scholarly journals Predicting patient-reported and objectively measured functional outcome 6 months after ankle fracture in people aged 60 years or over in the UK: prognostic model development and internal validation

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029813 ◽  
Author(s):  
David J Keene ◽  
Karan Vadher ◽  
Keith Willett ◽  
Dipesh Mistry ◽  
Matthew L Costa ◽  
...  
Keyword(s):  
Data Model ◽  
Ankle Fracture ◽  
Prognostic Model ◽  
Predictive Accuracy ◽  
Model Development ◽  
Internal Validation ◽  
Link Type ◽  
Ankle Function ◽  
Objectively Measured

ObjectiveTo predict functional outcomes 6 months after ankle fracture in people aged ≥60 years using post-treatment and 6-week follow-up data to inform anticipated recovery, and identify people who may benefit from additional monitoring or rehabilitation.DesignPrognostic model development and internal validation.Setting24 National Health Service hospitals, UK.MethodsParticipants were the Ankle Injury Management clinical trial cohort (n=618) (ISRCTN04180738), aged 60–96 years, 459/618 (74%) female, treated surgically or conservatively for unstable ankle fracture. Predictors were injury and sociodemographic variables collected at baseline (acute hospital setting) and 6-week follow-up (clinic). Outcome measures were 6-month postinjury (primary) self-reported ankle function, using the Olerud and Molander Ankle Score (OMAS), and (secondary) Timed Up and Go (TUG) test by blinded assessor. Missing data were managed with single imputation. Multivariable linear regression models were built to predict OMAS or TUG, using baseline variables or baseline and 6-week follow-up variables. Models were internally validated using bootstrapping.ResultsThe OMAS baseline data model included: alcohol per week (units), postinjury EQ-5D-3L visual analogue scale (VAS), sex, preinjury walking distance and walking aid use, smoking status and perceived health status. The baseline/6-week data model included the same baseline variables, minus EQ-5D-3L VAS, plus five 6-week predictors: radiological malalignment, injured ankle dorsiflexion and plantarflexion range of motion, and 6-week OMAS and EQ-5D-3L. The models explained approximately 23% and 26% of the outcome variation, respectively. Similar baseline and baseline/6 week data models to predict TUG explained around 30% and 32% of the outcome variation, respectively.ConclusionsPredictive accuracy of the prognostic models using commonly recorded clinical data to predict self-reported or objectively measured ankle function was relatively low and therefore unlikely to be beneficial for clinical practice and counselling of patients. Other potential predictors (eg, psychological factors such as catastrophising and fear avoidance) should be investigated to improve predictive accuracy.Trial registration numberISRCTN04180738; Post-results.

scholarly journals A study protocol for the development and internal validation of a multivariable prognostic model to determine lower extremity muscle injury risk in elite football (soccer) players, with further exploration of prognostic factors

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Tom Hughes ◽  
Richard Riley ◽  
Jamie C. Sergeant ◽  
Michael J. Callaghan
Keyword(s):  
Logistic Regression ◽  
Prognostic Factors ◽  
Clinical Reasoning ◽  
Prognostic Model ◽  
Model Development ◽  
Health Examination ◽  
Prevention Strategies ◽  
Internal Validation ◽  
Risk Estimates ◽  
Multivariable Logistic Regression

Abstract Background Indirect muscle injuries (IMIs) are a considerable burden to elite football (soccer) teams, and prevention of these injuries offers many benefits. Preseason medical, musculoskeletal and performance screening (termed periodic health examination (PHE)) can be used to help determine players at risk of injuries such as IMIs, where identification of PHE-derived prognostic factors (PF) may inform IMI prevention strategies. Furthermore, using several PFs in combination within a multivariable prognostic model may allow individualised IMI risk estimation and specific targeting of prevention strategies, based upon an individual’s PF profile. No such models have been developed in elite football and the current IMI prognostic factor evidence is limited. This study aims to (1) develop and internally validate a prognostic model for individualised IMI risk prediction within a season in elite footballers, using the extent of the prognostic evidence and clinical reasoning; and (2) explore potential PHE-derived PFs associated with IMI outcomes in elite footballers, using available PHE data from a professional team. Methods This is a protocol for a retrospective cohort study. PHE and injury data were routinely collected over 5 seasons (1 July 2013 to 19 May 2018), from a population of elite male players aged 16–40 years old. Of 60 candidate PFs, 15 were excluded. Twelve variables (derived from 10 PFs) will be included in model development that were identified from a systematic review, missing data assessment, measurement reliability evaluation and clinical reasoning. A full multivariable logistic regression model will be fitted, to ensure adjustment before backward elimination. The performance and internal validation of the model will be assessed. The remaining 35 candidate PFs are eligible for further exploration, using univariable logistic regression to obtain unadjusted risk estimates. Exploratory PFs will also be incorporated into multivariable logistic regression models to determine risk estimates whilst adjusting for age, height and body weight. Discussion This study will offer insights into clinical usefulness of a model to predict IMI risk in elite football and highlight the practicalities of model development in this setting. Further exploration may identify other relevant PFs for future confirmatory studies and model updating, or influence future injury prevention research.

