A core outcome set for evaluating the effectiveness of mixed-diagnosis falls prevention interventions for people with Multiple Sclerosis, Parkinson’s Disease and stroke

by Nicola O’Malley, Susan Coote, Fiona McCullough Staunton, Eileen O’Connor, Amanda M. Clifford

Introduction

Clinical trials evaluating the effectiveness of falls prevention interventions for people with Multiple Sclerosis (MS), Parkinson’s Disease (PD) and stroke measure heterogeneous outcomes, often omitting those meaningful to patients. A core outcome set (COS) is a standardised set of outcomes that should be assessed in all trials within a research area. The aim of this study was to develop a COS for evaluating mixed-diagnosis falls prevention interventions for people with MS, PD and stroke in non-acute and community settings, with input from relevant stakeholder groups.

Methods

Previously published research undertaken by the team, including a qualitative study with 20 patients and a review of the literature, were used to derive a longlist of potential outcomes. Outcomes were prioritised for inclusion in the COS using a three-round online Delphi survey. A multi-stakeholder, consensus meeting was conducted to agree upon the final COS and to provide a recommendation for a single outcome measure for each outcome in the COS.

Results

Forty-eight participants were recruited across four stakeholder groups (researchers, patients, clinicians, and service-planners/policymakers). A total of 42 participants (87.5%) completed all three rounds of the surveys. Sixty-two outcomes were considered for inclusion in the COS throughout the Delphi process. A total of 15 participants attended the consensus meeting where they agreed upon the final COS and accompanying measurement instruments: fall incidence, injurious fall incidence, quality of life, falls self-efficacy, fear of falling, activity curtailment due to fear of falling, and cost-effectiveness. Attendees at the consensus meeting recommended that the proposed mechanism of impact of an intervention is considered when selecting additional outcomes outside of those in the COS to assess.

Conclusions

This study identified a COS for evaluating the effectiveness of mixed-diagnosis falls prevention interventions for people with MS, PD and stroke. It is recommended that this COS and accompanying measurement instruments be used in all future trials in this research area so that findings can be combined and compared.

IL-6 serum level, ARDS, and AKI as risk factors for the COVID-19 infection’s mortality in children

by Idham Jaya Ganda, Try Kartika Eka Putri, Syarifuddin Rauf, Amiruddin Laompo, Ninny Meutia Pelupessy, Sitti Aizah Lawang, Nadirah Rasyid Ridha, Bahrul Fikri, Muhammad Nasrum Massi

Introduction

Dysregulated immune responses are developed in Coronavirus disease-2019 (COVID-19) and Interleukin-6 (IL-6) levels are reflecting the severity of the clinical presentation. This study aimed to analyze IL-6 serum level, Acute Respiratory Distress Syndrome (ARDS), and Acute Kidney Injury (AKI) as risk factors for mortality in children with COVID-19.

Methods

This prospective cohort study was conducted on children with COVID-19 infection confirmed by Real Time Polymerase Chain Reaction (RT-PCR) who were admitted to infection center at Dr. Wahidin Sudirohusodo Hospital from September 2021 to September 2022. Subjects were selected using the consecutive sampling method.

Results

A total of 2,060 COVID-19 RT-PCR tests were performed, and 1,065 children were confirmed positive. There were 291 cases that met the inclusion criteria, with 28.52 percent non-survives and 71.48% survives. The risk factors for mortality were IL-6, ARDS, AKI, Prothrombin Time / Activated Partial Thromboplastin Time (PT/aPTT), oxygen saturation, Absolut lymphocyte count (ALC), leukocytes, Length of Stay (LOS), and nutritional status (p80.97 pg/ml with 93% sensitivity and 90% specificity. Area Under Curve was 0.981 (95% CI), 0.960–1.000). A multivariate analysis showed IL-6 levels with OR 18.570 (95% CI 5.320–64.803), ARDS with Odds Ratio (OR) 10.177, (95% Confidence Interval (CI) 1.310–9.040), and AKI with OR 3.220 (95% CI 1.070–10.362). A combination of increased IL-6, ARDS, and AKI can predict a mortality probability as high as 98.3%.

Conclusion

IL-6, ARDS, and AKI are risk factors for mortality in children with COVID-19. IL-6 level was the highest mortality risk factor.

