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What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care
Get PDFBackground/aims: Serious adverse event reporting guidelines have largely been developed for pharmaceutical trials. There is evidence that serious adverse events, such as psychological distress, can also occur in non-pharmaceutical trials. Managing serious adverse event reporting and monitoring in palliative care non-pharmaceutical trials can be particularly challenging. This is because patients living with advanced malignant or non-malignant disease have a high risk of hospitalisation and/or death as a result of progression of their disease rather than due to the trial intervention or procedures. This paper presents a number of recommendations for managing serious adverse event reporting that are drawn from two palliative care non-pharmacological trials. Methods: The recommendations were iteratively developed across a number of exemplar trials. This included examining national and international safety reporting guidance, reviewing serious adverse event reporting procedures from other pharmacological and non-pharmacological trials, a review of the literature and collaboration between the ACTION study team and Data Safety Monitoring Committee. These two groups included expertise in oncology, palliative care, statistics and medical ethics and this collaboration led to the development of serious adverse event reporting procedures. Results: The recommendations included; allowing adequate time at the study planning stage to develop serious adverse event reporting procedures, especially in multi-national studies or research naïve settings; reviewing the level of trial oversight required; defining what a serious adverse event is in your trial based on your study population; development and implementation of standard operating procedures and training; refining the reporting procedures during the trial if necessary and publishing serious adverse events in findings papers. Conclusions: There is a need for researchers to share their experiences of managing this challenging aspect of trial conduct. This will ensure that the processes for managing serious adverse event reporting are continually refined and improved so optimising patient safety. Trial registration: ACTION trial registration number: ISRCTN63110516 (date of registration 03/10/2014). Namaste trial registration number: ISRCTN14948133 (date of registration 04/10/2017)
Practice Variation in Skin Cancer Treatment and Follow-Up Care: A Dutch Claims Database Analysis
Get PDFBackground: Quality indicators are used to benchmark and subsequently improve quality of healthcare. However, defining good quality indicators and applying them to high-volume care such as skin cancer is not always feasible. Objectives: To determine whether claims data could be used to benchmark high-volume skin cancer care and to assess clinical practice variation. Methods: All skin cancer care-related claims in dermatology in 2016 were extracted from a nationwide claims database (Vektis) in the Netherlands. Results: For over 220,000 patients, a skin cancer diagnosis-related group was reimbursed in 124 healthcare centres. Conventional excision reflected 75% of treatments for skin cancer but showed large variation between practices. Large practice variation was also found for 5-fluorouracil and imiquimod creams. The practice variation of Mohs micrographic surgery and photodynamic therapy was low under the 75th percentile, but outliers at the 100th percentile were detected, which indicates that few centres performed these therapies far more often than average. On average, patients received 1.8 follow-up visits in 2016. Conclusions: Claims data demonstrated large practice variation in treatments and follow-up visits of skin cancer and may be a valid and feasible data set to extract quality indicators. The next step is to investigate whether detected practice variation is unwarranted and if a reduction improves quality and efficiency of care
Matching walking speed of controls affects identification of gait deviations in patients with a total knee replacement
Get PDFBackground: The assessment of functional recovery of patients after a total knee replacement includes the quantification of gait deviations. Comparisons to comfortable gait of healthy controls may incorrectly suggest biomechanical gait deviations, since the usually lower walking speed of patients already causes biomechanical differences. Moreover, taking peak values as parameter might not be sensitive to actual differences. Therefore, this study investigates the effect of matching walking speed and full-waveform versus discrete analyses. Methods: Gait biomechanics of 25 knee replacement patients were compared to 22 controls in two ways: uncorrected and corrected for walking speed employing principal component analyses, to reconstruct control gait biomechanics at walking speeds matched to the patients. Ankle, knee and hip kinematics and kinetics were compared over the full gait cycle using statistical parametric mapping against using peak values. Findings: All joint kinematics and kinetics gait data were impacted by applying walking speed correction, especially the kinetics of the knee. The lower control walking speeds used for reference generally reduced the magnitude of differences between patient and control gait, however some were enlarged. Full-waveform analysis identified greater deviating gait cycle regions beyond the peaks, but did not make peak value analyses redundant. Interpretation: Matching walking speed of controls affects identification of gait deviations in patients with a total knee replacement, reducing deviations confounded by walking speed and revealing hidden gait deviations related to possible compensations. Full-waveform analysis should be used along peak values for a comprehensive quantification of differences in gait biomechanics
