The five aspect meal model as a conceptual framework for children with a gastrostomy tube in paediatric care

Background Cancer treatments may induce side effects and cause eating problems. A gastrostomy tube may be required in order to maintain and optimise the child\u27s nutritional needs. Despite the use of a gastrostomy tube, it is important to maintain a natural and attractive mealtime for the child. The Five Aspect Meal Model is age neutral and originally designed to improve restaurant visits. Its five aspects conceptualise what is necessary to ensure a complete meal experience. To date, there is lack of knowledge to guided model development about mealtimes adapted to children and limited knowledge regarding mealtime experiences for children with a gastrostomy tube. Aim The aim was to investigate whether the Five Aspect Meal Model could be appropriate to be used for children with a gastrostomy tube in caring science and paediatric care. Methods The design followed steps retrieved from Renjith and colleagues. Seven interviews were performed with the Five Aspect Meal Model as a base in the interview guide. The transcripts were analysed by using a qualitative directed content analysis with a deductive approach, which finally passed into a more inductive one. Findings All aspects of the Five Aspect Meal Model were represented in the interviews. There were also experiences related to the gastrostomy tube and the mealtimes that did not fit into any of the five predetermined categories. As a result, the modified version was developed, an adapted prescribing practice model that includes seven aspects, whereof bodily discomfort and time for change and acceptance are specific to children with a gastrostomy tube. Conclusion Based on children and their parent\u27s experiences, the Five Aspect Meal Model has been developed and adapted into a modified version, which includes seven aspects. The modified version seems to be appropriate to use within caring science and paediatric care

Pain and discomfort in children with gastrostomy tubes – In the context of hematopoietic stem cell transplantation

Background: In children with malignant and severe non-malignant disorders undergoing hematopoietic stem cell transplantation (HSCT), treatment related pain and discomfort are common. Food consumption may become troublesome, making the use of a gastrostomy tube (G-tube) necessary and resulting in complications, why the purpose was to explore pain and discomfort during the transplantation and post-transplantation time. Methods: This was a mixed methods study where data were collected along the child\u27s total health-care process between 2018 and 2021. Questions with fixed answer options were used, simultaneously, semi-structured interviews were performed. In total, sixteen families participated. Descriptive statistics and content analysis were used to describe analysed data. Findings: Intense pain was common during the post-surgery phase, especially in conjunction with G-tube care, which is why the children needed support to manage the situation. After the post-surgery phase when the skin has healed, most of the children experienced minor to no pain or bodily discomfort, why the G-tube became a well-functioning and supportive tool in daily life. Conclusions: This study describes variations in and experiences of pain and bodily discomfort in conjunction with G-tube insertion in a unique sample of children who had undergone HSCT. In conclusion, the children\u27s comfort in daily life after the post-surgery phase seemed to be only marginally affected by G-tube insertion. Children with severe non-malignant disorders seemed to experience a higher frequency and intensity of pain and bodily discomfort due to the G-tube than children with malignant disorders. Practice implications: The paediatric care team need competence in assessing G-tube related pain and awareness that experiences may differ depending on the child\u27s disorder

Experiences before and after nasogastric and gastrostomy tube insertion with emphasis on mealtimes: a case study of an adolescent with cerebral palsy

Purpose: Adolescents with cerebral palsy may need a feeding tube due to feeding challenges, since nutritional intake and mealtimes may be negatively affected. The purpose of the study was to describe and better understand how one adolescent with cerebral palsy and her parents experienced mealtimes before and after a nasogastric and gastrostomy tube insertion and how the use of these feeding tubes was experienced in daily life. Methods: Individual interviews were performed with one adolescent and each of her parents. In total, six interviews were conducted on two separate occasions. The qualitative approach known as Interpretive Description was used during the analysis. Results: Four thematic patterns were identified within the data: (i) struggling with nutritional intake, (ii) the paradox of using an aid, (iii) being different, and (iv) challenges of public mealtimes. Conclusions: The results showed that four themes influenced daily mealtimes in adolescents with cerebral palsy and a gastrostomy tube. Nutritional intake and mealtimes may be difficult, which is why using a gastrostomy tube can be a relief. However, the gastrostomy tube can also pose a challenge and a paradox. Time of change and acceptance seems necessary in order to meet these challenges

