Exploring the relationship between cultural and structural workforce issues and retention of nurses in general practice: A qualitative study protocol.

AIM(S): The aim of this study is to understand factors that challenge retention and support nurses to stay in general practice. BACKGROUND: One in four general practice nurse positions in England expected to be left unfilled within the next 10 years. Cultural and structural issues associated with working in general practice have been linked with nurses leaving general practice, re-evaluating their professional futures, adjusting work-life balance and bringing forward retirement. This has implications for the future of the general practice nursing workforce and patient care more broadly. DESIGN: Exploratory qualitative interview study funded by the General Nursing Council Trust for England and Wales. University of York ethics approval (Ref: HSRGC/2023/586/A) was gained in September 2023. The study will be conducted between September 2023 and August 2024. METHODS: Qualitative interviews will be conducted with a range of nurses working in, or who have worked in, general practice as well as nurse leaders associated with general practice across England and Wales. Recruitment will be via professional and social media networks and snowballing techniques. We aim to purposively recruit 30-40 participants for maximum variation. Cultural and structural influences which may contribute to retention decisions will be explored. Data will be analysed following framework analysis. DISCUSSION/CONCLUSION: This study will explore how underpinning cultural and structural issues may impact on retention of this highly skilled professional group and identify factors to support retention. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: By exploring factors that support or discourage nurses to remain in general practice, retention strategies can be better planned on order to address the general practice nursing workforce crisis. IMPACT: What problem did the study address? This study will address the retention crisis in nursing in general practice by exploring how cultural and structural issues may impact on retention of this highly skilled professional group and identify factors to support retention. Where and on whom will the research have an impact? From the study findings, recommendations will be developed to inform future policy and practice. Key factors to address attrition will be generated to support employers and policy makers in future primary care workforce planning, as well as supporting nurses, at an individual level, in negotiating their roles in practice. REPORTING METHOD: Standards for Reporting Qualitative Research (O'Brien et al., 2014). PATIENT OR PUBLIC CONTRIBUTION: As this is a workforce study protocol, there is no patient or public contribution.

Erlotinib or Gefitinib for Treating Advanced Epidermal Growth Factor Receptor Mutation-Positive Lung Cancer in Aotearoa New Zealand: Protocol for a National Whole-of-Patient-Population Retrospective Cohort Study and Results of a Validation Substudy.

BACKGROUND: Starting in 2010, the epidermal growth factor receptor (EGFR) kinase inhibitors erlotinib and gefitinib were introduced into routine use in Aotearoa New Zealand (NZ) for treating advanced lung cancer, but their impact in this setting is unknown. OBJECTIVE: The study described in this protocol aims to understand the effectiveness and safety of these new personalized lung cancer treatments and the contributions made by concomitant medicines and other factors to adverse outcomes in the general NZ patient population. A substudy aimed to validate national electronic health databases as the data source and the methods for determining patient eligibility and identifying outcomes and variables. METHODS: This study will include all NZ patients with advanced EGFR mutation-positive lung cancer who were first dispensed erlotinib or gefitinib before October 1, 2020, and followed until death or for at least 1 year. Routinely collected health administrative and clinical data will be collated from national electronic cancer registration, hospital discharge, mortality registration, and pharmaceutical dispensing databases by deterministic data linkage using National Health Index numbers. The primary effectiveness and safety outcomes will be time to treatment discontinuation and serious adverse events, respectively. The primary variable will be high-risk concomitant medicines use with erlotinib or gefitinib. For the validation substudy (n=100), data from clinical records were compared to those from national electronic health databases and analyzed by agreement analysis for categorical data and by paired 2-tailed t tests for numerical data. RESULTS: In the validation substudy, national electronic health databases and clinical records agreed in determining patient eligibility and for identifying serious adverse events, high-risk concomitant medicines use, and other categorical data with overall agreement and κ statistic of >90% and >0.8000, respectively; for example, for the determination of patient eligibility, the comparison of proxy and standard eligibility criteria applied to national electronic health databases and clinical records, respectively, showed overall agreement and κ statistic of 96% and 0.8936, respectively. Dates for estimating time to treatment discontinuation and other numerical variables and outcomes showed small differences, mostly with nonsignificant P values and 95% CIs overlapping with zero difference; for example, for the dates of the first dispensing of erlotinib or gefitinib, national electronic health databases and clinical records differed on average by approximately 4 days with a nonsignificant P value of .33 and 95% CIs overlapping with zero difference. As of May 2024, the main study is ongoing. CONCLUSIONS: A protocol is presented for a national whole-of-patient-population retrospective cohort study designed to describe the safety and effectiveness of erlotinib and gefitinib during their first decade of routine use in NZ for treating EGFR mutation-positive lung cancer. The validation substudy demonstrated the feasibility and validity of using national electronic health databases and the methods for determining patient eligibility and identifying the study outcomes and variables proposed in the study protocol. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000998549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368928. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51381.

