Key Guidelines for Responding to Reviewers.

Background: The process of preparing a scientific manuscript is intricate, encompassing several critical stages, including pre-writing, research development, drafting, peer review, editing, publication, dissemination, and access. Among these, the peer review process (PRP) stands out as a pivotal component requiring seamless collaboration among editors, reviewers, and authors. Reviewers play a crucial role in assessing the manuscript's quality and providing constructive feedback, which authors must adeptly navigate to enhance their work and meet journal standards. This process can often appear daunting and time-consuming, as authors are required to address numerous comments and requested changes. Authors are encouraged to perceive reviewers as consultants rather than adversaries, viewing their critiques as opportunities for improvement rather than personal attacks. Methods: Opinion article. Aim: To equip authors with practical strategies for engaging effectively in the PRP and improving their publication acceptance rates. Results: Key guidelines include thoroughly understanding and prioritizing feedback, maintaining professionalism, and systematically addressing each comment. In cases of significant disagreement or misunderstanding, authors have the option to refer the issue to the editor. Crafting a well-organized and scientific "response to reviews" along with the revised manuscript can substantially increase the likelihood of acceptance. Best practices for writing an effective response to reviews include expressing gratitude, addressing major revisions first, seeking opinions from co-authors and colleagues, and adhering strictly to journal guidelines. Emphasizing the importance of planning responses, highlighting changes in the revised manuscript, and conducting a final review ensures all corrections are properly documented. Conclusion: By following these guidelines, authors can enhance their manuscripts' quality, foster positive relationships with reviewers, and ultimately contribute to scholarly advancement.

Closing the loop: Strengthening course quality of Pharm.D. program via applying a comprehensive four-step review approach.

This study explores the course review process implemented by the College of Pharmacy at King Saud University for its Pharm.D. program. Through a qualitative research design, a dedicated course review committee was established to oversee the evaluation process. The committee gathered and analyzed data from various sources, including course reports, student evaluations, and exam center reports, to achieve a holistic understanding of each course's effectiveness. The evaluation process was structured into a Four-Step Course Evaluation Approach: data collection, data review and recommendations, taking appropriate action, and communicating the outcomes. The "closing the loop" stage ensured that recommendations were effectively implemented, and course evaluation data were systematically archived for future reference. The results of this study, based on the evaluation of 25 courses, revealed significant improvements in course quality, alignment with program learning outcomes, and adherence to accreditation standards. Key findings included the identification of gaps and discrepancies, leading to targeted interventions and enhanced course content. Overall, this study highlights the effectiveness of a structured course review process in enhancing the quality of education and ensuring continuous improvement within the college. The committee focuses on refining evaluation criteria, conducting workshops, and providing training to stay current with emerging accreditation standards and best practices. This systematic course review process demonstrates the College's commitment to providing high-quality education and preparing students for successful careers in pharmacy, with significant implications for the improvement of pharmacy education and the overall student learning experience.

Description of swine producer biosecurity planning for foreign animal disease preparedness using the Secure Pork Supply framework.

Introduction: Preventing potential foreign animal diseases is a high priority, with re-emerging threats such as African Swine Fever emerging close to North American borders. The Secure Pork Supply (SPS) plan provides a voluntary framework for swine producer biosecurity planning and disease outbreak preparedness. However, biosecurity knowledge varies greatly among swine veterinarians, managers, and caretakers within the industry, which impacts the understanding, quality, implementation and biosecurity plan agreements with the SPS guidelines unless review procedures and quality control mechanisms are in place. Therefore, this study aimed to describe and identify the level of biosecurity planning agreements between producer-and/or swine veterinarian-made biosecurity plans for commercial swine sites and the SPS plan guidelines during a review process. Material and methods: Biosecurity maps (N = 368) and written plans (N = 247) were obtained from six Midwest swine companies/veterinary clinics. Maps were evaluated on accuracy and placement of mandatory map features based on SPS guidelines, and discrepancies between the development of producer-made biosecurity maps and written biosecurity plans. Multivariable mixed logistic regression analyses were conducted to identify differences in SPS planning accuracy based on herd size, production stage, and characteristics related to geographical site location (e.g., land cover type and expected feral swine population density in the region). Results: In this study, 55.8% (205/368) of all provided biosecurity maps had to be revised due to misplaced or missing map features. In addition, 80.9% (200/247) of the written plans had one or more conflicts with the corresponding biosecurity maps. The main biosecurity planning issues involved feed delivery activities, where the mapping of vehicle movements (89.9%, 222/247) were in direct conflict with the written SPS plans. Sites located in areas with a moderate expected feral swine population density had 3-fold increased odds of needing map revisions compared to sites with low expected feral swine population density. Sites located in predominately farmland had 7.3% lower odds of having biosecurity map and SPS plan conflicts for every 1.0% increase in farmland landcover in a 10-km radius around the swine site. Discussion: Human oversight or lack of knowledge regarding biosecurity planning and implementation is common, which may culminate in important preparedness shortcomings in disease prevention and control strategies for U.S. swine farms. Future efforts should focus on additional biosecurity training for swine producers and veterinarians alongside with quality control benchmarking of producer made plans.

