Faculty Opinions recommendation of The impact of a tailored follow-up intervention on comprehensive geriatric assessment in older patients with cancer - a randomised controlled trial.

Author(s):  
Martine Extermann
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Troels G. Dolin ◽  
Marta Mikkelsen ◽  
Henrik L. Jakobsen ◽  
Tyge Nordentoft ◽  
Trine S. Pedersen ◽  
...  

Abstract Background The incidence of colorectal cancer (CRC) increases with age. Older patients are a heterogeneous group ranging from fit to frail with various comorbidities. Frail older patients with CRC are at increased risk of negative outcomes and functional decline after cancer surgery compared to younger and fit older patients. Maintenance of independence after treatment is rarely investigated in clinical trials despite older patients value it as high as survival. Comprehensive geriatric assessment (CGA) is an evaluation of an older persons’ medical, psychosocial, and functional capabilities to develop an overall plan for treatment and follow-up. The beneficial effect of CGA is well documented in the fields of medicine and orthopaedic surgery, but evidence is lacking in cancer surgery. We aim to investigate the effect of CGA on physical performance in older frail patients undergoing surgery for CRC. Methods GEPOC is a single centre randomised controlled trial including older patients (≥65 years) undergoing surgical resection for primary CRC. Frail patients (≤14/17 points using the G8 screening tool) will be randomised 1:1 to geriatric intervention and exercise (n = 50) or standard of care along (n = 50) with their standard surgical procedure. Intervention includes preoperative CGA, perioperative geriatric in-ward review and postoperative follow-up. All patients in the intervention group will participate in a pre- and postoperative resistance exercise programme (twice/week, 2 + 12 weeks). Primary endpoint is change in 30-s chair stand test. Assessment of primary endpoint will be performed by physiotherapists blinded to patient allocation. Secondary endpoints: changes in health related quality of life, physical strength and capacity (handgrip strength, gait speed and 6 min walking test), patient perceived quality of recovery, complications to surgery, body composition (Dual-energy X-ray absorptiometry and bioelectric impedance), serum biomarkers, readmission, length of stay and survival. Discussion This ongoing trial will provide valuable knowledge on whether preoperative CGA and postoperative geriatric follow-up and intervention including an exercise program can counteract physical decline and improve quality of life in frail CRC patients undergoing surgery. Trial registration Prospectively registered at Clinicaltrials.gov NCT03719573 (October 2018).


2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  

Abstract Background : Older people are frequent Emergency Department (ED) users who present with complex issues that are linked to poorer health outcomes post-index visit, often have increased ED length of stay and tend to have raised healthcare costs. Encouraging evidence suggests that ED teams involving health and social care professionals (HSCPs) can contribute to enhanced patient flow and improved patient experience by improving care decision-making and thus promoting timely and effective care. However, the evidence supporting the impact of HSCPs teams assessing and intervening with older adults in the ED is limited and identifies important methodological limitations, highlighting the need for more robust and comprehensive investigations of this model of care. This study aims to evaluate the impact of a dedicated ED-based HSCP team on the quality, safety, clinical and cost-effectiveness of care of older adults when compared to usual care. Methods : The study is a single-site randomised controlled trial whereby patients aged ≥65 years who present to the ED of a large Irish hospital will be randomised to the experimental group (ED-based HSCP assessment and intervention) or the control group (usual ED care). The recruitment target is 320 participants. The HSCP team will provide a comprehensive functional assessment as well as interventions to promote a safe discharge for the patient. The primary outcome is ED length of stay (from arrival to discharge). Secondary outcomes include: rates of hospital admissions from the ED, ED re-visits, unplanned hospital admissions and healthcare utilisation at 30-days, four and six-month follow-up; patient functional status and quality of life (at baseline and follow-up); patient satisfaction; costs-effectiveness in terms of costs associated with ED-based HSCP compared to usual care; and perceptions on implementation by ED staff members. Discussion : This is the first randomised controlled trial testing the impact of HSCPs working in teams in the ED on the quality, safety, clinical and cost-effectiveness of care for older patients. The findings of the study will provide important information on the effectiveness of this model of care for future implementation. Trial registration : ClinicalTrials.gov, NCT03739515; registered on 12 th November 2018. Protocol version 1. URL: https://clinicaltrials.gov/ct2/show/NCT03739515


2020 ◽  
Vol 11 (3) ◽  
pp. 488-495 ◽  
Author(s):  
Sambavy Nadaraja ◽  
Lars-Erik Matzen ◽  
Trine Lembrecht Jørgensen ◽  
Lars Dysager ◽  
Anja Ør Knudsen ◽  
...  

