Compensating patients in trials: Perspectives from an ethical committee versus sponsor.

BACKGROUND: According to European clinical research legislation, no undue influence, including financial incentives, should be used to encourage participation in clinical trials. Financial compensation should be based on the inconvenience experienced by patients and is determined by the sponsor. OBJECTIVES: The objective of this study was to assess the adequacy of patients' financial compensation by obtaining an external ethical opinion compared to the actual compensation provided. METHODS: We randomly selected and reviewed 50 clinical drug trials, including 25 academic and 25 industry-sponsored studies. An external ethics group consisting of three members from French ethics committees, blinded to the actual compensation and the sponsor, retrospectively reviewed the study characteristics and assessed whether financial compensation was appropriate. Cohen's Kappa test measured agreement between actual compensation and the ethics group's opinion, and the McNemar test measured discrepancies. RESULTS: There was no agreement between the actual financial compensation and the ethics group's opinion (K = -.07; 95% CI = [-.16-.02]). More discrepancies were found in favour of financial compensation according to the ethics group than provided by sponsors (12 vs. 2, p = .016). The ethics group recommended financial compensation in 12 out of 50 studies (24%), which were studies with a higher number of additional visits (p = .004) and were more frequently sponsored by industry (p = .008). Sponsors only provided financial compensation in 2 out of 50 studies (4%). CONCLUSION: Patients are rarely compensated despite the perceived inconvenience. Both sponsors and ethics members struggle to determine the need for financial compensation, indicating a need for more precise recommendations for both parties.

Impact of prolonged dinoprostone cervical ripening on the rate of artificial induction of labor: a prospective study of 330 patients.

AIM: The aim of this study was to evaluate two regimens of administration of sustained-release dinoprostone on the need for oxytocin induction of labor. MATERIAL AND METHODS: We carried out an open prospective study comparing labor, maternal and neonatal outcomes after 12 h of prostaglandin cervical ripening insert versus 24 h of prostaglandin cervical ripening insert in 284 patients (142 ripenings at 12 h [P12 group] and 142 ripenings at 24 h [P24 group]). RESULTS: The two groups were demographically similar. There was a significant difference in the need for artificial rupture of membranes/oxytocin induction of labor between the groups (49.3% for the P12 group vs 38% for the P24 group, P = 0.03). The delay between the beginning of ripening and delivery was significantly decreased in the P12 group, but the duration of active labor (6.6 h), the dose of oxytocics used (1326 UI), the rate of cesarean section, the rate of uterine hyperstimulation, the rates of hemorrhaging from delivery, the neonatal state and the experience of induction were similar in the two groups. CONCLUSION: This study allows us to show for the first time that sustained-release of dinoprostone leads to spontaneous induction of labor without increasing the obstetrical risk in a majority of patients.

[Not Available]. / Arrêt soudain des médicaments spécifiques de la démence au stade modéré à sévère de la maladie d'Alzheimer en institution : étude pilote longitudinale descriptive.

PURPOSE: The modalities for anti-dementia drugs' discontinuation are not consensual. OBJECTIVE: The objectives of the study were the followings, describe: i) the reasons for discontinuation of anti-dementia drugs of patients treated in a residency for dependent elderly people, ii) security of sudden discontinuation, iii) evolution of troubles. METHODS: Our longitudinal descriptive pilot study aimed at observing consequences of the sudden discontinuation of anti-dementia drugs in a population with a moderate to severe stage of Alzheimer's disease. The study took place in a French residency for dependent elderly people, treated with at least one of the following treatments: rivastigmine, donepezil, galantamine and/or memantine. Based on multidisciplinary decision, as recommended, patient's anti-dementia treatment have been stopped or not. Criteria have been collected for 6months and compared between the two groups: safety, motivation for discontinuation, score mini-mental state examination (MMSE), psycho-behavior criteria and finally the concomitant prescription of psychotropic drugs. RESULTS: Thirty-three patients were included: the revaluation of anti-dementia treatment led to 22 discontinuations and 11 continuations. Motivations to stop antidementia treatment were: too advanced dementia (48%), lack of therapeutic benefit (28%) or too much of psychotropic medications (24%). The sudden discontinuation was well tolerated with no withdrawal syndrome observed. The variation of MMSE at 6months was -1.8 (SD 2.2) in the discontinuation group (n=14) versus -2.2 (SD 2.0) in the continuation group (n=6). The psycho-behavior disorders have not been aggravated. A reduction in number of psychotropic drugs in the discontinuation group was observed. CONCLUSION: In this pilot study, the revaluation in accordance with the recommendations of the Haute autorité de santé (HAS) led to the discontinuation of two third of anti-dementia drugs. Safety of sudden discontinuation of MSD remains to be studied.

