Clinical Guideline Recommendations Research Articles

A Practical Guide to Understanding and Treating Peripheral Artery Disease.

Peripheral arterial disease (PAD) is the third leading cause of atherosclerotic morbidity after coronary heart disease and stroke yet is widely underdiagnosed and undertreated. Treatment of risk factors such as diabetes and cigarette smoking can benefit patients with PAD. Patients should have adequate blood pressure and lipid control to decrease clinical manifestations and symptoms of PAD. Use of antithrombotic medications should be individualized to the patient depending on the presence of symptoms, revascularization, and comorbidities. All patient care providers, including physicians, pharmacists, nurse practitioners, and physician assistants, should incorporate PAD screening in their at-risk patients to improve access for appropriate earlier diagnosis, initiation of guideline directed therapy, and risk factor modification to reduce both major adverse CV and limb outcomes. The purpose of this narrative review is to provide an overview of PAD and summarize clinical trial evidence and guideline recommendations for screening and treatment to increase awareness among health care providers to ultimately have a positive impact on patient care.

Performance of ChatGPT Compared to Clinical Practice Guidelines in Making Informed Decisions for Lumbosacral Radicular Pain: A Cross-sectional Study.

OBJECTIVE: To compare the accuracy of an artificial intelligence chatbot to clinical practice guidelines (CPGs) recommendations for providing answers to complex clinical questions on lumbosacral radicular pain. DESIGN: Cross-sectional study. METHODS: We extracted recommendations from recent CPGs for diagnosing and treating lumbosacral radicular pain. Relative clinical questions were developed and queried to OpenAI's ChatGPT (GPT-3.5). We compared ChatGPT answers to CPGs recommendations by assessing the (1) internal consistency of ChatGPT answers by measuring the percentage of text wording similarity when a clinical question was posed 3 times, (2) reliability between 2 independent reviewers in grading ChatGPT answers, and (3) accuracy of ChatGPT answers compared to CPGs recommendations. Reliability was estimated using Fleiss' kappa (κ) coefficients, and accuracy by interobserver agreement as the frequency of the agreements among all judgments. RESULTS: We tested 9 clinical questions. The internal consistency of text ChatGPT answers was unacceptable across all 3 trials in all clinical questions (mean percentage of 49%, standard deviation of 15). Intrareliability (reviewer 1: κ = 0.90, standard error [SE] = 0.09; reviewer 2: κ = 0.90, SE = 0.10) and interreliability (κ = 0.85, SE = 0.15) between the 2 reviewers was "almost perfect." Accuracy between ChatGPT answers and CPGs recommendations was slight, demonstrating agreement in 33% of recommendations. CONCLUSION: ChatGPT performed poorly in internal consistency and accuracy of the indications generated compared to clinical practice guideline recommendations for lumbosacral radicular pain. J Orthop Sports Phys Ther 2024;54(3):1-7. Epub 29 January 2024. doi:10.2519/jospt.2024.12151.

Frontline Perspectives on Buprenorphine for the Management of Chronic Pain.

Due to the prevalence of chronic pain and high-impact chronic pain in the US, a significant percentage of the population is prescribed opioids for pain management. However, opioid use disorder is associated with reduced quality of life, along with fatal opioid overdoses, and is a significant burden on the US economy. Considering the clinical needs of patients with intractable chronic pain and the potential harms associated with prescribed and illicit opioids in our communities, having a deep understanding of current treatment options, supporting evidence, and clinical practice guidelines is essential for optimizing treatment selections. Buprenorphine is a Schedule III opioid with a unique mechanism of action, allowing effective and long-lasting analgesia at microgram doses with fewer negative side effects and adverse events, including respiratory depression, when compared with other immediate-release, long-acting, and extended-release prescription opioids. Due to its relatively lower risk for overdose and misuse, buprenorphine was recently added to the Clinical Practice Guideline for the Use of Opioids in the Management of Chronic Pain as a first-line treatment for chronic pain managed by opioids by the US Departments of Defense and Veterans Affairs, and the Department of Health and Human Services recommends that buprenorphine be made available for the treatment of chronic pain. In this narrative review, we discuss the different buprenorphine formulations, clinical efficacy, advantages for older adults and other special populations, clinical practice guideline recommendations, and payer considerations of buprenorphine and suggest that buprenorphine products approved for chronic pain should be considered as a first-line treatment for this indication.

