Hybrid trials are a new trend in dermatological research that leverage mobile health technologies to decentralize a subset of clinical trial elements and thereby reduce the number of in-clinic visits. In a Phase I/IIa randomized controlled hybrid trial, the safety and efficacy of an anti-proliferative and anti-inflammatory drug inhibiting cytosolic phospholipase A2 (AVX001) was tested using 1%, 3% or vehicle gel in 60 patients with actinic keratosis (AK) and assessed in-clinic as well as remotely. Over the course of 12 weeks, patients were assessed in-clinic at baseline, end of treatment (EOT) and end of study (EOS), as well as 9 times remotely on a weekly to biweekly basis.
View Article and Find Full Text PDFObjectives: Sidekick Health launched a 16-week digital support programme for people with rheumatoid arthritis in 2021. The objective of this retrospective analysis was to understand whether quality of life (QoL; sleep quality, energy and stress levels) improved for users engaged with the programme in a real-world setting.
Methods: This analysis included 635 users who engaged with the programme after the first week, out of 1541 who enrolled.
Background: Wide-ranging patient recruitment not restricted to the location of the investigator will provide a better representation of the patient population in clinical studies.
Objective: Our goal was to assess the feasibility of a broad web-based recruitment strategy in an 8-week observational study of 500 study participants with psoriasis and healthy controls from locations remote from the investigator and to assess the cost associated with each participant.
Methods: A decentralized team in Denmark recruited patients with psoriasis and healthy controls using Google and Facebook advertisements and posts to Facebook groups.
Introduction: Actinic keratosis (AK) is the most common precancerous skin condition caused by long-term UV exposure. Given the high recurrence rate of 15%-53%, identifying safe and effective treatment options is warranted. AVX001, a cytosolic phospholipase Aα (cPLAα) enzyme inhibitor, is a novel anti-inflammatory drug for field-directed, self-administered, topical therapy of AK.
View Article and Find Full Text PDFBackground: The use of photographs to diagnose and monitor skin diseases is gaining ground.
Objectives: To investigate the validity and reliability of photographic assessments of atopic dermatitis (AD) severity.
Methods: AD severity was evaluated in the clinic by two assessors using the Eczema Area and Severity Index (EASI), SCOring Atopic Dermatitis (SCORAD), and Investigator's Global Assessment (IGA).
Background: Clinical trials often suffer from recruitment barriers and poor adherence, which increases costs and affects trial outcomes.
Objective: To investigate the feasibility of Decentralized Clinical Trial (DCT) design elements to recruit, enroll, and engage patients with type 2 diabetes mellitus (T2DM).
Methods: Patients with T2DM were recruited through a pharmacy and online recruitment using advert on Facebook, to 3 weeks monitoring of glucose and behaviometric parameters.
Background: Digital imaging of dermatological patients is a novel approach to remote assessment and has recently become more relevant since telehealth and remote decentralized clinical trials are gaining ground.
Objective: We aimed to investigate whether photographs taken by a smartphone are of adequate quality to allow severity assessments to be made and to explore the usefulness of an established atopic dermatitis severity assessment instrument on photograph evaluation.
Methods: During scheduled visits in a previously published study, the investigating doctor evaluated the severity of atopic dermatitis using the Scoring AD (SCORAD) index and took photographs of the most representative lesions (target lesions) with both a smartphone and a digital single-lens reflex camera (DSLR).
Introduction: Clinical trials often suffer from significant recruitment barriers, poor adherence, and dropouts, which increase costs and negatively affect trial outcomes. The aim of this study was to examine whether making it virtual and reward-based would enable nationwide recruitment, identify patients with variable disease severity, achieve high adherence, and reduce dropouts.
Methods: In a siteless, virtual feasibility study, individuals with atopic dermatitis (AD) were recruited online.
Introduction: Impaired isometric muscle strength was previously reported in adults with Fontan circulation. However, it is unclear if this impairment is present in children and adolescents with Fontan circulation. We investigated isometric muscle strength of the lower limb in patients (6-18 years) with Fontan circulation in comparison with healthy controls.
View Article and Find Full Text PDFAims: To provide an update of knowledge regarding the clinical presentation and neurophysiologic aspects of orofacial pain of cardiac origin in the form of a literature review.
