Energy compensation in the real world: Good compensation for small portions of chocolate and biscuits over short time periods in complicit consumers using commercially available foods

While investigations using covert food manipulations tend to suggest that individuals are poor at adjusting for previous energy intake, in the real world adults rarely consume foods of which they are ill-informed. This study investigated the impact in fully complicit consumers of consuming commercially available dark chocolate, milk chocolate, sweet biscuits and fruit bars on subsequent appetite. Using a repeated measures design, participants received four small portions (4 × 10-11 g) of either dark chocolate, milk chocolate, sweet biscuits, fruit bars or no food throughout five separate study days (counterbalanced in order), and test meal intake, hunger, liking and acceptability were measured. Participants consumed significantly less at lunch following dark chocolate, milk chocolate and sweet biscuits compared to no food (smallest t(19) = 2.47, p = 0.02), demonstrating very good energy compensation (269-334%). No effects were found for fruit bars (t(19) = 1.76, p = 0.09), in evening meal intakes (F(4,72) = 0.62, p = 0.65) or in total intake (lunch + evening meal + food portions) (F(4,72) = 0.40, p = 0.69). No differences between conditions were found in measures of hunger (largest F(4,76) = 1.26, p = 0.29), but fruit bars were significantly less familiar than all other foods (smallest t(19) = 3.14, p = 0.01). These findings demonstrate good compensation over the short term for small portions of familiar foods in complicit consumers. Findings are most plausibly explained as a result of participant awareness and cognitions, although the nature of these cognitions cannot be discerned from this study. These findings however, also suggest that covert manipulations may have limited transfer to real world scenarios.

Efficacy and safety of peri-prostatic local anaesthetic injection in tram-rectal biopsy of the prostrate:A prospective randomised study

Objective: To assess the efficacy and safety of periprostatic lignocaine injection in trans-rectal ultrasound (TRUS) -guided biopsy of the prostate gland.

Methods: Ninety- six men (mean age 65 years, range 47-74) undergoing TRUS biopsy were randomised into the local anaesthetic (LA) or placebo group. Six to twelve biopsy cores were taken, the majority being 10 cores. Patients were asked to fill in the expected pain score on a visual analogue scale (VAS) prior to the procedure. They also completed the actual pain experienced on VAS after the biopsy. The incidence of complications was documented.

Results: The age, mean prostate specific antigen (PSA) were comparable in both groups. The expected pain score was also comparable (5.2 +/- 1.6 in LA, 5.0 +/- 1.4 in Placebo). In the LA group, the mean actual pain score was 3.0 +/- 1.8 and in the placebo group it was 6.5 +/- 2.2 (P = 0.0001). When patients were asked whether they would undergo the procedure again in the same way, 100% of the LA group and only 64% of the placebo group responded 'yes'(P=0.002 using Fisher's test). The complication rates were not significantly different between the two groups.

Conclusion: Peri-prostatic injection of local anaesthetic is safe and reduces discomfort significantly, and should be routinely offered to patients.

Barriers to Goals of Care Discussions With Seriously Ill Hospitalized Patients and Their Families: A Multicenter Survey of Clinicians

Importance: Seriously ill hospitalized patients have identified communication and decision making about goals of care as high priorities for quality improvement in end-of-life care. Interventions to improve care are more likely to succeed if tailored to existing barriers.

Objective: To determine, from the perspective of hospital-based clinicians, (1) barriers impeding communication and decision making about goals of care with seriously ill hospitalized patients and their families and (2) their own willingness and the acceptability for other clinicians to engage in this process.

Design, Setting, and Participants: Multicenter survey of medical teaching units of nurses, internal medicine residents, and staff physicians from participating units at 13 university-based hospitals from 5 Canadian provinces.

Main Outcomes and Measures: Importance of 21 barriers to goals of care discussions rated on a 7-point scale (1 = extremely unimportant; 7 = extremely important).