The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program.

BACKGROUND: In Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening. METHODS: The ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31-64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories. CONCLUSION: The ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05656976.

Development and psychometric evaluation of the sexual satisfaction questionnaire for postmenopausal women (PWSSQ): an exploratory mixed method study protocol.

BACKGROUND: The concept of sexual satisfaction in menopausal women is very different from that in premenopausal women, and this difference is due to aging and physical, hormonal, cultural, and psychological changes. Therefore, the first step in discovering methods for assessing sexual satisfaction in postmenopausal women is to develop a measurement instrument. This study was conducted to develop and evaluate the psychometric properties of a sexual satisfaction instrument for postmenopausal women. METHODS: The current study is an exploratory-sequential mixed-methods research project that will be divided into two parts: qualitative and quantitative. Aligned with the primary objective of the research, which is to elucidate the concept of sexual satisfaction in postmenopausal women, the hybrid concept analysis model developed by Schwartz and Kim will be employed. This model comprises three key phases: the theoretical phase, the fieldwork phase, and the final analytical phase. Those who met the inclusion criteria and exhibited maximum variance in terms of age, educational level, employment status, and menopausal duration were recruited. The conventional content analysis will be carried out following the steps proposed by Graneheim and Lundman. Second, in the quantitative phase, the psychometric properties of the instrument were evaluated, including the content, face and construct validity and reliability via internal consistency and stability. The psychometric properties described in the COSMIN checklist will be utilized for designing the instrument. DISCUSSION: A valid and reliable scale for evaluating the sexual satisfaction of postmenopausal women should be developed, and educational content should be designed to improve the sexual satisfaction of this group of women.

Menopause is a natural event that is accompanied by numerous physical and psychological changes that create a complex period in the life of postmenopausal women. Sexual satisfaction is a component related to human sexuality and is known as the last stage of the sexual response cycle. Sexual satisfaction is defined as the emotional response resulting from the mental evaluation of positive and negative things in a sexual relationship. Sexual satisfaction is one of the important factors of satisfaction in married life. People who have sexual satisfaction have a significantly better quality of life than those who do not have sexual satisfaction. The concept of sexual satisfaction in menopausal women is very different from that in premenopausal women, and this difference is due to aging and physical, hormonal, cultural, and psychological changes. Sexual satisfaction is important for researchers for two reasons. First, sexual satisfaction provides a mechanism through which to assess a relationship partner's performance. Second, sexual satisfaction is a predictor of other aspects of the relationship, such as marital quality and stability. To discuss feelings and discover methods for achieving sexual satisfaction in postmenopausal women, it is necessary to understand the factors affecting sexual satisfaction and dissatisfaction in this group. The existing tools in the field of women's sexual satisfaction are not designed for this age group (menopausal women) and do not have the necessary comprehensiveness and adequacy to assess sexual satisfaction in menopausal women. Therefore, this study will be conducted to develop and evaluate the psychometric properties of the sexual satisfaction of postmenopausal women.

Effect of Treatment of the Cholinergic Precursor Choline Alphoscerate in Mild Cognitive Dysfunction: A Randomized Controlled Trial.

