Aim
To explore the attitudes of parents and healthcare professionals (HCPs), and facilitators and barrier to implementation of Kangaroo Care (KC) in the United Kingdom.
Methods
Online cross‐sectional ...survey; distributed via the British Association of Perinatal Medicine, Bliss (UK‐based charity), social media.
Results
Sixty HCPs responded. 37 (62%) were nurses/nurse practitioners. 57 (95%) regularly implement KC. The most important factor that supported KC implementation was the team's belief in benefits of KC. Increased workload, staff shortage and fear about safely of KC in unwell infants were recognised as the challenges preventing implementation.
Five hundred eighteen parents responded. 421 (81%) had a preterm baby within 3 years. 338 (80%) were familiar with KC. The main facilitator was the belief that their baby enjoyed it. Excess noise and crowding on the unit were the most frequently reported barriers. Lack of opportunity and limited staff support were the main reasons why they had been unable to practice KC.
Conclusion
We found that most HCPs and parents believe that KC is beneficial and would like to practice it. Lack of resources to enable effective implementation is the main barrier. Service development and implementation research is required to ensure that KC is delivered in all UK neonatal units.
The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being ...temporarily paused (whether that is a complete pause or pause in some activities) and/or adapting their processes. Trial managers have played a key role in decision-making, undertaking risk assessments and adapting trial processes, working closely with other members of the research team. This article presents some of the ways in which trial management processes have been altered and the key role that trial managers have played. It has been born out of discussions between trial managers in the UK who are members of the UK Trial Managers' Network (UKTMN), a national network of trial management professionals managing non-commercial trials.In these unprecedented times, clinical trials have faced many uncertainties and broad-ranging challenges encompassing a range of activities including prioritising patient safety amidst the pandemic, consenting and recruiting new participants into trials, data collection and management and intervention delivery. In many cases, recruitment has been paused whilst mitigations have been put in place to continue data collection. Innovative solutions have been implemented to ensure we continue, where possible, to deliver high-quality clinical trials. Technology has provided many solutions to these challenges, and trial managers have adapted to new ways of working whilst continuing to deliver their clinical trials. Trial management groups are now faced with new uncertainties around re-starting clinical trials, and it is unclear currently how this will go, though working together with sponsors, funders and site teams is clearly a priority.Clinical trial teams have worked together to ensure their trials have adapted quickly whilst ensuring participant safety is given utmost importance. There are clear examples where the trial community have come together to share experiences and expertise, and this should continue in the future to ensure the innovative practices developed become embedded in the design and conduct of clinical trials in the future.
Skin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.
We did a multicentre, pragmatic, ...parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment.
1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 95% CI 0·78 to 1·16, p=0·61; adjusted risk difference –1·2% –5·9 to 3·6). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (0·46) in the control group; adjusted incidence rate ratio 1·55 (95% CI 1·15 to 2·09).
We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn.
National Institute for Health Research Health Technology Assessment.
Patient-reported outcome measures (PROMs) are commonly used in eczema clinical trials. Several trials have used PROMs weekly for symptom monitoring. However, the increased frequency of ...patient-reported symptom monitoring may prompt participants to enhance the self-management of eczema and increase standard topical treatment use that can lead to improvements in outcomes over time. This is concerning as weekly symptom monitoring may constitute an unplanned intervention, which may mask small treatment effects and make it difficult to identify changes in the eczema resulting from the treatment under investigation.
To evaluate the effect of weekly patient-reported symptom monitoring on participants' outcomes and to inform the design of future eczema trials.
This was an online parallel-group nonblinded randomized controlled trial. Parents/carers of children with eczema and young people and adults with eczema were recruited online, excluding people scoring < 3 points on the Patient Oriented Eczema Measure (POEM), to avoid floor effects. Electronic PROMs were used for data collection. Participants were allocated using online randomization (1 : 1) to weekly POEM for 7 weeks (intervention) or no POEM during this period (control). The primary outcome was change in eczema severity based on POEM scores, assessed at baseline and week 8. Secondary outcomes included change in standard topical treatment use and data completeness at follow-up. Analyses were conducted according to randomized groups in those with complete data at week 8.
