A randomised controlled trial to evaluate the impact of a human rights based approach to dementia care in inpatient ward and care home settings

BackgroundAlthough it is widely recognised that adopting a person-centred approach is beneficial in the care of people living with dementia, a gap remains between the rhetoric and the reality of quality care. Some widely adopted care practices can result in the personhood of this group being threatened and their human rights being undermined.ObjectivesTo evaluate the impact of applying a human rights based approach in dementia inpatient wards and care homes on the quality of care delivered and the well-being of the person living with dementia.DesignA cluster randomised design was employed to compare the impact of implementing a human rights based approach intervention (i.e. training, applying the ‘Getting It Right’ assessment tool and receiving booster sessions) at 10 intervention sites with 10 control sites.SettingEight NHS dementia inpatient wards and 12 care homes in the north-west of England.ParticipantsPeople living with dementia who were residing on dementia inpatient wards or in care homes, and staff working at these sites. The aim was to recruit 280 people living with dementia.InterventionsA sample of staff (an average of 8.9 per site) at each of the sites was trained in a human rights based approach to care, including the application of the ‘Getting It Right’ assessment tool. The tool was then introduced at the site and monthly booster sessions were delivered.Main outcome measuresThe primary outcome measure used in the research was the Quality of Life in Alzheimer’s Disease scale to assess the subjective well-being of the person with dementia. Secondary outcome measures included measures of the quality of care provided (dementia care mapping) and direct measures of the effectiveness of the training in increasing knowledge of and attitudes towards human rights. The study also included an economic evaluation utilising the EuroQol-5 Dimensions, three-level version, and the Adult Social Care Outcomes Toolkit measure.ResultsThe study recruited 439 people living with dementia: 213 to the intervention arm and 226 to the control arm. Primary outcome data were analysed using a linear mixed model. There were no significant differences found in the reported quality of life of residents between the control and intervention groups after the intervention [F(1,16.51) = 3.63;p = 0.074]. The mean difference between the groups was 1.48 (95% confidence interval –7.86 to 10.82).ConclusionsDespite the fact that the training increased staff knowledge of and positive attitudes towards human rights, and although there were some changes in staff decision-making strategies in clinical situations, there was no change in the quality of care provided or in the reported well-being of people living with dementia in these settings. This led to questions about the efficacy of training in bringing about cultural change and improving care practices.LimitationsThere was limited uptake of the training and booster sessions that were integral to the intervention.Future workFuture work could usefully focus on understanding the difficulty in translating change in attitude and knowledge into behaviour.Trial registrationCurrent Controlled Trials ISRCTN94553028.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 6, No. 13. See the NIHR Journals Library website for further project information.</jats:sec

GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations

In 2012, genetically engineered (GE) crops were grown by 17.3 million farmers on over 170 million hectares. Over 70% of harvested GE biomass is fed to food producing animals, making them the major consumers of GE crops for the past 15 plus years. Prior to commercialization, GE crops go through an extensive regulatory evaluation. Over one hundred regulatory submissions have shown compositional equivalence, and comparable levels of safety, between GE crops and their conventional counterparts. One component of regulatory compliance is whole GE food/feed animal feeding studies. Both regulatory studies and independent peer-reviewed studies have shown that GE crops can be safely used in animal feed, and rDNA fragments have never been detected in products (e.g. milk, meat, eggs) derived from animals that consumed GE feed. Despite the fact that the scientific weight of evidence from these hundreds of studies have not revealed unique risks associated with GE feed, some groups are calling for more animal feeding studies, including long-term rodent studies and studies in target livestock species for the approval of GE crops. It is an opportune time to review the results of such studies as have been done to date to evaluate the value of the additional information obtained. Requiring long-term and target animal feeding studies would sharply increase regulatory compliance costs and prolong the regulatory process associated with the commercialization of GE crops. Such costs may impede the development of feed crops with enhanced nutritional characteristics and durability, particularly in the local varieties in small and poor developing countries. More generally it is time for regulatory evaluations to more explicitly consider both the reasonable and unique risks and benefits associated with the use of both GE plants and animals in agricultural systems, and weigh them against those associated with existing systems, and those of regulatory inaction. This would represent a shift away from a GE evaluation process that currently focuses only on risk assessment and identifying ever diminishing marginal hazards, to a regulatory approach that more objectively evaluates and communicates the likely impact of approving a new GE plant or animal on agricultural production systems