[Sudden Discontinuation of Anti-dementia Drugs in Moderate and Severe Alzheimer's Disease in a Residency for Dependent Elderly People: a Longitudinal Descriptive Pilot Study]. / Arrêt soudain des médicaments spécifiques de la démence au stade modéré à sévère de la maladie d'Alzheimer en institution : étude pilote longitudinale descriptive.

PURPOSE: The modalities for anti-dementia drugs' discontinuation are not consensual. OBJECTIVE: The objectives of the study were the followings, describe: i) the reasons for discontinuation of anti-dementia drugs of patients treated in a residency for dependent elderly people, ii) security of sudden discontinuation, iii) evolution of troubles. METHODS: Our longitudinal descriptive pilot study aimed at observing consequences of the sudden discontinuation of anti-dementia drugs in a population with a moderate to severe stage of Alzheimer's disease. The study took place in a French residency for dependent elderly people, treated with at least one of the following treatments: rivastigmine, donepezil, galantamine and/or memantine. Based on multidisciplinary decision, as recommended, patient's anti-dementia treatment have been stopped or not. Criteria have been collected for 6 months and compared between the two groups: safety, motivation for discontinuation, score mini-mental state examination (MMSE), psycho-behavior criteria and finally the concomitant prescription of psychotropic drugs. RESULTS: Thirty-three patients were included: the revaluation of anti-dementia treatment led to 22 discontinuations and 11 continuations. Motivations to stop antidementia treatment were: too advanced dementia (48%), lack of therapeutic benefit (28%) or too much of psychotropic medications (24%). The sudden discontinuation was well tolerated with no withdrawal syndrome observed. The variation of MMSE at 6 months was -1.8 (SD 2.2) in the discontinuation group (n = 14) versus -2.2 (SD 2.0) in the continuation group (n = 6). The psycho-behavior disorders have not been aggravated. A reduction in number of psychotropic drugs in the discontinuation group was observed. CONCLUSION: In this pilot study, the revaluation in accordance with the recommendations of the Haute autorité de santé (HAS) led to the discontinuation of two third of anti-dementia drugs. Safety of sudden discontinuation of MSD remains to be studied.

[Not Available]. / Nouvel effet indésirable fréquent des inhibiteurs de la pompe à protons chez le sujet âgé : l'hyponatrémie modérée.

Hyponatremia is a rare side effect described in the product characteristics of proton pump inhibitors (PPIs). Hyponatremia in the elderly (>65years) was assessed in patients with exposure to PPIs for at least one year compared to controls not exposed to PPIs counterparts. Included 145 patients, twenty-four patients (16.6%) had moderate hyponatremia ([120-134] mEq/L). Forty-eight patients (33.1%) were treated with PPIs. In the end, 31.3% [18.7%-46.3%] of the treated population for more than a year by PPI suffered moderate hyponatremia against only 9.3% [14.3%-16.9%] in the rest of the population, giving an odds ratio of 4.4 ([1.8-11.1], p=0.001). The relationship between hyponatremia dose was not significant (R(2)=0.05, p=0.74). By our study, we show that the risk of moderate hyponatremia is increased by chronic use of PPI in the elderly population. We also specify a notion of prevalence between 18.7% and 46.3%.

