Enhanced Notification of Radiographic Incidental Findings in Trauma Does Not Guarantee Follow-Up Compliance.

OBJECTIVES: Follow-up care for incidental findings (IFs) on trauma computed tomography scans is a component of comprehensive healthcare. Our objective was to assess the effectiveness of our IF predischarge disclosure practice guideline and identify factors contributing to follow-up failure. METHODS: This was a secondary analysis of a prospective observational database: 615 patients with IFs from November 2019 to February 2020. Follow-up compliance was determined by electronic medical record review and/or a telephone call after a mail-out request for voluntary participation. Volunteers answered a predetermined questionnaire regarding follow-up care. RESULTS: A total of 115 patients (19%) had computed tomography-based IFs recommending additional imaging or other follow-ups. Seventy-four (64%) patients were lost to inclusion as a result of death (12.1%), inability to contact (51.3%), or noninterest (5.2%). Of the remaining 36 patients, 19 received follow-up care (52.7%) and 17 did not (47.2%). No statistical differences existed among groups in age, sex, mechanism of injury, Glasgow Coma Scale score, whether informed by physicians or midlevel providers, or type of IF. A total of 15 (88%) nonfollow-up patients did not recall the disclosure or discharge paperwork instructions. Of 19 compliant patients: 9 had additional imaging only, 5 had biopsies and/or surgical intervention (n = 3 cancer, n = 2 benign), 3 had primary care advice against additional studies and 2 were referred to specialists. CONCLUSIONS: Predischarge disclosure of IFs can contribute significantly to overall patient health. Nonetheless, fewer than half of patients do not pursue follow-up recommendations, most often citing failure to recall verbal/written instructions. More effective communication with attention to health literacy, follow-up telephone calls, and postdischarge appointments are potential catalysts for improved patient compliance.

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Importance: Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal. Objective: To develop a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for factorial trials. Design: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT extension for factorial trials was developed by (1) generating a list of reporting recommendations for factorial trials using a scoping review of methodological articles identified using a MEDLINE search (from inception to May 2019) and supplemented with relevant articles from the personal collections of the authors; (2) a 3-round Delphi survey between January and June 2022 to identify additional items and assess the importance of each item, completed by 104 panelists from 14 countries; and (3) a hybrid consensus meeting attended by 15 panelists to finalize the selection and wording of items for the checklist. Findings: This CONSORT extension for factorial trials modifies 16 of the 37 items in the CONSORT 2010 checklist and adds 1 new item. The rationale for the importance of each item is provided. Key recommendations are (1) the reason for using a factorial design should be reported, including whether an interaction is hypothesized, (2) the treatment groups that form the main comparisons should be clearly identified, and (3) for each main comparison, the estimated interaction effect and its precision should be reported. Conclusions and Relevance: This extension of the CONSORT 2010 Statement provides guidance on the reporting of factorial randomized trials and should facilitate greater understanding of and transparency in their reporting.

Moving Forward with Reporting Back Individual Environmental Health Research Results.

BACKGROUND: The practice of reporting back individual results to participants in environmental health research has evolved significantly over the past 20 years. Research findings support the potential of report-back to enhance the ethics, quality, and impact of environmental health research. Nonetheless, implementation of environmental health report-back practices is not yet routine. OBJECTIVES: We propose a framework for institutionalizing appropriate report-back to participants of their individual results across the environmental health research enterprise. We provide a brief overview of the rationales for report-back, social science research on report-back experiences over the past two decades, and recent efforts to synthesize guidance in this field. We also describe barriers to be addressed in moving toward widespread implementation of report-back. DISCUSSION: Report-back of individual results is increasingly recognized as an ethical responsibility and essential component of impactful environmental health research. Experience shows that when personal results are returned with appropriate contextual information, report-back can increase environmental health literacy, promote individual actions, and enhance engagement in policy change. Therefore, report-back can promote environmental justice and reduce disparities in access to science. Despite this evidence base, report-back is not widely implemented. We recommend the collaborative development of guidelines, training, and resources to build capacity for appropriate report-back to study participants across the environmental health research enterprise, and we identify research priorities to advance the field. Development of tools and shared infrastructure for report-back holds promise for reducing barriers while ensuring high-quality personalized reports. Disseminating successful case studies could also advance excellence. We recommend including diverse scientific disciplines, community partners, representatives of study populations, clinicians, institutional review boards (IRBs), legal experts, public health professionals, and government officials in further developing this critical aspect of environmental health research. https://doi.org/10.1289/EHP12463.

Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed by Data Source and Funder Type.

This study examines the dissemination of trial results by data source (ie, ClinicalTrials.gov and PubMed) and funder type (ie, industry and nonindustry).

Industry Payments to Plastic Surgeons, 2013 to 2018: Who's Getting Paid?

BACKGROUND: The Physician Payments Sunshine Act of 2010 mandated that all industry payments to physicians be publicly disclosed. To date, industry support of plastic surgeons has not been longitudinally characterized. The authors seek to evaluate payment trends from 2013 to 2018 and characteristics across plastic surgeon recipients of industry payments. METHODS: The authors cross-referenced those in the 2019 American Society of Plastic Surgeons member database with Centers for Medicare & Medicaid Services Open Payments database physician profile identification number indicating industry funds received within the study period. We categorized surgeons by years since American Board of Plastic Surgery certification, practice region, and academic affiliation. RESULTS: A sum of $89,436,100 (247,614 payments) was received by 3855 plastic surgeons. The top 1 percent of earners (n = 39) by dollar amount received 52 percent of industry dollars to plastic surgeons; of these, nine (23 percent) were academic. Overall, 428 surgeons (11 percent) were academic and received comparable dollar amounts from industry as their nonacademic counterparts. Neither geographic location nor years of experience were independent predictors of payments received. The majority of individual transactions were for food and beverage, whereas the majority of industry dollars were typically for royalties or license. CONCLUSIONS: Over half of all industry dollars transferred went to just 1 percent of American Society of Plastic Surgeons members receiving payments between 2013 and 2018. Considerable heterogeneity exists when accounting for payment subcategories.

Egyptian patients'/guardians' experiences and perception about clinical informed consent and its purpose: Cross sectional study.

BACKGROUND: Informed consent (IC) is a healthcare standard emphasizing the meaning of human dignity as clarified in the Universal Declaration of Human Rights. Data about IC practices in Egypt is insufficient. This study aimed to assess the Egyptian patients'/guardians' experiences about IC and their expectations about its practices' purposes in general and according to the type of the healthcare facility. METHODS: Self-administered questionnaire was carried out for 1092 participants who had undergone or were scheduled to a procedure requiring an IC at three studied types for Egyptian health care facilities. Ten statements were ranked twice by the participants to reflect their perception of IC purpose as per what is currently practiced and what they believe should be practiced. RESULTS: IC implementation varies significantly (p<0.05) across the health care facilities in Egypt. The percentage of its implementation at the non-governmental facilities, governmental facilities, and university hospital was 85.9%, 77.8%, and 63.8 respectively. The first three ranked purposes of the current IC practices were: "Helping patient/guardian decide (64.9%)", "Documenting patient's/guardian's decision (59.3%)", and "Having shared decision (57.3%)". The perceived purposes of IC to be practiced were: "Informing the patient/guardian (68.4%)", "Making sure patient/guardian understand (65.3%)" and "Documenting patients/guardians decisions (65.1%)". "Being a meaningless routine" was reported by the majority to be ranked as a low purpose for IC current and preferred practices. CONCLUSION: The practice of IC is common within the Egyptian medical community. Participants believe that information disclosure "Making sure patients understand" has to help in IC decision making and its main purpose. However, unfortunately, this is not perceived as a current purpose of IC. There was consensus agreement that documenting the patient's/guardian's decision and informing the patient/guardian are perceived as both important current and preferred purposes for IC practices.

HIV Disclosure-Professional Body Guidelines, the Law and the Boundaries of Medical Advice.

