A controlled trial of early interventions to promote maternal adjustment and development in infants born with severe congenital heart disease

Background: Congenital heart disease can have a negative impact on both infant development and maternal adjustment. This study considered the impact of a new programme of early psychosocial interventions on such outcomes, following the birth of a child with severe congenital heart disease.
Methods: Seventy infants and their mothers were assigned to an intervention or control group based on order of presentation to the unit. Interventions aimed at bolstering mother–infant transactions, through psychoeducation, parent skills training and narrative therapy techniques were implemented.
Results: Clinically and statistically signi?cant gains were observed at 6-month follow-up on the mental (but not the psychomotor) scale of the Bayleys-II. Positive gains were also manifested on feeding practices, maternal anxiety, worry and appraisal of their situation.
Conclusions: A programme of generalizable psychosocial interventions is shown to have a positive impact on the infant with severe congenital heart disease and the mother.

Bax and the 'Celtic North'

A feature of scholarship on Arnold Bax is his indebtedness, in his early works, to the Irish literary revival (particularly in the mythology-suffused works of 'AE' and early Yeats) and, in his later works, to the music of Jean Sibelius, and the relationship between these periods. I argue that this relationship, which I summarize by using Bax's portmanteau term of 'Celtic North', is underpinned by the stimulus of landscape, which, as well as being a means by which to return to the Romantic idea of the sublime, also provides a means by which Bax critiques the more modernist relationship with landscape that underpins the English pastoral school of the 1920s. Thus the 'Celtic North' is the antithesis to the English 'south land' of Vaughan Williams and others.

Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials

Background: As trials of 5 years of tamoxifen in early breast cancer mature, the relevance of hormone receptor measurements (and other patient characteristics) to long-term outcome can be assessed increasingly reliably. We report updated meta-analyses of the trials of 5 years of adjuvant tamoxifen.
Methods: We undertook a collaborative meta-analysis of individual patient data from 20 trials (n=21457) in early breast cancer of about 5 years of tamoxifen versus no adjuvant tamoxifen, with about 80% compliance. Recurrence and death rate ratios (RRs) were from log-rank analyses by allocated treatment.
Findings: In oestrogen receptor (ER)-positive disease (n=10 645), allocation to about 5 years of tamoxifen substantially reduced recurrence rates throughout the first 10 years (RR 0.53 [SE 0.03] during years 0-4 and RR 0.68 [0.06] during years 5-9 [both 2p<0.00001]; but RR 0.97 [0.10] during years 10-14, suggesting no further gain or loss after year 10). Even in marginally ER-positive disease (10-19 fmol/mg cytosol protein) the recurrence reduction was substantial (RR 0.67 [0.08]). In ER-positive disease, the RR was approximately independent of progesterone receptor status (or level), age, nodal status, or use of chemotherapy. Breast cancer mortality was reduced by about a third throughout the first 15 years (RR 0.71 [0.05] during years 0-4, 0.66 [0.05] during years 5-9, and 0.68 [0.08] during years 10-14; p<0.0001 for extra mortality reduction during each separate time period). Overall non-breast-cancer mortality was little affected, despite small absolute increases in thromboembolic and uterine cancer mortality (both only in women older than 55 years), so all-cause mortality was substantially reduced. In ER-negative disease, tamoxifen had little or no effect on breast cancer recurrence or mortality.
Interpretation: 5 years of adjuvant tamoxifen safely reduces 15-year risks of breast cancer recurrence and death. ER status was the only recorded factor importantly predictive of the proportional reductions. Hence, the absolute risk reductions produced by tamoxifen depend on the absolute breast cancer risks (after any chemotherapy) without tamoxifen.
Funding: Cancer Research UK, British Heart Foundation, and Medical Research Council.

A History of Women in Ireland, 1500-1800

The first general survey of the history of women in early modern Ireland. Based on an impressive range of source material, it presents the results of original research into women’s lives and experiences in Ireland from 1500 to 1800. This was a time of considerable change in Ireland as English colonisation, religious reform and urbanisation transformed society on the island. Gaelic society based on dynastic lordships and Brehon Law gave way to an anglicised and centralised form of government and an English legal system.

Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care.

Background Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers’ and participants’ experiences of its implementation and to inform future strategies to maximise recruitment and retention. Methods In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. Results We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners’ contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. Conclusions Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A continuous dynamic process of monitoring progress within trials and tailoring strategies to particular circumstances, whilst not compromising trial protocols, should allow maximal recruitment and retention.

Unravelling the migration decision-making process: English early retirees moving to rural mid-Wales

There are established migrant reasons to explain rural in-migration. These include quality of life, rural idyll and lifestyle motivations. However, such one-dimensional sound bites portray rural in-migration in overly simplistic and stereotypical terms. In contrast, this paper distinguishes the decision to move from the reason for moving and in doing so sheds new light on the interconnections between different domains (family, work, finance, health) of the migrant's life which contribute to migration behaviour. Focussing on early retirees to mid-Wales and adopting a life course perspective the overall decision to move is disaggregated into a series of decisions. Giving voices to the migrants themselves demonstrates the combination of life events necessary to lead to migration behaviour, the variable factors (and often economic dominance) considered in the choice of destination (including that many are reluctant migrants to Wales), and the perceived 'accidental' choice of location and/or property. It is argued that quality of life, rural idyll and lifestyle sound bites offer an inadequate understanding of rural in-migration and associated decision-making processes. Moreover, they disguise the true nature of migrant decision making.