Background and Objectives: The focus on mild cognitive dysfunction in adults is of great interest, given the risk of worsening and conversion to dementia. Cognitive dysfunctions are characterized by a decrease in the weight and volume of the brain, due to cortical atrophy, with a widening of the grooves and flattening of the convolutions. Brain atrophy that mainly involves the hippocampus is related to the progression of cognitive impairment and the conversion from mild cognitive dysfunction to dementia. Currently, there is no treatment for MCI. Results from a trial on Alzheimer's disease (ASCOMALVA trial) suggest that a sustained cholinergic challenge can slow the progression of brain atrophy typical of Alzheimer's disease associated with vascular damage. This study intends to evaluate the efficacy of choline alphoscerate in patients with mild cognitive impairment (MCI) and associated vascular damage, in stabilizing and/or slowing brain atrophy typical of adult-onset cognitive dysfunction, and in improving and/or slowing the progression of cognitive and behavioral symptoms associated with MCI. Materials and Methods: This randomized controlled trial will recruit 60 patients that will be evaluated and randomized in a 1:1 ratio to receive choline alphoscerate (1200 mg/day) or placebo, for 12 months. Analyses will be carried out using SPSS vesion No 26 the Statistician in charge of this study, with the statistical significance level chosen as 0.05. Discussion: This trial may provide evidence about the efficacy of treatment with the cholinergic precursor choline alphoscerate in patients with mild cognitive dysfunction. The results of this study will be published in peer-reviewed journals. Registration: EudraCT number: 2020-000576-38.

Intraoral Acupuncture for Sialorrhea in Stroke Patients: a Study Protocol for a Randomized Controlled Trial.

Importance: Post-stroke sialorrhea (PSS) refers to excessive saliva flowing out the lip border after a stroke. PSS negatively affects patient self-image and social communication and may lead to depression. Limited evidence supports the link between excessive salivation and PSS. No large-scale, strictly controlled randomized controlled trials have shown the effectiveness of acupuncture in treating PSS patients. Objective: We aim to compare the effects of intraoral and sham acupuncture in PSS patients and explore relationships among salivation and drooling severity and frequency and swallowing function in stroke patients. Design: Clinical study protocol, SPIRIT compliant. Setting: Prospective, single-center, randomized, and sham-controlled trial. Population: We will recruit 106 PSS patients to receive 4-week intraoral or sham acupuncture. Additionally, 53 stroke patients without PSS will undergo a conventional 4-week treatment program to compare salivation between PSS and non-PSS patients. Exposures: Intraoral or sham acupuncture. Main Outcomes and Measures: The main evaluation index will be the 3-minute saliva weight (3MSW), comparing changes in 3MSW from baseline to weeks 4 and 8. Secondary assessment indices will include the "Drooling Severity and Frequency Scale" and "Functional Oral Intake Scale." Results: The results from this study will be published in peer-reviewed journals. Conclusion: Comparing effects of intraoral and sham acupuncture in PSS patients, this study may contribute important evidence for future PSS treatment and provide valuable insights into whether salivation issues in stroke patients are attributed to heightened salivary secretion or dysphagia.

A joint training of healthcare line managers and health and safety representatives in facilitating occupational health interventions: a feasibility study protocol for the Co-pilot project.

Healthcare employees are experiencing poor wellbeing at an increasing rate. The healthcare workforce is exposed to challenging tasks and a high work pace, a situation that worsened during and after the COVID-19 pandemic. In turn, exposure to these high demands contributes to poor health, increased turnover, reduced job satisfaction, reduced efficacy, and reduced patient satisfaction and safety. Therefore, it is imperative that we identify measures to mitigate this crisis. One piece of this puzzle is how to implement sustainable tools and processes to improve the work environment of healthcare organizations. In this paper, we present the study protocol for the outlining and piloting of a joint training for pairs of healthcare line managers and their associated health and safety representatives in a Swedish healthcare organization. The objective of the training is to aid and advance the implementation of interventions to improve the work environment at the unit level. Following recommendations in the literature, the training is based on a stepwise approach that considers the specific context and focuses on the involvement of employees in creating interventions based on their needs. A central component of the training is the development of the pairs' collaboration in prioritizing, developing, implementing, and evaluating the interventions. The training is based on an on-the-job train-the-trainer approach in which participants are progressively trained during four workshops in the steps of a participatory intervention process. Between these workshops, the pairs follow the same progressive steps together with their employees to develop and implement interventions at their unit. The pilot will involve four pairs (i.e., eight participants) representing different parts and functions of the organization and will be conducted over a period of three months. We will use a mixed method design to evaluate preconditions, the process, and proximal transfer and implementation outcome factors of the training. The overall aim of the pilot is to appraise its feasibility and be able to adjust the training before a potential scale-up.

