James T. Kuznicki

Validation of the Profile of Female Sexual Function (PFSF) in Surgically and Naturally Menopausal Women

The Profile of Female Sexual Function (PFSF) is a patient-based instrument for the measuring of loss of sexual function in menopausal women with low libido (hypoactive female sexual desire disorder). The instrument, which contains 37 items in seven domains (sexual desire, arousal, orgasm, sexual pleasure, sexual concerns, sexual responsiveness, and sexual self-image) and a single-item measure of overall satisfaction with sexuality, has been extensively developed and initially validated in over 500 oophorectomized women with low libido in North America, Europe, and Australia. Initial validation results showed the PFSF is capable of discriminating these patients from age-matched controls and produced consistent responses and sensitivity across geographies. The objective of this nonrandomized, parallel-group study was to examine the psychometric properties of the final PFSF in an independent group of surgically menopausal women with low libido and to extend validation to naturally menopausal women with low libido. Participants from 16 study centers in North America included surgically (n = 59) and naturally (n = 88) menopausal women with low libido and their age-matched control subjects, both premenopausal (n = 57) and naturally menopausal (n = 47), who reported no problems with libido. Subjects completed the PFSF at baseline and again 4 weeks later. Adjusted mean scores for each of the seven domains were statistically significantly lower (P < 0.0001) in surgically menopausal women with low libido compared with age-matched control women, and in naturally menopausal women with low libido compared with naturally menopausal control women, demonstrating excellent discriminant validity. Test-retest reliability ranged from 0.57 to 0.91 for the seven domain scores, whereas internal-consistency reliability ranged from 0.74 to 0.95. Results of this research support the conclusion that the PFSF is a valid and reliable instrument for measurement of loss of sexual function in both naturally and surgically menopausal women with low libido.

Profile of Female Sexual Function: A patient-based, international, psychometric instrument for the assessment of hypoactive sexual desire in oophorectomized women

Objective:The purpose of this study was to develop a self-administered, patient-based questionnaire to assess loss of sexual desire and associated symptoms in postmenopausal women with hypoactive sexual desire disorder (HSDD) experiencing distress. Design:Preliminary items and domains of sexual function were identified through individual and focus group interviews with postmenopausal women in the United States and Europe. A subset of items was selected for translation and further analysis. Cognitive interviews were conducted with women with HSDD and non-HSDD women in eight countries to ensure items would have the same meaning in seven languages. The resulting instrument was tested in 325 oophorectomized women with HSDD and 255 age-matched nonoophorectomized control women in the United States, Canada, Europe, and Australia. Results:Psychometric item reduction analyses resulted in 37 items organized into seven domains characterizing female sexual function in postmenopausal women with HSDD. Excellent reliability and validity of the domains of the Profile of Female Sexual Function (PFSF) were observed in all geographic areas tested. Statistically significant differences between oophorectomized women with low libido and control women were found for all domains and all geographic areas. Conclusions:The PFSF is a new instrument specifically designed for measurement of sexual desire in oophorectomized women with low libido. Robust psychometric properties have been established in a large number of geographic regions and languages, making it useful for assessing therapeutic change in multinational clinical trials.

The effects of caffeine on caffeine users and non-users.

This work examined the effects of consuming relatively small amounts of caffeine, from 20 to 160 mg, on performance and self-reports of mood in a group of caffeine users. A group of non-caffeine users were studied after ingesting 160 mg of caffeine. At regular intervals after consumption subjects were tested on several behavioral measures and blood samples were taken for caffeine analysis. Results showed caffeine users had higher blood caffeine levels and lower blood pressure at some doses than did non-users. Regular caffeine users showed a tendency toward better performance on a rotary pursuit task than non-caffeine users given a placebo treatment. They also experienced a performance decrement, relative to users given placebo, when blood caffeine levels were relatively high. Caffeine users showed no sign of caffeine withdrawal when compared to non-users before caffeine treatment. Performance of non-users given caffeine was poorer than control performance, and they tended not to report altering effects of caffeine. However, in caffeine users, the ratio of alertness:tension self-ratings tended to roughly track plasma caffeine with the lowest ratios occurring when plasma caffeine peaked after 160 mg dose. Low ratios were also found after 0, 20, and 40 mg caffeine treatments. The ratio was highest after 80 mg caffeine, suggesting that an optimum caffeine dose might exist for peak alertness:tension, with higher or lower doses resulting in a decrease of that ratio. These data suggest that real or expected mood and perhaps performance benefits experienced by caffeine users contribute to the motivation for consumption.

