Routine Imaging or Symptomatic Follow-Up After Resection of Pancreatic Adenocarcinoma.

Importance: International guidelines lack consistency in their recommendations regarding routine imaging in the follow-up after pancreatic resection for pancreatic ductal adenocarcinoma (PDAC). Consequently, follow-up strategies differ between centers worldwide. Objective: To compare clinical outcomes, including recurrence-focused treatment and survival, in patients with PDAC recurrence who received symptomatic follow-up or routine imaging after pancreatic resection in international centers affiliated with the European-African Hepato-Pancreato-Biliary Association (E-AHPBA). Design, Setting, and Participants: This was a prospective, international, cross-sectional study. Patients from a total of 33 E-AHPBA centers from 13 countries were included between 2020 and 2021. According to the predefined study protocol, patients who underwent PDAC resection and were diagnosed with disease recurrence were prospectively included. Patients were stratified according to postoperative follow-up strategy: symptomatic follow-up (ie, without routine imaging) or routine imaging. Exposures: Symptomatic follow-up or routine imaging in patients who underwent PDAC resection. Main Outcomes and Measures: Overall survival (OS) was estimated with Kaplan-Meier curves and compared using the log-rank test. To adjust for potential confounders, multivariable logistic regression was used to evaluate the association between follow-up strategy and recurrence-focused treatment. Multivariable Cox proportional hazard analysis was used to study the independent association between follow-up strategy and OS. Results: Overall, 333 patients (mean [SD] age, 65 [11] years; 184 male [55%]) with PDAC recurrence were included. Median (IQR) follow-up at time of analysis 2 years after inclusion of the last patient was 40 (30-58) months. Of the total cohort, 98 patients (29%) received symptomatic follow-up, and 235 patients (71%) received routine imaging. OS was 23 months (95% CI, 19-29 months) vs 28 months (95% CI, 24-30 months) in the groups who received symptomatic follow-up vs routine imaging, respectively (P = .01). Routine imaging was associated with receiving recurrence-focused treatment (adjusted odds ratio, 2.57; 95% CI, 1.22-5.41; P = .01) and prolonged OS (adjusted hazard ratio, 0.75; 95% CI, 0.56-.99; P = .04). Conclusion and Relevance: In this international, prospective, cross-sectional study, routine follow-up imaging after pancreatic resection for PDAC was independently associated with receiving recurrence-focused treatment and prolonged OS.

'So Let's Go On Like This?'-Shared Decision-Making and the Use of Outcome Information in Routine Care Management for People With Multiple Sclerosis.

INTRODUCTION: This study aimed to investigate how shared decision-making (SDM) and the use of different types of outcome information are applied in routine care management for people with multiple sclerosis (MS) in an academic outpatient clinic. METHODS: This qualitative study used the following: (a) observations of clinical encounters (N = 23) between patients and healthcare professionals (HCPs), (b) interviews with those patients (N = 17) and (c) interviews with those HCPs (N = 7). HCPs were not trained in SDM before the study. Audio recordings were transcribed literally. Transcriptions were analysed using qualitative thematic analysis. RESULTS: Outcome information was hardly discussed with patients, apart from clinical outcome information at an individual level, such as MRI or lab results. This use of clinical outcome information did not automatically lead to a process of SDM. HCPs tended to implicitly present choices to patients after signalling and discussing 'problems'. In the interviews, patients indicated that they tended to consent to the advice given by HCPs and to prefer not too much change in treatment plans. However, they also emphasized the importance of being informed about available options with benefits and harms. We observed multiple discussions about patients' preferences, especially related to patients' experiences and priorities. CONCLUSIONS: Overall, SDM and the use of different types of outcome information did not seem to be enacted in routine care management for people with MS, mostly because choices were not explicitly mentioned or discussed. However, discussions about patients' experiences and priorities did take place. Training HCPs further and developing patient information seem reasonable steps to proceed. PATIENT OR PUBLIC CONTRIBUTION: People with MS contributed as research participants and provided us with their experiences in interviews. Furthermore, representatives of two patient organizations contributed to the study by reviewing the interview protocol for people with MS.

Mood Associated With Health- and Social Care-Related Quality of Life in Patients With Advanced Multiple Sclerosis.

