Caregivers experience a higher burden due to disease symptoms such as impairment of functional autonomy and behavioral and cognitive impairment, whatever the etiology of the cognitive decline.

BackgroundThree arguments are usually invoked in favour of stepped wedge cluster randomised controlled trials: the logistic convenience of implementing an intervention in phases, the ethical benefit of providing the intervention to all clusters, and the potential to enhance the social acceptability of cluster randomised controlled trials. Are these alleged benefits real? We explored the logistic, ethical, and political dimensions of stepped wedge trials using case studies of six recent evaluations.MethodsWe identified completed or ongoing stepped wedge evaluations using two systematic reviews. We then purposively selected six with a focus on public health in high, middle, and low-income settings. We interviewed their authors about the logistic, ethical, and social issues faced by their teams. Two authors reviewed interview transcripts, identified emerging issues through qualitative thematic analysis, reflected upon them in the context of the literature, and invited all participants to co-author the manuscript.ResultsOur analysis raises three main points. First, the phased implementation of interventions can alleviate problems linked to simultaneous roll-out, but also brings new challenges. Issues to consider include the feasibility of organising intervention activities according to a randomised sequence, estimating time lags in implementation and effects, and accommodating policy changes during the trial period. Second, stepped wedge trials, like parallel cluster trials, require equipoise: without it, randomising participants to a control condition, even for a short time, remains problematic. In stepped wedge trials, equipoise is likely to lie in the degree of effect, effectiveness in a specific operational milieu, and the balance of benefit and harm, including the social value of better evaluation. Third, the strongest arguments for a stepped wedge design are logistic and political rather than ethical. The design is advantageous when simultaneous roll-out is impractical and when it increases the acceptability of using counterfactuals.ConclusionsThe logistic convenience of phased implementation is context-dependent, and may be vitiated by the additional requirements of phasing. The potential for stepped wedge trials to enhance the social acceptability of cluster randomised trials is real, but their ethical legitimacy still rests on demonstrating equipoise and its configuration for each research question and setting.

BackgroundThis study aims to review the methodologies used to identify the needs, the existing needs assessment instruments and the main topics of needs explored among caregivers of patients with mild cognitive impairment to dementia.MethodsMEDLINE, PsycINFO, The Cochrane Library and Web of science were searched from January 1980 to January 2017. Research studies in English or French were eligible for inclusion if they fulfilled the following criteria: quantitative, qualitative and mixed method studies that used instrument, focus group or semi-structured interviews to assess the informal caregiver’s needs in terms of information, coping skills, support and service.ResultsSeventy studies (n = 39 quantitative studies, n = 25 qualitative studies and n = 6 mixed method studies) met the inclusion criteria and were included. Thirty-six quantitative instruments were identified but only one has been validated for the needs assessment of dementia caregivers: the Carer’s Needs Assessment for Dementia (CNA-D). The main areas of needs explored in these instruments were: information, psychosocial, social, psychoeducational and other needs.ConclusionsNo instrument has been developed and validated to assess the needs of informal caregivers of patients with cognitive impairment, whatever the stage and the etiology of the disease. As the perceived needs of caregivers may evolve with the progression of the disease and the dementia transition, their needs should be regularly assessed.Electronic supplementary materialThe online version of this article (doi:10.1186/s12877-017-0481-9) contains supplementary material, which is available to authorized users.

