Placental growth factor in assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a stepped wedge cluster randomised control trial (PARROT Ireland).

OBJECTIVE: To determine whether the addition of placental growth factor (PlGF) measurement to current clinical assessment of women with suspected pre-eclampsia before 37 weeks' gestation would reduce maternal morbidity without increasing neonatal morbidity. DESIGN: Stepped wedge cluster randomised control trial from 29 June 2017 to 26 April 2019. SETTING: National multisite trial in seven maternity hospitals throughout the island of Ireland PARTICIPANTS: Women with a singleton pregnancy between 20+0 to 36+6 weeks' gestation, with signs or symptoms suggestive of evolving pre-eclampsia. Of the 5718 women screened, 2583 were eligible and 2313 elected to participate. INTERVENTION: Participants were assigned randomly to either usual care or to usual care plus the addition of point-of-care PlGF testing based on the randomisation status of their maternity hospital at the time point of enrolment. MAIN OUTCOMES MEASURES: Co-primary outcomes of composite maternal morbidity and composite neonatal morbidity. Analysis was on an individual participant level using mixed-effects Poisson regression adjusted for time effects (with robust standard errors) by intention-to-treat. RESULTS: Of the 4000 anticipated recruitment target, 2313 eligible participants (57%) were enrolled, of whom 2219 (96%) were included in the primary analysis. Of these, 1202 (54%) participants were assigned to the usual care group, and 1017 (46%) were assigned the intervention of additional point-of-care PlGF testing. The results demonstrate that the integration of point-of-care PlGF testing resulted in no evidence of a difference in maternal morbidity-457/1202 (38%) of women in the control group versus 330/1017 (32%) of women in the intervention group (adjusted risk ratio (RR) 1.01 (95% CI 0.76 to 1.36), P=0.92)-or in neonatal morbidity-527/1202 (43%) of neonates in the control group versus 484/1017 (47%) in the intervention group (adjusted RR 1.03 (0.89 to 1.21), P=0.67). CONCLUSIONS: This was a pragmatic evaluation of an interventional diagnostic test, conducted nationally across multiple sites. These results do not support the incorporation of PlGF testing into routine clinical investigations for women presenting with suspected preterm pre-eclampsia, but nor do they exclude its potential benefit. TRIAL REGISTRATION: ClinicalTrials.gov NCT02881073.

The effect of a novel Bayesian penalised likelihood PET reconstruction algorithm on the assessment of malignancy risk in solitary pulmonary nodules according to the British Thoracic Society guidelines.

PURPOSE: British Thoracic Society (BTS) guidelines advocate using FDG PET-CT with the Herder model to estimate malignancy risk in solitary pulmonary nodules (SPNs). Qualitative and semi-quantitative assessment of SPN uptake is based upon analysis of Ordered Subset Expected Maximisation (OSEM) PET images. Our aim was to assess the effect of a Bayesian Penalised Likelihood (BPL) PET reconstruction on the assessment of SPN FDG uptake and estimation of malignancy risk (Herder score). METHODS: Subjects with SPNs who underwent FDG PET-CT between 2014-2017, with histological confirmation of malignancy or histological/imaging follow-up confirmation of benignity were included. Two blinded readers independently classified SPN uptake on both OSEM and BPL (BTS score; 1 = none; 2 = ≤ mediastinal blood pool (MBP); 3 = >MBP but ≤ 2x liver; 4 = >2x liver), with resultant calculation of the Herder score (%) for both reconstructions. RESULTS: 97 subjects with 75 (77%) malignant SPNs were included. BPL increased the BTS score in 25 (26%) SPNs; 9 SPNs (7 malignant) increased from BTS score 2 to 3, 16 (13 malignant) from BTS score 3 to 4, with a mean Herder score increase of 18 ±â€¯22%. The mean Herder score for all SPNs with BPL was higher than OSEM (73 ±â€¯29 vs 68 ±â€¯32%, p = 0.001). There was no difference in Herder model diagnostic performance between BPL and OSEM, with similar areas under the curve (0.84 vs 0.83, p = 0.39). CONCLUSION: BPL increases the Herder score in 26% of SPNs compared to OSEM but does not alter the diagnostic performance of the Herder model.

Confined space manure storage and facilities safety assessment.

