U-Net based vessel segmentation for murine brains with small micro-magnetic resonance imaging reference datasets.

Identification and quantitative segmentation of individual blood vessels in mice visualized with preclinical imaging techniques is a tedious, manual or semiautomated task that can require weeks of reviewing hundreds of levels of individual data sets. Preclinical imaging, such as micro-magnetic resonance imaging (µMRI) can produce tomographic datasets of murine vasculature across length scales and organs, which is of outmost importance to study tumor progression, angiogenesis, or vascular risk factors for diseases such as Alzheimer's. Training a neural network capable of accurate segmentation results requires a sufficiently large amount of labelled data, which takes a long time to compile. Recently, several reasonably automated approaches have emerged in the preclinical context but still require significant manual input and are less accurate than the deep learning approach presented in this paper-quantified by the Dice score. In this work, the implementation of a shallow, three-dimensional U-Net architecture for the segmentation of vessels in murine brains is presented, which is (1) open-source, (2) can be achieved with a small dataset (in this work only 8 µMRI imaging stacks of mouse brains were available), and (3) requires only a small subset of labelled training data. The presented model is evaluated together with two post-processing methodologies using a cross-validation, which results in an average Dice score of 61.34% in its best setup. The results show, that the methodology is able to detect blood vessels faster and more reliably compared to state-of-the-art vesselness filters with an average Dice score of 43.88% for the used dataset.

Second opinion and time to knee arthroplasty: a prospective cohort study of 142 patients.

OBJECTIVE: The objective of this study was to determine the impact of obtaining a second opinion consultation on time to knee arthroplasty (KA). We further examined the frequency of KA and the determinants of KA following the second opinion. DESIGN: Prospective cohort study. SETTING: The second opinion programme was implemented at the Ludwig Maximilian University Hospital in Munich. PARTICIPANTS: Participants comprised patients with knee osteoarthritis who were insured with one of the largest statutory health insurance Allgemeine Ortskrankenkasse Bayern (mean age 64.3±9.6 years). Patients participated in a second-opinion programme and completed questionnaires on site before and after personal presentation for the second opinion consultation. Follow-up questionnaires were delivered by post at 3 and 12 months after the second opinion consultation. Of the 142 patients included in the study, 47 (33.1%) underwent KA within 12 months after obtaining the second opinion. PRIMARY OUTCOME MEASURES: Primary outcome measure was time until patients received KA. Cox proportional hazard modelling was used to calculate the associations between the selected predictors and time that elapsed between receipt of the second opinion to KA. RESULTS: Mean time until KA was 17 weeks. Kaplan-Meier curves showed significant differences in time to KA according to the recommendation given at second opinion consultation, knee-related quality of life and Kellgren-Lawrence grade. In multivariate Cox proportional hazard modelling, second opinion recommendation (HR 5.33, 95% CI 1.16, 24.41) and knee-related quality of life (HR 1.03, 95% CI 1.01, 1.06) were significant predictors of time from second opinion to KA. CONCLUSIONS: Obtaining a second opinion had significant impact on time to knee replacement. Those who were recommended immediate surgery also underwent surgery more quickly after the second opinion. The effect of knee-related quality of life supports the importance of patient-reported outcome measures in the decision for or against KA.

Routine data-based quality indicators for the treatment of gonarthrosis and coxarthrosis patients in the ambulatory care sector - A study protocol for a cluster-randomised pilot trial to evaluate the MobilE-ARTH study.

BACKGROUND: In 2019, Germany had the highest rate of hip replacement surgery and the fourth highest rate of knee replacement surgery among more than 30 OECD countries. The age-standardised rates were estimated at 174 hip joint and 137 knee joint replacements per 100,000 population. Against this background, the contrast between financial incentives for surgery and missing incentives for non-surgical treatment options is repeatedly discussed. Quality indicators (QIs) can serve to measure and transparently present the quality of evidence-based care. Comparing results in the form of audit and feedback has been shown to improve e.g. guideline-compliant ambulatory care. Existing QIs targeting the care of gon- and coxarthrosis mainly focus on discharge management after joint replacement surgery and/or require additional data collection. Therefore, as part of the MobilE-ARTH project, a set of QIs for ambulatory care prior to joint replacement surgery calculable based on routine data is being developed. The present study's aim is to evaluate the impact of this QI set in terms of providing feedback on the quality of care. METHODS: The MobilE-ARTH project comprises (Phase 1) developing a QI set following the RAND/UCLA Appropriateness Method, (Phase 2) implementing the QIs in established physician networks of a German statutory health insurance (SHI) within a prospective, non-blinded, cluster-randomised pilot study, and (Phase 3) evaluating the QI set's effectiveness. The physicians in the intervention networks will (a) receive feedback reports providing information about the routine data-based QIs of their gon- and/or coxarthrosis patients and aggregated results for their network, and (b) be invited to two voluntary, facilitated network meetings. In these network meetings, the physicians can use the information provided on the feedback reports to discuss multiprofessional care pathways for patients with gon- and/or coxarthrosis. Selected indicators of the QI set will serve as primary and secondary outcome measures. Routine data will be analysed within multi-level models using an intention-to-treat approach. DISCUSSION: Feedback reports help maintaining clinical standards and closing the gap between evidence and medical practice, thus enabling an overall improvement in health care. Providing physicians with QI-based information on quality of care promotes identifying strengths and weaknesses in medical treatments. TRIAL REGISTRATION: German Clinical Trials Register, number DRKS00027516 , Registered 25th January 2022 - Prospectively registered.

