Accuracy of Nutritional Screening Tools in Assessing the Risk of Undernutrition in Hospitalized Children.

OBJECTIVE: The aim of the present study was to evaluate the predictive accuracy of screening tools for assessing nutritional risk in hospitalized children in developed countries. METHODS: The study involved a systematic review of literature (MEDLINE, EMBASE, and Cochrane Central databases up to January 17, 2014) of studies on the diagnostic performance of pediatric nutritional screening tools. Methodological quality was assessed using a modified QUADAS tool. Sensitivity and specificity were calculated for each screening tool per validation method. A meta-analysis was performed to estimate the risk ratio of different screening result categories of being truly at nutritional risk. RESULTS: A total of 11 studies were included on ≥1 of the following screening tools: Pediatric Nutritional Risk Score, Screening Tool for the Assessment of Malnutrition in Paediatrics, Paediatric Yorkhill Malnutrition Score, and Screening Tool for Risk on Nutritional Status and Growth. Because of variation in reference standards, a direct comparison of the predictive accuracy of the screening tools was not possible. A meta-analysis was performed on 1629 children from 7 different studies. The risk ratio of being truly at nutritional risk was 0.349 (95% confidence interval [CI] 0.16-0.78) for children in the low versus moderate screening category and 0.292 (95% CI 0.19-0.44) in the moderate versus high screening category. CONCLUSIONS: There is insufficient evidence to choose 1 nutritional screening tool over another based on their predictive accuracy. The estimated risk of being at "true nutritional risk" increases with each category of screening test result. Each screening category should be linked to a specific course of action, although further research is needed.

Predictors and impact of non-adherence in adults with attention-deficit/hyperactivity disorder receiving OROS methylphenidate: results from a randomized, placebo-controlled trial.

BACKGROUND: Medication non-adherence has an important impact on treatment efficacy and healthcare burden across a range of conditions and therapeutic areas. The aim of this analysis was to determine predictors of non-adherence and impact of non-adherence on treatment response in adults with attention-deficit/hyperactivity disorder (ADHD). METHODS: Post-hoc analysis of a 13-week randomized, double-blind placebo-controlled study of OROS methylphenidate (MPH) 54 and 72 mg/day. Primary efficacy variable was the Conners' Adult ADHD Rating Scale - Screening Version (CAARS:O-SV). Daily adherence was calculated as average daily adherence (100 × capsules taken/2), with overall adherence calculated as the average daily adherence. Predictors of adherence were assessed using mixed-effects logistic regression. Descriptive statistics were generated for change in CAARS:O-SV score for adherent (> 95% adherence) and non-adherent subjects. Predictors of change were analyzed using a mixed model. RESULTS: Subjects were allocated to OROS MPH (54 mg, n = 87; 72 mg, n = 92) or placebo (n = 97). Mean adherence was 92.6% and 93.3% (OROS MPH 54 and 72 mg/day, respectively), versus 97.5% (placebo). Adherence was higher and less variable in completers. Factors significantly associated with non-adherence included female sex, shorter time since ADHD diagnosis, higher education level (completion of university) and score on the Drug Use Screening Inventory psychiatric disorders subscale. Improvements from baseline in CAARS:O-SV score were numerically greater in subjects defined as adherent than in those who were non-adherent. Significant predictors of CAARS:O-SV change in patients who completed the study included percentage adherence up to the point of assessment (p < 0.0001), baseline score (p < 0.0001) and family history of ADHD (p = 0.0003). CONCLUSION: The results of this analysis suggest that newly diagnosed patients, those with a high score on the DUSI-R psychiatric disorder scale, women, and subjects with high educational degrees may be at increased risk of non-adherence. Clinicians and policymakers should therefore pay special attention to these individuals, as non-adherence is a significant predictor of reduced response to treatment. TRIAL REGISTRATION: EudraCT #: 2007-002111-82.

Predicting long-term response to strong opioids in patients with low back pain: findings from a randomized, controlled trial of transdermal fentanyl and morphine.

BACKGROUND: Some patients with long-standing low back pain will benefit from treatment with strong opioids. However, it would be helpful to predict which patients will have a good response. A fixed-term opioid trial has been recommended, but there is little evidence to suggest how long this trial should be. We assessed data from a large-scale randomized comparison of transdermal fentanyl (TDF) and sustained-release oral morphine (slow-release morphine; SRM) to determine characteristics of treatment responders. METHODS: This was a secondary analysis of a previously published 13-month randomized trial involving 680 patients with long-standing low back pain (median age 52 years, 61% women, median duration of back pain 87 months). Pain relief was recorded using visual analogue scales (VAS). Treatment response was defined as pain relief of at least 30% from baseline to any point during the trial. We used a step-wise logistic regression to identify variables that might predict response to treatment. Covariates included treatment group, sex, age, duration of pain, presence of neuropathic pain, baseline pain scores, educational/employment status, use of high doses of opioids, and social functioning (SF)-36 scores. RESULTS: Over half the patients in both groups (n = 370; 54% TDF, 55% SRM) were treatment responders. There were no differences between the TDF and SRM responders in terms of age, sex, type or duration of pain between responders and non-responders. The difference in response to treatment between responders and non-responders could be detected at 3 weeks. Lack of response after 1 month had a stronger negative predictive value (i.e., ability to detect non-responders) than the presence of response after 1 month. The most influential factors for predicting a response were employment status (chi2 = 11.06, p = 0.0259) and use of high doses of opioids (chi2 = 3.04, p = 0.0811). CONCLUSION: No clear pattern of baseline pain (type or severity) or patient characteristics emerged that could be used to predict responders before the start of opioid treatment. However, a 1-month trial period appears sufficient to determine response and tolerability in most cases.