A mail survey of 1,200 farms across 16 states was conducted to identify the number, type, and size of manure storages per farm, as well as safety-related behaviors or actions related to entry into confined-space manure storage and handling facilities. Respondents provided data on 297 storage units and facilities, with approximately 75% reporting up to three storages per farm operation. Dimensions were provided for 254 manure pits: nearly 66% were less than or equal to 100 feet long, 75% were less than or equal to 40 feet wide, and 75% were less than or equal to 10 feet deep. Almost 14% of the reported storages were over 300 feet long, seven were wider than 100 feet, and 17 were more than 20 feet deep. Survey results suggest that most farm operations with confined-space manure storages do not follow best safety practices regarding their manure storages, including using gas detection equipment before entering a manure pit, using rescue lines when entering storages, or developing a written confined-space safety policy or plan. Survey results also suggest that few farmers post warning signs around their storages, post recommended ventilation times before entry, or conduct training for workers who enter confined-space manure storages. This article provides a benchmark against which the effectiveness of educational programs and design tools for confined-space manure pit ventilation systems and other confined-space manure pit safety interventions can be measured.

Instrumental delivery and ultrasound : a multicentre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery.

OBJECTIVE: To determine whether the use of ultrasound can reduce the incidence of incorrect diagnosis of the fetal head position at instrumental delivery and subsequent morbidity. DESIGN: Two-arm, parallel, randomised trial, conducted from June 2011 to December 2012. SETTING: Two maternity hospitals in the Republic of Ireland. SAMPLE: A cohort of 514 nulliparous women at term (≥37 weeks of gestation) with singleton cephalic pregnancies, aiming to deliver vaginally, were recruited prior to an induction of labour or in early labour. METHODS: If instrumental delivery was required, women who had provided written consent were randomised to receive clinical assessment (standard care) or ultrasound scan and clinical assessment (ultrasound). [Correction added on 17 April 2014, after first online publication: Sentence was amended.] MAIN OUTCOME MEASURE: Incorrect diagnosis of the fetal head position. RESULTS: The incidence of incorrect diagnosis was significantly lower in the ultrasound group than the standard care group (4/257, 1.6%, versus 52/257, 20.2%; odds ratio 0.06; 95% confidence interval 0.02-0.19; P < 0.001). The decision to delivery interval was similar in both groups (ultrasound mean 13.8 minutes, SD 8.7 minutes, versus standard care mean 14.6 minutes, SD 10.1 minutes, P = 0.35). The incidence of maternal and neonatal complications, failed instrumental delivery, and caesarean section was not significantly different between the two groups. CONCLUSIONS: An ultrasound assessment prior to instrumental delivery reduced the incidence of incorrect diagnosis of the fetal head position without delaying delivery, but did not prevent morbidity. A more integrated clinical skills-based approach is likely to be required to prevent adverse outcomes at instrumental delivery.

Operator assessment of tractor roll angle with and without a tractor stability visual feedback device.

According to a 2004 National Institute for Occupational Safety and Health (NIOSH) report, approximately 250 to 350 fatalities occur each year due to incidents involving production agriculture workers and tractors. Tractor overturns account for about 150 to 200 of these deaths. The goals of this project were to study operators' understanding of tractor roll angles and test a device to effectively deliver stability information to the tractor operator. This project required the design and construction of a full-scale tractor cab roll simulator that was used to identify lateral roll angles at which volunteer participants felt uncomfortable, as well as lateral roll angles at which they would no longer operate a tractor. In addition, the participants performed a series of tasks to test the functionality of a visual slope indicator that was designed to help them estimate slope angles. The project tested 231 tractor operators' perceptions of safe operation on side slopes and 128 participants' interactions with the visual slope indicator. Testing showed that the visual slope indicator was able to influence the angle estimations of the novice tractor operator population and helped the entire population of participants more accurately rank the simulator scenarios.

Development and testing of an assessment instrument for the formative peer review of significant event analyses.

AIM: To establish the content validity and specific aspects of reliability for an assessment instrument designed to provide formative feedback to general practitioners (GPs) on the quality of their written analysis of a significant event. METHODS: Content validity was quantified by application of a content validity index. Reliability testing involved a nested design, with 5 cells, each containing 4 assessors, rating 20 unique significant event analysis (SEA) reports (10 each from experienced GPs and GPs in training) using the assessment instrument. The variance attributable to each identified variable in the study was established by analysis of variance. Generalisability theory was then used to investigate the instrument's ability to discriminate among SEA reports. RESULTS: Content validity was demonstrated with at least 8 of 10 experts endorsing all 10 items of the assessment instrument. The overall G coefficient for the instrument was moderate to good (G>0.70), indicating that the instrument can provide consistent information on the standard achieved by the SEA report. There was moderate inter-rater reliability (G>0.60) when four raters were used to judge the quality of the SEA. CONCLUSIONS: This study provides the first steps towards validating an instrument that can provide educational feedback to GPs on their analysis of significant events. The key area identified to improve instrument reliability is variation among peer assessors in their assessment of SEA reports. Further validity and reliability testing should be carried out to provide GPs, their appraisers and contractual bodies with a validated feedback instrument on this aspect of the general practice quality agenda.