A combined intervention strategy to increase linkage to and retention in substance use treatment for individuals accessing hospital-based services: study protocol.

Background: In 2020, New Mexico had the highest alcohol related death and the 11th highest drug overdose rate in the U.S. Towards the long-term goal of addressing this public health problem, we are implementing and evaluating an multi-level intervention designed to identify adults at risk of substance use disorder (SUD) and encourage linkage to and retention in treatment. The first level includes equipping the ED and medical inpatient units of a safety-net hospital with a method to screen individuals at risk of a SUD. The second level includes Seeking Safety (SS), a trauma-specific treatment for PTSD and SUD; and pharmacotherapy for SUD. Motivational Interviewing (MI) is used throughout both levels. Using the SPIRIT guidelines and checklist, this study protocol describes the multi-level intervention and the methodology we are using to assess feasibility and effectiveness. Methods: We are using a Type 1 hybrid implementation design with a non-randomized approach (ISRCTN registration # ISRCTN33100750). We aim to enroll 110 adults ( ≧ 18 ) who screen positive for unhealthy use of alcohol, prescription medications (used nonmedically) and/or illicit drugs. Peer support workers are responsible for screening, using MI to increase engagement in screening and treatment and delivery of SS. Pharmacotherapy is provided by addiction clinical specialists. Treatment is provided post hospital discharge via telehealth to increase access to care. Participants are identified through (1) review of electronic health records for individuals with a chief or secondary complaint or mental health condition relating to alcohol and/or other drug use, (2) referrals from clinical staff and (3) screening in the ED and medical inpatient units. Feasibility is being measured through process data. Effectiveness will be determined by changes in two primary outcomes: (i) PTSD symptom severity; and (ii) substance use. Discussion: Our study will expand on research related to the implementation of treatment strategies for patients presenting at EDs and admitted to medical inpatients units wherein there is a significant window of opportunity to link patients with follow-up behavioral and clinical services for alcohol and/or drug misuse. The challenges associated with implementation and strategies that have been helpful to address these challenges will further inform the field.

Effect of acupuncture on tic disorder: a randomized controlled clinical trial based on energy metabolomics and infrared thermography.

BACKGROUND: Acupuncture is a method for treating tic disorder. However, there is a lack of sufficient clinical objective basis in regards of its treatment efficacy. Indeed, there are structural abnormalities present in energy metabolism and infrared thermography in children with tic disorder. Therefore, this study proposes a clinical trial scheme to explore the possible mechanism of acupuncture in treating tic disorder. METHODS: This randomized controlled trial will recruit a total of 90 children, in which they will be divided into non-intervention group and intervention group. The non-intervention group consists of 30 healthy children while the intervention group consists of 60 children with tic disorder. The intervention group will be randomly allocated into either the treatment group or the control group, with 30 children randomly assigned in each group. Children either received acupuncture treatment and behavioral therapy (treatment group) or sham acupuncture treatment and behavioral therapy (control group), 3 treatment sessions per week for a period of 12 weeks, with a total of 36 treatment sessions. Outcome measures include YGTSS, urinary and fecal metabolomics, infrared thermography of body surface including governor vessel. For the intervention group, these outcome measures will be collected at the baseline and 90th day prior to intervention. Whereas for the non-intervention group, outcome measures (excluding YGTSS) will be collected at the baseline. DISCUSSION: The main outcome will be to observe the changes of the severity of tic condition, the secondary outcome will be to observe the changes of structural characteristic of infrared thermography of body surface/acupoints along the governor vessel and to evaluate the changes of urinary and fecal metabolomics at the end of the treatment, so as to analyze the relationship between them and to provide further knowledge in understanding the possible mechanism of acupuncture in improving the clinical symptoms via regulating and restoring the body metabolomics network, which in future it can develop as a set of clinical guideline (diagnosis, treatment, assessment, prognosis) in treating tic disorder. ChiCTR2300075188(Chinese Clinical Trial Registry, http://www.chictr.org.cn , registered on 29 August 2023).

