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Objective To explore the effect on perinatal outcome of different fetal monitoring strategies for early‐onset fetal growth restriction (FGR). Methods This was a cohort analysis of individual participant data from two European multicenter trials of fetal monitoring methods for FGR: the Growth Restriction Intervention Study (GRIT) and the Trial of Umbilical and Fetal Flow in Europe (TRUFFLE). All women from GRIT (n = 238) and TRUFFLE (n = 503) who were randomized between 26 and 32 weeks' gestation were included. The women were grouped according to intervention and monitoring method: immediate delivery (GRIT) or delayed delivery with monitoring by conventional cardiotocography (CTG) (GRIT), computerized CTG (cCTG) only (GRIT and TRUFFLE) or cCTG and ductus venosus (DV) Doppler (TRUFFLE). The primary outcome was survival without neurodevelopmental impairment at 2 years of age. Results Gestational age at delivery and birth weight were similar in both studies. Fetal death rate was similar between the GRIT and TRUFFLE groups, but neonatal and late death were more frequent in GRIT (18% vs 6%; P, This article's abstract has been translated into Spanish and Chinese. Follow the links from the http://onlinelibrary.wiley.com/doi/10.1002/uog.20354/abstract to view the translations. This article has been selected for Journal Club. Click https://www.isuog.org/resource/uog-journal-club-January-2020.html to view slides and discussion points.

The purpose of this pilot study was to assess the effect of an individualized traditional Chinese medicine (TCM) acupuncture and moxibustion (Acu/Moxa) treatment on symptom control in patients with irritable bowel syndrome (IBS) in a preliminary, randomized, sham/placebo-controlled trial. Twenty-nine men and women with IBS were randomized to either individualized Acu/Moxa (treatment group) or sham/placebo Acu/Moxa (control group). All subjects were assessed by a diagnostic acupuncturist for a TCM evaluation and individualized point prescription. Only those subjects assigned to the experimental group received the individually prescribed treatment. The diagnostic acupuncturist did not administer treatments and was blind to treatment assignments. All subjects kept a symptom diary for the duration of the study, enabling measurement of symptom frequency, severity, and improvement. The Clinical Global Impression Scale was administered preintervention to establish baseline severity and on completion of the 4-week, eight-session treatment intervention. After 4 weeks of twice-weekly Acu/Moxa treatment, average daily abdominal pain/discomfort improved whereas the control group showed minimal reduction. This between-group difference adjusted for baseline difference was statistically significant. The intestinal gas, bloating, and stool consistency composite score showed a similar pattern of improvement. The findings indicate that Acu/Moxa treatment shows promise in the area of symptom management for IBS.

A large body of empirical research shows that psychosocial risk factors (PSRFs) such as low socio-economic status, social isolation, stress, type-D personality, depression and anxiety increase the risk of incident coronary heart disease (CHD) and also contribute to poorer health- related quality of life (HRQoL) and prognosis in patients with establishedCHD. PSRFs may also act as barriers to lifestyle changes and treatment adherence and may moderate the effects of cardiac rehabilitation (CR). Furthermore, there appears to be a bidirectional interaction between PSRFs and the cardiovascular system. Stress, anxiety and depression affect the cardiovascular system through immune, neuroendocrine and behavioural pathways. In turn, CHD and its associated treatments may lead to distress in patients, including anxiety and depression. In clinical practice, PSRFs can be assessed with single-item screening questions, standardised questionnaires, or structured clinical interviews. Psychotherapy and medication can be considered to alleviate any PSRF-related symptoms and to enhance HRQoL, but the evidence for a definite beneficial effect on cardiac endpoints is inconclusive. A multimodal behavioural intervention, integrating counselling for PSRFs and coping with illness should be included within comprehensive CR. Patients with clinically significant symptoms of distress should be referred for psychological counselling or psychologically focused interventions and/or psychopharmacological treatment. To conclude, the success of CR may critically depend on the interdependence of the body and mind and this interaction needs to be reflected through the assessment and management of PSRFs in line with robust scientific evidence, by trained staff, integrated within the core CR team.

