scholarly journals Prehabilitation for Frail Patients Undergoing Colorectal Surgery: Lessons Learnt From a Randomised Feasibility Study

2021 ◽  
Vol 2 ◽  
Author(s):  
Claire Furyk ◽  
Siva Senthuran ◽  
Dia Nye ◽  
Yik H. Ho ◽  
Anthony S. Leicht
Keyword(s):  
Randomised Controlled Trial ◽  
Colorectal Surgery ◽  
Controlled Trial ◽  
Activity Level ◽  
Surgical Patients ◽  
Supervised Exercise ◽  
Frail Patients ◽  
Randomised Controlled ◽  
The Impact

There is substantial interest by clinicians to improve the health outcomes of older and frail patients following major surgery, with prehabilitation a potential and important component of future standard patient care. We studied the feasibility of a randomised controlled trial of pre-operative prehabilitation in frail patients scheduled for colorectal surgery in regional Australia. We conducted a single blind, parallel arm, randomised controlled trial in a regional referral centre where colorectal surgical patients aged over 50 were invited to participate and screened for frailty. Frail patients were randomised to undertake either a 4-week supervised exercise program with dietary advice, or usual care. The primary outcome was 6-min-walk-distance at baseline, pre-surgery (4 weeks later) and at follow-up (4–6 weeks post-operation). Secondary outcomes included physical activity level, health-related quality of life, and post-surgical complications. Feasibility outcomes were numbers of patients reaching each stage and barriers or reasons for withdrawal. Of 106 patients eligible for screening during the 2-year study period, only five were able to be randomised, of which one alone completed the entire study to follow-up. Fewer patients than expected met the frailty criteria (23.6%), and many (22.6%) were offered surgery in a shorter timeframe than the required 4 weeks. Physical and psychological aspects of frailty and logistical issues were key for patients declining study participation and/or not complying with the intervention and/or all outcome assessments. Feasibility for a large randomised controlled trial of prehabilitation for frail colorectal patients was poor (~5%) for our regional location. Addressing barriers, examination of a large, dense population base, and utilisation of a frailty-screening tool validated in surgical patients are necessary for future studies to identify the impact of prehabilitation for frail patients.

scholarly journals A randomised controlled trial exploring the impact of a dedicated Health and Social Care Professionals team in the Emergency Department on the quality, safety, clinical and cost-effectiveness of care for older adults: Study Protocol

2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

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

scholarly journals Evaluating Registered Reports Funding Partnerships: a feasibility study

2021 ◽  
Vol 6 ◽  
pp. 231
Author(s):  
Robbie Clark ◽  
Katie Drax ◽  
Christopher D. Chambers ◽  
Marcus Munafò ◽  
Jacqueline Thompson
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Scale Up ◽  
Research Process ◽  
Research Quality ◽  
Structured Interviews ◽  
Randomised Controlled ◽  
The Impact ◽  
Full Trial

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.

scholarly journals eHBB: a randomised controlled trial of virtual reality or video for neonatal resuscitation refresher training in healthcare workers in resource-scarce settings

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e048506
Author(s):  
Rachel Umoren ◽  
Sherri Bucher ◽  
Daniel S Hippe ◽  
Beatrice Nkolika Ezenwa ◽  
Iretiola Bamikeolu Fajolu ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Randomised Controlled Trial ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Neonatal Resuscitation ◽  
Pass Rates ◽  
Healthcare Facilities ◽  
Randomised Controlled ◽  
The Impact

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.

scholarly journals A randomised controlled trial exploring the impact of a dedicated Health and Social Care Professionals team in the Emergency Department on the quality, safety, clinical and cost-effectiveness of care for older adults: Study Protocol

2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephan White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Model Of Care ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

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 outcomes include ED length of stay (from arrival to discharge) and incidence of inpatient admissions from the ED. Secondary outcomes include: ED re-visits, unplanned hospital admissions and healthcare utilisation at 30-days 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.

scholarly journals A randomised controlled trial exploring the impact of a dedicated health and social care professionals team in the emergency department on the quality, safety, clinical and cost-effectiveness of care for older adults: a study protocol

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Older people are frequent emergency department (ED) users who present with complex issues that are linked to poorer health outcomes following the 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 an improved patient experience by improving care decision-making and thus promoting timely and effective care. However, the evidence supporting the impact of HSCP 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, and clinical- and cost-effectiveness of care of older adults when compared with 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, and 4 and 6 months of follow-up; patient functional status and quality of life (at baseline and follow-up); patient satisfaction; cost-effectiveness in terms of costs associated with ED-based HSCP compared with 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, and clinical- and cost-effectiveness of care for older patients. The findings of this study will provide important information on the effectiveness of this model of care for future implementation. Trial registration ClinicalTrials.gov, NCT03739515. Registered on 12 November 2018.

scholarly journals Arthroscopic Bankart versus open Latarjet as a primary operative treatment for traumatic anteroinferior instability in young males: a randomised controlled trial with 2-year follow-up

2021 ◽  
pp. bjsports-2021-104028
Author(s):  
Juha Kukkonen ◽  
Sami Elamo ◽  
Tapio Flinkkilä ◽  
Juha Paloneva ◽  
Miia Mäntysaari ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Shoulder Instability ◽  
Controlled Trial ◽  
Activity Level ◽  
Secondary Outcome ◽  
Young Males ◽  
Group B ◽  
Randomised Controlled

ObjectivesTo compare the success rates of arthroscopic Bankart and open Latarjet procedure in the treatment of traumatic shoulder instability in young males.DesignMulticentre randomised controlled trial.SettingOrthopaedic departments in eight public hospitals in Finland.Participants122 young males, mean age 21 years (range 16–25 years) with traumatic shoulder anteroinferior instability were randomised.InterventionsArthroscopic Bankart (group B) or open Latarjet (group L) procedure.Main outcome measuresThe primary outcome measure was the reported recurrence of instability, that is, dislocation at 2-year follow-up. The secondary outcome measures included clinical apprehension, sports activity level, the Western Ontario Shoulder Instability Index, the pain Visual Analogue Scale, the Oxford Shoulder Instability Score, the Constant Score and the Subjective Shoulder Value scores and the progression of osteoarthritic changes in plain films and MRI.Results91 patients were available for analyses at 2-year follow-up (drop-out rate 25%). There were 10 (21%) patients with redislocations in group B and 1 (2%) in group L, p=0.006. One (9%) patient in group B and five (56%) patients in group L returned to their previous top level of competitive sports (p=0.004) at follow-up. There was no statistically significant between group differences in any of the other secondary outcome measures.ConclusionsArthroscopic Bankart operation carries a significant risk for short-term postoperative redislocations compared with open Latarjet operation, in the treatment of traumatic anteroinferior instability in young males. Patients should be counselled accordingly before deciding the surgical treatment.Trial registration numberNCT01998048.

scholarly journals A randomised controlled trial exploring the impact of a dedicated Health and Social Care Professionals team in the Emergency Department on the quality, safety, clinical and cost-effectiveness of care for older adults: Study Protocol

2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

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

scholarly journals A randomised controlled trial exploring the impact of a dedicated Health and Social Care Professionals team in the Emergency Department on the quality, safety, clinical and cost-effectiveness of care for older adults: Study Protocol

2019 ◽  
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
Stephen White ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Health And Social Care ◽  
Effectiveness Of Care ◽  
Randomised Controlled ◽  
The Impact

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

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