Background: Biobanks form key research support infrastructures that ensure the highest sample quality for scientific research. Their activity must align closely and proportionally to the interests... Show moreBackground: Biobanks form key research support infrastructures that ensure the highest sample quality for scientific research. Their activity must align closely and proportionally to the interests of researchers, donors, and society. Informed consent (IC) is a central tool to guarantee the protection of donors' rights and interests.Aim: This study aimed to analyze the challenges of obtaining IC for biobanking in clinical settings and ways to improve this process.Methods: Biobank Bellvitge University Hospital HUB-ICO-IDIBELL in Barcelona received 8671 IC forms between 2017 and 2020. The mistakes that caused IC forms to be rejected by the Biobank were analyzed. In addition, interventions aimed at physicians to improve the IC process were evaluated through a calculation of the relative risk (RR). Finally, physicians who submitted samples to the Biobank, most of whom are involved in research activities, were surveyed about the barriers to collecting IC and how to improve this process.Results: During 2017–2020, 19.6% of IC forms were rejected. The most relevant cause of rejection was the use of outdated IC forms, followed by missing patient information or mistakes having been made by the physician. Evaluation of the rejection rates before and after interventions to improve the IC process suggests significant improvement (27.7% before interventions (January 2017–May 2018) compared to 9.6% after interventions (February–December 2020), RR 0.4 95% CI 0.34–0.47; p < 0.0001). According to the physicians, the most important barrier to collecting IC is the time constraint, and they consider digitalization as a viable solution.Conclusions: Our research offers a view of the less well-understood practical challenges that physicians and biobanks face when collecting IC in clinical settings. It suggests that, despite multiple challenges, continuous monitoring, training, and information programs for physicians are key to optimizing the IC process in clinical settings. Show less
Self-management interventions (SMIs) may fail if they misalign with the local context. To optimize the implementation of SMIs in Chinese people with chronic lung disease (CLD), the local context... Show moreSelf-management interventions (SMIs) may fail if they misalign with the local context. To optimize the implementation of SMIs in Chinese people with chronic lung disease (CLD), the local context was identified in Chinese primary care (PC) and secondary care (SC). A mixed-method study using semi-structured interviews and quantitative surveys was conducted on people with CLD and healthcare professionals (HCPs). The qualitative data was collected until data saturation was reached, and participants were invited to complete the survey after the interview. The qualitative data-analyzed with the framework approach-was triangulated with the quantitative data. A total of 52 participants completed the interviews, and 48 also finished the survey. Four themes were identified; (a) illness perceptions (e.g., patients had poor CLD knowledge and SM, inadequate resources lead to suboptimal disease control in PC); (b) self-management skills (e.g., most patients delayed exacerbation recognition and action, and some were admitted at the crisis point); (c) factors influencing self-management skills (e.g., (in)adequate disease knowledge and medical expenditure affordability); and (d) needs for self-management (e.g., increased disease knowledge, individualized self-management plan, eHealth, (healthcare insurance) policy support). Identified themes were dependent on each other and should be leveraged when implementing SMIs. Ultimately, such SMIs can optimize patient health outcomes. Show less
Self-management interventions (SMIs) may fail if they misalign with the local context. To optimize the implementation of SMIs in Chinese people with chronic lung disease (CLD), the local context... Show moreSelf-management interventions (SMIs) may fail if they misalign with the local context. To optimize the implementation of SMIs in Chinese people with chronic lung disease (CLD), the local context was identified in Chinese primary care (PC) and secondary care (SC). A mixed-method study using semi-structured interviews and quantitative surveys was conducted on people with CLD and healthcare professionals (HCPs). The qualitative data was collected until data saturation was reached, and participants were invited to complete the survey after the interview. The qualitative data—analyzed with the framework approach—was triangulated with the quantitative data. A total of 52 participants completed the interviews, and 48 also finished the survey. Four themes were identified; (a) illness perceptions (e.g., patients had poor CLD knowledge and SM, inadequate resources lead to suboptimal disease control in PC); (b) self-management skills (e.g., most patients delayed exacerbation recognition and action, and some were admitted at the crisis point); (c) factors influencing self-management skills (e.g., (in)adequate disease knowledge and medical expenditure affordability); and (d) needs for self-management (e.g., increased disease knowledge, individualized self-management plan, eHealth, (healthcare insurance) policy support). Identified themes were dependent on each other and should be leveraged when implementing SMIs. Ultimately, such SMIs can optimize patient health outcomes. Show less
