Complexities of trial recruitment in the care home setting: an illustration via the EPIC trial

Conducting trials in care homes is complex on multiple levels. Here, we focus on recruitment issues surrounding: a) care home selection to participate in research, b) selection and involvement of participants fulfilling various roles (residents, relatives, staff), c) consent in the context of the Mental Capacity Act, and d) scheduling researcher time to undertake complex recruitment processes across multiple care homes. To ensure generalizability of results, DCM™ EPIC care homes were selected to form a stratified random sample of a known sampling frame. This was done by first defining catchment areas around each of three participating UK hubs. Randomly ordered listings of all eligible care homes within those areas were then produced, with batches of care homes sent trial information and followed up by researchers. Trial participation for a home requires agreement to take part from residents and their relatives (as personal consultees and providers of proxy data), as well as staff involvement to provide data (proxy and self) and be trained to deliver the DCMTM intervention. This requires complex, lengthy discussions with all parties, provision of tailored information sheets specific to intended role and capacity, and involvement of trial experts to explain DCMTM in more detail to staff. The trial aims to recruit 50 care homes (750 residents) by the end of 2015. Thus there is the need to balance the complexity of processes with required speed of recruitment – a task which is achieved by detailed monitoring of projected researcher workload in relation to care home commitments and availability

Interventions for promoting smoking cessation during pregnancy.

BACKGROUND: Smoking remains one of the few potentially preventable factors associated with low birthweight, preterm birth and perinatal death. OBJECTIVES: To assess the effects of smoking cessation programs implemented during pregnancy on the health of the fetus, infant, mother, and family. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Tobacco Addiction Group trials register (July 2003), MEDLINE (January 2002 to July 2003), EMBASE (January 2002 to July 2003), PsychLIT (January 2002 to July 2003), CINAHL (January 2002 to July 2003), and AUSTHEALTH (January 2002 to 2003). We contacted trial authors to locate additional unpublished data. We handsearched references of identified trials and recent obstetric journals. SELECTION CRITERIA: Randomised and quasi-randomised trials of smoking cessation programs implemented during pregnancy. DATA COLLECTION AND ANALYSIS: Four reviewers assessed trial quality and extracted data independently. MAIN RESULTS: This review included 64 trials. Fifty-one randomised controlled trials (20,931 women) and six cluster-randomised trials (over 7500 women) provided data on smoking cessation and/or perinatal outcomes. Despite substantial variation in the intensity of the intervention and the extent of reminders and reinforcement through pregnancy, there was an increase in the median intensity of both 'usual care' and interventions over time. There was a significant reduction in smoking in the intervention groups of the 48 trials included: (relative risk (RR) 0.94, 95% confidence interval (CI) 0.93 to 0.95), an absolute difference of six in 100 women continuing to smoke. The 36 trials with validated smoking cessation had a similar reduction (RR 0.94, 95% CI 0.92 to 0.95). Smoking cessation interventions reduced low birthweight (RR 0.81, 95% CI 0.70 to 0.94) and preterm birth (RR 0.84, 95% CI 0.72 to 0.98), and there was a 33 g (95% CI 11 g to 55 g) increase in mean birthweight. There were no statistically significant differences in very low birthweight, stillbirths, perinatal or neonatal mortality but these analyses had very limited power. One intervention strategy, rewards plus social support (two trials), resulted in a significantly greater smoking reduction than other strategies (RR 0.77, 95% CI 0.72 to 0.82). Five trials of smoking relapse prevention (over 800 women) showed no statistically significant reduction in relapse. REVIEWERS' CONCLUSIONS: Smoking cessation programs in pregnancy reduce the proportion of women who continue to smoke, and reduce low birthweight and preterm birth. The pooled trials have inadequate power to detect reductions in perinatal mortality or very low birthweight

Western Irish Sea Nephrops Grounds (FU15) 2019 UWTV Survey Report and catch options for 2020

This report provides the main results and findings of the 17th annual underwater television survey on the ‘Irish sea west Nephrops grounds’ ICES assessment area, Functional Unit 15. The survey was multi-disciplinary in nature collecting UWTV and other ecosystem data. The 2019 design consisted of a randomised isometric grid of 100 stations at 4.5 nautical mile intervals out over the full known extent the stock. The resulting krigged burrow abundance estimate was 4.4 billion burrows. This was a similar result of that obtained in 2015, but a 10% lower than the abundance in 2018. In contrast to 2017 the spatial distribution of burrows shows a high density band on the central western area of the survey ground. The abundance remains within previously observed ranges and is above MSY Btrigger. The CV (or relative standard error) of 3% is in line with previous estimates and well below the upper limit of 20% recommended by SGNEPS 2012. Total catches and landings options at various different fishing mortalities were calculated and fishing at Fmsy in 2020 implies a total catch option at Fmsy (=Fmax) of 10,377 tonnes estimated to result in landings of no more than 8,546 tonnes. Sea-pens were observed at 21% of stations with high densities observed in the south-west of the ground. Trawl marks were noted at 15% of the UWTV stations

