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Category: Research and Scholarly Communication

Hot Topics: Health-Related Quality of Life Not Sufficiently Measured in Oncology Studies

Jackie Werner Hot Topics in Research, Oncology, Research and Scholarly Communication

Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology: A Systematic Review and Quantitative Analysis

Kovic B, Jin X, Kennedy S, et al. Evaluating progression-free survival as a surrogate outcome for health-related quality of life in oncology: A systematic review and quantitative analysis. JAMA Internal Medicine. 2018. http://doi.org/10.1001/jamainternmed.2018.4710.

Importance  Progression-free survival (PFS) has become a commonly used outcome to assess the efficacy of new cancer drugs. However, it is not clear if delay in progression leads to improved quality of life with or without overall survival benefit.

Objective  To evaluate the association between PFS and health-related quality of life (HRQoL) in oncology through a systematic review and quantitative analysis of published randomized clinical trials. Eligible trials addressed oral, intravenous, intraperitoneal, or intrapleural chemotherapy or biological treatments, and reported PFS or health-related quality of life.

Data Sources  For this systematic review and quantitative analysis of randomized clinical trials of patients with cancer, we searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from January 1, 2000, through May 4, 2016.

Study Selection  Paired reviewers independently screened citations, extracted data, and assessed risk of bias of included studies.

Data Extraction and Synthesis  We examined the association of difference in median PFS duration (in months) between treatment groups with difference in global, physical, and emotional HRQoL scores between groups (standardized to a range of 0-100, with higher scores representing better HRQoL) using weighted simple regressions.

Main Outcome and Measure  The association between PFS duration and HRQoL.

Results  Of 35 960 records screened, 52 articles reporting on 38 randomized clinical trials involving 13 979 patients across 12 cancer types using 6 different HRQoL instruments were included. The mean (SD) difference in median PFS between the intervention and the control arms was 1.91 (3.35) months. The mean (SD) differences in change of HRQoL adjusted to per-month values were −0.39 (3.59) for the global domain, 0.26 (5.56) for the physical domain, and 1.08 (3.49) for the emotional domain. The slope of the association between the difference in median PFS and the difference in change for global HRQoL (n = 30 trials) was 0.12 (95% CI, −0.27 to 0.52); for physical HRQoL (n = 20 trials) it was −0.20 (95% CI, −0.62 to 0.23); and for emotional HRQoL (n = 13 trials) it was 0.78 (95% CI, −0.05 to 1.60).

Conclusions and Relevance  We failed to find a significant association between PFS and HRQoL in cancer clinical trials. These findings raise questions regarding the assumption that interventions prolonging PFS also improve HRQoL in patients with cancer. Therefore, to ensure that patients are truly obtaining important benefit from cancer therapies, clinical trial investigators should measure HRQoL directly and accurately, ensuring adequate duration and follow-up.

Hot Topics: Physicians in Small Practices Burn Out Less

Jackie Werner Hot Topics in Research, Psychology and Psychiatry, Research and Scholarly Communication

Correlates of Burnout in Small Independent Primary Care Practices in an Urban Setting

Blechter B, Jiang N, Cleland C, Berry C, Ogedegbe O, Shelley D. Correlates of burnout in small independent primary care practices in an urban setting. The Journal of the American Board of Family Medicine. 2018;31(4):529-536. http://www.doi.org/10.3122/jabfm.2018.04.170360.

Background: Little is known about the prevalence and correlates of burnout among providers who work in small independent primary care practices (<5 providers).

Methods: We conducted a cross-sectional analysis by using data collected from 235 providers practicing in 174 small independent primary care practices in New York City.

Results: The rate of provider-reported burnout was 13.5%. Using bivariate logistic regression, we found higher adaptive reserve scores were associated with lower odds of burnout (odds ratio, 0.12; 95% CI, 0.02–0.85; P = .034).

Conclusion: The burnout rate was relatively low among our sample of providers compared with previous surveys that focused primarily on larger practices. The independence and autonomy providers have in these small practices may provide some protection against symptoms of burnout. In addition, the relationship between adaptive reserve and lower rates of burnout point toward potential interventions for reducing burnout that include strengthening primary care practices’ learning and development capacity.

Hot Topics: Interim Publications of Randomized Trials Can Be Misleading

Jackie Werner Hot Topics in Research, Research and Scholarly Communication, Research Commentary

Characteristics of Interim Publications of Randomized Clinical Trials and Comparison With Final Publications

Woloshin S, Schwartz LM, Bagley PJ, Blunt HB, White B. Characteristics of interim publications of randomized clinical trials and comparison with final publications. JAMA. 2018;319(4). doi: 10.1001/jama.2017.20653.

Publication of interim results of randomized trials can be consequential, potentially undermining trial integrity by unblinding or encouraging dropouts and crossovers, introducing uncertainty because results based on fewer outcomes are less precise, or overstating true treatment effects as demonstrated primarily in trials terminated early but also in ongoing trials. Nevertheless, because interim results are new and often promising, they may generate substantial interest, which can be misleading if results change. We describe the characteristics of interim publications from ongoing randomized trials and compare their consistency and prominence with those of final publications.

