Randomizing a clinical trial in neuro-degenerative disease

The paper studies randomization rules for a sequential two-treatment, two-site clinical trial in Parkinson’s disease. An important feature is that we have values of responses and five potential prognostic factors from a sample of 144 patients similar to those to be enrolled in the trial. Analysis of this sample provides a model for trial analysis. The comparison of allocation rules is made by simulation yielding measures of loss due to imbalance and of potential bias. A major novelty of the paper is the use of this sample, via a two-stage algorithm, to provide an empirical distribution of covariates for the simulation; sampling of a correlated multivariate normal distribution is followed by transformation to variables following the empirical marginal distributions. Six allocation rules are evaluated. The paper concludes with some comments on general aspects of the evaluation of such rules and provides a recommendation for two allocation rules, one for each site, depending on the target number of patients to be enrolled

Safety perception in patients with advanced idiopathic Parkinson’s disease – a qualitative study

BackgroundA fundamental cornerstone of quality of healthcare is patient safety, which many people with life-limiting illnesses feel is being compromised. Perceptions of impaired safety are associated with the occurrence of psychological distress and healthcare utilization. However, little is known about how people with idiopathic Parkinson’s disease (iPD) perceive their own safety toward the end of life. The aim of our study was therefore to investigate factors that influence the perception of safety of patients with advanced iPD.MethodsWe conducted semi-structured interviews with a purposeful sample of 21 patients with advanced iPD. Participants were recruited at the neurology department of a tertiary care hospital in Germany between August 2021 and June 2022. Data were analyzed using reflexive thematic analysis.ResultsiPD-patients reported relevant impairment of their safety. While most participants expressed safety concerns based on the manifestation of disease, our analysis identified enablers and barriers to establishing safety in patients with advanced iPD, in 10 additional domains: relationship to the disease, informedness, self-perception, utilization of support and care structures, healthcare professionals and structures, treatment, social interaction, social security, spirituality, and environment.ConclusionThis study provides new insights into safety perceptions of patients with advanced iPD, which extend well beyond the physical realm. The findings suggest that clinicians and policy makers should consider a holistic and multidisciplinary approach to assessing and improving patients’ safety taking into account the enablers and barriers identified in this study

Moving towards Integrated and Personalized Care in Parkinson’s Disease: A Framework Proposal for Training Parkinson Nurses

Delivering healthcare to people living with Parkinson’s disease (PD) may be challenging in face of differentiated care needs during a PD journey and a growing complexity. In this regard, integrative care models may foster flexible solutions on patients’ care needs whereas Parkinson Nurses (PN) may be pivotal facilitators. However, at present hardly any training opportunities tailored to the care priorities of PD-patients are to be found for nurses. Following a conceptual approach, this article aims at setting a framework for training PN by reviewing existing literature on care priorities for PD. As a result, six prerequisites were formulated concerning a framework for training PN. The proposed training framework consist of three modules covering topics of PD: (i) comprehensive care, (ii) self-management support and (iii) health coaching. A fourth module on telemedicine may be added if applicable. The framework streamlines important theoretical concepts of professional PD management and may enable the development of novel, personalized care approaches

Impact of the COVID-19 pandemic on perceived access and quality of care in German people with parkinsonism

Due to the heterogeneous clinical presentation, people with Parkinsonism (PwP) develop individual healthcare needs as their disease progresses. However, because of limited health resources during the COVID-19 pandemic, many patients were put at risk of inadequate care. All this occurred in the context of inequitable healthcare provision within societies, especially for such vulnerable populations. This study aimed to investigate factors influencing satisfaction and unmet need for healthcare among PwP during the COVID-19 pandemic in Germany. Analyses relied on an anonymous online survey with a 49-item questionnaire. We aimed at describing access to health services before and during the early stages of the pandemic. To this end, a generalized linear model was used to derive significant predictors and a stepwise regression to subsummarize the main factors of perceived inadequate care. In total, 551 questionnaires showed that satisfaction with Parkinsonism-related care decreased significantly during the pandemic (p [ 0.001). In particular, factors such as lower educational level, lower perceived expertise of healthcare providers, less confidence in remote care, difficulties in obtaining healthcare, and restricted access to care before the pandemic but also lower densities of neurologists at residence and less ability to overcome barriers were indicative of higher odds to perceive unmet needs (p [ 0.05). The results unveil obstacles contributing to reduced access to healthcare during the COVID-19 pandemic for PwP. These findings enable considerations for improved provision of healthcare services to PwP

Deriving Implications for Care Delivery in Parkinson’s Disease by Co-Diagnosing Caregivers as Invisible Patients

For persons with Parkinson’s disease, the loss of autonomy in daily life leads to a high level of dependency on relatives’ support. Such dependency strongly correlates with high levels of perceived stress and psychosocial burden in informal caregivers. Global developments, such as demographic change and the associated thinning infrastructure in rural areas cause a continuously growing need for medical and nursing care. However, this need is not being adequately met. The resulting care gap is being made up by unpaid or underpaid work of informal caregivers. The double burden of care work and gainful employment creates enormous health-related impairments of the informal caregivers, so that they eventually become invisible patients themselves. Expectedly, those invisible patients do not receive the best care, leading to a decrease in quality of life and, in the end, to worse care for PD patients. Suggested solutions to relieve relatives, such as moving the person affected by Parkinson’s to a nursing home, often do not meet the wishes of patients and informal caregivers, nor does it appear as a structural solution in the light of demographic change against an economic background. Rather, it requires the development, implementation and evaluation of new, holistic approaches to care that make invisible patients visible

