Evaluating the Effect of Activity and Environment on Fall Risk in a Paradigm-Depending Laboratory Setting: Protocol for an Experimental Pilot Study.

BACKGROUND: Knowledge about the causal factors leading to falls is still limited, and fall prevention interventions urgently need to be more effective to limit the otherwise increasing burden caused by falls in older people. To identify individual fall risk, it is important to understand the complex interplay of fall-related factors. Although fall events are common, they are seldom observed, and fall reports are often biased. Due to the rapid development of wearable inertial sensors, an objective approach to capture fall events and the corresponding circumstances is provided. OBJECTIVE: The aim of this work is to operationalize a prototypical dynamic fall risk model regarding 4 ecologically valid real-world scenarios (opening a door, slipping, tripping, and usage of public transportation). We hypothesize that individual fall risk is associated with an interplay of intrinsic risk factors, activity, and environmental factors that can be estimated by using data measured within a laboratory simulation setting. METHODS: We will recruit 30 community-dwelling people aged 60 years or older. To identify several fall-related intrinsic fall risk factors, appropriate clinical assessments will be selected. The experimental setup is adaptable so that the level of fall risk for each activity and each environmental factor is adjustable. By different levels of difficulty, the effect on the risk of falling will be investigated. An 8-camera motion tracking system will be used to record absolute body motions and limits of stability. All laboratory experiments will also be recorded by inertial sensors (L5, dominant leg) and video camera. Logistic regression analyses will be used to model the association between risk factors and falls. Continuous fall risk will be modeled by generalized linear regression models using margin of stability as outcome parameter. RESULTS: The results of this project will prove the concept and establish methods to further use the dynamic fall risk model. Recruitment and measurement initially began in October 2020 but were halted because of the COVID-19 pandemic. Recruitment and measurements recommenced in October 2022, and by February 2023, a total of 25 of the planned 30 subjects have been measured. CONCLUSIONS: In the field of fall prevention, a more precise fall risk model will have a significant impact on research leading to more effective prevention approaches. Given the described burden related to falls and the high prevalence, considerable improvements in fall prevention will have a significant impact on individual quality of life and also on society in general by reducing institutionalization and health care costs. The setup will enable the analysis of fall events and their circumstances ecologically valid in a laboratory setting and thereby will provide important information to estimate the individual instantaneous fall risk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46930.

Co-designing and pilot testing an infographic to support patients/families through the REMAP-CAP consent process: a mixed-methods study protocol.

BACKGROUND: Informed consent is critical to the ethical conduct of clinical research and requires understanding of a trial including its purpose, process, potential risks and benefits, and alternatives to participation. This can be challenging for complex trials, such as platform trials, and in high-stress environments, such as the intensive care unit (ICU). REMAP-CAP (randomized, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia) is a platform trial which studies treatments for ICU patients with community-acquired pneumonia, including COVID-19. Patient/family partners (PFP) identified challenges during the REMAP-CAP consent process. METHODS: This is a patient-centred co-design study to refine and test an infographic to supplement current REMAP-CAP consent documents. Infographic prototypes were developed by patients, substitute decision-makers (SDMs), and researchers with lived experience in the ICU or with ICU research. We will apply a two-phase exploratory sequential, mixed-methods research design. In phase 1, we will conduct focus groups with ICU patients, SDMs, and research coordinators (RCs). We will use inductive content analysis to inform infographic refinement, to be pilot tested in phase 2. Phase 2 is a prospective study within a trial (SWAT) at ≤ 5 REMAP-CAP sites. We will collect self-reported data from patients/SDMs and RCs. The primary outcome is feasibility (eligible consent encounters, receipt of infographic, consent to follow-up, completion of follow-up surveys). Data will be integrated to understand if/how quantitative results build upon the qualitatively informed infographic. DISCUSSION: Phase 1 results will be used to co-design an infographic, directly informed by the perspectives of patients, SDMs, and RCs involved in ICU research consent discussions. Results from phase 2 will determine the feasibility of infographic implementation in REMAP-CAP consent encounters. These feasibility data will inform a larger SWAT to evaluate our consent infographic. If successful, use of a co-designed infographic to support REMAP-CAP consent documents may improve the experience of consent for patients, SDMs, and RCs. TRIAL REGISTRATION: The Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT no. 176).