The rubber hand illusion evaluated using different stimulation modalities

Tactile feedback plays a vital role in inducing ownership and improving motor control of prosthetic hands. However, commercially available prosthetic hands typically do not provide tactile feedback and because of that the prosthetic user must rely on visual input to adjust the grip. The classical rubber hand illusion (RHI) where a brush is stroking the rubber hand, and the user’s hidden hand synchronously can induce ownership of a rubber hand. In the classic RHI the stimulation is modality-matched, meaning that the stimulus on the real hand matches the stimulus on the rubber hand. The RHI has also been used in previous studies with a prosthetic hand as the “rubber hand,” suggesting that a hand prosthesis can be incorporated within the amputee’s body scheme. Interestingly, previous studies have shown that stimulation with a mismatched modality, where the rubber hand was brushed, and vibrations were felt on the hidden hand also induced the RHI. The aim of this study was to compare how well mechanotactile, vibrotactile, and electrotactile feedback induced the RHI in able-bodied participants and forearm amputees. 27 participants with intact hands and three transradial amputees took part in a modified RHI experiment. The rubber hand was stroked with a brush, and the participant’s hidden hand/residual limb received stimulation with either brush stroking, electricity, pressure, or vibration. The three latter stimulations were modality mismatched with regard to the brushstroke. Participants were tested for ten different combinations (stimulation blocks) where the stimulations were applied on the volar (glabrous skin), and dorsal (hairy skin) sides of the hand. Outcome was assessed using two standard tests (questionnaire and proprioceptive drift). All types of stimulation induced RHI but electrical and vibration stimulation induced a stronger RHI than pressure. After completing more stimulation blocks, the proprioceptive drift test showed that the difference between pre- and post-test was reduced. This indicates that the illusion was drifting toward the rubber hand further into the session

Standards for model-based early bactericidal activity analysis and sample size determination in tuberculosis drug development

Background: A critical step in tuberculosis (TB) drug development is the Phase 2a early bactericidal activity (EBA) study which informs if a new drug or treatment has short-term activity in humans. The aim of this work was to present a standardized pharmacometric model-based early bactericidal activity analysis workflow and determine sample sizes needed to detect early bactericidal activity or a difference between treatment arms.Methods: Seven different steps were identified and developed for a standardized pharmacometric model-based early bactericidal activity analysis approach. Non-linear mixed effects modeling was applied and different scenarios were explored for the sample size calculations. The sample sizes needed to detect early bactericidal activity given different TTP slopes and associated variability was assessed. In addition, the sample sizes needed to detect effect differences between two treatments given the impact of different TTP slopes, variability in TTP slope and effect differences were evaluated.Results: The presented early bactericidal activity analysis approach incorporates estimate of early bactericidal activity with uncertainty through the model-based estimate of TTP slope, variability in TTP slope, impact of covariates and pharmacokinetics on drug efficacy. Further it allows for treatment comparison or dose optimization in Phase 2a. To detect early bactericidal activity with 80% power and at a 5% significance level, 13 and 8 participants/arm were required for a treatment with a TTP-EBA0-14 as low as 11 h when accounting for variability in pharmacokinetics and when variability in TTP slope was 104% [coefficient of variation (CV)] and 22%, respectively. Higher sample sizes are required for smaller early bactericidal activity and when pharmacokinetics is not accounted for. Based on sample size determinations to detect a difference between two groups, TTP slope, variability in TTP slope and effect difference between two treatment arms needs to be considered.Conclusion: In conclusion, a robust standardized pharmacometric model-based EBA analysis approach was established in close collaboration between microbiologists, clinicians and pharmacometricians. The work illustrates the importance of accounting for covariates and drug exposure in EBA analysis in order to increase the power of detecting early bactericidal activity for a single treatment arm as well as differences in EBA between treatments arms in Phase 2a trials of TB drug development

