Low Frequency Ventilation During Cardiopulmonary Bypass to Protect Postoperative Lung Function in Cardiac Valvular Surgery: The PROTECTION Phase II Randomized Trial.

BACKGROUND: Cardiac surgery with cardiopulmonary bypass (CPB) triggers pulmonary injury. In this trial we assessed the feasibility, safety, and efficacy of low frequency ventilation (LFV) during CPB in patients undergoing valvular surgery. METHODS AND RESULTS: Patients with severe mitral or aortic valve disease were randomized to either LFV or usual care. Primary outcomes included release of generic inflammatory and vascular biomarkers and the lung-specific biomarker sRAGE (soluble receptor for advance glycation end products) up to 24 hours postsurgery. Secondary outcomes included pulmonary function tests and 6-minute walking test up to 8 weeks postdischarge. Sixty-three patients were randomized (33 LFV versus 30 usual care). Mean age was 66.8 years and 30% were female. LFV was associated with changes of sRAGE (soluble receptor for advance glycation end products) levels (geometric mean ratio, 3.05; [95% CI, 1.13-8.24] 10 minutes post CPB, and 1.07 [95% CI, 0.64-1.79], 0.84 [95% CI, 0.55-1.27], 0.67 [95% CI, 0.42-1.07], and 0.62 [95% CI, 0.45-0.85] at 2, 6, 12, and 24 hours post CPB respectively). No changes were observed for any of the generic biomarkers. Respiratory index soon after surgery (mean difference, -0.61 [95% CI, -1.24 to 0.015] 10 minutes post end of CPB), forced expiratory volume after 1 second/forced vital capacity ratio (0.050 [95% CI, 0.007-0.093] at 6 to 8 weeks pos-surgery), Forced vital capacity alone (95% CI, -0.191 L [-0.394 to 0.012]) and 6-minute walking test score at discharge (63.2 m [95% CI, 12.9-113.6]) were better preserved in the LFV group. No other differences were noted. CONCLUSIONS: The use of LFV during CPB in patients undergoing valvular surgery was feasible and safe and was associated with changes in sRAGE levels along with better preserved lung function and walking performance. These observations warrant further investigation in larger future studies. REGISTRATION: URL: https://www.isrctn.com; Unique Identifier: ISRCTN75795633.

Multimodality local consolidative treatment versus conventional care of advanced lung cancer after first-line systemic anti-cancer treatment: study protocol for the RAMON multicentre randomised controlled trial with an internal pilot.

INTRODUCTION: Lung cancer is the most common cause of cancer death worldwide and most patients present with extensive disease. One-year survival is improving but remains low (37%) despite novel systemic anti-cancer treatments forming the current standard of care. Although new therapies improve survival, most patients have residual disease after treatment, and little is known on how best to manage it. Therefore, residual disease management varies across the UK, with some patients receiving only maintenance systemic anti-cancer treatment while others receive local consolidative treatment (LCT), alongside maintenance systemic anti-cancer treatment. LCT can be a combination of surgery, radiotherapy and/or ablation to remove all remaining cancer within the lung and throughout the body. This is intensive, expensive and impacts quality of life, but we do not know if it results in better survival, nor the extent of impact on quality of life and what the cost might be for healthcare providers. The RAMON study (RAdical Management Of Advanced Non-small cell lung cancer) will evaluate the acceptability, effectiveness and cost-effectiveness of LCT versus no LCT after first-line systemic treatment for advanced lung cancer. METHODS AND ANALYSIS: RAMON is a pragmatic open multicentre, parallel group, superiority randomised controlled trial. We aim to recruit 244 patients aged 18 years and over with advanced non-small-cell lung cancer from 40 UK NHS hospitals. Participants will be randomised in a 1:1 ratio to receive LCT alongside maintenance treatment, or maintenance treatment alone. LCT will be tailored to each patient's specific disease sites. Participants will be followed up for a minimum of 2 years. The primary outcome is overall survival from randomisation. ETHICS AND DISSEMINATION: The West of Scotland Research Ethics Committee (22/WS/0121) gave ethical approval in August 2022 and the Health Research Authority in September 2022. Participants will provide written informed consent before participating in the study. Findings will be presented at international meetings, in peer-reviewed publications, through patient organisations and notifications to patients. TRIAL REGISTRATION NUMBER: ISRCTN11613852.

Formal consensus study on surgery to replace the aortic valve in adults aged 18-60 years.