UMOYA: a prospective longitudinal cohort study to evaluate novel diagnostic tools and to assess long-term impact on lung health in South African children with presumptive pulmonary TB-a study protocol.

BACKGROUND: Despite a high paediatric tuberculosis (TB) burden globally, sensitive and specific diagnostic tools are lacking. In addition, no data exist on the impact of pulmonary TB on long-term child lung health in low- and middle-income countries. The prospective observational UMOYA study aims (1) to build a state-of-the-art clinical, radiological, and biological repository of well-characterised children with presumptive pulmonary TB as a platform for future studies to explore new emerging diagnostic tools and biomarkers for early diagnosis and treatment response; and (2) to investigate the short and long-term impact of pulmonary TB on lung health and quality of life in children. METHODS: We will recruit up to 600 children (0-13 years) with presumptive pulmonary TB and 100 healthy controls. Recruitment started in November 2017 and is expected to continue until May 2023. Sputum and non-sputum-based samples are collected at enrolment and during follow-up in TB cases and symptomatic controls. TB treatment is started by routine care services. Intensive follow-up for 6 months will allow for TB cases to retrospectively be classified according to international consensus clinical case definitions for TB. Long-term follow-up, including imaging, comprehensive assessment of lung function and quality of life questionnaires, are done yearly up to 4 years after recruitment. DISCUSSION: The UMOYA study will provide a unique platform to evaluate new emerging diagnostic tools and biomarkers for early diagnosis and treatment response and to investigate long-term outcomes of pulmonary TB and other respiratory events on lung health in children.

Digital Health Service for Identification of Frailty Risk Factors in Community-Dwelling Older Adults: The SUNFRAIL+ Study Protocol.

This article reports the study protocol of a nationwide multicentric study in seven Italian regions aimed at assessing the effectiveness of a digitally supported approach for the early screening of frailty risk factors in community-dwelling older adults. SUNFRAIL+ is a prospective observational cohort study aimed at carrying out a multidimensional assessment of community-dwelling older adults through an IT platform, which allows to connect the items of the SUNFRAIL frailty assessment tool with a cascading multidimensional in-depth assessment of the bio-psycho-social domains of frailty. Seven centers in seven Italian regions will administer the SUNFRAIL questionnaire to 100 older adults. According to the answers provided by older adults, they will be subjected to one or more validated in-depth scale tests in order to perform further diagnostic or dimensional evaluations. The study aims to contribute to the implementation and validation of a multiprofessional and multistakeholder service model for the screening of frailty in community-dwelling older adult population.

Keep It Up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial.

BACKGROUND: Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims. METHODS: Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes. DISCUSSION: In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation.

EMDR for symptoms of depression, stress and burnout in health care workers exposed to COVID-19 (HARD): A study protocol for a trial within a cohort study.

Background: Stressful events during a pandemic are a major cause of serious health problems, such as burnout, depression and posttraumatic stress disorder (PTSD) among health care workers (HCWs). During three years, HCWs, on the frontline to fight the COVID-19 pandemic, have been at an increased risk of high levels of stress, anxiety, depression, burnout and PTSD. Regarding potential psychological interventions, Eye Movement Desensitization & Reprocessing (EMDR) is a structured, strongly recommended therapy based on its well-known efficacy in reducing PTSD symptoms and anxiety.Objectives: This study, designed as a trial within a cohort (TwiC), aims to 1) estimate the prevalence of depression, burnout and PTSD in a sample of HCWs after experiencing the COVID-19 emergency (cohort part) and 2) assess the efficacy and acceptability of 'EMDR + usual care' for HCWs from the cohort who report significant psychological symptoms (trial part).Methods: The study, designed as a TwiC, consists of a prospective cohort study (n = 3000) with an embedded, pragmatic, randomized open-label superiority trial with two groups (n = 900). Participants included in the trial part are HCWs recruited for the cohort with significant symptoms on at least one psychological dimension (depression, burnout, PTSD) at baseline, 3 months or 6 months, determined by using the Patient Health Questionnaire (PHQ-9), Professional Quality of Life (ProQOL) scale, and PTSD Checklist for the DSM-5 (PCL-5). The intervention consists of 12 separate EMDR sessions with a certified therapist. The control group receives usual care. The trial has three primary outcomes: changes in depression, burnout and PTSD scores from randomization to 6 months. All participants are followed up for 12 months.Conclusions: This study provides empirical evidence about the impact of the COVID-19 pandemic and the mental health burden it places on HCWs and assesses the effectiveness of EMDR as a psychological intervention.Trial registration NCT04570202.