Patients' and physicians' perspectives on opioid therapy for chronic cancer and musculoskeletal pain in Germany, Italy, and Turkey: PAin RESearch (PARES) survey.

OBJECTIVE: Under-treatment or lack of appropriate treatment for chronic pain remains an ongoing major healthcare problem. Opioids are being increasingly recognized as an effective option for chronic pain management. The objective of this survey was to understand the perspective of patients treated with opioids on quality of treatment, preferences, and possibilities to improve treatment and communication between patients and physicians. RESEARCH DESIGN: A large-scale PAin RESearch (PARES) survey of 2860 patients (Germany, Italy, and Turkey) with chronic cancer or musculoskeletal pain prescribed opioid therapy was conducted to assess various factors such as ease of use and compliance, sleep, quality-of-life, and polymedication. A physician component was also included. Relationships between variables and differences between groups were tested using Spearman and Wilcoxon signed-rank tests, respectively. RESULTS: Of the patients surveyed, 61% received strong opioids (WHO III) and 39% weak opioids (WHO II). Nearly 65% of the patients were currently on a twice daily or more dosing schedule; however, 61.5% of the patients responded that they considered once-daily dosing to be the most convenient schedule. Patients' responses indicated that different dosing schedules significantly influenced the occurrence of end-of-dose pain, feeling limited by the remaining level of pain, problems in falling asleep, and episodes of waking up at night or early in the morning. Physicians' responses showed that they were not surprised by 68.5% of patient responses; they also felt the need to change some aspect of pain treatment for a third of the patients, the commonest being pain medication (52.4%). CONCLUSIONS: The results of the survey suggest that patients prefer a convenient dosing scheme, which may have a positive impact on compliance. Physicians may have to communicate more closely with patients about their needs.

The STRONG(kids) nutritional screening tool in hospitalized children: a validation study.

OBJECTIVE: The STRONGkids is a nutritional screening tool for hospitalized children, which was found to predict a negative weight for height (WFH) standard deviation score (SDS) and a prolonged hospital length of stay (LOS) in a Dutch population of hospitalized children. This study aimed to test the ease of use and reproducibility of the STRONGkids, and to confirm its concurrent and prospective validity in a Belgian population of hospitalized children. METHODS: Reproducibility was tested in a cohort of 29 hospitalized children in a tertiary center and validity was tested in 368 children (105 hospitalized in a tertiary and 263 in three secondary hospitals) ages between 0.08 and 16.95 y (median 2.2 y). RESULTS: Substantial intrarater (κ = 0.66) and interrater (κ = 0.61) reliabilities were found between observations. STRONGkids scores correlated negatively with WFH SDS of the patients (ρ = -0.23; P < 0.01; odds ratio [OR], 2.47; 95% confidence interval [CI], 1.11-5.49; P < 0.05). It had a sensitivity and negative predictive value (NPV) of respectively 71.9% and 94.8% to identify acutely undernourished children. STRONGkids did not correlate with weight loss during hospitalization, but correlated with LOS (ρ = 0.25; OR 1.96; 95% CI, 1.25-3.07; both P < 0.01) and the set-up of a nutritional intervention during hospitalization (OR, 18.93; 95% CI, 4.48-80.00; P < 0.01). The sensitivity and NPV to predict a LOS ≥ 4 d were respectively 62.6% and 72%, and respectively 94.6% and 98.9% to predict a nutritional intervention. CONCLUSIONS: STRONGkids is an easy-to-use screening tool. Children classified as "low risk" have a 5% probability of being acutely malnourished, with only a 1% probability of a nutritional intervention during hospitalization.

Efficacy and safety of prolonged-release OROS methylphenidate in adults with attention deficit/hyperactivity disorder: a 13-week, randomized, double-blind, placebo-controlled, fixed-dose study.

OBJECTIVES: Methylphenidate (MPH) is effective for adults with attention-deficit/hyperactivity disorder (ADHD). This study aimed to evaluate the efficacy and safety of OROS MPH in adults with ADHD. METHODS: Randomized, double-blind study; 279 subjects received OROS MPH 54 or 72 mg/day, or placebo, for 13 weeks. Primary endpoint was the Conners' Adult ADHD Rating Scale - Screening Version (CAARS-O:SV). Secondary outcomes included CAARS Self Report - Short Version (CAARS-S:S), Sheehan Disability Scale (SDS) and ADHD Impact Module - Adult (AIM-A). RESULTS: Improvements in CAARS-O:SV were significantly greater with OROS MPH 72 mg vs. placebo (P = 0.0024). CAARS-S:S scores decreased significantly vs. placebo in both OROS MPH arms (P < 0.05). There was no significant change in SDS score from baseline in either treatment arm, although significant benefit vs. placebo was observed on several AIM-A subscales. Treatment was well tolerated. CONCLUSIONS: OROS MPH provided overall benefits in the treatment of adults with ADHD.

