Data integrity issues: catalyst for a more robust approach to research on perioperative oxygen therapy?

Oldman, Alex H.; Cumpstey, Andrew F.; Martin, Daniel; Grocott, Michael P.W.

doi:10.1186/s13741-019-0118-y

Cited by 6 publications

(5 citation statements)

References 24 publications

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“…Severe hypoxemia, common in critically ill patients, can rapidly cause irreversible tissue damage (permanent neurologic damage may result in less than 3 min [8]) and even death if not treated. Synthesis of data from contemporary studies in acutely unwell patients suggests increased harm with liberal oxygenation strategies (9)(10)(11), and there remains a paucity of high-quality evidence supporting high concentration oxygen use in the critically ill (12). Increased mortality risk associated with high Fio 2 , high blood oxygen levels, or both has been evidenced across many patient groups, including cardiac disease, cardiac arrest, neonatal resuscitation, stroke, and traumatic brain injury (TBI) (13)(14)(15)(16)(17).…”

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confidence: 99%

Oxygen Targets During Mechanical Ventilation in the ICU: A Systematic Review and Meta-Analysis

Cumpstey

Oldman

Martin

et al. 2022

Critical Care Explorations

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OBJECTIVES: Patients admitted to intensive care often require treatment with invasive mechanical ventilation and high concentrations of oxygen. Mechanical ventilation can cause acute lung injury that may be exacerbated by oxygen therapy. Uncertainty remains about which oxygen therapy targets result in the best clinical outcomes for these patients. This review aims to determine whether higher or lower oxygenation targets are beneficial for mechanically ventilated adult patients. DATA SOURCES: Excerpta Medica dataBASE, Medical Literature Analysis and Retrieval System Online, and Cochrane medical databases were searched from inception through to February 28, 2021. STUDY SELECTION: Randomized controlled trials comparing higher and lower oxygen targets in adult patients receiving invasive mechanical ventilation via an endotracheal tube or tracheostomy in an intensive care setting. DATA EXTRACTION: Study setting, participant type, participant numbers, and intervention targets were captured. Outcome measures included “mortality at longest follow-up” (primary), mechanical ventilator duration and free days, vasopressor-free days, patients on renal replacement therapy, renal replacement free days, cost benefit, and quality of life scores. Evidence certainty and risk of bias were evaluated using Grading of Recommendations Assessment, Development and Evaluation and the Cochrane Risk of Bias tool. A random-effects models was used. Post hoc subgroup analysis looked separately at studies comparing hypoxemia versus normoxemia and normoxemia versus hyperoxemia. DATA SYNTHESIS: Data from eight trials (4,415 participants) were analyzed. Comparing higher and lower oxygen targets, there was no difference in mortality (odds ratio, 0.95; 95% CI, 0.74–1.22), but heterogeneous and overlapping target ranges limit the validity and clinical relevance of this finding. Data from seven studies (n = 4,245) demonstrated targeting normoxemia compared with hyperoxemia may reduce mortality at longest follow-up (0.73 [0.57–0.95]) but this estimate had very low certainty. There was no difference in mortality between targeting relative hypoxemia or normoxemia (1.20 [0.83–1.73]). CONCLUSIONS: This systematic review and meta-analysis identified possible increased mortality with liberal oxygen targeting strategies and no difference in morbidity between high or low oxygen targets in mechanically ventilated adults. Findings were limited by substantial heterogeneity in study methodology and further research is urgently required to define optimal oxygen therapy targets.

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confidence: 99%

Oxygen Targets During Mechanical Ventilation in the ICU: A Systematic Review and Meta-Analysis

Cumpstey

Oldman

Martin

et al. 2022

Critical Care Explorations

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“…The results of the PROXI trial, still currently the largest randomised trial of perioperative oxygenation to have fully reported, were also questioned by the WHO's 2016 GDG who felt there was no plausible biological mechanism to explain results indicating that long-term survival may be better with normal oxygenation, particularly in patients with malignant disease. 7 This randomised study included 1400 patients undergoing elective or emergency laparotomy in Danish hospitals to receive an FiO 2 of 0.8 or 0.3 during and for 2 h after surgery and found no difference in SSI rates between the two groups (odds ratio [OR] 0.94, 95% CI 0.72–1.22, P =0.64). 21 Thirty-day mortality was noted to be higher in the FiO 2 0.8 group but this was not significant (30 [4.4%] vs 20 [2.9%], OR 1.56, 95% CI 0.88–2.77, P =0.15).…”

Section: The Who Vs Cochrane Controversy and The I...mentioning

confidence: 92%

“…Part of the reason is the conflicting evidence and controversies that this research area has been embroiled in over the last decade. 5 , 6 , 7 One of the major arguments used to advance the cause for delivering a higher FiO 2 (typically >0.6) intraoperatively has been the potential for this approach to lower the incidence of surgical site infections (SSIs). 8 The scientific premise to this approach is that neutrophils, one of the body's primary defences against bacterial infection, use oxidative killing to combat pathogens.…”

Section: World Health Organization Recommendations and The 30–80% Dogmamentioning

confidence: 99%

“… 17 The WHO's recommendation also provoked strong reactions from many in this field who criticised the recommendation for being too general and cited several methodological issues with the review; including the omission of additional relevant studies. 7 , 18 , 19 The reliability of some of the included studies was also questioned. Specifically, one group had been forced to retract several publications not focussing on oxygen because of research fraud, raising doubts over the data integrity of their oxygen therapy studies.…”

Section: The Who Vs Cochrane Controversy and The I...mentioning

confidence: 99%

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Perioperative oxygenation—what's the stress?

Larvin,

Edwards,

Martin

et al. 2024

BJA Open

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“…Perhaps our unwillingness to abide by the WHO recommendation is because critical appraisal of the systematic review and meta-analysis that these were based on highlighted several fundamental flaws in the use and interpretation of the evidence available at the time [13]. Or maybe it is because evidence included in the meta-analysis has since been retracted due to data fraud [14,15]. But it may also be due to a growing understanding that oxygen is not a benign drug and its use at higher concentrations is not without risk across a wide range of clinical scenarios [16].…”

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confidence: 99%