Clinical practice guideline recommendations to improve the mental health of adult trauma patients: protocol for a systematic review

IntroductionMental disorders are common in adult patients with traumatic injuries. To limit the burden of poor psychological well-being in this population, recognised authorities have issued recommendations through clinical practice guidelines...

Experienced Clinical Decision-Making in Physical Therapist Management of Concussion: A Qualitative Study.

The recent publication of the Physical Therapy Evaluation and Treatment After Concussion Clinical Practice Guideline is intended to assist clinicians in their decision-making specific to evaluation and intervention. Clinical practice guidelines are supported by best available evidence, though it is unknown what other factors drive clinical decision-making in the realm of concussion management. The purpose of this study was to explore factors related to the process of clinical decision-making of experienced physical therapists who treat individuals with concussion. This grounded theory approach used semi-structured interviews of physical therapists who have practiced concussion management ≥3years and have treated ≥15 individuals for postconcussion symptoms in the last year. Following the inductive approach, deductive qualitative methodology was used to explore alignment with recent guidelines. Member checking was used to ensure trustworthiness. Ten therapists' experience in treating concussion ranged from 5 to 20years. Four overarching themes were identified that contribute to clinical decision-making: expert practice behaviors through use of reflection in action, clinical reasoning, collaboration, and evidenced informed practice; therapeutic alliance building using individualized education, reassurance, and relationship building; adaptability in prioritizing, assessing, and responding to patients' needs; and listening and observing. Clinician decision-making statements showed alignment with clinical practice guideline recommendations. Experienced therapists demonstrate a consistent approach that parallels the current clinical practice guideline while building off clinical experience to tailor individualized care focusing on patient centeredness. These factors may assist more novice clinicians to develop and improve their management strategies for optimal outcomes. Identified themes may broaden frameworks and guidelines for the management of individuals postconcussion specific to the field of physical therapy.

GRADE pearls and pitfalls-Part 2: Clinical practice guidelines.

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach is the de facto standard framework for summarising evidence in systematic reviews and developing recommendations in clinical practice guidelines. We describe how the GRADE approach is used in clinical practice guidelines, including key points and examples. The intended audience of this overview of GRADE is clinicians and researchers who are, or plan to be, involved in the development or assessment of clinical practice guidelines. We cover guideline endorsement and adaptation; guideline panels and sponsors; conflicts of interest; guideline questions and outcome prioritisation; systematic review creation, updating and re-use; rating the overall certainty of evidence; development of recommendations and implications; and peer review, publication, implementation and updating of guidelines. This overview aims to help developers, assessors and users of clinical practice guidelines understand how trustworthy, high-quality guidelines are developed using the GRADE approach.

Adequacy of clinical guideline recommendations for patients with low-risk cancer managed with monitoring: systematic review

ObjectivesThe aim of this systematic review was to summarize national and international guidelines that made recommendations for monitoring patients diagnosed with low-risk cancer. It appraised the quality of guidelines and determined whether the guidelines adequately identified patients for monitoring, specified which tests to use, defined monitoring intervals, and stated triggers for further intervention. It then assessed the evidence to support each recommendation. Study Design and SettingFollowing the Preferred Reporting Items for Systematic Reviews and Meta-analyses, we searched PubMed and Turning Research into Practice databases for national and international guidelines' that were written in English and developed or updated between 2012 and 2023. Quality of individual guidelines was assessed using the AGREE II tool. ResultsAcross the 41 published guidelines, 48 different recommendations were identified: 15 (31%) for prostate cancer, 11 (23%) for renal cancer, 6 (12.5%) for thyroid cancer, and 10 (21%) for blood cancer. The remaining 6 (12.5%) were for brain, gastrointestinal, oral cavity, bone and pheochromocytoma and paraganglioma cancer. When combining all guidelines, 48 (100%) stated which patients qualify for monitoring, 31 (65%) specified which tests to use, 25 (52%) provided recommendations for surveillance intervals, and 23 (48%) outlined triggers to initiate intervention. Across all cancer sites, there was a strong positive trend with higher levels of evidence being associated with an increased likelihood of a recommendation being specific (P = 0.001) and the evidence for intervals was based on expert opinion or other guidance. ConclusionWith the exception of prostate cancer, the evidence base for monitoring low-risk cancer is weak and consequently recommendations in clinical guidelines are inconsistent. There is a lack of direct evidence to support monitoring recommendations in the literature making guideline developers reliant on expert opinion, alternative guidelines, or indirect or nonspecific evidence.