Testing the effectiveness of the culturally adapted skills training START NOW to reduce mental health problems in adolescent refugees: study protocol for a randomized controlled trial.

Background: Adolescent refugees are particularly vulnerable to mental health problems, as they experience many risk factors associated with their resettlement at crucial stages of their physical and emotional development. However, despite having a greater healthcare needs than others, they face significant barriers to accessing healthcare services. Therefore, this study aims to test the effectiveness of a low-threshold, culturally adapted version of the skills training START NOW - START NOW Adapted - in reducing mental health problems among adolescent refugees. Methods: We will recruit 80 adolescent refugees (15-18 years) with symptoms of anxiety and depression or high perceived stress in Northwestern Switzerland. They will be randomly assigned to one of two study groups: an intervention group, receiving START NOW Adapted, and a control group, receiving treatment as usual (TAU). The intervention will last 10 weeks and will consist of one-hour sessions per week provided by a trained facilitator with the same cultural background, in the respective language. Assessments to collect depressive and anxious symptoms, perceived stress, social-ecological resilience, and emotion recognition abilities will be conducted pre-intervention, post-intervention (11 weeks later) and at the 3-month follow-up. Multilevel models will be computed with primary and secondary outcome measures as dependent variables. An effect of at least moderate size will be considered clinically relevant. Discussion: This randomized controlled trial aims to investigate the effectiveness of a culturally adapted version of START NOW, providing valuable insights to improve current health promotion for adolescent refugees in Switzerland (or rather lack thereof). Ultimately, the effects of START NOW may facilitate integration and promote healthy development while decreasing costs associated with treating migration- or conflict-related trauma.Clinical trial registration: ClinicalTrials.gov, identifier: NCT06324864.

Iran osteoporosis registry: protocol for nationwide study.

Background: Osteoporotic fractures can result in significant health complications and an increased risk of death. Registry studies could provide better treatment options and improve patient outcomes by providing useful information about the disease. The present study describes the protocol for an osteoporosis registry in Iran. Materials and methods: This registry is a prospective multicenter cohort study recruiting patients with osteoporosis from Iran. The inclusion criteria of the study are individuals diagnosed with primary or secondary osteoporosis according to the diagnostic criteria of the study; patients will be identified and recruited from outpatient clinics in this registry. All patients diagnosed with primary or secondary osteoporosis are the target population of the study. Our expected sample size is 1000 participants and the study will continue for at least 2 years. The measurements of the Iranian Osteoporosis Registry include four parts: (i) variables measured by the specific questionnaires package, (ii) bone mineral density (BMD, (iii) clinical examination, and (iv) lab data. The final questionnaire package includes "demographics information", "socioeconomic status", "lifestyle", "reproductive health", "medical history and medication", "Osteoporosis diagnosis gap", "Osteoporosis adherence and treatment gap", "fracture history and fall risk assessment", "FRAX ® tool ", "hospitalization and death outcomes", "low back pain", "hospitalization history", "attitude toward osteoporosis", "osteoporosis awareness", "osteoporosis related-performance", "quality of life (Iranian version of SF12 questionnaire )", and "food frequency questionnaire (FFQ)". Clinical examination of this registry includes anthropometric measurements (including height, weight, body mass index (BMI), waist circumference, hip circumference, and right wrist circumference), and blood pressure. The baseline questionnaires will be filled out right after patients are diagnosed with osteoporosis and then osteoporotic patients will be followed up regularly on a yearly basis. In the follow-up visit, variables that may have changed over time are updated. The main outcomes include registration of fall, fracture, hospitalization, medication adherence, and death. An online web-based user-friendly software is also developed for data collection. Data analysis will be conducted with the collaboration of data-mining experts and epidemiologists at the end of each follow-up. Conclusion: The Iran Osteoporosis Registry will be a valuable source of information regarding osteoporosis outcomes (i.e. fractures, hospitalizations, adherence, and death at the national level), and its results will be very beneficial and practical for policy makers in the field of musculoskeletal diseases.

