[Synthetic indicator of compliance with standards for Quality Units of health centers and multicenter prospective pilot study]. / Indicador sintético de cumplimiento de estándares para Unidades de Calidad de centros sanitarios y estudio de pilotaje prospectivo multicéntrico.

BACKGROUND AND OBJECTIVE: In Spain, Quality Units play a key and unique role in advising healthcare centers on the methodology of healthcare quality. The objectives of the study were to develop computer algorithms to obtain a synthetic indicator of standard compliance for Quality Units and to pilot its functioning in these units. MATERIALS AND METHODS: The Excel program was used to establish evaluation algorithms, and quantitatively interrelate and weight various categories of standards, as a computer evaluation tool, to build a continuous improvement cycle system, and offer a global synthetic indicator of compliance. The tool was tested in a prospective multicenter pilot study, in which coordinators of Quality Units from different health centers and care settings participated, to evaluate the usefulness of the tool and compliance with the standards, in addition to analyzing the content validity of each standard. RESULTS: The formulas for the structured computer algorithms were developed, consecutively, in a «PLAN-DO-CHECK-ACT¼ improvement cycle for the 9 categories of standards, resulting in a single synthetic indicator of compliance. Twenty-one Quality Units participated in the piloting. The overall average compliance rate for the synthetic indicator was 55.63% with differences between centers (P=.002) and between categories (P<.0001), but not by autonomous communities (P=.86) or by areas (P=.97). Content validity was ensured through the variable of «understanding¼ of the standards (P<.001), and through their «justification¼ with documentary evidence (P<.001). CONCLUSIONS: The computer tool with the synthetic indicator have allowed for the evaluation of standard compliance in Quality Units of healthcare centers.

A randomized feasibility trial of medium chain triglyceride-supplemented ketogenic diet in people with Parkinson's disease.

BACKGROUND: A ketogenic diet (KD) may benefit people with neurodegenerative disorders marked by mitochondrial depolarization/insufficiency, including Parkinson's disease (PD). OBJECTIVE: Evaluate whether a KD supplemented by medium chain triglyceride (MCT-KD) oil is feasible and acceptable for PD patients. Furthermore, we explored the effects of MCT-KD on blood ketone levels, metabolic parameters, levodopa absorption, mobility, nonmotor symptoms, simple motor and cognitive tests, autonomic function, and resting-state electroencephalography (rsEEG). METHODS: A one-week in-hospital, double-blind, randomized, placebo-controlled diet (MCT-KD vs. standard diet (SD)), followed by an at-home two-week open-label extension. The primary outcome was KD feasibility and acceptability. The secondary outcome was the change in Timed Up & Go (TUG) on day 7 of the diet intervention. Additional exploratory outcomes included the N-Back task, Unified Parkinson's Disease Rating Scale, Non-Motor Symptom Scale, and rsEEG connectivity. RESULTS: A total of 15/16 subjects completed the study. The mean acceptability was 2.3/3, indicating willingness to continue the KD. Day 7 TUG time was not significantly different between the SD and KD groups. The nonmotor symptom severity score was reduced at the week 3 visit and to a greater extent in the KD group. UPDRS, 3-back, and rsEEG measures were not significantly different between groups. Blood ketosis was attained by day 4 in the KD group and to a greater extent at week 3 than in the SD group. The plasma levodopa metabolites DOPAC and dopamine both showed nonsignificant increasing trends over 3 days in the KD vs. SD groups. CONCLUSIONS: An MCT-supplemented KD is feasible and acceptable to PD patients but requires further study to understand its effects on symptoms and disease. TRIAL REGISTRATION: Trial Registration Number NCT04584346, registration dates were Oct 14, 2020 - Sept 13, 2022.

A pilot study exploring the use of hyaluronic acid in treating insertional achilles tendinopathy.

PURPOSE: This study explores the use of ultrasound-guided Hyaluronic Acid (HA) injections for Insertional Achilles Tendinopathy (IAT). METHODS: A cohort of 15 ankles diagnosed with IAT received three weekly ultrasound-guided HA injections. The Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire scored the severity of symptoms and functional impairment before treatment, and at one and six months post-treatment. RESULTS: Significant improvement was observed in VISA-A scores post-treatment, rising from an average baseline of 34.8 ± 15.2 (11-63) to 53.6 ± 20.9 (15-77) after one month, and then to 50.7 ± 18.6 (20-75) after six months. No adverse reactions were noted, underscoring the safety of the intervention. CONCLUSION: The pilot study presents HA injections as a potentially effective treatment for IAT, while interpretation of these findings must take into account the variability in results, indicating a range of patient responses. It encourages further research to confirm these findings and to explore HA's full potential in managing IAT, despite the limitations of a small sample size and lack of control group.