Self-management interventions (SMIs) may fail if they misalign with the local context. To optimize the implementation of SMIs in Chinese people with chronic lung disease (CLD), the local context... Show moreSelf-management interventions (SMIs) may fail if they misalign with the local context. To optimize the implementation of SMIs in Chinese people with chronic lung disease (CLD), the local context was identified in Chinese primary care (PC) and secondary care (SC). A mixed-method study using semi-structured interviews and quantitative surveys was conducted on people with CLD and healthcare professionals (HCPs). The qualitative data was collected until data saturation was reached, and participants were invited to complete the survey after the interview. The qualitative data—analyzed with the framework approach—was triangulated with the quantitative data. A total of 52 participants completed the interviews, and 48 also finished the survey. Four themes were identified; (a) illness perceptions (e.g., patients had poor CLD knowledge and SM, inadequate resources lead to suboptimal disease control in PC); (b) self-management skills (e.g., most patients delayed exacerbation recognition and action, and some were admitted at the crisis point); (c) factors influencing self-management skills (e.g., (in)adequate disease knowledge and medical expenditure affordability); and (d) needs for self-management (e.g., increased disease knowledge, individualized self-management plan, eHealth, (healthcare insurance) policy support). Identified themes were dependent on each other and should be leveraged when implementing SMIs. Ultimately, such SMIs can optimize patient health outcomes. Show less
Self-management interventions (SMIs) may fail if they misalign with the local context. To optimize the implementation of SMIs in Chinese people with chronic lung disease (CLD), the local context... Show moreSelf-management interventions (SMIs) may fail if they misalign with the local context. To optimize the implementation of SMIs in Chinese people with chronic lung disease (CLD), the local context was identified in Chinese primary care (PC) and secondary care (SC). A mixed-method study using semi-structured interviews and quantitative surveys was conducted on people with CLD and healthcare professionals (HCPs). The qualitative data was collected until data saturation was reached, and participants were invited to complete the survey after the interview. The qualitative data—analyzed with the framework approach—was triangulated with the quantitative data. A total of 52 participants completed the interviews, and 48 also finished the survey. Four themes were identified; (a) illness perceptions (e.g., patients had poor CLD knowledge and SM, inadequate resources lead to suboptimal disease control in PC); (b) self-management skills (e.g., most patients delayed exacerbation recognition and action, and some were admitted at the crisis point); (c) factors influencing self-management skills (e.g., (in)adequate disease knowledge and medical expenditure affordability); and (d) needs for self-management (e.g., increased disease knowledge, individualized self-management plan, eHealth, (healthcare insurance) policy support). Identified themes were dependent on each other and should be leveraged when implementing SMIs. Ultimately, such SMIs can optimize patient health outcomes. Show less
Background: In recent years, the delivery of evidence-based therapies targeting posttraumatic stress disorder (PTSD) has been the focus of the Departments of Defense in countries such as Canada,... Show moreBackground: In recent years, the delivery of evidence-based therapies targeting posttraumatic stress disorder (PTSD) has been the focus of the Departments of Defense in countries such as Canada, the Netherlands, and the United States. More than 66% of military members continue to experience symptoms of PTSD that significantly impact their daily functioning and quality of life after completing evidence-based treatments. Innovative, engaging, and effective treatments for PTSD are needed. Multimodal motion-assisted memory desensitization and reconsolidation (3MDR) is an exposure-based, virtual reality-supported therapy used to treat military members and veterans with treatment-resistant PTSD. Given the demonstrated efficacy of 3MDR in recently published randomized control trials, there is both an interest in and a need to adapt the intervention to other populations affected by trauma and to improve accessibility to the treatment.Objective: We aimed to further innovate, develop, and validate new and existing hardware and software components of 3MDR to enhance its mobility, accessibility, feasibility, and applicability to other populations affected by trauma, including public safety personnel (PSP), via international collaboration.Methods: This study used a modified Delphi expert consultation method and mixed methods quasi-experimental validation with the purpose of software validation among PSP (first responders, health care providers) participants (N=35). A team of international experts from the Netherlands, the United States, and Canada met on the web on a weekly basis since September 2020 to discuss the adoption of 3MDR in real-world contexts, hardware and software development, and software validation. The evolution of 3MDR hardware and software was undertaken followed by a mixed