Validity, reliability and responsiveness to change of the French version of the drooling impact scale.

BACKGROUND: work still needs to be done to measure the impact of sialorrhea on quality of life and define the efficacy of different therapies. The Drooling Impact Scale showed good validity and sensitivity to change, especially after botulinum toxin injection. The aim of this study is to present its French translation and to explore its validity, reliability and responsiveness to change in a group of children with Cerebral Palsy. METHODS: multicentre study at six rehabilitation centres in France. Children with Cerebral Palsy aged 4-18 years with sialorrhea problems were included (n = 55), either in a control group (n = 33) or in the intervention group (n = 22, with 3 drug treatment and 19 botulinum toxin injections). The French Drooling Impact Scale was administered twice, 1 month apart. RESULTS: The French Drooling Impact Scale total score at inclusion was meanly 53.9 (Standard Deviation 11.9) in the stable control group and 66.0 (16.1) in the intervention group (p = 0.0058). The validity of the scale was established, as well as an adequate internal consistency (Cronbach's α = 0.71); correlations between each item and the total score were found between 0.5 and 0.71 except for item 5 (r = 0.38) and item 7 (0.41). The test-retest reliability in stable children was good (Lin coefficient = 0.83, bias correction factor = 0.92 and Pearson correlation coefficient = 0.89). There was a high responsiveness to change, mean change was -40.0 in the intervention group and -3.6 in the stable group (p < 0.0001), with Standard Error of Measurement = 2.6. CONCLUSION: the French Drooling Impact Scale has shown sufficient clinometric properties to be used now by clinicians or researchers.IMPLICATIONS FOR REHABILITATIONThe Drooling Impact scale has now its French version.The French version of the Drooling Impact Scale has shown its validity and a good test-retest reliability.The responsiveness to change was explored in a group of children undergoing saliva-control interventions and the scale was able to show a big change.The authors recommend to use this questionnaire in a semi-directed interview conducted by a health professional.

Myocardial infarction: Economic, health, and social impacts on informal caregivers.

OBJECTIVES: The aim of the study was to measure the economic impact of informal care (IC) on caregivers assisting myocardial infarction (MI) survivors in France. Health and social impacts were also described. METHODS: Data from the prospective 2008 Health and Disabilities Households Survey (Enquête Handicap-Santé), carried out among the French general population, were used to obtain information about patients with MI and their informal caregivers. To estimate the approximate monetary value of IC, three methods were used: the proxy good method, opportunity cost method (OCM), and contingent valuation method (CVM). A multivariate analysis was performed to determine the associations of the IC duration and the existence of professional care with the health indicators stated by caregivers. RESULTS: The analysis included data from 147 caregivers. The mean value of IC ranged from €9,679 per year using the CVM to €11,288 per year using the OCM (p > .05). The mean willingness to pay for an additional hour of IC was €10.9 (SD = 8.3). A total of 46.2 percent of caregivers reported that IC negatively affected theirs physical condition, and 46.3 percent reported that it negatively affected their psychological health. In addition, 40.1 percent declared that caregiving activity made them anxious and 38.8 percent stated they felt alone. Associations were identified between the duration of IC and feeling the need to be replaced, feeling alone and making sacrifices (p < .05). CONCLUSIONS: Informal caregiver burden may be recognized in health technology assessment in order not to underestimate the cost of strategies and to facilitate the comparability of cost-effectiveness outcomes between studies.

National cost study versus hospital cost accounting for organ recovery cost assessment in a French hospital group.

BACKGROUND: The choice of cost data sources is crucial, because it influences the results of cost studies, decisions of hospital managers and ultimately national directives of policy makers. The main objective of this study was to compare a hospital cost accounting system in a French hospital group and the national cost study (ENC) considering the cost of organ recovery procedures. The secondary objective was to compare these approaches to the weighting method used in the ENC to assess organ recovery costs. METHODS: The resources consumed during the hospital stay and organ recovery procedure were identified and quantified retrospectively from hospital discharge abstracts and the national discharge abstract database. Identified items were valued using hospital cost accounting, followed by 2010-2011 ENC data, and then weighted using 2010-2011 ENC data. A Kruskal-Wallis test was used to determine whether at least two of the cost databases provided different results. Then, a Mann-Whitney test was used to compare the three cost databases. RESULTS: The costs assessed using hospital cost accounting differed significantly from those obtained using the ENC data (Mann-Whitney; P-value < 0.001). In the ENC, the mean costs for hospital stays and organ recovery procedures were determined to be €4961 (SD €7295) and €862 (SD €887), respectively, versus €12,074 (SD €6956) and €4311 (SD €1738) for the hospital cost accounting assessment. The use of a weighted methodology reduced the differences observed between these two data sources. CONCLUSIONS: Readers, hospital managers and decision makers must know the strengths and weaknesses of each database to interpret the results in an informed context.

Islet transplantation versus insulin therapy in patients with type 1 diabetes with severe hypoglycaemia or poorly controlled glycaemia after kidney transplantation (TRIMECO): a multicentre, randomised controlled trial.

BACKGROUND: Islet transplantation is indicated for patients with type 1 diabetes with severe hypoglycaemia or after kidney transplantation. We did a randomised trial to assess the efficacy and safety of islet transplantation compared with insulin therapy in these patients. METHODS: In this multicentre, open-label, randomised controlled trial, we randomly assigned (1:1) patients with type 1 diabetes at 15 university hospitals to receive immediate islet transplantation or intensive insulin therapy (followed by delayed islet transplantation). Eligible patients were aged 18-65 years and had severe hypoglycaemia or hypoglycaemia unawareness, or kidney grafts with poor glycaemic control. We used computer-generated randomisation, stratified by centre and type of patient. Islet recipients were scheduled to receive 11 000 islet equivalents per kg bodyweight in one to three infusions. The primary outcome was proportion of patients with a modified ß-score (in which an overall score of 0 was not allocated when stimulated C-peptide was negative) of 6 or higher at 6 months after first islet infusion in the immediate transplantation group or 6 months after randomisation in the insulin group. The primary analysis included all patients who received the allocated intervention; safety was assessed in all patients who received islet infusions. This trial is registered with ClinicalTrials.gov, number NCT01148680, and is completed. FINDINGS: Between July 8, 2010, and July 29, 2013, 50 patients were randomly assigned to immediate islet transplantation (n=26) or insulin treatment (n=24), of whom three (one in the immediate islet transplantation group and two in the insulin therapy group) did not receive the allocated intervention. Median follow-up was 184 days (IQR 181-186) in the immediate transplantation group and 185 days (172-201) in the insulin therapy group. At 6 months, 16 (64% [95% CI 43-82]) of 25 patients in the immediate islet transplantation group had a modified ß-score of 6 or higher versus none (0% [0-15]) of the 22 patients in the insulin group (p<0·0001). At 12 months after first infusion, bleeding complications had occurred in four (7% [2-18]) of 55 infusions, and a decrease in median glomerular filtration rate from 90·5 mL/min (IQR 76·6-94·0) to 71·8 mL/min (59·0-89·0) was observed in islet recipients who had not previously received a kidney graft and from 63·0 mL/min (55·0-71·0) to 57·0 mL/min (45·5-65·1) in islet recipients who had previously received a kidney graft. INTERPRETATION: For the indications assessed in this study, islet transplantation effectively improves metabolic outcomes. Although studies with longer-term follow-up are needed, islet transplantation seems to be a valid option for patients with severe, unstable type 1 diabetes who are not responding to intensive medical treatments. However, immunosuppression can affect kidney function, necessitating careful selection of patients. FUNDING: Programme Hospitalier de Recherche Clinique grant from the French Government.