Peer review of clinical and translational research manuscripts: Perspectives from statistical collaborators.

Research articles in the clinical and translational science literature commonly use quantitative data to inform evaluation of interventions, learn about the etiology of disease, or develop methods for diagnostic testing or risk prediction of future events. The peer review process must evaluate the methodology used therein, including use of quantitative statistical methods. In this manuscript, we provide guidance for peer reviewers tasked with assessing quantitative methodology, intended to complement guidelines and recommendations that exist for manuscript authors.

Association of Life Expectancy With Surveillance Colonoscopy Findings and Follow-up Recommendations in Older Adults.

Importance: Surveillance after prior colon polyps is the most frequent indication for colonoscopy in older adults. However, to our knowledge, the current use of surveillance colonoscopy, clinical outcomes, and follow-up recommendations in association with life expectancy, factoring in both age and comorbidities, have not been studied.

Objective: To evaluate the association of estimated life expectancy with surveillance colonoscopy findings and follow-up recommendations among older adults.

Preventing metastatic recurrence in low-risk ER/PR + breast cancer patients-a retrospective clinical study exploring the evolving challenge of persistence with adjuvant endocrine therapy.

Purpose: In the genomic era, more women with low-risk breast cancer will forego chemotherapy and rely on adjuvant endocrine therapy (AET) to prevent metastatic recurrence. However, some of these patients will unfortunately relapse. We sought to understand this outcome.

Sensitizing brain metastases to stereotactic radiosurgery using hyperbaric oxygen: A proof-of-principle study.

Purpose: Increased oxygen levels may enhance the radiosensitivity of brain metastases treated with stereotactic radiosurgery (SRS). This project administered hyperbaric oxygen (HBO) prior to SRS to assess feasibility, safety, and response.

Methods: 38 patients were studied, 19 with 25 brain metastases treated with HBO prior to SRS, and 19 historical controls with 27 metastases, matched for histology, GPA, resection status, and lesion size.

Adoption of Telemedicine in a Rural US Cancer Center Amid the COVID-19 Pandemic: Qualitative Study.

Background: The COVID-19 pandemic necessitated a rapid shift to telemedicine to minimize patient and provider exposure risks. While telemedicine has been used in a variety of primary and specialty care settings for many years, it has been slow to be adopted in oncology care. Health care provider and administrator perspectives on factors affecting telemedicine use in oncology settings are not well understood, and the conditions associated with the COVID-19 pandemic offered the opportunity to study the adoption of telemedicine and the resulting provider and staff perspectives on its use.

Factors Influencing Telemedicine Use at a Northern New England Cancer Center During the COVID-19 Pandemic.

Purpose: To characterize the use of telemedicine for oncology care over the course of the COVID-19 pandemic in Northern New England with a focus on factors affecting trends.

Methods: We performed a retrospective observational study using patient visit data from electronic health records from hematology-oncology and radiation-oncology service lines spanning the local onset of the pandemic from March 18, 2020, through March 31, 2021. This period was subdivided into four phases designated as lockdown, transition, stabilization, and second wave.

Effectiveness of a Self-Management Program to Improve Cognition and Quality of Life in Epilepsy: A Pragmatic, Randomized, Multicenter Trial.

Background And Objectives: We conducted a multisite, pragmatic replication trial at 4 New England epilepsy centers to determine the effectiveness of Home-Based Self-Management and Cognitive Training Changes Lives (HOBSCOTCH) in a real-world setting and to assess feasibility of a virtual intervention.

Methods: HOBSCOTCH is an 8-session intervention addressing cognitive impairment and quality of life (QoL) for people with epilepsy (PWE). Participants were recruited from epilepsy centers in 4 states and block-randomized into the following groups: in-person HOBSCOTCH (H-IP), virtual HOBSCOTCH (H-V), and waitlist control.

Colonoscopy utilization and outcomes in older adults: Data from the New Hampshire Colonoscopy Registry.

Background: Colonoscopy is frequently performed in older adults, yet data on current use, and clinical outcomes of and follow-up recommendations after colonoscopy in older adults are lacking.

Methods: This was an observational study using the New Hampshire Colonoscopy Registry of adults age ≥65 years undergoing colonoscopy for screening, surveillance of prior polyps, or evaluation of symptoms. The main outcomes were clinical findings of polyps and colorectal cancer and recommendations for future colonoscopy by age.

Guidance for biostatisticians on their essential contributions to clinical and translational research protocol review.

Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician's input is relevant only to sample size/power and statistical analysis sections of a protocol.

Pathogenic DPYD Variants and Treatment-Related Mortality in Patients Receiving Fluoropyrimidine Chemotherapy: A Systematic Review and Meta-Analysis.

Background: Pathogenic variants of the DPYD gene are strongly associated with grade ≥3 toxicity during fluoropyrimidine chemotherapy. We conducted a systematic review and meta-analysis to estimate the risk of treatment-related death associated with DPYD gene variants.

Materials And Methods: We searched for reports published prior to September 17, 2020, that described patients receiving standard-dose fluoropyrimidine chemotherapy (5-fluorouracil or capecitabine) who had baseline testing for at least one of four pathogenic DPYD variants (c.

Geriatric Snowmobile Trauma: Longer Courses After Similar Injuries.

Background: Snowmobiling is a popular activity that leads to geriatric trauma admissions; however, this unique trauma population is not well characterized. We aimed to compare the injury burden and outcomes for geriatric versus nongeriatric adults injured riding snowmobiles.

Materials And Methods: A retrospective cohort study was performed using the National Trauma Databank comparing nongeriatric (18-64) and geriatric adults (≥65) presenting after snowmobile-related trauma at level 1 and 2 trauma centers from 2011 to 2015.

