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1.  Vocal Acoustic Biomarkers of Depression Severity and Treatment Response 
Biological psychiatry  2012;72(7):580-587.
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.
doi:10.1016/j.biopsych.2012.03.015
PMCID: PMC3409931  PMID: 22541039
Depression assessment; methodology; speech; voice acoustics; telephone; interactive voice response (IVR)
2.  Patient self-report for evaluating mild cognitive impairment and prodromal Alzheimer's disease 
Patient-reported outcome (PRO) measures are used to evaluate disease and treatments in many therapeutic areas, capturing relevant aspects of the disorder not obtainable through clinician or informant report, including those for which patients may have a greater level of awareness than those around them. Using PRO measures in mild cognitive impairment (MCI) and prodromal Alzheimer's disease (AD) presents challenges given the presence of cognitive impairment and loss of insight. This overview presents issues relevant to the value of patient report with emphasis on the role of insight. Complex activities of daily living functioning and executive functioning emerge as areas of particular promise for obtaining patient self-report. The full promise of patient self-report has yet to be realized in MCI and prodromal AD, however, in part because of lack of PRO measures developed specifically for mild disease, limited use of best practices in new measure development, and limited attention to psychometric evaluation. Resolving different diagnostic definitions and improving clinical understanding of MCI and prodromal AD will also be critical to the development and use of PRO measures.
doi:10.1186/alzrt97
PMCID: PMC3308024  PMID: 22152342
3.  Responsiveness and minimal important differences for patient reported outcomes 
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.
doi:10.1186/1477-7525-4-70
PMCID: PMC1586195  PMID: 17005038
4.  Childhood Sexual Abuse Among Homosexual Men 
Of 327 homosexual and bisexual men participating in an ongoing cohort study pertaining to risk factors for HIV infection who completed a survey regarding history of sexual abuse, 116 (35.5%) reported being sexually abused as children. Those abused were more likely to have more lifetime male partners, to report more childhood stress, to have lied in the past in order to have sex, and to have had unprotected receptive anal intercourse in the past 6 months (odds ratio 2.13; 95% confidence interval 1.15–3.95). Sexual abuse remained a significant predictor of unprotected receptive anal intercourse in a logistic model adjusting for potential confounding variables.
doi:10.1046/j.1525-1497.1997.012004250.x
PMCID: PMC1497098  PMID: 9127231
sexual abuse; HIV transmission; safe sex

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