This study aimed to compare contrast-enhanced CT (CE-CT) and
F-FDG PET/CT for response monitoring in metastatic breast cancer using the standardized response evaluation criteria RECIST 1.1 and ...PERCIST. The objective was to examine whether progressive disease was detected systematically earlier by one of the modalities.
Women with biopsy-verified metastatic breast cancer were enrolled prospectively and monitored using combined CE-CT and
F-FDG PET/CT every 9-12 wk to evaluate response to first-line treatment. CE-CT scans and RECIST 1.1 were used for clinical decision-making without accessing the
F-FDG PET/CT scans. At study completion,
F-FDG PET/CT scans were unmasked and assessed according to PERCIST. Visual assessment was used if response criteria could not be applied. The modality-specific time to progression was defined as the time from the baseline scan until the first scan demonstrating progression. Paired comparative analyses for CE-CT versus
F-FDG PET/CT were applied, and the primary endpoint was earlier detection of progression by one modality. Secondary endpoints were time to detection of progression, response categorization, visualization of changes in response over time, and measurable disease according to RECIST and PERCIST.
In total, 87 women were evaluable, with a median of 6 (1-11) follow-up scans. Progression was detected first by
F-FDG PET/CT in 43 (49.4%) of 87 patients and first by CE-CT in 1 (1.15%) of 87 patients (
< 0.0001). Excluding patients without progression (
= 32), progression was seen first on
F-FDG PET/CT in 78.2% (43/55) of patients. The median time from detection of progression by
F-FDG PET/CT to that of CE-CT was 6 mo (95% CI, 4.3-6.4 mo). At baseline, 76 (87.4%) of 87 patients had measurable disease according to PERCIST and 51 (58.6%) of 87 patients had measurable disease according to RECIST 1.1. Moreover,
F-FDG PET/CT provided improved visualization of changes in response over time, as seen in the graphical abstract.
Disease progression was detected earlier by
F-FDG PET/CT than by CE-CT in most patients, with a potentially clinically relevant median 6-mo delay for CE-CT. More patients had measurable disease according to PERCIST than according to RECIST 1.1. The magnitude of the final benefit for patients is a perspective for future research.
To examine the impact of spinal defects on urinary function, sexual outcome and quality of life in adult patients born with anorectal malformations.
A prospective cohort study at Odense University ...Hospital in Denmark was conducted. From 1985 to 2000, 93 patients were found eligible for participation. Twenty-seven (29%) consented to participate. One patient refrained from clinical examinations. Patients were examined with magnetic resonance imaging, uroflowmetry, and validated questionnaires on urinary function, sexual function, and quality of life.
There were 14 were females and 13 were males, median age of 25 (range 19-31) years and 23 (18-32) years, respectively. The type of anorectal malformations in females were vestibular fistula (n = 6), anocutaneous fistula (n = 4), anal stenosis (n = 3), and cloaca (n = 1). In males the type of malformations were anocutaneous fistula (n = 4), bulbar fistula (n = 4), rectovesical fistula (n = 2), anal stenosis (n = 1), rectal atresia (n = 1), and anal atresia with no fistula (n = 1). Patients with spinal defects had a lower average voiding rate compared to patients with normal spinal anatomy (P .03), a lower voiding-related quality of life (P .02), and a tendency was observed toward a worse total urinary incontinence-related quality of life score (P .06). Moreover in patients with spinal defect a tendency was seen toward a worse general quality of life (P .09).
Spinal defects detected by magnetic resonance imaging in adults with anorectal malformations were found to be associated with urinary voiding function.
We compared response categories and impacts on treatment decisions for metastatic breast cancer (MBC) patients that are response-monitored with contrast-enhanced computed-tomography (CE-CT) or ...fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT). A comparative diagnostic study was performed on MBC patients undergoing response monitoring by CE-CT (n = 34) or FDG-PET/CT (n = 31) at the Odense University Hospital (Denmark). The responses were assessed visually and allocated into categories of complete response (CR/CMR), partial response (PR/PMR), stable disease (SD/SMD), and progressive disease (PD/PMD). Response categories, clinical impact, and positive predictive values (PPV) were compared for follow-up scans. A total of 286 CE-CT and 189 FDG-PET/CT response monitoring scans were performed. Response categories were distributed into CR (3.8%), PR (8.4%), SD (70.6%), PD (15%), and others (2.1%) by CE-CT and into CMR (22.2%), PMR (23.8%), SMD (31.2%), PMD (18.5%), and others (4.4%) by FDG-PET/CT, revealing a significant difference between the groups (P < 0.001). PD and PMD caused changes of treatment in 79.1% and 60%, respectively (P = 0.083). PPV for CE-CT and FDG-PET/CT was 0.85 (95% CI: 0.72–0.97) and 0.70 (95% CI: 0.53–0.87), respectively (P = 0.17). FDG-PET/CT indicated regression of disease more frequently than CE-CT, while CE-CT indicated stable disease more often. FDG-PET/CT seems to be more sensitive than CE-CT for monitoring response in metastatic breast cancer.