Views on Early Diagnosis of Alzheimer's Disease among Dutch Physicians: A Qualitative Interview Study
Get PDFBackground: Hope for future treatments to prevent or slow down dementia motivates researchers to strive for ever-earlier diagnoses of Alzheimer's disease (AD) based on biomarkers, even before symptoms occur. But is a biomarker-based early diagnosis desirable in clinical practice? Objective: This study explores the ethical considerations that shape current clinical practice regarding early AD diagnostics and the use of biomarkers. Methods: In this qualitative study, Dutch physicians were interviewed. Topics included physicians' views concerning early AD diagnosis in persons with no or mild cognitive impairment, physicians' considerations regarding current and expected future practices of early AD diagnosis, the use of biomarkers, and the use of the concepts preclinical and prodromal AD. We analyzed the transcripts using directed content analysis. Results: 15 general practitioners, neurologists, and geriatricians in the Netherlands were interviewed. Most of them interpreted an early AD diagnosis with an early diagnosis of dementia. We identified six clusters of considerations sometimes in favor but most often against pursuing an early AD diagnosis in people with no or mild cognitive impairment that influence physicians' diagnostic decision-making: preferences and characteristics of persons, test characteristics, impact on care, type of setting, disease concepts, and issues on a societal level. Conclusion: The discussion concerning an early AD diagnosis based on biomarkers which is widely held in the scientific field, has not entered clinical practice structurally. A biomarker-based early diagnosis does not fit within Dutch physicians' views on what good care for people with no, subjective, or mild cognitive impairment should entail
The Force of Numbers: Investigating Manual Signatures of Embodied Number Processing
Get PDFThe study has two objectives: (1) to introduce grip force recording as a new technique for studying embodied numerical processing; and (2) to demonstrate how three competing accounts of numerical magnitude representation can be tested by using this new technique: the Mental Number Line (MNL), A Theory of Magnitude (ATOM) and Embodied Cognition (finger counting-based) account. While 26 healthy adults processed visually presented single digits in a go/no-go n-back paradigm, their passive holding forces for two small sensors were recorded in both hands. Spontaneous and unconscious grip force changes related to number magnitude occurred in the left hand already 100–140 ms after stimulus presentation and continued systematically. Our results support a two-step model of number processing where an initial stage is related to the automatic activation of all stimulus properties whereas a later stage consists of deeper conscious processing of the stimulus. This interpretation generalizes previous work with linguistic stimuli and elaborates the timeline of embodied cognition. We hope that the use of grip force recording will advance the field of numerical cognition research
Lipid droplets and their interactions with other organelles in liver diseases
Get PDFLipid droplets are cellular organelles used for lipid storage with a hydrophobic core of neutral lipids enclosed by a phospholipid monolayer. Besides presenting as giant single organelles in fat tissue, lipid droplets are also widely present as a multitude of small structures in hepatocytes, where they play key roles in health and disease of the liver. In addition to lipid storage, lipid droplets are also directly involved in lipid metabolism, membrane biosynthesis, cell signaling, inflammation, pathogen-host interaction and cancer development. In addition, they interact with other cellular organelles to regulate cellular biology. It is fair to say that the exact functions of lipid droplets in cellular physiology remain largely obscure. Thus prompted, here we aim to analyze the corpus of contemporary biomedical literature to create a framework as to how the role of lipid droplets in hepatocyte physiology and pathophysiology should be understood. The resulting framework should help understanding the interaction of lipid droplets with other organelles in important liver diseases, including fatty liver disease, viral hepatitis and liver cancer and direct further research directions
Exposure to Bullying and General Psychopathology: A Prospective, Longitudinal Study
Get PDFAlthough there is mounting evidence that the experience of being bullied associates with both internalizing and externalizing symptoms, it is not known yet whether the identified associations are specific to these symptoms, or shared between them. The primary focus of this study is to assess the prospective associations of bullying exposure with both general and specific (i.e., internalizing, externalizing) factors of psychopathology. This study included data from 6,210 children participating in the Avon Longitudinal Study of Parents and Children (ALSPAC). Child bullying was measured by self-report at ages 8 and 10 years. Child psychopathology symptoms were assessed by parent-interview, using the Development and Well-being Assessment (DAWBA) at ages 7 and 13 years. Bullying exposure significantly associated with the general psychopathology factor in early adolescence. In particular, chronically victimized youth exposed to multiple forms of bullying (i.e., both overt and relational) showed higher levels of general psychopathology. Bullying exposure also associated with both internalizing and externalizing factors from the correlated-factors model. However, the effect estimates for these factors decreased considerably in size and dropped to insignificant for the internalizing factor after extracting the shared variance that belongs to the general factor of psychopathology. Using an integrative longitudinal model, we found that higher levels of general psychopathology at age 7 also associated with bullying exposure at age 8 which, in turn, associated with general psychopathology at age 13 through its two-year continuity. Findings suggest that exposure to bullying is a risk factor for a more general vulnerability to psychopathology