Health care workers are at increased risk of stress, anxiety, depression, burnout and PTSD following the COVID-19 pandemic.In this study, the effectiveness of EMDR in reducing depression, burnout and PTSD in health care workers exposed to COVID-19 is investigated.In this study, an original 'trial within a cohort' (TwiC) design that consists of a cohort study with an embedded pragmatic randomized trial is used.The study is fully web-based, including online screening, consent and assessments.

Mixed-methods study protocol for exploring the perception of nurses' resilience in the COVID-19 pandemic: Designing, implementing and evaluation of intervention.

BACKGROUND: While the necessity for interventions to build resilient nurses in the COVID-19 pandemic is recognized, there is disagreement about the effective methods for achieving this. AIM: We present our research protocol that describes plans to design and test an interventional program for promoting nurses' resilience. DESIGN: This sequential exploratory interventional mixed-methods study is conducted in three phases (qualitative, intervention design, and quantitative). METHODS: It was funded from May 2021 for 24 months. In phase 1, we explored strategies for promoting resilience in the COVID-19 pandemic from nurses' perspectives (through semi-structured interviews). In phase 2, we will design an interventional program for promoting nurses' resilience (using the qualitative phase and literature review results). We will assess the program's effectiveness on nurses' resilience in a randomized controlled trial in phase 3. DISCUSSION: Given the different experiences of nurses of resilience in COVID-19, our innovative program can guide future research to enhance nurses' resilience based on specific situations.

Prevalence of Mood Disorders and Associated Factors at the Time of the COVID-19 Pandemic: Potocol for a Community Survey in La Manouba Governorate, Tunisia.

Aims: The present survey aims to assess the overall mood disorder prevalence and identify associated socio-demographic and clinical factors in a Tunisian community sample, with special attention to the COVID-19 pandemic. Background: Mood disorders are one of the leading causes of all non-fatal burdens of disease, with depression being at the top of the list. The COVID-19 pandemic may have increased the prevalence of mood disorders, especially in Low and Middle-income countries (LMICs) and in vulnerable populations. Objective: 1/ Assess point and lifetime prevalence of depressive and bipolar disorders as well as subthreshold bipolarity in a representative population sample of La Manouba governorate and assess treatment patterns for these disorders; 2/Study socio-demographic and clinical correlates of mood disorders 3/ Assess the association between mood disorders and quality of life 4/ Study the impact of the COVID-pandemic on the prevalence of mood disorders 5/ Assess coping mechanisms to the COVID-pandemic and whether these mechanisms moderate the appearance of mood disorders or symptoms since the beginning of the pandemic. Methods: This is a household cross-sectional observational survey to be conducted in La Manouba Governorate in a sample of 4540 randomly selected individuals aged ≥ 15 years. Data collection will be carried out by trained interviewers with clinical experience, through face-to-face interviews and the use of the computer assisted personal interviewing approach (CAPI). The following assessment tools are administered. Results: Structured clinical Interview for DSM IV-TR (Mood disorder section and Screening questions on Anxiety), Mood Disorder Questionnaire (MDQ), Suicide Behaviors Questionnaire-Revised (SBQ), 12-item Short Form Survey (SF-12), the Brief-COPE, and a questionnaire about a headache. In addition, socio-demographic and clinical data will be collected. Conclusion: This will be one of the very few household surveys in a general population sample to assess mental health problems and COVID-19-related variables since the beginning of the pandemic. Through this research, we aim to obtain an epidemiological profile of mood disorders in Tunisia and an estimation of the impact of the COVID-19 pandemic on their prevalence. Results should contribute to improving mental health care in Tunisia.