[New frequent adverse reaction of PPI in older adults: mild hyponatremia]. / Nouvel effet indésirable fréquent des inhibiteurs de la pompe à protons chez le sujet âgé : l'hyponatrémie modérée.

Hyponatremia is a rare side effect described in the product characteristics of proton pump inhibitors (PPIs). Hyponatremia in the elderly (>65 years) was assessed in patients with exposure to PPIs for at least one year compared to controls not exposed to PPIs counterparts. Included 145 patients, twenty-four patients (16.6%) had moderate hyponatremia ([120-134] mEq/L). Forty-eight patients (33.1%) were treated with PPIs. In the end, 31.3% [18.7%-46.3%] of the treated population for more than a year by PPI suffered moderate hyponatremia against only 9.3% [14.3%-16.9%] in the rest of the population, giving an odds ratio of 4.4 ([1.8-11.1], p=0.001). The relationship between hyponatremia dose was not significant (R2=0.05, p=0.74). By our study, we show that the risk of moderate hyponatremia is increased by chronic use of PPI in the elderly population. We also specify a notion of prevalence between 18.7% and 46.3%.

[Moderate potentially drug-induced hyponatremia in older adults: benefit in drug reduction]. / L'hyponatrémie modérée potentiellement médicamenteuse du sujet âgé : bénéfice de la réduction des médicaments.

OBJECTIVE: This study aimed at evaluating the benefit of changing drug therapy in elderly patients with moderate, potentially drug-induced hyponatremia. METHODS: Hospitalized older adults, with moderate hyponatremia, potentially induced by drugs, were randomized into two arms: an interventional group, whose drug therapy was changed, and a reference group, which received standard care. The effectiveness of the intervention was evaluated by the normalization of serum sodium after four weeks and by the incidence of falls three months later. RESULTS: Nineteen patients were randomized, fourteen evaluated at 4 weeks. Serum sodium was normalized more frequently in the interventional group than in the reference group: 75% (6/8) IC95% [35-97] versus 0% (0/6) IC95% [0-46]; p=0.01. A greater reduction in falls occurred in the therapeutic intervention group 75% (3/4) IC95% [19-99] versus 0% (0/5) IC95% [0-52]; p=0.048. CONCLUSION: This study showed the biological and clinical benefit of a pharmalogical intervention. Registration number of the study: ID RCB 2010-A00778-31.

Radio-opaque ethylcellulose-ethanol is a safe and efficient sclerosing agent for venous malformations.

OBJECTIVE: To evaluate the efficacy and safety of gelified ethanol, a newly developed sclerosing agent for slow-flow vascular malformations. METHODS: Seventy-nine sclerotherapy procedures were performed on 44 patients with 37 venous malformations, 2 glomuvenous malformations, 2 lymphatic malformations, 2 lymphatico-venous malformations, and 1 Klippel-Trenaunay syndrome. The median injected volume was 1.00 mL/site of injection. Effects of sclerotherapy on pain, functional and cosmetic disturbance were statistically evaluated with a final result score. Local and systemic complications were recorded. RESULTS: The mean Visual Analogue Scores were 5.20 ± 2.81 before and 1.52 ± 1.25 after treatment (p < 0.001). Functional and aesthetic improvement was achieved in 31/35 patients (89%) and in 33/41 (80%), respectively. Minor local side effects included necrosis with or without issue of ethylcellulose, palpable residue, and hematoma. No systemic side-effects occurred. CONCLUSION: Per mL used, radio-opaque gelified ethanol is at least as effective as absolute ethanol. No systemic complication was observed, as only a low dose of ethanol was injected. Indications for sclerotherapy can be widened to areas with higher risk for local side effects (hands and periocular region), as ethanol is trapped in the lesion. Careful injection procedure is though necessary, because only a limited amount of ethylcellulose can be used per puncture. Key Points • Development of a new sclerosing agent for venous malformations. • Interesting novel way to deliver alcohol to slow-flow vascular malformations. • Alcohol-based with less local and systemic side-effects.