Dementia Care Mapping™ to reduce agitation in care home residents with dementia: the EPIC cluster RCT

Background The quality of care for people with dementia in care homes is of concern. Interventions that can improve care outcomes are required. Objective To investigate the clinical effectiveness and cost-effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation and improving care outcomes for people living with dementia in care homes, versus usual care. Design A pragmatic, cluster randomised controlled trial with an open-cohort design, follow-up at 6 and 16 months, integrated cost-effectiveness analysis and process evaluation. Clusters were not blinded to allocation. The primary end point was completed by staff proxy and independent assessors. Setting Stratified randomisation of 50 care homes to the intervention and control groups on a 3 : 2 ratio by type, size, staff exposure to dementia training and recruiting hub. Participants Fifty care homes were randomised (intervention, n = 31; control, n = 19), with 726 residents recruited at baseline and a further 261 recruited after 16 months. Care homes were eligible if they recruited a minimum of 10 residents, were not subject to improvement notices, had not used DCM in the previous 18 months and were not participating in conflicting research. Residents were eligible if they lived there permanently, had a formal diagnosis of dementia or a score of 4+ on the Functional Assessment Staging Test of Alzheimer’s Disease, were proficient in English and were not terminally ill or permanently cared for in bed. All homes were audited on the delivery of dementia and person-centred care awareness training. Those not reaching a minimum standard were provided training ahead of randomisation. Eighteen homes took part in the process evaluation. Intervention Two staff members from each intervention home were trained to use DCM and were asked to carry out three DCM cycles; the first was supported by an external expert. Main outcome measures The primary outcome was agitation (Cohen-Mansfield Agitation Inventory), measured at 16 months. Secondary outcomes included resident behaviours and quality of life. Results There were 675 residents in the final analysis (intervention, n = 388; control, n = 287). There was no evidence of a difference in agitation levels between the treatment arms. The adjusted mean difference in Cohen-Mansfield Agitation Inventory score was –2.11 points, being lower in the intervention group than in the control (95% confidence interval –4.66 to 0.44; p = 0.104; adjusted intracluster correlation coefficient: control = 0, intervention = 0.001). The sensitivity analyses results supported the primary analysis. No differences were detected in any of the secondary outcomes. The health economic analyses indicated that DCM was not cost-effective. Intervention adherence was problematic; only 26% of homes completed more than their first DCM cycle. Impacts, barriers to and facilitators of DCM implementation were identified. Limitations The primary completion of resident outcomes was by staff proxy, owing to self-report difficulties for residents with advanced dementia. Clusters were not blinded to allocation, although supportive analyses suggested that any reporting bias was not clinically important. Conclusions There was no benefit of DCM over control for any outcomes. The implementation of DCM by care home staff was suboptimal compared with the protocol in the majority of homes. Future work Alternative models of DCM implementation should be considered that do not rely solely on leadership by care home staff. Trial registration Current Controlled Trials ISRCTN82288852. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 16. See the NIHR Journals Library website for further project information

Shifts between gelatinous and crustacean plankton in a coastal upwellin region

proyectos RADIALES (IEO) y EURO-BASIN (Ref. 264933, 7FP)Variability in the dominance of copepods vs. gelatinous plankton was analysed using monthly time-series covering the last 55 years and related to changes in climatic, oceanographic, and fishery conditions in the upwelling region of Galicia (NW Spain). Seasonality was generally the main component of variability in all groups, both along the coast and in the nearby ocean, but no common long-term trend was found. Coastal copepods increased since the early 1990s, and gelatinous plankton increased in the ocean during the 1980s. Different trends were found for gelatinous plankton in two coastal sites, characterized by increases in either medusae or tunicates. In all series, multiyear periods of relative dominance of gelatinous vs. copepod plankton were evident. In general, copepod periods were observed in positive phases of the main modes of regional climatic variability. Conversely, gelatinous periods occurred during negative climatic phases. However, the low correlations between gelatinous plankton and climatic, oceanographic, or fishery variables suggest that local factors play a major role in their proliferations.7FP, IEOPreprin

Movement Patterns for a Critically Endangered Species, the Leatherback Turtle (Dermochelys coriacea), Linked to Foraging Success and Population Status