Methods: The peer-reviewed databases Scopus/Embase, NCBI (PubMed), and Science Direct were searched up to December 2018.
Results: Patients with myocardial infarction presenting without chest pain run a higher risk of death due to missed diagnosis and subsequently a significantly greater delay between the onset of symptoms and arrival at the hospital.
We recently found craniofacial pain to be the sole symptom of an acute myocardial infarction (AMI) in 4% of patients. We hypothesized that this scenario is also true for symptoms of prodromal (pre-infarction) angina. We studied 326 consecutive patients who experienced myocardial ischemia.
View Article and Find Full Text PDFJ Oral Facial Pain Headache
December 2014
Aims: To investigate possible associations between the presence of craniofacial pain of cardiac origin and the location of cardiac ischemia and conventional risk factors.
Methods: A total of 326 consecutive patients with confirmed myocardial ischemia (192 males, 134 females, mean age 64 years) were studied. Demographic details, health history, factors, prodromal symptoms, electrocardiogram (ECG) findings, and pain characteristics during the ischemic episode were assessed.
Oral Surg Oral Med Oral Pathol Oral Radiol
April 2014
Objective: This study aimed to determine the incidence, prevalence, and progression of temporomandibular joint (TMJ) magnetic resonance (MR) imaging findings and symptoms in patients over a 15-year period after whiplash trauma, compared with control participants.
Study Design: Sixty consecutive patients were enrolled directly after whiplash trauma. The study protocol included TMJ MR imaging at inception and 15 years later, as well as a questionnaire and interview at inception, at 1-year follow-up, and at 15-year follow-up.
Purpose: To determine the incidence, prevalence, and progression of temporomandibular joint (TMJ) magnetic resonance (MR) imaging findings and symptoms during 15 years in adult asymptomatic and symptomatic volunteers (nonpatients).
Materials And Methods: A regional committee for medical research ethics approved the study, and informed volunteer consent was obtained. Fifty-three volunteers were examined at study inception.
Int J Oral Maxillofac Surg
June 2011
Recent experimental research demonstrated that non-reducing temporomandibular joint (TMJ) disc displacement in growing rabbits impaired mandibular growth. TMJ disc displacement is also shown to induce histological changes of the condylar cartilage. The authors hypothesized that the severity of these changes would correlate to the magnitude of mandibular growth.
View Article and Find Full Text PDFBackground: Researchers have conducted studies regarding whiplash-induced temporomandibular joint (TMJ) pain and dysfunction mainly under the presumption that patients' memory of symptoms remains accurate across time. In this prospective study, the authors aimed to determine the frequency of patients' inaccurate retrospective reports of TMJ pain and dysfunction after whiplash trauma.
Methods: The authors assessed TMJ pain and dysfunction in 60 patients consecutively seen in a hospital emergency department directly after the patients experienced whiplash trauma in rear-end automobile accidents.
Craniofacial pain, whether odontogenic or caused by cardiac ischemia, is commonly referred to the same locations, posing a diagnostic challenge. We hypothesized that the validity of pain characteristics would be high in assessment of differential diagnosis. Pain quality, intensity, and gender characteristics were assessed for referred craniofacial pain from dental (n = 359) vs.
View Article and Find Full Text PDFBackground: Swallowing disorders following treatment for oral and pharyngeal cancer are mainly considered a surgical sequel. The recent finding that radiotherapy-induced decline in intraoral sensory abilities established an incentive to elucidate any association between the degree of sensory decline and the degree of swallowing dysfunction.
Methods: Oral and pharyngeal swallowing was cineradiographically examined in 15 patients with oral or pharyngeal cancer before and after treatment.
Background: The Quebec Task Force on Whiplash-Associated Disorders urged for controlled, prognostic studies of symptoms after whiplash trauma. The authors conducted a study that met the design requirements to enhance knowledge about short-term and long-term temporomandibular joint (TMJ) pain, dysfunction or both induced by whiplash trauma.
Methods: The authors studied 60 consecutive patients who had neck symptoms after whiplash trauma and were seen at a hospital emergency department.
Background: Craniofacial pain can be the only symptom of cardiac ischemia. Failure to recognize its cardiac source can put the patient's life at risk. The authors conducted a study to reveal the prevalence of, the distribution of and sex differences regarding craniofacial pain of cardiac origin.
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