Randomized controlled trials: not always the "gold standard" for evidence in obstetrics and gynecology.

Randomized controlled trials are considered the "gold standard" for therapeutic interventions, and it is not uncommon for sweeping changes in medical practice to follow positive results from such trials. However, randomized controlled trials are not without their limitations. Physicians frequently view randomized controlled trials as infallible, whereas they tend to dismiss evidence derived from sources other than randomized controlled trials as less credible or reliable. In several situations in obstetrics and gynecology, there are no randomized controlled trials to help guide the clinician. In these circumstances, it is important to evaluate the entire body of evidence including observational studies, rather than dismiss interventions altogether simply because no randomized controlled trials exist. Randomized controlled trials and observational studies should be viewed as complementary rather than at odds with each other. Some reversals in widely adopted clinical practice have recently been implemented following subsequent studies that contradicted the outcomes of major randomized controlled trials. The most notable of these was the withdrawal from the market of 17-hydroxyprogesterone caproate for preterm birth prevention. Such reversals could potentially have been averted if the inherent limitations of randomized controlled trials were carefully considered before implementing these universal practice changes. This Clinical Opinion underscores the limitations of an exclusive reliance on randomized controlled trials while disregarding other evidence in determining how best to care for patients. Solutions are proposed that advocate that clinicians adopt a more balanced perspective that considers the entirety of the available medical evidence and the individual patient characteristics, needs, and wishes.

Leveraging generative AI for clinical evidence synthesis needs to ensure trustworthiness.

Evidence-based medicine promises to improve the quality of healthcare by empowering medical decisions and practices with the best available evidence. The rapid growth of medical evidence, which can be obtained from various sources, poses a challenge in collecting, appraising, and synthesizing the evidential information. Recent advancements in generative AI, exemplified by large language models, hold promise in facilitating the arduous task. However, developing accountable, fair, and inclusive models remains a complicated undertaking. In this perspective, we discuss the trustworthiness of generative AI in the context of automated summarization of medical evidence.

Medical and Legal Uncertainties and Controversies in "Shaken Baby Syndrome" or Infant "Abusive Head Trauma".

Uncertainties and controversies surround "shaken baby syndrome" or infant "abusive head trauma". We explore Vinaccia v The Queen (2022) 70 VR 36; [2022] VSCA 107 and other selected cases from Australia, the United Kingdom and the United States. On expert opinion alone, a "triad" of clinical signs (severe retinal haemorrhages, subdural haematoma and encephalopathy) is dogmatically attributed diagnostically to severe deliberate shaking with or without head trauma. However, the evidence for this mechanism is of the lowest scientific level and of low to very low quality and therefore unreliable. Consequently, expert opinion should not determine legal outcomes in prosecuted cases. Expert witnesses should reveal the basis of their opinions and the uncertainties and controversies of the diagnosis. Further, the reliability of admissions of guilt while in custody should be considered cautiously. We suggest abandonment of the inherently inculpatory diagnostic terms "shaken baby syndrome" and "abusive head trauma" and their appropriate replacement with "infantile retinodural haemorrhage".

The Role of Medical Evidence in Determining the Outcome of Medical Negligence Cases When Peer Professional Opinion Is Used.

Important changes in civil liability laws arose from the Review of the Law of Negligence in Australia undertaken in 2002 (the Ipp Report). One key recommendation of this review was the introduction of a modification of the Bolam Principle: "Medical Practitioners will not be found negligent if the treatment provided is in accordance with a significant body of opinion in the medical profession." This article examines the concept of practitioner competence in medical negligence cases. It also examines the diverse forms of medical evidence used and evaluates whether the changes in laws have altered the legal approach to the use of medical evidence in cases utilising peer professional opinion. This article argues that, despite the amendments in 2002, regulatory concepts of medical competence are little used by the courts. Peer professional opinion utilising medical evidence has played only a minor role in determining the outcome of medical negligence cases.

Assessing social values for California's efforts to reduce the overuse of unnecessary medical care.

BACKGROUND: A partnership of large health-care purchasers created a workgroup to reduce the overuse of harmful and wasteful medical care in California. OBJECTIVE: Employ a civic engagement process to identify the social values important to the public in considering different strategies to reduce overuse. INTERVENTION: Use of deliberation techniques for 3 case examples that explore possible strategies: physician oversight, physician compensation, increased patient cost-sharing or taking no definitive action. RESULTS: Five themes were identified, including strong support for physicians' leadership role to reduce overuse; nuanced enthusiasm for increasing patient cost-sharing to discourage excessive demand; and marked disapproval of physician compensation as a motivator. CONCLUSION: Most but not all of the perspectives voiced by participants are congruent with efforts to reduce overuse that is being initiated or discussed at the state, provider and health plan level. As health-care policymakers and leaders consider more targeted approaches to reducing overuse, these findings will inform decision-making.