Optimizing Clinical Implementation of Hypofractionation: Comprehensive Evidence Synthesis and Practical Guidelines for Low- and Middle-Income Settings

The global cancer burden, especially in low- and middle-income countries (LMICs), worsens existing disparities, amplified by the rising costs of advanced treatments. The shortage of radiation therapy (RT) services is a significant issue in LMICs. Extended conventional treatment regimens pose significant challenges, especially in resource-limited settings. Hypofractionated radiotherapy (HRT) and ultra-hypofractionated/stereotactic body radiation therapy (SBRT) offer promising alternatives by shortening treatment durations. This approach optimizes the utilization of radiotherapy machines, making them more effective in meeting the growing demand for cancer care. Adopting HRT/SBRT holds significant potential, especially in LMICs. This review provides the latest clinical evidence and guideline recommendations for the application of HRT/SBRT in the treatment of breast, prostate, and lung cancers. It emphasizes the critical importance of rigorous training, technology, stringent quality assurance, and safety protocols to ensure precise and secure treatments. Additionally, it addresses practical considerations for implementing these treatments in LMICs, highlighting the need for comprehensive support and collaboration to enhance patient access to advanced cancer care.

P1141 Global perspectives on managing Inflammatory Bowel Disease (IBD) during pregnancy and lactation: current state and the necessity for enhancements

Abstract Background Reproduction is an essential part of life. Our aim was to obtain a global perspective on IBD management by gastroenterologists (GIs) during preconception, pregnancy, lactation and neonatal period. Methods An anonymous survey (75 questions) was developed to investigate different aspects of clinical practice concerning the management of pregnancy and breastfeeding in patients with IBD. A national representative from each European country, USA, Latin America, Australia and New Zealand was selected to distribute the survey among their GI colleagues who treat patients with IBD (irrespectively of their experience). Results A total of 856 GIs from 36 countries participated in the survey. Among the participants, 63% had over a decade of experience as GIs, and 61% identified themselves as IBD specialist (IBDologists). The most relevant survey results and sub-analyses based on expertise are presented in tables 1 and 2. In the management of pregnant patients in remission, treatment discontinuation occurred either consistently or occasionally as follows: 20% thiopurines, 37% vedolizumab, 31% ustekinumab, and 96% small molecules. Notably, 13% did not always discontinue small molecules in patients contemplating pregnancy. Safety was the main reason for discontinuing IBD therapy during pregnancy. Contrary to the recommendations in clinical practice guidelines, many GIs avoid starting oral or rectal budesonide, anti-TNF, vedolizumab or ustekinumab during a disease flare. Further, a third of GIs would start thiopurines for a flare during pregnancy. Moreover, 13% will never perform a colonoscopy in a pregnant patient to guide decision making. Half of GIs implemented a dedicated outpatient follow-up program for pregnant patients in remission, with 87% enrolling all pregnant patients in this program. Concerning breastfeeding, 14% believed that all drugs can be used while breastfeeding. Regarding offspring’s vaccination, about 20% recommend against the administration of non-live vaccines and only 50% recommended avoiding live vaccines during the first 12 months for children exposed to anti-TNF in-utero. Among those GIs who recommended delaying vaccines in such cases, only 41% recommended testing the infant for detectable anti-TNF levels if live vaccines were required. Among the surveyed GIs, only a minority had a referral obstetrician, and only 35% referred patients with active or complicated IBD, while 45% had a referral paediatrician with expertise in IBD. Conclusion The management of IBD during pregnancy, lactation, and neonatal period is notably suboptimal, even among GIs specifically dedicated to IBD. It is crucial to address this current need and implement urgent educational measures in this area.