2021 ◽  
Vol 6 ◽  
pp. 231
Author(s):  
Robbie Clark ◽  
Katie Drax ◽  
Christopher D. Chambers ◽  
Marcus Munafò ◽  
Jacqueline Thompson

Background: We studied a novel initiative – Registered Reports Funding Partnerships (RRFPs) – whereby research funders and journals partner in order to integrate their procedures for funding applications and Registered Reports submissions into one process. We investigated the feasibility of conducting a randomised controlled trial (RCT) of the impact of RRFPs on (1) research quality and (2) the efficiency of the research process, from funding to publication. Methods: We conducted 32 semi-structured interviews and follow-up questionnaires with stakeholders (funders, editors, authors, and reviewers) across six different RRFPs. Results: A RCT of RRFPs appears to be feasible in principle. The partnership concept seems worthwhile to pursue further and is adaptable to the needs of various funders and publishers, and across disciplines. Three primary outcomes of interest should be measurable, and participant randomisation could conceivably be done in a number of ways. In practice, however, the current volume of submissions going through existing partnerships is too low to support a full trial.   Conclusions: Although a RCT of RRFPs is conceptually feasible, it will only be possible if organisations are willing to form new partnerships, scale up existing ones, and incorporate a trial (i.e., randomisation) into these partnerships.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e048506
Author(s):  
Rachel Umoren ◽  
Sherri Bucher ◽  
Daniel S Hippe ◽  
Beatrice Nkolika Ezenwa ◽  
Iretiola Bamikeolu Fajolu ◽  
...  

ObjectiveTo assess the impact of mobile virtual reality (VR) simulations using electronic Helping Babies Breathe (eHBB) or video for the maintenance of neonatal resuscitation skills in healthcare workers in resource-scarce settings.DesignRandomised controlled trial with 6-month follow-up (2018–2020).SettingSecondary and tertiary healthcare facilities.Participants274 nurses and midwives assigned to labour and delivery, operating room and newborn care units were recruited from 20 healthcare facilities in Nigeria and Kenya and randomised to one of three groups: VR (eHBB+digital guide), video (video+digital guide) or control (digital guide only) groups before an in-person HBB course.Intervention(s)eHBB VR simulation or neonatal resuscitation video.Main outcome(s)Healthcare worker neonatal resuscitation skills using standardised checklists in a simulated setting at 1 month, 3 months and 6 months.ResultsNeonatal resuscitation skills pass rates were similar among the groups at 6-month follow-up for bag-and-mask ventilation (BMV) skills check (VR 28%, video 25%, control 22%, p=0.71), objective structured clinical examination (OSCE) A (VR 76%, video 76%, control 72%, p=0.78) and OSCE B (VR 62%, video 60%, control 49%, p=0.18). Relative to the immediate postcourse assessments, there was greater retention of BMV skills at 6 months in the VR group (−15% VR, p=0.10; −21% video, p<0.01, –27% control, p=0.001). OSCE B pass rates in the VR group were numerically higher at 3 months (+4%, p=0.64) and 6 months (+3%, p=0.74) and lower in the video (−21% at 3 months, p<0.001; −14% at 6 months, p=0.066) and control groups (−7% at 3 months, p=0.43; −14% at 6 months, p=0.10). On follow-up survey, 95% (n=65) of respondents in the VR group and 98% (n=82) in the video group would use their assigned intervention again.ConclusioneHBB VR training was highly acceptable to healthcare workers in low-income to middle-income countries and may provide additional support for neonatal resuscitation skills retention compared with other digital interventions.


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