Data Model Development for Fire Related Extreme Events: An Activity Theory Approach

MIS Quarterly ◽  
2013 ◽  
Vol 37 (1) ◽  
pp. 125-147 ◽  
Author(s):  
Rui Chen ◽  
◽  
Raj Sharman ◽  
H. Raghav Rao ◽  
Shambhu J. Upadhyaya ◽  
...  
Keyword(s):  
Activity Theory ◽  
Extreme Events ◽  
Data Model ◽  
Model Development ◽  
Theory Approach

scholarly journals Homeopathy for Covid-19 in Primary Care: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ubiratan Cardinalli Adler ◽  
Maristela Schiabel Adler ◽  
Livia Mitchiguian Hotta ◽  
Ana Elisa Madureira Padula ◽  
Amarilys de Toledo Cesar ◽  
...  
Keyword(s):  
Primary Care ◽  
Alternative Hypothesis ◽  
University Hospital ◽  
List Type ◽  
Study Medication ◽  
Link Type ◽  
Care Protocol ◽  
Full Protocol ◽  
Isolation Period

Abstract Objectives To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of COVID-19 in Primary Health Care. Trial design A randomized, two-armed (1:1), parallel, placebo-controlled, double-blind, clinical trial is being performed to test the following hypotheses: H0: homeopathic medicines = placebo (null hypothesis) vs. H1: homeopathic medicines ≠ placebo (alternative hypothesis) for mild cases of COVID-19 in Primary Care. Participants Setting: Primary Care of São Carlos – São Paulo – Brazil. One hundred participants aged 18 years or older, with Influenza-like symptoms and a positive RT-PCR for SARS-CoV-2. Willingness to give informed consent and to comply with the study procedures is also required. Exclusion criterium: severe acute respiratory syndrome. Intervention and comparator Homeopathy: 1 globule of Natrum muriaticum LM2 diluted in 20 mL of alcohol 30% and dispensed in a 30 ml bottle. Placebo: 20 mL of alcohol 30% dispensed in a 30 ml bottle. Posology: one drop taken orally every 4 hours (6 doses/day) while there is fever, cough, tiredness, or pain (headache, sore throat, muscle aches, chest pain, etc.) followed by one drop every 6 hours (4 doses/day) until the fourteenth day of use. The bottle of study medication should be submitted to 10 vigorous shakes (succussions) before each dose. Posology may be changed by telemedicine, with no break in blinding. Study medication should be maintained during home isolation. According to the Primary Care protocol, the home isolation period lasts until the 10th day after the appearance of the first symptom, or up to 72 hours without symptoms. Main outcomes The primary endpoint will be time to recovery, defined as the number of days elapsed before all COVID-19 Influenza-like symptoms are recorded as mild or absent during home isolation period. Secondary measures are recovery time for each COVID-19 symptom; score of the scale created for the study (COVID-Simile Scale); medicines used during follow-up; number of days of follow-up; number of visits to emergency services; number of hospitalizations; other symptoms and Adverse Events during home isolation period. Randomisation The study Statistician generated a block randomization list, using a 1:1 ratio of the two groups (denoted as A and B) and a web-based tool (http://www.random.org/lists). Blinding (masking) The clinical investigators, the statistician, the Primary Care teams, the study collaborators, and the participants will remain blinded from the identity of the two treatment groups until the end of the study. Numbers to be randomised (sample size) One hundred participants are planned to be randomized (1:1) to placebo (50) or homeopathy (50). Trial Status Protocol version/date May 21, 2020. Recruitment is ongoing. First participant was recruited/included on June 29,2020. Due to recruitment adaptations to Primary Care changes, the authors anticipate the trial will finish recruiting on April 10, 2021. Trial registration COVID-Simile Study was registered at the University Hospital Medical Information Network (UMIN - https://www.umin.ac.jp/ctr/index.htm) on June 1st, 2020, and the trial start date was June 15, 2020. Unique ID: UMIN000040602. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marouf Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Helicobacter Pylori Infection ◽  
First Line ◽  
Link Type ◽  
Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