Medical Evidence of Capacity in a Legal Setting: To What Extent Do Courts and Tribunals Make Their Own Decisions?

The extent to which legal determinations of capacity are genuinely separate from medical opinion on capacity presented to the court as evidence, is an open and important question. In order to explore this question, an empirical study was done on the use of medical and non-medical evidence to establish capacity in three different capacity contexts: personal/financial capacity, testamentary capacity and legal matters capacity. The study showed that the use of medical evidence to establish capacity was by far the heaviest in personal/financial capacity matters, often to the point of effective exclusion of other forms of evidence. Concerns with the weight given to medical evidence in personal/financial capacity matters were identified. The concerns have implications for the specific jurisdiction considered, and for the wider question of how capacity is and should be determined in a legal setting.

Medical Judgments Across the Range of Reported Pain Severity: Clinician and Lay Perspectives.

BACKGROUND: While increasing evidence suggests that observers discount high-severity chronic pain, factors that occasion such discounting are poorly understood, particularly regarding health provider vs lay perspectives. OBJECTIVE: This study examined the effects of supporting medical evidence and comorbid psychological distress (pain behavior) on medical student and lay clinical judgments of increasingly severe patient pain reports. DESIGN: In a 2 × 2 × 2 × (7) mixed between- and within-subject design, participants (medical students vs lay) made clinical judgments after reading vignettes describing a hypothetical patient that varied in levels of medical evidence and pain behavior (low vs high) and pain severity (4/10-10/10). SUBJECTS: Fourth-year medical students (N = 115) and lay persons in the community (N = 300) participated in this research. RESULTS: While both medical student and lay judgments plateaued at high levels of pain severity, judgments regarding cause (medical vs psychological), treatment (opioid prescription), and disability showed growing divergence as levels of reported pain severity increased. Divergence relative to medical and psychological causes of pain was found irrespective of the level of supporting medical evidence; divergence relative to opioid treatment and support for a disability claim was found when supporting medical evidence was low. CONCLUSIONS: The results indicate differing expectations of chronic pain treatment for health care providers relative to the lay public that could impact clinical care, especially at high pain severity levels, where lay expectations diverge significantly from those of health professionals.

Comorbidity ascertainment from the ESRD Medical Evidence Report and Medicare claims around dialysis initiation: a comparison using US Renal Data System data.

BACKGROUND: The end-stage renal disease Medical Evidence Report serves as a source of comorbid condition data for risk adjustment of quality metrics. We sought to compare comorbid condition data in the Medical Evidence Report around dialysis therapy initiation with diagnosis codes in Medicare claims. STUDY DESIGN: Observational cohort study using US Renal Data System data. SETTING & PARTICIPANTS: Medicare-enrolled elderly (≥66 years) patients who initiated maintenance dialysis therapy July 1 to December 31, 2007, 2008, or 2009. INDEX TESTS: 12 comorbid conditions ascertained from claims during the 6 months before dialysis therapy initiation, the Medical Evidence Report, and claims during the 3 months after dialysis therapy initiation. REFERENCE TEST: None. RESULTS: Comorbid condition prevalence according to claims before dialysis therapy initiation generally exceeded prevalence according to the Medical Evidence Report. The κ statistics for comorbid condition designations other than diabetes ranged from 0.06 to 0.43. Discordance of designations was associated with age, race, sex, and end-stage renal disease Network. During 23,930 patient-years of follow-up from 4 to 12 months after dialysis therapy initiation (8,930 deaths), designations from claims during the 3 months after initiation better discriminated risk of death than designations from the Medical Evidence Report (C statistics of 0.674 vs 0.616). Between the Medical Evidence Report and claims, standardized mortality ratios changed by >10% for more than half the dialysis facilities. LIMITATIONS: Neither the Medical Evidence Report nor diagnosis codes in claims constitute a gold standard of comorbid condition data; results may not apply to nonelderly patients or patients without Medicare coverage. CONCLUSIONS: Discordance of comorbid condition designations from the Medical Evidence Report and claims around dialysis therapy initiation was substantial and significantly associated with patient characteristics, including location. These patterns may engender bias in risk-adjusted quality metrics. In lieu of the Medical Evidence Report, claims during the 3 months after dialysis therapy initiation may constitute a useful source of comorbid condition data.

The influence of medical and behavioral evidence on conviction rates in cases of child sexual abuse.

