The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: a multi-center randomized trial.

OBJECTIVE: The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice. METHODS: A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored. RESULTS: A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate -3.61; (confidence interval, -7.01, 0.22), and values clarity (estimate -3.57; confidence interval (-5.85,-1.30). Borderline effect was seen for the total decisional conflict score (estimate -1.75; confidence interval (-3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. CONCLUSION: The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.

Immediate and subsequent effects of matched and unmatched stimuli on targeted vocal stereotypy and untargeted motor stereotypy.

The authors evaluated the effects of matched and unmatched stimuli on immediate and subsequent engagement in targeted vocal stereotypy (Experiment 1) and untargeted motor stereotypy (Experiment 2). Results of Experiment 1 showed that (a) matched stimulation decreased immediate engagement in vocal stereotypy for 8 of 11 participants and increased subsequent engagement in vocal stereotypy for only 1 of the 8 participants and (b) unmatched stimulation decreased immediate engagement in vocal stereotypy for only 1 of 10 participants and did not increase subsequent engagement in vocal stereotypy for this participant. Results of Experiment 2 showed that for 8 of 14 participants, untargeted stereotypy increased when the matched or unmatched stimulus was present, after it was removed, or both. The authors briefly discuss the potential clinical implications of using matched stimulation to decrease vocal stereotypy and limitations of the findings.

Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.

BACKGROUND: Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer. METHODS: Patients with: locally advanced (T3 or T4) prostate cancer (n=1057); or organ-confined disease (T2) with either a prostate-specific antigen (PSA) concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25), were randomly assigned (done centrally with stratification and dynamic minimisation, not masked) to receive lifelong ADT and RT (65-69 Gy to the prostate and seminal vesicles, 45 Gy to the pelvic nodes). The primary endpoint was overall survival. The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded. All efficacy analyses were done by intention to treat and were based on data from all patients. This trial is registered at controlledtrials.com as ISRCTN24991896 and Clinicaltrials.gov as NCT00002633. RESULTS: Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6·0 years (IQR 4·4-8·0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74%, 95% CI 70-78 vs 66%, 60-70; hazard ratio [HR] 0·77, 95% CI 0·61-0·98, p=0·033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade >3, three patients (0·5%) in the ADT only group, two (0·3%) in the ADT and RT group; diarrhoea grade >3, four patients (0·7%) vs eight (1·3%); urinary toxicity grade >3, 14 patients (2·3%) in both groups). INTERPRETATION: The benefits of combined modality treatment--ADT and RT--should be discussed with all patients with locally advanced prostate cancer. FUNDING: Canadian Cancer Society Research Institute, US National Cancer Institute, and UK Medical Research Council.

A comparison of reliability measures for continuous and discontinuous recording methods: inflated agreement scores with partial interval recording and momentary time sampling for duration events.

The authors evaluated the extent to which interobserver agreement (IOA) scores, using the block-by-block method for events scored with continuous duration recording (CDR), were higher when the data from the same sessions were converted to discontinuous methods. Sessions with IOA scores of 89% or less with CDR were rescored using 10-s partial interval recording (PIR) and 10-s momentary time sampling (MTS). Results indicated that IOA scores for 10-s PIR and 10-s MTS were consistently higher than IOA scores based on CDR for the same sessions. Specifically, 10-s MTS provided higher overestimations for low-duration events, whereas 10-s PIR produced higher overestimations for moderate- and high-duration events. Implications for researchers and clinicians are briefly discussed.

Predicting preference for items during periods of extended access based on early response allocation.

Top-ranked items were identified during 30-min free-operant preference assessments for 9 individuals. Data from each session were analyzed to identify the item (a) that was engaged with first in each session and (b) to which the most responding was allocated after 5 min, 10 min, 15 min, 20 min, and 25 min had elapsed in each session. The results indicated that the first-engaged item and the 5-min high-allocation item predicted the top-ranked item in 55% and 62% of the sessions, respectively. The results also showed that engagement with the top-ranked item from the first session decreased across subsequent sessions for 6 of the 9 participants. The implications of the results for brief versus extended stimulus preference assessments are discussed.

Temporary increases in problem behavior and sleep disruption following decreases in medication: a descriptive analysis of conditional rates.

Conditional rates of problem behavior for weeks that followed medication decreases and no medication changes were compared for 12 individuals who exhibited severe problem behavior (e.g., self-injury, aggression). The results indicate that conditional rates of problem behavior were higher following medication decreases than following no changes in medication. During the subsequent week, rates of problem behavior typically decreased without reinstating the prior dosage of medication. Additional analyses suggest that the first medication decrease typically produced the highest increase in problem behavior. Decreases in medication also disrupted sleep patterns for several individuals. Possible operant conceptualizations of behavior changes produced by medication decreases are discussed.