BACKGROUND: Individuals with advanced multiple sclerosis (MS) have complex care requirements and are more likely to use long-term facilities. This study determined the associations between mood and social care-related quality of life (SCRQOL), and health-related quality of life (HRQOL) and examined the association between HRQOL and SCRQOL. METHODS: Baseline data from a cohort study were used. Patients completed questionnaires, including the Hospital Anxiety and Depression Scale (HADS), Adult Social Care Outcomes Toolkit (ASCOT), and EuroQOL 5D-5L (EQ-5D-5L) and EQ-Visual Analogue Scale (EQ-VAS). Linear regression analyses were employed to assess the relationships between mood and both outcomes of QOL while controlling for relevant confounding factors (ßs; 95% CI). The cross-sectional association between SCRQOL and HRQOL was examined using Pearson correlation coefficients (r). RESULTS: A total of 75 patients, with a mean age of 56.1 years and a disease duration of 17.3 years, were enrolled from a long-term care facility in the Netherlands. Results showed that after controlling for confounders, HADS is an independent determinant of ASCOT (ßs = -.368; 95% CI, -.581 to -.154) and EQ-5D-5L (ßs = -.297; 95% CI, -.507 to -.087). Also, there are significant but weak correlations between ASCOT and EQ-5D-5L (r = 0.242; 95% CI, .015-.468), between ASCOT and EQ-VAS (r = 0.230; 95% CI, .003-.457) and between EQ-5D-5L and EQ-VAS (r = 0.227; 95% CI, .000-.454). CONCLUSIONS: Mood, especially the depression component, is an important determinant of both HRQOL and SCRQOL in advanced MS. Focusing on mood in health care and social care may contribute to the improvement of QOL in a broader sense.

Digital outcome measures are associated with brain atrophy in patients with multiple sclerosis.

BACKGROUND: Digital monitoring of people with multiple sclerosis (PwMS) using smartphone-based monitoring tools is a promising method to assess disease activity and progression. OBJECTIVE: To study cross-sectional and longitudinal associations between active and passive digital monitoring parameters and MRI volume measures in PwMS. METHODS: In this prospective study, 92 PwMS were included. Clinical tests [Expanded Disability Status Scale (EDSS), Timed 25 Foot Walk test (T25FW), 9-Hole Peg Test (NHPT), and Symbol Digit Modalities Test (SDMT)] and structural MRI scans were performed at baseline (M0) and 12-month follow-up (M12). Active monitoring included the smartphone-based Symbol Digit Modalities Test (sSDMT) and 2 Minute Walk Test (s2MWT), while passive monitoring was based on smartphone keystroke dynamics (KD). Linear regression analyses were used to determine cross-sectional and longitudinal relations between digital and clinical outcomes and brain volumes, with age, disease duration and sex as covariates. RESULTS: In PwMS, both sSDMT and SDMT were associated with thalamic volumes and lesion volumes. KD were related to brain, ventricular, thalamic and lesion volumes. No relations were found between s2MWT and MRI volumes. NHPT scores were associated with lesion volumes only, while EDSS and T25FW were not related to MRI. No longitudinal associations were found for any of the outcome measures between M0 and M12. CONCLUSION: Our results show clear cross-sectional correlations between digital biomarkers and brain volumes in PwMS, which were not all present for conventional clinical outcomes, supporting the potential added value of digital monitoring tools.

Implementing Individually Tailored Prescription of Physical Activity in Routine Clinical Care: A Process Evaluation of the Physicians Implement Exercise = Medicine Project.

BACKGROUND: Although the prescription of physical activity in clinical care has been advocated worldwide, in the Netherlands, "Exercise is Medicine" (E = M) is not yet routinely implemented in clinical care. METHODS: A set of implementation strategies was pilot implemented to test its feasibility for use in routine care by clinicians in 2 departments of a university medical center. An extensive learning process evaluation was performed, using structured mixed methods methodology, in accordance with the Reach, Effect, Adoption, Implementation, and Maintenance framework. RESULTS: From 5 implementation strategies employed (education, E = M tool embedded in the electronic medical records, lifestyle coach situated within the department, overviews of referral options, and project support), the presence of adequate project support was a strong facilitator of the implementation of E = M. Also, the presence of the lifestyle coach within the department seemed essential for referral rate. Although clinicians appreciated the E = M tool, barriers hampered its use in practice. CONCLUSIONS: Specific implementation strategies, tailored to the setting, are effective in facilitating the implementation of E = M with specific regard to education for clinicians on E = M, deployment of a lifestyle coach within a department, and project coordination. Care providers do see a future for lifestyle coaches who are structurally embedded in the hospital, to whom they can easily refer.

