Research Spotlight

Posted December 15th 2019

Best practice versus actual practice: an audit of survey pretesting practices reported in a sample of medical education journals.

Alejandro C. Arroliga M.D.
Alejandro C. Arroliga M.D.

Colbert, C. Y., J. C. French, A. C. Arroliga and S. B. Bierer (2019). “Best practice versus actual practice: an audit of survey pretesting practices reported in a sample of medical education journals.” Med Educ Online 24(1): 1673596.

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Background: Despite recommendations from survey scientists, surveys appear to be utilized in medical education without the critical step of pretesting prior to survey launch. Pretesting helps ensure respondents understand questions as survey developers intended and that items and response options are relevant to respondents and adequately address constructs, topics, issues or problems. While psychometric testing is important in assessing aspects of question quality and item performance, it cannot discern how respondents, based upon their lived experiences, interpret the questions we pose.Aim: This audit study explored whether authors of medical education journal articles within audited journals reported pretesting survey instruments during survey development, as recommended by survey scientists and established guidelines/standards for survey instrument development.Methods: Five national and international medical education journals publishing survey articles from Jan. 2014 – Dec. 2015 were audited to determine whether authors reported pretesting during survey development. All abstracts within all issues of these journals were initially reviewed. Two hundred fifty-one articles met inclusion criteria using a protocol piloted and revised prior to use.Results: The number of survey articles published per journal ranged from 11 to 106. Of 251 audited articles, 181 (72.11%) described using a new instrument without pretesting, while 17 (6.77%) described using a new instrument where items were pretested. Fifty-three (21.12%) articles described using pre-existing instruments; of these, no articles (0%) reported pretesting existing survey instruments prior to use.Conclusions: Findings from this audit study indicate that reported survey pretesting appears to be lower than that reported in healthcare journals. This is concerning, as results of survey studies and evaluation projects are used to inform educational practices, guide future research, and influence policy and program development. Findings apply to both survey developers and faculty across a range of fields, including evaluation and medical education research.


Posted December 15th 2019

Baseline Characteristics, Treatment Patterns, and Outcomes in Patients with HER2-Positive Metastatic Breast Cancer by Hormone Receptor Status From SystHERs.

Joyce O'Shaughnessy M.D.
Joyce O’Shaughnessy M.D.

Cobleigh, M., D. Yardley, A. M. Brufsky, H. S. Rugo, S. M. Swain, P. A. Kaufman, D. Tripathy, S. A. Hurvitz, J. O’Shaughnessy, G. Mason, V. Antao, H. Li, L. Chu and M. Jahanzeb (2019). “Baseline Characteristics, Treatment Patterns, and Outcomes in Patients with HER2-Positive Metastatic Breast Cancer by Hormone Receptor Status From SystHERs.” Clin Cancer Res Nov 26. [Epub ahead of print].

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BACKGROUND: We report treatments and outcomes in a contemporary patient population with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) by hormone receptor (HR) status from the Systemic Therapies for HER2-positive Metastatic Breast Cancer Study (SystHERs). METHODS: SystHERs (NCT01615068) was an observational, prospective registry study of US-based patients with newly diagnosed HER2-positive MBC. Endpoints included treatment patterns and clinical outcomes. RESULTS: Of 977 eligible patients (enrolled from 2012-2016), 70.1% (n=685) had HR-positive and 29.9% (n=292) had HR-negative disease. Overall, 59.1% (405/685) of patients with HR-positive disease received any first-line endocrine therapy (with or without HER2-targeted therapy or chemotherapy); 34.9% (239/685) received HER2-targeted therapy + chemotherapy + sequential endocrine therapy. Patients with HR-positive versus HR-negative disease had longer median overall survival (OS; 53.0 vs. 43.4 months; hazard ratio 0.70, 95% confidence interval 0.56-0.87). Compared with patients with high HR-positive staining (10-100%, n=550), those with low HR-positive staining (1%-9%, n=60) received endocrine therapy less commonly (64.2% vs. 33.3%) and had shorter median OS (53.8 vs. 40.1 months). Similar median OS (43.4 vs. 40.1 months) was observed in patients with HR-negative versus low HR-positive tumors (1%-9%). CONCLUSIONS: Despite evidence that first-line HER2-targeted therapy, chemotherapy, and sequential endocrine therapy improves survival in patients with HR-positive, HER2-positive disease, only 34.9% of patients in this real-world setting received such treatment. Patients with low tumor HR positivity (1%-9%) had lower endocrine therapy use and worse survival than those with high tumor HR positivity (10%-100%).


Posted December 15th 2019

Regulation and accreditation of pre-licensure education of registered nurses: a scoping review protocol.

Sonya A. Flanders M.S.N.
Sonya A. Flanders M.S.N.

Flanders, S. A. and K. A. Baker (2019). “Regulation and accreditation of pre-licensure education of registered nurses: a scoping review protocol.” JBI Database System Rev Implement Rep Nov 26. [Epub ahead of print].