This study aimed to assess whether exposure to anticholinergic and sedative medications and its evolution was associated with increased risk of in-hospital falls and all-cause mortality. Furthermore, results were compared with 2 definitions of drug burden index (DBI) against the outcomes.This observational, multicentric, and longitudinal study was conducted among patients aged 65 years or older, in 3 geriatric hospitals, in Francheville, Lyon, and Villeurbanne, France (duration of follow-up, 11.6 months). The exposure to anticholinergic and sedative medications was quantified using a DBI, at admission and at the end of observation for 337 patients. The evolution of exposure was the absolute difference between the index at admission and at the end of observation. The outcomes were in-hospital falls and all-cause mortality.Overall, 5.9% of patients experienced a fall. The risk of fall was nearly 3-fold in patients whose DBI increased during hospital stay compared to those with stable or decreased DBI (hazard ratio, 2.9 [1.14-7.12]; P = 0.03), after adjustment for comorbidities.The overall proportion of mortality was 6.5%. The evolution of DBI during hospital stay was not related to the risk of mortality (hazard ratio, 1.9 [0.8-4.4]; P = 0.14). Results were similar with the 2 definitions of DBI.Increased exposure to anticholinergic and sedative medications during hospital stay is associated with a higher risk of in-hospital falls but not with mortality. The DBI could be implemented in hospital, to guide prescription and reduce anticholinergic and sedative drug exposure.

Background and Purpose-Because acute ischemic strokes (ISs) are mainly hospitalized, hospital discharge data could be used to routinely follow their incidence management. We aimed to assess sensitivity and positive predictive value of the French hospital discharge database (HDD) to identify patients with acute IS using a prospective and exhaustive cohort (AVC69) of acute IS cases. Methods-A selection algorithm based on IS diagnosis coded with the International Classification of Diseases and cerebral imaging codes was used to identify all hospital stays with the primary diagnosis of IS in the HDD of the university hospitals of the Rhône area. Cases identified through HDD search were compared with IS cases identified through an exhaustive cohort study conducted in the Rhône district and confirmed on medical records review. Results-There were 465 confirmed cases of IS hospitalized in 1 of the 4 university hospitals during the study period. The HDD search identified 313 among those (true-positive cases) but missed 152 cases (false-negative cases). The sensitivity of the HDD search was 67.3% (95% confidence interval, 63.1-71.5), and the positive predictive value was 95.1% (95% confidence interval, 92.8-97.4). Additionally, HDD search retrieved 16 cases, which were not eventually IS (false positives). Sensitivity was better when patients were hospitalized in neurological departments. Conclusions-The lack of sensitivity to identify acute IS patients through HDD search does not seem to be accurate enough to validate the use of these data for incidence estimates. Efforts have to be made to improve the coding quality. Key Words: hospital discharge database ■ ischemic stroke ■ positive predictive value ■ sensitivity

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BackgroundPostoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Although several interventions have proved their effectiveness to prevent it, the Cochrane advises an assessment of multifaceted intervention using rigorous methodology based on randomized study design. Our purpose is to present the methodology and expected results of the CONFUCIUS trial, which aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.Method/DesignStudy design is a stepped wedge cluster randomized trial within 3 surgical wards of three French university hospitals. All patients aged 75 and older, and admitted for scheduled surgery will be included. The multifaceted program will be conducted by mobile geriatric team, including geriatric preoperative consultation, training of the surgical staff and implementation of the Hospital Elder Life Program, and morbidity and mortality conference related to delirium cases. The primary outcome is based on postoperative delirium rate within 7 days after surgery. This program is planned to be implemented along four successive time periods within all the surgical wards. Each one will be affected successively to the control arm and to the intervention arm of the trial and the order of program introduction within each surgical ward will be randomly assigned. Based on a 20% reduction of postoperative delirium rate (ICC = 0.25, α = 0.05, β = 0.1), three hundred sixty patients will be included i.e. thirty patients per service and per time period. Endpoints comparison between intervention and control arms of the trial will be performed by considering the cluster and time effects.DiscussionBetter prevention of delirium is expected from the multifaceted program, including a decrease of postoperative delirium, and its consequences (mortality, morbidity, postoperative complications and length of hospital stay) among elderly patients. This study should allow better diagnosis of delirium and strengthen the collaboration between surgical and mobile geriatric teams. Should the program have a substantial impact on the prevention of postoperative delirium in elderly, it could be extended to other facilities.Trial registrationClinicalTrials.gov: NCT01316965

ClinicalTrials.govNCT02825732.