Visuo-haptic processing of unfamiliar shapes: Comparing children and adults

by Furat AlAhmed, Anne Rau, Christian Wallraven

The question of how our sensory perception abilities develop has been an active area of research, establishing trajectories of development from infancy that last well into late childhood and even adolescence. In this context, several studies have established changes in sensory processing of vision and touch around the age of 8 to 9 years. In this experiment, we explored the visual and haptic perceptual development of elementary school children of ages 6–11 in similarity-rating tasks of unfamiliar objects and compared their performance to adults. The participants were presented with parametrically-defined objects to be explored haptically and visually in separate groups for both children and adults. Our results showed that the raw similarity ratings of the children had more variability compared to adults. A detailed multidimensional scaling analysis revealed that the reconstructed perceptual space of the adult haptic group was significantly closer to the parameter space compared to the children group, whereas both groups’ visual perceptual space was similarly well reconstructed. Beyond this, however, we found no clear evidence for an age effect in either modality within the children group. These results suggest that haptic processing of unfamiliar, abstract shapes may continue to develop beyond the age of 11 years later into adolescence.

Time for You: A process evaluation of the rapid implementation of a multi-level mental health support intervention for frontline workers during the COVID-19 pandemic

by Bryan McCann, Simon C. Hunter, Kareena McAloney-Kocaman, Paul McCarthy, Jan Smith, Eileen Calveley

The coronavirus (COVID-19) pandemic had wide-ranging negative impacts on mental health. The pandemic also placed extraordinary strain on frontline workers who were required to continue working and putting themselves at risk to provide essential services at a time when their normal support mechanisms may not have been available. This paper presents an evaluation of the Time for You service, a rapidly developed and implemented intervention aimed at providing frontline workers with quick access to flexible online mental health support. Time for You provided service users with three service options: self-guided online cognitive behavioural therapy (CBT) resources; guided engagement with online CBT resources; 1–1 psychological therapy with trainee sport and exercise psychologists and trainee health psychologists. A process evaluation informed by the Consolidated Framework for Implementation Research considered service fidelity, adaptations, perceived impact, reach, barriers, and facilitators. Interviews with project managers (n = 5), delivery staff (n = 10), and service users (n = 14) explored perceptions of the service implementation and outcomes, supported by data regarding engagement with the online CBT platform (n = 217). Findings indicated that service users valued the flexibility of the service and the speed with which they were able to access support. The support offered by Trainee Psychologists was perceived to be of high quality, and the service was perceived by service users to have improved mental health and wellbeing. The rapid implementation contributed to issues regarding appropriate service user screening that led to trainee psychologists being unable to provide the service users with the support they needed as the presenting issues were outside of trainees’ competencies. Overall, the findings suggest that interventions offering flexible, online psychological support to frontline workers can be an effective model for future interventions. Trainee psychologists are also able to play an important role in delivering such services when clear screening processes are in place.

Oral health in patients with different sites of head and neck squamous cell carcinoma is not different

by Philipp Kanzow, Katharina Mielke, Franziska Haupt, Susanne Wiegand, Henning Schliephake, Dirk Beutner, Annette Wiegand

Oral health might not only act as risk factor for head and neck squamous cell carcinoma (HNSCC), but might also have a predictive value for the patients’ survival. Currently, information on the effect of oral health on survival of patients with different sites of HNSCC is lacking. This single-center retrospective study aimed to compare oral health in patients with different sites of HNSCC and to analyse whether oral health is associated with survival in the different subsets of HNSCC patients. Dental records of HNSCC patients referred for dental assessment prior to radio(chemo)therapy were included. Patient-related parameters (age at time of diagnosis, sex, tobacco exposure, alcohol consumption, HPV status), treatment data (primary treatment, intent), performance status, tumor demographics (anatomical site, TNM staging), and oral health parameters (DMFT, periodontal health, teeth with/without root canal treatment and with/without periodontitis apicalis) were obtained. Oral health parameters were compared between different anatomical sites. Survival of all HNSCC patients and of individual subsets was assessed using Kaplan-Meier statistics, and the effect of tumor demographics, patient-related parameters, and oral health on survival was analysed by cox regression analyses (α = 5%). 371 patients with HNSCC (oral: n = 86, oropharyngeal: n = 174, hypopharyngeal: n = 59, laryngeal: n = 15, other: n = 37) were included. Oral health parameters did not differ between subsets (p_adj.≥0.199). Five-year cumulative survival of HNSCC patients amounted to 78.6%. Only for HNSCC originating in the oral cavity and oropharynx, survival was associated with the treatment intent (p = 0.015) or performance status (p = 0.007) in the multivariable analyses, respectively. Within the limitations of this study, oral health was not different between different subsets and had no significant effect on survival of HNSCC patients.