Scientific standards for human intervention trials evaluating health benefits of foods, and their application to infants, children and adolescents

Associations between the consumption of particular foods and health outcomes may be indicated by observational studies. However, intervention trials that evaluate the health benefits of foods provide the strongest evidence to support dietary recommendations for health. Thus, it is important that these trials are carried out safely, and to high scientific standards. Accepted standards for the reporting of the health benefits of pharmaceutical and other medical interventions have been provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. However, there are no generally accepted standards for trials to evaluate the health benefits of foods. Trials with foods differ from medical trials in issues related to safety, ethics, research governance and practical implementation. Furthermore, these important issues can deter the conduct of both medical and nutrition trials in infants, children and adolescents. This paper provides standards for the planning, design, conduct, statistical analysis and interpretation of human intervention trials to evaluate the health benefits of foods that are based on the CONSORT guidelines, and outlines the key issues that need to be addressed in trials in participants in the paediatric age range.

The contribution of visual feedback to visuomotor adaptation: How much and when?

We investigated the role of visual feedback in adapting to novel visuomotor environments. Participants produced isometric elbow torques to move a cursor towards visual targets. Following trials with no rotation, participants adapted to a 60 degrees rotation of the visual feedback before returning to the non-rotated condition. Participants received continuous visual feedback (CF) of cursor position during task execution or post-trial visual feedback (PF). With training, reductions of the angular deviations of the cursor path occurred to a similar extent and at a similar rate for CF and PF groups. However, upon re-exposure to the non-rotated environment only CF participants exhibited post-training aftereffects, manifested as increased angular deviation of the cursor path, with respect to the pre-rotation trials. These aftereffects occurred despite colour cues permitting identification of the change in environment. The results show that concurrent feedback permits automatic recalibration of the visuomotor mapping while post-trial feedback permits performance improvement via a cognitive strategy. (C) 2008 Elsevier B.V. All rights reserved.

Enteral feeding methods for nutritional management in patients with head and neck cancers being treated with radiotherapy and/or chemotherapy

Background: This is an update of a Cochrane review first published in The Cochrane Library in Issue 3, 2010.
For many patients with head and neck cancer, oral nutrition will not provide adequate nourishment during treatment with radiotherapy or chemoradiotherapy due to the acute toxicity of treatment, obstruction caused by the tumour, or both. The optimal method of enteral feeding for this patient group has yet to be established.

Objectives: To compare the effectiveness of different enteral feeding methods used in the nutritional management of patients with head and neck cancer receiving radiotherapy or chemoradiotherapy using the clinical outcomes, nutritional status, quality of life and rates of complications.

Search methods: Our extensive search included the Cochrane ENT Group Trials Register, CENTRAL, PubMed, EMBASE, CINAHL, AMED and ISI Web of Science. The date of the most recent search was 13 February 2012.

Selection criteria:Randomised controlled trials comparing one method of enteral feeding with another, e.g. nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) feeding, for adult patients with a diagnosis of head and neck cancer receiving radiotherapy and/or chemoradiotherapy.

Data collection and analysis:Two authors independently assessed trial quality and extracted data using standardised forms. We contacted study authors for additional information.

Main results: One randomised controlled trial met the criteria for inclusion in this review. No further studies were identified when we updated the searches in 2012.
Patients diagnosed with head and neck cancer, being treated with chemoradiotherapy, were randomised to PEG or NG feeding. In total only 33 patients were eligible for analysis as the trial was terminated early due to poor accrual. A high degree of bias was identified in the study.
Weight loss was greater for the NG group at six weeks post-treatment than for the PEG group (P = 0.001). At six months post-treatment, however, there was no significant difference in weight loss between the two groups. Anthropometric measurements recorded six weeks post-treatment demonstrated lower triceps skin fold thickness for the NG group compared to the PEG group (P = 0.03). No statistically significant difference was found between the two different enteral feeding techniques in relation to complication rates or patient satisfaction. The duration of PEG feeding was significantly longer than for the NG group (P = 0.0006). In addition, the study calculated the cost of PEG feeding to be 10 times greater than that of NG, though this was not found to be significant. There was no difference in the treatment received by the two groups. However, four PEG fed patients and two NG fed patients required unscheduled treatment breaks of a median of two and six days respectively.
We identified no studies of enteral feeding involving any form of radiologically inserted gastrostomy (RIG) feeding or comparing prophylactic PEG versus PEG for inclusion in the review.

Authors' conclusions: There is not sufficient evidence to determine the optimal method of enteral feeding for patients with head and neck cancer receiving radiotherapy and/or chemoradiotherapy. Further trials of the two methods of enteral feeding, incorporating larger sample sizes, are required.

Indirect comparisons of treatments based on systematic reviews of randomised controlled trials

Randomised controlled trials are the most effective way to differentiate between the effects of competing interventions. However, head-to-head studies are unlikely to have been conducted for all competing interventions.

Biogeographical conditions, the transition to agriculture and long-run growth

We use new data on the timing of the transition to agriculture, developed by Putterman and Trainor (2006), to test the theory of Diamond (1997) and Olsson and Hibbs (2005) that an earlier transition is reflected in higher incomes today. Our results confirm the theory, even after controlling for institutional quality and other geographical factors. The date of transition is correlated with prehistoric biogeography (the availability of wild grasses and large domesticable animal species). The factors conducive to high per capita incomes today are good institutions, an early transition to agriculture, access to the sea and a low incidence of fatal malaria. Geographical influences have been at work in all of these proximate determinants of per capita income.