Results: Between September 2012 and March 2013, questionnaires were returned by 1256 of 1617 eligible clinicians, for an overall response rate of 77.7% (512 of 646 nurses [79.3%], 484 of 634 residents [76.3%], 260 of 337 staff physicians [77.2%]). The following family member-related and patient-related factors were consistently identified by all 3 clinician groups as the most important barriers to goals of care discussions: family members' or patients' difficulty accepting a poor prognosis (mean [SD] score, 5.8 [1.2] and 5.6 [1.3], respectively), family members' or patients' difficulty understanding the limitations and complications of life-sustaining treatments (5.8 [1.2] for both groups), disagreement among family members about goals of care (5.8 [1.2]), and patients' incapacity to make goals of care decisions (5.6 [1.2]). Clinicians perceived their own skills and system factors as less important barriers. Participants viewed it as acceptable for all clinician groups to engage in goals of care discussions-including a role for advance practice nurses, nurses, and social workers to initiate goals of care discussions and be a decision coach.

Conclusions and Relevance: Hospital-based clinicians perceive family member-related and patient-related factors as the most important barriers to goals of care discussions. All health care professionals were viewed as playing important roles in addressing goals of care. These findings can inform the design of future interventions to improve communication and decision making about goals of care.

Parents' perceptions of microneedle-mediated monitoring as an alternative to blood sampling in the monitoring of their infants

OBJECTIVES: Microneedle (MN) arrays could offer a pain-free, minimally invasive approach to monitoring. This is envisaged to be particularly beneficial for younger patients, but parents' views to date are unknown. The aim of this study was to explore parental perceptions of MN-mediated ISF monitoring, as an alternative to the use of conventional blood sampling, and to understand the important factors for technique approval.

METHODS: Semi-structured interviews were conducted with parents with recent experience of a premature birth. Recruitment was through the Northern Ireland premature infant charity, Tinylife. Interviews progressed until data saturation was reached and thematic analysis employed.

KEY FINDINGS: The study included 16 parents. Parental support for MN-mediated monitoring was evident, alongside the unpopularity of traditional blood sampling in neonates. Factors facilitating MN approval included the opportunity for pain reduction, the simplicity of the procedure, the potential for increased parental involvement and the more favourable appearance, owing to the minute size of MNs and similarities with a sticking plaster. Confirmation of correct application, a pain-free patch removal and endorsement from trusted healthcare professionals were important.

CONCLUSION: These findings will inform researchers in the field of MN development and enlighten practitioners regarding parental distress resulting from conventional blood sampling. Further work is necessary to understand MN acceptability among practitioners. This work should assist in the development of an acceptable MN device and facilitate the reduction of parental distress.

Paediatricians' opinions of microneedle-mediated monitoring: a key stage in the translation of microneedle technology from laboratory into clinical practice

Microneedle (MN) arrays could offer an alternative method to traditional drug delivery and blood sampling methods. However, acceptance among key end-users is critical for new technologies to succeed. MNs have been advocated for use in children and so, paediatricians are key potential end-users. However, the opinions of paediatricians on MN use have been previously unexplored. The aim of this study was to investigate the views of UK paediatricians on the use of MN technology within neonatal and paediatric care. An online survey was developed and distributed among UK paediatricians to gain their opinions of MN technology and its use in the neonatal and paediatric care settings, particularly for MN-mediated monitoring. A total of 145 responses were obtained, with a completion response rate of 13.7 %. Respondents believed an alternative monitoring technique to blood sampling in children was required. Furthermore, 83 % of paediatricians believed there was a particular need in premature neonates. Overall, this potential end-user group approved of the MN technology and a MN-mediated monitoring approach. Minimal pain and the perceived ease of use were important elements in gaining favour. Concerns included the need for confirmation of correct application and the potential for skin irritation. The findings of this study provide an initial indication of MN acceptability among a key potential end-user group. Furthermore, the concerns identified present a challenge to those working within the MN field to provide solutions to further improve this technology. The work strengthens the rationale behind MN technology and facilitates the translation of MN technology from lab bench into the clinical setting.