Effects of a medical second opinion programme on patients' decision for or against knee arthroplasty and their satisfaction with the programme.

BACKGROUND: German social legislation gives patients the right to obtain a second opinion before elective surgery and defines quality criteria for reimbursement by statutory health insurances. However, the effects of second opinions before elective surgery are largely unknown. The aim of this study was to evaluate the effects of a second opinion programme in patients recommended for knee arthroplasty. METHODS: The largest statutory health insurance funds in Bavaria offered patients who had been recommended to have knee arthroplasty the opportunity to partake in a second opinion programme which consisted of an in person presentation to an experienced knee surgeon. In this cohort study, consecutive patients from this second opinion programme who signed informed consent were included from 07/10/2016 to 14/02/2020. Data were collected before and after the second opinion visit. RESULTS: A total of 141 (66%) of 215 patients who presented for a second opinion participated in the evaluation study. The second opinion physician recommended knee arthroplasty to 40% of the patients, later knee arthroplasty if the conditions worsened to 40%, and no knee arthroplasty to 20%. After receiving the second opinion 28 of 56 (41%) undecided patients preferred knee arthroplasty, 14 no knee arthroplasty, 14 remained undecided. Four of 46 patients with a preference for "arthroplasty" changed their decision to "no arthroplasty", five of 35 patients from "no arthroplasty" to "arthroplasty". The patients were more confident in their decision according to the decision confidence scale (before: 5.4 ± 3.0; after: 7.8 ± 2.5; p < 0.001). They rated their satisfaction with the second opinion programme with a mean grade of 1.35 (± 0.60) (best:1; worst:6). Logistic regression analyses showed that the recommendation of the second opinion physician for joint arthroplasty was associated with the guideline criteria radiological severity of osteoarthritis (p = 0.001) and knee-joint-specific quality of life (p = 0.041). CONCLUSION: The second opinion of an experienced knee surgeon frequently deviates from the initial recommendation for knee arthroplasty. The association of guideline criteria to the second recommendation suggests a high quality of the second opinion. From the patient perspective, the second opinion reduces uncertainties in their treatment decision.

Progressive resistance training in cachectic head and neck cancer patients undergoing radiotherapy: a randomized controlled pilot feasibility trial.

BACKGROUND: Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purposes of this pilot randomized controlled trial were to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy and to explore possible risks and benefits. METHODS: Twenty cachectic participants with head and neck cancer receiving radiation were randomized to obtain either a machine supported progressive resistance training (n = 10) or usual care (n = 10). The training took place 3 times weekly for 30 min. Intervention included 3 exercises for major muscle groups with 8-12 repetition maximum for 3 sets each. Bioelectrical impedance analysis, hand-held dynamometry, Six-Minute Walk Test and standardized questionnaires for fatigue and quality of life were used for evaluating outcomes at baseline before radiotherapy (t1), after 7 weeks of radiotherapy (t2) and 8 weeks after the end of radiotherapy (t3). RESULTS: All participants (n = 20) completed the trial. No serious adverse events occurred. At the initial assessment the cachectic patients had already lost 7.1 ± 5.2% of their body weight. General fatigue (score 10.7 ± 3.3) and reduced quality of life (score 71.3 ± 20.6) were prevalent in cachectic head and neck cancer patients even before radiotherapy. An average improvement of weight loading for leg press (+ 19.0%), chest press (+ 29.8%) and latissimus pull-down (+ 22.8%) was possible in the intervention group. Participants had at least 13 training sessions. The outcome measures showed nonsignificant changes at t2 and t3, but a trend for a better course of general fatigue and quality of life at t2 in the intervention group. CONCLUSIONS: Despite advanced tumor stage and burdensome treatment the intervention adherence is excellent. Progressive resistance training in cachectic head and neck cancer patients during radiotherapy seems to be safe and feasible and may have beneficial effects of general fatigue and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03524755 . Registered 15 May 2018 - Retrospectively registered.