Prediction of Shoulder Stiffness After Arthroscopic Rotator Cuff Repair

2021 ◽  
pp. 036354652110289
Author(s):  
Laurent Audigé ◽  
Soheila Aghlmandi ◽  
Cécile Grobet ◽  
Thomas Stojanov ◽  
Andreas M. Müller ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Rotator Cuff Repair ◽  
Prognostic Model ◽  
Predictive Accuracy ◽  
Arthroscopic Rotator Cuff Repair ◽  
Shoulder Abduction ◽  
Related Factors ◽  
Shoulder Stiffness ◽  
Arthroscopic Rotator Cuff ◽  
Cuff Repair

Background: Postoperative shoulder stiffness (POSS) is a prevalent adverse event after arthroscopic rotator cuff repair (ARCR) that is associated with major limitations in everyday activities and prolonged rehabilitation. Purpose/Hypothesis: The purpose was to develop a predictive model for determining the risk of POSS within 6 months after primary ARCR. We hypothesized that sufficient discrimination ability of such a model could be achieved using a local institutional database. Study Design: Case-control study; Level of evidence, 3. Methods: Consecutive primary ARCRs documented in a local clinical registry between 2013 and 2017 were included, and patients who experienced POSS before the final clinical 6-month follow-up were identified. A total of 29 prognostic factor candidates were considered, including patient-related factors (n = 7), disease-related factors (n = 9), rotator cuff integrity factors (n = 6), and operative details (n = 7). We used imputed data for the primary analysis, and a sensitivity analysis was conducted using complete case data. Logistic regression was applied to develop a model based on clinical relevance and statistical criteria. To avoid overfitting in the multivariable model, highly correlated predictors were not included together in any model. A final prognostic model with a maximum of 8 prognostic factors was considered. The model’s predictive accuracy was assessed by the area under the receiver operating characteristic curve (AUC). Internal validation was performed using bootstrapping. Results: Of 1330 ARCR cases (N = 1330 patients), 112 (8.4%) patients had POSS. Our final model had a moderate predictive ability with an AUC of 0.67. The predicted risks of POSS ranged from 2.3% to 38.9% and were significantly higher in women; patients with partial tears, low baseline passive shoulder abduction, and lack of tendon degeneration; and when no acromioplasty was performed. Conclusion: A prognostic model for POSS was developed for patients with ARCR, offering a personalized risk evaluation to support the future decision process for surgery and rehabilitation.

scholarly journals Cohort profile: the Chinese Pregnant Women Cohort Study and Offspring Follow-up (CPWCSaOF)

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044933
Author(s):  
Tianchen Lyu ◽  
Yunli Chen ◽  
Yongle Zhan ◽  
Yingjie Shi ◽  
Hexin Yue ◽  
...  
Keyword(s):  
Cohort Study ◽  
Pregnant Women ◽  
First Trimester ◽  
Health Problems ◽  
Environmental Data ◽  
Geographical Information ◽  
Obstetric Outcomes ◽  
Factors Affecting ◽  
Link Type