A total of 296 participants were randomized from 14 September 2021 to 16 January 2022 (71% female, 77% white, mean age 26.7 years). The follow-up completion rate was 81.7% n = 242; intervention group, n = 118/147 (80.3%); control group n = 124/149 (83.2%). After adjusting for baseline disease severity and age, eczema severity improved in the intervention group (mean difference in POEM score -1.64, 95% confidence interval -2.91 to -0.38; P = 0.01). No between-group differences were noted in the use of standard topical treatments and data completeness at follow-up.
Weekly patient-reported symptom monitoring led to a small perceived improvement in eczema severity.
For very preterm births, to compare alternative policies for umbilical cord clamping and immediate neonatal care.
Parallel group randomised (1:1) trial, using sealed opaque numbered envelopes.
Eight ...UK tertiary maternity units.
261 women expected to have a live birth before 32 weeks, and their 276 babies.
Cord clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and immediate neonatal care after clamping.
Intraventricular haemorrhage (IVH), death before discharge.
132 women (137 babies) were allocated clamping ≥2 min and neonatal care cord intact, and 129 (139) clamping ≤20 s and neonatal care after clamping; six mother-infant dyads were excluded (2, 4) as birth was after 35
weeks, one withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 min, and 29.2 for those allocated clamping ≤20 s. Median time to clamping was 120 and 11 s, respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 min died and 15 of 135 (11.1%) allocated clamping ≤20 s; risk difference (RD) -5.9% (95% CI -12.4% to 0.6%). Of live births, 43 of 134 (32%) had IVH vs 47 of 132 (36%), respectively; RD -3.5% (-14.9% to 7.8%). There were no clear differences in other outcomes for infants or mothers.
This is promising evidence that clamping after at least 2 min and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed.
ISRCTN 21456601.
Abstract
Background
Participant recruitment into clinical trials remains challenging. The global increase in the number of social media users has accelerated the use of social media as a modality of ...recruitment, particularly during the COVID-19 pandemic when traditional recruitment methods were reduced. However, there is limited evidence on the performance of social media recruitment strategies into eczema clinical trials.
Methods
From September 2021 to January 2022, we recruited participants with eczema into an online randomised controlled trial using free advertising on Twitter, Facebook, Instagram and Reddit (unpaid methods), followed by paid Facebook advertisements (paid method). Unpaid methods were used periodically for 63 days, whilst the paid method for 16 days. Interested individuals who clicked on the advertisement link were directed to the study website, where they could sign up to participate. Consenting, randomisation and data collection occurred exclusively online, using a database management web platform. Evaluation of the social media recruitment methods was performed, including the number of expression of interests, enrolment yield, cost, baseline characteristics and retention.
Results
Our multi-platform based social media recruitment strategy resulted in 400 expressions of interests, leading to 296 participants. Unpaid methods accounted for 136 (45.9%) of participants, incurring no financial cost. Paid Facebook adverts reached 154,370 individuals, resulting in 123 (41.6%) trial participants for a total cost of £259.93 (£2.11 per participant) and other recruitment methods resulted in 37 (12.5%) enrolments. Paid advertisements predominantly attracted younger participants below the age of 20, whereas unpaid methods mainly drew in participants between 20–29 years of age. The social media platforms recruited an ethnically diverse participant population. Completion rate of follow-up was slightly higher for the paid method (
n
= 103, 83.7%) compared with the unpaid methods (
n
= 111, 81.6%).
Conclusions
Unpaid social media posts recruited the most participants; however, it was time consuming for the researcher. Paid Facebook adverts rapidly recruited a large number of participants for a low cost and provided flexibility to target specific audiences. Our findings indicate that social media is an efficient tool that can potentially support recruitment to clinical trials.
Trial registration
ISRCTN45167024. Registered on 29 June 2021.
The optimal timing of umbilical cord clamping in preterm infants has been contested for years. Previously, it was common practice to clamp the cord immediately after birth. There is now high-quality ...evidence that delayed cord clamping (DCC) (>60 seconds) reduces mortality in preterm infants by allowing placental transfusion. However, it is unclear how well DCC has been implemented into practice. This study aims to assess current practice of timing of cord clamping for both stable and unstable preterm infants in LMICs, where rates of preterm birth and neonatal mortality are high and where there is the potential to see the greatest benefit from implementation of DCC.
An online survey was created and, following user-testing, circulated to maternity workers in LMICs via The International Federation of Gynaecology and Obstetrics (FIGO), social media and other existing collaborators. Analyses were conducted using SPSS.
