P100 Recruitment barriers in multicentre collaborative studies as demonstrated by a single unit experience of the Management of Acutely Symptomatic Hernias (MASH) study

Abstract Introduction MASH is a multi-centre prospective cohort study assessing the management of patients presenting with symptomatic abdominal wall hernia. Consenting patients are recruited during acute admission, with telephone follow up at day 30 and 90. We performed a retrospective review of all patients referred to a single general surgical unit with a symptomatic hernia to quantify recruitment rate and identify barriers to recruitment. Methods Patients meeting the inclusion criteria 1st August to 18th September were identified from prospective handover lists and electronic records and compared to the prospectively compiled screening log. Reason for not enrolment was coded according to protocol with an additional code added for patients not identified at time of admission. Results 8/23 (35%) eligible patients were enrolled. 15/23 (65%) were not enrolled due to; Patient not identified at time of admission n = 9 (60%), declined n = 2 (13.3%), too unwell to consent n = 2 (13.3%), translational barrier n = 1 (6.6%) and lacking capacity n = 1 (6.6%). Patients not identified at time of admission included those seen by clinicians not involved in study (new starters and locums) and those discharged directly from A&E with insufficient time and resources to gain consent. Conclusion In our unit 65% of eligible patients were not recruited, the majority of whom were missed at time of presentation. This study will generate important information on management and outcomes of acute hernias however strategies are required to recognise and mitigate recruitment bias. Staff turnover may be a significant factor in prospective studies, particularly those prolonged during the COVID-19 pandemic.

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Emphysematous pyelonephritis: is conservative management effective? Our experience and review of literature

International Surgery Journal ◽

10.18203/2349-2902.isj20200531 ◽

2020 ◽

Vol 7 (3) ◽

pp. 849

Author(s):

Atul Kumar Khandelwal

Keyword(s):

Percutaneous Drainage ◽

Early Stage ◽

Abdominal Mass ◽

Review Of Literature ◽

Emphysematous Pyelonephritis ◽

Life Threatening ◽

Laboratory Investigations ◽

Time Of Presentation ◽

Time Of Admission

Background: Emphysematous pyelonephritis (EPN) is a urologic emergency caused by a life-threatening necrotizing infection of the kidney leading to an accumulation of gas in the renal parenchyma and perirenal tissue. we present the clinical details and outcome of twelve patients of managed at our institute and discuss their management and outcomes.Methods: Twelve consecutive patients with EPN were managed in our institute from July 2014 to July 2018. Data on demographic profile, clinical features, laboratory investigations, imaging studies, outcome of patients and follow up details were recorded.Results: Out of 12 patients with EPN, nine were female and three were male. Ten patients were diabetic (83%). All the diabetic patient had raised blood sugar at the time of admission ureteric stone was present in two nondiabetic patients. All the patients had fever at the time of presentation while localized flank pain was present in 6 (50%) patients. On examination, renal angle tenderness was present in ten patients while abdominal mass found in three patients. Pyuria was found in all patients while leukocytosis found in 10 patients. Two patients had thrombocytopenia while 4 had deranged renal parameters at the time of admission. Urine culture showed Escherichia coli in 8 patients and Klebsiella in two patients. Four patients required percutaneous drainage. Interval nephrectomy was done in one patient due to non-functioning kidney.Conclusions: Majority of patients diagnosed as emphysematous pyelonephritis were managed conservatively due to diagnosed at an early stage. Percutaneous drainage is successfully utilized in patients with more advanced disease.

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Extremely Elevated Cerebrospinal Fluid Protein and Glucose Level in a Neonate with Hypernatremic Dehydration

Journal of Pediatric Neurology ◽

10.1055/s-0040-1708496 ◽

2020 ◽

Author(s):

Arti Maria ◽

Tapas Bandyopadhyay

Keyword(s):