Current trends in retraction of plastic surgery and reconstruction research.

BACKGROUND: Various studies regarding retractions of publications have determined the rate of retraction has increased in recent years. Although this trend may apply to any field, there is a paucity of literature exploring the publication of erroneous studies within plastic and reconstructive surgery. The present study aims to identify trends in frequency and reasons for retraction of plastic and reconstructive surgery studies, with analysis of subspecialty and journals. METHODS: A database search was conducted for retracted papers within plastic and reconstructive surgery. The initial search yielded 2347 results, which were analyzed by two independent reviewers. 77 studies were jointly identified for data collection. RESULTS: The most common reasons for retractions were duplication (n = 20, 25.9 %), request of author (n = 15, 19.5 %), plagiarism (n = 9, 11.6 %), error (n = 9, 11.6 %), fraud (n = 2, 2.6 %), and conflict of interest (n = 1, 1.3 %). 15 were basic science studies (19.4 %), 58 were clinical science studies (75.3 %), and 4 were not categorized (5.2 %). Subspecialties of retracted papers were maxillofacial (n = 29, 37.7 %), reconstructive (n = 17, 22.0 %), wound healing (n = 8, 10.4 %), burn (n = 6, 7.8 %), esthetics (n = 5, 6.5 %), breast (n = 3, 3.9 %), and trauma (n = 1, 1.3 %). Mean impact factor was 2.9 and average time from publication to retraction was 32 months. CONCLUSION: Analysis of retracted plastic surgery studies revealed a recent rise in frequency of retractions, spanning a wide spectrum of journals and subspecialties.

Impact of institutional review board stipulations on turnaround time for approvals of surgical studies.

BACKGROUND: We have examined the number and types of stipulations received following the submission of surgical study protocols to the Institutional Review Boards (IRBs) for review, and their effect on turnaround time for approval. This analysis will enable our organization to improve the quality of applications and design of study protocols, which can streamline the approval process and increase efficiency of the startup phase for clinical research. METHODS: IRB stipulations for 48 surgical studies were analyzed. Various factors were assessed: surgical specialty, type of study by design, clinical trial phase, type of investigational product, type of IRB utilized (local or centralized), study complexity score, type of review (e.g., exempt, expedited, or full board), turnaround time, and number of stipulations received. Statistical analyses were performed to examine associations between the number/type of stipulations received during the IRB review process and any of the aforementioned study-related factors. RESULTS: For analyzed surgical studies, the number of stipulations allotted to a study and time taken for approval had moderate association with the complexity of the study. The turnaround time for approval was the highest for randomized, controlled trials and studies undergoing full board review. CONCLUSION: This study elucidates characteristics that are associated with increased time for IRB approval. Analysis of IRB stipulations can help improve the turnaround time for the approval process, increase efficiency of startup phase, and transition to execution phase faster, which will allow more time for enrollment of research subjects, and increase return on investment made into research and development programs.

The Peer Review System: A Journal Editor's 30-Year Perspective.

The peer review system has become the standard by which scientific articles are refereed. Unfortunately, even from its beginnings in the mid-1800s it has been fraught with difficulties. Potential reviewers are volunteers who may be inundated with requests to review yet these reviews take considerable time and effort. There is little motivation to complete a review causing significant delays in the publication process. There may be biases unintentionally built into the system between reviewers, authors, editors, and journals. Attempts to overcome these biases by various blinding schemes have been met with limited success. Finally, the recent advent of Artificial Intelligence has the potential to completely upend the system, for good or bad.

