The development of these minimum measurement standards is intended to promote the appropriate use of PRO measures to inform PCOR and CER, which in turn can improve the effectiveness and efficiency of healthcare delivery. A next step is to expand these minimum standards to identify best practices for selecting decision-relevant PRO measures.

The electronic administration of PRO measures offers many advantages over paper administration. We provide a general framework for decisions regarding the level of evidence needed to support modifications that are made to PRO measures when they are migrated from paper to ePRO devices. The key issues include: 1) the determination of the extent of modification required to administer the PRO on the ePRO device and 2) the selection and implementation of an effective strategy for testing the measurement equivalence of the two modes of administration. We hope that these good research practice recommendations provide a path forward for researchers interested in migrating PRO measures to electronic data collection platforms.

Patient reported outcomes provide the patient's perspective on the effectiveness of treatment. The draft Food and Drug Administration guidance on patient reported outcomes for labeling and promotional claims raises a number of method and measurement issues that require further clarification, including methods of determining responsiveness and minimal important differences. For clinical trials, instruments need to be based on a clear conceptual framework, have evidence supporting content validity and acceptable psychometric qualities. The measures must also have evidence documenting responsiveness and interpretation guidelines (i.e., minimal important difference) to be most useful as effectiveness endpoints in clinical trials. The recommended approach is to estimate the minimal important difference based on several anchor-based methods, with relevant clinical or patient-based indicators, and to examine various distribution-based estimates (i.e., effect size, standardized response mean, standard error of measurement) as supportive information, and then to triangulate on a single value or small range of values for the MID. Confidence in a specific MID value evolves over time and is confirmed by additional research evidence, including clinical trial experience. The MID may vary by population and context, and no one MID will be valid for all study applications involving a PRO instrument. Responsiveness and MID must be demonstrated and documented for the particular study population, and these measurement characteristics are needed for PRO labeling and promotional claims.

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This study was designed to determine the effectiveness ofa group stress reduction program based on mindfulness meditation for patients with anxiety disorders. Method: The 22 study participants were screened with a structured clinical interview and found to meet the DSM-IH-R criteria for generalized anxiety disorder or panic disorder with or without agoraphobia. Assessments, including self-ratings and therapists' ratings, were obtained weekly bef ore and during the meditation-based stress reduction and relaxation program and monthly during the 3-month follow-up period. Results: Repeated measures analyses ofvariance documented significant reductions in anxiety and depression scores after treatment for 20 of the subjects-changes that were maintained at follow-up. The number of subjects experiencing panic symptoms was also substantially reduced. A comparison of the study subjects with a group ofnonstudy participants in the program who met the initial screening criteria for entry into the study showed that both groups achieved similiar reductions in anxiety scores on the SCL-90-R and on the Medical Symptom Checklist, suggesting generalizability of the study f indings. Conclusions: A group mindfulness meditation training program can effectively reduce symptoms ofanxiety and panic and can help maintain these reductions in patients with generalized anxiety disorder, panic disorder, or panic disorder with agoraphobia.

Using a combination of classical test theory and Rasch item analysis, we developed a short scale designed to measure the effectiveness of mental health treatment across a wide range of mental health services and populations. Item development for the scale was guided by literature review and interviews with senior clinicians and with patients. Using 3 different samples consisting of inpatients, outpatients, and nonpatients, we reduced our initial item pool from 81 to 10 items. The 10-item scale had an alpha of .96 and showed strong correlations with commonly used measures of psychological well-being and distress. Our results suggest that the scale appears to measure a broad domain of psychological health. The scale appeared to lack ceiling and floor effects, and it discriminated between inpatients, outpatients, and nonpatients, suggesting the scale has excellent potential to be broadly responsive to a variety of treatment effects. In addition, the new scale proved to be sensitive to treatment changes in a sample of 20 psychiatric inpatients. Overall, the initial data suggest that we have developed a brief, sensitive outcome measure designed to have wide application across psychiatric and psychological treatments and populations.

Background Valid, reliable biomarkers of depression severity and treatment response would provide new targets for clinical research. Noticeable differences in speech production between depressed and nondepressed patients have been suggested as a potential biomarker. Methods One hundred and five adults with Major Depression were recruited into a four-week, randomized, double-blind, placebo-controlled research methodology study. An exploratory objective of the study was to evaluate the generalizability and repeatability of prior study results indicating vocal acoustic properties in speech may serve as biomarkers for depression severity and response to treatment. Speech samples, collected at baseline and study end-point using an automated telephone system, were analyzed as a function of clinician-rated and patient-reported measures of depression severity and treatment response. Results Regression models of speech pattern changes associated with clinical outcomes in the prior study were found to be reliable and significant predictors of outcome in the current study despite differences in the methodological design and implementation of the two studies. Results of the current study replicate and support findings from the prior study. Clinical changes in depressive symptoms among patients responding to the treatments provided also reflected significant differences in speech production patterns. Depressed patients who did not improve clinically showed smaller vocal acoustic changes and/or changes that were directionally opposite to treatment responders. Conclusions This study supports the feasibility and validity of obtaining clinically important, biologically-based vocal acoustic measures of depression severity and treatment response using an automated telephone system. National Institutes of Health Clinical Trials Registry: http://clinicaltrials.gov Identifier: NCT00406952.

While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO's relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time.