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Background: An objective, physiological measurement taken using a medical device may reduce the incidence of pressure ulcers through earlier detection of problems signs before visual signs appear. Research in this field is hampered by variations in clinical practice and patient-level confounders. Aim: The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues. Method: Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials. Results: A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered. Conclusion: The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care. [ABSTRACT FROM AUTHOR]

Background: Maternal obesity is associated with an increased risk of pregnancy complications, including gestational diabetes. Physical activity (PA) might improve glucose metabolism and reduce the incidence of gestational diabetes. The purpose of this study was to explore patterns of PA and factors associated with change in PA in obese pregnant women. Methods: PA was assessed objectively by accelerometer at 16 - 18 weeks' (T0), 27 - 28 weeks' (T1) and 35 - 36 weeks' gestation (T2) in 183 obese pregnant women recruited to a pilot randomised trial of a combined diet and PA intervention (the UPBEAT study). Results: Valid PA data were available for 140 (77%), 76 (42%) and 54 (30%) women at T0, T1 and T2 respectively. Moderate and vigorous physical activity as a proportion of accelerometer wear time declined with gestation from a median of 4.8% at T0 to 3% at T2 (p < 0.05). Total activity as a proportion of accelerometer wear time did not change. Being more active in early pregnancy was associated with a higher level of PA later in pregnancy. The intervention had no effect on PA. Conclusions: PA in early pregnancy was the factor most strongly associated with PA at later gestations. Women should be encouraged to participate in PA before becoming pregnant and to maintain their activity levels during pregnancy. There is a need for effective interventions, tailored to the needs of individuals and delivered early in pregnancy to support obese women to be sufficiently active during pregnancy. [ABSTRACT FROM AUTHOR]

Background: Nausea and vomiting in pregnancy (NVP) affects up to 85% of all women during pregnancy, but for the majority self-management suffices. For the remainder, symptoms are more severe and the most severe form of NVP - hyperemesis gravidarum (HG) - affects 0.3-1.0% of pregnant women. There is no widely accepted point at which NVP becomes HG., Objectives: This study aimed to determine the relative clinical effectiveness and cost-effectiveness of treatments for NVP and HG., Data Sources: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, PsycINFO, Commonwealth Agricultural Bureaux (CAB) Abstracts, Latin American and Caribbean Health Sciences Literature, Allied and Complementary Medicine Database, British Nursing Index, Science Citation Index, Social Sciences Citation Index, Scopus, Conference Proceedings Index, NHS Economic Evaluation Database, Health Economic Evaluations Database, China National Knowledge Infrastructure, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effects were searched from inception to September 2014. References from studies and literature reviews identified were also examined. Obstetric Medicine was hand-searched, as were websites of relevant organisations. Costs came from NHS sources., Review Methods: A systematic review of randomised and non-randomised controlled trials (RCTs) for effectiveness, and population-based case series for adverse events and fetal outcomes. Treatments: vitamins B6 and B12, ginger, acupressure/acupuncture, hypnotherapy, antiemetics, dopamine antagonists, 5-hydroxytryptamine receptor antagonists, intravenous (i.v.) fluids, corticosteroids, enteral and parenteral feeding or other novel treatment. Two reviewers extracted data and quality assessed studies. Results were narratively synthesised; planned meta-analysis was not possible due to heterogeneity and incomplete reporting. A simple economic evaluation considered the implied values of treatments., Results: Seventy-three studies (75 reports) met the inclusion criteria. For RCTs, 33 and 11 studies had a low and high risk of bias respectively. For the remainder ( n  = 20) it was unclear. The non-randomised studies ( n  = 9) were low quality. There were 33 separate comparators. The most common were acupressure versus placebo ( n  = 12); steroid versus usual treatment ( n  = 7); ginger versus placebo ( n  = 6); ginger versus vitamin B6 ( n  = 6); and vitamin B6 versus placebo ( n  = 4). There was evidence that ginger, antihistamines, metoclopramide (mild disease) and vitamin B6 (mild to severe disease) are better than placebo. Diclectin ® [Duchesnay Inc.; doxylamine succinate (10 mg) plus pyridoxine hydrochloride (10 mg) slow release tablet] is more effective than placebo and ondansetron is more effective at reducing nausea than pyridoxine plus doxylamine. Diclectin before symptoms of NVP begin for women at high risk of severe NVP recurrence reduces risk of moderate/severe NVP compared with taking Diclectin once symptoms begin. Promethazine is as, and ondansetron is more, effective than metoclopramide for severe NVP/HG. I.v. fluids help correct dehydration and improve symptoms. Dextrose saline may be more effective at reducing nausea than normal saline. Transdermal clonidine patches may be effective for severe HG. Enteral feeding is effective but extreme method treatment for very severe symptoms. Day case management for moderate/severe symptoms is feasible, acceptable and as effective as inpatient care. For all other interventions and comparisons, evidence is unclear. The economic analysis was limited by lack of effectiveness data, but comparison of costs between treatments highlights the implications of different choices., Limitations: The main limitations were the quantity and quality of the data available., Conclusion: There was evidence of some improvement in symptoms for some treatments, but these data may not be transferable across disease severities. Methodologically sound and larger trials of the main therapies considered within the UK NHS are needed., Study Registration: This study is registered as PROSPERO CRD42013006642., Funding: The National Institute for Health Research Health Technology Assessment programme.

Objective: To assess the feasibility of implementing a complex intervention involving rapid intravenous rehydration and ongoing midwifery support as compared to routine in-patient care for women suffering from severe nausea and vomiting in pregnancy, (NVP)/hyperemesis gravidarum (HG)., Study Design: 53 pregnant women attending the Maternity Assessment Unit (MAU), Newcastle upon Tyne NHS Foundation Trust, Newcastle, UK with moderate-severe NVP, (as determined by a Pregnancy Unique Quantification of Emesis and Vomiting [PUQE] score ≥nine), consented to participate in this pilot randomised controlled trial (RCT). Subsequently 27 were randomised to the intervention group, 26 to the control group. Women in the intervention group received rapid rehydration (three litres Hartman's solution over 6h) and symptom relief on the MAU followed by ongoing midwifery telephone support. The control group were admitted to the antenatal ward for routine in-patient care. Quality of life (QoL) determined by SF36.V2 score and PUQE score were measured 7 days following randomisation. Completion rates, readmission rate, length of hospital stay and pregnancy outcomes data were collected., Results: Groups were comparable at baseline. Questionnaire two return rate was disappointing, only 18 women in the control group (69%) and 13 women in the intervention groups (44%). Nonetheless there were no differences between groups on Day 7 in terms of QoL, mean PUQE score, satisfaction with care, obstetric and neonatal outcomes or readmission rates. However, total combined admission time was higher in the control group (94h versus 27h, p=0.001)., Conclusions: This study suggests that day-case management plus ongoing midwifery support may be an effective alternative for treating women with severe NVP/HG. A larger trial is needed to determine if this intervention affects women's QoL., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)