We aimed to evaluate the etiologies of constipation in patients with anorectal malformations having a good prognosis for bowel control but a high risk of constipation. We included twenty-five ...patients from the Odense university hospital in Denmark. Patients were subjected to colon transit time examination and high resolution anorectal manometry (HRAM). The median age was 18 (14-24) and 48% (12/25) were females. Fifty-two % (13/25) of patients were diagnosed with constipation. Types of anorectal malformation were perineal fistula (9/25), rectovestibular fistula (8/25), rectourethral bulbar fistula (5/25) and no fistula (3/25). No difference in neither total colon transit time nor segmental colon transit times were found based on the presence of constipation. Only four of the constipated patients fulfilled criteria for dyssynergic defecation with a dyssynergic pattern at HRAM and prolonged colon transit time. A Type I dyssynergic pattern was dominant in constipated patients (7/13). A Dyssynergic defecation pattern was due to isolated contraction of puborectalis muscle in 9 out of 13constipated patients. We found a dyssynergic pattern during attempted defecation in patients with anorectal malformations disregarded the presence of constipation. In the majority of constipated patients an isolated contraction of the puborectalis muscle was visualized with HRAM.
The development of digital health solutions for current health care settings requires an understanding of the complexities of the health care system, organizational setting, and stakeholder groups ...and of the underlying interplay between stakeholders and the technology. The digital health solution was founded on the basis of an information and communication technology platform and point-of-care devices enabling home-based monitoring of disease progression and treatment outcome for patients with rheumatoid arthritis (RA).
The aim of this paper is to describe and discuss the applicability of an iterative evaluation process in guiding the development of a digital health solution as a technical and organizational entity in three different health care systems.
The formative evaluation comprised the methodologies of contextual understanding, participatory design, and feasibility studies and included patients, healthcare professionals, and hardware and software developers. In total, the evaluation involved 45 patients and 25 health care professionals at 3 clinical sites in Europe.
The formative evaluation served as ongoing and relevant input to the development process of the digital health solution. Through initial field studies key stakeholder groups were identified and knowledge obtained about the different health care systems, the professional competencies involved in routine RA treatment, the clinics' working procedures, and the use of communication technologies. A theory-based stakeholder evaluation achieved a multifaceted picture of the ideas and assumptions held by stakeholder groups at the three clinical sites, which also represented the diversity of three different language zones and cultures. Experiences and suggestions from the patients and health care professionals were sought through participatory design processes and real-life testing and actively used for adjusting the visual, conceptual, and practical design of the solution. The learnings captured through these activities aided in forming the solution and in developing a common understanding of the overall vision and aim of this solution. During this process, the 3 participating sites learned from each other's feed-back with the ensuing multicultural inspiration. Moreover, these efforts also enabled the consortium to identify a 'tipping point' during a pilot study, revealing serious challenges and a need for further development of the solution. We achieved valuable learning during the evaluation activities, and the remaining challenges have been clarified more extensively than a single-site development would have discovered. The further obstacles have been defined as has the need to resolve these before designing and conducting a real-life clinical test to assess the outcome from a digital health solution for RA treatment.
A formative evaluation process with ongoing involvement of stakeholder groups from 3 different cultures and countries have helped to inform and influence the development of a novel digital health solution, and provided constructive input and feedback enabling the consortium to control the development process.
Purpose
We aimed to assess the association of fecal incontinence to the anatomy of the anal sphincter complex and lower bony spinal anomalies as investigated with magnetic resonance imaging (MRI) in ...adolescents and adults with anorectal malformations (ARM) after posterior sagittal anorectoplasty (PSARP).
Methods
We conducted a cross-sectional study in 20 patients with ARM after PSARP. Anatomy of the anorectum and spine were examined with MRI and functional outcome assessed with the Wexner incontinence score.
Results
We included 20 patient (12 males) had a median age of 19.5 years (14–27). One patient was excluded leaving 19 patients for outcome analysis. Fecal incontinence was found in 12 out of 19 patients (63%). Interposed fat was present in 9 patients (47%). The presence (
r
= 0.597,
p
= 0.012) and thickness of interposed fat (
r
= 0.832,
p
= 0.005) between the anal sphincter complex and bowel were positively correlated to the Wexner fecal incontinence score. No correlation was found between lower bony spinal anomalies and fecal incontinence.
Conclusions
A positive correlation between interposed fat and higher Wexner fecal incontinence score was found indicating a more severe fecal incontinence but no other correlation between anatomy of the anal sphincter complex and neorectum to functional bowel outcome was observed.
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