Challenges to undertaking randomised trials with looked after children in social care settings

Background: Randomised controlled trials (RCTs) are widely viewed as the gold standard for assessing effectiveness in health research; however many researchers and practitioners believe that RCTs are inappropriate and un-doable in social care settings, particularly in relation to looked after children. The aim of this article is to describe the challenges faced in conducting a pilot study and phase II RCT of a peer mentoring intervention to reduce teenage pregnancy in looked after children in a social care setting.

Methods: Interviews were undertaken with social care professionals and looked after children, and a survey conducted with looked after children, to establish the feasibility and acceptability of the intervention and research design.

Results: Barriers to recruitment and in managing the intervention were identified, including social workers acting as informal gatekeepers; social workers concerns and misconceptions about the recruitment criteria and the need for and purpose of randomisation; resource limitations, which made it difficult to prioritise research over other demands on their time and difficulties in engaging and retaining looked after children in the study.

Conclusions: The relative absence of a research infrastructure and culture in social care and the lack of research support funding available for social care agencies, compared to health organisations, has implications for increasing evidence-based practice in social care settings, particularly in this very vulnerable group of young people.

Novel Delivery Systems for Transdermal and Intradermal Drug Delivery

This research book covers the major aspects relating to the use of novel delivery systems in enhancing both transdermal and intradermal drug delivery. It provides a review of transdermal and intradermal drug delivery, including the history of the field and the various methods employed to produce delivery systems from different materials such as device design, construction and evaluation, so as to provide a sound background to the use of novel systems in enhanced delivery applications.

Furthermore, it presents in-depth analyses of recent developments in this exponentially growing field, with a focus on microneedle arrays, needle-free injections, nanoparticulate systems and peptide-carrier-type systems. It also covers conventional physical enhancement strategies, such as tape-stripping, sonophoresis, iontophoresis, electroporation and thermal/suction/laser ablation Discussions about the penetration of the stratum corneum by the various novel strategies highlight the importance of the application method. Comprehensive and critical reviews of transdermal and intradermal delivery research using such systems focus on the outcomes of in vivoanimal and human studies. The book includes laboratory, clinical and commercial case studies featuring safety and patient acceptability studies carried out to date, and depicts a growing area for use of these novel systems is in intradermal vaccine delivery. The final chapters review recent patents in this field and describe the work ongoing in industry.

Recruiting schools, adolescents and parents to a sexual-health trial: experiences, challenges and lessons learned from the Jack Trial

Background
Recruitment to school-based randomised trials is challenging; even more so when the focus of the study is a sensitive issue such as sexual health. The Jack Feasibility Trial aims to determine the facilitators and barriers to recruitment and retention to a school-based sexual health trial and identify optimal multi-level strategies for a full trial.
Method
The Jack Trial is an NIHR-funded feasibility study of a film-based sexual health intervention, recruiting over 800 adolescents from 8 post-primary schools in Northern Ireland. In order to examine the feasibility of piloted recruitment and retention methods and assess acceptability of participation across the range of schools and individuals approached, we analysed qualitative data from triangulated sources including a parents’ survey and semi-structured interviews with principals, vice-principals, teachers and parents recruited to the study.
Results
With reference to Social Learning Theory, we identified a number of individual, behavioural and environmental level factors which influenced recruitment and retention. Commonly identified facilitators included the perceived relevance and potential benefit of the intervention to adolescents, the credibility of the organisation running the study, support offered by trial staff, and financial incentives. Key barriers were prior commitment to other research, lack of time and resources, and perceptions that the intervention was incompatible with adolescent needs or school ethos.
Conclusion
This study highlights pertinent general and trial-specific facilitators and barriers to recruitment to a sexual health trial in a school setting, which will prove useful for successful conduct of future trials with schools, adolescents and parents.

