ABSTRACT
BACKGROUND: When caring for mechanically ventilated adults with acute hypoxaemic respiratory failure (AHRF), clinicians are faced with an uncertain choice between ventilator modes allowing for spontaneous breaths or ventilation fully controlled by the ventilator. The preferences of clinicians managing such patients, and what motivates their choice of ventilator mode, are largely unknown. To better understand how clinicians' preferences may impact the choice of ventilatory support for patients with AHRF, we issued a survey to an international network of intensive care unit (ICU) researchers. METHODS: We distributed an online survey with 32 broadly similar and interlinked questions on how clinicians prioritise spontaneous or controlled ventilation in invasively ventilated patients with AHRF of different severity, and which factors determine their choice. RESULTS: The survey was distributed to 1337 recipients in 12 countries. Of these, 415 (31%) completed the survey either fully (52%) or partially (48%). Most respondents were identified as medical specialists (87%) or physicians in training (11%). Modes allowing for spontaneous ventilation were considered preferable in mild AHRF, with controlled ventilation considered as progressively more important in moderate and severe AHRF. Among respondents there was strong support (90%) for a randomised clinical trial comparing spontaneous with controlled ventilation in patients with moderate AHRF. CONCLUSIONS: The responses from this international survey suggest that there is clinical equipoise for the preferred ventilator mode in patients with AHRF of moderate severity. We found strong support for a randomised trial comparing modes of ventilation in patients with moderate AHRF.
Subject(s)
Respiratory Insufficiency , Adult , Humans , Respiratory Insufficiency/therapy , Respiration, Artificial , Lung , Intensive Care Units , RespirationABSTRACT
INTRODUCTION: In intensive care unit (ICU) patients with acute kidney injury, specific recommendations to guide the decision to cease continuous kidney replacement therapy (CKRT) are lacking. METHODS: We performed a survey to identify criteria currently used to cease CKRT in real-life clinical practice in the Netherlands. We used an online questionnaire with multiple choice questions designed with web-based software from SurveyMonkey. RESULTS: We received 169 completed questionnaires from intensivists (n = 126) and nephrologists (n = 43). Essential determinants for the cessation of CKRT were a spontaneously increasing diuresis (indicated by 92% of the respondents), absence of fluid overload (indicated by 88% of the respondents), and improvement in creatinine clearance (indicated by 61% of the respondents; intensivists 56%; nephrologists 77%, p = 0.03). Most often mentioned cut-off values used for increase in diuresis were 0.25 and 0.5 mL/kg/h (35% and 33%, respectively). Actual CKRT cessation was often postponed until the filter clots or until circuit disconnection is needed because of patient transport for diagnostic or intervention procedures (indicated by 58% of the respondents). Expected discharge from the ICU was the most frequently reported determinant to switch from CKRT to hemodialysis (indicated by 67% of the respondents). CONCLUSIONS: CKRT cessation in clinical practice is mostly based on spontaneously increasing diuresis, absence of fluid overload, and improvement in creatinine clearance and is often delayed until filter clotting or disconnection of the circuit because of logistic reasons.
Subject(s)
Acute Kidney Injury , Continuous Renal Replacement Therapy , Humans , Creatinine , Continuous Renal Replacement Therapy/methods , Renal Dialysis/adverse effects , Acute Kidney Injury/therapy , Acute Kidney Injury/etiology , Intensive Care Units , Renal Replacement Therapy/methodsABSTRACT
OBJECTIVE: To develop and validate Clinical Diversity In Meta-analyses (CDIM), a new tool for assessing clinical diversity between trials in meta-analyses of interventions. STUDY DESIGN AND SETTING: The development of CDIM was based on consensus work informed by empirical literature and expertise. We drafted the CDIM tool, refined it, and validated CDIM for interrater scale reliability and agreement in three groups. RESULTS: CDIM measures clinical diversity on a scale that includes four domains with 11 items overall: setting (time of conduct/country development status/units type); population (age, sex, patient inclusion criteria/baseline disease severity, comorbidities); interventions (intervention intensity/strength/duration of intervention, timing, control intervention, cointerventions); and outcome (definition of outcome, timing of outcome assessment). The CDIM is completed in two steps: first two authors independently assess clinical diversity in the four domains. Second, after agreeing upon scores of individual items a consensus score is achieved. Interrater scale reliability and agreement ranged from moderate to almost perfect depending on the type of raters. CONCLUSION: CDIM is the first tool developed for assessing clinical diversity in meta-analyses of interventions. We found CDIM to be a reliable tool for assessing clinical diversity among trials in meta-analysis.
