The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.

https://www.bmj.com/content/bmj/355/bmj.i5239.full.pdf

CONSORT 2010 statement: extension to randomised pilot and feasibility trials.

on behalf of the PAFS consensus group authors (listed alphabetically): Doug Altman (address 1), Frank Bretz (2), Marion Campbell (3), Erik Cobo (4), Peter Craig (5), Peter Davidson (6), Trish Groves (7), Freedom Gumedze (8), Jenny Hewison (9), Allison Hirst (10), Pat Hoddinott (11), Sarah E Lamb (12), Tom Lang (13), Elaine McColl (14), Alicia O’Cathain (15), Daniel R Shanahan (16), Chris Sutton (17), Peter Tugwell (18)

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CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Objective  To develop a practical evidence based list of clinical risk factors that can be assessed by a clinician at ≤16 weeks’ gestation to estimate a woman’s risk of pre-eclampsia. Design  Systematic review and meta-analysis of cohort studies. Data sources  PubMed and Embase databases, 2000-15. Eligibility criteria for selecting studies  Cohort studies with ≥1000 participants that evaluated the risk of pre-eclampsia in relation to a common and generally accepted clinical risk factor assessed at ≤16 weeks’ gestation. Data extraction  Two independent reviewers extracted data from included studies. A pooled event rate and pooled relative risk for pre-eclampsia were calculated for each of 14 risk factors. Results  There were 25 356 688 pregnancies among 92 studies. The pooled relative risk for each risk factor significantly exceeded 1.0, except for prior intrauterine growth restriction. Women with antiphospholipid antibody syndrome had the highest pooled rate of pre-eclampsia (17.3%, 95% confidence interval 6.8% to 31.4%). Those with prior pre-eclampsia had the greatest pooled relative risk (8.4, 7.1 to 9.9). Chronic hypertension ranked second, both in terms of its pooled rate (16.0%, 12.6% to 19.7%) and pooled relative risk (5.1, 4.0 to 6.5) of pre-eclampsia. Pregestational diabetes (pooled rate 11.0%, 8.4% to 13.8%; pooled relative risk 3.7, 3.1 to 4.3), prepregnancy body mass index (BMI) >30 (7.1%, 6.1% to 8.2%; 2.8, 2.6 to 3.1), and use of assisted reproductive technology (6.2%, 4.7% to 7.9%; 1.8, 1.6 to 2.1) were other prominent risk factors. Conclusions  There are several practical clinical risk factors that, either alone or in combination, might identify women in early pregnancy who are at “high risk” of pre-eclampsia. These data can inform the generation of a clinical prediction model for pre-eclampsia and the use of aspirin prophylaxis in pregnancy.

https://www.bmj.com/content/bmj/353/bmj.i1753.full.pdf

Clinical risk factors for pre-eclampsia determined in early pregnancy: systematic review and meta-analysis of large cohort studies

Family Support and Family-Centered Care in the Neonatal Intensive Care Unit: Origins, Advances, Impact

The demand for platelets in England was stable at around 220,000 adult therapeutic doses (ATD) per year until 2007/8 at which point demand has increased year on year to 275,000 ATD in 2014/15, an increase of 25%. Similar rises in demand have been seen in Australia and the United States. A recent review which considered causes for this dramatic rise identified that an ageing population and an increase in the incidence of haematological malignancies (with increased treatment intensity, duration and survival) accounted for most of this change (Estcourt 2014). This guideline aims to provide practical advice on platelet transfusions to help clinicians to decide when support is expected to be beneficial and to reduce inappropriate use.

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Guidelines for the Use of Platelet Transfusions

WHAT THIS STUDY ADDS: This study was conducted in a large population, and the results confirm the association between packed red blood cell transfusion and NEC. Adjusted odds for NEC in infants who received a transfusion were 2.3, and there was a preponderance of male donors for blood transfused preceding NEC. abstract To determine if infants with very low birth weight who receive packed red blood cell (PRBC) transfusions have increased odds of developing necrotizing enterocolitis (NEC), to determine the rate of NEC after PRBC transfusion, and to characterize the blood transfused preceding the onset of NEC. STUDY DESIGN: A retrospective cohort design was used. The study population included infants with a birth weight of 1500 g who were from a single center. NEC after transfusion was defined as NEC that occurred in the 48 hours after initiation of PRBC transfusion. Statistical analysis included unadjusted and multivariable analyses. RESULTS: The study sample included 2311 infants. A total of 122 infants (5.3%) developed NEC, and 33 (27%) of 122 NEC cases occurred after transfusion. NEC occurred after 33 (1.4%) of 2315 total transfusions. Infants who received a transfusion had increased adjusted odds (odds ratio: 2.3 (95% confidence interval: 1.2- 4.2)) of developing NEC com- pared with infants who did not receive a transfusion. PRBCs transfused before NEC were predominantly (83%) from male donors and were a median of 5 days old. CONCLUSIONS: In our study sample, PRBC transfusion was associated with increased odds of NEC. The rate of NEC after transfusion was 1.4%. From our data we could not determine if PRBC transfusions were part of the causal pathway for NEC or were indicative of other factors that may be causal for NEC. Pediatrics 2011;127:635-641

Increased Odds of Necrotizing Enterocolitis After Transfusion of Red Blood Cells in Premature Infants

To determine what sources of information are most helpful for neonatal intensive care unit (NICU) parents, who provides NICU parents with the information, and also what expectations parents have regarding obtaining information. A 19-item questionnaire was given to the parents of infants 32 weeks or younger prior to discharge from the NICU. Out of the 101 parents who consented, almost all of the parents (96%) felt that ‘the medical team gave them the information they needed about their baby’ and that the ‘neonatologist did a good job of communicating’ with them (91%). However, the nurse was chosen as ‘the person who spent the most time explaining the baby's condition, ‘the best source of information,’ and the person who told them ‘about important changes in their baby's condition’ (P<0.01). Although the neonatologist's role in parent education is satisfactory, the parents identified the nurses as the primary source of information.

Communicating with parents of premature infants: who is the informant?

PURPOSE:To evaluate and compare the presence of perceived paternal stress and depressive symptomatology in fathers of preterm infants over time.SUBJECTS:Fathers of NICU infants born before 30 weeks of gestation.DESIGN:Prospective convenience sample.METHODS:Consenting fathers were given 2 self-report

Forgotten parent: NICU paternal emotional response.

Effect of antenatal corticosteroids on survival for neonates born at 23 weeks of gestation.

The purpose of this study was to identify and measure components of perceived stress in fathers of infants in a surgical neonatal intensive care unit (NICU). The Parent Stressor Scale: Infant Hospitalization (PSS:IH) was used to assess perceived stress in 22 fathers. Paternal stress was highest in the domains of "Parental Role Alteration" and "Infant Appearance and Behavior." "Sights and Sounds" did not appear to be associated with self-reported stress. This study demonstrates elevated levels of perceived stress among fathers of surgical NICU babies. Attention to fathers may be assisted by findings.

Amy Mackley

Papers

Increased Odds of Necrotizing Enterocolitis After Transfusion of Red Blood Cells in Premature Infants

Communicating with parents of premature infants: who is the informant?

Forgotten parent: NICU paternal emotional response.

Effect of antenatal corticosteroids on survival for neonates born at 23 weeks of gestation.

Stress in fathers of surgical neonatal intensive care unit babies.