Towards a tactile artifical hand

Amputation of a hand is a life-changing event, and the loss of motor and sensory functions leads to disability and has devastating effects on the individual. What is normally performed using two hands must be solved with only one, and the loss also affects body balance and body posture. In addition, amputation of a hand has psychological effects, and has an influence on social life, participation, and identity. A hand prosthesis has an important role in reducing the negative effects of an amputation. However, rejection of the prosthesis is common, due to expectations that are too high to be fulfilled and limitations in technical solutions, with possible overuse of the existing hand as a consequence. The overall aim of this work has been to further develop and implement a non-invasive concept for sensory feedback in hand prostheses. Specific aims were to explore forearm amputees’ views of prosthesis use and perception of sensory feedback, to investigate the sensory qualities of phantom hand maps (PHMs) in amputees, to determine whether it is possible to learn to associate sensory stimuli on the skin of the forearm to specific fingers in healthy non-amputee volunteers, and lastly to evaluate a non-invasive sensory feedback system for a prosthetic hand in the everyday lives of forearm amputees.Initial findings indicated that today’s myoelectric hand prostheses allow the wearer to experience agency―the experience of controlling one’s own motor acts―but the lack of sensory feedback appears to limit achievement of a sense of body ownership of the prosthesis. A PHM on the residual limb is a phenomenon seen in many amputees, and when it is touched it generates a perception of touch on the hand that no longer exists. The neurobiological basis of the phenomenon is not fully understood, but it probably originates from plastic changes within the brain following amputation and also changes in peripheral nerves. We have demonstrated that the PHM has better discriminative sensibility than the corresponding skin area on the uninjured arm. Thus, the PHM is an ideal target for a non-invasive concept to achieve sensory feedback in prostheses. Given that not all amputees have a PHM, it was also found that it is possible to learn to associate stimuli on the skin of the forearm with specific fingers, i.e. it is possible to create a PHM. An evaluation of the non-invasive sensory feedback system based on the PHM in a prototype prosthesis during four weeks of use at home was also performed. The participants experienced the sensory feedback as being real, which gave a strong feeling of being complete, linked to body ownership. However, this was not verified by the quantitative measurements. This thesis shows that the PHM may be a possible target for non-invasive somatotopically matched sensory feedback systems in hand prostheses. The fact that it is possible to learn to associate sensory stimuli on the skin of the forearm to specific fingers is also promising for future development of sensory feedback systems, e.g. for congenital amputees or amputees who do not experience a PHM. The long-term goal is that this non-invasive concept for sensory feedback will be applicable to several types of hand prostheses, for various levels of amputation

Forearm amputees' views of prosthesis use and sensory feedback.

Qualitative descriptive

Outcomes of Proximal Interphalangeal Joint Pyrocarbon Implants.