methods software validation study with triangulation of results to inform the further development of 3MDR.Results: This study resulted in the identification, description, and evolution of hardware and software components and the development of new 3MDR software. Within the software validation, PSP participants widely acknowledged that the newly developed 3MDR software would be applicable and feasible for PSP affected by trauma within their professions. The key themes that emerged from the thematic analysis among the PSP included the desire for occupationally tailored environments, individually tailored immersion, and the applicability of 3MDR beyond military populations.Conclusions: Within the modified Delphi consultation and software validation study, support for 3MDR as an intervention was communicated. PSP participants perceived that 3MDR was relevant for populations affected by trauma beyond military members and veterans. The resulting hardware and software evolution addressed the recommendations and themes that arose from PSP participants. 3MDR is a novel, structured, exposure-based, virtual reality-supported therapy that is currently used to treat military members and veterans with PTSD. Going forward, it is necessary to innovate and adapt 3MDR, as well as other trauma interventions, to increase effectiveness, accessibility, cost-effectiveness, and efficacy among other populations affected by trauma. Show less
Feleus, S.; Schaijk, M. van; Roos, R.A.C.; Bot, S.T. de 2022
Huntington's Disease (HD) is a rare, neurodegenerative disorder characterized by chorea, cognitive decline, and behavioral changes. Despite wide clinical use since the mid-1980s, tiapride was... Show moreHuntington's Disease (HD) is a rare, neurodegenerative disorder characterized by chorea, cognitive decline, and behavioral changes. Despite wide clinical use since the mid-1980s, tiapride was recently withdrawn from the Dutch market without rationale. Although alternatives are available, many patients experienced dysregulation after this unwanted change. We provide insight into the impact of sudden tiapride withdrawal by reviewing medical records of HD patients who were using tiapride at the time of withdrawal. In addition, we performed a systematic search in five databases on tiapride efficacy and its safety profile in HD. Original research and expert opinions were included. In our patient group on tiapride, 50% required tiapride import from abroad. Regarding the review, 12 articles on original datasets and three expert opinions were included. The majority of studies showed an improvement in chorea while patients were on tiapride. Due to limited sample sizes, not all studies performed statistical tests on their results. Fifty percent of clinical experts prefer tiapride as initial chorea monotherapy, especially when comorbid behavioral symptoms are present. Side effects are often rare and mild. No safety concerns were reported. In conclusion, tiapride is almost irreplaceable for some patients and is an effective and safe chorea treatment in HD. Show less
Lennaerts-Kats, H.; Ebenau, A.; Steen, J.T. van der; Munneke, M.; Bloem, B.R.; Vissers, K.C.P.; ... ; Groot, M.M. 2022
Background: Palliative care for persons with Parkinson's disease (PD) is developing. However, little is known about the experiences of patients with PD in the palliative phase and of their family... Show moreBackground: Palliative care for persons with Parkinson's disease (PD) is developing. However, little is known about the experiences of patients with PD in the palliative phase and of their family caregivers. Objective: To explore needs of patients with PD in the palliative phase and of their family caregivers. Methods: A mixed methods case study design. Health care professionals included patients for whom the answer on the question "Would you be surprised if this patient died in the next 12 months?" was negative. At baseline, and after six and twelve months, we conducted semi-structured interviews with patients and caregivers. Participants completed questionnaires on quality of life, disease burden, caregiver burden, grief, and positive aspects of caregiving. We analyzed quantitative data using descriptive statistics, while we used thematic analysis for qualitative data. Results: Ten patients and eight family caregivers participated, of whom five patients died during the study period. While the quantitative data reflected a moderate disease burden, the qualitative findings indicated a higher disease burden. Longitudinal results showed small differences and changes in time. Patients reported a diverse range of symptoms, such as fatigue, immobility, cognitive changes, and hallucinations, which had a tremendous impact on their lives. Nevertheless, they rated their overall quality of life as moderate to positive. Family caregivers gradually learned to cope with difficult situations such delirium, fluctuations in functioning and hallucinations. They had great expertise in caring for the person with PD but did not automatically share this with health care professionals. Patients sensed a lack of time to discuss their complex needs with clinicians. Furthermore, palliative care was rarely discussed, and none of these patients had been referred to specialist palliative care services. Conclusion: Patients with PD experienced many difficulties in daily living. Patients seems to adapt to living with PD as they rated their quality of life as moderate to positive. Family caregivers became experts in the care for their loved one, but often learned on their own. An early implementation of the palliative care approach can be beneficial in addressing the needs of patients with PD and their family caregivers. Show less
