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Postapproval trials versus patient registries: comparability of advanced melanoma patients with brain metastases
Get PDFPostapproval trials and patient registries have their pros and cons in the generation of postapproval data. No direct comparison between clinical outcomes of these data sources currently exists for advanced melanoma patients. We aimed to investigate whether a patient registry can complement or even replace postapproval trials. Postapproval single-arm clinical trial data from the Medicines Evaluation Board and real-world data from the Dutch Melanoma Treatment Registry were used. The study population consisted of advanced melanoma patients with brain metastases treated with targeted therapies (BRAF- or BRAF-MEK inhibitors) in the first line. A Cox hazard regression model and a propensity score matching (PSM) model were used to compare the two patient populations. Compared to patients treated in postapproval trials (n = 467), real-world patients (n = 602) had significantly higher age, higher ECOG performance status, more often ≥3 organ involvement and more symptomatic brain metastases. Lactate dehydrogenase levels were similar between both groups. The unadjusted median overall survival (mOS) in postapproval clinical trial patients was 8.7 (95% CI, 8.1-10.4) months compared to 7.2 (95% CI, 6.5-7.7) months (P < 0.01) in real-world patients. With the Cox hazard regression model, survival was adjusted for prognostic factors, which led to a statistically insignificant difference in mOS for trial and real-world patients of 8.7 (95% CI, 7.9-10.4) months compared to 7.3 (95% CI, 6.3-7.9) months, respectively. The PSM model resulted in 310 matched patients with similar survival (P = 0.9). Clinical outcomes of both data sources were similar. Registries could be a complementary data source to postapproval clinical trials to establish information on clinical outcomes in specific subpopulations
Clinical performance and future potential of magnetic resonance thermometry in hyperthermia
Get PDFHyperthermia treatments in the clinic rely on accurate temperature measurements to guide treatments and evaluate clinical outcome. Currently, magnetic resonance thermometry (MRT) is the only clinical option to non-invasively measure 3D temperature distributions. In this review, we evaluate the status quo and emerging approaches in this evolving technology for replacing conventional dosimetry based on intraluminal or invasively placed probes. First, we define standard-ized MRT performance thresholds, aiming at facilitating transparency in this field when comparing MR temperature mapping performance for the various scenarios that hyperthermia is currently applied in the clinic. This is based upon our clinical experience of treating nearly 4000 patients with superficial and deep hyperthermia. Second, we perform a systematic literature review, assessing MRT performance in (I) clinical and (II) pre-clinical papers. From (I) we identify the current clinical status of MRT, including the problems faced and from (II) we extract promising new techniques with the potential to accelerate progress. From (I) we found that the basic requirements for MRT during hyperthermia in the clinic are largely met for regions without motion, for example extremities. In more challenging regions (abdomen and thorax), progress has been stagnating after the clinical introduction of MRT-guided hyperthermia over 20 years ago. One clear difficulty for advancement is that performance is not or not uniformly reported, but also that studies often omit important details regarding their approach. Motion was found to be the common main issue hindering accurate MRT. Based on (II), we reported and highlighted promising developments to tackle the issues resulting from motion (directly or indirectly), including new developments as well as optimization of already existing strategies. Combined, these may have the potential to facilitate improvement in MRT in the form of more stable and reliable measurements via better stability and accuracy
Decisional conflict in breast cancer patients considering immediate breast reconstruction
Get PDFBackground: Breast cancer (BC) patients who are treated with mastectomy are frequently offered immediate breast reconstruction. This study aimed to assess decisional conflict in patients considering immediate breast reconstruction, and to identify factors associated with clinically significant decisional conflict (CSDC). Methods: Baseline data of a multicenter randomized controlled trial evaluating the impact of an online decision aid for BC patients considering immediate breast reconstruction after mastectomy were analyzed. Participants completed questionnaires assessing sociodemographic and clinical characteristics, decisional conflict and other patient-reported outcomes related to decision-making such as breast reconstruction preference, knowledge, information resources used, preferred involvement in decision-making, information coping style, and anxiety. Multivariable logistic regression analysis was performed to identify factors associated with CSDC (score > 37.5 on decisional conflict). Results: Of the 250 participants, 68% experienced CSDC. Patients with a slight preference for breast reconstruction (odds ratio (OR) = 6.19, p < .01), with no preference for or against breast reconstruction (OR = 11.84, p < .01), and with a strong preference for no breast reconstruction (OR = 5.20, p < .05) were more likely to experience CSDC than patients with a strong preference for breast reconstruction. Furthermore, patients with more anxiety were more likely to experience CSDC (OR = 1.03, p = .01). Conclusion: A majority of BC patients who consider immediate breast reconstruction after mastectomy experience clinically significant decisional conflict. The findings emphasize the need for decision support, especially for patients who do not have a strong preference for breast reconstruction