PURPOSE: To prospectively register and report the hand function and occupational performance of patients with proximal interphalangeal joint-pyrocarbon arthroplasty, using both objective tests and subjective outcome instruments. METHODS: From 2004 to 2008, 53 joints in 43 patients were reconstructed with a proximal interphalangeal joint-pyrocarbon prosthesis. The patients underwent a rehabilitation program allowing early motion with an extension stop to limit hyperextension. Range of motion, grip strength, and pain (Visual Analog Scale [VAS]) were recorded and the subjective outcome was evaluated using Canadian Occupational Performance Measure (COPM) and Disabilities of the Arm, Shoulder, and Hand score. RESULTS: Seven patients were reoperated on (2 infections, 2 arthrodesis, 2 tenolysis, and 1 hyperextension). Pain (VAS) at rest improved from 3.1 cm preoperatively to 0.4 cm (p < .001) and pain (VAS) at activity from 6.2 to 2.0 cm (p < .001) at the latest follow-up (mean, 24 months; minimum, 12 months [+/- 2 weeks]). Disabilities of the Arm, Shoulder, and Hand score improved from a median of 39 to 29 (p = .026). The COPM subjective measurement of occupational performance, improved from a median of 4.6 preoperatively to 5.9 (p = .013) at the latest follow-up, and the COPM, measurement of satisfaction improved from a median of 3.8 to 5.9 (p = .002). Range of motion and grip strength were unchanged. CONCLUSIONS: All patients reported decreased pain, and although we found no improvement in range of motion and grip strength, one third of patients reported a clinically significant improvement in occupational performance and satisfaction. A total of 13% of the joints required a secondary surgical procedure. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV

Finding the right hazard function for time-to-event modeling : A tutorial and Shiny application

Parametric time-to-event analysis is an important pharmacometric method to predict the probability of an event up until a certain time as a function of covariates and/or drug exposure. Modeling is performed at the level of the hazard function describing the instantaneous rate of an event occurring at that timepoint. We give an overview of the parametric time-to-event analysis starting with graphical exploration by Kaplan-Meier plotting for the event data including censoring and nonparametric hazard estimators such as the kernel-based visual hazard comparison for the underlying hazard. The most common hazard functions including the exponential, Gompertz, Weibull, log-normal, log-logistic, and circadian functions are described in detail. A Shiny application was developed to graphically guide the modeler which of the most common hazard functions presents a similar shape compared to the data in order to guide which hazard functions to test in the parametric time-to-event analysis. For the chosen hazard function(s), the Shiny application can additionally be used to explore corresponding parameter values to inform on suitable initial estimates for parametric modeling as well as on possible covariate or treatment relationships to certain parameters. Moreover, it can be used for the dissemination of results as well as communication, training, and workshops on time-to-event analysis. By guiding the modeler on which functions and what parameter values to test and compare as well as to assist in dissemination, the Shiny application developed here greatly supports the modeler in complicated parametric time-to-event modeling

Sensory Feedback in Hand Prostheses : A Prospective Study of Everyday Use

Introduction: Sensory feedback in hand prostheses is lacking but wished for. Many amputees experience a phantom hand map on their residual forearm. When the phantom hand map is touched, it is experienced as touch on the amputated hand. A non-invasive sensory feedback system, applicable to existing hand prostheses, can transfer somatotopical sensory information via phantom hand map. The aim was to evaluate how forearm amputees experienced a non-invasive sensory feedback system used in daily life over a 4-week period. Methods: This longitudinal cohort study included seven forearm amputees. A non-invasive sensory feedback system was used over 4 weeks. For analysis, a mixed method was used, including quantitative tests (ACMC, proprioceptive pointing task, questionnaire) and interviews. A directed content analysis with predefined categories sensory feedback from the prosthesis, agency, body ownership, performance in activity, and suggestions for improvements was applied. Results: The results from interviews showed that sensory feedback was experienced as a feeling of touch which contributed to an experience of completeness. However, the results from the questionnaire showed that the sense of agency and performance remained unchanged or deteriorated. The ability to feel and manipulate small objects was difficult and a stronger feedback was wished for. Phantom pain was alleviated in four out of five patients. Conclusion: This is the first time a non-invasive sensory feedback system for hand prostheses was implemented in the home environment. The qualitative and quantitative results diverged. The sensory feedback was experienced as a feeling of touch which contributed to a feeling of completeness, linked to body ownership. The qualitative result was not verified in the quantitative measurements. Clinical Trial Registration: Name: Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses. Date of registration: March 15, 2019. Date the first participant was enrolled: April 1, 2015. ClinicalTrials.gov Identifier: NCT03876405 ORCID ID: https://orcid.org/0000-0002-4140-7478