A study protocol for a pilot randomised trial of a structured education programme for the self-management of type 2 diabetes for adults with intellectual disabilities

BACKGROUND: The need for structured education programmes for type 2 diabetes is a high priority for many governments around the world. One such national education programme in the United Kingdom is the DESMOND Programme, which has been shown to be robust and effective for patients in general. However, these programmes are not generally targeted to people with intellectual disabilities (ID), and robust evidence on their effects for this population is lacking. We have adapted the DESMOND Programme for people with ID and type 2 diabetes to produce an amended programme known as DESMOND-ID. This protocol is for a pilot trial to determine whether a large-scale randomised trial is feasible, to test if DESMOND-ID is more effective than usual care in adults with ID for self-management of their type 2 diabetes, in particular as a means to reduce glycated haemoglobin (Hb1Ac), improve psychological wellbeing and quality of life and promote a healthier lifestyle. This protocol describes the rationale, methods, proposed analysis plan and organisational and administrative details.

METHODS/DESIGN: This trial is a two arm, individually randomised, pilot trial for adults with ID and type 2 diabetes, and their family and/or paid carers. It compares the DESMOND-ID programme with usual care. Approximately 36 adults with mild to moderate ID will be recruited from three countries in the United Kingdom. Family and/or paid carers may also participate in the study. Participants will be randomly assigned to one of two conditions using a secure computerised system with robust allocation concealment. A range of data will be collected from the adults with ID (biomedical, psychosocial and self-management strategies) and from their carers. Focus groups with all the participants will assess the acceptability of the intervention and the trial.

DISCUSSION: The lack of appropriate structured education programmes and educational materials for this population leads to secondary health conditions and may lead to premature deaths. There are significant benefits to be gained globally, if structured education programmes are adapted and shown to be successful for people with ID and other cognitive impairments.

TRIAL REGISTRATION: Registered with International Standard Randomised Controlled Trial (identifier: ISRCTN93185560 ) on 10 November 2014.

Factors that impact on the use of mechanical ventilation weaning protocols in critically ill adults and children: a qualitative-evidence synthesis

Background:
Prolonged mechanical ventilation is associated with a longer intensive care unit (ICU) length of stay and higher mortality. Consequently, methods to improve ventilator weaning processes have been sought. Two recent Cochrane systematic reviews in ICU adult and paediatric populations concluded that protocols can be effective in reducing the duration of mechanical ventilation, but there was significant heterogeneity in study findings. Growing awareness of the benefits of understanding the contextual factors impacting on effectiveness has encouraged the integration of qualitative evidence syntheses with effectiveness reviews, which has delivered important insights into the reasons underpinning (differential) effectiveness of healthcare interventions.

Objectives:
1. To locate, appraise and synthesize qualitative evidence concerning the barriers and facilitators of the use of protocols for weaning critically-ill adults and children from mechanical ventilation;

2. To integrate this synthesis with two Cochrane effectiveness reviews of protocolized weaning to help explain observed heterogeneity by identifying contextual factors that impact on the use of protocols for weaning critically-ill adults and children from mechanical ventilation;

3. To use the integrated body of evidence to suggest the circumstances in which weaning protocols are most likely to be used.

Search methods:
We used a range of search terms identified with the help of the SPICE (Setting, Perspective, Intervention, Comparison, Evaluation) mnemonic. Where available, we used appropriate methodological filters for specific databases. We searched the following databases: Ovid MEDLINE, Embase, OVID, PsycINFO, CINAHL Plus, EBSCOHost, Web of Science Core Collection, ASSIA, IBSS, Sociological Abstracts, ProQuest and LILACS on the 26th February 2015. In addition, we searched: the grey literature; the websites of professional associations for relevant publications; and the reference lists of all publications reviewed. We also contacted authors of the trials included in the effectiveness reviews as well as of studies (potentially) included in the qualitative synthesis, conducted citation searches of the publications reporting these studies, and contacted content experts.

We reran the search on 3rd July 2016 and found three studies, which are awaiting classification.