Chat Generative Pretrained Transformer (ChatGPT) and Bard: Artificial Intelligence Does not yet Provide Clinically Supported Answers for Hip and Knee Osteoarthritis

BackgroundAdvancements in artificial intelligence (AI) have led to the creation of large language models (LLMs), such as Chat Generative Pretrained Transformer (ChatGPT) and Bard, that analyze online resources to synthesize responses to user queries. Despite their popularity, the accuracy of LLM responses to medical questions remains unknown. This study aimed to compare the responses of ChatGPT and Bard regarding treatments for hip and knee osteoarthritis with the American Academy of Orthopaedic Surgeons (AAOS) Evidence-Based Clinical Practice Guidelines (CPGs) recommendations. MethodsBoth ChatGPT (Open AI) and Bard (Google) were queried regarding 20 treatments (10 for hip and 10 for knee osteoarthritis) from the AAOS CPGs. Responses were classified by 2 reviewers as being in “Concordance,” “Discordance,” or “No Concordance” with AAOS CPGs. A Cohen’s Kappa coefficient was used to assess inter-rater reliability, and Chi-squared analyses were used to compare responses between LLMs. ResultsOverall, ChatGPT and Bard provided responses that were concordant with the AAOS CPGs for 16 (80%) and 12 (60%) treatments, respectively. Notably, ChatGPT and Bard encouraged the use of non-recommended treatments in 30% and 60% of queries, respectively. There were no differences in performance when evaluating by joint or by recommended versus non-recommended treatments. Studies were referenced in 6 (30%) of the Bard responses and none (0%) of the ChatGPT responses. Of the 6 Bard responses, studies could only be identified for 1 (16.7%). Of the remaining, 2 (33.3%) responses cited studies in journals that did not exist, 2 (33.3%) cited studies that could not be found with the information given, and 1 (16.7%) provided links to unrelated studies. ConclusionsBoth ChatGPT and Bard do not consistently provide responses that align with the AAOS CPGs. Consequently, physicians and patients should temper expectations on the guidance AI platforms can currently provide.

Acupuncture: Effective and Recommended but More Implementation Needed

Abstract Acupuncture enjoys a robust evidence base for dozens of clinical conditions and decades of research exploring its mechanisms of action. It has over 9,000 positive recommendations from official government and clinical guidelines. However, it still remains relatively inaccessible in the United States, Europe and elsewhere, especially compared to the strength of evidence-based recommendations for its use. Acupuncture would benefit from robust implementation strategies, utilizing insights and approaches from implementation science. The clinical use of Botox for migraine suffered from weaker evidence of effectiveness and greater evidence of harm, but using a streamlined and robust implementation strategy, Allergan was able to achieve widespread implementation from when it began its efforts around 2010. Such a systematic approach that identifies and overcomes barriers to implementation for acupuncture would benefit millions of people who currently are offered less effective and more invasive treatments, contrary to the recommendations of clinical guidelines.

Inadequate harms reporting among randomized controlled trials cited as supporting evidence in the AAOS management of hip fractures in older adults clinical practice guideline recommendations

BackgroundRecommendations within clinical practice guidelines (CPGs) are heavily influenced by results from randomized controlled trials (RCTs). Therefore, it is imperative that all RCT outcomes are reported thoroughly to ensure CPGs are created using accurate information. Here, we evaluate the quality of harms reporting using the CONSORT Extension for Harms in RCTs underpinning recommendations in the American Academy of Orthopedic Surgeons (AAOS) Management of Hip Fractures in Older Adults CPG. MethodsEach RCT cited as evidence for recommendations in the AAOS Management of Hip Fractures in Older Adults CPG was evaluated using the CONSORT Extension for Harms to determine the quality of harms reporting. Descriptive statistics (frequencies, percentages, 95 % confidence intervals) were used to summarize adherence to CONSORT Harms items. A linear regression model was used to evaluate the CONSORT Harms influence on the quality of reporting over time. ResultsAmong the 156 RCTs identified, there were a total of 31,848 participants. Most RCTs were conducted at a single center (137; 87.8 %) and in a single-blind manner (130; 83.3 %). Fifty-four (34.6 %) RCTs did not provide funding statements. Trials adequately reported an average of 6.65 out of 18 CONSORT Extension for Harms items (37.0 %). One RCT adequately reported all items, while five reported zero items. Forty-seven RCTs (30.1 %) reported ≥ 50 % of items and 73 (46.8 %) reported ≤ 33.3 % of items. The linear regression model demonstrated no significant increase in mean adherence over time (adjusted R2 = –0.006; p = 0.563). ConclusionOur results highlight inadequate harms reporting among RCTs in the AAOS Management of Hip Fractures in Older Patients CPG. While the CONSORT Harms Extension was intended to enhance reporting, the linear regression model did not demonstrate significant improvements over time.