Adopting recommendations for implementing patient involvement in cancer research: a funder's approach.

BACKGROUND: The role of patients in cancer research is undergoing a significant evolution as all stakeholders seek to enhance the level of direct patient involvement in the design and development of clinical trials. However, there are significant hurdles that patients, patient advocates, laboratory researchers, clinical investigators, and funding institutions must overcome to implement relevant patient involvement in all aspects of biomedical research. By using innovative grant funding models, philanthropic organizations can lead the field in overcoming these challenges. Rising Tide Foundation for Clinical Cancer Research (RTFCCR), a private philanthropy that funds academic research, has developed a novel approach for requiring and supporting partnerships among grantees and patients in designing and conducting research projects. This paper presents a reflective case study of efforts to advance the field of patient involvement in clinical research. METHODS: The decision to focus on patient involvement stems from an expressed focus area established by the RTFCCR board of directors. In conducting this work, RTFCCR partnered with Patvocates, a patient advocacy and engagement network, to create a set of guiding documents and resources aimed at public and private health research funders within various national, international, and therapeutic settings. This effort included a landscape assessment, interviews with experts, and an iterative development process. RESULTS: To date, RTFCCR has completed and disseminated three guiding documents, one for funders, one for grant applicants, and one for patient advocates. These resources have already generated three major ongoing initiatives at RTFCCR: (1) inclusion of these recommendations in the foundation's funding guidelines; patient input to prioritization of research focus areas; and in topic selection for calls for proposals; (2) direct involvement of patient experts in the grant review process; and (3) a commitment to support high impact clinical research projects in Low- and Middle-Income Countries. Moreover, the foundation has launched a partnership with the International Cancer Research Partnership, the global alliance of cancer research organizations. CONCLUSION: By using its grantmaking function and developing standardized approaches for implementation of patient involvement, RTFCCR is seeking to advance patient-centric cancer clinical research. This approach will continue to develop as it is implemented and shared with partners throughout the world.

The Rising Tide Foundation for Clinical Cancer Research (RTFCCR), a private philanthropy that funds academic research, has developed a novel approach for requiring and supporting partnerships among grantees (scientists) and patients in designing and conducting research projects.The decision to focus on patient involvement stems from an expressed focus area established by the RTFCCR board of directors. In conducting this work, RTFCCR partnered with Patvocates, a patient advocacy and engagement network. Patvocates conducted a landscape assessment, interviews with experts, and their collective experience as patient advocates. This work generated a set of guiding documents and resources. These resources are to help public and private health research funders to better understand current challenges and support scientists and patients through their funding mechanisms. Three guiding documents, one for funders, one for grant applicants, and one for patient advocates are now available for download at the RTFCCR website: https://www.risingtide-foundation.org/clinical-cancer-research/patient-engagement#start Delivering a paradigm change involves not only the introduction of additional requirements and rules, but also enhanced education of patients and investigators. By using its grantmaking function and developing standardized approaches for implementation of patient involvement, RTFCCR is seeking to advance patient-centric cancer clinical research.Development and implementation of consistent policies and procedures for the integration of the patients' view in the design and review of research proposals is needed for funders as well as for research institutes, both public and private.

How to write a revised manuscript in clinical medicine.

Although there are several books or manuscripts regarding how to prepare scientific manuscripts, the literatures focusing on the preparation of the revised manuscript are sparse. The process of revisions may be different between experimental medicine and clinical medicine. In this review, we summarize the tips for the revised manuscript in clinical medicine. When the authors receive the invitation of revisions from the editors, the authors should try to resubmit the revised manuscript at the earliest convenience. In the preparation of the rebuttal letter, the authors must respect the reviewers' effort for their manuscript. It is important for the authors to make the reviewers feel that the authors take a best effort to verify the reviewer's request.

Learning from hospital deaths.

Current guidelines and regulations require trusts to take full responsibility for deaths within their premises. Higher than expected deaths indicate poor standards of care or negligence. NHS Trusts need to put systems in place to ensure that they learn and extrapolate risk factors through in-depth review of care provided to patients prior to their deaths, curb and ultimately diminish relative mortality through improved practices, and improve care and safety for the whole organisation. Mortality reviews can provide insight into the standard of care that dying patients receive; this matters as NHS Hospitals are the main providers of terminal care, nationally.