70 responses were received across 10 LMICs. 42/70 (60%) participants reported practising DCC for stable preterm infants, compared to only 4/70 (6%) for unstable infants. For stable infants, 22/42 (52%) of those who practised DCC gave their main reason as being “recommended by guidelines”. 13/70 (19%) participants said they didn’t follow any guidelines for the timing of cord clamping. Only 25/70 (36%) were aware of guidelines for cord clamping in their hospitals, and 9/70 (13%) were aware of related quality improvement projects (QIPs).
Despite evidence to support the use of DCC, timing of cord clamping in LMICs is variable. Unstable infants requiring stabilisation could benefit most from placental transfusion, yet few respondents practised DCC and few hospitals had QIPs in place. Higher-quality guidelines and training could increase implementation of DCC, and development of affordable equipment to allow bedside resuscitation with the cord intact could aid in reducing neonatal mortality.
Caesarean sections (CS) account for 26% of all births in the UK, of which at least 5% are done at full dilatation, in the second stage of labour. Second stage CS may be complicated by the fetal head ...being deeply impacted in the maternal pelvis, requiring specialist skills to achieve a safe birth. Numerous techniques are used to manage impacted fetal head, however, there are no national clinical guidelines in the UK.
To explore health professionals' and women's views on the acceptability and feasibility of a randomised controlled trial (RCT) designed to explore approaches to managing an impacted fetal head during emergency CS.
Semi-structured interviews with 10 obstetricians and 16 women (6 pregnant and 10 who experienced an emergency second stage CS). Interviews were transcribed and analysed using systematic thematic analysis.
The findings considered the time at which you obtain consent, how and when information about the RCT is presented, and barriers and facilitators to recruiting health professionals and women into the RCT. Obstetricians emphasised the importance of training in the techniques, as well as the potential conflict between the RCT protocol and current site or individual practices. Women said they would trust health professionals' to use the most appropriate technique and abandon the RCT protocol if necessary. Similarly, obstetricians raised the tension between the RCT protocol versus safety in reverting to what they knew under emergency situations. Both groups reflected on how this might affect the authenticity of the results. A range of important maternal, infant and clinical outcomes were raised by women and obstetricians. However, there were varying views on which of the two RCT designs presented to participants would be preferred. Most participants thought the RCT would be feasible and acceptable.
This study suggests an RCT designed to evaluate different techniques for managing an impacted fetal head would be feasible and acceptable. However, it also identified a number of challenges that need to be considered when designing such an RCT. Results can be used to inform the design of RCTs in this area.
Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE ...treatment is a significant cost burden for health care providers. The purpose of the trial is to investigate whether daily application of emollients for the first year of life can prevent AE developing in high-risk infants (first-degree relative with asthma, AE or allergic rhinitis).
This is a protocol for a pragmatic, two-arm, randomised controlled, multicentre trial. Up to 1400 term infants at high risk of developing AE will be recruited through the community, primary and secondary care in England. Participating families will be randomised in a 1:1 ratio to receive general infant skin-care advice, or general skin-care advice plus emollients with advice to apply daily to the infant for the first year of life. Families will not be blinded to treatment allocation. The primary outcome will be a blinded assessment of AE at 24 months of age using the UK Working Party Diagnostic Criteria for Atopic Eczema. Secondary outcomes are other definitions of AE, time to AE onset, severity of AE (EASI and POEM), presence of other allergic diseases including food allergy, asthma and hay fever, allergic sensitisation, quality of life, cost-effectiveness and safety of the emollients. Subgroup analyses are planned for the primary outcome according to filaggrin genotype and the number of first-degree relatives with AE and other atopic diseases. Families will be followed up by online and postal questionnaire at 3, 6, 12 and 18 months with a face-to-face visit at 24 months. Long-term follow-up until 60 months will be via annual questionnaires.
This trial will demonstrate whether skin-barrier enhancement through daily emollient for the first year of life can prevent AE from developing in high-risk infants. If effective, this simple and cheap intervention has the potential to result in significant cost savings for health care providers throughout the world by preventing AE and possibly other associated allergic diseases.
ISRCTN registry; ID: ISRCTN21528841 . Registered on 25 July 2014.
The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments ...(in addition to standard care) for the management of eczema in children with moderate to severe disease.
This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights 25th to 75th centile 57% to 96% and 34% of days 25th to 75th centile 10% to 76%). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects.
Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema.
Current Controlled Trials ISRCTN77261365.
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