Measurement properties and feasibility of chronic pain assessment tools for use with children and young people with cerebral palsy.

PURPOSE: Chronic pain assessment tools exist for children, but may not be valid, reliable, and feasible for populations with functional, cognitive or communication limitations, for example, cerebral palsy (CP). This study aimed to (i) identify chronic pain assessment tools used with children and young people and rate their measurement properties; (ii) develop a CP specific feasibility rating tool to assess the feasibility of tools in CP; and (iii) categorise tools according to reporting method. MATERIALS AND METHODS: Assessment tools were identified by literature review. Their measurement properties were rated using the COnsensus based standards for the Selection of health Measurement INstruments. The CP specific Feasibility Rating Tool was developed and used to rate the tools. RESULTS: Fifty-seven chronic pain assessment tools were identified. Six have content validity for CP, four of these use proxy-report. Forty-two tools were considered feasible for people with CP; 24 self report and 18 observational/proxy-report. Only the Paediatric Pain Profile has content validity and feasibility for people with CP unable to self-report. CONCLUSIONS: There are few valid, reliable and feasible tools to assess chronic pain in CP. Further research is required to modify tools to enable people with cognitive limitations and/or complex communication to self-report pain.

Few of the existing chronic pain assessment tools are feasible or valid to use with all young people with cerebral palsy (CP).Modifications to self-report tools are needed to improve access for young people who have cognitive impairment or use alternative and augmentative communication.The pain assessment tool with the strongest feasibility and measurement properties for young people who cannot self-report is the Paediatric Pain Profile.Clinicians will need to consider a range of chronic pain assessment tools to assess the biopsychosocial domains important to young people with cerebral palsy.

Chronic pain in children and young people with cerebral palsy: a narrative review of challenges, advances, and future directions.

BACKGROUND: Cerebral palsy (CP), the most common physical disability of childhood, is often accompanied by a range of comorbidities including pain. Pain is highly prevalent in children and young people with CP, yet has been poorly understood, inaccurately assessed, and inadequately managed in this vulnerable population. This narrative review presents recent research advances for understanding and managing pain in children and young people with CP, focusing on chronic pain, and highlights future research directions. MAIN BODY: Pain prevalence rates in CP vary due to different methodologies of studies. Recent systematic reviews report up to 85% of children experience pain; higher in older children, females, and those with dyskinesia and greater motor impairment. Research examining the lived experience perspectives of children and their families demonstrate that even those with mild motor impairments have pain, children want to self-report pain where possible to feel heard and believed, and management approaches should be individualized. Notably, many children with cognitive and communication impairments can self-report their pain if adjustments are provided and they are given a chance. Past inadequacies of pain assessment in CP relate to a focus on pain intensity and frequency with little focus on pain interference and coping, a lack of tools appropriate for the CP population, and an assumption that many children with cognitive and/or communication limitations are unable to self-report. Recent systematic reviews have identified the most reliable and valid assessment tools for assessing chronic pain. Many were not developed for people with CP and, in their current form, are not appropriate for the spectrum of physical, communication, and cognitive limitations seen. Recently, consensus and co-design in partnership with people with lived experience and clinicians have identified tools appropriate for use in CP considering the biopsychosocial framework. Modifications to tools are underway to ensure feasibility and applicability for the spectrum of abilities seen. CONCLUSION: Recent research advances have improved our understanding of the prevalence, characteristics and lived experience of chronic pain, and refined assessment methods in children and young people with CP. However, the very limited evidence for effective and novel management of chronic pain in this population is where research should now focus.

Anti-oppression pedagogy in health professions: a scoping review.

Health professional learners are increasingly called to learn about health inequity to reduce inequities and improve patient care and health outcomes. Anti-oppression pedagogy (AOP) addresses the need for health professional learners to understand multiple health inequities and the structures and systems that produce inequities. However, the inclusion of AOP in health professions education varies and there is a lack of clarity in its conceptualization and integration. A scoping review was conducted to address this gap and to understand how AOP is conceptualized and integrated in health professions education. Thirty-six articles met the inclusion criteria. The articles demonstrated that AOP is not commonly utilized terminology within health professions education. When AOP is integrated, it is not consistently conceptualized but is generally viewed as a broad concept that focuses on antiracism; decoloniality; intersectionality; and supporting learners to understand, critically reflect on, and act against structural and systemic forms of oppressions. In addition, there is variation in the integration of AOP in health professions education with the most common methods consisting of discussions, cases, reflection, learning through lived experiences, and the incorporation of humanities within a longitudinal curriculum. The results of this scoping review highlight the need for health professions education to develop one clear concept that educators use when teaching about anti-oppression, which may reduce working in silos and allow educators to better collaborate with each other in advancing this work. In addition, this review suggests that health professional programs should consider incorporating AOP in curricula with a broad and longitudinal approach utilizing the common methods of delivery. To better support programs in including AOP in curricula, further research is required to emphasize the benefits, provide clarity on its conceptualization, and determine the most effective methods of integration.