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OBJECTIVE: The objective of the scoping review is to examine and map the literature that reports outcomes of the regulation and accreditation of pre-licensure education of registered nurses (RNs). INTRODUCTION: Pre-licensure nursing education is the basic education that a person must complete before becoming an RN. Regulation and accreditation of nursing education vary by country and may vary within a country. The intended purpose of regulation and accreditation is to protect the public and ensure the quality of education programs; however, there is a gap in published evidence on the outcomes of such regulation and accreditation. INCLUSION CRITERIA: Published and unpublished studies worldwide of any pre-licensure RN students or any pre-licensure graduates of RN programs will be considered. Concepts of interest for the proposed review are reported outcomes related to regulatory activities or accreditation requirements affecting any pre-licensure education programs preparing students to become RNs. The context is pre-licensure regulation or accreditation of RN education in any country or setting. This review will consider quantitative research designs, qualitative research designs, economic evidence evaluations, and textual evidence/gray literature. METHODS: Databases to be searched include CINAHL Complete, Cochrane Central Register of Controlled Trials, Directory of Open Access Journals, Education Source, Health Policy Reference Center, MEDLINE Complete, Epistemonikos, JBI Database of Systematic Reviews and Implementation Reports and Ovid Nursing. Articles published in English will be included. No date limits will be set. Selected studies will be reviewed and data extracted by two independent reviewers. Extracted data will be placed in a table and synthesized in narrative format.


Posted December 15th 2019

American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on the Role of Neuromonitoring in Perioperative Outcomes: Electroencephalography.

Michael A.E. Ramsay M.D.
Michael A.E. Ramsay M.D.

Chan, M. T. V., T. L. Hedrick, T. D. Egan, P. S. Garcia, S. Koch, P. L. Purdon, M. A. Ramsay, T. E. Miller, M. D. McEvoy and T. J. Gan (2019). “American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on the Role of Neuromonitoring in Perioperative Outcomes: Electroencephalography.” Anesth Analg Nov 18. [Epub ahead of print].

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Electroencephalographic (EEG) monitoring to indicate brain state during anesthesia has become widely available. It remains unclear whether EEG-guided anesthesia influences perioperative outcomes. The sixth Perioperative Quality Initiative (POQI-6) brought together an international team of multidisciplinary experts from anesthesiology, biomedical engineering, neurology, and surgery to review the current literature and to develop consensus recommendations on the utility of EEG monitoring during anesthesia. We retrieved a total of 1023 articles addressing the use of EEG monitoring during anesthesia and conducted meta-analyses from 15 trials to determine the effect of EEG-guided anesthesia on the rate of unintentional awareness, postoperative delirium, neurocognitive disorder, and long-term mortality after surgery. After considering current evidence, the working group recommends that EEG monitoring should be considered as part of the vital organ monitors to guide anesthetic management. In addition, we encourage anesthesiologists to be knowledgeable in basic EEG interpretation, such as raw waveform, spectrogram, and processed indices, when using these devices. Current evidence suggests that EEG-guided anesthesia reduces the rate of awareness during total intravenous anesthesia and has similar efficacy in preventing awareness as compared with end-tidal anesthetic gas monitoring. There is, however, insufficient evidence to recommend the use of EEG monitoring for preventing postoperative delirium, neurocognitive disorder, or postoperative mortality.


Posted December 15th 2019

Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients With Heart Failure and Secondary Mitral Regurgitation: Results From the COAPT Trial.

Michael J. Mack M.D.
Michael J. Mack M.D.

Baron, S. J., K. Wang, S. V. Arnold, E. A. Magnuson, B. Whisenant, A. Brieke, M. Rinaldi, A. W. Asgar, J. Lindenfeld, W. T. Abraham, M. J. Mack, G. W. Stone and D. J. Cohen (2019). “Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients With Heart Failure and Secondary Mitral Regurgitation: Results From the COAPT Trial.” Circulation 140(23): 1881-1891.

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BACKGROUND: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip resulted in reduced mortality and heart failure hospitalizations and improved quality of life compared with maximally tolerated guideline-directed medical therapy (GDMT) in patients with heart failure and 3 to 4+ secondary mitral regurgitation. Whether TMVr is cost-effective compared with GDMT in this population is unknown. METHODS: We used data from the COAPT trial to perform a formal patient-level economic analysis of TMVr+GDMT versus GDMT alone for patients with heart failure and 3 to 4+ secondary mitral regurgitation from the perspective of the US healthcare system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated on the basis of medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline and 1, 6, 12, and 24 months with the Short Form Six-Dimension Health Survey. RESULTS: Initial costs for the TMVr procedure and index hospitalization were $35 755 and $48 198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26 654 versus $38 345; P=0.018), cumulative 2-year costs remained higher with TMVr because of the upfront cost of the index procedure ($73 416 versus $38 345; P<0.001). When in-trial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life expectancy by 1.13 years and quality-adjusted life-years by 0.82 years at a cost of $45 648, yielding a lifetime incremental cost-effectiveness ratio of $40 361 per life-year gained and $55 600 per quality-adjusted life-year gained. CONCLUSIONS: For symptomatic patients with heart failure and 3 to 4+ secondary mitral regurgitation, TMVr increases life expectancy and quality-adjusted life expectancy compared with GDMT at an incremental cost per quality-adjusted life-year gained that represents acceptable economic value according to current US thresholds. Clinical Trial Registration Unique Identifier: NCT01626079