Improving Summative Assessment Through a Resource-Efficient Faculty Review Process.

Committee reviews improve the quality of multiple-choice question (MCQ) exams; however, such review processes are typically highly resource-intensive and time-consuming. We report a review process that requires limited faculty time and administrative resources. A small committee reviewed selected items (14-20%) of the final exams of six independent block courses taken by first- and second-year medical students. This process resulted in a significant increase in the item discrimination of reviewed questions in all exams. Our findings support the utility of a review process and may offer health profession educators a more practical and efficient approach for improving the quality of in-house MCQ exams. Supplementary Information: The online version contains supplementary material available at 10.1007/s40670-022-01631-9.

Errors detected during physics plan review for external beam radiotherapy.

Background and purpose: Risk management in radiotherapy is of high importance. There is not much data published on errors occurring in the treatment planning process of external beam techniques. The aim of this study was to investigate errors occurring during physics plan review in external beam radiotherapy. Materials and methods: Over a period of 14 months errors observed during the physical review process are reported. The errors were grouped and evaluated regarding treatment machine, technique, and treatment site. In addition, a correlation between frequency of errors and staff shortage was analyzed. Results: Subgroups of grave errors (g-errors) and slight errors (s-errors) were defined to consider the different impact on the patient and clinical workflow of the errors. In 1056 plans reviewed, 110 errors (41 g-errors, 69 s-errors) were detected. The most common g-errors and s-errors were "Wrong gantry angle at setup field" (n = 19) and "Wrong field label" (n = 24), respectively. A correlation of number of errors and treatment machine, technique, or anatomical site could not be found. No correlation between staff shortage and number of errors was observed. Conclusions: The process of reviewing treatment plans is a relevant topic to consider in risk analysis of the radiotherapy workflow. The review process could be improved by enhancements in the treatment planning systems, use of digital dose prescription, and treatment planning templates.

Trend of drug clinical trials in mainland China from 2009 to 2020.

With the development of linnovative regulations on drug clinical trials in mainland China, the quantity and quality of drug clinical trials have gradually improved over the past decade. Based on the information of the clinical trials from the online drug clinical trial registration platform of National Medical Products Administration, we reviewed the data of drug clinical trials in mainland China from 2009 to 2020. A total of 8,593 clinical trials have been conducted during this period. The annual number of clinical trials has been increasing gradually, and peaked in 2017. There were 2,127, 1,051, 1,551, and 156 phases I, II, III, and IV clinical trials respectively. In addition, there were 3,441 bioequivalence studies. Trials for anti-tumor drugs ranked the highest (19.45%), followed by trials of drugs for infections and infestations (12.96%) and those for cardiovascular diseases (9.00%). Meanwhile the number of the clinical trial sites also increased annually. However, there were only 116 and 130 clinical trials of drugs for children and rare diseases respectively. The geographical distribution of the sites was uneven. This mapping review provides an overall look of clinical trials in China, which may be useful for domestic and international sponsors.

Patient safety indicators from a spine surgery perspective: the importance of a specialty specific clinician working with the documentation team and the impact to your hospital.

BACKGROUND CONTEXT: The Hospital Acquired Conditions (HAC) Reduction Program supports the Centers for Medicare and Medicaid Services (CMS) effort to prevent harm to patients by providing a financial incentive to reduce HACs. HAC scores are impacted by Patient Safety Indicators (PSIs), potentially preventable hospital-related events associated with harmful patient outcomes. PSIs are identified using International Classification of Diseases (ICD) coding; however, ICD coding does not always reflect the patient's true medical course. PURPOSE: To evaluate the efficacy of and costs savings associated with a clinical documentation review process in tandem with clinician collaboration in identifying incorrectly generated PSIs. STUDY DESIGN: Retrospective chart review. PATIENT SAMPLE: All patients undergoing spine surgery at a single multi-surgeon tertiary spine center. OUTCOME MEASURES: Occurrence of PSI. METHODS: Over two 11-month periods, all PSIs attributable to spine surgery were determined. The number and type of spine related PSIs were compared before (Control) and after the implementation of a specialty specific clinical review (Intervention) to identify incorrectly generated PSIs. The financial impact of this intervention was calculated in the form of an annual cost savings to our hospital system. RESULTS: During the Control phase, 61 PSIs were reported in 3368 spine cases, representing a total of 3.6 PSIs/month. During Intervention phase, 26 PSIs in 4,482 spine cases, resulting in a statistically significant decrease of 1.5 PSIs per month. The percentage of PSIs across all surgical cases attributable to spine surgery had a statistically significant decrease during the Intervention period compared to the Control period (16% vs. 10%, p=.034), resulting in the avoidance of a 1% CMS cost reduction, an annual cost saving of approximately $3-4 million dollars per year. CONCLUSIONS: The implementation of a clinical documentation review process with clinician collaboration to ensure ICD-10 coding accurately reflects the patient's medical course leads to more accurate PSI reporting, with the potential for substantial cost-savings for hospitals from CMS reimbursement.

