No abstract

Sildenafil was effective and well tolerated in postmenopausal women with FSAD without concomitant HSDD or contributory emotional, relationship or historical abuse issues. All patients had protocol specified estradiol and free testosterone concentrations or were receiving estrogen and/or androgen replacement therapy.

No abstract

We estimate that up to 9.0% of US patients with cancer may be exposed to ICIs that have had negative phase 3 trial results, which may lower estimated response rates from 12.5% to as low as 10.9%. With faster approval of potentially beneficial drugs, there is also a risk of approving drugs that are later found to be ineffective. Although negative phase 3 trial results are the main reason for lower estimates of eligibility, we also saw lower estimates because of lower numbers of deaths from cancers such as non-small cell lung cancer and melanoma. This was partially offset by increased eligibility to ICIs, most notably for those with triple-negative breast cancer. Our analysis was limited in that estimates were based on clinical trial data and may not be generalizable because of access to medications, off-label use, or response rates in the general population.

IMPORTANCE Quality of life (QoL) is an important consideration in cancer medicine, especially because drugs are becoming more costly and may only result in modest gains in overall survival.However, there has been no descriptive analysis for the points at which QoL is measured in cancer trials.OBJECTIVE To estimate the prevalence of studies that measure QoL at different points and see how many studies measure QoL for the entirety of a patient's life. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional analysis includes all articles ononcology clinical trials in the 3 highest-impact oncology journals, published between July 2015 and June 2018, that reported QoL outcomes. MAIN OUTCOMES AND MEASURESData were abstracted on when QoL was assessed and the characteristics of these studies. RESULTSFor all 149 studies that met inclusion criteria, QoL assessment was high during treatment (104 articles [69.8%]), during follow-up (81 articles [54.4%]), and after the end of the intervention (68 articles [45.6%]). In 5 of the 149 studies (3.4%), QoL was assessed until death, including in only 1 of the 74 studies on metastatic or incurable cancers. Among these 5 studies, only 1 (20%) used a drug intervention, 1 (20%) used a behavioral intervention, and 2 (40%) used a radiation intervention; only 1 of 5 was in the metastatic setting. The number of studies that reported a positive QoL outcome (ie, QoL outcome was more favorable in the intervention group than in the control group) was between 42 of 81 articles (51.9%) and 16 of 28 articles (57.1%) for most QoL assessment points but only 1 of 5 articles (20%) for studies measuring QoL until death. CONCLUSIONS AND RELEVANCEThis study found that most clinical trials assessed QoL during the treatment or intervention and often during a given amount of follow-up but infrequently assessed QoL on disease progression and rarely followed QoL until the end of the patient's life. Most studies reporting QoL until the end of life reported worse QoL outcomes for the intervention group than the control group. Future research and policy recommendations should consider not just short-term QoL outcomes but QoL outcomes throughout the patient's cancer care. Question How often do oncology studies assess quality of life (QoL) throughout a patient's disease course? Findings This cross-sectional analysis of 149 oncology studies published in highimpact medical and oncology journals found that most studies (69.8%) assessed QoL during the intervention, whereas only 3.4% of studies assessed QoL until the time of death. Meaning These findings suggest that many oncology studies only assess QoL during the intervention; future research should consider the long-term outcomes throughout the patient's life.Oncology, and JAMA Oncology. For each of the journals, we searched for the term quality of life on the journal's website, and we limited the search to research articles only. Selected articles needed to (1) be an RCT, (2) have performed the analysis in the originally randomized groups, (3) have evaluated QoL in ...