Design and implementation of a national quality registry of thyroid cancer in Iran: study protocol.

Purpose: Thyroid cancer is recognized as the predominant form of endocrine cancer. The likelihood of cancer recurrence and the development of distant metastases varies depending on the cancer's pathology and stage. Iran currently lacks country-specific data on thyroid cancer, which can potentially result in clinicians deviating from the optimal treatment. The primary objectives of establishing such a registry are to determine the incidence, identify risk factors, and evaluate treatment outcomes for thyroid cancer within the Iranian population. Ultimately, the overarching goal of this protocol study is to reduce mortality and morbidity rates among thyroid cancer patients by implementing appropriate interventions based on the findings derived from this registration system. Methods: The study will enroll all individuals aged 18 years and older who have received a diagnosis of primary thyroid carcinoma based on pathology criteria. Data will be collected from various thyroid clinic centers. The participating centers include the Endocrinology Clinic at Shariati Hospital, the Thyroid Clinic in the Nuclear Medicine Center at Shariati Hospital, as well as pathology and nuclear medicine centers in Kerman and Bushehr. Patient records comprise information on outpatient visits to the clinic. Conclusion: The registry aims to enhance treatment approaches and follow-up protocols while serving as a foundation for conducting clinical, epidemiological, and basic science studies based on robust evidence-based data.

Nurse-led sequential multiple assignment randomized trial of nudging intervention for early antiretroviral therapy initiation among patients with HIV/AIDS: Implementation study protocol.

AIMS: In China, more than 30% of patients have not initiated treatment within 30 days of HIV diagnosis. Delayed initiation has a detrimental influence on disease outcomes and increases HIV transmission. The study aims to evaluate the effectiveness of a nurse-led antiretroviral therapy initiation nudging intervention for people newly diagnosed with HIV in China to find the optimal intervention implementation strategy. METHODS: A Hybrid Type II sequential multiple assignment randomized trial will be conducted at four Centers for Disease Control and Prevention in Hunan, China. This study will recruit 447 people newly diagnosed with HIV aged ≥18 years and randomly assign them into two intervention groups and one control group. On top of the regular counselling services and referrals, intervention groups will receive a 4-week, 2-phase intervention based on the dual-system theory and the nudge theory. The control group will follow the currently recommended referral procedures. The primary outcomes are whether treatment is initiated, as well as the length of time it takes. The study outcomes will be measured at the baseline, day 15, day 30, week 12, week 24 and week 48. Generalized estimating equations and survival analysis will be used to compare effectiveness and explore factors associated with antiretroviral therapy initiation. Both qualitative and quantitative information will be collected to assess implementation outcomes. DISCUSSION: Existing strategies mostly target institutional-level factors, with little consideration given to patients' decision-making. To close this gap, we aim to develop an effective theory-driven nudging strategy to improve early ART initiation. IMPACT: This nurse-led study will help to prevent delayed initiation by employing implementation science strategies for people newly diagnosed with HIV. This study contributes to the United Nations' objective of ending the AIDS pandemic by 2030. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2300070140. The trial was prospectively registered before the first participant was recruited. PATIENT AND PUBLIC INVOLVEMENT: The nudging intervention was finalized through the Nominal Group Technique where we invited five experts in the related field and five people living with HIV to participate.

The protocol for an observational Australian cohort study of CADASIL: The AusCADASIL study.