Establishing the doctor of nursing practice project ethical review process to improve standardization, efficiency, and timeliness.

BACKGROUND: DNP Scholarly projects require review for scientific merit and human subject protection. Rapid growth of DNP programs and projects has increased Institutional Review Board (IRB) burden and increased the length of project approval time when most DNP scholarly projects are quality improvement (QI) projects and not deemed Human Subjects Research (HSR). PURPOSE: Develop a process and describe the rationale for creating and implementing a Project Ethical Review Committee (PERC) in the School of Nursing and to evaluate the experience of the first cohort of submissions. PROCESS: Committee was formed using expert consensus approach, in collaboration with IRB. Standards of Procedures and training materials created. OUTCOME MEASURE: 100 projects submitted to committee; 95 deemed QI (95%) and 5 projects considered HSR (5%). First 94 projects were reviewed, and approval letters sent within 8 weeks. DISCUSSION: This paper discusses how PERC ensures rigorous and ethical review process for standardization, timeliness, and efficiency.

Barriers to Medication Review Process Implementation-Cross-Sectional Study among Community Pharmacists in Jordan.

The medication review process (MRP) is an extended, vital role of community pharmacists in improving health outcomes of medication use, yet it is neither systematically nor comprehensively provided bycommunity pharmacies in Jordan. This study aimed to identify the potential barriers hinderingMRP implementation bycommunity pharmacists in Jordan. A total of 550 community pharmacists electronically received a previously constructed and validated Arabic questionnaire explicitly developed to assess the current medication review practices and factors hindering the MRP, of whom 417 answered the questionnaire, giving a response rate of 75.8%. Among the investigated six categories' seventeen barriers tothe implementation of the MRP, the highest rating was found for remuneration barriers (55.8%), followed by barriers related to regulations and patients, which scored 52.3% and 48.8%, respectively. Resource-related barriers were recognizedby 44.6% of participants, while qualifications and barriers related to physicians scored 42.9% and 41.8%, respectively. Although community pharmacists in Jordan are eager to extend their roles from traditional to more patient-centered ones, they encounter various barriers hinderingsuch development. Regulation adjustments accompanied by cost-effective remuneration and proper training are strong facilitators for community pharmacists to initiate the medication review service; make available the needed resources; and invest efforts, time, and money to operate it.

Leveraging the COVID-19 Research Spike to Provide Medical Students with Practical Experience in Data Appraisal and Grant Review.

In April and May 2020, a group of students and professors from the Hackensack Meridian School of Medicine (HMSOM) created an elective to review pre-selected, de-identified COVID-19-related research proposals by physicians and researchers within the Hackensack Meridian Health (HMH) network. Students discussed and rated each proposal's significance, innovation, and approach using grading criteria that paralleled the National Institute of Health's (NIH) study section-based grant review process. In discussing these topics under the guidance of faculty with experience in writing and reviewing research grants, students gained a better understanding of what constitutes a quality research study and a compelling grant proposal.

Alice through the Looking-glass: Can We Improve Peer Review?

Peer review is an essential component for the evaluation of material submitted to medical and scientific journals. This process usually involves single blind, double blind or open peer review. In the present Editorial, we discuss the advantages and disadvantages of these peer review options. Our comments are influenced by our experience as Editors-in-Chief. We also outline new developments in the field of peer review.