Predictors of mortality and short-term physical and cognitive dependence in critically ill persons 75 years and older: a prospective cohort study.

BACKGROUND: The purpose of this study was to identify predictors of 3-month mortality in critically ill older persons under medical care and to assess the clinical impact of an ICU stay on physical and cognitive dependence and subjective health status in survivors. METHODS: We conducted a prospective observational cohort study including all older persons 75 years and older consecutively admitted into ICU during a one-year period, except those admitted after cardiac arrest, All patients were followed for 3 months or until death. Comorbidities were assessed using the Charlson index and physical dependence was evaluated using the Katz index of Activity of Daily Living (ADL). Cognitive dependence was determined by a score based on the individual components of the Lawton index of Daily Living and subjective health status was evaluated using the Nottingham Health Profile (NHP) score. RESULTS: One hundred patients were included in the analysis. The mean age was 79.3 ± 3.4 years. The median Charlson index was 6 [IQR, 4 to 7] and the mean ADL and cognitive scores were 5.4 ± 1.1 and 1.2 ± 1.4, respectively, corresponding to a population with a high level of comorbidities but low physical and cognitive dependence. Mortality was 61/100 (61%) at 3 months. In multivariate analysis only comorbidities assessed by the Charlson index [Adjusted Odds Ratio, 1.6; 95% CI, 1.2-2.2; p < 0.003] and the number of organ failures assessed by the SOFA score [Adjusted Odds Ratio, 2.5; 95% CI, 1.1-5.2; p < 0.02] were independently associated with 3-month mortality. All 22 patients needing renal support after Day 3 died. Compared with pre-admission, physical (p = 0.04), and cognitive (p = 0.62) dependence in survivors had changed very little at 3 months. In addition, the mean NHP score was 213.1 ± 132.8 at 3 months, suggesting an acceptable perception of their quality of life. CONCLUSIONS: In a selected population of non surgical patients 75 years and older, admission into the ICU is associated with a 3-month survival rate of 38% with little impact on physical and cognitive dependence and subjective health status. Nevertheless, a high comorbidity level (ie, Charlson index), multi-organ failure, and the need for extra-renal support at the early phase of intensive care could be considered as predictors of death.

Serum neuron-specific enolase as predictor of outcome in comatose cardiac-arrest survivors: a prospective cohort study.

BACKGROUND: The prediction of neurological outcome in comatose patients after cardiac arrest has major ethical and socioeconomic implications. The purpose of this study was to assess the capability of serum neuron-specific enolase (NSE), a biomarker of hypoxic brain damage, to predict death or vegetative state in comatose cardiac-arrest survivors. METHODS: We conducted a prospective observational cohort study in one university hospital and one general hospital Intensive Care Unit (ICU). All consecutive patients who suffered cardiac arrest and were subsequently admitted from June 2007 to February 2009 were considered for inclusion in the study. Patients who died or awoke within the first 48 hours of admission were excluded from the analysis. Patients were followed for 3 months or until death after cardiopulmonary resuscitation. The Cerebral Performance Categories scale (CPC) was used as the outcome measure; a CPC of 4-5 was regarded as a poor outcome, and a CPC of 1-3 a good outcome. Measurement of serum NSE was performed at 24 h and at 72 h after the time of cardiac arrest using an enzyme immunoassay. Clinicians were blinded to NSE results. RESULTS: Ninety-seven patients were included. All patients were actively supported during the first days following cardiac arrest. Sixty-five patients (67%) underwent cooling after resuscitation. At 3 months 72 (74%) patients had a poor outcome (CPC 4-5) and 25 (26%) a good outcome (CPC 1-3). The median and Interquartile Range [IQR] levels of NSE at 24 h and at 72 h were significantly higher in patients with poor outcomes: NSE at 24 h: 59.4 ng/mL [37-106] versus 28.8 ng/mL [18-41] (p < 0.0001); and NSE at 72 h: 129.5 ng/mL [40-247] versus 15.7 ng/mL [12-19] (p < 0.0001). The Receiver Operator Characteristics (ROC) curve for poor outcome for the highest observed NSE value for each patient determined a cut-off value for NSE of 97 ng/mL to predict a poor neurological outcome with a specificity of 100% [95% CI = 87-100] and a sensitivity of 49% [95% CI = 37-60]. However, an approach based on a combination of SSEPs, NSE and clinical-EEG tests allowed to increase the number of patients (63/72 (88%)) identified as having a poor outcome and for whom intensive treatment could be regarded as futile. CONCLUSION: NSE levels measured early in the course of patient care for those who remained comatose after cardiac arrest were significantly higher in patients with outcomes of death or vegetative state. In addition, we provide a cut-off value for NSE (> 97 ng/mL) with 100% positive predictive value of poor outcome. Nevertheless, for decisions concerning the continuation of treatment in this setting, we emphasize that an approach based on a combination of SSEPs, NSE and clinical EEG would be more accurate for identifying patients with a poor neurological outcome.

