Principles and Problems in the Assessment of Quality of Life in Health Care

A remarkable surge in efforts to assess the quality of life of patients has occurred in recent years in medical research. Philosophical discussions of these developments have focused, on the one hand, on epistemological reservations about the plausibility of measuring quality of life and, on the other hand, on moral and ethical qualms about the meaning of life conveyed in such assessments. Whilst providing an important note of caution, such critiques fail to recognise two basic principles of quality of life in medical research. Firstly it is intended to provide understanding about groups and categories of patients rather than individuals. Secondly the purpose of such research is to produce generalisations about the relative costs and benefits of specific health care interventions rather than absolute judgements regarding the quality of life of patients per se. Selecting a good quality of life measure for a clinical trial requires balancing criteria such as validity with practical feasibility. Such measures will play an increasingly central role in providing research evidence to improve health care.     

Effects of Peer-Mediated Accountability on Opportunities to Respond and Correct Skill Performance by Elementary School Children in Physical Education

We investigated the effects of group instruction, peer-dyads, and peer-mediated accountability on the number of trials performed and the number of correct trials during one-minute timed trials of volleyball skills. Peer-mediated accountability consisted of teacher goal setting, peer recording of performance, public posting of performance, and special content-related activities that served as public recognition of achievement. Twenty-four students in a Grade 4 physical education class participated. A reversal A-B-A-C design was used to assess the effects of each condition. Results indicated that students performed more trials and were more successful in the peer-mediated accountability condition than during either group instruction of peer dyads conditions. Findings are discussed in terms of the contingent relation between performance and consequences created by the peer-mediated accountability variable.     

Uncertainty and the Ethics of Clinical Trials

A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible.     

Cognitive therapy for post-traumatic stress disorder: development and evaluation

The paper describes the development of a cognitive therapy (CT) program for post-traumatic stress disorder (PTSD) that is based on a recent cognitive model (Behav. Res. Therapy 38 (2000) 319). In a consecutive case series, 20 PTSD patients treated with CT showed highly significant improvement in symptoms of PTSD, depression and anxiety. A subsequent randomized controlled trial compared CT (N = 14) and a 3-month waitlist condition (WL, N = 14). CT led to large reductions in PTSD symptoms, disability, depression and anxiety, whereas the waitlist group did not improve. In both studies, treatment gains were well maintained at 6-month follow-up. CT was highly acceptable, with an overall dropout rate of only 3%. The intent-to-treat effect sizes for the degree of change in PTSD symptoms from pre to post-treatment were 2.70-2.82 (self-report), and 2.07 (assessor-rated). The controlled effect sizes for CT versus WL post-treatment scores were 2.25 (self-report) and 2.18 (assessor-rated). As predicted by the cognitive model, good treatment outcome was related to greater changes in dysfunctional post-traumatic cognitions. Patient characteristics such as comorbidity, type of trauma, history of previous trauma, or time since the traumatic event did not predict treatment response, however, low educational attainment and low socioeconomic status were related to better outcome.     

Effects of Participant’s Choice of Different Digital Interventions on Outcomes for Binge-Spectrum Eating Disorders: A Pilot Doubly Randomized Preference Trial

It is unclear whether offering individuals a choice between different digital intervention programs affects treatment outcomes. To generate initial insights, we conducted a pilot doubly randomized preference trial to test whether offering individuals with binge-spectrum eating disorder a choice between two digital interventions is causally linked with superior outcomes than random assignment to these interventions. Participants with recurrent binge eating were randomized to either a choice (n = 77) or no-choice (n = 78) group. Those in the choice group could choose one of the two digital programs, while those in the no-choice group were assigned a program at random. The two digital interventions (a broad and a focused program) took 4 weeks to complete, were based on cognitive-behavioral principles and have demonstrated comparable efficacy, but differ in scope, content, and targeted change mechanisms. Most participants (79%) allocated to the choice condition chose the broad program. While both groups experienced improvements in primary (Eating Disorder Examination Questionnaire global scores and number of binge eating episodes over the past month) and secondary outcomes (dietary restraint, body image concerns, etc.), no significant between-group differences were observed. The two groups did not differ on dropout rates, nor on most indices of intervention engagement. Findings provide preliminary insights towards the role of client preferences in digital mental health interventions for eating disorders. Client preferences may not determine outcomes when digital interventions are based on similar underlying principles, although larger trials are needed to confirm this.     

Process Analyses of Impulsive Behavior in Binge-Eating Disorder During the Randomized Controlled IMPULS Trial

Impulsivity represents a risk factor for patients with binge-eating disorder, and we therefore investigated the treatment process of impulsive behaviors including binge-eating episodes in the randomized controlled IMPULS trial. Using 8 weekly online questionnaires throughout the assessment period, we compared 41 patients participating in the IMPULS program, which emphasized impulsive eating behavior (IG), with 39 control patients who received no intervention (CG). We assessed the frequency of binge eating, other impulsive behaviors, situations in which such behaviors could be inhibited, and the execution of alternative behaviors. Results indicate a stronger binge-eating reduction in the IG compared to the CG at the fifth, seventh, and eighth treatment weeks. Overall, both groups reduced other impulsive behaviors. They did not differ in the amount of inhibited impulsive behaviors and showed similar alternative behaviors, “distraction” most frequently used. IG patients evaluated the IMPULS program as very helpful. The stronger reduction of binge eating in the IG and positive evaluation of the treatment indicate a specific treatment effect regarding impulsive eating behavior. The reduction of other impulsive behaviors across both groups, and the initial reduction of binge eating within the CG, could be explained by an increased degree of self-observation.     