Hot Topics: Medical Journal Editor Conflicts of Interest Common and Underreported

Jackie Werner Ethics, Hot Topics in Research, Research and Scholarly Communication

Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study

Liu, J. J., Bell, C. M., Matelski, J. J., Detsky, A. S., & Cram, P. (2017). Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: Retrospective observational study. BMJ, 359 doi:10.1136/bmj.j4619

Objective To estimate financial payments from industry to US journal editors.

Design Retrospective observational study.

Setting 52 influential (high impact factor for their specialty) US medical journals from 26 specialties and US Open Payments database, 2014.

Participants 713 editors at the associate level and above identified from each journal’s online masthead.

Main outcome measures All general payments (eg, personal income) and research related payments from pharmaceutical and medical device manufacturers to eligible physicians in 2014. Percentages of editors receiving payments and the magnitude of such payments were compared across journals and by specialty. Journal websites were also reviewed to determine if conflict of interest policies for editors were readily accessible.

Results Of 713 eligible editors, 361 (50.6%) received some (>$0) general payments in 2014, and 139 (19.5%) received research payments. The median general payment was $11 (£8; €9) (interquartile range $0-2923) and the median research payment was $0 ($0-0). The mean general payment was $28 136 (SD $415 045), and the mean research payment was $37 963 (SD $175 239). The highest median general payments were received by journal editors from endocrinology ($7207, $0-85 816), cardiology ($2664, $0-12 912), gastroenterology ($696, $0-20 002), rheumatology ($515, $0-14 280), and urology ($480, $90-669). For high impact general medicine journals, median payments were $0 ($0-14). A review of the 52 journal websites revealed that editor conflict of interest policies were readily accessible (ie, within five minutes) for 17/52 (32.7%) of journals.

Conclusions Industry payments to journal editors are common and often large, particularly for certain subspecialties. Journals should consider the potential impact of such payments on public trust in published research.

Hot Topics: Visual Abstracts Increase Reach of Research

Jackie Werner Hot Topics in Research, Research and Scholarly Communication
Graphic showing findings of Visual Abstracts Increase Article Dissemination study
Credit Andrew Ibrahim, University of Michigan/Annals of Surgery

Visual Abstracts to Disseminate Research on Social Media: A Prospective, Case-control Crossover Study

Ibrahim AM, Lillemoe KD, Klingensmith ME, Dimick JB. Visual abstracts to disseminate research on social media: A prospective, case-control crossover study. Ann Surg. 2017. doi: 10.1097/SLA.0000000000002277.

Nearly all major academic research journals have adopted social media platforms, such as Twitter, to disseminate their publications and make them more accessible to readers. One recent study suggested that articles featured on Twitter may be 3 times more likely to be read versus those that were not. Despite the widespread adoption of Twitter by academic journals, the extent to which the social media platforms and strategies can influence practical outcomes, such as number of article reads, remain understudied.

In July of 2016, Annals of Surgery adopted the use of ‘‘visual abstracts’’ as a novel strategy to improve dissemination of the journal’s publications. A visual abstract is simply a visual representation of the key findings typically found in the abstract portion of an article. They are produced by the journal after an article is accepted. Examples can be found in Figure 1. As of March 2017, more than 15 journals have utilized visual abstracts in their social media dissemination strategy, yet no data exist describing how their use impacts dissemination of publications.

In this context, a case-control crossover study was conducted to compare tweets that included only the title of the article versus tweets that contain the title and a visual abstract. Such information would be valuable to help journals and authors understand the impact of different dissemination strategies for their publications.

Hot Topics: NIH Encourages Preprint Inclusion in Grant Proposals

Jackie Werner Hot Topics in Research, Research and Scholarly Communication, Research Commentary

Reporting Preprints and Other Interim Research Products

Office of Policy for Extramural Research Administration, National Institutes of Health. (2017). Reporting Preprints and Other Interim Research Products (Notice Number: NOT-OD-17-050). Retrieved from https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-050.html

Purpose
The NIH encourages investigators to use interim research products, such as preprints, to speed the dissemination and enhance the rigor of their work. This notice clarifies reporting instructions to allow investigators to cite their interim research products and claim them as products of NIH funding.

Definitions
Interim Research Products are complete, public research products that are not final.

A common form is the preprint, which is a complete and public draft of a scientific document. Preprints are typically unreviewed manuscripts written in the style of a peer-reviewed journal article. Scientists issue preprints to speed dissemination, establish priority, obtain feedback, and offset publication bias.

Another common type of interim product is a preregistered protocol, where a scientist publicly declares key elements of their research protocol in advance. Preregistration can help scientists enhance the rigor of their work.

Notes:

  • Awardees are not required to create interim research products through their NIH award.
  • Applicants are not required to cite interim research products as part of their grant applications.
  • Since preprints are not published in peer-reviewed journals, they do not fall under the NIH public access policy.
  • This guide notice does not apply to clinical trial registration. See ClinicalTrials.gov about registration of clinical trial protocols.