Performance of ChatGPT on NASS Clinical Guidelines for the Diagnosis and Treatment of Low Back Pain: A Comparison Study.

Comparative analysis. To evaluate Chat Generative Pre-trained Transformer (ChatGPT's) ability to predict appropriate clinical recommendations based on the most recent clinical guidelines for the diagnosis and treatment of low back pain. Low back pain is a very common and often debilitating condition that affects many people globally. ChatGPT is an artificial intelligence model that may be able to generate recommendations for low back pain. Using the North American Spine Society Evidence-Based Clinical Guidelines as the gold standard, 82 clinical questions relating to low back pain were entered into ChatGPT (GPT-3.5) independently. For each question, we recorded ChatGPT's answer, then used a point-answer system-the point being the guideline recommendation and the answer being ChatGPT's response-and asked ChatGPT if the point was mentioned in the answer to assess for accuracy. This response accuracy was repeated with one caveat-a prior prompt is given in ChatGPT to answer as an experienced orthopedic surgeon-for each question by guideline category. A two-sample proportion z test was used to assess any differences between the preprompt and postprompt scenarios with alpha=0.05. ChatGPT's response was accurate 65% (72% postprompt, P =0.41) for guidelines with clinical recommendations, 46% (58% postprompt, P =0.11) for guidelines with insufficient or conflicting data, and 49% (16% postprompt, P =0.003*) for guidelines with no adequate study to address the clinical question. For guidelines with insufficient or conflicting data, 44% (25% postprompt, P =0.01*) of ChatGPT responses wrongly suggested that sufficient evidence existed. ChatGPT was able to produce a sufficient clinical guideline recommendation for low back pain, with overall improvements if initially prompted. However, it tended to wrongly suggest evidence and often failed to mention, especially postprompt, when there is not enough evidence to adequately give an accurate recommendation.

An Evidence Map of Clinical Practice Guideline Recommendations on Stroke Rehabilitation.

The purpose of this study was to provide an evidence map for explaining research trends and gaps. Four databases and CPGs-related websites were searched up to March 2022. Basic information, methodological quality, reporting quality of CPGs, and similar stroke recommendations were extracted. The methodological and reporting quality of stroke CPGs were evaluated using the AGREE II instrument and the RIGHT checklist. The bubble plot format of the evidence map helped visualize the overall quality. Data management and analysis were performed using Excel 2013 and SPSS 22.0 software. A total of 12 CPGs, published between 1997 and 2020 were included for in-depth analysis. The identified CPGs had a mixed quality and scored poorly in the developmental rigor and applicability domains by AGREE II. According to the RIGHT checklist, field four (clarity of expression) showed the highest (79.2%), and field three (rigor of formulation) secured the lowest (28%) reporting rates. The stroke rehabilitation recommendations primarily focused on organizational management, timing and intensity, rehabilitation and nutritional management of dysphagia, return to work, communication, speech, and language function. This would promote improvement in developing trustworthy CPGs for stroke rehabilitation.

ChatGPT v4 outperforming v3.5 on cancer treatment recommendations in quality, clinical guideline, and expert opinion concordance.