Safety perception in patients with advanced idiopathic Parkinson's disease - a qualitative study

BackgroundA fundamental cornerstone of quality of healthcare is patient safety, which many people with life-limiting illnesses feel is being compromised. Perceptions of impaired safety are associated with the occurrence of psychological distress and healthcare utilization. However, little is known about how people with idiopathic Parkinson's disease (iPD) perceive their own safety toward the end of life. The aim of our study was therefore to investigate factors that influence the perception of safety of patients with advanced iPD.MethodsWe conducted semi-structured interviews with a purposeful sample of 21 patients with advanced iPD. Participants were recruited at the neurology department of a tertiary care hospital in Germany between August 2021 and June 2022. Data were analyzed using reflexive thematic analysis.ResultsiPD-patients reported relevant impairment of their safety. While most participants expressed safety concerns based on the manifestation of disease, our analysis identified enablers and barriers to establishing safety in patients with advanced iPD, in 10 additional domains: relationship to the disease, informedness, self-perception, utilization of support and care structures, healthcare professionals and structures, treatment, social interaction, social security, spirituality, and environment.ConclusionThis study provides new insights into safety perceptions of patients with advanced iPD, which extend well beyond the physical realm. The findings suggest that clinicians and policy makers should consider a holistic and multidisciplinary approach to assessing and improving patients' safety taking into account the enablers and barriers identified in this study

Randomizing a clinical trial in neuro-degenerative disease

The paper studies randomization rules for a sequential two-treatment, two-site clinical trial in Parkinson’s disease. An important feature is that we have values of responses and five potential prognostic factors from a sample of 144 patients similar to those to be enrolled in the trial. Analysis of this sample provides a model for trial analysis. The comparison of allocation rules is made by simulation yielding measures of loss due to imbalance and of potential bias. A major novelty of the paper is the use of this sample, via a two-stage algorithm, to provide an empirical distribution of covariates for the simulation; sampling of a correlated multivariate normal distribution is followed by transformation to variables following the empirical marginal distributions. Six allocation rules are evaluated. The paper concludes with some comments on general aspects of the evaluation of such rules and provides a recommendation for two allocation rules, one for each site, depending on the target number of patients to be enrolled

Building a Parkinson-Network–Experiences from Germany

Parkinson’s disease is a complex neurodegenerative disease that can be best treated with a multi-disciplinary care approach. Building care networks has been shown as a useful tool to facilitate the integration of care services and improve outcomes for patients and care providers. However, experiences and practices relating to building a network are very limited in the field of Parkinson’s disease. This paper portrays existing Parkinson networks in Germany. With the help of a standardized template, description of networks and their building-blocks, so-called modules, were collected from all over Germany. Modules were rated in terms of their expected benefit and the required effort when implementing them, with the help of an expert survey. The rating showed that some modules were perceived as more important than others, but all modules were recognized as beneficial for patients and care providers. Overall, the German experience shows that building a Parkinson network facilitates the integration of care and provides a benefit to all stakeholders involved

Coping Styles in Patients with Parkinson's Disease: Consideration in the Co-Designing of Integrated Care Concepts

Integrated care models may help in designing care for Parkinson's disease (PD) that is more efficient and patient-centered. However, in order to implement such models successfully, it is important to design these models around patients' needs and preferences. Personality traits and coping styles play a well-studied important role in patients' disease perception and their utilization of medical and social services to cope with their disease. There is evidence that coping styles remain largely unchanged over the course of PD; coping styles are defined in the early stages of life and extend over the entire lifespan of the patient. Therefore, it seems necessary to consider aspects of the personality traits and coping styles of PD patients in the development and implementation of care models. We postulate that by taking patients' personality traits and coping styles into account, care models for PD can be designed in a more individualized and, thus, more effective way. This paper, structured in three main sections, attempts to structure the uptake of patients' coping styles in the co-design of integrated care models. However, further studies are needed to better develop tailored care concepts to the needs of people living with PD and their individual coping styles

The role of Parkinson Nurses for personalizing care in Parkinsons disease : a systematic review and meta-analysis

BACKGROUND: Quality of life (QoL) of persons with Parkinson’s disease (PD) is diminished by (non-)motor symptoms, that require personalized care. Parkinson Nurses (PN) may be pivotal promoting tailored care offerings. This systematic review and meta-analysis investigates PD care models and aims at furnishing current concepts of PN to offer personalized care. OBJECTIVE: The purpose of this study is to identify the various roles and functions that PN may hold for personalized PD care. METHODS: We performed a systematic literature review, utilizing: PubMed, Web of Science, The Cochrane Library, and PsycINFO. The review qualitatively evaluated articles, which described personalized care models involving PNs and was guided by the personalized care management model. A meta-analysis compared patient-reported QoL (quantified using the 39-item Parkinson’s Disease Questionnaire) between personalized care interventions involving PN versus standard care with. RESULTS: Twenty-seven publications were identified, including six randomized, controlled trials ascertaining with health related QoL (n = 1830 PwPs). The qualitative evaluation revealed that PN contribute to all aspects of personalized care. The meta-analysis showed no improved QoL in personalized care models compared to standard care, thought a great heterogeneity among study design and interventions was outlined (Standardized Mean Difference = –0.8935; 95% Confidence Interval, –2.1177 to 0.3307; z = –1.43, p = 0.1526). CONCLUSION: PN fulfil important functions in personalized PD care. For the future, a clear role definition will be necessary to adjust training for PN across healthcare systems and care settings but especially to realize their full potential for PD care