Dissociable effect of acute varenicline on tonic versus cue-provoked craving in non-treatment-motivated heavy smokers.

RATIONALE: The effectiveness of varenicline for smoking cessation has been established, but little is known about the psychological processes that mediate this clinical outcome. OBJECTIVES: This study evaluated the effect of a single dose of varenicline on tonic and cue-provoked changes in craving, withdrawal, and affect using a randomized, double-blind, placebo-controlled, cross-over design. METHODS: Following overnight abstinence, 38 non-treatment-motivated smokers received either varenicline 2mg or matched placebo, then tonic measures of craving, withdrawal, and positive and negative affect were obtained at 30-min intervals. At 4-h post-administration, a cue exposure session obtained the same subjective measures at three time-points following the physical handling of a lit cigarette versus the sharpening and handling of a pencil. RESULTS: At 4-h post-administration, varenicline reduced tonic craving as well as craving across the smoking and neutral cue conditions, relative to placebo. By contrast, the capacity of the smoking cue to enhance craving relative to the neutral cue was unaffected by varenicline. Measures of withdrawal and positive and negative affect produced mixed results. CONCLUSIONS: Acute varenicline selectively attenuates tonic but not cue-provoked craving. This dissociation provides insight into the specific psychological processes that might mediate the effectiveness of varenicline, and highlights cue-provoked craving as a discrete target for advancing smoking cessation pharmacotherapy.

Development of a family functioning scale for major depressive disorder.

OBJECTIVE: To better understand depression's impact on family functioning from the perspectives of patients with major depressive disorder (MDD) and their partners; to develop and test patient and partner versions of a new self-reported measure, the Depression and Family Functioning Scale (DFFS), for use in clinical trials. METHODS: Concept elicitation interviews were conducted with 32 adults with clinician-diagnosed moderate-to-severe MDD and their respective partners. Twenty-six items were drafted to address relevant aspects of family functioning and were then tested and refined through two iterative sets of cognitive debriefing interviews, each conducted by the same pair of highly experienced researchers, including a licensed clinical psychologist. RESULTS: Depression negatively affects family functioning through poorer communication, increased conflicts, decreased family interaction, and decreased intimacy. No existing instrument measured all domains of interest, or had been rigorously developed and psychometrically validated in the target populations. The draft DFFS items generally tested well and only minor modifications were made to the items after the second set of interviews. Both patients and partners indicated that the final set of 15 DFFS items addresses all concepts of importance. CONCLUSIONS: The DFFS evaluates the impact of depression on family functioning and has the potential to provide important information that can facilitate a more comprehensive evaluation of new treatments in clinical trial settings. Although MDD severity was not confirmed with a standardized interview, in clinical practice in the US, MDD is generally not diagnosed with the use of a structured clinical interview or clinician-administered tool. In the current study, depression severity had little (if any) impact on the specific concepts elicited as being important to family functioning. In fact, patients with milder depression had more insight and were able to better articulate changes in family functioning with treatment.

A Population-Based Study of Peyronie's Disease: Prevalence and Treatment Patterns in the United States.

Purpose. To estimate the US prevalence of Peyronie's disease (PD) from patient-reported data and to identify diagnosis and treatment patterns. Methods. 11,420 US males ≥18 years old completed a brief web-based survey regarding the presence of PD, past treatments, and penile symptoms (Phase 1). Phase 1 respondents with PD diagnosis, history of treatment, or PD-related symptoms then completed a disease-specific survey (Phase 2). Results. Estimated prevalence of PD ranged from 0.5% (diagnosis of PD) to 13% (diagnosis, treatment, or penile symptoms). Thirty-six percent of Phase 2 participants reported that penile symptoms interfered with sexual activities. Of participants who sought treatment for penile symptoms (n = 128), 73% initially saw a primary care physician, 74% did not receive treatment from their first doctor, and 92% were not diagnosed with PD. Conclusions. PD may be underdiagnosed/undertreated in the US. Improved awareness is needed of PD symptoms and treatment options among health care professionals.

Prevalence, incidence, and treatments of Dupuytren's disease in the United States: results from a population-based study.