The effectiveness of early interventions for post-stroke spasticity: a systematic review.

PURPOSE: To synthesize evidence on the effect of early post-stroke spasticity interventions. METHODS: Systematic literature search (PubMed, Embase, and Web of Science) encompassing studies on spasticity reducing interventions within 3 months post stroke on outcome defined within the International Classification of Functioning (ICF). RESULTS: In total, 27 studies were identified with n = 1.658 cases. Botulinum toxin (2-12 weeks; 10 studies, n = 794) showed consistent and significant reduced spasticity by Modified Ashworth Scale (MAS) or electromyography (EMG). Electrical muscle stimulation (1-8 weeks; 6 studies, n = 335) showed lower MAS/Composite Spasticity Scale scores in 4 studies. Transcranial stimulation (3 studies; n = 131), oral spasmolytics (1 study; n = 38), shockwave (1 study; n = 40), orthotics (3 studies; n = 197 and robot-assisted therapy (3 studies; n = 123) showed inconclusive results. Effects on ICF activity domain could not be established due to limited data and large outcome measures heterogeneity. One out of two studies showed significant benefit for early compared to late BoNT intervention (< 90 vs> 90 days). CONCLUSION: This study provides evidence for early applied (<3 months) BoNT to effectively reduce spasticity and probable effectiveness of electrical stimulation. Establishing effects of interventions in the acute/hospitalization phase (<7 days) needs further work, specifically on the ICF activity domain. Standardization of outcome measures is required.

Spasticity, which may develop in the first weeks after stroke, is now mostly treated in the chronic phase.This study shows that early applied Botulinum Toxin (within three months after stroke) effectively reduces spasticity and suggests that electrical stimulation may reduce spasticity.Early application of treatment with Botulinum Toxin should be considered when spasticity occurs within three months post-stroke.

Perceived and physiological strains of societal participation in people with multiple sclerosis: a real-time assessment study.

OBJECTIVE: To examine the relationship between perceived and physiological strains of real-time societal participation in people with multiple sclerosis. DESIGN: Observational study. SUBJECTS/PATIENTS: 70 people with multiple sclerosis. METHODS: Perceived and physiological strain of societal participation (10 participation-at-location and 9 transport domains) were measured in real time using the Whereabouts smartphone app and Fitbit over 7 consecutive days. Longitudinal relationships between perceived (1 not strenuous to 10 most strenuous) and physiological strains (heart rate reserve) were examined using mixed-model analyses. Type of event (participation-at-location or transport) was added as covariate, with further adjustments for fatigue and walking ability. RESULTS: Median perceived strain, summarized for all societal participation domains, varied between 3 and 6 (range: 1-10), whereas physiological strain varied between 18.5% and 33.2% heart rate reserve. Perceived strain (outcome) and physiological strain were not associated (ß -0.001, 95%CI -0.008; 0.005, with a 7-day longitudinal correlation coefficient of -0.001). Transport domains were perceived as less strenuous (ß -0.80, 95%CI -0.92; -0.68). Higher fatigue levels resulted in higher perceived strain (all societal participation domains) (ß 0.05, 95%CI 0.02; 0.08). CONCLUSION: Societal participation resulted in low-to-moderate perceived and physiological strain. Perceived and physiological strain of societal participation were unrelated and should be considered different constructs in multiple sclerosis.

The presence of attentional and interpretation biases in patients with severe MS-related fatigue.

OBJECTIVE: Severe fatigue is a prevalent and disabling symptom in multiple sclerosis (MS). This study tested if a fatigue- and physical activity-related attentional bias (AB) and a somatic interpretation bias (IB) are present in severely fatigued patients with MS. Biases were compared to healthy controls and patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). METHOD: Severely fatigued patients with MS or ME/CFS and healthy controls completed a Visual Probe Task (VPT) assessing fatigue- and physical activity-related AB and an IB task that assesses the tendency to interpret ambiguous information in either a somatically threatening way or in a more neutral manner. The VPT was completed by 38 MS patients, 44 ME/CFS patients, and 46 healthy controls; the IB task was completed by 156, 40 and 46 participants respectively. RESULTS: ANOVA showed no statistically significant group differences in a fatigue-related AB or physical activity-related AB (omnibus test of interaction between topic × condition: F2,125 = 1.87; p = .159). Both patient groups showed a tendency to interpret ambiguous information in a somatically threatening way compared to healthy controls (F1,2 = 27.61, p < .001). This IB was significantly stronger in MS patients compared to ME/CFS patients. IB was significantly correlated with cognitive responses to symptoms in MS patients. CONCLUSION: MS patients tend to interpret ambiguous information in a somatically threatening way. This may feed into unhelpful ways of dealing with symptoms, possibly contributing to the perpetuation of severe fatigue in MS.