Pilot study of a health promotion intervention in sports clubs / Étude pilote d'une intervention de promotion de la santé au sein de clubs de sport.

Sports clubs (SCs) are an ideal setting for promoting health. However existing health promotion (HP) interventions in SCs mainly target a single health behavior and men who do sports, and evaluations of such interventions provides little information about their deployment. To overcome these limitations, the PROSCeSS intervention was co-constructed based on the theoretical model of the health-promoting SC and multi-level, multi-determinant health strategies. The aim of this pilot study was to evaluate the deployment of the PROSCeSS intervention and identify the factors influencing its deployment. A qualitative study, using recordings of meetings, email and telephone exchanges, and interviews with project leaders of fourteen SC, was carried out. Although a low number of SCs had completed the intervention, they all considered that they have a role to play in helping their members maintain good health. Their ability to develop HP activities and to implement the intervention was influenced by the resources available, the support they received from their sports federation, and the ability of each project leader to get involved in the intervention. The SCs that deployed the intervention implemented several strategies enabling them to integrate health into the organizational, social, economic, and environmental habits of the SCs and to develop new HP activities, such as adapted sports activity sessions and activities to teach members about first aid, nutrition, and good practices for warming up. This study highlights the importance of understanding the specificities of the contexts in which HP interventions are deployed. Having led to a reworking of the intervention steps and the development of an appropriate evaluation design, it also highlights the essential role of pilot studies in the development and evaluation of interventions.

Le club de sport (CS) est un milieu de vie privilégié pour promouvoir la santé. Cependant, les interventions de promotion de la santé (PS) existantes dans les CS ciblent majoritairement un seul comportement de santé et des pratiquants sportifs masculins, et leurs évaluations renseignent peu leurs déploiements. Pour dépasser ces limites, l'intervention PROSCeSS a été co-construite à partir du modèle théorique du CS promoteur de santé et de stratégies multi-niveaux et multi-déterminants de santé. L'objectif de cette étude pilote était d'évaluer le déploiement de l'intervention PROSCeSS et d'identifier les facteurs influençant son déploiement. Une étude qualitative comprenant des enregistrements de réunions, des échanges par e-mails et par téléphone, et des entretiens avec les référents de 14 CS a été réalisée. Même si le nombre de CS qui sont allés au bout de l'intervention est faible, ceux-ci considèrent qu'ils ont un rôle à jouer dans la santé de leurs membres. Leur capacité à développer des activités de PS et à déployer les étapes de l'intervention est influencée par les ressources disponibles, le soutien qu'ils reçoivent de leur fédération sportive et la capacité d'un porteur de projet (référent) à s'impliquer. Les CS qui ont déployé l'intervention ont mis en place plusieurs stratégies qui leur permettent d'intégrer la santé dans les habitudes organisationnelles, sociales, économiques et environnementales du CS et de développer de nouvelles activités de PS, telles que des sessions d'activités sportives adaptées et des activités de sensibilisation à l'échauffement, à l'alimentation et aux gestes de premier secours. Cette étude montre qu'il est important de comprendre les spécificités des contextes dans lesquels les interventions de PS sont déployées. Parce qu'elle a conduit à retravailler les étapes de l'intervention et à développer un nouveau design d'évaluation, elle met en évidence le rôle essentiel des études pilotes pour le développement et l'évaluation des interventions.

"Being an informal caregiver - strengthening resources": mixed methods evaluation of a psychoeducational intervention supporting informal caregivers in palliative care.