Kynurenine-Induced Aryl Hydrocarbon Receptor Signaling in Mice Causes Body Mass Gain, Liver Steatosis, and Hyperglycemia.

Objective: The aryl hydrocarbon receptor (AHR) plays a key role in obesity. In vitro studies revealed that the tryptophan metabolite kynurenine (Kyn) activates AHR signaling in cultured hepatocytes. The objective of this study was to determine whether Kyn activated the AHR in mice to induce obesity.

Geriatric Skiers: Active But Still at Risk, a National Trauma Data Bank Study.

Background: Downhill skiing accounts for a large portion of geriatric sport-related trauma. We assessed the national burden of geriatric versus nongeriatric ski trauma.

Materials And Methods: Adults presenting to level 1/2 trauma centers after ski-associated injuries from 2011 to 2015 were identified from the National Trauma Data Bank by ICD-9 code.

ANALYSES OF PREVENTIVE CARE MEASURES WITH INCOMPLETE HISTORICAL DATA IN ELECTRONIC MEDICAL RECORDS: AN EXAMPLE FROM COLORECTAL CANCER SCREENING.

The calculation of quality of care measures based on electronic medical records (EMRs) may be inaccurate because of incomplete capture of past services. We evaluate the influence of different statistical approaches for calculating the proportion of patients who are up-to-date for a preventive service, using the example of colorectal cancer (CRC) screening. We propose an extension of traditional mixture models to account for the uncertainty in compliance, which is further complicated by the choice of various screening modalities with different recommended screening intervals.

A Randomized Prospective Trial of Supine MRI-Guided Versus Wire-Localized Lumpectomy for Breast Cancer.

Background: Wire-localized excision of non-palpable breast cancer is imprecise, resulting in positive margins 15-35% of the time.

Methods: Women with a confirmed diagnosis of non-palpable invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) were randomized to a new technique using preoperative supine magnetic resonance imaging (MRI) with intraoperative optical scanning and tracking (MRI group) or wire-localized (WL group) partial mastectomy. The main outcome measure was the positive margin rate.

Multi-level Influences on Breast Cancer Screening in Primary Care.

Background: Use of breast cancer screening is influenced by factors associated with patients, primary care providers, practices, and health systems.

Objective: We examined the relative effects of these nested levels on four breast cancer screening metrics.

Design: A web-based survey was completed at 15 primary care practices within two health systems representing 306 primary care providers (PCPs) serving 46,944 women with a primary care visit between 1/2011-9/2014.

Considering Spine Surgery: A Web-Based Calculator for Communicating Estimates of Personalized Treatment Outcomes.

Study Design: Prospective evaluation of an informational web-based calculator for communicating estimates of personalized treatment outcomes.

Objective: To evaluate the usability, effectiveness in communicating benefits and risks, and impact on decision quality of a calculator tool for patients with intervertebral disc herniations, spinal stenosis, and degenerative spondylolisthesis who are deciding between surgical and nonsurgical treatments.

Summary Of Background Data: The decision to have back surgery is preference-sensitive and warrants shared decision making.

Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT).

Study Design: Randomized trial with a concurrent observational cohort study.

Objective: To compare 8-year outcomes between surgery and nonoperative care and among different fusion techniques for symptomatic lumbar degenerative spondylolisthesis (DS).

Summary Of Background Data: Surgical treatment of DS has been shown to be more effective than nonoperative treatment out to 4 years.

Immediate Symptom Relief After a First Session of Massage Therapy or Reiki in Hospitalized Patients: A 5-Year Clinical Experience from a Rural Academic Medical Center.

Objectives: There is an increasing demand for and use of alternative and complementary therapies, such as reiki and massage therapy, in hospital-based settings. Most controlled studies and practice-based reports include oncology and surgical patient populations; thus the effect in a more heterogeneous hospitalized patient population is hard to estimate. We examined the immediate symptom relief from a single reiki or massage session in a hospitalized population at a rural academic medical center.

Medical Care Costs Were Similar Across the Low-dose Computed Tomography and Chest X-Ray Arms of the National Lung Screening Trial Despite Different Rates of Significant Incidental Findings.

Background: The National Lung Screening Trial (NLST) reported lung cancer and all-cause mortality reductions for low-dose computed tomography (LDCT) versus chest x-ray (CXR) screening. Although LDCT lung screening has received a grade B from the United States Preventive Services Task Force and is a covered service under most health plans, concerns remain on the costs engendered by screening, and the impact of the high rate of significant incidental finding (SIF) detection on those costs.

Methods: We linked American College of Radiology Imaging Network NLST and Medicare fee-for-service claims data for participants from 23 sites for 2002-2009.

Short-term Preoperative Diet Decreases Bleeding After Partial Hepatectomy: Results From a Multi-institutional Randomized Controlled Trial.

Background: Our previous case series suggested that a 1-week, low-calorie and low-fat diet was associated with decreased intraoperative blood loss in patients undergoing liver surgery.

Objective: The current study evaluates the effect of this diet in a randomized controlled trial.

Methods: We randomly assigned 60 patients with a body mass index ≥25 kg/m(2) to no special diet or an 800-kcal, 20 g fat, and 70 g protein diet for 1 week before liver resection.

Does reduction in sciatica symptoms precede improvement in disability and physical health among those treated surgically for intervertebral disc herniation? Analysis of temporal patterns in data from the Spine Patient Outcomes Research Trial.

Background Context: Pain, pain-related disability, and functional limitations are common consequences of intervertebral disc herniation (IDH). We hypothesized that surgical treatment reduces pain, leading to improvement in pain-related disability and, ultimately, better physical health.

Purpose: The present study aims to evaluate pathways for improvements in quality of life during the first year after surgery for IDH by studying temporal relationships between sciatica symptoms, pain-related disability, and physical health.