White matter microstructure correlates of age, sex, handedness and motor ability in a population-based sample of 3031 school-age children
Get PDFUnderstanding the development of white matter microstructure in the general population is an imperative precursor to identifying its involvement in psychopathology. Previous studies have reported changes in white matter microstructure associated with age and different developmental patterns between boys and girls. Handedness has also been related to white matter in adults. Motor performance, tightly dependent on overall neuronal myelination, has been related to the corpus callosum. However, the association between motor performance and global white matter microstructure has not been reported in the literature. In general, these age, sex, handedness, and motor performance associations have been observed using small and poorly representative samples. We examined the relationships between age, sex, handedness, and motor performance, measured with a finger tapping task, and white matter microstructure in the forceps major and minor and in 5 tracts bilaterally (cingulum, corticospinal, inferior and superior longitudinal fasciculi, and uncinate) in a population-based sample of 3031 children between 8 and 12 years of age. Diffusion tensor imaging (DTI) data were acquired using a single, study-dedicated 3 Tesla scanner. We extracted and quantified features of white matter microstructure for each tract. We computed global DTI metrics by combining scalar values across multiple tracts into single latent factors using a confirmatory factor analysis. The adjusted linear regression models indicated that age was associated with global fractional anisotropy (FA), global mean diffusivity (MD), and almost all the tracts. Further, girls showed lower global MD than boys, while FA values differed by tract, and no age-sex interactions were found. No differences were observed in white matter microstructure between right- and left-handed children. We observed that FA in forceps major was associated with right-hand finger tapping performance. White matter FA in association tracts was only related to motor function before multiple testing correction. Our findings do not provide evidence for a relationship between finger tapping task performance and global white matter microstructure
Testing bias in professional forecasts
Get PDFProfessional forecasters can rely on econometric models, on their personal expertise or on both. To accommodate for adjustments to model forecasts, this paper proposes to use two stage least squares (TSLS) (and not ordinary least squares [OLS]) for the familiar Mincer–Zarnowitz regression when examining bias in professional forecasts, where the instrumental variable is the consensus forecast. An illustration for 15 professional forecasters with their quotes for real gross domestic product (GDP) growth, inflation and unemployment for the United States documents the usefulness of this new estimation method. It also shows that TSLS suggests less bias than OLS does
Complex skin cancer treatment requiring reconstructive plastic surgery: an interview study on the experiences and needs of patients
Get PDFTo provide patient-centered care, it is essential to explore what patients consider important and to adjust care accordingly. This may specifically be relevant for patients with complex skin cancer, for whom the care process is often more complicated and psychological and social problems may play a larger role. The objective was to explore the experiences and needs of patients who had undergone surgical treatment by a dermatologist for a complex skin cancer with a subsequent reconstruction by a plastic surgeon. An interview study was conducted among 16 patients who had undergone surgical treatment by a dermatologist and reconstruction by a plastic surgeon for basal cell carcinoma, cutaneous squamous cell carcinoma, or lentigo maligna. The interviews focused on patients’ experiences and needs regarding care using a predefined topic list. All interviews were audio-taped, transcribed verbatim and inductively analyzed using Atlas.ti. Patients reported a need for a skilled and friendly physician who tailors information and communication to their individual situation. A need for continuity of care and improved collaboration between healthcare providers was also emphasized. Furthermore, patients experienced complications and unmet expectations and expressed a need for shared decision-making at various steps throughout the treatment process (depending on age). Patients also considered completeness of tumor removal, follow-up visits with multiple specialists to be planned the same day and recognition of the psychological impact of the disease on the partner important. To improve patient-centered care for complex skin cancer patients, more efforts should be directed towards improving continuity of care and collaboration. Furthermore, it is advocated for physicians to be sensitive to the individual needs of patients and their partner and adjust information, communication and (supportive) care accordingly