BACKGROUND: Informal caregivers are key support for patients with progressive incurable diseases. However, their own needs often remain unmet. Therefore, we developed, manualised and implemented the intervention "Being an informal caregiver - strengthening resources" aiming to support and empower informal caregivers by addressing relevant information-related, physical, psychological and social needs. METHODS: In this pilot study, we evaluated the acceptance and experiences with this psychoeducational intervention. The study was conducted over two years (2019-2021). Informal caregivers were recruited from the University Medical Centre Hamburg-Eppendorf and the metropolitan region of Hamburg, Germany. The intervention was aimed at adult persons who identified themselves as an informal caregiver to an adult patient with a progressive incurable cancer and non-cancer disease. For the evaluation we used a mixed methods approach, combining a longitudinal questionnaire survey (pre-intervention, after each module, 3-months follow-up) and semi-structured interviews post-intervention. Quantitative data were analysed using descriptive statistics and a paired t-Test, interviews were analysed based on the qualitative content analysis according to Mayring. Results were triangulated using a convergent triangulation design. RESULTS: Of 31 informal caregivers who received the intervention, 25 returned the follow-up questionnaire and 20 informal caregivers were interviewed. Triangulated results showed a high satisfaction with the implementation of the intervention. Of a broad range of subjective benefits, gaining knowledge, self-awareness and self-efficacy were most apparent. Informal caregivers reported improved preparedness, awareness of own needs as well as confidence regarding handling own emotions and interacting with the ill person. However, implementing the learned skills into daily life can be challenging due to internal and external factors. Motivations and challenges for participating as well as potential for improvement were identified. CONCLUSIONS: This pilot study showed an overall positive evaluation and several subjective benefits of the psychoeducational intervention "Being an informal caregiver - strengthening resources". Further research is needed to measure the efficacy of this intervention on informal caregivers' outcomes. Therefore, a multicentre randomized prospective study is planned.

Usability and preliminary effectiveness of an app-based physical activity and education program for people with hip or knee osteoarthritis - a pilot randomized controlled trial.

BACKGROUND: Hip and knee osteoarthritis (OA) are highly prevalent worldwide. The guidelines recommend physical activity and education as the core treatments for osteoarthritis. Digital health has the potential to engage people in physical activity and disease management. Therefore, we conducted a pilot trial to assess the usability and preliminary effectiveness of an app-based physical activity and education program (Join2Move) compared to usual care for people with hip and/or knee OA in Germany. METHODS: A randomized controlled pilot study was conducted. Individuals with diagnosed or self-reported knee and hip OA were included. Allocation to the intervention or control group was randomized. The intervention group received the Join2Move program. The Join2Move program was previously developed as a website and evaluated in the Netherlands. For the current study, the program was translated and adapted to the German context and adjusted from a website to an app. The control group received usual care. The primary outcomes were usability and preliminary effectiveness (pain and physical functioning). Measurements were taken at baseline and at twelve weeks. The data analysis was performed using SPSS (IBM SPSS Statistics 29.0). RESULTS: Sixty participants, with a mean age of 61.9 (SD ± 7.2) years, were allocated to the intervention (n = 32) or the control group (n = 28) and included in the analysis. The majority of participants had knee OA (68%), and 12% had hip and knee OA. The dropout rate was n = 11 (18%). No adverse events were reported. Usability was rated as acceptable (mean System Usability Scale = 71.3/100) with a wide range (32.5 to 100). Statistically significant between-group differences were found only for pain (mean difference 8.52 (95% CI 1.01 to 16.04), p = 0.027). CONCLUSIONS: Join2Move demonstrated acceptable usability. The preliminary results of the pilot trial indicate the potential of a stand-alone app for the treatment of patients with hip or knee OA. However, the acceptable usability of Join2Move limits its recommendation for everyone. There appears to be room for improvement in app usability and in identifying patients for whom the app is suitable and the right time to use a stand-alone app. TRIAL REGISTRATION: German Clinical Trials Register DRKS00027164 .

The efficacy of heart rate variability biofeedback training on sleep disorders and impact of fibromyalgia: Results of a phase II randomized controlled trial.

OBJECTIVE: Fibromyalgia syndrome (FMs) is a chronic, musculoskeletal pain disorder characterized by sleep disturbances, fatigue, and cognitive dysfunction. Heart rate variability biofeedback (HRV-BF) aiming to improve self-regulation and strengthen the parasympathetic nervous system has been shown to be effective in several pain syndromes, but its efficacy in FMs has not been adequately investigated. This Phase II trial aimed to assess the feasibility and preliminary measurement of the improvement induced by HRV-BF in FMs. METHODS: Sixty-four patients with FMs were recruited. Patients were randomly assigned to either the experimental group (EG) or the control group (CG). The EG received 10 HRV-BF training sessions in addition to pharmacological standard therapy. The CG received standard therapies for 10 weeks. The FMs impact on daily life, sleep regularity, sense of coherence, depression symptoms and pain has been assessed as primary outcomes, quality of life as secondary. RESULT: 23 (71.9%) of EG patients completed the intervention and 20 (62.5%) of the CG were re-evaluated at time T1. No side effects were reported. It was not found any statistical differences between groups over time in primary and secondary outcomes. CONCLUSIONS: The HRV-BF intervention did not demonstrate efficacy in both primary and secondary outcomes. However, it is quite feasible in terms of drop-out rate and side effects. Further studies with larger sample sizes are needed to determine its actual efficacy. CLINICALTRIALS: gov with code: NCT04121832.