Cerebrospinal Fluid ◽

Neurodevelopmental Outcome ◽

Neurological Sequelae ◽

Glucose Levels ◽

Csf Analysis ◽

First Case ◽

Time Of Admission ◽

Cerebrospinal Fluid Protein ◽

Hypernatremic Dehydration

AbstractWe describe the case of a term newborn who presented with hypernatremic dehydration on day 19 of life. The baby was otherwise hemodynamically stable with no evidence of focal or asymmetric neurological signs. The laboratory tests at the time of admission were negative except for hypernatremia and the extremely elevated levels of cerebrospinal fluid (CSF) protein (717 mg/dL) and glucose levels (97 mg/dL). The hypernatremic dehydration was corrected as per the unit protocol over 48 hours. Repeat CSF analysis done after 5 days showed normalization of the protein and glucose levels. Serial follow-up and neuroimaging showed no evidence of neurological sequelae. Unique feature of our case is this is the first case reporting such an extreme elevation of CSF protein and glucose levels that have had no bearing on neurodevelopmental outcome at 1 month and 3 months of follow-up.

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71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

Emergency Medicine Journal ◽

10.1136/emj-2020-rcemabstracts.21 ◽

2020 ◽

Vol 37 (12) ◽

pp. 835.3-836

Author(s):

Hamza Malik ◽

Andrew Appelboam ◽

Gordon Taylor ◽

Daryl Wood ◽

Karen Knapp

Keyword(s):

Data Collection ◽

Controlled Trial ◽

Wrist Fracture ◽

Recruitment Rate ◽

Feasibility Trial ◽

Point Of Care Ultrasound ◽

Distal Radial Fractures ◽

Definitive Trial ◽

Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

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Liver Failure in a Dog Following Suspected Ingestion of Blue-Green Algae (Microcystis spp.): A Case Report and Review of the Toxin

Journal of the American Animal Hospital Association ◽

10.5326/jaaha-ms-5913 ◽

2013 ◽

Vol 49 (5) ◽

pp. 342-346 ◽

Cited By ~ 15

Author(s):

Lionel Sebbag ◽

Nicole Smee ◽

Deon van der Merwe ◽

Dustin Schmid

Keyword(s):

Green Algae ◽

Acute Hepatic Failure ◽

Fresh Frozen Plasma ◽

Blue Green Algae ◽

Fresh Frozen ◽

Adenosyl Methionine ◽

B Complex Vitamins ◽

Time Of Admission ◽

Frozen Plasma

A 2.5 yr old spayed female Weimaraner presented after ingestion of blue-green algae (Microcystis spp.). One day prior to presentation, the patient was swimming at a local lake known to be contaminated with high levels of blue-green algae that was responsible for deaths of several other dogs the same summer. The patient presented 24 hr after exposure with vomiting, inappetence, weakness, and lethargy. Blood work at the time of admission was consistent with acute hepatic failure, characteristic findings of intoxication by Microcystis spp. Diagnosis was suspected by analyzing a water sample from the location where the patient was swimming. Supportive care including fluids, fresh frozen plasma, whole blood, vitamin K, B complex vitamins, S-adenosyl methionine, and Silybum marianum were started. The patient was discharged on supportive medications, and follow-up blood work showed continued improvement. Ingestion is typically fatal for most patients. This is the first canine to be reported in the literature to survive treatment after known exposure.

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Stereotactic radiosurgery at a low marginal dose for the treatment of pediatric arteriovenous malformations: obliteration, complications, and functional outcomes

Journal of Neurosurgery Pediatrics ◽

10.3171/2014.3.peds13381 ◽

2014 ◽

Vol 14 (1) ◽

pp. 1-11 ◽

Cited By ~ 33

Author(s):

Matthew B. Potts ◽

Sunil A. Sheth ◽

Jonathan Louie ◽

Matthew D. Smyth ◽

Penny K. Sneed ◽

...

