Karen Crowell

Non-publication of large randomized clinical trials: cross sectional analysis

Objective To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public. Design Cross sectional analysis Setting Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009. Data sources PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database. Main outcome measures The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database. Results Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov. Conclusions Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results.

Geriatric Assessment in Surgical Oncology: A Systematic Review

BACKGROUND The comprehensive geriatric assessment (CGA) has developed as an important prognostic tool to risk stratify older adults and has recently been applied to the surgical field. In this systematic review, we examined the utility of CGA components as predictors of adverse outcomes among geriatric patients undergoing major oncologic surgery. MATERIALS AND METHODS MEDLINE, Embase, and the Cochrane Library were searched for prospective studies examining the association of components of the CGA with specific outcomes among geriatric patients undergoing elective oncologic surgery. Outcome parameters included 30-d postoperative complications (POC), mortality, and discharge to a nonhome institution. RESULTS The initial search identified 178 potentially relevant articles, with six studies meeting inclusion criteria. Deficiencies in instrumental activities of daily living, activities of daily living, fatigue, cognition, frailty, and cognitive impairment were associated with increased POC. No CGA predictors were identified for postoperative mortality whereas frailty, deficiencies in instrumental activities of daily living, and depression predicted discharge to a nonhome institution. CONCLUSIONS Across a variety of surgical oncologic populations and cancer types, components of the CGA appear to be predictive of POC and discharge to a nonhome institution. These results argue for inclusion of focused geriatric assessments as part of routine preoperative care in the geriatric surgical oncology population.

Undergoing varicocele repair before assisted reproduction improves pregnancy rate and live birth rate in azoospermic and oligospermic men with a varicocele: a systematic review and meta-analysis

OBJECTIVE To evaluate how varicocele repair (VR) impacts pregnancy (PRs) and live birth rates in infertile couples undergoing assisted reproduction wherein the male partner has oligospermia or azoospermia and a history of varicocele. DESIGN Systematic review and meta-analysis. SETTING Not applicable. PATIENT(S) Azoospermic and oligospermic males with varicoceles and in couples undergoing assisted reproductive technology (ART) with IUI, IVF, or testicular sperm extraction (TESE) with IVF and intracytoplasmic sperm injection (ICSI). INTERVENTION(S) Measurement of PRs, live birth, and sperm extraction rates. MAIN OUTCOME MEASURE(S) Odds ratios for the impact of VR on PRs, live birth, and sperm extraction rates for couples undergoing ART. RESULT(S) Seven articles involving a total of 1,241 patients were included. Meta-analysis showed that VR improved live birth rates for the oligospermic (odds ratio [OR] = 1.699) and combined oligospermic/azoospermic groups (OR = 1.761). Pregnancy rates were higher in the azoospermic group (OR = 2.336) and combined oligospermic/azoospermic groups (OR = 1.760). Live birth rates were higher for patients undergoing IUI after VR (OR = 8.360). Sperm retrieval rates were higher in persistently azoospermic men after VR (OR = 2.509). CONCLUSION(S) Oligospermic and azoospermic patients with clinical varicocele who undergo VR experience improved live birth rates and PRs with IVF or IVF/ICSI. For persistently azoospermic men after VR requiring TESE for IVF/ICSI, VR improves sperm retrieval rates. Therefore, VR should be considered to have substantial benefits for couples with a clinical varicocele even if oligospermia or azoospermia persists after repair and ART is required.

Functional Outcomes Following Radical Cystectomy in Women with Bladder Cancer: A Systematic Review

CONTEXT Gender-specific functional and health-related quality of life (HRQOL) outcomes following radical cystectomy (RC) for bladder cancer (BCa) remain unclear, with many studies excluding women from the study population. OBJECTIVE To better characterize female-specific functional outcomes following RC and urinary diversion for BCa. EVIDENCE ACQUISITION We performed a critical review of PubMed/Medline and Embase in August 2015 according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. Outcomes of interest included urinary function (for orthotopic neobladder), sexual function, bowel function, and quality of life. Excluded were nonbladder malignancies, RCs performed for neurogenic bladder dysfunction, and patients with exposure to radiation therapy prior to surgery. Forty-five publications were selected for inclusion in this analysis. EVIDENCE SYNTHESIS Included reports addressed urinary function (34 studies), sexual function (11 studies), and HRQOL (9 studies). All studies had a high risk of bias and ranged significantly in sample size, inclusion criteria, and follow-up time, precluding meaningful meta-analysis. Daytime incontinence approximated 20%, nighttime incontinence 20%, and hypercontinence 10-20%. Sexual function appeared to be better among those patients undergoing genitalia-sparing RC, but generally poor outcomes were noted among those undergoing routine RC. Only 40% of studies assessed sexual function using standardized instruments. HRQOL differences between diversion types appeared to be minimal, whereas comparisons with the general population revealed significant differences in emotional problems, role functioning, fatigue, and appetite. CONCLUSIONS Functional outcomes among women undergoing RC for BCa are poorly studied with limitations regarding use of validated questionnaires, heterogeneous patient populations, and small sample sizes. Collaborative efforts will be needed to better define functional outcomes among this poorly studied patient population. PATIENT SUMMARY We reviewed functional outcomes following cystectomy among women with bladder cancer. We found that urinary, sexual, and bowel function and quality of life are poorly studied among women, with function ranging significantly across studies.

Complementary and Alternative Medical Reference Software for Personal Digital Assistants: Evidence of Clinical Applicability

To assess the quality and clinical applicability of complementary and alternative medicine (CAM) software databases for personal digital assistants (PDAs), a standard challenge of 52 CAM clinical questions was developed. Benchmark answers were identified from standard texts. Aphysician evaluator then used each of 11 PDACAMsoftware programs to answer the challenge questions and assessed the programs for comprehensiveness, accuracy, and ease of use. Breadth of coverage of the challenge questions ranged from 23% to 87% and clinical reliability from 58% to 97%. The two most clearly useful products were the Natural Medicines Comprehensive Database and the Natural Standard. None of the programs covered combination substances, and only the Natural Standard provided some information on therapeutic modalities other than the herbal and supplement aspects of CAM. The use of a standard clinical challenge as an evaluation tool may be a good way to assess reference software in this clinical area.

ClinicalAccess: A Clinical Decision Support Tool

ClinicalAccess is a new clinical decision support tool that uses a question-and-answer format to mirror clinical decision-making strategies. The unique format of ClinicalAccess delivers concise, authoritative answers to more than 120,000 clinical questions. This column presents a review of the product, a sample search, and a comparison with other point-of-care search engines.

Listening to YOUR HEALTH: Librarians and Physicians Collaborating on the Radio and Online

The Chapel Hill campus of the University of North Carolina (UNC) is home to the University of North Carolina’s (UNC) NC Memorial Hospital, NC Children’s Hospital, NC Women’s Hospital, NC Neurosciences Hospital, and NC Cancer Hospital. UNC’s Health Affairs schools provide training for several health professions: Medicine, Dentistry, Nursing, Pharmacy, Public Health, and Allied Health Sciences. The Health Sciences Library (HSL), located at the center of the Health Affairs campus, has served all of these institutions as they grew in size and scope. As an academic library, the focus has primarily been on the information needs of the faculty, students, researchers, clinicians, and other health care practitioners. However, serving the health information needs of the public has been a stated part of the library’s mission for over a decade. HSL is open to the public, and many local residents use the library’s resources, especially the computers and Internet access. HSL had a small Consumer