The Evaluation of a Clinical Decision Support Tool Using Natural Language Processing to Screen Hospitalized Adults for Unhealthy Substance Use: Protocol for a Quasi-Experimental Design.

BACKGROUND: Automated and data-driven methods for screening using natural language processing (NLP) and machine learning may replace resource-intensive manual approaches in the usual care of patients hospitalized with conditions related to unhealthy substance use. The rigorous evaluation of tools that use artificial intelligence (AI) is necessary to demonstrate effectiveness before system-wide implementation. An NLP tool to use routinely collected data in the electronic health record was previously validated for diagnostic accuracy in a retrospective study for screening unhealthy substance use. Our next step is a noninferiority design incorporated into a research protocol for clinical implementation with prospective evaluation of clinical effectiveness in a large health system. OBJECTIVE: This study aims to provide a study protocol to evaluate health outcomes and the costs and benefits of an AI-driven automated screener compared to manual human screening for unhealthy substance use. METHODS: A pre-post design is proposed to evaluate 12 months of manual screening followed by 12 months of automated screening across surgical and medical wards at a single medical center. The preintervention period consists of usual care with manual screening by nurses and social workers and referrals to a multidisciplinary Substance Use Intervention Team (SUIT). Facilitated by a NLP pipeline in the postintervention period, clinical notes from the first 24 hours of hospitalization will be processed and scored by a machine learning model, and the SUIT will be similarly alerted to patients who flagged positive for substance misuse. Flowsheets within the electronic health record have been updated to capture rates of interventions for the primary outcome (brief intervention/motivational interviewing, medication-assisted treatment, naloxone dispensing, and referral to outpatient care). Effectiveness in terms of patient outcomes will be determined by noninferior rates of interventions (primary outcome), as well as rates of readmission within 6 months, average time to consult, and discharge rates against medical advice (secondary outcomes) in the postintervention period by a SUIT compared to the preintervention period. A separate analysis will be performed to assess the costs and benefits to the health system by using automated screening. Changes from the pre- to postintervention period will be assessed in covariate-adjusted generalized linear mixed-effects models. RESULTS: The study will begin in September 2022. Monthly data monitoring and Data Safety Monitoring Board reporting are scheduled every 6 months throughout the study period. We anticipate reporting final results by June 2025. CONCLUSIONS: The use of augmented intelligence for clinical decision support is growing with an increasing number of AI tools. We provide a research protocol for prospective evaluation of an automated NLP system for screening unhealthy substance use using a noninferiority design to demonstrate comprehensive screening that may be as effective as manual screening but less costly via automated solutions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03833804; https://clinicaltrials.gov/ct2/show/NCT03833804. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42971.

Kangyi Qiangshen Gong exercise prescription for pulmonary function and quality of life in patients recovered from COVID-19: a study protocol for a randomized controlled trial.

BACKGROUND: Since early 2022, patients with 2019 novel coronavirus (COVID-19) infection have increased rapidly in Shanghai, China. Nevertheless, there is no widely used unified rehabilitation treatment available for discharged patients with post-infection sequelae such as dyspnea, depression, and fatigue. To promote the rehabilitation of discharged patients, our team formulated Kangyi Qiangshen Gong exercise prescription on the basis of traditional Chinese medicine rehabilitation exercises (TCMRE). We designed a randomized controlled trial to evaluate the efficacy of rehabilitation and advantages of KQG for discharged patients with post-COVID-19 syndrome. METHODS/DESIGN: This is a parallel-design, two-arm, analyst assessor-blinded, randomized controlled trial. In total, 60 discharged patients with COVID-19 sequelae, aged from 20 to 80 years will be recruited and randomly assigned to the World Health Organization instructed breathing techniques (BT) group and the Kangyi Qiangshen Gong exercise prescription (KQG) group at a ratio of 1:1. The patients in the BT group will perform breathing techniques exercise, and the patients in the KQG group will perform KQG exercise. Both groups will perform exercises twice a day for 3 months. The primary outcome will be measured with the Modified Medical Research Council Dyspnea Scale, and the secondary outcomes will include the Modified Borg Scale, Fatigue Scale-14, Patient Health Questionnaire-9 Scale, Pittsburgh Sleep Quality Index, and the Respiratory Symptoms Scale. Clinical scales will be assessed at three points (pre-exercise, 3 months post-exercise, and 3 months follow-up). Adverse events will be recorded for safety assessment. DISCUSSION: This trial will serve high-quality evidence of the value of KQG for treating discharged patients with COVID-19 in rehabilitation period. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2200059504. Registered on 03 May 2022. DISSEMINATION: The results will be published in peer-reviewed journals and disseminated through the study's website, and conferences.