Wound debridement: Comparative reliability of three methods for measuring fibrin percentage in chronic wounds.

The purpose of this study was to examine the intra- and interrater reliability of three methods to measure the percentage of fibrin within a wound, hence reflecting wound debridement. The three methods include visual assessment, a portable wound measurement system (PWMS) Visitrak(R), and a computerized planimetry software Canvas(R). The main objective was to compare the computerized planimetry with visual analysis. For each wound, a series of two repeated recordings of fibrin percentage based on the same Day 1 photograph at Day 8 and Day 15, respectively, was assessed by four evaluators using the two methods. Additional objectives consisted in the assessment of the inter-rater reliability of computerized planimetry and PWMS to assess fibrin percentage and total surface area. Twenty-four patients were included for a total of 31 wounds. Intraclass correlation coefficient revealed improved reproducibility and repeatability of computerized planimetry. The reproducibility of computerized planimetry was better than PWMS when measuring the percentage of fibrin and total wound area. Because average visual estimations were very close to the computerized planimetry, bedside evaluation of fibrin percentage and wound debridement was considered as reliable, and consequently a valid technique for daily practice. PWMS proved to be less convenient, owing to difficulties in identifying fibrin margins. The higher intra and interrater reliability of computerized planimetry probably reflected the fact that subjective clinical assessment and objective calculation of percentages were mandatory for correct wound evaluation. Therefore, digital image analysis was considered as an accurate method for double-blind and multicentric trials.

A clinical and EEG scoring system that predicts early cortical response (N20) to somatosensory evoked potentials and outcome after cardiac arrest.

BACKGROUND: Anoxic coma following cardiac arrest is a common problem with ethical, social, and legal consequences. Except for unfavorable somatosensory-evoked potentials (SSEP) results, predictors of unfavorable outcome with a 100% specificity and a high sensitivity are lacking. The aim of the current research was to construct a clinical and EEG scoring system that predicts early cortical response (N20) to somatosensory evoked potentials and 6-months outcome in comatose patients after cardiac arrest. METHODS: We retrospectively reviewed the records of all consecutive patients who suffered cardiac arrest outside our hospital and were subsequently admitted to our facility from November 2002 to July 2006. We scored each case based on early clinical and EEG factors associated with unfavorable SSEPs, and we assessed the ability of this score to predict SSEP results and outcome. RESULTS: Sixty-six patients qualified for inclusion in the cohort. Among them, 34 (52%) had unfavorable SSEP results. At day three, factors independently associated with unfavorable SSEPs were: absence of corneal (14 points) and pupillary (21 points) reflexes, myoclonus (25 points), extensor or absent motor response to painful stimulation (28 points), and malignant EEG (11 points). A score >40 points had a sensitivity of 85%, a specificity of 84%, and a positive predictive value (PPV) of 85% to predict unfavorable SSEP results. A score >88 points had a PPV of 100%, but a sensitivity of 18%. Overall, this score had an area under ROC curves of 0.919. In addition, at day three, a score > 69 points had a PPV of 100% with a sensitivity of 32% to predict death or vegetative state. CONCLUSION: A scoring system based on a combination of clinical and EEG findings can predict the absence of early cortical response to SSEPs. In settings without access to SSEPs, this score may help decision-making in a subset of comatose survivors after a cardiac arrest.