Selection criteria:
We included qualitative studies that described: the circumstances in which protocols are designed, implemented or used, or both, and the views and experiences of healthcare professionals either involved in the design, implementation or use of weaning protocols or involved in the weaning of critically-ill adults and children from mechanical ventilation not using protocols. We included studies that: reflected on any aspect of the use of protocols, explored contextual factors relevant to the development, implementation or use of weaning protocols, and reported contextual phenomena and outcomes identified as relevant to the effectiveness of protocolized weaning from mechanical ventilation.

Data collection and analysis:
At each stage, two review authors undertook designated tasks, with the results shared amongst the wider team for discussion and final development. We independently reviewed all retrieved titles, abstracts and full papers for inclusion, and independently extracted selected data from included studies. We used the findings of the included studies to develop a new set of analytic themes focused on the barriers and facilitators to the use of protocols, and further refined them to produce a set of summary statements. We used the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) framework to arrive at a final assessment of the overall confidence of the evidence used in the synthesis. We included all studies but undertook two sensitivity analyses to determine how the removal of certain bodies of evidence impacted on the content and confidence of the synthesis. We deployed a logic model to integrate the findings of the qualitative evidence synthesis with those of the Cochrane effectiveness reviews.

Main results:
We included 11 studies in our synthesis, involving 267 participants (one study did not report the number of participants). Five more studies are awaiting classification and will be dealt with when we update the review.

The quality of the evidence was mixed; of the 35 summary statements, we assessed 17 as ‘low’, 13 as ‘moderate’ and five as ‘high’ confidence. Our synthesis produced nine analytical themes, which report potential barriers and facilitators to the use of protocols. The themes are: the need for continual staff training and development; clinical experience as this promotes felt and perceived competence and confidence to wean; the vulnerability of weaning to disparate interprofessional working; an understanding of protocols as militating against a necessary proactivity in clinical practice; perceived nursing scope of practice and professional risk; ICU structure and processes of care; the ability of protocols to act as a prompt for shared care and consistency in weaning practice; maximizing the use of protocols through visibility and ease of implementation; and the ability of protocols to act as a framework for communication with parents.

Authors' conclusions:
There is a clear need for weaning protocols to take account of the social and cultural environment in which they are to be implemented. Irrespective of its inherent strengths, a protocol will not be used if it does not accommodate these complexities. In terms of protocol development, comprehensive interprofessional input will help to ensure broad-based understanding and a sense of ‘ownership’. In terms of implementation, all relevant ICU staff will benefit from general weaning as well as protocol-specific training; not only will this help secure a relevant clinical knowledge base and operational understanding, but will also demonstrate to others that this knowledge and understanding is in place. In order to maximize relevance and acceptability, protocols should be designed with the patient profile and requirements of the target ICU in mind. Predictably, an under-resourced ICU will impact adversely on protocol implementation, as staff will prioritize management of acutely deteriorating and critically-ill patients.

Learning from the QUEST multicentre feasibility randomization trials in breast reconstruction after mastectomy

BACKGROUND: Breast reconstruction aims to improve health-related quality of life after mastectomy. However, evidence guiding patients and surgeons in shared decision-making concerning the optimal type or timing of surgery is lacking.

METHODS: QUEST comprised two parallel feasibility phase III randomized multicentre trials to assess the impact of the type and timing of latissimus dorsi breast reconstruction on health-related quality of life when postmastectomy radiotherapy is unlikely (QUEST A) or highly probable (QUEST B). The primary endpoint for the feasibility phase was the proportion of women who accepted randomization, and it would be considered feasible if patient acceptability rates exceeded 25 per cent of women approached. A companion QUEST Perspectives Study (QPS) of patients (both accepting and declining trial participation) and healthcare professionals assessed trial acceptability.

RESULTS: The QUEST trials opened in 15 UK centres. After 18 months of recruitment, 17 patients were randomized to QUEST A and eight to QUEST B, with overall acceptance rates of 19 per cent (17 of 88) and 22 per cent (8 of 36) respectively. The QPS recruited 56 patients and 51 healthcare professionals. Patient preference was the predominant reason for declining trial entry, given by 47 (53 per cent) of the 88 patients approached for QUEST A and 22 (61 per cent) of the 36 approached for QUEST B. Both trials closed to recruitment in December 2012, acknowledging the challenges of achieving satisfactory patient accrual.