The Difficulty of Detecting Occult Metastases in Patients with Potentially Resectable Pancreatic Cancer: Development and External Validation of a Preoperative Prediction Model.

Occult metastases are detected in 10-15% of patients during exploratory laparotomy for pancreatic cancer. This study developed and externally validated a model to predict occult metastases in patients with potentially resectable pancreatic cancer. Model development was performed within the Dutch Pancreatic Cancer Audit, including all patients operated for pancreatic cancer (January 2013-December 2017). Multivariable logistic regression analysis based on the Akaike Information Criteria was performed with intraoperative pathologically proven metastases as the outcome. The model was externally validated with a cohort from the University Hospital of Verona (January 2013-December 2017). For model development, 2262 patients were included of whom 235 (10%) had occult metastases, located in the liver (n = 143, 61%), peritoneum (n = 73, 31%), or both (n = 19, 8%). The model included age (OR 1.02, 95% CI 1.00-1.03), BMI (OR 0.96, 95% CI 0.93-0.99), preoperative nutritional support (OR 1.73, 95% CI 1.01-2.74), tumor diameter (OR 1.60, 95% CI 1.04-2.45), tumor composition (solid vs. cystic) (OR 2.33, 95% CI 1.20-4.35), and indeterminate lesions on preoperative imaging (OR 4.01, 95% CI 2.16-7.43). External validation showed poor discrimination with a C-statistic of 0.56. Although some predictor variables were significantly associated with occult metastases, the model performed insufficiently at external validation.

Physical Activity Levels, Correlates, and All-Cause Mortality Risk in People Living With Different Health Conditions.

BACKGROUND: To better understand physical activity behavior and its health benefits in people living with health conditions, we studied people with and without 20 different self-reported health conditions with regard to (1) their physical activity levels, (2) factors correlated with these physical activity levels, and (3) the association between physical activity and all-cause mortality. METHODS: We used a subsample (n = 88,659) of the Lifelines cohort study from the Netherlands. For people living with and without 20 different self-reported health conditions, we studied the aforementioned factors in relation to physical activity. Physical activity was assessed with the Short Questionnaire to Assess Health-Enhancing Physical Activity Questionnaire, and mortality data were obtained from the Dutch death register. RESULTS: People with a reported health condition were less likely to meet physical activity guidelines than people without a reported health condition (odds ratios ranging from 0.55 to 0.89). Higher body mass index and sitting time, and lower self-rated health, physical functioning, and education levels were associated with lower odds of meeting physical activity guidelines across most health conditions. Finally, we found a protective association between physical activity and all-cause mortality in both people living with and without different health conditions. CONCLUSION: People living with different health conditions are generally less physically active compared with people living without a health condition. Both people living with and without self-reported health conditions share a number of key factors associated with physical activity levels. We also observed the expected protective association between physical activity and all-cause mortality.

Relative aerobic load of walking in people with multiple sclerosis.

OBJECTIVE: To examine the energy demand of walking relative to aerobic capacity in people with multiple sclerosis. DESIGN: Cross-sectional cohort study. PATIENTS: A total of 45 people with multiple sclerosis (32 females), median disease duration 15 years (interquartile range (IQR) 9; 20), median Expanded Disability Status Scale 4 (min-max range: 2.0; 6.0). METHODS: Aerobic capacity, derived from a cardiopulmonary exercise test and gas exchange measurements, assessed during a 6-min overground walk test at comfortable speed, were analysed. The relative aerobic load of walking was determined as the energy demand of walking relative to oxygen uptake at peak and at the first ventilatory threshold. Healthy reference data were used for clinical inference. RESULTS: People with multiple sclerosis walk at a mean relative aerobic load of 60.0% (standard deviation 12.8%) relative to peak aerobic capacity, and 89.1% (standard deviation 19.9%) relative to the first ventilatory threshold. Fourteen participants walked above the first ventilatory threshold (31%). Peak aerobic capacity was reduced in 45% of participants, and energy demands were increased in 52% of participants. CONCLUSION: People with multiple sclerosis walk at a relative aerobic load close to their first ventilatory threshold. A high relative aerobic load can guide clinicians to improve aerobic capacity or reduce the energy demands of walking.