Evaluating the User Experience of a Smartphone-Delivered Sexual Health Promotion Program for Older Adults in the Netherlands: Single-Arm Pilot Study.

BACKGROUND: Sexual health is an important component of quality of life in older adults. However, older adults often face barriers to attaining a fulfilling sexual life because of issues such as stigma, lack of information, or difficult access to adequate support. OBJECTIVE: We aimed to evaluate the user experience of a self-guided, smartphone-delivered program to promote sexual health among older adults. METHODS: The mobile app was made available to community-dwelling older adults in the Netherlands, who freely used the app for 8 weeks. User experience and its respective components were assessed using self-developed questionnaires, the System Usability Scale, and semistructured interviews. Quantitative and qualitative data were descriptively and thematically analyzed, respectively. RESULTS: In total, 15 participants (mean age 71.7, SD 9.5 years) completed the trial. Participants showed a neutral to positive stance regarding the mobile app's usefulness and ease of use. Usability was assessed as "Ok/Fair." The participants felt confident about using the mobile app. To increase user experience, participants offered suggestions to improve content and interaction, including access to specialized sexual health services. CONCLUSIONS: The sexual health promotion program delivered through a smartphone in a self-guided mode was usable. Participants' perception is that improvements to user experience, namely in content and interaction, as well as connection to external services, will likely improve usefulness and acceptance.

Evaluation of the therapeutic effect of very small stem cells from peripheral blood on the treatment of Premature Ovarian Failure: A pilot study.

OBJECTIVE: Premature ovary failure (POF) is a severe health condition with multiple negative outcomes, which deteriorate a patient's life. The current study aimed to evaluate the therapeutic effect of mesenchymal stem cells (MSCs) derived from peripheral blood in the treatment of women with the POF background. METHODS: The current study was a pilot study carried-out on women younger than 40 with premature ovarian failure. Study participants underwent 4-months cell therapy using Mesenchymal stem cells extracted from peripheral bloods. Serum level of Follicle-stimulating hormone (FSH), Estradiol (E2), Anti-mullerian hormone (AMH), and Antral follicle count (AFC) were the main investigated outcomes that were assessed at baseline, month two and month four of the very small stem cell intervention. RESULTS: Average serum level of FSH was 45.0 (12.1) mIU/mL at baseline and continually decreased during the study and reached 33.2 (12.4) mIU/mL in the fourth month. The average AMH level was 0.10 ng/mL prior to the intervention and increased to 0.13 ng/mL in the 2nd month and 0.15 ng/mL in the fourth month. The level E2 was 85.7 (23.6) pg/ml on average at baseline, while the average E2 reduced to 77.2 (25.6) pg/ml in the fourth month. Average number of AFC was 2.0 (0.8) at baseline. We observed a gradual increase in the second month (Mean AFC=2.2) and after four months it increased to 3.1 (1.8) as the highest menstrual restoration and pregnancy was observed in 10% of our study participants. CONCLUSIONS: MSCs could significantly improve hormone secretion in women with POF. Implantation of MSCs in women with POF background was associated with an increase in AMH and AFC, while it downed the serum level of E2 and FSH. MSCs could also lead to menstrual restoration and pregnancy in women with POF.

Machine Learning-Based Prediction of Changes in the Clinical Condition of Patients With Complex Chronic Diseases: 2-Phase Pilot Prospective Single-Center Observational Study.