Introduction: Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) is a rare genetic condition with a broad phenotypic presentation. This study aims to establish the first Australian cohort of individuals affected by CADASIL (AusCADASIL) and examine its clinical features and longitudinal course, and to investigate neuroimaging and blood biomarkers to assist in early diagnosis and identify disease progression. Methods: Participants will be recruited from six study centres across Australia for an observational study of CADASIL. We aim to recruit 150 participants with diagnosed CADASIL, family history of CADASIL or suspected CADASIL symptoms, and 150 cognitively normal NOTCH3 negative individuals as controls. Participants will complete: 1) online questionnaires on medical and family history, mental health, and wellbeing; 2) neuropsychological evaluation; 3) neurological examination and brain MRI; 4) ocular examination and 5) blood sample donation. Participants will have annual follow-up for 4 years to assess their progression and will be asked to invite a study partner to corroborate their self-reported cognitive and functional abilities.Primary outcomes include cognitive function and neuroimaging abnormalities. Secondary outcomes include investigation of genetics and blood and ocular biomarkers. Data from the cohort will contribute to an international consortium, and cohort participants will be invited to access future treatment/health intervention trials. Discussion: AusCADASIL will be the first study of an Australian cohort of individuals with CADASIL. The study will identify common pathogenic variants in this cohort, and characterise the pattern of clinical presentation and longitudinal progression, including imaging features, blood and ocular biomarkers and cognitive profile.

The effect of an improved ICU physical environment on outcomes and post-ICU recovery-a protocol.

BACKGROUND: Intensive care medicine continues to improve, with advances in technology and care provision leading to improved patient survival. However, this has not been matched by similar advances in ICU bedspace design. Environmental factors including excessive noise, suboptimal lighting, and lack of natural lights and views can adversely impact staff wellbeing and short- and long-term patient outcomes. The personal, social, and economic costs associated with this are potentially large. The ICU of the Future project was conceived to address these issues. This is a mixed-method project, aiming to improve the ICU bedspace environment and assess impact on patient outcomes. Two innovative and adaptive ICU bedspaces capable of being individualised to patients' personal and changing needs were co-designed and implemented. The aim of this study is to evaluate the effect of an improved ICU bedspace environment on patient outcomes and operational impact. METHODS: This is a prospective multi-component, mixed methods study including a randomised controlled trial. Over a 2-year study period, the two upgraded bedspaces will serve as intervention beds, while the remaining 25 bedspaces in the study ICU function as control beds. Study components encompass (1) an objective environmental assessment; (2) a qualitative investigation of the ICU environment and its impact from the perspective of patients, families, and staff; (3) sleep investigations; (4) circadian rhythm investigations; (5) delirium measurements; (6) assessment of medium-term patient outcomes; and (7) a health economic evaluation. DISCUSSION: Despite growing evidence of the negative impact the ICU environment can have on patient recovery, this is an area of critical care medicine that is understudied and commonly not considered when ICUs are being designed. This study will provide new information on how an improved ICU environment impact holistic patient recovery and outcomes, potentially influencing ICU design worldwide. TRIAL REGISTRATION: ACTRN12623000541606. Registered on May 22, 2023. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385845&isReview=true .

The TELEhealth Shared decision-making Coaching and Navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators.

Background: Lung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching intervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm. Methods: Patients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching session about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3 months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18 months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods. Discussion: We will assess whether a decision coaching and patient navigation intervention can feasibly support high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations. Trial Registration: This study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022.

Nonclinical Safety Testing of RNA Vaccines.

In this chapter, we will first consider the overall goal of nonclinical safety testing during drug development and have a brief overview of its regulatory background. We will then discuss some basic requirements of safety/toxicity testing before concentrating on the safety testing of RNA vaccines and developing a sample RNA vaccine safety testing program.

The diabetes body project: Study protocol of a multi-site trial of a virtually delivered eating disorder prevention program for young women with type 1 diabetes.