Predictors of placebo response in adults with attention-deficit/hyperactivity disorder: data from 2 randomized trials of osmotic-release oral system methylphenidate.

OBJECTIVE: To find potential correlates of placebo response in adults with attention-deficit/hyperactivity disorder (ADHD) and gain insights into why placebo response may be high in clinical trials. METHOD: Post hoc analysis of placebo data from 2 randomized controlled trials of osmotic-release oral system (OROS) methylphenidate in adults with ADHD defined according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition: the Long-Acting Methylphenidate in Adults with ADHD (LAMDA-I) study (2005-2006, 5 weeks, n = 95) and the LAMDA-II study (2008-2009, 13 weeks, n = 97). The primary efficacy measure was the Conners' Adult ADHD Rating Scale-observer rated, short version (CAARS:O-SV). Predictors of CAARS:O-SV change were assessed using a random-intercepts model with demographic and disease-related parameters as independent variables. Sensitivity analyses were conducted using the CAARS self-report (CAARS:S-S) and a categorical response criterion (improvement of > 30% in CAARS:O-SV), and in subjects who completed the study. RESULTS: In LAMDA-I, mean ± SD change in CAARS:O-SV was -7.6 ± 9.9 with placebo and -11.9 ± 10.6 with OROS methylphenidate. Higher baseline CAARS score (P = .007) and lower educational achievement (P = .014) were significantly associated with greater improvement in placebo-treated subjects. In LAMDA-II, mean ± SD change in CAARS:O-SV was -10.4 ± 11.0 and -14.1 ± 10.7 in subjects receiving placebo and OROS methylphenidate, respectively. Variables significantly associated with greater placebo response were higher baseline CAARS:O-SV (P = .019), shorter time since ADHD diagnosis (P < .045), and younger age (P = .014). None of the sensitivity analyses challenged the outcomes. CONCLUSIONS: Possible predictors of placebo response in adults with ADHD include higher severity of ADHD symptoms, younger age, shorter time since diagnosis, and lower educational level.

Predictors of treatment outcome in adults with ADHD treated with OROS® methylphenidate.

BACKGROUND: We conducted a post-hoc analysis of the Long-Acting MethylpheniDate in Adult attention-deficit hyperactivity disorder (LAMDA) study to investigate predictors of response in adults with ADHD randomly assigned to Osmotic Release Oral System (OROS)(®)-methylphenidate hydrochloride (MPH) 18, 36 or 72 mg or placebo. METHODS: LAMDA comprised a 5-week, double-blind (DB) period, followed by a 7-week, open-label (OL) period. A post-hoc analysis of covariance and a logistic regression analysis were undertaken to detect whether specific baseline parameters or overall treatment compliance during the double-blind phase contributed to response. The initial model included all covariates as independent variables; a backward stepwise selection method was used, with stay criteria of p<0.10. Six outcomes were considered: change from baseline CAARS:O-SV (physician-rated) and CAARS:S-S (self-report) scores at DB and OL end points, and response rate (≥30% decrease in CAARS:O-SV score from baseline) and normalization of CAARS:O-SV score at DB end point. RESULTS: Taking into account a significant effect of OROS(®)-MPH treatment versus placebo in the original analysis (p≤0.015), across the outcomes considered in this post-hoc analysis, higher baseline CAARS scores were most strongly predictive of superior outcomes. Male gender and lower academic achievement were also predictive for improved results with certain outcomes. CONCLUSIONS: Several baseline factors may help to predict better treatment outcomes in adults receiving OROS(®)-MPH; however, further research is required to confirm these findings and examine their neurobiological underpinnings.

Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder.

The osmotic release oral system (OROS) methylphenidate formulation is a prolonged-release medication for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. We conducted a seven-week open-label extension of a double-blind study to assess the safety and tolerability of OROS methylphenidate in a flexible dose regimen (18-90 mg daily) for the treatment of adults diagnosed with ADHD (N =370). Medication was adjusted to optimize efficacy and tolerability for each patient. Adverse events, vital signs, and laboratory parameters were assessed. Most patients (337; 91%) completed the seven-week treatment and the final dispensed dose was 18 mg (8%), 36 mg (29%), 54 mg (34%), 72 mg (20%), or 90 mg (9%). Adverse events were reported in 253 (68%) patients and most were mild or moderate in severity; most frequently reported included headache (17%), decreased appetite (13%), and insomnia (11%). Adverse events were rarely serious (<1%; 2/370). Small mean increases in systolic and diastolic blood pressure (both 2.4 mmHg) and pulse (3.2 bpm) were observed. Body weight decreased slightly (-1.5 kg). The results provide additional support for the safety and tolerability of prolonged-release OROS methylphenidate in a flexible dose regimen (18-90 mg/day) for the treatment of adults with ADHD.