Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials.

Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials.

Innov Clin Neurosci. 2013 5; 10(5-6 Suppl A): 4S-19S
Keefe RS, Kraemer HC, Epstein RS, Frank E, Haynes G, Laughren TP, McNulty J, Reed SD, Sanchez J, Leon AC

Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. HubMed – drug

Study Site Experiences and Attitudes Toward Prospective Assessments of Suicidal Ideation and Behavior in Clinical Trials: Results of an Internet-based Survey.

Innov Clin Neurosci. 2013 5; 10(5-6 Suppl A): 20S-28S
Stewart M, Butler A, Alphs L, Chappell PB, Feltner DE, Lenderking WR, Mahableshwarkar AR, Makumi CW, Dubrava S

Objective: The International Society for CNS Clinical Trials and Methodology Suicidal Ideation and Behavior Assessment Working Group conducted an online survey regarding clinical trial site experiences and attitudes toward suicidal ideation and behavior data collection following the 2010 release of the initial United States Food and Drug Administration draft guidance on prospective assessment of suicidal ideation and behavior in clinical trials. Sites that had participated in at least one central nervous system clinical trial in the prior two years (N=6,058) were invited, via email, to complete a 20-item online assessment survey. Results: Nine hundred and seventy-nine evaluable responses were collected (42% United States). Respondents included principal investigators (36%), raters (28%), coordinators (25%), and others (10%). The majority were psychiatrists (43%) and reported using suicidal ideation and behavior assessments across many indications. Most respondents (80%) personally conducted suicidal ideation and behavior assessments. Overall, respondents indicated that suicidal ideation and behavior assessments were readily incorporated into the conduct of clinical trials and improved subject safety. The greatest challenge was obtaining an accurate baseline lifetime history (51%), while the greatest benefit was identifying subjects at risk of suicide (84%). Approximately a quarter of respondents reported implementation challenges such as training. Differences based on geographical region, respondents’ roles, and responsibility for assessments were observed. Open-ended responses revealed additional challenges, e.g., use in cognitively impaired populations. Conclusion: Prospective suicidal ideation and behavior monitoring was generally viewed positively, though specific challenges were identified. Limitations include self-report survey methodology and recruitment of only central nervous system clinical trials sites. These findings may help guide development of better methodologies for suicidal ideation and behavior assessment in clinical trials. HubMed – drug

Use of data mining techniques to determine and predict length of stay of cardiac patients.

Healthc Inform Res. 2013 Jun; 19(2): 121-9
Hachesu PR, Ahmadi M, Alizadeh S, Sadoughi F

Predicting the length of stay (LOS) of patients in a hospital is important in providing them with better services and higher satisfaction, as well as helping the hospital management plan and managing hospital resources as meticulously as possible. We propose applying data mining techniques to extract useful knowledge and draw an accurate model to predict the LOS of heart patients.Data were collected from patients with coronary artery disease (CAD). The patient records of 4,948 patients who had suffered CAD were included in the analysis. The techniques used are classification with three algorithms, namely, decision tree, support vector machines (SVM), and artificial neural network (ANN). LOS is the target variable, and 36 input variables are used for prediction. A confusion matrix was obtained to calculate sensitivity, specificity, and accuracy.The overall accuracy of SVM was 96.4% in the training set. Most single patients (64.3%) had an LOS ?5 days, whereas 41.2% of married patients had an LOS >10 days. Moreover, the study showed that comorbidity states, such as lung disorders and hemorrhage with drug consumption have an impact on long LOS. The presence of comorbidities, an ejection fraction <2, being a current smoker, and having social security type insurance in coronary artery patients led to longer LOS than other subjects.All three algorithms are able to predict LOS with various degrees of accuracy. The findings demonstrated that the SVM was the best fit. There was a significant tendency for LOS to be longer in patients with lung or respiratory disorders and high blood pressure. HubMed – drug

Role of computerized physician order entry usability in the reduction of prescribing errors.

Healthc Inform Res. 2013 Jun; 19(2): 93-101
Peikari HR, Zakaria MS, Yasin NM, Shah MH, Elhissi A

Some hospitals have implemented computerized physician order entry (CPOE) systems to reduce the medical error rates. However, research in this area has been very limited, especially regarding the impact of CPOE use on the reduction of prescribing errors. Moreover, the past studies have dealt with the overall impact of CPOE on the reduction of broadly termed “medical errors”, and they have not specified which medical errors have been reduced by CPOE. Furthermore, the majority of the past research in this field has been either qualitative or has not used robust empirical techniques. This research examined the impacts of usability of CPOE systems on the reduction of doctors’ prescribing errors.One hundred and sixty-six questionnaires were used for quantitative data analyses. Since the data was not normally distributed, partial least square path modelling-as the second generation of multivariate data analyses-was applied to analyze data.It was found that the ease of use of the system and information quality can significantly reduce prescribing errors. Moreover, the user interface consistency and system error prevention have a significant positive impact on the perceived ease of use. More than 50% of the respondents believed that CPOE reduces the likelihood of drug allergy, drug interaction, and drug dosing errors thus improving patient safety.Prescribing errors in terms of drug allergy, drug interaction, and drug dosing errors are reduced if the CPOE is not error-prone and easy to use, if the user interface is consistent, and if it provides quality information to doctors. HubMed – drug

A review of common methods to convert morphine to methadone.

J Community Hosp Intern Med Perspect. 2012; 2(4):
Wong E, Walker KA

When dosed appropriately on carefully chosen patients, methadone can be a very safe and effective choice in managing chronic pain. Many authors have discussed important issues surrounding patient selection, drug interactions, screening for QTc prolongation and monitoring. This article will focus on the dosing dilemma that exists after the patient is deemed an appropriate candidate for methadone and a conversion is necessary from another opioid. Despite many publications dedicated to addressing this challenging topic, there is no consensus on the most appropriate method for converting an opioid regimen to methadone. Given the lack of concrete guidance, clinicians in a community setting are likely to be faced with an increased challenge if there are no available pain specialists to provide clinical support. Common methods for converting morphine to methadone will be reviewed and two clinical patient scenarios used to illustrate the outcomes of applying the methods. HubMed – drug