Examining tools for assessing the impact of chronic pain on emotional functioning in children and young people with cerebral palsy: stakeholder preference and recommendations for modification.

PURPOSE: To firstly identify tools for assessing the impact of chronic pain on emotional functioning in children and young people with cerebral palsy (CP), and secondly identify suggestions to improve their relevance, comprehensiveness, comprehensibility and feasibility for the CP population. Improving assessment of the impact of pain on emotional functioning can enhance quality of life by improving access to interventions for pain-related physical disability, anxiety and depression. METHODS: Ethics approval was granted through the Women's and Children's Health Network Human Research Ethics Committee (2022/HRE00154). A mixed methods study with people with lived experience and clinicians, and guided by the Consensus-based Standards for Measurement Instruments (COSMIN), was undertaken. An online survey identified the highest rated tools for validation and/or modification for young people with CP and chronic pain. Focus groups and interviews investigated content validity and feasibility of the tools identified as highest rated. RESULTS: The Fear of Pain Questionnaire for Children-SF (FOPQ-C-SF) and Modified Brief Pain Inventory (mBPI) were the highest rated for pain coping and multidimensional assessment (respectively) from the online survey (n = 61) of eight tools presented. Focus group and interview data (n = 30), including 58 unique modification suggestions, were coded to six categories: accessibility, comprehensibility, feasibility, relevance, presentation and comprehensiveness. CONCLUSION: Potential modifications have been identified to improve the appropriateness and feasibility of the FOPQ-C-SF and mBPI for children and young people with CP. Future research should implement and test these modifications, prioritising the involvement of people with lived experience to ensure their needs are met alongside clinicians.

Up to 75% of children and young people with cerebral palsy report chronic pain, which is much higher than those without cerebral palsy. Assessing how pain impacts emotional functioning, and how each individual copes with pain, is of particular importance due to known links between emotional functioning and long term pain outcomes. Reliable assessment of how pain impacts emotional functioning may also help to identify those who would benefit from psychological treatments. Although pain questionnaires are available, many are not suitable for children and young people with cerebral palsy with different communication, cognitive and movement abilities. This study had two aims: (1) to work out which of the currently available tools that assess how pain impacts emotional functioning are considered best for people with cerebral palsy, and (2) to identify potential modifications to these tools. The two most relevant and easy to understand questionnaires selected for modification were the Fear of Pain Questionnaire for Children and the modified Brief Pain Inventory. A number of modifications were identified, including improving how relevant the questions were to people with cerebral palsy, improving accessibility for people with complex communication needs or cognitive impairment and improving how easy to understand the questions and answer options are. These modifications can now be implemented to make it easier for people with cerebral palsy to use the pain assessments. They should then be tested in people with cerebral palsy with different communication, cognitive and movement abilities.

Campus climate impacts on sexual violence: a Bayesian comparison of undergraduate and community colleges.

OBJECTIVE: Sexual violence is endemic on college campuses. Four-year campuses present high-risk environments for sexual violence and heavy episodic drinking is a robust risk factor for victimization. However, limited literature exists on sexual violence at two-year institutions, with most research focused on four-year campuses. We examined whether campus climates affect sexual violence prevalence rates. PARTICIPANTS: Sexual misconduct campus climate data from two-year and four-year campus students. METHODS: We used Bayesian logistic regressions to compare sexual victimization odds between two- and four-year campuses. RESULTS: Four-year students were twice as likely to have experienced sexual victimization and 2.5 times more likely to engage in heavy episodic drinking compared to two-year students. The risk of sexual victimization associated with heavy episodic drinking was reliably similar across campus types. CONCLUSIONS: Campus climates reliably impact student's risk of sexual victimization. Based on these findings, two- and four-year campuses may need to implement distinct prevention services.