Keyword(s):

Stereotactic Radiosurgery ◽

Functional Outcomes ◽

Arteriovenous Malformations ◽

Target Volume ◽

Neurological Deficits ◽

Single Institution ◽

Risks And Benefits ◽

Scale Scores ◽

Time Of Presentation

Object Stereotactic radiosurgery (SRS) is an established treatment modality for brain arteriovenous malformations (AVMs) in children, but the optimal treatment parameters and associated treatment-related complications are not fully understood. The authors present their single-institution experience of using SRS, at a relatively low marginal dose, to treat AVMs in children for nearly 20 years; they report angiographic outcomes, posttreatment hemorrhage rates, adverse treatment-related events, and functional outcomes. Methods The authors conducted a retrospective review of 2 cohorts of children (18 years of age or younger) with AVMs treated from 1991 to 1998 and from 2000 to 2010. Results A total of 80 patients with follow-up data after SRS were identified. Mean age at SRS was 12.7 years, and 56% of patients had hemorrhage at the time of presentation. Median target volume was 3.1 cm3 (range 0.09–62.3 cm3), and median prescription marginal dose used was 17.5 Gy (range 12–20 Gy). Angiograms acquired 3 years after treatment were available for 47% of patients; AVM obliteration was achieved in 52% of patients who received a dose of 18–20 Gy and in 16% who received less than 18 Gy. At 5 years after SRS, the cumulative incidence of hemorrhage was 25% (95% CI 16%–37%). No permanent neurological deficits occurred in patients who did not experience posttreatment hemorrhage. Overall, good functional outcomes (modified Rankin Scale Scores 0–2) were observed for 78% of patients; for 66% of patients, functional status improved or remained the same as before treatment. Conclusions A low marginal dose minimizes SRS-related neurological deficits but leads to low rates of obliteration and high rates of hemorrhage. To maximize AVM obliteration and minimize posttreatment hemorrhage, the authors recommend a prescription marginal dose of 18 Gy or more. In addition, SRS-related symptoms such as headache and seizures should be considered when discussing risks and benefits of SRS for treating AVMs in children.

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ALX148, a CD47 Blocker, in Combination with Rituximab in Patients with Non-Hodgkin Lymphoma

Blood ◽

10.1182/blood-2020-135941 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 13-14 ◽

Cited By ~ 1

Author(s):

Tae Min Kim ◽

Nehal Lakhani ◽

Justin Gainor ◽

Manali Kamdar ◽

Philip Fanning ◽

...

Keyword(s):