Decision-making and outcomes of prolonged ICU stays in seriously ill patients.

BACKGROUND: Despite concern about the high costs and the uncertain benefit of prolonged treatment in the intensive care unit (ICU), there has been little research examining decision-making and outcomes for patients with prolonged ICU stays. OBJECTIVES: To evaluate decision-making and outcomes for seriously ill patients with an ICU stay of at least 14 days. DESIGN: A prospective cohort study. SETTING: Five teaching hospitals. PARTICIPANTS: Seriously ill patients enrolled in the Study To Understand Prognoses and Preferences for Risks and Outcomes of Treatments (SUPPORT). MEASUREMENT: Patients, their surrogate decision-makers, and their physicians were interviewed about prognosis, communication, and goals of medical care. Based on age, diagnoses, comorbid illnesses, and acute physiology data, the SUPPORT Prognostic Model provided estimates of 6-month survival on study days 1, 3, 7, and 14. Hospital costs were estimated from hospital billing data. RESULTS: Of the 9105 patients enrolled in SUPPORT, 1494 (16%) had ICU stays of 14 days or longer. The median length of stay in an ICU was 4 days for the entire SUPPORT cohort and 35 days for patients who were treated in an ICU for 14 days or longer. Median hospital costs were $76,501 for patients who had ICU stays 14 days or longer and $10,916 for patients who did not have long ICU stays. Fifty-five percent of patients with long ICU stays had died by 6 months, and an additional 19% had substantial functional impairment. Among patients with ICU stays of at least 14 days, only 20% had estimates of 6-month survival that fell below 10% at any time during their hospitalization. For patients with long ICU stays, the mean predicted probability of 6-month survival was 0.46 on study Day 3 and 0.47 on study Day 14. Fewer than 40% of patients (or their surrogates) reported that their physicians had talked with them about their prognoses or preferences for life-sustaining treatment. Among the patients who preferred a palliative approach to care, only 29% thought that their care was consistent with that aim. Those who discussed their preferences for care with a physician were 1.9 times more likely to believe that treatment was in accord with their preferences for palliation (95% CI, 1.4-2.5) CONCLUSIONS: Prolonged ICU stays were expensive and were often followed by death or disability. Patients reported low rates of discussions with their physicians about their prognoses and preferences for life-sustaining treatments. Many preferred that care focus on palliation and believed that care was inconsistent with their preferences. Patients were more likely to receive care consistent with their preferences if they had discussed their care preferences with their physicians.

An occupational health and safety intervention research agenda for production agriculture: does safety education work?

It is clear that agriculture has not kept pace with other hazardous industries in reducing its injury rate. For example, between 1960 and 1990 the work death rate for agriculture decreased only 28% while the work death rates decreased 65% for mining and 55% for construction [Purschwitz (1992)]. A national conference in Iowa in 1988 came to the forceful conclusion that "America's most productive workforce was being systematically liquidated by an epidemic of occupational disease and traumatic death and injury" [NCASH (1988)]. In 1991, the nation's top public health officer, the U.S. Surgeon General, convened a conference titled "FarmSafe 2000-A National Coalition for Local Action," to formally address agricultural safety and health issues. Importantly, conferees recognized that preventing injury and disease was superior to trying to rehabilitate people after an injury occurred. But does participation in farm safety and health educational programs lead to a reduction in risk of injury from farm work? Questions are being raised about the value of farm safety and health educational information, campaigns, programs, and related activities. The questions have identified a critical gap in the literature of farm safety and health education. There is currently no good evidence demonstrating that farm safety and health education, campaigns, programs, or related activities lead to a relatively stable reduction of risk on the farm. In other words, do farmers and their families actually put to use, in a relatively permanent or stable manner, the educational information regarding elimination, reduction, or control of physical hazards and the modification of work behavior that may cause injury?

GUIDe (Guidelines for the Use of Intensive Care in Denver): a community effort to define futile and inappropriate care.

