Perioperative goal-directed therapy: what’s the best study design to investigate its impact on patient outcome?

Saugel, Bernd; Joosten, Alexandre; Scheeren, Thomas

doi:10.1007/s10877-018-0196-2

Cited by 7 publications

(10 citation statements)

References 19 publications

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“…7 Perioperative outcomes are influenced by a wide range of factors throughout the preoperative journey and need to account for the truly multidisciplinary nature of perioperative care, by including nursing as well as medical interventions during each phase of care in study designs. 6,8 Therefore, the complexity of the perioperative pathway needs to be considered in both the design of primary studies and the assessment of these studies via systematic review. Authors have recently questioned the status of randomized controlled trials in remaining the "gold standard" design to inform perioperative decision-making.…”

Section: Experimental Research In the Perioperative Settingmentioning

confidence: 99%

<p>Nurse-Led Randomized Controlled Trials in the Perioperative Setting: A Scoping Review</p>

Munday¹,

Higgins²,

Mathew³

et al. 2020

JMDH

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Purpose: Nurses provide care at each phase of the complex, perioperative pathway and are well placed to identify areas of care requiring investigation in randomized controlled trials. Yet, currently, the scope of nurse-led randomized controlled trials conducted within the perioperative setting are unknown. This scoping review aims to identify areas of perioperative care in which nurse-led randomized controlled trials have been conducted, to identify issues impacting upon the quality of these trials and identify gaps for future investigation. Methods: This scoping review was conducted in reference to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Searches were conducted in PubMed, Embase, Cumulative Index for Nursing and Allied Health Literature and the Cochrane Central Register of Controlled Trials, with a date range of 2014-19. Sources of unpublished literature included Open Grey, and ProQuest Dissertation and Theses, Clinical Trials.gov and the Australian and New Zealand Clinical Trials Registry. After title and abstract checking, full-text retrieval and data extraction, studies were appraised using the Joanna Briggs Institute Critical Appraisal Checklists for randomized controlled trials. Data were synthesized according to the main objectives. Key information was tabulated. Results: From the 86 included studies, key areas where nurses have led randomized controlled trials include patient or caregiver anxiety; postoperative pain relief; surgical site infection prevention: patient and caregiver knowledge; perioperative hypothermia prevention; postoperative nausea and vomiting; in addition to other diverse outcomes. Issues impacting upon quality (including poorly reported randomization), and gaps for future investigation (including a focus on vulnerable populations), are evident. Conclusion: Nurse-led randomized controlled trials in the perioperative setting have focused on key areas of perioperative care. Yet, opportunities exist for nurses to lead experimental research in other perioperative priority areas and within different populations that have been neglected, such as in the population of older adults undergoing surgery.

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Section: Experimental Research In the Perioperative Settingmentioning

confidence: 99%

<p>Nurse-Led Randomized Controlled Trials in the Perioperative Setting: A Scoping Review</p>

Munday¹,

Higgins²,

Mathew³

et al. 2020

JMDH

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“…The Local Research Ethics Committee approved the study and waived the need for consent since the pGDT protocol was considered clinical practice for patients undergoing elective HRS in our hospital. The study, undertaken at an academic teaching hospital was set-up using a before-after design [19]. In the before-group, data were retrospectively collected from patients who underwent HRS before the implementation of the pGDT protocol (August 2013 to February 2015).…”

Section: Study Design and Patientsmentioning

confidence: 99%

“…Before-after studies show the effects of implementing a protocol more realistically than a randomized controlled trial. Nevertheless, this type of research has the disadvantage that confounders potentially influence results [19]. Protocol compliance as confounder has been studied in other areas of perioperative and postoperative research, which have shown that higher protocol compliance leads to better patient outcomes [9,31,32].…”

Section: Implications and Generalizabilitymentioning

confidence: 99%

“…We implemented a quality improvement program in which a pGDT protocol was introduced as an addition to clinical practice for patients undergoing HRS. As we have expressed previously, such a 'before and after' model allows evaluating the effectiveness of pGDT under real-life conditions [19]. We hypothesized that high compliance with a pGDT protocol improves postoperative outcomes compared to low compliance.…”

Section: Introductionmentioning

confidence: 99%

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The effect of compliance with a perioperative goal-directed therapy protocol on outcomes after high-risk surgery: a before-after study

Boekel

Venema

Kaufmann

et al. 2020

J Clin Monit Comput

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Perioperative goal-directed therapy is considered to improve patient outcomes after high-risk surgery. The association of compliance with perioperative goal-directed therapy protocols and postoperative outcomes is unclear. The purpose of this study is to determine the effect of protocol compliance on postoperative outcomes following high-risk surgery, after implementation of a perioperative goal-directed therapy protocol. Through a before-after study design, patients undergoing elective high-risk surgery before (before-group) and after implementation of a perioperative goal-directed therapy protocol (after-group) were included. Perioperative goal-directed therapy in the after-group consisted of optimized stroke volume variation or stroke volume index and optimized cardiac index. Additionally, the association of protocol compliance with postoperative complications when using perioperative goal-directed therapy was assessed. High protocol compliance was defined as ≥ 85% of the procedure time spent within the individual targets. The difference in complications during the first 30 postoperative days before and after implementation of the protocol was assessed. In the before-group, 214 patients were included and 193 patients in the after-group. The number of complications was higher in the before-group compared to the after-group (n = 414 vs. 282; p = 0.031). In the after-group, patients with high protocol compliance for stroke volume variation or stroke volume index had less complications compared to patients with low protocol compliance for stroke volume variation or stroke volume index (n = 187 vs. 90; p = 0.01). Protocol compliance by the attending clinicians is essential and should be monitored to facilitate an improvement in postoperative outcomes desired by the implementation of perioperative goal-directed therapy protocols.

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“…The advantages and disadvantages of a before-after study design as opposed to the scientific standard of a randomized controlled trial were discussed in the accompanying editorial comment by Saugel et al [33]. While the question about the best study design to investigate a potentially beneficial impact of pGDT on patient outcome cannot be definitely answered, the editorial comes to the conclusion that both study designs have their place and value in contributing to find out if pGDT actually improves patient outcome in reallife daily clinical practice.…”

Section: Perioperative Goal-directed Therapymentioning

confidence: 99%

Journal of Clinical Monitoring and Computing end of year summary 2019: hemodynamic monitoring and management

Saugel

Critchley

Kaufmann

et al. 2020

J Clin Monit Comput

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Perioperative goal-directed therapy: what’s the best study design to investigate its impact on patient outcome?

Cited by 7 publications

References 19 publications

<p>Nurse-Led Randomized Controlled Trials in the Perioperative Setting: A Scoping Review</p>

<p>Nurse-Led Randomized Controlled Trials in the Perioperative Setting: A Scoping Review</p>

The effect of compliance with a perioperative goal-directed therapy protocol on outcomes after high-risk surgery: a before-after study

Journal of Clinical Monitoring and Computing end of year summary 2019: hemodynamic monitoring and management

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