Barriers and facilitators associated with the upscaling of the Transmural Trauma Care Model: a qualitative study.

BACKGROUND: To assess the barriers and facilitators associated with upscaling the Transmural Trauma Care Model (TTCM), a multidisciplinary and patient-centred transmural rehabilitation care model. METHODS: Semi-structured interviews were conducted with eight trauma surgeons, eight hospital-based physiotherapists, eight trauma patients, and eight primary care physiotherapists who were part of a trauma rehabilitation network. Audio recordings of the interviews were made and transcribed verbatim. Data were analysed using a framework method based on the "constellation approach". Identified barriers and facilitators were grouped into categories related to structure, culture, and practice. RESULTS: Various barriers and facilitators to upscaling were identified. Under structure, barriers and facilitators belonged to one of five themes: "financial structure", "communication structure", "physical structures and resources", "rules and regulations", and "organisation of the network". Under culture, the five themes were "commitment", "job satisfaction", "acting as a team", "quality and efficiency of care", and "patients' experience". Under practice, the two themes were "practical issues at the outpatient clinic" and "knowledge gained". CONCLUSION: The success of upscaling the TTCM differed across hospitals and settings. The most important prerequisites for successfully upscaling the TTCM were adequate financial support and presence of "key actors" within an organisation who felt a sense of urgency for change and/or expected the intervention to increase their job satisfaction. TRIAL REGISTRATION: NL8163 The Netherlands National Trial Register, date of registration 16-11-2019.

Don't be late! Postponing cognitive decline and preventing early unemployment in people with multiple sclerosis: a study protocol.

BACKGROUND: Up to 65% of people with multiple sclerosis (PwMS) develop cognitive deficits, which hampers their ability to work, participating in day-to-day life and ultimately reducing quality of life (QoL). Early cognitive symptoms are often less tangible to PwMS and their direct environment and are noticed only when symptoms and work functioning problems become more advanced, i.e., when (brain) damage is already advanced. Treatment of symptoms at a late stage can lead to cognitive impairment and unemployment, highlighting the need for preventative interventions in PwMS. AIMS: This study aims to evaluate the (cost-) effectiveness of two innovative preventative interventions, aimed at postponing cognitive decline and work functioning problems, compared to enhanced usual care in improving health-related QoL (HRQoL). METHODS: Randomised controlled trial including 270 PwMS with mild cognitive impairment, who have paid employment ≥ 12 h per week and are able to participate in physical exercise (Expanded Disability Status Scale < 6.0). Participants are randomised across three study arms: 1) 'strengthening the brain' - a lifestyle intervention combining personal fitness, mental coaching, dietary advice, and cognitive training; 2) 'strengthening the mind' - a work-focused intervention combining the capability approach and the participatory approach in one-on-one coaching by trained work coaches who have MS themselves; 3) Control group-receiving general information about cognitive impairment in MS and receiving care as usual. Intervention duration is four months, with short-term and long-term follow-up measurements at 10 and 16 months, respectively. The primary outcome measure of the Don't be late! intervention study will be HRQoL as measured with the 36-item Short Form. Secondary outcomes include cognition, work related outcomes, physical functioning, structural and functional brain changes, psychological functioning, and societal costs. Semi-structured interviews and focus groups with stakeholders will be organised to qualitatively reflect on the process and outcome of the interventions. DISCUSSION: This study seeks to prevent (further) cognitive decline and job loss due to MS by introducing tailor-made interventions at an early stage of cognitive symptoms, thereby maintaining or improving HRQoL. Qualitative analyses will be performed to allow successful implementation into clinical practice. TRIAL REGISTRATION: Retrospectively registered at ClinicalTrials.gov with reference number NCT06068582 on 10 October 2023.

Don't be late! Timely identification of cognitive impairment in people with multiple sclerosis: a study protocol.