To assess the quality and alignment of ChatGPT's cancer treatment recommendations (RECs) with National Comprehensive Cancer Network (NCCN) guidelines and expert opinions. Three urologists performed quantitative and qualitative assessments in October 2023 analyzing responses from ChatGPT-4 and ChatGPT-3.5 to 108 prostate, kidney, and bladder cancer prompts using two zero-shot prompt templates. Performance evaluation involved calculating five ratios: expert-approved/expert-disagreed and NCCN-aligned RECs against total ChatGPT RECs plus coverage and adherence rates to NCCN. Experts rated the response's quality on a 1-5 scale considering correctness, comprehensiveness, specificity, and appropriateness. ChatGPT-4 outperformed ChatGPT-3.5 in prostate cancer inquiries, with an average word count of 317.3 versus 124.4 (p < 0.001) and 6.1 versus 3.9 RECs (p < 0.001). Its rater-approved REC ratio (96.1% vs. 89.4%) and alignment with NCCN guidelines (76.8% vs. 49.1%, p = 0.001) were superior and scored significantly better on all quality dimensions. Across 108 prompts covering three cancers, ChatGPT-4 produced an average of 6.0 RECs per case, with an 88.5% approval rate from raters, 86.7% NCCN concordance, and only a 9.5% disagreement rate. It achieved high marks in correctness (4.5), comprehensiveness (4.4), specificity (4.0), and appropriateness (4.4). Subgroup analyses across cancer types, disease statuses, and different prompt templates were reported. ChatGPT-4 demonstrated significant improvement in providing accurate and detailed treatment recommendations for urological cancers in line with clinical guidelines and expert opinion. However, it is vital to recognize that AI tools are not without flaws and should be utilized with caution. ChatGPT could supplement, but not replace, personalized advice from healthcare professionals.

Optimizing Cardiac Resynchronization Therapy in Heart Failure Patients With Prolonged QRS Duration: Insights Into Electrical and Mechanical Dyssynchrony

Heart failure (HF) represents a critical stage of cardiac disease, associated with high morbidity and mortality. Cardiac resynchronization therapy (CRT) has become a pivotal treatment for HF patients with prolonged QRS duration. This therapy employs a biventricular pacing system to correct cardiac electromechanical dyssynchrony, thereby improving cardiac function, symptoms, and prognosis. Numerous clinical trials have consistently highlighted the benefits of CRT in this subgroup, leading to its unanimous recommendation in clinical practice guidelines. However, a significant proportion of patients do not achieve an adequate therapeutic response, despite adherence to these guidelines. As CRT treats patients by correcting cardiac electromechanical dyssynchrony, assessing electrical and mechanical dyssynchrony is crucial in candidate selection. This review explores the evidence, recent clinical practice guidelines, and insight into electrical and mechanical dyssynchrony to optimize CRT candidate selection in HF patients with prolonged QRS duration.

Applying implementation science theories to support practice change in the assessment of cognition by occupational therapists.

Background Understanding cognitive impairments is essential for effective rehabilitation and discharge planning for adults with neurological conditions. The aim of this study was to identify barriers to completing standardised cognitive assessments and evaluate the implementation of an intervention to support practice change. Methods A mixed-methods approach was applied to translate cognitive assessment recommendations into clinical practice using the Theoretical Domains Framework (TDF) and the Capability, Opportunity, and Motivation Behaviour model (COM-B) theories. Occupational therapists at one metropolitan health service in Australia were invited to participate. Pre- and post-implementation file audits and surveys were conducted, along with focus groups that collected qualitative data analysed using the TDF and COM-B. Results Survey 1 (n =40) and focus group data (n =24) identified barriers in the TDF domains of knowledge (selection of assessments), environment and resources (equipment and time constraints), and social influences (pressure from other disciplines). To address barriers to implementing a cognitive assessment framework, scripts, cue cards, video-recorded training, and posters were developed as guided by the Behaviour Change Wheel (BCW). Survey 2 showed increased capability to physically administer cognitive assessments (53-74%) and improved clinician understanding of relevant clinical practice guideline (CPG) recommendations (22-50%). File audit data indicated a 30% increase in the number of standardised assessments completed. Conclusions The application of two implementation theories led to the development of an intervention that increased occupational therapists' confidence and their adherence to CPG recommendations. This study serves as a potential model for using the TDF and COM-B to create implementation interventions in various clinical practice areas.

Increasing trends of pharmaceutical payments to breast cancer specialists in Japan: A retrospective study from 2016 to 2019.