Immune Response ◽

Hodgkin Lymphoma ◽

Research Funding ◽

Tolerability Profile ◽

Low Grade ◽

Publicly Traded ◽

Private Company ◽

Non Hodgkin Lymphoma ◽

Time Of Presentation

Background: CD47 is a myeloid checkpoint upregulated by tumor cells to evade the host's immune response. The high affinity CD47 blocker fusion protein, ALX148, is linked to an inactive immunoglobulin Fc region to minimize toxicity. ALX148 is half the size of an antibody, has been well tolerated, and enhances the innate and adaptive immune response against cancer in combination with anticancer therapeutics across solid and hematologic tumors (ASCO 2020 #3056, EHA 2020 #EP1247). Characterization of ALX148's tolerability profile and antitumor activity in combination with rituximab are reported in patients (pts) with non-Hodgkin Lymphoma (NHL). Methods: Patients with relapsed or refractory CD20-positive B-cell NHL for which no curative therapy was available received ALX148 (10 mg/kg QW or 15 mg/kg QW) in combination with rituximab (375 mg/m2 weekly for 4 doses followed by once monthly for 8 doses). The primary endpoint for the safety population was dose limiting toxicity (DLT). Tumor response, pharmacokinetic (PK), and pharmacodynamic (PD) markers were assessed in all pts. Data are reported as of 30Jun2020 in these fully enrolled cohorts with final data to be updated at the time of presentation. Results: A total of 33 patients with NHL were administered ALX148 in combination with rituximab. Twenty-two pts with median age of 66 years (range 32-80) were administered ALX148, 10 mg/kg QW (ALX10), in combination with rituximab [DLBCL, n=11; mantle cell lymphoma (MCL), n=4; follicular lymphoma (FL), n=5; and marginal zone lymphoma (MZL), n=2]. Eleven pts with median age of 64 years (range 53-78) were administered ALX148, 15 mg/kg QW (ALX15), in combination with rituximab (DLBCL, n=6; MCL, n=1; FL, n=3; and MZL, n=1). There have been no DLTs reported in the fully enrolled safety cohorts, and the MTD of ALX148 in combination with rituximab has not been reached. The maximum ALX148 administered dose is 15 mg/kg QW. Twenty-eight pts experienced any AE, while 16 pts reported mostly low grade treatment-related adverse events (TRAE). The most common TRAEs were rash (21%, n=7), fatigue (9%, n=3), anemia, nausea, neutropenia, and pruritus (6%, n=2 each). With a median follow up of 14 months, objective responses were observed across all histologies in response-evaluable ALX10 pts: 40.9% ORR (4CR,5PR, 6SD, n=22 total) and with a median follow up of 9 months in ALX15 pts: 63.6% ORR (3CR, 4PR, 1SD, n=11 total). Preliminary results indicate favorable ALX148 PK and near complete CD47 receptor occupancy across the dosing interval. Final results will be updated at time of presentation. Conclusions: ALX148 demonstrates excellent tolerability with durable responses in combination with rituximab in patients with relapsed/refractory NHL. The MTD of ALX148 in combination with rituximab was not reached. Encouraging preliminary activity and favorable PK/PD characteristics in combination with rituximab were observed at all dose levels with greater objective response rates reported at the MAD of 15 mg/kg QW. Disclosures Kim: Boryung: Consultancy; Voronoi: Consultancy; F. Hoffmann-La Roche Ltd/Genentech, Inc.: Consultancy; Sanofi: Consultancy; Novartis: Consultancy; Takeda: Consultancy; AstraZeneca and Korea Health Industry Development Institute: Research Funding; AstraZeneca: Consultancy. Lakhani:incyte: Research Funding; merck: Research Funding; mersana: Research Funding; northern biologics: Research Funding; odonate: Research Funding; pfizer: Research Funding; ikena: Research Funding; symphogen: Research Funding; taiRx: Research Funding; tesaro: Research Funding; livzon: Research Funding; loxo: Research Funding; macrogenics: Research Funding; inhibRx: Research Funding; cytomx: Research Funding; formation biologics: Research Funding; forty seven inc: Research Funding; alexion Pharmaceuticals: Research Funding; Alpine Biosciences: Research Funding; ALX Oncology Inc.: Research Funding; Apexian: Research Funding; asana biosciences: Research Funding; ascentage pharma: Research Funding; beigene: Research Funding; celgene: Research Funding; cerulean pharma: Research Funding; constellation pharma: Research Funding; coordination therapeutics: Research Funding; regeneron: Research Funding; sapience therapeutics: Research Funding; shattuck labs: Research Funding; innovent bio: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; jounce therapeutics: Research Funding. Gainor:theravance: Consultancy; adaptimmune: Research Funding; ariad: Research Funding; astrazeneka: Research Funding; blueprint medicines: Research Funding; lily: Consultancy; gilead sciences: Consultancy; merck: Consultancy, Research Funding; moderna therapeutics: Consultancy, Research Funding; tesaro: Research Funding; blueprint medicines: Consultancy; novartis: Research Funding; oncorus: Consultancy; regeneron: Consultancy; bristol-myers Squibb: Consultancy, Research Funding; amgen: Consultancy; array biopharma: Consultancy, Research Funding; agios: Consultancy; ironwood pharmaceuticals: Consultancy; takeda: Consultancy; genentech: Consultancy, Research Funding; jounce therapeutics: Consultancy, Research Funding. Kamdar:Roche: Research Funding. Fanning:ALX Oncology Inc.: Current Employment, Current equity holder in publicly-traded company. Squifflet:ALX Oncology Inc.: Consultancy; IDDI: Current Employment. Jin:ALX Oncology Inc.: Current Employment. Forgie:ALX Oncology Inc.: Current Employment, Current equity holder in publicly-traded company; Pfizer Inc.: Ended employment in the past 24 months. Wan:Tallac Therapeutics: Current Employment, Current equity holder in private company; ALX Oncology Inc.: Consultancy, Current equity holder in publicly-traded company. Pons:ALX Oncology Inc.: Current Employment, Current equity holder in publicly-traded company. Randolph:ALX Oncology Inc.: Current Employment, Current equity holder in publicly-traded company. Kim:F. Hoffmann-La Roche: Research Funding; Pfizer: Research Funding; JJ: Research Funding; Celltrion: Research Funding; Kyowa Kirn: Research Funding; Donga: Research Funding; Mundipharma: Research Funding.