BACKGROUND: This large population-based study was conducted to estimate the prevalence of Dupuytren's disease in US adults and describe associated treatment patterns. METHODS: A total of 23,103 individuals from an Internet-based research panel representative of the US population completed a brief online survey designed to identify individuals with symptoms, diagnoses, and/or treatment experience indicative of Dupuytren's disease (mean age = 50 years). RESULTS: The prevalence of Dupuytren's disease defined as a self-reported physician diagnosis and/or surgical treatment was estimated as 1% (95% CI = 0.8-1.2), but the estimated prevalence is much higher (7.3%) when including self-reported symptoms of ropelike growth or hard bumps on the hand. The annual incidence proportion was estimated at about 3 cases per 10,000 adults. A total of 326 participants who reported relevant Dupuytren's symptoms, treatment, and/or diagnosis completed a more in-depth survey focusing on timing of medical treatments after first symptom noticed, description of functional impairment, treatment patterns, and family history. From the second survey, most patients who reported seeking treatment for hand symptoms initially saw a primary care physician, and the mean time from noticing the first hand symptom to seeing a doctor was 23.1 months. At their first doctor visit for hand symptoms, only 9% of patients received a diagnosis of Dupuytren's disease and 48% were advised to "wait and see" or received no treatment. CONCLUSIONS: Results from the current study indicate a number of unmet medical needs, so strategies to raise physician awareness of disease symptoms and effective treatment options may be helpful.

The development and validation of the daily electronic Endometriosis Pain and Bleeding Diary.

BACKGROUND: The objective of this study was to develop and validate a daily electronic Endometriosis Pain and Bleeding Diary (EPBD) for assessing treatment-related changes in endometriosis symptoms from the patient's perspective in a clinical trial setting. METHODS: The EPBD items were developed based on clinician input and the results of 5 focus groups (N = 38) and 3 iterative sets of cognitive interviews (N = 22). The psychometric properties were evaluated using data collected in a usual-practice, non-intervention study conducted at 4 sites in the United States. Existing questionnaires were also administered to explore the construct validity of the EPBD. The development and validation processes were consistent with the recommendations in the 2009 FDA Patient Reported Outcomes Guidance to Industry. RESULTS: Focus group participants described 2 distinct types of pain (intermittent and continuous), which they felt were relevant and important to monitor. Participants also indicated that pain and bleeding/spotting associated with intercourse were important symptoms related to endometriosis. Cognitive interviews with additional endometriosis patients served to optimize item content, wording, and response options. Psychometric analyses found the EPBD items to behave as expected, for example, item-level means for subjects with severe endometriosis symptoms were higher (i.e., worse) compared with subjects with mild symptoms. Item-total correlations for the EPBD pain items (range 0.40-0.89) indicated that the items were related but not redundant. EPBD pain ratings correlated highly with the modified Brief Pain Inventory-Short Form Pain Intensity score (range 0.46-0.61). Women with severe endometriosis symptoms reported significantly higher intermittent and continuous dysmenorrhea and intermittent and continuous pelvic pain ratings and greater interference with daily activities compared with women with mild symptoms (all p < 0.01). CONCLUSIONS: The results of this study show that the 17-item EPBD reliably and validly characterizes the types of pain that endometriosis patients identified as being important. As a daily patient-reported assessment, it overcomes the significant potential for intra- and inter-rater variability and rater and recall bias that is inherent in the Biberoglu and Behrman Scale. Additional studies are required to confirm the dimensionality and optimal scoring of the EPBD, to corroborate the present results, and to assess other important measurement properties, such as responsiveness.

Development and psychometric evaluation of the Endometriosis Treatment Satisfaction Questionnaire.

PURPOSE: To develop and psychometrically evaluate the Endometriosis Treatment Satisfaction Questionnaire, a patient-reported assessment of satisfaction with endometriosis treatment. METHODS: The Endometriosis Treatment Satisfaction Questionnaire was developed based on the results of five focus groups and three iterative sets of cognitive interviews along with expert opinion and a review of the literature. The psychometric properties were assessed using data collected during a multicenter, randomized, proof-of-concept trial. The development and validation processes followed the guidance recommended by the United States FDA for patient-reported outcome instruments. RESULTS: The Endometriosis Treatment Satisfaction Questionnaire's reliability, validity, and utility as a measure of patient satisfaction with their endometriosis treatment were supported. The results of the item-level analyses showed no evidence of distributional anomalies or response scale biases. The Endometriosis Treatment Satisfaction Questionnaire is unidimensional, has excellent internal consistency reliability, and discriminates well between known groups. Scores correlated well with other patient-reported outcome measures of endometriosis without being redundant. CONCLUSIONS: The Endometriosis Treatment Satisfaction Questionnaire has utility for assessing patient satisfaction with endometriosis treatment and may be useful in clinical trials that are assessing new treatments for endometriosis, especially when deciding between competing treatments or regimens that are found to have similar tolerability and efficacy.