A Randomized Community-Based Trial of Behavior Therapy vs. Usual Care for Adolescent ADHD: Secondary Outcomes and Effects on Comorbidity

Though behavior therapy (BT) for ADHD in adolescence is evidence-based, almost no work examines its implementation and effectiveness in community settings. A recent randomized community-based trial of an evidence-based BT for adolescent ADHD (Supporting Teens’ Autonomy Daily; STAND; N = 278) reported high clinician, parent, and youth acceptability but variable implementation fidelity. Primary outcome analyses suggested no significant differences between STAND and usual care (UC) unless the clinician delivering STAND was licensed. The present study reports secondary outcomes for this trial on indices of comorbidity (anxiety, depression, oppositional defiant disorder, conduct disorder) and ADHD outcomes not targeted by the active treatment (social skills, sluggish cognitive tempo). We also examine whether therapist licensure moderated treatment effects (as in primary outcome analyses). Using intent-to-treat and per protocol linear mixed models, patients randomized to STAND were compared to those randomized to UC over approximately 10 months of follow-up. Group × Time effects revealed that, overall, STAND did not outperform usual care when implemented by community clinicians. However, a Group × Time × Licensure interaction revealed a significant effect on conduct problems when STAND was delivered by licensed clinicians (d = .19–.47). When delivered in community settings, behavior therapy for adolescent ADHD can outperform UC with respect to conduct problems reduction. Community mental health clinics should consider: (1) assigning adolescent ADHD cases to licensed professionals to maximize impact and (2) choosing psychosocial approaches when ADHD presents with comorbid conduct problems. There is also a need to reduce implementation barriers for unlicensed clinicians in community settings.     

Randomized controlled trial of a prenatal focused coparenting consultation for unmarried black fathers and mothers: One-year infant and family outcomes

In the infant mental health field, scant conceptual attention has been given to coparenting and family adaptations of non-white family systems, with no evidence-based, community-informed coparenting interventions responsive to unmarried Black mothers’ and fathers’ life circumstances. This study examined 1-year post-partum child and family outcomes of a novel, modest dosage (six sessions) prenatal focused coparenting consultation (FCC) using randomized controlled trial methodology. One-hundred-thirty-eight expectant families (one or both parents identified as Black/African American) were randomized to an intervention (N = 70) or treatment-as-usual (TAU; control) condition (N = 68). TAU families received navigational support in accessing existing community services for pregnant families. Intervention families received TAU plus 6 dyadic FCC sessions led by a Black male-female Community Mentor team. When infants were three and 12 months old, parents reported on coparenting, father engagement, interparental aggression, depressive symptoms, and infant social and emotional adjustment. Intent-to-treat analyses focusing on 12-month post-partum data indicated significant intervention effects on coparenting, interparental psychological aggression, and infants’ emotional adjustment. Improvement was also seen in depression and father engagement, with gains for both groups. Results suggest FCC delivered by same-race Community Mentors to unmarried Black coparents transitioning to parenthood supports infant and family adaptation during the first year of life.     

TREATMENT OF PICA THROUGH MULTIPLE ANALYSES OF ITS REINFORCING FUNCTIONS

We conducted functional analyses of the pica of 3 participants. The pica of 1 participant appeared to be maintained by automatic reinforcement; that of the other 2 participants appeared to be multiply controlled by social and automatic reinforcement. Subsequent preference and treatment analyses were used to identify stimuli that would compete with the automatic function of pica for the 3 participants. These analyses also identified the specific aspect of oral stimulation that served as automatic reinforcement for 2 of the participants. In addition, functional analysis-based treatments were used to address the socially motivated components of 2 of the participants' pica. Results are discussed in terms of (a) the importance of using the results of functional analyses to develop treatments for pica and (b) the advantages of developing indirect analyses to identify specific sources of reinforcement for automatically reinforced behavior.     

Effects of sequential 1-minute time trials with and without inter-trial feedback and self-correction on general and special education students' fluency with math facts

We measured the effects of two procedures for implementing 1-min time trials on the rate and accuracy with which elementary students wrote answers to single-digit math facts in two concurrent experiments in a first grade classroom and a special education classroom. On-task behavior of three students in each class was also measured. Baseline was a 10-min work period in which students were told to answer as many problems as you can. The two time trial conditions, each of which was also conducted within a 10-min period, consisted of: (1) a series of seven 1-min time trials with a 20-s rest period following each timing; and (2) two 1-min timings, each followed by a teacher-directed feedback and self-correction activity. Students in both classrooms answered correctly more problems per minute during both time trial conditions than they did during the 10-min work period, with the highest levels of fluency occurring during the two time trials with self-correction. The emphasis on going fast did not impair students' accuracy of performance. In both classrooms the percentage of attempted problems answered correctly was high during the initial baseline and increased slightly over the course of the study. On-task behavior was higher during both time trial conditions than during the 10-min work period. When asked at the study's conclusion which of the three methods for practicing math facts (1) helped you learn the most and (2) would you like to do again, the majority of the students in both classrooms chose the time trials followed by feedback and self-correction.