CONCLUSION: Despite extensive efforts to overcome recruitment barriers, it was not feasible to reach timely recruitment targets within a feasibility study. Patient preferences for breast reconstruction types and timings were common, rendering patients unwilling to enter the trial.

HPV vaccine acceptance in males

Background Despite Human Papillomavirus (HPV)’s impact on the health of both sexes, there is debate around the inclusion of males in HPV vaccination programmes. The aim of this scoping review was to synthesize the evidence on vaccine acceptability to males. Given that the vaccine is most effective in adolescent males, vaccine acceptance in parents and health care professionals (HCPs) was also examined. Method A rapid synthesis using specified key words of published systematic reviews into vaccine acceptability in adolescent males, parents and HCPs was conducted. The most common electronic databases were searched including: Medline, EMBASE, PsychINFO, and CINAHL. Results There was variability amongst studies with respect to design and methodological approaches. Despite this there appears to be a positive attitude towards male HPV vaccination from both parents and older males. There is currently insufficient evidence on vaccine acceptance to adolescent males. Understanding the risks involved in HPV acquisition, and receiving a recommendation from a HCP, appear to be the major factors involved in males deciding to be vaccinated. Parents consistently report the importance of a HCP recommendation, yet HCPs (in the US) appear to have a preference for vaccinating older than younger adolescents, and for vaccinating females. Conclusions The absence of an agreed definition of vaccine acceptance leads to a lack of a universally accepted tool for its measurement. This makes comparison of studies difficult. With no established theoretical framework the identification and exploration of factors that influence vaccine uptake can be variable. In addition, acceptance is not indicative of uptake. The majority of studies are cross-sectional which makes the identification of factors that lead to actual vaccine uptake difficult. Prospective, longitudinal studies identifying individuals that acted on vaccine intention should be conducted to identify the factors that mediate the uptake.

Measurement of intraocular pressure with pressure phosphene tonometry in children.

PURPOSE: To study the accuracy and acceptability of intraocular pressure (IOP) measurement by the pressure phosphene tonometer, non-contact tonometer, and Goldmann tonometer in children. METHODS: Fifty children (5 to 14 years old) participated in this prospective comparative study. IOP was measured with the pressure phosphene tonometer, non-contact tonometer, and Goldmann tonometer by three different examiners who were masked to the results. The children were also asked to grade the degree of discomfort from 0 to 5 (0 = no discomfort; 5 = most discomfort). RESULTS: The mean IOPs measured by the Goldmann tonometer, pressure phosphene tonometer, and non-contact tonometer were 15.9 mm Hg (standard deviation [SD]: = 5.5 mm Hg; range: 10 to 36 mm Hg), 16.0 mm Hg (SD: 2.9 mm Hg; range: 12 to 25 mm Hg), and 15.7 mm Hg (SD = 5.1 mm Hg; range: 8 to 32 mm Hg), respectively (P = .722). The mean difference between pressure phosphene tonometer and Goldmann tonometer readings was 2.9 mm Hg and that between non-contact tonometer and Goldmann tonometer readings was 2.1 mm Hg. The 95% confidence interval of the mean difference between pressure phosphene tonometer and Goldmann tonometer readings was -1.07 and 1.19, and that between non-contact tonometer and Goldmann tonometer readings was -1.07 and 0.53. The mean discomfort ratings for the pressure phosphene tonometer, non-contact tonometer, and Goldmann tonometer were 0.6, 2.0, and 2.3, respectively (P < .001). CONCLUSION: Although the pressure phosphene tonometer was less accurate than the non-contact tonometer compared with Goldmann tonometer, it gave a reasonably close estimate and had a high specificity of raised IOP. In addition, measurement by the pressure phosphene tonometer is most acceptable to children. The pressure phosphene tonometer can be considered as an alternative method of IOP measurement in children.