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Oral dexamethasone for the prevention of acute migraine recurrence in pediatric patients presenting to the emergency department with migraine

Cephalalgia Reports ◽

10.1177/2515816318804158 ◽

2018 ◽

Vol 1 ◽

pp. 251581631880415

Author(s):

Serena L Orr ◽

Lawrence Richer ◽

Nick Barrowman ◽

Roger Zemek

Keyword(s):

Emergency Department ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Pilot Trial ◽

Recruitment Rate ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Oral Dexamethasone ◽

Safety Outcomes

Objective: To assess the feasibility of a randomized controlled trial protocol that aims to determine the efficacy and safety of oral dexamethasone compared to placebo for the prevention of migraine recurrence in children and adolescents visiting the pediatric emergency department (ED) with migraine. Methods: This study was a two-arm, parallel-group, randomized, placebo-controlled, double-blind pilot trial of patients presenting to the pediatric ED with migraine. Eligible participants were randomized at 1:1 ratio to receive either oral dexamethasone 0.6 mg/kg (maximum 15 mg) or matched placebo as a single dose. Efficacy and safety outcomes were assessed at discharge, 48 h and 7 days after discharge. The primary outcome of the trial was feasibility and was assessed through participant recruitment rate, follow-up completion rates, participant satisfaction ratings and comparison of enrolled versus non-enrolled participants. Efficacy and safety outcomes were not analyzed given that this was a pilot study. Results: Twelve participants were enrolled over the 6-month recruitment period. This represents 60% of the planned sample size and a 10.5% recruitment rate. No other feasibility issues were identified and patients expressed high satisfaction rates with their treatment: 90.9% were satisfied with their treatment at discharge and at 48-h follow-up and 81.8% were satisfied with their treatment at 7-day follow-up (81.8%). There were no significant differences observed when comparing enrolled participants to those not enrolled. Conclusion: This pilot randomized controlled trial is the first to assess dexamethasone in the pediatric ED for the prevention of migraine recurrence. The protocol is feasible but recruitment in a single center was lower than expected. Future pediatric ED migraine studies may use innovative or pragmatic trial designs to maximize feasibility from a recruitment standpoint.

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Management of a pseudo-aneurysm in the hepatic artery after a laparoscopic cholecystectomy

Annals of The Royal College of Surgeons of England ◽

10.1308/rcsann.2016.0182 ◽

2016 ◽

Vol 98 (7) ◽

pp. 456-460 ◽

Cited By ~ 5

Author(s):

MP Senthilkumar ◽

N Battula ◽

MTPR Perera ◽

R Marudanayagam ◽

J Isaac ◽

...

Keyword(s):

Computed Tomography ◽

Laparoscopic Cholecystectomy ◽

Hepatic Artery ◽

Computed Tomography Angiography ◽

Rare Complication ◽

Artery Pseudoaneurysm ◽

Pseudo Aneurysm ◽

High Index Of Suspicion ◽

Time Of Presentation

Introduction Symptomatic hepatic-artery pseudoaneurysm (HAP) after bile-duct injury (BDI) is a rare complication with a varied (but clinically urgent) presentation. Methods A prospectively maintained database of all patients with BDI at laparoscopic cholecystectomy (LC) referred to a tertiary specialist hepatobiliary centre between 1992 and 2011 was searched systematically to identify patients with a symptomatic HAP. Care and outcome of these patients was studied. Results Eight (6 men) of 236 patients with BDI (3.4%) with a median age of 65 (range: 54?6) years presented with symptomatic HAP. Median time of presentation of the HAP from the index LC was 31 (range: 13?16) days. Bleeding was the dominant presentation in 7 patients. One patient presented late (>2 years) with abdominal pain alone. Computed tomography angiography was the most useful investigation. Angioembolisation was successful in 7 patients. One patient died, and another patient developed liver infarction. Three patients (38%) developed biliary strictures after embolisation. Seven patients are alive and well at a median follow-up of 66 months. Conclusions Presentation of HAP is often delayed. A high index of suspicion is necessary for the diagnosis. Computed tomography angiography is the first-line investigation and selective angioembolisation can yield successful outcomes.