BACKGROUND: Cognitive impairment occurs in up to 65% of people with multiple sclerosis (PwMS), negatively affecting daily functioning and health-related quality of life. In general, neuropsychological testing is not part of standard MS-care due to insufficient time and trained personnel. Consequently, a baseline assessment of cognitive functioning is often lacking, hampering early identification of cognitive decline and change within a person over time. To assess cognitive functioning in PwMS in a time-efficient manner, a BICAMS-based self-explanatory digital screening tool called the Multiple Screener©, has recently been developed. The aim of the current study is to validate the Multiple Screener© in a representative sample of PwMS in the Netherlands. Additionally, we aim to investigate how cognitive functioning is related to psychological factors, and both work and societal participation. METHODS: In this cross-sectional multicentre study, 750 PwMS (aged 18-67 years) are included. To obtain a representative sample, PwMS are recruited via 12 hospitals across the Netherlands. They undergo assessment with the Minimal Assessment of Cognitive Functioning in MS (MACFIMS; reference-standard) and the Multiple Screener©. Sensitivity, specificity, and predictive values for identifying (mild) cognitive impairment are determined in a subset of 300 participants. In a second step, the identified cut-off values are tested in an independent subset of at least 150 PwMS. Moreover, test-retest reliability for the Multiple Screener© is determined in 30 PwMS. Information on psychological and work-related factors is assessed with questionnaires. DISCUSSION: Validating the Multiple Screener© in PwMS and investigating cognition and its determinants will further facilitate early identification and adequate monitoring of cognitive decline in PwMS.

Dynamics of Serum CA19-9 in Patients Undergoing Pancreatic Cancer Resection.

BACKGROUND: Carbohydrate antigen (CA) 19-9 is an established perioperative prognostic biomarker for pancreatic ductal adenocarcinoma (PDAC). However, it is unclear how CA19-9 monitoring should be used during postoperative surveillance to detect recurrence and to guide the initiation of recurrence-focused therapy. OBJECTIVE: This study aimed to elucidate the value of CA19-9 as a diagnostic biomarker for disease recurrence in patients who underwent PDAC resection. METHODS: Serum CA19-9 levels at diagnosis, after surgery, and during postoperative follow-up were analyzed in patients who underwent PDAC resection. All patients with at least two postoperative follow-up CA19-9 measurements before recurrence were included. Patients deemed to be nonsecretors of CA19-9 were excluded. The relative increase in postoperative CA19-9 was calculated for each patient by dividing the maximum postoperative CA19-9 value by the first postoperative value. Receiver operating characteristic analysis was performed to identify the optimal threshold for the relative increase in CA19-9 levels to identify recurrence in the training set using Youden's index. The performance of this cutoff was validated in a test set by calculating the area under the curve (AUC) and was compared to the performance of the optimal cutoff for postoperative CA19-9 measurements as a continuous value. In addition, sensitivity, specificity, and predictive values were assessed. RESULTS: In total, 271 patients were included, of whom 208 (77%) developed recurrence. Receiver operating characteristic analysis demonstrated that a relative increase in postoperative serum CA19-9 of 2.6× was predictive of recurrence, with 58% sensitivity, 83% specificity, 95% positive predictive value, and 28% negative predictive value. The AUC for a 2.6× relative increase in the CA19-9 level was 0.719 in the training set and 0.663 in the test set. The AUC of postoperative CA19-9 as a continuous value (optimal threshold, 52) was 0.671 in the training set. In the training set, the detection of a 2.6-fold increase in CA19-9 preceded the detection of recurrence by a mean difference of 7 months ( P <0.001) and in the test set by 10 months ( P <0.001). CONCLUSIONS: A relative increase in the postoperative serum CA19-9 level of 2.6-fold is a stronger predictive marker for recurrence than a continuous CA19-9 cutoff. A relative CA19-9 increase can precede the detection of recurrence on imaging for up to 7 to 10 months. Therefore, CA19-9 dynamics can be used as a biomarker to guide the initiation of recurrence-focused treatment.

Effectiveness of a blended booster programme for the long-term outcome of cognitive behavioural therapy for MS-related fatigue: A randomized controlled trial.