A scoping review protocol of age-friendly practices during the COVID-19 pandemic.

Background: Actions focused on age-friendly environments contribute to promote and maintain older people's functional ability and may enable them to contribute to their communities and enjoy life. As such, age-friendly practices require collaboration between diverse stakeholders across multiple sectors responsible for natural, built, and social environments, which can be particularly relevant during public health emergencies when socio-ecological vulnerabilities become more salient and may disproportionally affect older people. This paper presents a protocol for a scoping review aiming to investigate the breadth of evidence concerning the development, implementation, and evaluation of age-friendly practices during the COVID-19 pandemic. The protocol sets out the objectives, methods, and dissemination plans for the review. Methods: The scoping review will be conducted in line with the Joanna Briggs Institute (JBI) scoping review methodology. We will search databases (PubMed, Web of Science, Embase, CINAHL, Scopus, PsychNet) and grey literature sources. Publications relating to practices across the 8 domains of the World Health Organization's age-friendly cities and communities' framework will be included. A tabular data extraction tool will be used to facilitate a narrative synthesis of results. Ethics and dissemination: Ethical approval is not required as the methods proposed for this scoping review consist of collecting publicly available data. Findings will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews (PRISMA-ScR) and submitted to a journal for academic dissemination. Lay dissemination plans include an infographic and a blog-style article presenting our core results. Conclusion: The publication of this protocol allows for transparency in the systematic process of a scoping review focused on age-friendly practices during COVID-19. Findings emerging from the scoping review will provide insights into the evidence available regarding age-friendly activities during COVID-19 and may inform future age-friendly practices during public health emergencies and beyond.

Use of an electronic medication management support system in patients with polypharmacy in general practice: study protocol of a quantitative process evaluation of the AdAM trial.

BACKGROUND: Interventional studies on polypharmacy often fail to significantly improve patient-relevant outcomes, or confine themselves to measuring surrogate parameters. Interventions and settings are complex, with many factors affecting results. The AdAM study's aim is to reduce hospitalization and death by requiring general practitioners (GPs) to use a computerized decision-support system (CDSS). The study will undergo a process evaluation to identify factors for successful implementation and to assess whether the intervention was implemented as intended. OBJECTIVE: To evaluate our complex intervention, based on the Medical Research Council's guideline dimensions. RESEARCH QUESTIONS: We will assess implementation (reach, fidelity, dose, tailoring) by asking: (1) Who took part in the intervention (proportion of GPs using the CDSS, proportion of patients enrolled in them)? Information on GPs' and patients' characteristics will also be collected. (2) How many and which medication alerts were dealt with? (3) Was the intervention implemented as intended? (4) On what days did GPs use the intervention tool? METHODS: The process evaluation is part of a stepped-wedge cluster-randomized controlled trial. Characteristics of practices, GPs and patients using the CDSS will be compared with the non-participating population. CDSS log data will be analyzed to evaluate how the number of medication alerts changed between baseline and 2 months later, and to identify the kind of alerts that were dealt with. Comparison of enrolled patients on weekdays versus weekends will shed light on GPs' use of the CDSS in the absence or presence of patients. Outcomes will be presented using descriptive statistics, and significance tests will be used to identify associations between them. We will conduct subgroup analyses, including time effects to account for software improvements. DISCUSSION: This study protocol is the basis for conducting analyses of the quantitative process evaluation. By providing insight into how GPs conduct medication reviews, the evaluation will provide context to the trial results and support their interpretation. The evaluation relies on the proper documentation by GPs, potentially limiting its explanatory power.