Energy requirements in hospitalized elderly people.

OBJECTIVES: To estimate energy intake and energy expenditure (EE) in elderly hospitalized patients recovering from an acute illness. DESIGN: Cross-sectional evaluation of the disparity between energy intake and expenditure. PARTICIPANTS: Ninety geriatric patients (mean age+/-standard deviation 79.7+/-7.5) admitted to acute care or rehabilitation units. MEASUREMENTS: Patients' energy intake and resting EE (REE) were measured over a 3-day period. Blood samples were taken to determine C-reactive protein (CRP), creatinine, and albumin concentrations and to check renal function. RESULTS: Energy intake was higher than REE by a factor of 1.29, but it was lower than the energy requirement. Energy intake, adjusted for differences in body weight, was independent of sex, highest in those who were malnourished (defined as a body mass index (BMI) <21), and lowest in patients who scored poorly on the Mini-Mental State Examination. Energy intake and REE were independent of plasma CRP, creatinine, and albumin concentrations, as well as the initial diagnosis. REE was similar in men and women, at 18.8 kcal/kg per day. REE was 21.4 kcal/kg per day in patients with a BMI of 21 or less and 18.4 kcal/kg per day in those with a BMI greater than 21 kg/m2. The Harris-Benedict equation accurately predicted mean REE. CONCLUSION: The mean REE of the geriatric patients studied was 18.8 kcal/kg per day, whereas energy intake was just sufficient to cover minimal requirements. Thus, hospitalized elderly patients are likely to benefit from higher calorie intake.

Real versus sham proximal biofield therapy in the treatment of warts of the hands and feet in adults: study protocol for a randomized controlled trial (MAGNETIK study).

BACKGROUND: Despite the lack of scientific studies on biofield therapies, they are widely acclaimed by patients. The mechanisms of action are not explained by current allopathic medical approaches. Warts are common and contagious viral lesions that may be refractory to standard dermatologic treatments such as cryotherapy, laser therapy, and keratolytic ointments. Biofield therapies are efficient in various pathologies. Their ability to treat warts has never been demonstrated in a scientific study with a robust methodology. Patients with refractory warts often place their trust in these alternative therapies because of the poor results obtained from traditional medicine. We propose a prospective, randomized, single-blind, assessor-blind trial to evaluate the efficacy of treatment of warts by biofield therapy. METHODS/DESIGN: Subjects with warts on their feet or hands will be randomized into two groups: real biofield therapy versus sham therapy. The diagnosis will be made at the time of inclusion, and follow-up will take place in week 3. Comparison of pictures of the warts at baseline and after 3 weeks will be used as the primary outcome measure. The hypothesis is that the extent of the disappearance of the original wart in the group treated by real biofield therapy will be 70% and that it will be 30% in the group treated by sham therapy. Using 90% power and an alpha risk of 5%, 31 subjects are required in each group for a two-tailed proportion comparison test. DISCUSSION: To our knowledge, this is the first study to evaluate the efficacy of biofield therapy on warts. Therefore, the aim of this study is to extend knowledge of biofield therapy to another area of medicine such as dermatology and to propose complementary or alternative practices to improve patient well-being. The main strength of the study is that it is a randomized, single-blind, assessor-blind, placebo-controlled study. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02773719 . Registered on 22 April 2016.

Overview of adverse events related to invasive procedures in the intensive care unit.