Spierings, J.; Ende, C.H.M. van den; Schriemer, R.M.; Moens, H.J.B.; Bijl, E.A. van der; Bonte-Mineur, F.; ... ; ARCH Study Grp 2020
Objectives. To gain insight into SSc patients' perspective on quality of care and to survey their preferred quality indicators.Methods. An online questionnaire about healthcare setting, perceived... Show moreObjectives. To gain insight into SSc patients' perspective on quality of care and to survey their preferred quality indicators.Methods. An online questionnaire about healthcare setting, perceived quality of care (CQ index) and quality indicators, was sent to 2093 patients from 13 Dutch hospitals.Results. Six hundred and fifty patients (mean age 59 years, 75% women, 32% limited cutaneous SSc, 20% diffuse cutaneous SSc) completed the questionnaire. Mean time to diagnosis was 4.3 years (s.d. 6.9) and was longer in women compared with men (4.8 (s.d. 7.3) vs 2.5 (s.d. 5.0) years). Treatment took place in a SSc expert centre for 58%, regional centre for 29% or in both for 39% of patients. Thirteen percent of patients was not aware of whether their hospital was specialized in SSc. The perceived quality of care was rated with a mean score of 3.2 (s.d. 0.5) (range 1.0-4.0). There were no relevant differences between expert and regional centres. The three prioritized process indicators were: good patient-physician interaction (80%), structural multidisciplinary collaboration (46%) and receiving treatment according to SSc guidelines (44%). Absence of disease progression (66%), organ involvement (33%) and digital ulcers (27%) were the three highest rated outcome indicators.Conclusion. The perceived quality of care evaluated in our study was fair to good. No differences between expert and regional centres were observed. Our prioritized process and outcome indicators can be added to indicators suggested by SSc experts in earlier studies and can be used to evaluate the quality of care in SSc. Show less
Recent research has examined patients' drawings of their illness as a means to identify patients' illness representations. The aim of this systematic review was to examine which representations are... Show moreRecent research has examined patients' drawings of their illness as a means to identify patients' illness representations. The aim of this systematic review was to examine which representations are evident in patients' drawings, and whether drawing assessments are associated with patient outcomes. Ten electronic databases were searched for published journal papers in English up to 1 July 2017. Narrative synthesis summarised findings by participant characteristics, study design, illness representations, and associations with outcomes. There were 101 eligible studies, published across 29 different countries, with 27 different disease categories; 54 of the studies were with adults and 80 were cross-sectional. All core illness perception domains were evident; the most common being identity and related concepts (including symptoms, anatomy, pathophysiology), and emotional representations (including fear, denial, stigma). Perceptions of treatment and the clinical and social environment were evident. More organ damage drawn and larger drawing size were associated with worse perceptions and health outcomes, and drawings distinguished between patient groups. Limitations include the inability to conduct meta-analysis. In conclusion, patients' drawings reveal additional domains of illness representations, specifically perceptions of pathophysiology, treatment and social environments, as well as illness pre-occupation. These findings expand theories of self-regulation and suggest image-based intervention strategies. Show less
Roon-Mom, W.M.C. van; Roos, R.A.C.; Bot, S.T. de 2018
INTRODUCTION\nDrug-target binding kinetics are major determinants of the time course of drug action for several drugs, as clearly described for the irreversible binders omeprazole and aspirin.... Show moreINTRODUCTION\nDrug-target binding kinetics are major determinants of the time course of drug action for several drugs, as clearly described for the irreversible binders omeprazole and aspirin. This supports the increasing interest to incorporate newly developed high-throughput assays for drug-target binding kinetics in drug discovery. A meaningful application of in vitro drug-target binding kinetics in drug discovery requires insight into the relation between in vivo drug effect and in vitro measured drug-target binding kinetics.\nAREAS COVERED\nIn this review, the authors discuss both the relation between in vitro and in vivo measured binding kinetics and the relation between in vivo binding kinetics, target occupancy and effect profiles.\nEXPERT OPINION\nMore scientific evidence is required for the rational selection and development of drug-candidates on the basis of in vitro estimates of drug-target binding kinetics. To elucidate the value of in vitro binding kinetics measurements, it is necessary to obtain information on system-specific properties which influence the kinetics of target occupancy and drug effect. Mathematical integration of this information enables the identification of drug-specific properties which lead to optimal target occupancy and drug effect in patients. Show less