Utilizing Social Media Advertisements and Participant Social Networks to Recruit African American Breast Cancer Survivors: Design and Rationale.

Purpose: Our objective is to pilot an advertisement-driven sampling procedure among African American (AA) breast cancer survivors living in Maryland. These pilot study methods will inform a future population-based study of AA breast cancer survivors at high risk of poor outcomes due to biological differences and social inequities. Methods: This cross-sectional study utilizes an innovative, social media-based advertisement campaign with an associated social media study page to recruit 100 AA breast cancer survivors. Participants are biologically female, aged 18 and older, identify as AA/Black, have a diagnosis of breast cancer, and reside in Maryland. A preset "Audience" was created via Meta (formerly Facebook) to automatically target potential interest in the online study via geolocation and public social media interests (estimated range = 101,000 women). Eligible participants complete an online survey including demographic and clinical characteristics, cancer screening, healthcare access, and utilization, COVID-19 impact, quality of doctor-patient communication, and preferences for future study participation. Results: Recruitment began on 5 January 2022 and remains ongoing. As of 7 June 2002: 124 completed the screener, 110/124 (88.7%) consented passively, 24/110 (21.8%) started but did not complete survey, 86/110 (78.1%) completed the survey. Conclusions: Results from this study will inform a statewide multilevel prospective population-based study to improve health behaviors, disease management, and self-efficacy of chronic disease management among AA breast cancer survivors.

Mindful Parenting Intervention MinUTo App for Parents of Preschool Children: Study Protocol of a Randomised Controlled Trial.

BACKGROUND: Mindful parenting and the use of technology for parenting intervention have expanded separately from one another with promising results, but their relationship is underexplored. The current study protocol proposes a new universal intervention via app, MINd Us TOghether (MinUTo), based on mindful parenting for parents of typically developing children of 4-5 years of age. METHODS: The effect of the intervention is evaluated using a randomised controlled trial. Around 2000 parents are enrolled and randomised to the intervention and control groups. Data are collected in three different waves from parents at baseline and endline; APP usage data allow for the analysis of intervention adherence. The MinUTo app proposes contents and activities for five dimensions of mindful parenting. Each dimension is presented within a two-week distance, explaining its importance, providing information, and offering activities for parents and children. EXPECTED RESULTS: We hypothesise a positive effect of the intervention on primary outcomes (mindful parenting, parenting stress, parent behaviours and parental time investment), increasing parents' skills and promoting a positive parent-child relationship. We also test possible effects on secondary outcomes (parenting attitudes and beliefs) at an explorative level. CONCLUSIONS: The study will add new considerations about the psychological and economic impact of technologies in implementing parenting interventions in non-clinical populations.

Process evaluation of a multi-disciplinary complex intervention to improve care for older patients with chronic conditions in rural areas (the HandinHand Study): study protocol.

BACKGROUND: To improve health care in rural areas, especially for increasing numbers of people with chronic diseases, academically qualified nurses could take over expanded roles to meet the challenges of an ageing society and a decreasing number of General Practitioners (GPs). In the project "HandinHand" (HiH), qualified nurses (Expert nurses, ENs) will carry out home visits to older people with chronic diseases over a period of six months. ENs will prepare a care plan in cooperation with GPs to stabilise the care situation and avoid unplanned hospital admissions and GP visits. The process evaluation aims to provide an in-depth analysis of the implementation process and gather important information on barriers and facilitators to the implementation of ENs as a complementary health care structure in primary care, taking into account several context factors. METHODS: Based on the Medical Research Council (MRC) Framework for complex interventions, a logic model was developed and applied as the basis for data collection. Qualitative and quantitative data will be collected during the study. A mixed methods approach should allow to gain important insights from participants (e.g. ENs, GPs, patients) involved in the study as well as relevant stakeholders. Semi-structured interviews and surveys will be conducted. Data analysis will be based on the logical model, combining qualitative and quantitative data. Qualitative data will be analysed inductively-deductively using qualitative thematic framework analysis. DISCUSSION: The process evaluation will provide guidance and conclusions on further development and transferability. Of particular interest is the expanded role of ENs in primary care, which has barely been implemented in Germany and can be seen as a precursor to the development of an Advanced Practice Nursing (APN) role in primary care.