Psychometric evaluation of the Satisfaction with Oral Anti-Diabetic Agent Scale (SOADAS).

In this study we developed and evaluated the psychometric properties of the Satisfaction with Oral Anti-Diabetic Agent Scale (SOADAS), the first treatment satisfaction instrument specific to oral anti-diabetic agents (OADs). Three focus groups and three rounds of cognitive debriefing interviews with type 2 diabetes patients using OADs informed the development of the six-item SOADAS. The measurement properties of the SOADAS were evaluated in a US cross-sectional study. Patients completed the SOADAS, Treatment Satisfaction for Medication Questionnaire (TSQM), the Short Form-12 (SF-12) Health Survey and a demographic questionnaire. The first half of the recruited patient population was asked to return at 7 days follow-up to complete the SOADAS again. An exploratory factor analysis on the SOADAS yielded a one-factor solution, indicating that the SOADAS was uni-dimensional. The SOADAS had high internal consistency reliability (Cronbach's alpha=0.86) and acceptable test-retest reliability (ICC=0.79). It was correlated most highly with the TSQM (r=0.71, p<0.001) and least with the mental summary component score of the SF-12 (r=0.24, p=0.014). Mean SOADAS scores were approximately two points higher for participants with lower HbA(1c) values (<7%) versus those with higher values, and for participants without versus with selected symptoms (p<0.05). The findings from this study suggest that the SOADAS is a valid and reliable measure of patient satisfaction with oral anti-diabetic medications. This questionnaire may be useful for assessing outcomes in future clinical studies of oral anti-diabetic medications.

Healthcare seeking and treatment for menopausal symptoms in the United States.

OBJECTIVES: A population-based study was used to describe healthcare seeking behavior for menopausal symptoms and treatment among women 40-65 years old in the United States. METHODS: Participants were recruited into the Menopause Epidemiology Study from the KnowledgePanel(SM), which is selected by random digit dialing and probability sampling from the US population. From this source, 6201 women 40-65 years old were contacted and 4402 women participated. From the 3135 peri- and postmenopausal women, detailed information was obtained on menopausal symptoms, healthcare seeking, medication usage, and symptom relief from the medication. RESULTS: Many women (60%) reported seeking health care for their menopausal symptoms. More than half of these women sought health care in the past 12 months. Vasomotor symptoms were the most frequently reported menopause symptoms across all races/ethnicities, and the most common symptoms discussed with a health care professional. One-third of the women (34%) used only hormone therapies, 12% used complementary and/or alternative medicines, and 16% used both for treatment of menopausal symptoms. CONCLUSIONS: This study has shown that a large number of women consult healthcare providers for menopausal symptoms, indicating these symptoms are bothersome. Yet, in the United States, there is considerable variation in the symptomatology, healthcare seeking, and use of therapies for menopausal symptoms across cultures. To alleviate these symptoms women have tried alternative treatments as well as hormone therapies, yet many women did not get complete relief of specific symptoms.

The treatment satisfaction scale: a multidimensional instrument for the assessment of treatment satisfaction for erectile dysfunction patients and their partners.

BACKGROUND: The development of the Treatment Satisfaction Scale (TSS) was previously reported (Kubin et al., 2004). OBJECTIVE: This article describes the psychometric validation process and psychometric properties (e.g., reliability, validity, and responsiveness) of TSS. METHODS: Initial patient and partner questionnaires were administered in a multi-national clinical trial. On the basis of exploratory analyses, iterative psychometric testing, and consideration of face validity and interpretability, the number of items was reduced, and six scales were constructed: "Satisfaction with Medication," "Ease with Erection," "Satisfaction with Erectile Function," "Pleasure from Sexual Activity," "Satisfaction with Orgasm," and either "Sexual Confidence" (for patients) or "Confidence in Completion" (for partners). RESULTS: Multi-item scales had good internal consistency reliability and concurrent validity with the IIEF. All patient scales and most partner scales were valid in relation to clinical criteria, and all tested scales were responsive to change over time. CONCLUSION: The TSS is brief, culturally valid, and the most comprehensive multidimensional measure of satisfaction with ED treatment for patients and their partners, and addresses some of the shortcomings of existing measures.