Negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI-2 trial): study protocol for a pragmatic, multicentre, cross surgical specialty, randomised controlled trial.

BACKGROUND: The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI. METHODS: SWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use. DISCUSSION: Given the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres. TRIAL REGISTRATION: ISRCTN 26277546 . Prospectively registered on 25 March 2019.

Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial.

BACKGROUND: Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. However, some wounds may break open or be left to heal from the bottom up (i.e. healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) are often more complex to manage, and require additional treatments during the course of healing. There is significant uncertainty regarding the best treatment for these complex wounds, with limited robust evidence regarding the clinical and cost-effectiveness of different dressings and treatments; one such treatment is Negative Pressure Wound Therapy (NPWT) which is frequently used in the management of SWHSI. Previous randomised controlled trials (RCTs) of NPWT have failed to recruit to time and target, thus we aimed to conduct a pilot RCT to assess the feasibility of conducting a future, full-scale RCT. METHODS: This pilot RCT will test the methods and feasibility of recruiting, randomising, and retaining participants into a larger trial of NPWT verses usual care for patients with SWHSI. Participants will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 3 months. DISCUSSION: This study will provide a full assessment of methods for, and feasibility of, recruiting, randomising, and retaining patients with SWHSI in a trial of NPWT versus usual care. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. TRIAL REGISTRATION: Clinical Trial Registry: ISRCTN12761776 , registered on 10 December 2015 - retrospective registration.

Preventing errors in healthcare: a call for action.

Medical errors cause up to 98,000 people to die annually in the United States. They are the fifth leading cause of death and cost the United States dollar 29 billion annually (Kohn 1999). Medical errors fall into 4 main categories: diagnostic, treatment, preventative, and other. A review of literature reveals several proposed solutions to the medical error problem. One solution is to change the system for reporting medical errors. This would allow for the tracking of errors and provide information on potential problematic areas. A National Center for Patient Safety is proposed, which would set national goals towards medical errors. Another solution is the setting of performance standards among individual entities of healthcare delivery, such as hospitals and clinics. Another solution involves implementing a culture of safety among healthcare organizations. This would put the responsibility of safety on everyone in the organization. A change in education is yet another proposed solution. Informing medical students about errors and how to deal with them will help future physicians prevent such errors. The final solution involves improvements in information technology. These improvements will help track errors, but also will prevent errors. A combination of these solutions will change the focus of the healthcare industry toward safety and will eventually lead to billions in savings, but more importantly, the saving of lives.

On the independence of compliance and reliance: are automation false alarms worse than misses?

OBJECTIVE: Participants performed a tracking task and system monitoring task while aided by diagnostic automation. The goal of the study was to examine operator compliance and reliance as affected by automation failures and to clarify claims regarding independence of these two constructs. BACKGROUND: Background data revealed a trend toward nonindependence of the compliance-reliance constructs. METHOD: Thirty-two undergraduate students performed the simulation that presented the visual display while dependent measures were collected. RESULTS: False alarm-prone automation hurt overall performance more than miss-prone automation. False alarm-prone automation also clearly affected both operator compliance and reliance, whereas miss-prone automation appeared to affect only operator reliance. CONCLUSION: Compliance and reliance do not appear to be entirely independent of each other. APPLICATION: False alarms appear to be more damaging to overall performance than misses, and designers must take the compliance-reliance constructs into consideration.

Automation reliability in unmanned aerial vehicle control: a reliance-compliance model of automation dependence in high workload.

OBJECTIVE: Two experiments were conducted in which participants navigated a simulated unmanned aerial vehicle (UAV) through a series of mission legs while searching for targets and monitoring system parameters. The goal of the study was to highlight the qualitatively different effects of automation false alarms and misses as they relate to operator compliance and reliance, respectively. BACKGROUND: Background data suggest that automation false alarms cause reduced compliance, whereas misses cause reduced reliance. METHOD: In two studies, 32 and 24 participants, including some licensed pilots, performed in-lab UAV simulations that presented the visual world and collected dependent measures. RESULTS: Results indicated that with the low-reliability aids, false alarms correlated with poorer performance in the system failure task, whereas misses correlated with poorer performance in the concurrent tasks. CONCLUSION: Compliance and reliance do appear to be affected by false alarms and misses, respectively, and are relatively independent of each other. APPLICATION: Practical implications are that automated aids must be fairly reliable to provide global benefits and that false alarms and misses have qualitatively different effects on performance.

Mission control of multiple unmanned aerial vehicles: a workload analysis.

With unmanned aerial vehicles (UAVs), 36 licensed pilots flew both single-UAV and dual-UAV simulated military missions. Pilots were required to navigate each UAV through a series of mission legs in one of the following three conditions: a baseline condition, an auditory autoalert condition, and an autopilot condition. Pilots were responsible for (a) mission completion, (b) target search, and (c) systems monitoring. Results revealed that both the autoalert and the autopilot automation improved overall performance by reducing task interference and alleviating workload. The autoalert system benefited performance both in the automated task and mission completion task, whereas the autopilot system benefited performance in the automated task, the mission completion task, and the target search task. Practical implications for the study include the suggestion that reliable automation can help alleviate task interference and reduce workload, thereby allowing pilots to better handle concurrent tasks during single- and multiple-UAV flight control.