PurposeA multicentre prospective cohort study, known as the Chinese Pregnant Women Cohort Study (CPWCS), was established in 2017 to collect exposure data during pregnancy (except environmental exposure) and analyse the relationship between lifestyle during pregnancy and obstetric outcomes. Data about mothers and their children’s life and health as well as children’s laboratory testing will be collected during the offspring follow-up of CPWCS, which will enable us to further investigate the longitudinal relationship between exposure in different periods (during pregnancy and childhood) and children’s development.Participants9193 pregnant women in 24 hospitals in China who were in their first trimester (5–13 weeks gestational age) from 25 July 2017 to 26 November 2018 were included in CPWCS by convenience sampling. Five hospitals in China which participated in CPWCS with good cooperation will be selected as the sample source for the Chinese Pregnant Women Cohort Study (Offspring Follow-up) (CPWCS-OF).Findings to dateSome factors affecting pregnancy outcomes and health problems during pregnancy have been discovered through data analysis. The details are discussed in the ‘Findings to date’ section.Future plansInfants and children and their mothers who meet the criteria will be enrolled in the study and will be followed up every 2 years. The longitudinal relationship between exposure (questionnaire data, physical examination and biospecimens, medical records, and objective environmental data collected through geographical information system and remote sensing technology) in different periods (during pregnancy and childhood) and children’s health (such as sleeping problem, oral health, bowel health and allergy-related health problems) will be analysed.Trail registration numberCPWCS was registered with ClinicalTrials.gov on 18 January 2018: NCT03403543. CPWCS-OF was registered with ClinicalTrials.gov on 24 June 2020: NCT04444791.

scholarly journals Association of weight change with cerebrospinal fluid biomarkers and amyloid positron emission tomography in preclinical Alzheimer’s disease

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Oriol Grau-Rivera ◽  
◽  
Irene Navalpotro-Gomez ◽  
Gonzalo Sánchez-Benavides ◽  
Marc Suárez-Calvet ◽  
...  
Keyword(s):  
Positron Emission Tomography ◽  
Weight Loss ◽  
Cerebrospinal Fluid ◽  
Weight Change ◽  
Emission Tomography ◽  
Link Type ◽  
Preclinical Ad ◽  
Positron Emission ◽  
T Tau

Abstract Background Recognizing clinical manifestations heralding the development of Alzheimer’s disease (AD)-related cognitive impairment could improve the identification of individuals at higher risk of AD who may benefit from potential prevention strategies targeting preclinical population. We aim to characterize the association of body weight change with cognitive changes and AD biomarkers in cognitively unimpaired middle-aged adults. Methods This prospective cohort study included data from cognitively unimpaired adults from the ALFA study (n = 2743), a research platform focused on preclinical AD. Cognitive and anthropometric data were collected at baseline between April 2013 and November 2014. Between October 2016 and February 2020, 450 participants were visited in the context of the nested ALFA+ study and underwent cerebrospinal fluid (CSF) extraction and acquisition of positron emission tomography images with [18F]flutemetamol (FTM-PET). From these, 408 (90.1%) were included in the present study. We used data from two visits (average interval 4.1 years) to compute rates of change in weight and cognitive performance. We tested associations between these variables and between weight change and categorical and continuous measures of CSF and neuroimaging AD biomarkers obtained at follow-up. We classified participants with CSF data according to the AT (amyloid, tau) system and assessed between-group differences in weight change. Results Weight loss predicted a higher likelihood of positive FTM-PET visual read (OR 1.27, 95% CI 1.00–1.61, p = 0.049), abnormal CSF p-tau levels (OR 1.50, 95% CI 1.19–1.89, p = 0.001), and an A+T+ profile (OR 1.64, 95% CI 1.25–2.20, p = 0.001) and was greater among participants with an A+T+ profile (p < 0.01) at follow-up. Weight change was positively associated with CSF Aβ42/40 ratio (β = 0.099, p = 0.032) and negatively associated with CSF p-tau (β = − 0.141, p = 0.005), t-tau (β = − 0.147 p = 0.004) and neurogranin levels (β = − 0.158, p = 0.002). In stratified analyses, weight loss was significantly associated with higher t-tau, p-tau, neurofilament light, and neurogranin, as well as faster cognitive decline in A+ participants only. Conclusions Weight loss predicts AD CSF and PET biomarker results and may occur downstream to amyloid-β accumulation in preclinical AD, paralleling cognitive decline. Accordingly, it should be considered as an indicator of increased risk of AD-related cognitive impairment. Trial registration NCT01835717, NCT02485730, NCT02685969.