Subject(s)
Meta-Analysis as Topic , Research Design/statistics & numerical data , Bias , Humans , Reproducibility of ResultsABSTRACT
OBJECTIVES: Risks of random type I and II errors are associated with false positive and false negative findings. In conventional meta-analyses, the risks of random errors are insufficiently evaluated. Many meta-analyses, which appear conclusive, might, in fact, be inconclusive because of risks of random errors. We hypothesize that, for interventions in critical care, false positive and false negative findings frequently become apparent when accounting for the risks of random error. We aim to investigate to which extent apparently conclusive conventional meta-analyses remain conclusive when adjusting statistical significance levels and confidence intervals considering sparse data and repeated testing through Trial Sequential Analysis (TSA). METHODS: We searched The Cochrane Library, MEDLINE, and EMBASE for reviews of interventions in critical care. We used TSA with the relative risk reduction from the estimated meta-analyzed intervention effects adjusted for heterogeneity based on the observed diversity. We report proportions of meta-analyses and potential inconclusive findings of positive, neutral, and negative conclusions based on conventional naïve meta-analyses, which use an alpha of 5% and 95% confidence intervals. In TSA-controlled meta-analyses showing a beneficial or harmful intervention effect, we assessed the risk of bias by six Cochrane domains. RESULTS: A total of 464 reviews containing 1,080 meta-analyses of (co-)primary outcomes were analyzed. From the 266 conventional meta-analyses suggesting a beneficial effect, 133 (50%) were true positive and 133 (50%) were potentially false positive according to TSA. From the 755 conventional meta-analyses suggesting a neutral effect, there were 214 (28%) true neutral and 541 (72%) were potentially false neutral according to TSA. From the 59 conventional meta-analyses suggesting a harmful effect, 17 (29%) were true negative and 42 (71%) were potentially false negative according to TSA. When the true beneficial and true harmful meta-analyses according to TSA were evaluated for risk of bias, new TSAs conducted on only trials with overall low risk of bias showed only firm evidence of a beneficial effect on one outcome and a harmful effect on one outcome. CONCLUSIONS: Of all meta-analyses in critical care, a large proportion may reach false conclusions because of unknown risks of random type I or type II errors. Future critical care meta-analyses should aim for establishing an effect of interventions accounting for risks of bias and random errors.
Subject(s)
Critical Care/statistics & numerical data , Meta-Analysis as Topic , Adult , Confidence Intervals , Data Interpretation, Statistical , False Negative Reactions , False Positive Reactions , Humans , Randomized Controlled Trials as Topic/statistics & numerical data , Risk , Selection Bias , Systematic Reviews as TopicABSTRACT
BACKGROUND: Survival rates in the elderly after cardiac surgery have improved over the last decades and therewith more attention is directed toward Quality of Life (QoL) as a patient reported outcome measure. OBJECTIVE: The purpose of this study was to explore QoL in patients one year after coronary artery bypass grafting, with special interest in the elderly patients (≥80 years). METHODS: In a quantitative, retrospective single-center study patients with isolated coronary artery bypass grafting (eg, nonvalve) surgery aged 80 years or older and operated in 2013 were included (n = 32). A control group of patients aged younger than 80 years was selected by matching based on gender and a recalculated (for age) logistic European System for Cardiac Operative Risk Evaluation (log EuroSCORE I) during the same period (n = 48). QoL assessment by the EuroQol questionnaire (EQ-5D) and additional questions were performed at one-year follow-up. RESULTS: QoL in elderly patients was 0.79 versus 0.90 in younger patients (P = 0.013). Overall, 54.8% of the elderly experience some or extreme problems in mobility versus 18.8% in the younger group (P = 0.001). Elderly patients also experience more problems in self care (19.3 vs 4.2%, P = 0.029). Nine of the elderly (29%) valued their postoperative health status to be worse than preoperatively versus 5 (10%) in the younger group (P = 0.028). Only patients aged 80 years or older would choose not to have surgery again (12.9%). Hospital mortality was 3.1% in the elderly group (n = 32) and 0% in the younger group (n = 48). CONCLUSION: Not all elderly patients experience benefits in terms of QoL one year after cardiac surgery. Therefore, potential benefits and risks need to be considered and discussed by physicians and patients before making the decision to operate or not.
Subject(s)
Coronary Artery Bypass/adverse effects , Health Status , Postoperative Complications/epidemiology , Quality of Life/psychology , Age Factors , Aged , Aged, 80 and over , Coronary Artery Bypass/mortality , Female , Follow-Up Studies , Hospital Mortality , Humans , Male , Postoperative Complications/mortality , Retrospective Studies , Risk Assessment , Surveys and Questionnaires , Treatment OutcomeABSTRACT
BACKGROUND: Anterior open treatment of the inguinal hernia with a tension-free mesh has reduced the incidence of hernia recurrence. The Lichtenstein procedure is the current reference technique for inguinal hernia treatment. Chronic pain has become the main postoperative complication after surgical inguinal hernia repair, especially following Lichtenstein. Preliminary experiences with a soft mesh positioned in the preperitoneal space (PPS) by transinguinal preperitoneal (TIPP) or total extraperitoneal (TEP) technique, showed promising results considering the reduction of postoperative chronic pain. Evolution of surgical innovations for inguinal hernia repair led to an open, direct approach with preperitoneal mesh position, such as TIPP. Based on the TIPP procedure, another preperitoneal repair has been recently developed, the transrectus sheath preperitoneal (TREPP) mesh repair. METHODS: The ENTREPPMENT trial is a multicentre randomized clinical trial. Patients will be randomly allocated to anterior inguinal hernia repair according to the TREPP mesh repair or TIPP procedure. All patients with a primary unilateral inguinal hernia, eligible for operation, will be invited to participate in the trial. The primary outcome measure will be the number of patients with postoperative chronic pain. Secondary outcome measures will be serious adverse events (SAEs), including recurrence, hemorrhage, return to daily activities (for example work), operative time and hospital stay. Alongside the trial health status, an economic evaluation will be performed. To demonstrate that inguinal hernia repair according to the TREPP technique reduces the percentage of patients with postoperative chronic pain from 12% to <6%, a sample size of 800 patients is required (two-sided test, α = 0.05, 80% power).The ENTREPPMENT trial aims to evaluate the TREPP and TIPP procedures from patients' perspective. It is hypothesized that the TREPP technique may reduce the number of patients with any form of postoperative chronic pain by 50% compared to the TIPP procedure. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN18591339.