Background Although delivery is widely used for preterm babies failing to thrive in utero, the effect of altering delivery timing has never been assessed in a randomised controlled trial. We aimed to compare the effect of delivering early with delaying birth for as long as possible. Methods 548 pregnant women were recruited by 69 hospitals in 13 European countries. Participants had fetal compromise between 24 and 36 weeks, an umbilical-artery doppler waveform recorded, and clinical uncertainty about whether immediate delivery was indicated. Before birth, 588 babies were randomly assigned to immediate delivery (n=296) or delayed delivery until the obstetrician was no longer uncertain (n=292). The main outcome was death or disability at or beyond 2 years of age. Disability was defined as a Griffiths developmental quotient of 70 or less or the presence of motor or perceptual severe disability. Analysis was by intention-to-treat. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN41358726. Findings Primary outcomes were available on 290 (98%) immediate and 283 (97%) deferred deliveries. Overall rate of death or severe disability at 2 years was 55 (19%) of 290 immediate births, and 44 (16%) of 283 delayed births. With adjustment for gestational age and umbilical-artery doppler category, the odds ratio (95% CrI) was 1·1 (0·7–1·8). Most of the observed difference was in disability in babies younger than 31 weeks of gestation at randomisation: 14 (13%) immediate versus five (5%) delayed deliveries. No important differences in the median Griffiths developmental quotient in survivors was seen. Interpretation The lack of difference in mortality suggests that obstetricians are delivering sick preterm babies at about the correct moment to minimise mortality. However, they could be delivering too early to minimise brain damage. These results do not lend support to the idea that obstetricians can deliver before terminal hypoxaemia to improve brain development.

Traditional Chinese medicine (TCM) diagnosis is a complex multifaceted process that often yields multiple differential diagnoses and subdiagnoses.The aims of this study were to (1) understand cognitive strategies and diagnostic reasoning processes of TCM practitioners engaged in tongue diagnosis and (2) investigate TCM practitioners' diagnostic accuracy. Clinical decision making and problem solving frameworks served as a basis for this study.Nine TCM practitioners verbalized their thinking processes via think-aloud protocols and were audiotaped while engaged in the cognitive task of tongue diagnosis. Protocol analysis was used to identify TCM diagnostic reasoning patterns. Diagnostic accuracy was assessed by participant self-report and via independent TCM expert judges.Protocol analysis revealed that TCM practitioners use systematic processes to arrive at diagnoses and that there were differences between novices and experts in both pre- and post-adjustments after viewing case histories. Novices tended to use more descriptors and come to the diagnoses earlier. Experts tended to use higher-level intellectual processes when coming to their diagnoses and tended to use these terms earlier in the process. Correlations between practitioner self-assessment and judges' ratings of diagnostic accuracy were noted and corollary case history information improved diagnostic accuracies.TCM practitioners use systematic reasoning patterns to determine diagnoses associated with evaluation of tongues. These processes are congruent with those observed in Western medicine whereby clinician reasoning involves a combination of analytical reasoning of domain knowledge and the use of exemplar patterns. An explicit understanding of TCM reasoning processes can inform clinical practice and education and will facilitate the development of supporting technologies and identification of best practices.

This article describes the recruitment and retention strategies implemented for a prospective, randomized, clinical trial conducted at a single study facility. The purpose of the study was to examine the effects of a nutritional intervention to reduce the episodes of diarrhea in patients with the human immunodeficiency virus/acquired immune deficiency syndrome. This article reviews the challenges faced by the research team during the conduct of the study and discusses the approaches implemented to reduce the barriers to study participation.