Cultivating Vital Conditions For Perinatal Well-Being And A Sustained Commitment To Reproductive Justice.

Perinatal mental illness is a leading cause of death during pregnancy and the first postpartum year in the United States. Although better acute care services for mental health conditions are desperately needed, urgent services alone cannot create the conditions to thrive. Cultivating well-being requires a sustained commitment to reproductive justice, "the human right to maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities." To support reproductive justice for pregnant and birthing people, the Rippel Foundation's Vital Conditions for Health and Well-Being framework offers a holistic approach comprising seven domains: a thriving natural world; basic needs for health and safety; humane housing; meaningful work and wealth; lifelong learning; reliable transportation; and, central to all of these, belonging and civic muscle. Here we review the evidence for each of the vital conditions as key drivers of perinatal mental health, and we outline how this public health approach can advance well-being across generations.

The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE).

INTRODUCTION: The Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) was developed to improve the quality of reporting of risk minimization program evaluations. In light of continued inadequacies in study reporting, and high-profile program implementation failures, we updated the RIMES Checklist to incorporate additional concepts from the Standards for Reporting of Implementation studies (StaRI). METHODS: The development of the updated checklist, the RIMES-StaRI Extension (RIMES-SE), entailed developing a study protocol and drafting an initial pool of items based on a mapping of the RIMES against the StaRI checklist. A modified e-Delphi exercise was then conducted to determine the importance and understandability of items for checklist inclusion. An expert workshop and an online commentary period for additional feedback followed. RESULTS: The RIMES-SE contains 27 items. It includes two signature features of the StaRI Checklist: 1) a dual strand of items (represented in two columns) describing the risk minimization program (the 'intervention') and the corresponding implementation strategy; and 2) applicable to an array of different research methodologies. CONCLUSIONS: The RIMES-SE Statement and Checklist extends the reporting guidelines set forth in the original RIMES Checklist via inclusion of key implementation science concepts. It is intended to improve the quality and transparency of reporting of risk minimization evaluation studies so as to advance drug safety science.

Ambulatory trans-femoral intra-aortic balloon pump.

A 53-year-old man with inotrope-dependent advanced heart failure was admitted with acute decompensation and underwent urgent listing for heart transplant.

The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review.

BACKGROUND: The uptake, adoption and integration of new medicines and treatment regimens within healthcare delivery can take a decade or more. Increasingly, implementation science (IS) research is being used to bridge this gap between the availability of new therapeutic evidence and its actual application in clinical practice. Little is known, however, about the quality of IS research in this area, including the degree to which theories, models and frameworks (TMFs) are being used. The objective of this study was to conduct a scoping review of the use of TMFs in implementation research involving medicinal products. METHODS: A search was conducted for English language abstracts and manuscripts describing the application of TMFs in IS studies for medicinal products. Eligible publications were those published between 1 January 1974 and 12 December 2022. All records were screened at the title and abstract stage; included full-text papers were abstracted using data extraction tables designed for the study. Study quality was appraised using the Implementation Research Development Tool. RESULTS: The initial scoping search identified 2697 publications, of which 9 were ultimately eligible for inclusion in the review. Most studies were published after 2020 and varied in their objectives, design and therapeutic area. Most studies had sample sizes of fewer than 50 participants, and all focused on the post-marketing phase of drug development. The TMF most frequently used was the Consolidated Framework for Implementation Research (CFIR). Although most studies applied all TMF domains, TMF use was limited to instrument development and/or qualitative analysis. Quality appraisals indicated the need for engaging patients and other stakeholders in the implementation research, reporting on the cost of implementation strategies, and evaluating the unintended consequences of implementation efforts. CONCLUSIONS: We found that few IS studies involving medicinal products reported using TMFs. Those that did encompassed a wide variety of therapeutic indications and medicinal products; all were in the post-marketing phase and involved limited application of the TMFs. Researchers should consider conducting IS in earlier phases of drug development and integrating the TMFs throughout the research process. More consistent and in-depth use of TMFs may help advance research in this area.

Engaging older Australians in sexual health research: SHAPE2 survey recruitment and sample.