BACKGROUND: This study was conducted to determine the frequency, predictors, and clinical impact of adverse events (AEs) related to invasive procedures in the intensive care unit (ICU). METHODS: This was a prospective observational study of ICUs in a university hospital. RESULTS: A total of 893 patients requiring invasive procedures were admitted over a 1-year period. Among these, 310 patients (34.7%) experienced a total of 505 AEs. The mean number of AEs per patient was 1.6 ± 1.1 (range, 1-7). Infectious AEs were significantly more frequent than mechanical AEs (60.4% vs 39.6%; P = .01). Factors independently associated with AE occurrence were isolation of multidrug-resistant bacteria at ICU admission, >5 invasive procedures, and ICU length of stay >8 days. Thirty-three AEs (6.5%) resulted in severe clinical impact, including 24 deaths. Ventilator-associated pneumonia (VAP) accounted for 62.5% of the deaths related to AEs. CONCLUSIONS: One-third of critically ill patients experienced AEs related to invasive procedures. Severe AEs were associated with 11% of all ICU deaths. VAP was the most frequent AE related to death. An improved assessment of the risk-benefit balance before each invasive procedure and increased efforts to decrease VAP prevalence are needed to reduce AE-related mortality.

Health-e-Child project: mechanical dyssynchrony in children with dilated cardiomyopathy.

OBJECTIVE: Left ventricular mechanical dyssynchrony has been poorly studied in the pediatric population with dilated cardiomyopathy. We investigated the degree of dyssynchrony in children with dilated cardiomyopathy using tissue Doppler imaging and speckle tracking strain. METHODS: Twenty-five children with dilated cardiomyopathy were compared with healthy subjects. Left ventricular mechanical dyssynchrony was assessed by speckle tracking strain and tissue Doppler imaging. Both radial and longitudinal dyssynchrony were analyzed. Left ventricular end-diastolic diameter was measured to assess the relation between dyssynchrony and ventricular function and remodeling. RESULTS: Radial and longitudinal dyssynchrony parameters were significantly higher in the dilated cardiomyopathy group and correlated with Z-score left ventricular end-diastolic diameter. A logarithmic correlation between left ventricular ejection fraction and left ventricular end-diastolic diameter parameters was found. CONCLUSION: In children with dilated cardiomyopathy, tissue Doppler imaging and speckle tracking strain allowed the detection of dyssynchrony, which correlates with the severity of left ventricular function.

Are elderly hospitalized patients getting enough protein?

OBJECTIVES: To determine the protein requirements of elderly hospitalized patients. DESIGN: Cross-sectional evaluation of nitrogen balance. SETTING: Short-stay geriatric ward or rehabilitation care unit. PARTICIPANTS: Thirty-six elderly hospitalized patients (aged 65-99) admitted to short-stay and rehabilitation care units. MEASUREMENTS: Resting energy expenditure and nitrogen balance were determined under usual and spontaneous energy and protein intake after subjects were clinically stable (3-5 days after admission). All items consumed over a 3-day period were weighed to determine energy and protein intake. RESULTS: Energy (23.5+/-6.3 kcal/kg per day) and protein (0.99+/-0.24 g/kg per day) intake were similar in men and women, and nitrogen balance was neutral (0.37+/-2.6 g/day; P=.41 vs a neutral nitrogen balance, i.e., 0 g/d). Half of the patients had a positive nitrogen balance. Plasma C-reactive protein, renal function, nutritional status, and initial diagnosis had no influence on nitrogen balance. In contrast, energy and protein intakes correlated positively with nitrogen balance. Linear regression analysis suggested that an elderly hospitalized patient with an energy intake of 1.31 times resting energy expenditure or greater appears to require a minimum protein intake of 1.06+/-0.28 g/kg per day. CONCLUSION: Mean protein intake to reach a neutral nitrogen balance in elderly hospitalized patients is 1.06+/-0.28 g/kg per day, which is higher than current recommendations for healthy elderly people. Safe protein intake (that would be adequate to ensure that 95% of patients remain in positive nitrogen balance) is difficult to establish.