BACKGROUND: Functional impairment is one of the most decisive prognostic factors in patients with complex chronic diseases. A more significant functional impairment indicates that the disease is progressing, which requires implementing diagnostic and therapeutic actions that stop the exacerbation of the disease. OBJECTIVE: This study aimed to predict alterations in the clinical condition of patients with complex chronic diseases by predicting the Barthel Index (BI), to assess their clinical and functional status using an artificial intelligence model and data collected through an internet of things mobility device. METHODS: A 2-phase pilot prospective single-center observational study was designed. During both phases, patients were recruited, and a wearable activity tracker was allocated to gather physical activity data. Patients were categorized into class A (BI≤20; total dependence), class B (2060; moderate or mild dependence, or independent). Data preprocessing and machine learning techniques were used to analyze mobility data. A decision tree was used to achieve a robust and interpretable model. To assess the quality of the predictions, several metrics including the mean absolute error, median absolute error, and root mean squared error were considered. Statistical analysis was performed using SPSS and Python for the machine learning modeling. RESULTS: Overall, 90 patients with complex chronic diseases were included: 50 during phase 1 (class A: n=10; class B: n=20; and class C: n=20) and 40 during phase 2 (class B: n=20 and class C: n=20). Most patients (n=85, 94%) had a caregiver. The mean value of the BI was 58.31 (SD 24.5). Concerning mobility aids, 60% (n=52) of patients required no aids, whereas the others required walkers (n=18, 20%), wheelchairs (n=15, 17%), canes (n=4, 7%), and crutches (n=1, 1%). Regarding clinical complexity, 85% (n=76) met patient with polypathology criteria with a mean of 2.7 (SD 1.25) categories, 69% (n=61) met the frailty criteria, and 21% (n=19) met the patients with complex chronic diseases criteria. The most characteristic symptoms were dyspnea (n=73, 82%), chronic pain (n=63, 70%), asthenia (n=62, 68%), and anxiety (n=41, 46%). Polypharmacy was presented in 87% (n=78) of patients. The most important variables for predicting the BI were identified as the maximum step count during evening and morning periods and the absence of a mobility device. The model exhibited consistency in the median prediction error with a median absolute error close to 5 in the training, validation, and production-like test sets. The model accuracy for identifying the BI class was 91%, 88%, and 90% in the training, validation, and test sets, respectively. CONCLUSIONS: Using commercially available mobility recording devices makes it possible to identify different mobility patterns and relate them to functional capacity in patients with polypathology according to the BI without using clinical parameters.

A Serious Game for Cognitive Stimulation of Older People With Mild Cognitive Impairment: Design and Pilot Usability Study.

Background: Cognitive stimulation of older people helps prevent, and even treat, age-related diseases, such as mild cognitive impairment. Playing games reduces the probability of experiencing this pathology, which is related to the loss of the ability to carry out some instrumental activities of daily living. Objective: This work describes the design and development of a serious game for the cognitive stimulation of older people, with exercises related to the daily life task of shopping. A pilot study for its preliminary usability validation is also presented. Methods: The designed serious game includes 4 exercises consisting of shopping in a hypermarket, ordering products, making payments, and organizing the purchase, thus dealing with the most frequent cognitive problems of older people associated with episodic declarative memory, naming, calculation, and organization, respectively. Results: A total of 19 older people participated in the pilot study for the usability validation of the serious game. They indicated that they like the aesthetic and interesting topic of the game. They reported that it provides a high level of entertainment and could be useful in daily life for mental stimulation. The participants found the serious game to be intuitive, but the ease of use and readability of the instructions could be improved. Conclusions: This study suggests that the innovative serious game developed could be accepted by older people for their cognitive stimulation to prevent or treat mild cognitive impairment, although a long-term intervention study should be performed as future work. Its ecological validity design, with everyday tasks, adaptable levels of difficulty, and motivational mechanisms, is a differentiating factor compared to similar serious games.

Psycho-emotional intervention with parents of very preterm babies during the first year: A single-arm pilot study.

Studies of intervention programs that aim to improve the emotional state of parents of children admitted to the neonatal intensive care units (NICU) are scarce in Spain. The aims of this single-arm pilot study are to get to know the emotional profile of parents of high-risk preterm newborns, and to explore parents' patterns of emotional well-being before and after a psychological program called the Parental Empowerment Program, to increase parental readiness levels. The sample was made up of 100 parents (50 couples) who participated in the program. Measurements were taken of post-traumatic stress, depression, and resilience at 1 month and 12 months. Repeated measurements and dyadic data analyses were performed. One month after the birth of the baby and prior to the start of the program, mothers show more symptoms of stress and depression than fathers. After the intervention, both parents experienced improvements in their mood levels. The evidence obtained seems to show that high resilience levels and low post-traumatic stress symptoms are associated with reduced depression levels after implementing the program. However, the heterogeneity of the responses obtained, the observed associations between stress, resilience, and maternal depression, along with the reciprocal influence between maternal and paternal depression 1 year after the intervention, highlight the need for a more in-depth exploration of the interplay between risk and protective factors in this population. Despite the identified potential threats to validity, further work in this direction is recommended, including the implementation of clinical trials to demonstrate intervention efficacy. The adaptation of the parents' mutual emotional adjustment at each stage would allow them to participate more actively in the baby's care.