A multi-stakeholder approach to eHealth development: Promoting sustained healthy living among cardiovascular patients
Get PDFBackground: Healthy living is key in the prevention and rehabilitation of cardiovascular disease (CVD). Yet, supporting and maintaining a healthy lifestyle is exceptionally difficult and people differ in their needs regarding optimal support for healthy lifestyle interventions. Objective: The goals of this study were threefold: to uncover stakeholders’ needs and preferences, to translate these to core values, and develop eHealth technology based on these core values. Our primary research question is: What type of eHealth application to support healthy living among people with (a high risk of) CVD would provide the greatest benefit for all stakeholders? Methods: User-centered design principles from the CeHRes roadmap for eHealth development were followed to guide the uncovering of important stakeholder values. Data were synthesized from various qualitative studies (i.e., literature studies, interviews, think-aloud sessions, focus groups) and usability tests (i.e., heuristic evaluation, cognitive walkthrough, think aloud study). We also developed an innovative application evaluation tool to perform a competitor analysis on 33 eHealth applications. Finally, to make sure to take into account all end-users needs and preferences in eHealth technology development, we created personas and a customer journey. Results: We uncovered 10 universal values to which eHealth-based initiatives to support healthy living in the context of CVD prevention and rehabilitation should adhere to (e.g., providing social support, stimulating intrinsic motivation, offering continuity of care). These values were translated to 14 desired core attributes and then prototype designs. Interestingly, we found that the primary attribute of good eHealth technology was not a single intervention principle, but rather that the technology should be in the form of a digital platform disseminating various interventions, i.e., a ‘one-stop-shop’. Conclusion: Various stakeholders in the field of cardiovascular prevention and rehabilitation may benefit most from utilizing one personalized eHealth platform that integrates a variety of evidence-based interventions, rather than a new tool. Instead of a one-size-fits-all approach, this digital platform should aid the matchmaking between patients and specific interventions based on personal characteristics and preferences
Deficiencies in Theory of Mind in patients with schizophrenia, bipolar disorder, and major depressive disorder: A systematic review of secondary literature
Get PDFDeficiencies in Theory of Mind (ToM) are consistently found in individuals with schizophrenia (SZ), major depressive disorder (MDD), and bipolar disorder (BD). However, the character of these deficits and their role in the pathogenesis of mental illness remains poorly understood. This systematic review synthesizes the available secondary literature pertaining to ToM functioning in individuals with MDD, BD, or SZ, and their respective spectrum disorders in order to delineate disorder or symptom specific patterns of ToM impairment. Literature suggests that ToM deficits increase in severity along the affective-psychotic spectrum, with mild deficits in patients with MDD, and severe deficits in patients with mania or psychosis. Furthermore, ToM deficits appear to be part of a broader developmental phenotype associated with SZ and BD, as suggested by findings of attenuated impairments in ToM in remitted patients with SZ or BD, unaffected first-degree relatives of patients, and clinical high-risk groups. Future psychiatric research on ToM should aim to disentangle relationships between ToM deficits and specific symptom dimensions transdiagnostically, and employ standardized, construct-specific ToM tasks
Owner Identity and Interdependent Markets: an examination of ownership filters of institutional complexity, coalitional change and value creation in disrupted two sided market categories
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Social Networks of At-Risk Youth: Social Support from Bonding and Bridging Relationships
Get PDFThis dissertation sheds light on the role of social networks in supporting at-risk youth. Findings show the relation between social support and youth's wellbeing, and options for strengthening the network through mentoring are being explored
Site Visit Frequency Policies for Mobile Family Planning Services
Get PDFImproving access to family planning services is key to achieving many of the United
Nations sustainable development goals. To scale up access in remote areas and urban slums,
many developing countries deploy mobile family planning teams that visit “outreach sites”
several times per year. Visit frequencies have a significant effect on the total number of clients
served and hence the impact of the outreach program. Using a large dataset of visits in
Madagascar, Uganda and Zimbabwe, our study models the relationship between the number
of clients seen during a visit and the time since the last visit and uses this model to analyse
the characteristics of optimal frequencies. We use the latter to develop simple frequency
policies for practical use, prove bounds on the worst-case optimality gap, and test the impact
of the policies with a simulation model. Our main finding is that despite the complexity of the
frequency optimisation problem, simple policies yield near-optimal results. This holds even
when few data are available and when the relationship between client volume and the time
since the last visit is misspecified or substantially biased. The simulation for Uganda shows a
potential increase in client numbers of between 7% and 10%, which corresponds to more than
12,000 additional families to whom family planning services could be provided. Our results
can assist policymakers in determining when to start data-driven frequency determination
and which policies to implement