Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

BACKGROUND: There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. METHODS: Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. RESULTS: Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. CONCLUSIONS: Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. PROSPERO REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525 . Registered on 12 March 2015 revised on 15 March 2016.

Hydropic leiomyoma of the uterus presenting as a giant abdominal mass

We describe a case of a 35-year-old woman with a pedunculated uterine leiomyoma with diffuse hydropic degeneration presenting as a giant abdominal mass. The patient was admitted in the emergency department because of diffuse abdominal bloating and discomfort. Ultrasonography (US) showed a heterogeneous abdominopelvic mass. Magnetic resonance imaging (MRI) was performed to further characterise and revealed a myometrial pedunculated tumour. Despite its marked T2-signal heterogeneity and volume, there were no other suspicious findings to suggest a malignant nature; therefore, fertility-sparing myomectomy was performed. Leiomyomas frequently undergo degenerative changes altering their imaging appearances. Leiomyomas with uncommon degenerative changes may be difficult to differentiate from malignant myometrial tumours, based solely on imaging. To the best of our knowledge, a diffuse hydropic degeneration imaging appearance has only been described twice in the literature. We describe the imaging appearance of this rare form of leio

Prevalence of vocal problems in portuguese primary and secondary shool level teachers

This study compared the prevalence of vocal problems in two Portuguese groups: 73 teachers that use their voice as professional tool (teachers’ group) and 73 non-voice professionals (control group). It also identified the risk factors that contributed to teachers’ group voice problems. A questionnaire was applied to both goups in order to obtain information about vocal health, hygiene and behavior, professional activity and general physical health. Statistical results revealed that the teachers’ group presented a higher prevalence of vocal problems than the control group: 52% reported hoarseness, 46.6% vocal fatigue and 45.2% vocal discomfort compared with 31.5%, 20.5 % e 28.7%, respectively. Environmental factors (eg., smoke and cold temperatures), vocal abuse and upper respiratory pathologies (e.g., colds, laryngitis and pharyngitis) seemed to increase teachers’ voice disorders (p-value < .05). In conclusion, the absence of vocal pedagogy in the curricular plan of teachers’ higher education associated to poor working environmental conditions and professional voice demands explained the higher prevalence of vocal problems in teachers’ group.

Sexual dysfunction in breast cancer survivors: cross-cultural adaptation of the Sexual Activity Questionnaire for use in Portugal

"Introduction: The increasing survivor population of breast cancer has shifted research and practice interests into the impacts of the disease and treatment in quality of life aspects. The lack of tools available in Portuguese to objectively evaluate sexual function led to the development of this study, which aimed to cross-culturally adapt and validate the Sexual Activity Questionnaire for use in Portugal. Material and Methods: The questionnaire was translated and back-translated, refined following face-to-face interviews with seven breast cancer survivors, and then self-administered by a larger sample at baseline and a fortnight later to test validity and reliability. Results: Following cognitive debriefing (n = 7), minor changes were made and the Sexual Activity Questionnaire was then tested with 134 breast cancer survivors. A 3-factor structure explained 75.5% of the variance, comprising the Pleasure, Habit and Discomfort scales, all yielding good internal consistency (Cronbach’s α > 0.70). Concurrent validity with the FACt-An and the BCPT checklist was good (Spearman’s r > 0.65; p-value < 0.001) and reliability acceptable (Cohen’s k > 0.444). The Sexual Activity Questionnaire allowed the identification of 23.9% of sexually inactive women, for whom the main reasons were lack of interest or motivation and not having a partner. Discussion: Patient-reported outcomes led to a more comprehensive and improved approach to cancer, tackling areas previously abandoned. Future research should focus on the validation of this scale in samples with different characteristics and even in the overall population to enable generalizability of the findings. Conclusion: The adapted Sexual Activity Questionnaire is a valid tool for assessing sexual function in breast cancer survivors in Portugal."