BACKGROUND: Cognitive behavioural therapy (CBT) reduces MS-related fatigue. However, studies on the long-term effects show inconsistent findings. OBJECTIVE: To evaluate whether a blended booster programme improves the outcome of CBT for MS-related fatigue on fatigue severity at 1-year follow-up. METHOD: A multicentre randomized clinical trial in which 126 patients with MS were allocated to either a booster programme or no booster programme (control), after following 20-week tailored CBT for MS-related fatigue. Primary outcome was fatigue severity assessed with the Checklist Individual Strength fatigue subscale 1 year after start of treatment (T52). Mixed model analysis was performed by a statistician blinded for treatment-allocation to determine between-group differences in fatigue severity. RESULTS: Fatigue severity at 1-year follow-up did not differ significantly between the booster (N = 62) and control condition (N = 64) (B = -2.01, 95% confidence interval (CI) = -4.76 to 0.75). No significant increase in fatigue severity was found at T52 compared with directly post-treatment (T20) in both conditions (B = 0.44, 95% CI = -0.97 to 1.85). CONCLUSION: Effects of CBT were sustained up to 1 year in both conditions. The booster programme did not significantly improve the long-term outcome of CBT for MS-related fatigue. TRIAL REGISTRATION: Dutch Trial Register (NTR6966), registered 18 January 2018 https://www.trialregister.nl/trial/6782.

Recent Advances and Future Challenges in Pancreatic Cancer Care: Early Detection, Liquid Biopsies, Precision Medicine and Artificial Intelligence.

The incidence of pancreatic ductal adenocarcinoma (PDAC) is rising. While surgical techniques and peri-operative care have improved, the overall survival for PDAC remains poor. Thus, novel and bold research initiatives are needed along the spectrum of clinical care, a few of which will be discussed in this article. Early detection is crucial, with specific high-risk groups possibly benefiting from targeted screening programs. Liquid biopsies (such as circulating exosomes, tumor DNA, or tumor cells) offer promise as multifunctional biomarkers for early detection, treatment guidance, and recurrence monitoring. Precision medicine is being explored via targeted therapies for actionable mutations, such as PARP inhibitors for BRCA mutations, and immunotherapy strategies. Artificial intelligence (AI) is emerging as a powerful tool in medical imaging, biomarker discovery, genetics research, and treatment planning, and it can aid in diagnosis, treatment selection, and patient monitoring. However, its associated challenges include ethics, data security, algorithm reliability, and validation. Collaborative efforts between medical professionals, researchers, and AI experts are vital for unlocking AI's potential to enhance pancreatic cancer care. In conclusion, despite the challenges, advancements in liquid biopsies, precision medicine, and AI offer hope for enhancing the diagnosis, treatment, and management of pancreatic cancer.

The efficacy of a blended intervention to improve physical activity and protein intake for optimal physical recovery after oncological gastrointestinal and lung cancer surgery, the Optimal Physical Recovery After Hospitalization (OPRAH) trial: study protocol for a randomized controlled multicenter trial.

BACKGROUND: Improving physical activity, especially in combination with optimizing protein intake, after surgery has a potential positive effect on recovery of physical functioning in patients after gastrointestinal and lung cancer surgery. The aim of this randomized controlled trial is to evaluate the efficacy of a blended intervention to improve physical activity and protein intake after hospital discharge on recovery of physical functioning in these patients. METHODS: In this multicenter single-blinded randomized controlled trial, 161 adult patients scheduled for elective gastrointestinal or lung cancer surgery will be randomly assigned to the intervention or control group. The purpose of the Optimal Physical Recovery After Hospitalization (OPRAH) intervention is to encourage self-management of patients in their functional recovery, by using a smartphone application and corresponding accelerometer in combination with coaching by a physiotherapist and dietician during three months after hospital discharge. Study outcomes will be measured prior to surgery (baseline) and one, four, eight, and twelve weeks and six months after hospital discharge. The primary outcome is recovery in physical functioning six months after surgery, and the most important secondary outcome is physical activity. Other outcomes include lean body mass, muscle mass, protein intake, symptoms, physical performance, self-reported limitations in activities and participation, self-efficacy, hospital readmissions and adverse events. DISCUSSION: The results of this study will demonstrate whether a blended intervention to support patients increasing their level of physical activity and protein intake after hospital discharge improves recovery in physical functioning in patients after gastrointestinal and lung cancer surgery. TRIAL REGISTRATION: The trial has been registered at the International Clinical Trials Registry Platform at 14-10-2021 with registration number NL9793. Trial registration data are presented in Table 1.