Objectives To compare the effect of delivering early to pre-empt terminal hypoxaemia with delaying for as long as possible to increase maturity. Design A randomised controlled trial. Setting 69 hospitals in 13 European countries. Participants Pregnant women with fetal compromise between 24 and 36 weeks, an umbilical artery Doppler waveform recorded and clinical uncertainty whether immediate delivery was indicated. Methods The interventions were 'immediate delivery' or 'delay until the obstetrician is no longer uncertain'. The data monitoring and analysis were Bayesian. Main outcome measures 'Survival to hospital discharge' and 'developmental quotient at two years of age', this latter to be reported later. Results Of 548 women (588 babies) recruited, outcomes were available on 547 mothers.(587 babies). The median time-to-delivery intervals were 0.9 days in the immediate group and 4.9 days in the delay group. Total deaths prior to discharge were 29 (10%) in the immediate group versus 27 (9%) in the delay group (odds ratio 1.1, 95% CI 0.61-1.8). Total caesarean sections were 249 (91%) in the immediate group versus 217 (79%) in the delay group: (OR 2.7; 95% CI 1.6-4.5). These odds ratios were similar for those randomised at gestational ages above or below 30 weeks. Interpretation The lack of difference in overall mortality suggests that clinicians participating in this trial were on average prepared to randomise at about the correct equivocal threshold between delivery and delay. However, there was insufficient evidence to convince enthusiasts for either immediate or delayed delivery that they were wrong.

Objectives. To compare the effect of delivering early to pre-empt terminal hypoxaemia with delaying for as long as possible to increase maturity. Design. A randomised controlled trial. Setting. 69 hospitals in 13 European countries. Participants. Pregnant women with fetal compromise between 24 and 36 weeks, an umbilical artery Doppler waveform recorded and clinical uncertainty whether immediate delivery was indicated. Methods. The interventions were 'immediate delivery' or 'delay until the obstetrician is no longer uncertain'. The data monitoring and analysis were Bayesian. Main outcome measures. 'Survival to hospital discharge' and 'developmental quotient at two years of age', this latter to be reported later. Results. Of 548 women (588 babies) recruited, outcomes were available on 547 mothers (587 babies). The median time-to-delivery intervals were 0.9 days in the immediate group and 4.9 days in the delay group. Total deaths prior to discharge were 29 (10%) in the immediate group versus 27 (9%) in the delay group (odds ratio 1.1, 95% CI 0.61-1.8). Total caesarean sections were 249 (91%) in the immediate group versus 217 (79%) in the delay group: (OR 2.7; 95% CI 1.6-4.5). These odds ratios were similar for those randomised at gestational ages above or below 30 weeks. Interpretation. The lack of difference in overall mortality suggests that clinicians participating in this trial were on average prepared to randomise at about the correct equivocal threshold between delivery and delay. However, there was insufficient evidence to convince enthusiasts for either immediate or delayed delivery that they were wrong.

Objectives The ‘enhancing human resources and the use of appropriate technologies for maternal and perinatal survival in sub-Saharan Africa’ (ETATMBA) project is training emergency obstetric and new-born care (EmONC) non-physician clinicians (NPCs) as advanced clinical leaders. Our objectives were to evaluate the implementation and changes to practice.\ud \ud Design A mixed methods process evaluation with the predominate methodology being qualitative.\ud \ud Setting Rural and urban hospitals in 8 of the 14 districts of northern and central Malawi.\ud \ud Participants 54 EmONC NPCs with 3 years’ plus experience.\ud \ud Intervention Training designed and delivered by clinicians from the UK and Malawi; it is a 2-year plus package of training (classroom, mentorship and assignments).\ud \ud Results We conducted 79 trainee interviews over three time points during the training, as well as a convenience sample of 10 colleagues, 7 district officers and 2 UK obstetricians. Trainees worked in a context of substantial variation in the rates of maternal and neonatal deaths between districts. Training reached trainees working across the target regions. For 46 trainees (8 dropped out of the course), dose delivered in terms of attendance was high and all 46 spent time working alongside an obstetrician. In early interviews trainees recalled course content unprompted indicating training had been received. Colleagues and district officers reported cascading of knowledge and initial changes in practice indicating early implementation. By asking trainees to describe actual cases we found they had implemented new knowledge and skills. These included life-saving interventions for postpartum haemorrhage and eclampsia. Trainees identified the leadership training as enabling them to confidently change their own practice and initiate change in their health facility.\ud \ud Conclusions This process evaluation suggests that trainees have made positive changes in their practice. Clear impacts on maternal and perinatal mortality are yet to be elucidated.