The feasibility and acceptability of an app-based intervention with brief behavioural support (APPROACH) to promote brisk walking in people diagnosed with breast, prostate and colorectal cancer in the UK.

INTRODUCTION: Increased moderate to vigorous physical activity (MVPA) can improve clinical and psychosocial outcomes for people living with and beyond cancer (LWBC). This study aimed to assess the feasibility and acceptability of trial procedures in a pilot randomised controlled trial (RCT) of a theory-driven app-based intervention with behavioural support focused on promoting brisk walking (a form of MVPA) in people LWBC (APPROACH). METHODS: Participants diagnosed with breast, prostate or colorectal cancer were recruited from a single UK hospital site. Assessments at baseline and 3 months included online questionnaires, device-measured brisk walking (activPAL accelerometer) and self-reported weight and height. Participants were randomised to intervention or control (care as usual). The intervention comprised a non-cancer-specific app to promote brisk walking (National Health Service 'Active 10') augmented with print information about habit formation, a walking planner and two behavioural support telephone calls. Feasibility and acceptability of trial procedures were explored. Initial estimates for physical activity informed a power calculation for a phase III RCT. A preliminary health economics analysis was conducted. RESULTS: Of those medically eligible, 369/577 (64%) were willing to answer further eligibility questions and 90/148 (61%) of those eligible were enrolled. Feasibility outcomes, including retention (97%), assessment completion rates (>86%) and app download rates in the intervention group (96%), suggest that the trial procedures are acceptable and that the intervention is feasible. The phase III RCT will require 472 participants to be randomised. As expected, the preliminary health economic analyses indicate a high level of uncertainty around the cost-effectiveness of the intervention. CONCLUSIONS: This pilot study demonstrates that a large trial of the brisk walking intervention with behavioural support is both feasible and acceptable to people LWBC. The results support progression onto a confirmatory phase III trial to determine the efficacy and cost-effectiveness of the intervention.

Addressing psychosocial needs in patients with Long-COVID (PsyLoCo-Study): study protocol of a pilot-study of a specialized modular intervention.

Introduction: After an acute infection with the corona virus 10-20% of those affected suffer from ongoing or new symptoms. A causal therapy for the phenomenon known as Long/Post-COVID is still lacking and specific therapies addressing psychosocial needs of these patients are imperatively needed. The aim of the PsyLoCo-study is developing and piloting a psychotherapeutic manual, which addresses Long/Post-COVID-related psychosocial needs and supports in coping with persistent bodily symptoms as well as depressive or anxiety symptoms. Methods and analysis: This pilot trial implements a multi-centre, 2-arm (N=120; allocation ratio: 1:1), parallel group, randomised controlled design. The pilot trial is designed to test the feasibility and estimate the effect of 1) a 12-session psychotherapeutic intervention compared to 2) a wait-list control condition on psychosocial needs as well as bodily and affective symptoms in patients suffering from Long/Post-COVID. The intervention uses an integrative, manualized, psychotherapeutic approach. The primary study outcome is health-related quality of life. Outcome variables will be assessed at three timepoints, pre-intervention (t1), post-intervention (t2) and three months after completed intervention (t3). To determine the primary outcome, changes from t1 to t2 are examined. The analysis will be used for the planning of the RCT to test the efficacy of the developed intervention. Discussion: The pilot study will evaluate a 12-session treatment manual for Long/Post-COVID sufferers and the therapy components it contains. The analysis will provide insights into the extent to which psychotherapeutic treatment approaches improve the symptoms of Long/Post-COVID sufferers. The treatment manual is designed to be carried out by psychotherapists as well as people with basic training in psychotherapeutic techniques. This approach was chosen to enable a larger number of practitioners to provide therapeutic support for Long/Post-COVID patients. After completion of the pilot study, it is planned to follow up with a randomized controlled study and to develop a treatment guideline for general practitioners and interested specialists. Trial registration: The pilot trial has been registered with the German Clinical Trials Register (Deutsches Register Klinischer Studien; Trial-ID: DRKS00030866; URL: https://drks.de/search/de/trial/DRKS00030866) on March 7, 2023.