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MANAGEMENT OF THROMBOANGIITIS OBLITERANS - A CASE REPORT

November 2020 - International Ayurvedic Medical Journal ◽

10.46607/iamj3909072021 ◽

2021 ◽

Vol 9 (7) ◽

pp. 1560-1563

Author(s):

Vishal Chougule ◽

Shailesh Shetty

Keyword(s):

Case Report ◽

Strong Association ◽

Complete Healing ◽

Lower Limbs ◽

Thromboangiitis Obliterans ◽

Foul Smell ◽

Treatment Principle ◽

The Right ◽

Time Of Admission

Thromboangitis obliterans (TAOs) is a rare disease affecting arteries and veins of the upper and lower limbs. The condition has a strong association with the use of tobacco. Thromboangitis obliterans also known as Buerger's disease is found in the age group between 40 to 45 years, and men are most prone to get affected. The present case is a male aged 65 years complaining of a wound on the heel on the right foot, associated with pain, discharge, slough, foul smell, edema and discolouration of the skin for which he visited our hospital, the patient was previ- ously diagnosed as TAO, considering his clinical features at the time of admission, an intervention was planned based on the treatment principle of Dusta Vrana like Virechana, Basti and Raktamokshana. There was complete healing of the wound at the end of the treatment with no signs of recurrence during the follow-up suggesting the need for Shodhana in the effective management of TAO. Keywords: Dushta Vrana, Thromboangiitis Obliterans, Ayurveda, Panchakarma, Shodhana, Case report

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The added value of cognition-targeted exercise versus symptom-targeted exercise for multiple sclerosis fatigue: A randomized controlled pilot trial

PLoS ONE ◽

10.1371/journal.pone.0258752 ◽

2021 ◽

Vol 16 (11) ◽

pp. e0258752

Author(s):

Azza Alketbi ◽

Salah Basit ◽

Nouran Hamza ◽

Lori M. Walton ◽

Ibrahim M. Moustafa

Keyword(s):

Multiple Sclerosis ◽

Clinical Outcome ◽

Outcome Measures ◽

Recruitment Rate ◽

Control Group ◽

Entire Study ◽

Randomized Controlled ◽

Significant Difference ◽

Intervention Protocol

Background Fatigue is considered one of the most common symptoms of multiple sclerosis (MS) and lacks a current standardized treatment. Therefore, the aim of this study was to examine the feasibility and effectiveness of a cognition-targeted exercise versus symptom-targeted exercise for MS fatigue. Methods In this Pilot, parallel-group, randomized controlled trial, sixty participants with multiple sclerosis, were randomly assigned to either a Cognition-Targeted Exercise (CTE) (N = 30, mean age 41) or a Symptom-Targeted Exercise (STE) (N = 30, mean age 42). The participants in the experimental group received eight, 50-minute sessions of weekly Cognitive Behavior Therapy (CBT) in addition to a CTE Program; whereas, participants in the control group received eight, 50-minute sessions of weekly CBT in addition to the standardized physiotherapy program (STE Program). Feasibility was assessed through recruitment rate, participant retention, adherence and safety, in addition to clinical outcome measures, including: (1) Modified Fatigue Impact Scale (MFIS), (2) Work and Social Adjustment Scale (WSAS), (3) Hospital Anxiety and Depression Scale (HADS), and Perceived Stress Scale (PSS). All outcome measures were assessed at baseline (pretreatment), following completion of the eight visit intervention protocol, and at 3-months follow-up. Results The recruitment rate was 60% and 93% of participants completed the entire study. The recruited participants complied with 98% of the required visits. No adverse events were recorded. A Generalized Estimation Equation Model revealed a significant difference over time as an interaction term during the post and follow up visit for all clinical outcome measures (p < .001). Conclusion The addition of CTE to CBT exhibited positive and more lasting influence on MS fatigue outcomes compared to Symptom-Targeted Exercise (STE). Feasibility and efficacy data from this pilot study provide support for a full-scale RCT of CTE as an integral component of Multiple Sclerosis fatigue management.

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