Our primary objective was to determine the proportion of trials that report the number of patients assessed for eligibility before randomization. We performed the systematic retrieval and analysis of all phase II, III, and IV RCTs published between 2013 and 2015 in four high-impact-factor journals in the field of clinical oncology. Among 456 RCTs reviewed, 236 trials (51.8%) reported the number of patients assessed for eligibility. Among the 236 trials that reported the entire enrollment process, the reasons for patient exclusion could be found in 184 trials (78%). A flow diagram was presented in 452 trials (99.1%), and 98 trials (21.5%) included a discussion on generalizability. Reporting the parameters of external validity in medical oncology RCTs is challenging. Improving adherence to the 2010 CONSORT guidelines concerning the enrollment process could help clinicians and health policymakers establish to whom trial results apply.

UNASSIGNED: Randomized controlled trials (\"randomized trials\") can provide evidence to assess the equity impact of an intervention. Decision makers need to know about equity impacts of healthcare interventions so that people get healthcare that is best for them. To better understand the equity impacts of healthcare interventions, a range of people who were potentially the ultimate users of research results were involved in a six-phase project to extend the CONsolidated Standards Of Reporting Trials Statement for health equity (\"CONSORT-Equity 2017\"). We identified these \"knowledge users\" as: patients and healthcare researchers, decision makers and providers. This paper reports on one project phase: specifically, a qualitative study designed to integrate the expertise of knowledge users. The experiences and perspectives of knowledge users provided many insights about the reporting of health equity issues in randomized trials. This paper describes key informant interviews with knowledge users that contribute to a better understanding of the effects of an intervention on health equity. Additionally, the paper shows how these insights were used to develop CONSORT-Equity 2017.
UNASSIGNED: A qualitative study that used the framework analysis method was conducted in collaboration with an international study executive and advisory board team. In-depth semi-structured interviews were conducted with a purposive sample of key informants who: consider the research ethics of, fund, conduct, participate in, publish, or use research evidence generated in randomized trials. Transcripts were coded and analyzed using the seven-stage framework analysis method, and data reported to reflect knowledge user suggestions to develop CONSORT-Equity 2017.
UNASSIGNED: Thirteen key informants, of which three were patients, chose to participate in interviews. Seven themes emerged: \"Differentiate the type of trial\", \"Prompts for health equity\", \"Ethics matter\", \"Describe unique research strategies\", \"Clarity of reporting\", \"Implications of equity for sampling and analysis\", \"Think beyond the immediate trial\". The interviews provided direction for the extension of 16 CONSORT-Equity 2017 items.
UNASSIGNED: Key informant interviews were used to identify new concepts that were not generated in our other studies and to develop CONSORT-Equity 2017. We encourage the use of key informant interviews in guideline development to obtain and include the real-life expertise of knowledge users.

OBJECTIVE: Examine the impact of a PACE (Prepare, Ask, Check, Express) inspired web-based communication intervention alone or combined with a workshop on reaching treatment goals for patients suffering from chronic diseases (CDs), compared to usual care.
METHODS: Three arm single-blind RCT in community primary care (PC) practices. PC practitioners (n=18) had a CD patient caseload, and practicing >5 years. Patients >40 years old, English speaking, computer literate, not reaching treatment goals for hypertension, type II diabetes, and/or dyslipidemia.
METHODS: (1) web-intervention and (2) web intervention and nurse facilitated workshop and (3) usual care.
RESULTS: Proportion of patients meeting all treatment suggested guidelines for the diagnoses they were enrolled for.
RESULTS: Patients (n=322) were randomized, and of these 221 returned for follow up. Patients in the web group were 1.42 times more likely to meet targets compared to usual care [95% CI: 1.00-2.00], a statistical difference not seen in the combined group. Sensitivity analyses were performed to mitigate bias due to loss to follow up.
CONCLUSIONS: Training patients in communication skills using a website positively affects reaching treatment goals for hypertensive, diabetic and dyslipidemic patients.
CONCLUSIONS: Web communication interventions are an effective tool that can be used in primary care.