BACKGROUND: Sexual health research rarely includes older age groups and the sexual health needs of older Australians are not well understood. Older adults are online in increasing numbers; however, internet surveys involving samples of older adults and sensitive topics remain uncommon. In 2021, we developed an online survey to explore the sexual health needs of Australians aged 60+years. We describe here survey recruitment and sample obtained, comparing it with national population data (Australian Bureau of Statistics) and the sample of the similar 'Sex, Age and Me' study from 2015. METHODS: We recruited 1470 people with a staggered three-phase strategy: (1) emails to organisations and community groups; (2) paid Facebook advertising; and (3) passive recruitment. Half (50.6%) found out about the study via an organisation or group and just over a third (35.7%) from Facebook. RESULTS: The sample was equally balanced between men (49.9%) and women (49.7%) (0.4% other gender identities). Participants were aged 60-92years (median 69years) with all Australian States/Territories represented. Facebook recruits were younger, more likely to be working rather than retired, and more likely to live outside a major city, than those recruited by other means. CONCLUSIONS: Using the recruitment methods described, we successfully obtained a diverse and fairly representative sample of older Australians within the constraints of a convenience sample and on a modest budget. This research sheds light on ways to engage an under-served demographic in sexual health research. Our experience shows that many older adults are amenable to recruitment for online sexual health surveys using the approaches outlined.

Low-Field Magnetic Resonance Imaging Findings of the Fetlock Region of Nonracehorses.

Low-field, magnetic resonance imaging (MRI) is an advanced imaging modality widely used to diagnose distal limb pathology in horses, but there are limited data regarding lesion distribution within the metacarpo/metatarsophalangeal joint (MCP/MTPJ) region in lame nonracehorses. The aim of this study was to describe the low-field MRI findings and lesion distribution in nonracehorses with MCP/MTPJ region pain. Clinical records from horses undergoing MRI of the MCP/MTPJ region between July 2016 and March 2023 were reviewed. Horses were included if pain causing lameness was localized to this region and conventional imaging failed to provide a definitive diagnosis. Eighty-four horses met the inclusion criteria. Soft tissues were affected in 76 (90.5%) horses, with suspensory ligament branch injuries being the most frequent (60.7%) soft tissue pathology identified. Osseous pathology was diagnosed in 51 horses. The subchondral bone (SCB) of the distal third metacarpal/metatarsal bone (MC3/MT3) was the osseous structure most frequently affected (40.5%), with 79.4% of these horses having lesions on the dorsal aspect of the bone. Osteoarthritis was present in 48 (57.1%) horses. The main limitations of the study were the lack of a standardized diagnostic analgesia pattern due to varying veterinary surgeon involvement, and the absence of bilateral magnetic resonance (MR) sequences in all limbs. MRI is a useful diagnostic tool to assess soft tissue structures in the MCP/MTP region, especially in horses with thick skin, which may make ultrasonographic imaging unreliable.

Examining the Role of Women, Infant, and Children in Black Women Breastfeeding Duration and Exclusivity: A Systematic Review.

Background: African American women continue to experience low rates of breastfeeding initiation as well as low rates of exclusive breastfeeding for 6 months. Research has indicated that there are several social determinants that impact breastfeeding rates, but there is a dearth of literature that allows African American women to give voice to their experiences. In addition, research has shown women, infant, and children (WIC) participants to have lower breastfeeding rates than non-WIC eligible women. Research Aim/Question: The aim of this systematic review was to examine the relationship between WIC program participation and breastfeeding initiation and duration among non-Hispanic African American/Black women. Methods: The approach for this review used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Four online databases, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, MEDLINE, and SCOPUS, were used to search for peer-reviewed articles and grey literature. Results: Two hundred eighteen articles were retrieved through the database search and underwent initial screening, yielding 59 potential eligible articles. Full-text articles were further reviewed and 11 met the inclusion criteria and were included in this systematic review. Conclusions: Included studies show mixed results regarding the association between WIC participation and breastfeeding initiation, but there is a general negative association between WIC participation and breastfeeding duration, especially among Black women.

We know all too well the significant psychological impact of miscarriage and recurrent miscarriage: so where is the support?