Taste profiles from single human taste papillae.

Earlier psychophysical research on single human fungiform taste papillae employed a procedure which limited subjects to selecting only one taste to describe the sensations they experienced. That procedure precludes the possibility of determining whether single papillae can mediate complex tastes, i.e., tastes consisting of more than one sensation experienced simultaneously. By using highly trained subjects and allowing them freedom to describe all sensations simultaneously elicited by a given taste stimulus, single papilla taste profiles were obtained. It is suggested that obtaining taste profiles may increase the utility of single papillae as models for study of the taste system.

Cross-enhancement of the sour taste on single human taste papillae.

The subjective intensity of one taste quality can be increased by prior exposure of the tongue to a different taste quality stimulus. This phenomenon, called cross-enhancement, may be the result of interactions among the physiological mechanisms that code taste quality. Another possible explanation is that the water solvent of the second stimulus acquires a taste after exposure of the tongue to the first stimulus. This water taste could add to the taste of the solute in the second stimulus and result in an increase of its subjective intensity. A third possibility is that taste receptors on the tongue may be sensitized by exposure to a taste stimulus. Using a small number of highly trained subjects, we have demonstrated that sucrose can enhance the intensity of an acid taste on the single papilla. Neither water taste nor sweet taste system activation played any role in the mediation of this enhancement. Through a series of experimentally derived inferential steps, we conclude that this phenomenon depends on the removal of protons from the acid receptors. In addition, we have demonstrated in the single papilla, that suppression of the acid taste when in mixture with sucrose can occur without sweet system activity. We conclude that sugars, through their capacity to bind protons, act to reduce the availability of protons to the acid receptors.

Application and maintenance habits do make a difference in adhesion of Alora® transdermal systems

OBJECTIVESnTo explore and evaluate Alora placebo patch application and maintenance habits of women in order to identify the factors that influence adhesion success.nnnMETHODSnThis single-center, open-label, placebo, randomized, multiple-application, parallel-group study involved 99 healthy naïve users of transdermal patches. Participants applied and wore an Alora placebo patch for ten consecutive applications of approximately 3.5 days each and evaluated adhesion of the patches twice-daily. Three subgroups comprising participants achieving low, moderate or high adhesion success took part in focus groups to discuss their wear habits, practices and attitudes regarding transdermal patches.nnnRESULTSnThere was a significant behavioral component involved in patch adhesion. The habits, practices and attitudes of high achievers were clearly different from the other two subgroups. The three most important issues identified to improve adhesion were: mastering the removal of the patch liner, identifying the best site of application, and developing and implementing techniques to maintain patch adhesion. The Alora placebo patch was well tolerated throughout the study.nnnCONCLUSIONnThe data showed that there is a learning curve involved in achieving maximal adhesion with a transdermal patch. During the study, a novel patch application method (press, fold and slide) was demonstrated for the participants. This method was very well received by all participants and was more easily executed than the previous method. An adaptation of this method was incorporated into the Alora patient information leaflet, together with several other changes to help improve adhesion success.

MAGNITUDE ESTIMATES OF DISTANCES ALONG CATEGORY RATING SCALES

Discrimination power of category rating scales increases with increases in the number of categories. This increasing fineness of category rating scales was measured directly by having subjects give magnitude estimates of distances between adjacent categories. It was found that the increasing fineness could be well described by a power function. However, distances between categories were not estimated as being equal except on a 5-category scale, which was rated as very nearly equal-interval. The implications of this finding for accepting category ratings at face value and for the construction of interval scales from such data are discussed.