Child sexual abuse cases have one of the lowest conviction rates across all charges. While research has investigated the impact of attitudes and beliefs in judicial decision makers, little is known about the influence of medical evidence. The aim of this study was to examine how the presence or absence of evidence impacts on conviction. A sample of 113 child sexual abuse cases from Australia were coded for the types of evidence that were presented as well as other relevant descriptive data. The most significant predictor of verdict was the behavior of the child rather than the presence of medical evidence. This finding suggests that greater attention might be given to the collection and reporting of this evidence in future trials.

Challenging management dogma where evidence is non-existent, weak, or outdated: part II.

Many dogmas influence daily clinical practice, and critical care medicine is no exception. We previously highlighted the weak, questionable, and often contrary evidence base underpinning four established medical managements-loop diuretics for acute heart failure, routine use of heparin thromboprophylaxis, rate of sodium correction for hyponatremia, and 'every hour counts' for treating bacterial meningitis. We now provide four further examples in this "Dogma II" piece (a week's course of antibiotics, diabetic ketoacidosis algorithms, sodium bicarbonate to improve ventricular contractility during severe metabolic acidosis, and phosphate replacement for hypophosphatemia) where routine practice warrants re-appraisal.

Methodology for the Differential Classification of Dengue and Chikungunya According to the PAHO 2022 Diagnostic Guide.

Arboviruses such as dengue, Zika, and chikungunya present similar symptoms in the early stages, which complicates their differential and timely diagnosis. In 2022, the PAHO published a guide to address this challenge. This study proposes a methodological framework that transforms qualitative information into quantitative information, establishing differential weights in relation to symptoms according to the medical evidence and the GRADE scale based on recommendation 1 of the said guide. To achieve this, common variables from the dataset were identified using the PAHO guide, and quality rules were established. A linear interpolation function was then parameterised to assign weights to the symptoms according to the evidence. Machine learning was used to compare the different models, achieving 99% accuracy compared with 79% without the methodology. This proposal represents a significant advancement, allowing the direct application of the PAHO recommendations to the dataset and improving the differential classification of arboviruses.

An Analysis of Studies Pertaining to Masks in Morbidity and Mortality Weekly Report: Characteristics and Quality of Studies through 2023.

BACKGROUND: The purpose of this study was to describe and evaluate the nature and methodology of reports and appropriateness of conclusions in The Morbidity and Mortality Weekly Report (MMWR) pertaining to masks. Because MMWR has substantial influence on United States health policy and is not externally peer-reviewed, it is critical to understand the scientific process within the journal. Mask policies have been highly influenced by data published in the MMWR. METHODS: Retrospective cross-sectional study of MMWR publications pertaining to masks through 2023. Outcomes included study design, whether the study was able to assess mask effectiveness, if results were statistically significant, if masks were concluded to be effective, if randomized evidence or conflicting data were mentioned or cited, and appropriateness of causal statements. RESULTS: There were 77 studies, all published after 2019, that met our inclusion criteria. The most common study design was observational without a comparator group: 22/77 (28.6%); 0/77 were randomized; 23/77 (29.9%) assessed mask effectiveness; 11/77 (14.3%) were statistically significant, but 58/77 (75.3%) stated that masks were effective. Of these, 41/58 (70.7%) used causal language. One mannequin study used causal language appropriately (1.3%). None cited randomized data; 1/77 (1.3%) cited conflicting evidence. CONCLUSIONS: MMWR publications pertaining to masks drew positive conclusions about mask effectiveness >75% of the time despite only 30% testing masks and <15% having statistically significant results. No studies were randomized, yet over half drew causal conclusions. The level of evidence generated was low and the conclusions were most often unsupported by the data. Our findings raise concern about the reliability of the journal for informing health policy.

Medical-Legal Issues in Traumatic Brain Injury.

Traumatic Brain Injury (TBI) cases often involve both medical and legal issues, litigation and prolonged recovery timelines. As TBI cases are often complex, and can have a significant impact on the lives of the patients and their families/caregivers, having a comprehensive understanding of the causes, diagnoses, treatments and long term outcomes will be valuable in understanding the medical and legal aspects of this type of injury. Patients, families, and health care professionals will all benefit from a deeper understanding of the medical and legal aspects of TBI, which should help improve rehabilitation and recovery outcomes.

Men after the sexual assault: The journey from medical service to court.

