Recommendations and guidelines for creating scholarly biomedical journals: A scoping review.

BACKGROUND: Scholarly journals play a key role in the dissemination of research findings. However, little focus is given to the process of establishing new, credible journals and the obstacles faced in achieving this. This scoping review aimed to identify and describe existing recommendations for starting a biomedical scholarly journal. METHODS: We searched five bibliographic databases: OVID Medline + Medline in Process, Embase Classic + Embase, ERIC, APA PsycINFO, and Web of Science on January 14, 2022. A related grey literature search was conducted on March 19, 2022. Eligible sources were those published in English in any year, of any format, and that described guidance for starting a biomedical journal. Titles and abstracts of obtained sources were screened. We extracted descriptive characteristics including author name, year and country of publication, journal name, and source type, and any recommendations from the included sources discussing guidance for starting a biomedical journal. These recommendations were categorized and thematically grouped. RESULTS: A total of 5626 unique sources were obtained. Thirty-three sources met our inclusion criteria. Most sources were blog posts (10/33; 30.30%), and only 10 sources were supported by evidence. We extracted 51 unique recommendations from these 33 sources, which we thematically classified into nine themes which were: journal operations, editorial review processes, peer review processes, open access publishing, copyediting/typesetting, production, archiving/indexing/metrics, marketing/promotion, and funding. CONCLUSIONS: There is little formal guidance regarding how to start a scholarly journal. The development of an evidence-based guideline may help uphold scholarly publishing quality, provide insight into obstacles new journals will face, and equip novice publishers with the tools to meet best practices.

Clinical Quality Measures: A Challenge for-and to-Family Physicians.

INTRODUCTION: Improving design, selection and implementation of appropriate clinical quality measures can reduce harms and costs of health care and improve the quality and experience of care delivery. These measures have not been evaluated for appropriateness for use in performance measurement in a systematic, reproducible, and widely accepted manner. METHODS: We defined 10 criteria for evaluation of measure appropriateness in 4 domains: Patient-centeredness of outcomes, specification of population measured and measure detail, reliable evidence that benefits likely outweigh harms, and independence from significant confounders. We applied these criteria to 24 measures under consideration for statewide use in Massachusetts in public and private incentive-based programs. We appraised each measure as Appropriate or Not Appropriate for such use. RESULTS: We rated 15 measures as Appropriate (62.5%). Three measures (12.5%) were considered Appropriate only if applied at a system level but not for patient-provider assessment and 6 measures (25%) were rated Not Appropriate. Reasons for designation as "Not Appropriate" included benefits not clearly outweighing harms, lack of preservation of patient autonomy, inappropriate specification of population and measure detail, confounding by locus of control, and confounding by social determinants of health. CONCLUSIONS: Using this consensus-driven, 10-criteria methodology we were able to evaluate appropriateness of clinical quality measures. This methodology may improve measure design and inform selection of the most appropriate measures for use in quality measurement, financial incentives, and reporting.

Gluten-induced Neurocognitive Impairment: Results of a Nationwide Study.

GOALS: This study aimed to understand the neurocognitive symptoms associated with gluten exposure in individuals with self-reported celiac disease (CD) and nonceliac gluten sensitivity (NCGS). BACKGROUND: While gluten-induced neurocognitive impairment (GINI; eg, "celiac fog" or "brain fog") is commonly described by individuals with CD and NCGS, there are little data regarding the prevalence and symptoms associated with these experiences. STUDY: A 9-question online survey was accessed by 1396 individuals (1143 with CD; 253 with NCGS). Forced choice and free-response questions were asked of participants to obtain a description of neurocognitive symptoms experienced after gluten ingestion. Free-response answers were coded using a coding structure developed based on the Health-Related Quality of Life Instrument. RESULTS: The majority of survey participants (89% of CD and 95% of NCGS) reported having GINI symptoms. When describing symptoms, the most common word descriptors for both groups were difficulty concentrating, forgetfulness, and grogginess. Timing of symptoms, including onset and symptom peak, were similar across the 2 groups. Coding of free responses found the most common references were to cognitive, physical, psychological, and overall quality of life impacts. CONCLUSIONS: This survey suggests that GINI is common and may be severe in both individuals with CD and NCGS. Cognitive impairment and decline in physical functioning may be similar to that occurring in other illnesses, such as lupus. Clinical follow-up with both individuals with CD and NCGS should include assessment of GINI symptoms. Further research is warranted, including the development of a patient-reported outcome measure including neurocognitive effects of gluten exposure.

Insights into pediatric rhabdomyosarcoma research: Challenges and goals.

Overall survival rates for pediatric patients with high-risk or relapsed rhabdomyosarcoma (RMS) have not improved significantly since the 1980s. Recent studies have identified a number of targetable vulnerabilities in RMS, but these discoveries have infrequently translated into clinical trials. We propose streamlining the process by which agents are selected for clinical evaluation in RMS. We believe that strong consideration should be given to the development of combination therapies that add biologically targeted agents to conventional cytotoxic drugs. One example of this type of combination is the addition of the WEE1 inhibitor AZD1775 to the conventional cytotoxic chemotherapeutics, vincristine and irinotecan.

Rhabdomyosarcoma: current challenges and their implications for developing therapies.

Rhabdomyosarcoma (RMS) represents a rare, heterogeneous group of mesodermal malignancies with skeletal muscle differentiation. One major subgroup of RMS tumors (so-called "fusion-positive" tumors) carries exclusive chromosomal translocations that join the DNA-binding domain of the PAX3 or PAX7 gene to the transactivation domain of the FOXO1 (previously known as FKHR) gene. Fusion-negative RMS represents a heterogeneous spectrum of tumors with frequent RAS pathway activation. Overtly metastatic disease at diagnosis is more frequently found in individuals with fusion-positive than in those with fusion-negative tumors. RMS is the most common pediatric soft-tissue sarcoma, and approximately 60% of all children and adolescents diagnosed with RMS are cured by currently available multimodal therapies. However, a curative outcome is achieved in <30% of high-risk individuals with RMS, including all those diagnosed as adults, those diagnosed with fusion-positive tumors during childhood (including metastatic and nonmetastatic tumors), and those diagnosed with metastatic disease during childhood (including fusion-positive and fusion-negative tumors). This white paper outlines current challenges in RMS research and their implications for developing more effective therapies. Urgent clinical problems include local control, systemic disease, need for improved risk stratification, and characterization of differences in disease course in children and adults. Biological challenges include definition of the cellular functions of PAX-FOXO1 fusion proteins, clarification of disease heterogeneity, elucidation of the cellular origins of RMS, delineation of the tumor microenvironment, and identification of means for rational selection and testing of new combination therapies. To streamline future therapeutic developments, it will be critical to improve access to fresh tumor tissue for research purposes, consider alternative trial designs to optimize early clinical testing of candidate drugs, coalesce advocacy efforts to garner public and industry support, and facilitate collaborative efforts between academia and industry.