Prostate biopsy and postbiopsy complications represent important risks of prostate-specific antigen (PSA) screening. Although landmark randomized trials and updated guidelines have challenged routine PSA screening, it is unclear whether these publications have affected rates of biopsy or postbiopsy complications.
To evaluate whether publication of the 2008 and 2012 US Preventive Services Task Force (USPSTF) recommendations, the 2009 European Randomized Study of Screening for Prostate Cancer and the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, or the 2013 American Urological Association (AUA) guidelines was associated with changes in rates of biopsy or postbiopsy complications, and to identify predictors of postbiopsy complications.
This quasiexperimental study used administrative claims of 5279315 commercially insured US men aged ≥40 yr from 2005 to 2014, of whom 104584 underwent biopsy.
Publications on PSA screening.
Interrupted time-series analysis was used to evaluate the association of publications with rates of biopsy and 30-d complications. Logistic regression was performed to identify predictors of complications.
From 2005 to 2014, biopsy rates fell 33% from 64.1 to 42.8 per 100000 person-months, with immediate reductions following the 2008 USPSTF recommendations (-10.1; 95% confidence interval [CI], -17.1 to -3.0; p<0.001), 2012 USPSTF recommendations (-13.8; 95% CI, -21.0 to -6.7; p<0 .001), and 2013 AUA guidelines (-8.8; 95% CI, -16.7 to -0.92; p=0.03). Concurrently, complication rates decreased 10% from 8.7 to 7.8 per 100000 person-months, with a reduction following the 2012 USPSTF recommendations (-2.5; 95% CI, -4.5 to -0.45; p=0.02). However, the proportion of men undergoing biopsy who experienced complications increased from 14% to 18%, driven by nonsepsis infectious complications (p<0.001). Predictors of complications included prior fluoroquinolone use (odds ratio [OR]: 1.27; 95% CI, 1.22-1.32; p<0.001), anticoagulant use (OR: 1.14; 95% CI, 1.04-1.25; p=0.004), and age ≥70 yr (OR: 1.25; 95% CI, 1.15-1.36; p<0.001). Limitations included the retrospective design.
Although there has been an absolute reduction in rates of biopsy and 30-d complications, the relative morbidity of biopsy continues to increase. These observations suggest a need to reduce the morbidity of biopsy.
Absolute rates of biopsy and postbiopsy complications have decreased following landmark publications about prostate-specific antigen screening; however, the relative morbidity of biopsy continues to increase.

Incidental moderate mitral regurgitation (MR) in patients presenting for coronary artery bypass grafting (CABG) is not only common but also probably adversely affects clinical outcome. The echocardiographic evaluation of incidental MR must be comprehensive and integrated, as it remains a cornerstone in management decisions. Current guidelines support surgical mitral intervention in this setting as a reasonable option, reflecting clinical equipoise towards moderate MR in the setting of planned CABG. There are currently 2 major randomized trials in progress that will test whether surgical correction of moderate MR combined with CABG improves major clinical outcomes as compared to CABG alone. These landmark trials will be completed in the near future. In the interim, significant progress in the fields of cardiac resynchronization therapy, transcatheter mitral valve intervention, and minimally invasive mitral valve surgery promise to affect the management alternatives for moderate MR in patients undergoing CABG regardless of operative risk. It is likely that in the coming decade there will be less tolerance for incidental moderate MR given its already known outcome effects and the multimodal interventions that continue to mature with better safety profiles.

OBJECTIVE: The aims of this study were to evaluate the quality of randomized controlled trial (RCT) abstracts published in the field of oncology and identify characteristics associated with better reporting quality.
METHODS: All phase III trials published during 2005-2007 [before Consolidated Standards of Reporting Trials (CONSORT)] and 2010-2012 (after CONSORT) were searched electronically in MEDLINE/PubMed and retrieved for review using an 18-point overall quality score (OQS) for reporting based on the CONSORT for Abstract guidelines. Descriptive statistics followed by multivariate linear regression were used to identify features associated with improved reporting quality.
RESULTS: The mean OQS was 8.2 (range: 5-13; 95% confidence interval (CI): 8.0, 8.3) and 9.9 (range: 5-18; 95% CI: 9.7, 10.2) in the pre- and post-CONSORT periods, respectively. The method for random sequence generation, allocation concealment, blinding details, and funding sources were missing in pre-CONSORT abstracts and insufficiently reported (<20%) in post-CONSORT abstracts. A high impact factor (P < 0.001) and the journal of publication (P < 0.001) were independent factors that were significantly associated with higher reporting quality on multivariate analysis.
CONCLUSIONS: The reporting quality of RCT abstracts in oncology showed suboptimal improvement over time. Thus, stricter adherence to the CONSORT for Abstract guidelines is needed to improve the reporting quality of RCT abstracts published in oncology.