Electromyogram Biofeedback in Patients with Fibromyalgia: A Randomized Controlled Trial.

BACKGROUND/AIM: Electromyogram (EMG) biofeedback is used in chronic pain but its effectiveness in patients with fibromyalgia is unclear. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of EMG biofeedback in patients with fibromyalgia. METHODS: Patients were recruited from a waiting list at the fibromyalgia day care clinic at the University Hospital Munich. The study intervention comprised 14 sessions of EMG biofeedback during 8 weeks in addition to the usual care. The control intervention was usual care alone. Assessments were scheduled before intervention (T0), after intervention (T1), and 3 months after the end of intervention (T2). The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). Secondary outcome measures included additional patient-oriented measures and the pressure-pain threshold in the trapezius muscles. Effectiveness was analyzed by significance tests and standardized effect sizes (ES). RESULTS: 36 patients completed the study. EMG biofeedback did not improve the health status (FIQ, T1: p = 0.95, ES = 0.02; T2: p = 0.52, ES = 0.26). Among the secondary outcome measures, only the pressure-pain threshold at the trapezius muscles showed an improvement in the intervention group (T1: p = 0.016, ES = 0.84). CONCLUSION: EMG biofeedback showed no health status improvement in patients with fibromyalgia.

Parental bonding and alexithymia in adults with fibromyalgia.

In a cross-sectional study, the authors investigated 40 female patients with fibromyalgia syndrome (FS) for the degree of alexithymia and parental bonding style. Alexithymia was assessed by the Toronto Alexithymia Scale-26; parental style by the FDEB (a German version of the Measure of Parental Style). In 15% of patients with FS, clinically significant alexithymia was found. Also, there was a positive association between the alexithymia scores (TAS total score) and "maternal abuse" and higher values in "paternal indifference," which predicted higher scores on "Difficulties identifying feelings" (TAS). The results of this study suggest that parental styles are associated with higher alexithymia scores.

Identification of relevant ICF categories in patients with chronic health conditions: a Delphi exercise.

OBJECTIVES: To identify the most typical and relevant categories of the International Classification of Functioning, Disability and Health (ICF) for patients with low back pain, osteoporosis, rheumatoid arthritis, osteoarthritis, chronic generalized pain, stroke, depression, obesity, chronic ischaemic heart disease, obstructive pulmonary disease, diabetes mellitus, and breast cancer. METHODS: An international expert survey using the Delphi technique was conducted. Data were collected in 3 rounds. Answers were linked to the ICF and analysed for the degree of consensus. RESULTS: Between 21 (osteoporosis, chronic ischaemic heart disease, and obstructive pulmonary disease) and 43 (stroke) experts responded in each of the conditions. In all conditions, with the exception of depression, there were categories in all ICF components that were considered typical and/or relevant by at least 80% of the responders. While all conditions had a distinct typical spectrum of relevant ICF categories, there were also some common relevant categories throughout the majority of conditions. CONCLUSION: Lists of ICF categories that are considered relevant and typical for specific conditions by international experts could be created. This is an important step towards identifying ICF Core Sets for chronic conditions.

Identifying the concepts contained in outcome measures of clinical trials on breast cancer using the International Classification of Functioning, Disability and Health as a reference.

OBJECTIVES: To systematically identify and quantify the concepts contained in outcome measures of clinical breast cancer trials using the International Classification of Functioning, Disability and Health (ICF) as a reference. METHODS: Randomized controlled trials between 1991 and 2000 were located in MEDLINE and selected according predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked to the ICF. RESULTS: A total of 640 trials were included. Ninety-four different health status questionnaires were extracted. Three questionnaires were breast cancer-specific and 12 cancer-specific. Of 19,692 extracted concepts, 88% could be linked to the ICF. The most used ICF categories within the components body structures, body functions, and activities and participation were structure of the reproductive system (s630), sensations associated with the digestive system (b535), and looking after one's health (d570) with frequencies of 64%, 46% and 14%, respectively. No category of the environmental factors component reached a frequency of 10%. CONCLUSION: The ICF provides a useful reference to identify and quantify the concepts contained in outcome assessment used in clinical breast cancer trials. There seems to be a lack of health concepts evaluating specific aspects of disability and participation in breast cancer. Similarly, environmental factors with an impact on individual life of breast cancer survivors seem to be poorly represented.