General Practice Nurses' experiences of changing care delivery during COVID-19. Implications for future practice: Qualitative study protocol.

AIM: To explore how General Practice Nurses experience implementing change at pace and scale in delivering care during consecutive waves of the COVID-19 pandemic. To evaluate the impact of changes to general practice nurses' working practices on professional wellbeing. BACKGROUND: In response to the COVID-19 pandemic, general practice rapidly and extensively changed care delivery. There has been little exploration of the experiences of General Practice Nurses and care delivery, job satisfaction, workload, stress and professional support. DESIGN: A qualitative case study design of three to five general practice case sites will explore General Practice Nurses' experiences during the Covid-19 pandemic. The study was funded and approved by the General Nursing Council Trust in June 2021. University ethics approval was gained in July 2021. Health Research Authority approval has been obtained [IRAS:30353. Protocol number: R23982. Ref 21/HRA/5132. CPMS: 51834]. METHODS: Data will consist of focus groups and/or semi-structured interviews with General Practice Nurses, primary healthcare team members and other key informants. Business/strategy and nurse team meetings relating to workforce planning/review will be observed. Documents will be analysed and routinely collected general practice data will provide descriptive contextualisation at each site. The study will be theoretically underpinned by the Non-adoption, Abandonment, Scale-up, Spread and Sustainability Framework and data analysed using framework analysis. DISCUSSION: General Practice Nurses have a unique sphere of knowledge and undertake specific work in primary care. This workforce is challenged by recruitment, retention and retirement issues, leading to the loss of highly experienced and knowledgeable professionals. It is important to explore how working practices brought about by Covid-19 affect General Practice Nurses. IMPACT: This study will explore working practices brought about by the Covid-19 pandemic to inform care delivery, patient care and support General Practice Nursing workforce wellbeing and will highlight and mitigate negative aspects of novel and changing care delivery. Key factors in implementing and supporting future practice and change implementation will be developed. TRIAL REGISTRATION: CPMS: 51834.

Seroepidemiological study on the spread of SARS-CoV-2 in Germany: Study protocol of the CORONA-MONITORING bundesweit' study (RKI-SOEP study).

The SARS-CoV-2 coronavirus has spread rapidly across Germany. Infections are likely to be under-recorded in the notification data from local health authorities on laboratory-confirmed cases since SARS-CoV-2 infections can proceed with few symptoms and then often remain undetected. Seroepidemiological studies allow the estimation of the proportion in the population that has been infected with SARS-CoV-2 (seroprevalence) as well as the extent of undetected infections. The 'CORONA-MONITORING bundesweit' study (RKI-SOEP study) collects biospecimens and interview data in a nationwide population sample drawn from the German Socio-Economic Panel (SOEP). Participants are sent materials to self-collect a dry blood sample of capillary blood from their finger and a swab sample from their mouth and nose, as well as a questionnaire. The samples returned are tested for SARS-CoV-2 IgG antibodies and SARS-CoV-2 RNA to identify past or present infections. The methods applied enable the identification of SARS-CoV-2 infections, including those that previously went undetected. In addition, by linking the data collected with available SOEP data, the study has the potential to investigate social and health-related differences in infection status. Thus, the study contributes to an improved understanding of the extent of the epidemic in Germany, as well as identification of target groups for infection protection.

Supporting Relatives Prior to Caregiver Burden-Preventive E-Mental Health Short Intervention for Family Members of Individuals with Parkinsonism in an Early Phase of the Disease: Protocol for a Feasibility Study.