Miscarriage and recurrent miscarriage affect a significant proportion of every population with research consistently showing it results in profound and often prolonged psychological impacts. Despite the serious psychological impacts, support for miscarriage remains grossly inadequate. There are many ways to ameliorate the impact of these losses, which are not difficult, expensive, or time consuming. At a basic level, people want and need acknowledgment and validation of their grief and loss and greater information provision at the time of loss. A clear discrepancy also exists between the bereavement care offered by health care providers and the care wanted and needed by those affected, that must be addressed as a matter of urgency. At a health care system level, the collection of national miscarriage data must begin, to allow for a true understanding of the socioeconomic cost of miscarriage and the burden of early pregnancy loss on individuals, families, and our social systems. Furthermore, to direct research funding appropriately, establishing national research funding priorities for miscarriage support, as they have in the United Kingdom, is vital in assisting researchers and other key stakeholders to effectively target research in areas that are likely to have the greatest public health benefit. Consumers, health practitioners, and policymakers could achieve a lot for many with just a little commitment to change.

Young Australians' receptiveness to discussing sexual health with a general practitioner.

BACKGROUND: Most sexual health care in Australia is provided through general practice. However, many young Australians experience barriers to accessing sexual health care. This research examines young Australians' receptiveness to discussing sexual health with a general practitioner (GP). METHODS: We conducted an anonymous online sexual health survey (open 2 May to 21 June 2022). Anyone living in Australia aged 16-29years was eligible to participate. Participants were recruited via social media and asked whether they agreed with five statements exploring their receptivity to discussing sexual health with GPs. We explored characteristics associated with responses using multivariable logistic regression. RESULTS: Among 1915 participants, 69.3% were cisgender women, with a median age of 20years; 48.5% were heterosexual. Approximately one-fifth agreed they might not tell a GP the whole truth about their sexual history, would be worried about confidentiality when discussing their sexual history and would be too embarrassed to see their usual GP if they thought they had a sexually transmitted infection. Over half (55.8%) agreed they would be comfortable with a GP bringing up sexual health in an unrelated consultation, but 39.6% would be nervous to bring up sexual health in case they needed an intimate examination. Multivariate regression identified several characteristics associated with responses. Notably, having a school-based sex education and a usual GP were factors associated with increased receptivity to discussing sexual health. CONCLUSIONS: Young Australians were generally open to discussing sexual health with a GP. School-based sex education and GP-patient relationships are key to promoting sexual health among young people.

Will a fee-for-service payment for a young people's health assessment in general practice increase the detection of health risk behaviours and health conditions? Protocol for a cluster randomised controlled trial (RAd Health Trial).

INTRODUCTION: Adolescence is a period of major transition in physical, cognitive, social and emotional development, and the peak time for the onset of mental health conditions, substance use disorders and sexual and reproductive health risks. Prevention and treatment during this time can improve health and well-being now and into the future. However, despite clinical guidelines recommending annual preventive health assessments for young people, health professionals cite lack of consultation time and adequate funding as key barriers. This trial aims to determine whether a specific fee-for-service ('rebate payment') for a young person's health assessment, is effective and cost-effective at increasing the detection and management of health risk behaviours and conditions among young people. METHODS AND ANALYSIS: This cluster randomised controlled trial will be conducted in Australian general practice. 42 general practices (clusters) will be randomly allocated 1:1 to either an intervention arm where general practitioners receive a rebate payment for each annual health assessment undertaken for 14-24-year-olds during a 2 year study period, or a control arm (no rebate). The rebate amount will be based on the Medical Benefits Schedule (Australia's list of health professional services subsidised by the Australian Government) currently available for similar age-based assessments. Our primary outcome will be the annual rate of risk behaviours and health conditions recorded in the patient electronic health record (eg, alcohol/drug use, sexual activity and mental health issues). Secondary outcomes include the annual rate of patient management activities related to health risks and conditions identified (eg, contraception prescribed, sexually transmitted infection tests ordered). A process evaluation will assess acceptability, adoption, fidelity and sustainability of the rebate; an economic evaluation will assess its cost-effectiveness. Analyses will be intention-to-treat. ETHICS AND DISSEMINATION: Ethics approval has been obtained from University of Melbourne Human and Research Ethics Committee (2022-23435-29990-3). Findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12622000114741.

Balancing benefits and risks in lung cancer therapies: patient preferences for lung cancer treatment alternatives.