Improving newborn screening test performance for metachromatic leukodystrophy: Recommendation from a pre-pilot study that identified a late-infantile case for treatment.

Metachromatic leukodystrophy (MLD) is a devastating rare neurodegenerative disease. Typically, loss of motor and cognitive skills precedes early death. The disease is characterised by deficient lysosomal arylsulphatase A (ARSA) activity and an accumulation of undegraded sulphatide due to pathogenic variants in the ARSA gene. Atidarsagene autotemcel (arsa-cel), an ex vivo haematopoietic stem cell gene therapy was approved for use in the UK in 2021 to treat early-onset forms of pre- or early-symptomatic MLD. Optimal outcomes require early diagnosis, but in the absence of family history this is difficult to achieve without newborn screening (NBS). A pre-pilot MLD NBS study was conducted as a feasibility study in Manchester UK using a two-tiered screening test algorithm. Pre-established cutoff values (COV) for the first-tier C16:0 sulphatide (C16:0-S) and the second-tier ARSA tests were evaluated. Before the pre-pilot study, initial test validation using non­neonatal diagnostic bloodspots demonstrated ARSA pseudodeficiency status was associated with normal C16:0-S results for age (n = 43) and hence not expected to cause false positive results in this first-tier test. Instability of ARSA in bloodspot required transfer of NBS bloodspots from ambient temperature to -20°C storage within 7-8 days after heel prick, the earliest possible in this UK pre-pilot study. Eleven of 3687 de-identified NBS samples in the pre-pilot were positive for C16:0-S based on the pre-established COV of ≥170 nmol/l or ≥ 1.8 multiples of median (MoM). All 11 samples were subsequently tested negative determined by the ARSA COV of <20% mean of negative controls. However, two of 20 NBS samples from MLD patients would be missed by this C16:0-S COV. A further suspected false negative case that displayed 4% mean ARSA activity by single ARSA analysis for the initial test validation was confirmed by genotyping of this NBS bloodspot, a severe late infantile MLD phenotype was predicted. This led to urgent assessment of this child by authority approval and timely commencement of arsa-cel gene therapy at 11 months old. Secondary C16:0-S analysis of this NBS bloodspot was 150 nmol/l or 1.67 MoM. This was the lowest result reported thus far, a new COV of 1.65 MoM is recommended for future pilot studies. Furthermore, preliminary data of this study showed C16:1-OH sulphatide is more specific for MLD than C16:0-S. In conclusion, this pre-pilot study adds to the international evidence that recommends newborn screening for MLD, making it possible for patients to benefit fully from treatment through early diagnosis.

Methodologies and key considerations for implementing the International Classification of Diseases-11th revision morbidity coding: insights from a national pilot study in China.

OBJECTIVE: The aim of this study was to disseminate insights from a nationwide pilot of the International Classification of Diseases-11th revision (ICD-11). MATERIALS AND METHODS: The strategies and methodologies employed to implement the ICD-11 morbidity coding in 59 hospitals in China are described. The key considerations for the ICD-11 implementation were summarized based on feedback obtained from the pilot hospitals. Coding accuracy and Krippendorff's alpha reliability were computed based on the coding results in the ICD-11 exam. RESULTS: Among the 59 pilot hospitals, 58 integrated ICD-11 Coding Software into their health information management systems and 56 implemented the ICD-11 in morbidity coding, resulting in 3 723 959 diagnoses for 873 425 patients being coded over a 2-month pilot coding phase. The key considerations in the transition to the ICD-11 in morbidity coding encompassed the enrichment of ICD-11 content, refinement of tools, provision of systematic and tailored training, improvement of clinical documentation, promotion of downstream data utilization, and the establishment of a national process and mechanism for implementation. The overall coding accuracy was 82.9% when considering the entire coding field (including postcoordination) and 92.2% when only one stem code was considered. Krippendorff's alpha was 0.792 (95% CI, 0.788-0.796) and 0.799 (95% CI, 0.795-0.803) with and without consideration of the code sequence, respectively. CONCLUSION: This nationwide pilot study has enhanced national technical readiness for the ICD-11 implementation in morbidity, elucidating key factors warranting careful consideration in future endeavors. The good accuracy and intercoder reliability of the ICD-11 coding achieved following a brief training program underscore the potential for the ICD-11 to reduce training costs and provide high-quality health data. Experiences and lessons learned from this study have contributed to WHO's work on the ICD-11 and can inform other countries when formulating their transition plan.

