Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG-COUSIN) supports the development of core outcomes in dermatology. In the second CSG-COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers.
Standardized assessment instruments are deemed important for estimating pressure ulcer risk. Today, more than 40 so-called pressure ulcer risk assessment scales are available but still there is an ongoing debate about their usefulness. From a measurement point of view pressure ulcer (PU) risk assessment scales have serious limitations. Empirical evidence supporting the validity of PU risk assessment scale scores is weak and obtained scores contain varying amounts of measurement error. The concept of pressure ulcer risk is strongly related to the general health status and severity of illness. A clinical impact due do the application of these scales could also not be demonstrated. It is questionable whether completion of standardized pressure ulcer risk scales in clinical practice is really needed.
Background
antipsychotic drugs are regularly prescribed as first-line treatment for neuropsychiatric symptoms in persons with dementia although guidelines clearly prioritise non-pharmacological interventions.
Objective
we investigated a person-centred care approach, which has been successfully evaluated in nursing homes in the UK, and adapted it to German conditions.
Design
a 2-armed 12-month cluster-randomised controlled trial.
Setting
nursing homes in East, North and West Germany.
Methods
all prescribing physicians from both study arms received medication reviews for individual patients and were offered access to 2 h of continuing medical education. Nursing homes in the intervention group received educational interventions on person-centred care and a continuous supervision programme. Primary outcome: proportion of residents receiving at least one antipsychotic prescription after 12 months of follow-up. Secondary outcomes: quality of life, agitated behaviour, falls and fall-related medical attention, a health economics evaluation and a process evaluation.
Results
the study was conducted in 37 nursing homes with
n
= 1,153 residents (intervention group:
n
= 493; control group:
n
= 660). The proportion of residents with at least one antipsychotic medication changed after 12 months from 44.6% to 44.8% in the intervention group and from 39.8 to 33.3% in the control group. After 12 months, the difference in the prevalence was 11.4% between the intervention and control groups (95% confidence interval: 0.9–21.9;
P
= 0.033); odds ratio: 1.621 (95% confidence interval: 1.038–2.532).
Conclusions
the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes.
Trial registration
ClinicalTrials.gov NCT02295462.
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