Background: In the treatment of Non-Small Cell Lung Cancer (NSCLC) the combination of Immuno- Oncotherapy (IO) and chemotherapy (CT) has been found to be superior to IO or CT alone for patients' survival. Patients and clinicians are confronted with a preference sensitive choice between a more aggressive treatment with a greater negative effect on quality of life versus alternatives that are less effective but have fewer side effects. Objectives: The aims of this study were to: (a) quantify patients' preferences for relevant attributes related to Immuno-Oncotherapy treatment alternatives, and (b) evaluate the maximum acceptable risk (MAR)/Minimum acceptable benefit (MAB) that patients would accept for treatment alternatives. Methods: An online preference survey using discrete-choice experiment (DCE) was completed by NSCLC patients from two hospitals in Italy and Belgium. The survey asked patients' preferences for five patient- relevant treatment attributes. The DCE was developed using a Bayesian D-efficient design. DCE analyses were performed using mixed logit models. Information regarding patient demographics, health literacy, locus of control, and quality of life was also collected. Results: 307 patients (158 Italian, 149 Belgian), stage I to IV, completed the survey. Patients preferred treatments with a higher 5-year survival chance as the most important attribute over all the other attributes. Preference heterogeneity for the attribute weights depended on health literacy, patients' age and locus of control. Patients were willing to accept a substantially increased risks of developing side effects in exchange for the slightest increase (1%) in the chance of surviving at least 5 years from the diagnosis of cancer. Similarly, patients were willing to accept a switch in the mode of administration or complete loss of hair to obtain an increase in survival. Conclusion: In this study, the proportion of respondents who systematically preferred survival over all other treatment attributes was particularly high. Age, objective health literacy and locus of control accounted for heterogeneity in patients' preferences. Evidence on how NSCLC patients trade between survival and other NSCLC attributes can support regulators and other stakeholders on assessing clinical trial evidence and protocols, based on patients' conditions and socio-demographic parameters.

Challenges and lessons learned birthing during the COVID-19 pandemic: A scoping review.

Background and Aims: The impact of the COVID-19 pandemic on the healthcare system facilitated a change in policies to redress the consequences of increased demand and fear of disease transmission. Restrictive measures throughout the healthcare system limiting access to accompanying partners of birthing people in addition to fears of contracting COVID-19, an increasing number of birthing people chose to have an out-of-hospital birth. Out-of-hospital births are not prevalent in the United States. However, in recent years the percentage of out-of-hospital births has been steadily increasing. COVID-19 was a novel virus imposing a unique birthing situation for millions of women, complicated by lack of integration and varied policies in the U.S. Methods: To better understand the challenges of birthing people during the pandemic a scoping review was conducted to explore the literature during the first wave of the pandemic related to out-of-hospital births. The approach for this review made use of the methodology manual published by the Joanna Briggs Institute for scoping reviews. All manner of publications (i.e. peer-reviewed published articles, grey articles, conference proceedings, webinars, editorials, and textbook chapters) were included in the review. Results: Articles retrieved from the database search yielded sixty-three articles, after duplicate removal forty-six records were available for screening. Articles were further excluded using the PRISMA process, yielding thirty-one remaining records. From the thirty-one records twelve themes emerged, which were collapsed into four meta-themes. Conclusion: These meta-themes focused on (a) advocacy, (b) homebirth infrastructure, (c) support networks, and (d) uncertainty during the pandemic. COVID-19 has accelerated this movement to birthing at home and thought must be given to how the healthcare system is going to support and integrate this mode of birthing.

A Road Map for Peer Review of Real-World Evidence Studies on Safety and Effectiveness of Treatments.

The growing acceptance of real-world evidence (RWE) in clinical and regulatory decision-making, coupled with increasing availability of health care data and advances in automated analytic approaches, has contributed to a marked expansion of RWE studies of diabetes and other diseases. However, a recent spate of high-profile retractions highlights the need for improvements in the conduct of RWE research as well as in the associated peer review and editorial processes. We review best pharmacoepidemiologic practices and common pitfalls regarding design, measurement, analysis, data validity, appropriateness, and generalizability of RWE studies. To enhance RWE study assessments, we propose that journal editors require 1) study authors to complete RECORD-PE, a reporting guideline for pharmacoepidemiological studies on routinely collected data, 2) availability of predetermined study protocols and analysis plans, 3) inclusion of pharmacoepidemiologists on the peer review team, and 4) provision of detail on data provenance, characterization, and custodianship to facilitate assessment of the data source. We recognize that none of these steps guarantees a high-quality research study. Collectively, however, they permit an informed assessment of whether the study was adequately designed and conducted and whether the data source used was fit for purpose.