Research on support for relatives of patients with Parkinsonism has mainly focused on caregivers, while preventive offers for non-caregiving relatives are lacking. Thus, the aim of this multicenter pilot study is to develop and assess the feasibility of a preventive psychosocial support program for relatives of patients with Parkinsonism. It specifically focuses on family members of patients who are in an early phase of the disease, are not currently caregiving, and have not yet developed distress symptoms. It includes a telemedicine-based, 6-week preventive psychological short intervention (PPSI). The main objective of this feasibility mixed-methods study is to specify the demand for an early, low-threshold, and low-cost short intervention and to collect feedback based on qualitative and quantitative data of N = 20 relatives. Secondary objectives are an evaluation of the effects of the intervention and an analysis of the study design. Future directions are to further develop the PPSI using these data. This study can serve as a basis for future randomized controlled studies on this intervention, which might fill an important gap in clinical supply.

Study Protocol for Evaluation of an Extended Maintenance Intervention on Life Satisfaction and BMI Among 7-14-Year-Old Children Following a Stay at a Residential Health Camp in Denmark.

Background: It is challenging to maintain effects of public health interventions. For residential health camps benefits often disappear as the child returns home. Furthermore, long-term effects are often not measured or reported. This paper presents the study protocol for an evaluation of an extended maintenance intervention offered to children who have completed a 10-week residential health camp at one of the five Danish Christmas Seal Houses (DCSH). The target group of DSCH is 7-14-year-olds with social, mental, and/or overweight issues and the overall aim of the camp is to increase life satisfaction and a healthy lifestyle. The primary aim of this study is to assess the effectiveness of the maintenance intervention on children's life satisfaction (primary outcome) and BMI Z-score (secondary outcome) 1 year after health camp. Methods: The extended maintenance intervention is developed by DCSH and delivered to each child and family individually by an intervention coordinator to help children maintain positive benefits of the health camp on life satisfaction and health behaviors after returning to their homes. Intervention activities target the child and the family. The effect will be tested in a quasi-experimental design: The intervention is offered to half of the children at one of the five DSCH (intervention group, N~144) while the other half and the children at the other four DSCH receive a standard maintenance intervention (control group, N~894). Children will complete questionnaires on life satisfaction measured by an adapted version of the Cantril ladder and height and weight prior to health camp, at the end of health camp, 3 months and 1 year after the end of health camp. To enable per protocol analysis and nuanced interpretation of effect estimates, we will monitor the implementation of the intervention by a process evaluation study among children, parents, and follow up coordinators using qualitative and quantitative methods. Discussion: We present a systematic approach to evaluating practice-based interventions in a research design. The study will provide new knowledge on the effectiveness of individualized maintenance interventions on long-term effects on life satisfaction and weight loss among children. Trial registration: Prospectively registered at Current Controlled Trials ISRCTN 13011465 https://www.isrctn.com/ISRCTN13011465.

Use of convalescent plasma in the treatment of critically ill COVID-19 patients: a study protocol

Use of convalescent plasma (CP) has shown promising results during early studies of COVID-19 patients. This study aims to prepare a protocol for the use of CP to treat critically ill COVID-19 patients. This will be a multicentre, double-blinded, controlled randomised trial. Subjects will be randomly assigned to the treatments, and evaluations will be taken at baseline and at intervals according to the protocol. Only those subjects who meet all inclusion criteria will be enrolled in the study. The experimental treatment group will receive CP at volume of 6 mL/kg divided into two doses separated by 24 hours, in addition to the standard treatment for COVID-19. The control group will receive only the standard treatments. The result assessed at the end of this trial will be the primary and secondary endpoints. The primary endpoints (efficacy indicators) will be the discharge from the ICU, discharge from the hospital, days of hospitalisation, days on mechanical ventilation and death. The main secondary endpoints (safety indicators) will be the severe transfusion reactions and transfusion-transmitted diseases. The authors developed the study protocol using standardised criteria for the development of a clinical trial protocol. This study protocol addressed all aspects that are necessary for the standardised implementation of CP for the treatment of COVID-19 patients, including CP collection, administration, evaluation, and follow up. [ FROM AUTHOR] Copyright of Signa Vitae is the property of Pharmamed Mado Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)