The introduction of new drugs often leads to aggressive promotion and potential financial conflicts of interest, which may bias treatment decisions and potentially harm patients. The breast cancer therapeutics market is rapidly evolving globally, and Japan is no exception. This study aimed to analyze trends in pharmaceutical payments to breast cancer specialists in Japan from 2016 to 2019, focusing on company-level data, relationships with new drug introductions, and individual specialist payment patterns. This retrospective study examined financial relationships between pharmaceutical companies and breast cancer specialists in Japan from 2016 to 2019. The analysis focused on certified specialists as of May 2023 and used payment data from 93 pharmaceutical companies for activities such as lecturing, writing, and consulting. First, a company-level analysis examined total payments, categories, and trends for all companies and the top 10 individually; second, a specialist-level analysis looked at payment amounts amount and counts. The Gini index was employed to assess the concentration of payments among specialists. Total payments reached USD 13,329,911, growing at 10.1% annually, with 81.4% allocated to lecturing engagements. The top 10 companies, led by Chugai Pharmaceutical, Eisai, and AstraZeneca, accounted for 89.5% of all payments. Companies like Pfizer Japan and Eli Lilly Japan saw notable increases following the introduction of new drugs such as palbociclib and abemaciclib. Payment distribution was highly skewed, with an average of $7,692 per specialist but a median of only $2,884. A Gini index of 0.994 further confirmed that a small group of specialists received a disproportionately large share of the payments. From 2016 to 2019, pharmaceutical payments to Japanese breast cancer specialists increased significantly, coinciding with new drug introductions. The concentration of payments among a select group of specialists raises concerns about potential influences on clinical decision-making and guideline recommendations.

Clinical Practice Guideline Recommendations in Pediatric Mild Traumatic Brain Injury: A Systematic Review

Our primary objectives were to identify clinical practice guideline recommendations for children with acute mild traumatic brain injury (mTBI) presenting to an emergency department (ED), appraise their overall quality, and synthesize the quality of evidence and the strength of included recommendations. We searched MEDLINE, EMBASE, Cochrane Central, Web of Science, and medical association websites from January 2012 to May 2023 for clinical practice guidelines with at least 1 recommendation targeting pediatric mTBI populations presenting to the ED within 48 hours of injury for any diagnostic or therapeutic intervention in the acute phase of care (ED and inhospital). Pairs of reviewers independently assessed overall clinical practice guideline quality using the Appraisal of Guidelines Research and Evaluation (AGREE) II tool. The quality of evidence on recommendations was synthesized using a matrix based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Evidence-to-Decision framework. We included 11 clinical practice guidelines, of which 6 (55%) were rated high quality. These included 101 recommendations, of which 34 (34%) were based on moderate- to high-quality evidence, covering initial assessment, initial diagnostic imaging, monitoring/observation, therapeutic interventions, discharge advice, follow-up, and patient and family support. We did not identify any evidence-based recommendations in high-quality clinical practice guidelines for repeat imaging, neurosurgical consultation, or hospital admission. Lack of strategies and tools to aid implementation and editorial independence were the most common methodological weaknesses. We identified 34 recommendations based on moderate- to high-quality evidence that may be considered for implementation in clinical settings. Our review highlights important areas for future research. This review also underlines the importance of providing strategies to facilitate the implementation of clinical practice guideline recommendations for pediatric mTBI.

Variation in clinical practice guideline recommendations for medication use in pregnancy in Australia: A systematic review.

Medication use in pregnancy is common; however, it is unknown if clinical practice guideline (CPG) prescribing recommendations referred to in Australia at the state, national and international level are consistent. This systematic review aimed to: (1) identify sources of CPGs that inform prescribing during pregnancy in Australia; (2) assess CPG quality; and (3) evaluate variation within CPG recommendations for medication use in three common conditions in pregnancy: prophylactic antibiotics following premature rupture of membranes (PROM) at term, antidepressants in pregnancy and metformin in gestational diabetes mellitus (GDM). A literature search was conducted across PubMed, Scopus and EMBASE databases. Grey literature was identified through publicly available Australian policy statements. Prescribing recommendations for prophylactic antibiotics following PROM at term, antidepressants in pregnancy and metformin in GDM, were compared at the state, national and international levels. CPG quality was assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. We identified 39 CPG sources that inform prescribing during pregnancy in Australia. CPG quality varied between resources. There was minor variation in recommendations for antibiotic prophylaxis in PROM at term. Recommendations regarding metformin use in GDM were also variable, with CPGs either recommending its use as a first-line agent when lifestyle modifications are not effective or when insulin therapy is not practicable. Recommendations for antidepressant use were consistent across CPGs analysed. Multiple CPGs exist to inform prescribing during pregnancy in Australia, with variation present within CPG quality and recommendations. These findings offer insight into potential sources of variation in maternal and neonatal health outcomes.