AIM: Young women with type 1 diabetes are a high-risk population for eating disorders (ED). Prevention programs are lacking. In young women without diabetes, the Body Project has produced reductions in ED risk factors, ED symptoms and future ED onset. Therefore, the Body Project was adapted to type 1 diabetes, the Diabetes Body Project (DBP). In this protocol, we describe the multi-site randomized controlled trial (RCT) to evaluate efficacy of the DBP. METHODS: This is an ongoing RCT with four sites (Europe and US). In total 280, 14-35 year-old, women with type 1 diabetes ≥1 year and some level of body image concerns will be recruited in 2023. Participants are randomized to either virtual DBP groups or an educational control. The study constitutes 5 measurement points distributed over 2 years. The primary aim is to test if DBP will produce significantly greater reductions in ED behaviours, ED symptoms and future ED onset. The secondary aim is to test if DBP has significantly greater improvements in diabetes distress, quality of life and glycaemic outcomes. RESULTS: We expect that DBP will be more efficacious in reducing ED behaviours, ED symptoms and ED onset compared to the control condition. Additionally, we hope to gain new knowledge on how DBP may affect diabetes-related outcomes. CONCLUSIONS: If DBP proves efficacious, it has potential for immediate, clinical implementation at low-cost and may contribute to broad prevention of future ED onset among young women with type 1 diabetes. GOV IDENTIFIER: NCT05399446.

Prolonged intermittent theta burst stimulation for post-stroke aphasia: protocol of a randomized, double-blinded, sham-controlled trial.

Background: Post-stroke aphasia (PSA) is one of the most devastating symptoms after stroke, yet limited treatment options are available. Prolonged intermittent theta burst stimulation (piTBS) is a promising therapy for PSA. However, its efficacy remains unclear. Therefore, we aim to investigate the efficacy of piTBS over the left supplementary motor area (SMA) in improving language function for PSA patients and further explore the mechanism of language recovery. Methods: This is a randomized, double-blinded, sham-controlled trial. A total of 30 PSA patients will be randomly allocated to receive either piTBS stimulation or sham stimulation for 15 sessions over a period of 3 weeks. The primary outcome is the Western Aphasia Battery Revised (WAB-R) changes after treatment. The secondary outcomes include The Stroke and Aphasia Quality of Life Scale (SAQOL-39 g), resting-state electroencephalogram (resting-state EEG), Event-related potentials (ERP), brain derived neurotrophic factor (BDNF). These outcome measures are assessed before treatment, after treatment, and at 4-weeks follow up. This study was registered in Chinese Clinical Trial Registry (No. ChiCTR23000203238). Discussion: This study protocol is promising for improving language in PSA patients. Resting-state EEG, ERP, and blood examination can be used to explore the neural mechanisms of PSA treatment with piTBS. Clinical trial registration: https://www.chictr.org.cn/index.html, ChiCTR2300074533.

Person-centred care and the work-related health and job satisfaction of health and social care professionals: protocol for a prospective longitudinal cohort study combined with qualitative studies (the PCC@Work project).

BACKGROUND: The interplay of ethical stress, heavy workloads, and job dissatisfaction poses challenges to both the recruitment and retention of health and social care professionals. Person-centred care, rooted in ethical principles, involves collaborative care, and is expected to improve care and job satisfaction. However, prior research on the impact of person-centred care practices on professionals' work-related health and job satisfaction has yielded mixed results, and most studies emanate from residential care. Understanding how person-centred care practices influence health and social care professionals across different care settings thus requires further exploration through rigorous methodology. The overall aim of PCC@Work is to follow, describe, assess, and explore the impact of person-centred care practices in hospital wards, primary care centres and municipal care on health and social care professionals' work-related health and job satisfaction. METHODS: PCC@Work is designed as a prospective, longitudinal cohort study combined with qualitative studies. A web-based questionnaire will be distributed on five occasions within two years to health and social care professionals in the three care settings. In addition, focus groups and interviews will be conducted with a selection of health and social care professionals to explore their experiences of work-related health and job satisfaction in relation to person-centred practices. DISCUSSION: PCC@Work will highlight some of the knowledge gaps on the impact of person-centred care practices regarding work-related health and job satisfaction of health and social care professionals. The uniqueness of the project lies in the multi-method design, combining a prospective longitudinal cohort study with qualitative studies, and the involvement of various professions and settings. This means we will be able to provide a comprehensive and representative understanding of person-centred care practices as a critical component for effective change in the working conditions of health and social care.