (IHC) detected N. caninum in 9/16 and ISH in 9/16. Histopathology revealed inflammatory myopathy in 10/16, necrotizing myopathy in 5/16, borderline changes in 1/16 and tachyzoites in 9/16. In 4 cases, N. caninum infection was confirmed with all 5 diagnostic methods, 3 cases with 4, 2 with 3, 6 with 2, and 1 animal with 1. Diagnosis of N. caninum infection should rely on a multimodal diagnostic approach and negativity of 1 single test should not allow for exclusion. Serology in combination with direct parasite identification via histopathology, DNA via PCR, or both modalities, appears a reliable diagnostic approach.

Laparoscopic Pancreaticoduodenectomy With Open Reconstruction: The Buddha's Middle Path.

Laparoscopic pancreaticoduodenectomy (LPD) is not universally adopted because of its steep learning curve. Its technical complexity discourages many surgeons. We believe that laparoscopic pancreaticoduodenectomy with open reconstruction (LPOR) has all the benefits of LPD without its drawbacks and combines the ease of open surgery with the benefits of minimal access surgery. We assessed the feasibility and safety of LPOR and compared it with open pancreaticoduodenectomy (OPD), with the objectives being perioperative and short-term clinical/oncologic outcomes. Retrospective review of prospectively maintained database; study period from January 2013 to December 2019. Till 2015, we did only OPD. In 2016, we started with LPD but soon switched to LPOR. The resection part was done laparoscopically and the reconstruction part was done through a 8-cm mini-laparotomy. We did 19 OPDs and 15 LPORs. Demographic data of the 2 groups were comparable. The duration of surgery was significantly longer in the LPOR group (360 vs. 410min; P=0.01), whereas the blood loss and hospital stay were longer in the OPD group (520 vs. 360mL; P=0.03 and 13 vs. 11d; P=0.08, respectively). Clinically significant complication rates, including delayed gastric emptying and postoperative pancreatic fistulas, were not different in either group. No patients in the LPOR group had wound-related/pulmonary complications. Lymph node yield was similar in both groups (20 vs. 22) and we had 100% R0 resections. LPOR was better than OPD in terms of short-term outcomes and was not inferior to OPD in terms of complications/oncologic outcomes.