An Ecological Mobile Momentary Intervention to Support Dynamic Goal Pursuit: Feasibility and Acceptability Study.

BACKGROUND: Individuals can experience difficulties pursuing their goals amid multiple competing priorities in their environment. Effective goal dynamics require flexible and generalizable pursuit skills. Supporting successful goal pursuit requires a perpetually adapting intervention responsive to internal states. OBJECTIVE: The purpose of this study was to (1) develop a flexible intervention that can adapt to an individual's changing short to medium-term goals and be applied to their daily life and (2) examine the feasibility and acceptability of the just-in-time adaptive intervention for goal pursuit. METHODS: This study involved 3 iterations to test and systematically enhance all aspects of the intervention. During the pilot phase, 73 participants engaged in an ecological momentary assessment (EMA) over 1 month. After week 1, they attended an intervention training session and received just-in-time intervention prompts during the following 3 weeks. The training employed the Capability, Opportunity, Motivation, and Behavior (COM-B) framework for goal setting, along with mental contrasting with implementation intentions (MCII). Subsequent prompts, triggered by variability in goal pursuit, guided the participants to engage in MCII in relation to their current goal. We evaluated feasibility and acceptability, efficacy, and individual change processes by combining intensive (single-case experimental design) and extensive methods. RESULTS: The results suggest that the digital intervention was feasible and acceptable to participants. Compliance with the intervention was high (n=63, 86%). The participants endorsed high acceptability ratings relating to both the study procedures and the intervention. All participants (N=73, 100%) demonstrated significant improvements in goal pursuit with an average difference of 0.495 units in the outcome (P<.001). The results of the dynamic network modeling suggest that self-monitoring behavior (EMA) and implementing the MCII strategy may aid in goal reprioritization, where goal pursuit itself is a driver of further goal pursuit. CONCLUSIONS: This pilot study demonstrated the feasibility and acceptability of a just-in-time adaptive intervention among a nonclinical adult sample. This intervention used self-monitoring of behavior, the COM-B framework, and MCII strategies to improve dynamic goal pursuit. It was delivered via an Ecological Momentary Intervention (EMI) procedure. Future research should consider the utility of this approach as an additional intervention element within psychological interventions to improve goal pursuit. Sustaining goal pursuit throughout interventions is central to their effectiveness and warrants further evaluation.

Assessment of the microbial electrochemical sensor (SENTRY™) as a potential wastewater quality monitoring tool for common pollutants found in Malaysia.

Bioelectrochemical sensors for environment monitoring have the potential to provide facility operators with real-time data, allowing for better and more timely decision-making regarding water and wastewater treatment. To assess the robustness and sensitivity of the Sentry™ biosensor in local conditions, it was tested in Malaysia using domestically available wastewater. The study objectives included (1) enrich the biosensor locally, (2) operate and test the biosensor with local domestic wastewater, and (3) determine the biosensor's responsiveness to model pollutants through pollutant spike and immersion test as well as response to absence of wastewater. Lab-scale operation shows the biosensor was successfully enriched with (1) local University Kebangsaan Malaysia's, microbial community strain collection and (2) local municipal wastewater microflora, operated for more than 50 days with a stable yet responsive carbon consumption rate (CCR) signal. Meanwhile, two independent biosensors were also enriched and operated in Indah Water Research Centre's crude sewage holding tank, showing a stable response to the wastewater. Next, a pilot scale setup was constructed to test the enriched biosensors for the spiked-pollutant test. The biosensors showed a proportional CCR response (pollutant presence detected) towards several organic compounds in the sewage, including ethanol, chicken blood, and dilution of tested sewage but less to curry powder, methanol, and isopropanol. Conversely, there was no significant response (pollutant presence not detected) towards hexane, Congo red, engine oil, and paint, which may be due to their non-biodegradability and/or insoluble nature. Additionally, the biosensors were exposed to air for 6 h to assess their robustness towards aerobic shock with a positive result. Overall, the study suggested that the biosensor could be a powerful monitoring tool, given its responsiveness towards organic compounds in sewage under normal conditions.