Several issues force us to critically evaluate futile or inappropriate intensive care. These issues include cost control, quality of care, and professional and family integrity. The debate has progressed along three avenues: ethical discourse, prognostic scoring systems, and debate in the courts. Despite these arenas of discussion, a consensus about futile or inappropriate care has not been reached. The healthcare profession and the public need to work together to forge a consensus. We describe one model that facilitates this political process. Guidelines for the Use of Intensive Care in Denver (GUIDe) is a consortium of metropolitan Denver hospitals and other healthcare institutions whose goal is to develop guidelines for the use of futile or inappropriate intensive care. The building of consensus starts with subcommittees (adult intensive care, neonatal intensive care, and long-term care) that present proposals at plenary sessions. Other subcommittees (public liaison and legal subcommittees) facilitate dialogue with the public. Feedback from the plenary sessions, the greater medical community, and the public lead to proposal revisions. We expect to present hospitals with actual guidelines in approximately 3 yrs.

An overview of allocation and rationing: implications for geriatrics.

Geriatricians are faced with increasing pressure from insurers and the public to control costs. At the same time, subspecialist colleagues, patients, and the courts often demand ever more costly high-technology interventions. This conflict will only intensify given the sustained increase in the percentage of GNP spent on medical care. A number of prominent biomedical ethicists and others have explored rationing of medical care services as one response to these concerns. This is the second in a series of articles in the Journal in response to the Oregon Health Decisions Initiative and is designed to provide (1) a brief ethical perspective on rationing and allocation; (2) an analysis of our present, largely implicit, approach to rationing and allocation; and (3) some suggestions that might move the United States closer to a more coherent and reasonable means of allocating and rationing health care.

Improving advance directives for healthy older people.

The quality and quantity of advance directives for healthy older people need to increase. Quality will improve with literal interpretations of do-not-resuscitate orders and more comprehensive directives. Changing the term "DNR" to "No ACLS (Advanced Cardiac Life Support)" should discourage health-care providers from subsuming other limitations under the directive to withhold resuscitation. Other aggressive medical and surgical interventions should be prospectively considered in addition to resuscitation. The quantity of advance directives will increase when physicians feel motivated to devote time and expertise to thorough discussions of advance directives. Although education and legislation will motivate physicians to some extent, their roles are limited. Fair reimbursement for this primary-care service is the most effective motive. The initial investment by Medicare may save large sums in the long run by reducing expensive, undesired care for older people.

Life-sustaining therapy. A model for appropriate use.

New strategies are needed to curb the proliferation of life-sustaining therapies that rarely benefit patients. We propose a model for appropriate use of such therapies that incorporates effectiveness, utility, and marginal costs. If a therapy is rarely effective and rarely desirable, it is considered medically inappropriate. If the marginal cost-effectiveness ratio is inordinately high, it is considered economically inappropriate. If a therapy is either medically or economically inappropriate, it should not be automatically offered. The model provides an operational definition of futility and is illustrated with an analysis of out-of-hospital cardiopulmonary resuscitation for chronically ill older people. Advance directives, explicit health care rationing, and defining futile therapy based on survival predictions are alternatives to the appropriate care model, but are insufficient strategies to solve the problem of inappropriate life-sustaining care.

KIE: The authors propose a mathematical model for deciding appropriate use of life-sustaining care, using as an example out-of-hospital cardiopulmonary resuscitation for chronically ill older persons. Incorporating determinations of effectiveness, utility, and marginal costs, the model helps physicians and patients decide which life-sustaining treatments are medically and/or economically appropriate. Physicians need not automatically offer patients therapies that have been shown to be neither medically nor economically appropriate. Murphy and Matchar discuss advance directives, health care rationing, and identifying futile therapies based on survival predictions as other mechanisms for limiting life-sustaining care. They conclude that these three options are inadequate alternatives to the appropriate care model.

Do-not-resuscitate orders. Time for reappraisal in long-term-care institutions.

KIE: Murphy, a physician, proposes a policy under which the attending physician and nurses would consider the resuscitation status of patients after their admission to a long-term-care (LTC) facility and make unilateral decisions about writing do-not-resuscitate (DNR) orders for severely demented patients and for chronically ill patients for whom CPR is believed to be futile. He reasons that the ethical consensus that patient autonomy should prevail in DNR determinations does not apply to the LTC population where medical indications should be given first priority in ethical decision making. Murphy notes that the broad spectrum of cases adjudicated show that, with few exceptions, courts usually rule that withholding or withdrawing therapy in these instances is legally acceptable.^ieng