Foraging success for pelagic vertebrates may be revealed by horizontal and vertical movement patterns. We show markedly different patterns for leatherback turtles in the North Atlantic versus Eastern Pacific, which feed on gelatinous zooplankton that are only occasionally found in high densities. In the Atlantic, travel speed was characterized by two modes, indicative of high foraging success at low speeds (<15 km d−1) and transit at high speeds (20–45 km d−1). Only a single mode was evident in the Pacific, which occurred at speeds of 21 km d−1 indicative of transit. The mean dive depth was more variable in relation to latitude but closer to the mean annual depth of the thermocline and nutricline for North Atlantic than Eastern Pacific turtles. The most parsimonious explanation for these findings is that Eastern Pacific turtles rarely achieve high foraging success. This is the first support for foraging behaviour differences between populations of this critically endangered species and suggests that longer periods searching for prey may be hindering population recovery in the Pacific while aiding population maintenance in the Atlantic

Massive Consumption of Gelatinous Plankton by Mediterranean Apex Predators

Stable isotopes of carbon and nitrogen were used to test the hypothesis that stomach content analysis has systematically overlooked the consumption of gelatinous zooplankton by pelagic mesopredators and apex predators. The results strongly supported a major role of gelatinous plankton in the diet of bluefin tuna (Thunnus thynnus), little tunny (Euthynnus alletteratus), spearfish (Tetrapturus belone) and swordfish (Xiphias gladius). Loggerhead sea turtles (Caretta caretta) in the oceanic stage and ocean sunfish (Mola mola) also primarily relied on gelatinous zooplankton. In contrast, stable isotope ratios ruled out any relevant consumption of gelatinous plankton by bluefish (Pomatomus saltatrix), blue shark (Prionace glauca), leerfish (Lichia amia), bonito (Sarda sarda), striped dolphin (Stenella caerueloalba) and loggerhead sea turtles (Caretta caretta) in the neritic stage, all of which primarily relied on fish and squid. Fin whales (Balaenoptera physalus) were confirmed as crustacean consumers. The ratios of stable isotopes in albacore (Thunnus alalunga), amberjack (Seriola dumerili), blue butterfish (Stromaeus fiatola), bullet tuna (Auxis rochei), dolphinfish (Coryphaena hyppurus), horse mackerel (Trachurus trachurus), mackerel (Scomber scombrus) and pompano (Trachinotus ovatus) were consistent with mixed diets revealed by stomach content analysis, including nekton and crustaceans, but the consumption of gelatinous plankton could not be ruled out completely. In conclusion, the jellyvorous guild in the Mediterranean integrates two specialists (ocean sunfish and loggerhead sea turtles in the oceanic stage) and several opportunists (bluefin tuna, little tunny, spearfish, swordfish and, perhaps, blue butterfish), most of them with shrinking populations due to overfishing

Evaluating the effectiveness and cost-effectiveness of Dementia Care Mapping™ to enable person-centred care for people with dementia and their carers (DCM-EPIC) in care homes: study protocol for a randomised controlled trial

Background Up to 90 % of people living with dementia in care homes experience one or more behaviours that staff may describe as challenging to support (BSC). Of these agitation is the most common and difficult to manage. The presence of agitation is associated with fewer visits from relatives, poorer quality of life and social isolation. It is recommended that agitation is treated through psychosocial interventions. Dementia Care Mapping™ (DCM™) is an established, widely used observational tool and practice development cycle, for ensuring a systematic approach to providing person-centred care. There is a body of practice-based literature and experience to suggests that DCM™ is potentially effective but limited robust evidence for its effectiveness, and no examination of its cost-effectiveness, as a UK health care intervention. Therefore, a definitive randomised controlled trial (RCT) of DCM™ in the UK is urgently needed. Methods/design A pragmatic, multi-centre, cluster-randomised controlled trial of Dementia Care Mapping (DCM™) plus Usual Care (UC) versus UC alone, where UC is the normal care delivered within the care home following a minimum level of dementia awareness training. The trial will take place in residential, nursing and dementia-specialist care homes across West Yorkshire, Oxfordshire and London, with residents with dementia. A random sample of 50 care homes will be selected within which a minimum of 750 residents will be registered. Care homes will be randomised in an allocation ratio of 3:2 to receive either intervention or control. Outcome measures will be obtained at 6 and 16 months following randomisation. The primary outcome is agitation as measured by the Cohen-Mansfield Agitation Inventory, at 16 months post randomisation. Key secondary outcomes are other BSC and quality of life. There will be an integral cost-effectiveness analysis and a process evaluation. Discussion The protocol was refined following a pilot of trial procedures. Changes include replacement of a questionnaire, whose wording caused some residents distress, to an adapted version specifically designed for use in care homes, a change to the randomisation stratification factors, adaption in how the staff measures are collected to encourage greater compliance, and additional reminders to intervention homes of when mapping cycles are due, via text message. Trial registration Current Controlled Trials ISRCTN82288852. Registered on 16 January 2014. Full protocol version and date: v7.1: 18 December 2015