BACKGROUND: There may be significant physical and psychological consequences and impacts for males who experience sexual assault as adults, however, published literature in this context is sparse, specifically for the investigative outcomes in the criminal legal process. METHOD: This clinical audit tracked 138 adult males who presented for forensic and medical sexual assault care from initial presentation to ACT Police investigation and court outcome from 2004 to 2022. RESULTS: There were 103/138 (74.6%) males who attended for medical and forensic care within 72 h of the reported assault. Pre-existing mental health conditions were self-reported in 59/138 (42.7%) males. Nearly half of males 67/138 (48.5%) had a medical evidence kit collected. Males presenting for medical care 44/138 (31.2%) went on to report to ACT Policing, 36/44 (81.2%) of cases did not proceed to court. The most common clearance type was inadequate evidence to proceed (17/44, 38.6%). In 8/44 (18.2%) of adult male cases who subsequently reported to ACT Police, the investigation resulted in entry to the judicial process with a suspect charged with a sexual offence. Five of those cases resulting in a conviction. CONCLUSIONS: Many adult male patients presented within timeframes that enabled the provision of time critical medical care and provided an opportunity for forensic medical evidence collection. Many adult males 59 (42.7%) self-reported pre-existing mental health conditions upon initial presentation. Attrition occurred throughout the patient journey with many males not reporting to police and thus not presenting in the legal process. This further emphasises the need for independent sexual violence patient advisors to support adult male victims through the medical and criminal justice process.

Rethinking the pros and cons of randomized controlled trials and observational studies in the era of big data and advanced methods: a panel discussion.

Randomized controlled trials (RCTs) have traditionally been considered the gold standard for medical evidence. However, in light of emerging methodologies in data science, many experts question the role of RCTs. Within this context, experts in the USA and Canada came together to debate whether the primacy of RCTs as the gold standard for medical evidence, still holds in light of recent methodological advances in data science and in the era of big data. The purpose of this manuscript, aims to raise awareness of the pros and cons of RCTs and observational studies in order to help guide clinicians, researchers, students, and decision-makers in making informed decisions on the quality of medical evidence to support their work. In particular, new and underappreciated advantages and disadvantages of both designs are contrasted. Innovations taking place in both of these research methodologies, which can blur the lines between the two, are also discussed. Finally, practical guidance for clinicians and future directions in assessing the quality of evidence is offered.

Analysis of predictive performance and reliability of classifiers for quality assessment of medical evidence revealed important variation by medical area.

OBJECTIVES: A major obstacle in deployment of models for automated quality assessment is their reliability. To analyze their calibration and selective classification performance. STUDY DESIGN AND SETTING: We examine two systems for assessing the quality of medical evidence, EvidenceGRADEr and RobotReviewer, both developed from Cochrane Database of Systematic Reviews (CDSR) to measure strength of bodies of evidence and risk of bias (RoB) of individual studies, respectively. We report their calibration error and Brier scores, present their reliability diagrams, and analyze the risk-coverage trade-off in selective classification. RESULTS: The models are reasonably well calibrated on most quality criteria (expected calibration error [ECE] 0.04-0.09 for EvidenceGRADEr, 0.03-0.10 for RobotReviewer). However, we discover that both calibration and predictive performance vary significantly by medical area. This has ramifications for the application of such models in practice, as average performance is a poor indicator of group-level performance (e.g., health and safety at work, allergy and intolerance, and public health see much worse performance than cancer, pain, and anesthesia, and Neurology). We explore the reasons behind this disparity. CONCLUSION: Practitioners adopting automated quality assessment should expect large fluctuations in system reliability and predictive performance depending on the medical area. Prospective indicators of such behavior should be further researched.

"No signs of rape": corroboration, resistance and the science of disbelief in the medico-legal jurisprudence of Bangladesh.

A major impediment to justice for rape in Bangladesh is the colonial rule of corroboration, which requires judges to verify the truthfulness of a rape complainant's testimony with other evidence. Medical evidence is the most commonly sought mode of corroboration and can be used to contradict the complainant's own testimony. The corresponding rule of resistance in turn guides how the rule of corroboration takes on a scientific character, whereby injuries in specific parts of the complainant's body are sought by doctors and judges as corroborative "signs of rape". If no "signs of rape" are found, this observation is then noted in the medical report and used to discredit the testimony of a rape complainant, by indicating that either the sexual intercourse was consensual or the rape accusation is false. This paper shows how the unfettered operation of these two rules gives birth to the "science of disbelief" in rape cases, whereby the institutional disbelief in a rape complainant's testimony is justified on ostensibly scientific grounds and largely restricts their right to seek justice. It illustrates how the science of disbelief was created and preserved through successive legal and institutional reforms in Bangladesh. This paper challenges the long-held yet seemingly unquestioned notion in Bangladesh that medical evidence should be the primary basis through which rape can be proved in court by analysing the pernicious jurisprudence and legal standards this assumption has created.