OBJECTIVE: There is uncertainty about surgical procedures for adult patients aged 18-60 years undergoing aortic valve replacement (AVR). Options include conventional AVR (mechanical, mAVR; tissue, tAVR), the pulmonary autograft (Ross) and aortic valve neocuspidisation (Ozaki). Transcatheter treatment may be an option for selected patients. We used formal consensus methodology to make recommendations about the suitability of each procedure. METHODS: A working group, supported by a patient advisory group, developed a list of clinical scenarios across seven domains (anatomy, presentation, cardiac/non-cardiac comorbidities, concurrent treatments, lifestyle, preferences). A consensus group of 12 clinicians rated the appropriateness of each surgical procedure for each scenario on a 9-point Likert scale on two separate occasions (before and after a 1-day meeting). RESULTS: There was a consensus that each procedure was appropriate (A) or inappropriate (I) for all clinical scenarios as follows: mAVR: total 76% (57% A, 19% I); tAVR: total 68% (68% A, 0% I); Ross: total 66% (39% A, 27% I); Ozaki: total 31% (3% A, 28% I). The remainder of percentages to 100% reflects the degree of uncertainty. There was a consensus that transcatheter aortic valve implantation is appropriate for 5 of 68 (7%) of all clinical scenarios (including frailty, prohibitive surgical risk and very limited life span). CONCLUSIONS: Evidence-based expert opinion emerging from a formal consensus process indicates that besides conventional AVR options, there is a high degree of certainty about the suitability of the Ross procedure in patients aged 18-60 years. Future clinical guidelines should include the option of the Ross procedure in aortic prosthetic valve selection.

A feasibility study of dementia communication training based on the VERA framework for pre-registration nurses: Part II impact on student experience.

BACKGROUND: People living with dementia have complex communication needs, especially during acute hospital admissions. The VERA framework (validation, emotion, reassurance, activity) was designed to promote person centred communication between student nurses and people living with dementia, but there is limited evaluation of its impact. AIM: To measure the impact of dementia communication training (based on VERA) plus older adult unit (OAU) placement on students' ability to recognise opportunities for person centred (PC) communication compared to OAU placement alone. METHOD: A control pre-post-study design was used. Dementia communication training plus follow-up during OAU placement was delivered to 51 students (5 OAU, two hospitals) while 66 students (7 OAUs, five hospitals) acted as controls. The primary outcome was students' ability to recognise PC communication assessed using case vignettes. Data were collected using electronic survey and focus group interviews. Data analysis used independent non-parametric Mann-Whitney U test and thematic analysis. RESULTS: In total 52 students (response rate 40%) completed surveys at the end of placements (38 intervention, 14 control group students). In the intervention group, participants were significantly more likely to identify PC responses with a mean score of 10.5 (SD 3.0) compared with 7.5 (SD 3.0) in the control group (p = 0.006). In focus group interviews (n = 19 students), the main themes were connecting with patients, VERA in practice, communication challenges, and learning environment. VERA was described as a flexible approach that added to participants' communication toolkit. The learning environment, complexity of patients and organisational resources were important contextual factors. CONCLUSION: The VERA framework has potential as a foundation level dementia communication training intervention, but it requires more rigorous testing. Nursing can lead the way in developing and embedding evidence-based, interdisciplinary dementia communication training in preregistration curricula.

A dementia communication training intervention based on the VERA framework for pre-registration nurses: Part I developing and testing an implementation strategy.

BACKGROUND: People living with dementia experience progressive difficulty in expressing physical and emotional needs. Health care staff including student nurses require training to develop compensatory communication strategies. However, there is no standardised foundation level dementia communication training within pre-registration curricula. AIM: This article describes the theoretical underpinnings and development of a foundation level dementia communication skills training based on the VERA (Validation, Emotion, Reassurance, Activity) framework. METHOD: The training strategies drew on behavioural change theory using the COM-B model and Gagné's 9 Events of Instruction. The VERA framework was operationalised using a multicomponent teaching strategy. The intervention was refined based on quality improvement Plan-Do-Study-Act cycles with feedback from people living with dementia, facilitators and student nurses. Data collection used semi-structured questionnaires (n = 51) and four focus group (n = 19) interviews with students. Data analysis involved descriptive statistics and thematic analysis. RESULTS: The intervention was a 2.5-hour face-to-face training session delivered at the start of students' older adult unit placement with follow-up reflection sessions during placement. Training was delivered to 51 students, all students described the training as useful and would recommend it to their peers. Elements of the training that were highly valued were: opportunities to express concerns in caring for people with dementia, applying the VERA framework using role play and outlining realistic expectations of VERA. Students recognised the need for on-going training especially for more complex patients. CONCLUSION: Combining behaviour change and education theory with stakeholder feedback strengthened the development of VERA as a foundation level dementia communication training for pre-registration nurses.