Nurturing attachments in looked after children: a feasibility study of a group-based programme for carers

Introduction: The attachment related difficulties of Looked after Children are well recognised in literature with difficulties linked to early experiences hypothesised to be perpetuated by experiences of the care system itself. Recent policy guidelines have emphasised the importance of relationships for children in care, one of the most important being with their primary carer. Golding (2014) published a group format training resource entitled ‘Nurturing Attachments’ which aims to promote ‘therapeutic parenting’; however there is limited knowledge on the feasibility of this intensive approach.
Aims: To assess the feasibility of Nurturing Attachments through exploring (i.) recruitment, retention and attrition, (ii.) initial outcomes, (iii.) acceptability and (iv.) ability of the programme to be delivered in line with the manual content and structure.
Method Two Health and Social Care Trusts in NI participated in the study by facilitating a Nurturing Attachments group in each site with adoptive parents, foster carers and kinship carers (N = 26). Carers completed pre and post measures to explore initial outcome, completing an evaluation questionnaire to explore acceptability. Acceptability was also explored with Trust stakeholders and group facilitators through focus group and interview. To explore if the manual can be delivered as intended, each group completed debrief tools.
Results: The overall response rate for uptake was 13.9%, which impacted on engagement for a ‘treatment as usual’ group. Once engaged in the programme, attrition was low and attendance was high. Initial outcomes have shown positive effects for both young person and carers. Feedback suggests a positive response regarding acceptability with limited expressed concern. The manual can be delivered in a standardised way; however can be flexible enough to allow for group processes.
Conclusions: Further research is needed to continue to explore efficacy, however the current study has provided supporting evidence that Nurturing Attachments as an intervention has positively impacted on many levels of the LAAC system.

ThermoSpots to detect hypothermia in children with severe acute malnutrition

INTRODUCTION: Hypothermia is a risk factor for increased mortality in children with severe acute malnutrition (SAM). Yet frequent temperature measurement remains unfeasible in under-resourced units in developing countries. ThermoSpot is a continuous temperature monitoring sticker designed originally for neonates. When applied to skin, its liquid crystals are designed to turn black with hypothermia and remain green with normothermia.

AIMS: To (i) estimate the diagnostic accuracy of ThermoSpots for detecting WHO-defined hypothermia (core temperature <35.5°C or peripheral temperature <35.0°C) in children with SAM and (ii) determine their acceptability amongst mothers.

METHODS: Children with SAM in a malnutrition unit in Malawi were enrolled during March-July 2010. The sensitivity and specificity of ThermoSpots were calculated by comparing the device colour against 'gold standard' rectal temperatures taken on admission and follow up peripheral temperatures taken until discharge. Guardians completed a questionnaire to assess acceptability.

RESULTS: Hypothermia was uncommon amongst the 162 children enrolled. ThermoSpot successfully detected the one rectal temperature and two peripheral temperatures recorded that met the WHO definition of hypothermia. Overall, 3/846 (0.35%) temperature measurements were in the WHO-defined hypothermia range. Interpreting the brown transition colour (between black and green) as hypothermia improved sensitivities. For milder hypothermia definitions, sensitivities declined (<35.4°C, 50.0%; <35.9°C, 39.2%). Specificity was consistently above 94%. From questionnaires, 40/43 (93%) mothers reported they were 90-100% happy with the device overall. Free-text answers revealed themes of "Skin Rashes", "User-satisfaction" and "Empowerment".

CONCLUSION: Although hypothermia was uncommon in this study, ThermoSpots successfully detected these episodes in malnourished children and were acceptable to mothers. Research in settings where hypothermia is common is needed to determine performance with certainty. Instructing users to act when the device's transition colour appears could improve accuracy. If reliable, ThermoSpots may offer simple, acceptable and continuous temperature measurement for high-burden areas and reduce the workload of over-stretched staff.