Type I error rates from likelihood‐based repeated measures analyses of incomplete longitudinal data

The last observation carried forward (LOCF) approach is commonly utilized to handle missing values in the primary analysis of clinical trials. However, recent evidence suggests that likelihood‐based analyses developed under the missing at random (MAR) framework are sensible alternatives. The objective of this study was to assess the Type I error rates from a likelihood‐based MAR approach – mixed‐model repeated measures (MMRM) – compared with LOCF when estimating treatment contrasts for mean change from baseline to endpoint (Δ). Data emulating neuropsychiatric clinical trials were simulated in a 4 × 4 factorial arrangement of scenarios, using four patterns of mean changes over time and four strategies for deleting data to generate subject dropout via an MAR mechanism. In data with no dropout, estimates of Δ and SE_Δ from MMRM and LOCF were identical. In data with dropout, the Type I error rates (averaged across all scenarios) for MMRM and LOCF were 5.49% and 16.76%, respectively. In 11 of the 16 scenarios, the Type I error rate from MMRM was at least 1.00% closer to the expected rate of 5.00% than the corresponding rate from LOCF. In no scenario did LOCF yield a Type I error rate that was at least 1.00% closer to the expected rate than the corresponding rate from MMRM. The average estimate of SE_Δ from MMRM was greater in data with dropout than in complete data, whereas the average estimate of SE_Δ from LOCF was smaller in data with dropout than in complete data, suggesting that standard errors from MMRM better reflected the uncertainty in the data. The results from this investigation support those from previous studies, which found that MMRM provided reasonable control of Type I error even in the presence of MNAR missingness. No universally best approach to analysis of longitudinal data exists. However, likelihood‐based MAR approaches have been shown to perform well in a variety of situations and are a sensible alternative to the LOCF approach. MNAR methods can be used within a sensitivity analysis framework to test the potential presence and impact of MNAR data, thereby assessing robustness of results from an MAR method. Copyright © 2004 John Wiley & Sons, Ltd.     

Choice of the primary analysis in longitudinal clinical trials

Missing data, and the bias they can cause, are an almost ever‐present concern in clinical trials. The last observation carried forward (LOCF) approach has been frequently utilized to handle missing data in clinical trials, and is often specified in conjunction with analysis of variance (LOCF ANOVA) for the primary analysis. Considerable advances in statistical methodology, and in our ability to implement these methods, have been made in recent years. Likelihood‐based, mixed‐effects model approaches implemented under the missing at random (MAR) framework are now easy to implement, and are commonly used to analyse clinical trial data. Furthermore, such approaches are more robust to the biases from missing data, and provide better control of Type I and Type II errors than LOCF ANOVA. Empirical research and analytic proof have demonstrated that the behaviour of LOCF is uncertain, and in many situations it has not been conservative. Using LOCF as a composite measure of safety, tolerability and efficacy can lead to erroneous conclusions regarding the effectiveness of a drug. This approach also violates the fundamental basis of statistics as it involves testing an outcome that is not a physical parameter of the population, but rather a quantity that can be influenced by investigator behaviour, trial design, etc. Practice should shift away from using LOCF ANOVA as the primary analysis and focus on likelihood‐based, mixed‐effects model approaches developed under the MAR framework, with missing not at random methods used to assess robustness of the primary analysis. Copyright © 2004 John Wiley & Sons, Ltd.     

Setting operational goals for corporate social responsibility

In this article the author argues that more formality in social responsibility planning efforts is a concept which is extremely pertinent in today's conditions. Rewards will accrue to the organization that can move beyond aesthetic objectives and achieve operationality in social responsibility goal setting. This requires, basically, the application of techniques that have proved to be successful in MBO programs. By translating broadly stated social objectives into goals that are clear, concise, time related and cost related, management will inject an increased measure of integrity into its planning process, improve social responsibility programs, assure future successes in the social performance arena, facilitate the appraisal of management personnel, and enhance the organization's credibility with its multiple publics. Positive benefits will flow to the organization, its immediate publics, and to the society at large as a consequence of operational planning methods as described herein.     

Family court ordered “reunification therapy:” junk science in the guise of helping parent/child relationships?

This Commentary addresses the issue of the ethics of mental health professionals recommending or doing what family courts and some others are calling “Reunification Therapy.” This is often being recommended and used across the country, and ordered by family courts, as if it has a scientific basis for successful therapy between an estranged parent and a child who does not wish to re-engage with that parent, often where the child has alleged the parent has abused them physically, sexually, or psychologically. This Commentary challenges the ethics and validity of such approaches and programs.     

Process evaluation of an environmental walking and healthy eating pilot in small rural worksites

Small Steps are Easier Together (SS) was a pilot environmental intervention in small rural worksites in Upstate New York in collaboration with Extension educators. Worksite leaders teamed with co-workers to select and implement environmental changes to increase walking steps over individual baseline and to choose healthy eating options over 10 weeks. Participants were 226 primarily white, women employees in 5 sites. A mixed methods process evaluation, conducted to identify determinants of intervention effectiveness and to explain differences in outcomes across worksites, included surveys, self-reports of walking and eating, interviews, focus groups, and an intervention log. The evaluation assessed reach, characteristics of recruited participants, dose delivered, dose received, and context and compared sites on walking and eating outcomes. Emergent elements of participant-reported dose received included: active leadership, visible environmental changes, critical mass of participants, public display of accomplishments, accountability to co-workers, and group decision making. Participants at sites with high reach and dose were significantly more likely than sites with low reach and dose to achieve intervention goals. Although this small pilot needs replication, these findings describe how these evaluation methods can be applied and analyzed in an environmental intervention and provide information on trends in the data.     

Differing Relationship Outcomes When Sex Happens Before,On, or After First Dates

While recent studies have suggested that the timing of sexual initiation within a couple's romantic relationship has important associations with later relationship success, few studies have examined how such timing is associated with relationship quality among unmarried couples. Using a sample of 10,932 individuals in unmarried, romantic relationships, we examined how four sexual-timing patterns (i.e., having sex prior to dating, initiating sex on the first date or shortly after, having sex after a few weeks of dating, and sexual abstinence) were associated with relationship satisfaction, stability, and communication in dating relationships. Results suggested that waiting to initiate sexual intimacy in unmarried relationships was generally associated with positive outcomes. This effect was strongly moderated by relationship length, with individuals who reported early sexual initiation reporting increasingly lower outcomes in relationships of longer than two years.     

Randomized controlled trial of the Resilience and Coping Intervention (RCI) with undergraduate university students

Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18–23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an intervention (n = 64) or a control (n = 65) group. Intervention participants received three 45-minute RCI sessions over subsequent weeks. All participants completed pre- and post-intervention assessments at the beginning of Week 1 and end of Week 3. Student resilience, coping, hope, stress, depression, and anxiety were assessed. Results. RCI participants reported significantly more hope and less stress and depression from Week 1 to Week 3 compared with control participants. Results for resilience also approached statistical significance. Effect sizes were small to moderate. Conclusions: This study found preliminary evidence that RCI is an effective resilience intervention for use with college students.