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Link Type ◽  
Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

scholarly journals A 20-Year Follow-Up Study of Objectively Measured Physical Activity

2021 ◽  
Vol 18 (6) ◽  
pp. 3076
Author(s):  
Anders Raustorp ◽  
Andreas Fröberg
Keyword(s):  
Physical Activity ◽  
Early Adolescence ◽  
Total Sample ◽  
Short Time Span ◽  
Steps Per Day ◽  
Objectively Measured ◽  
Short Time ◽  
Objectively Measured Physical Activity

Background: The objectives of this study were to explore the effect of time, long-term tracking, and the proportion of objectively measured physical activity (PA) from early adolescence to the mid-thirties. Methods: PA was measured as mean steps per day (SPD) with pedometers during 2000 (T1), 2003 (T2), 2005 (T3), 2010 (T4), 2016 (T5) and 2020 (T6). Data from 64 participants (n = 32 males) were analysed from their early adolescence (T1) to their mid-thirties (T6). Results: SPD decreased in the total sample and among males and females (all, p < 0.001). Males took more mean SPD than females during T1 (p = 0.002), whereas females took more mean SPD during T2 (p = 0.009) and T6 (p = 0.008). Males’ mean SPD tracked between T1 and T2 (p = 0.021), T2 and T3 (p = 0.030), T3 and T4 (p = 0.015) and T4 and T5 (p = 0.003). Females’ mean SPD tracked between T3 and T4 (p = 0.024) and T5 and T6 (p < 0.001). In the total sample, more mean SPD were found on weekdays compared to weekend days at T3 (p = 0.017) and T5 (p < 0.001). Conclusions: SPD decreased between T1 and T6. Mean SPD tracked low-to-moderate in the short time span. From late adolescence to the mid-thirties, more mean SPD was observed during weekdays compared to weekend days.

scholarly journals Automatized Hepatic Tumor Volume Analysis of Neuroendocrine Liver Metastases by Gd-EOB MRI—A Deep-Learning Model to Support Multidisciplinary Cancer Conference Decision-Making

Cancers ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 2726
Author(s):  
Uli Fehrenbach ◽  
Siyi Xin ◽  
Alexander Hartenstein ◽  
Timo Alexander Auer ◽  
Franziska Dräger ◽  
...  
Keyword(s):  
Liver Metastases ◽  
External Validation ◽  
High Accuracy ◽  
Hepatic Tumor ◽  
Liver Malignancies ◽  
Internal Validation ◽  
Matthew’S Correlation Coefficient ◽  
Therapy Success ◽  
Neuroendocrine Liver Metastases

Background: Rapid quantification of liver metastasis for diagnosis and follow-up is an unmet medical need in patients with secondary liver malignancies. We present a 3D-quantification model of neuroendocrine liver metastases (NELM) using gadoxetic-acid (Gd-EOB)-enhanced MRI as a useful tool for multidisciplinary cancer conferences (MCC). Methods: Manual 3D-segmentations of NELM and livers (149 patients in 278 Gd-EOB MRI scans) were used to train a neural network (U-Net architecture). Clinical usefulness was evaluated in another 33 patients who were discussed in our MCC and received a Gd-EOB MRI both at baseline and follow-up examination (n = 66) over 12 months. Model measurements (NELM volume; hepatic tumor load (HTL)) with corresponding absolute (ΔabsNELM; ΔabsHTL) and relative changes (ΔrelNELM; ΔrelHTL) between baseline and follow-up were compared to MCC decisions (therapy success/failure). Results: Internal validation of the model’s accuracy showed a high overlap for NELM and livers (Matthew’s correlation coefficient (φ): 0.76/0.95, respectively) with higher φ in larger NELM volume (φ = 0.80 vs. 0.71; p = 0.003). External validation confirmed the high accuracy for NELM (φ = 0.86) and livers (φ = 0.96). MCC decisions were significantly differentiated by all response variables (ΔabsNELM; ΔabsHTL; ΔrelNELM; ΔrelHTL) (p < 0.001). ΔrelNELM and ΔrelHTL showed optimal discrimination between therapy success or failure (AUC: 1.000; p < 0.001). Conclusion: The model shows high accuracy in 3D-quantification of NELM and HTL in Gd-EOB-MRI. The model’s measurements correlated well with MCC’s evaluation of therapeutic response.

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