Patient Perceptions of Physician Burden in the Treatment of Chronic Pain.

While patient perceptions of burden to caregivers is of recognized clinical significance among people with chronic pain, perceived burden to treating physicians has not been studied. This study examined how people with chronic pain perceived levels of medical evidence (low vs high) and pain severity (4,6,8/10) to influence physician burden and how burden then mediated expected clinical judgments. 476 people with chronic pain read vignettes describing a hypothetical patient with varying levels of medical evidence and pain severity from the perspective of a treating physician, rated the burden that patient care would pose, and made a range of clinical judgments. The effect of pain severity on clinical judgments was expected to interact with medical evidence and be conditionally mediated by burden. Although no associations with burden were found for the pain severity x medical evidence interaction or for pain severity alone, low levels of supporting medical evidence yielded higher burden ratings. Burden significantly mediated medical evidence effects on judgments of symptom credibility, clinical improvement, and psychosocial dysfunction. Results indicate that perceived physician burden negatively influenced judgments of patients with chronic pain, beyond the direct effects of medical evidence. Implications are discussed for clinical practice, as well as future research. PERSPECTIVE: : People with chronic pain expect physicians to view the care of patients without supporting medical evidence as burdensome. Higher burden is associated with less symptom credibility, more psychosocial dysfunction, and less treatment benefit. Perceived physician burden appears to impact how patients approach treatment, with potentially adverse implications for clinical practice.

A neuro-symbolic method for understanding free-text medical evidence.

OBJECTIVE: We introduce Medical evidence Dependency (MD)-informed attention, a novel neuro-symbolic model for understanding free-text clinical trial publications with generalizability and interpretability. MATERIALS AND METHODS: We trained one head in the multi-head self-attention model to attend to the Medical evidence Ddependency (MD) and to pass linguistic and domain knowledge on to later layers (MD informed). This MD-informed attention model was integrated into BioBERT and tested on 2 public machine reading comprehension benchmarks for clinical trial publications: Evidence Inference 2.0 and PubMedQA. We also curated a small set of recently published articles reporting randomized controlled trials on COVID-19 (coronavirus disease 2019) following the Evidence Inference 2.0 guidelines to evaluate the model's robustness to unseen data. RESULTS: The integration of MD-informed attention head improves BioBERT substantially in both benchmark tasks-as large as an increase of +30% in the F1 score-and achieves the new state-of-the-art performance on the Evidence Inference 2.0. It achieves 84% and 82% in overall accuracy and F1 score, respectively, on the unseen COVID-19 data. CONCLUSIONS: MD-informed attention empowers neural reading comprehension models with interpretability and generalizability via reusable domain knowledge. Its compositionality can benefit any transformer-based architecture for machine reading comprehension of free-text medical evidence.

Overturned abusive head trauma and shaken baby syndrome convictions in the United States: Prevalence, legal basis, and medical evidence.

BACKGROUND: Media reports and the Innocence Network assert that wrongful Abusive Head Trauma (AHT)/Shaken Baby Syndrome (SBS) convictions pervade the United States (U.S.) criminal justice system. Yet, no empirical evaluation of overturned AHT/SBS convictions has been conducted. OBJECTIVE: To evaluate the prevalence, legal basis, and characteristics of appellate rulings of AHT/SBS convictions. PARTICIPANTS AND SETTING: U.S. appellate cases in a legal database, Westlaw. METHODS: Retrospective review of AHT/SBS convictions that had appellate rulings from January 2008 through December 2018. Multiple search terms ensured all potential AHT/SBS cases were included. A mixed-methods analysis was conducted on overturned AHT/SBS convictions. RESULTS: We identified a total of 1431 unique AHT/SBS criminal convictions that had appellate rulings since 2008. Of those, 49 convictions (3%) were overturned, and 1382 (97%) were affirmed/upheld. Of those overturned, 20 cases (1% overall) were overturned on medical evidence-related grounds. The most common themes from the medical evidence-related reversals were controversy over the AHT/SBS diagnosis (n = 12) and accidental injury mechanism (n = 11). After being overturned on appeal, upon retrial, 42% of defendants either re-plead guilty to or were convicted again of the same offense. CONCLUSION(S): AHT/SBS convictions are rarely overturned on medical evidence-related grounds. When overturned, medical evidence-related themes seldom reflect new scientific or clinical discoveries, but rather are alternative or differing medical opinions from those offered at the original trial. Our data tends to support the concerns of other authors regarding irresponsible communication of medical information in AHT/SBS cases.