This article examines the current BHIVA/BASHH guidelines on the disclosure of HIV+ status in the context of sexual activity. It assesses whether the guidance provided on how to avoid criminal prosecution accurately reflects the prevailing position in law. Given that aspects of the guidance related to non-disclosure of HIV infection in the context of low or negligible risk are as yet untested in UK law, it is argued that there is some uncertainty as to whether the professional body guidelines and the law can be reconciled with each other. The article also considers whether the BHIVA/BASHH guidelines stray beyond the boundaries of medical advice as normally understood (focused on the protection of health and the prevention of onward transmission), by posing both as legal advice on how to avoid prosecution and offering what could be viewed as a moral judgement as to when disclosure is required. While a bio-medical assessment of risk naturally shapes clinical guidelines and may also inform views as to appropriate sexual behaviour and risk-taking, it is unclear whether scientific assessment of risk should be the sole guide when it comes to determining the nature of any disclosure obligation or the medical advice to be given on this matter.

The Future of the Pharmaceutical Industry: Beyond Government-Granted Monopolies.

Just as tariffs lead to economic distortions and provide incentives for corruption, so do patent monopolies on prescription drugs, except the impact is often an order of magnitude larger.

Is it time to report carrier state for recessive disorders in every microarray analysis?-A pilot model based on hearing loss genes deletions.

This study aimed to examine the implications of reporting heterozygous losses of recessive genes in Chromosomal Microarray Analysis (CMA), based on the incidence of microdeletions of three common hearing impairment genes in the local cohort and the prevalence of sequence variants in these genes in worldwide databases. Prevalence of heterozygous microdeletions in OTOA and STRC genes, as well as deletions in the DFNB1 locus encompassing GJB6 gene, was determined using electronic database of Rabin Medical Center. ClinVar archive and Deafness Variation Database were used to generate a list of clinically significant sequence variants in these three genes, as well as GJB2 gene, and estimation of the frequency of sequence variants was performed. Of the 19,189 CMA tests were performed in our laboratory, 107 STRC microdeletions were found (0.56%), followed in frequency by OTOA deletions (39, 0.2%), and DFNB1 locus deletions (10, 0.05%). The estimated risk for a hearing loss in the examined individual carrying the microdeletion was estimated as 0.11-0.67% for STRC, 0.016-0.13% for OTOA, and 1.9-7.5% in the DFNB1 locus (including double heterozygocity with GJB2 clinically significant sequence variants). The risks were higher in specific populations. In conclusion, we believe that that general decision whether to report or to disregard such incidental findings cannot be part of a uniform policy, but rather based on a detailed evaluation of origin-specific variants for each gene, with a careful consideration and discussion whether to include the microdeletion in the final report for each patient.

Guidance on the use of social media in reproductive medicine practice.

The term "social media" refers to computer-mediated technologies that enable individuals and communities to gather, communicate, network, and share information. These technologies represent useful tools for enabling individual providers and their clinics to broadcast content that educates, informs, advertises, and narrates content to a larger audience. There are multiple benefits to maintaining a presence on social media, either as an individual physician or as a clinic, but several pitfalls deserve consideration as well. This guidance document does not endorse any specific cloud-based platform or service, though some are mentioned for the purposes of illustration.

Incidental Findings in the Trauma Population: Interdisciplinary Approach and Electronic Medical Record Reminder Association with Pre-Discharge Reporting and Medicolegal Risk.

BACKGROUND: Incidental findings (IFs) are reported in 20% or more of trauma CT scans. In addition to the importance of patient disclosure, there is considerable legal pressure to avoid missed diagnoses. We reported previously that 63.5% of IFs were disclosed before discharge and with 20% were nondisclosed. We initiated a multidisciplinary systemic plan to effect predischarge disclosure by synoptic CT reports with American College of Radiology recommended follow-up, electronic medical records discharge prompts, and provider education. STUDY DESIGN: Prospective observational series patients from November 2019 to February 2020 were included. Statistical analysis was performed with SPSS, version 21 (IBM Corp). RESULTS: Eight hundred and seventy-seven patients underwent 1 or more CT scans for the evaluation of trauma (507 were male and 370 were female). Mean age of the patients was 57 years (range 14 to 99 years) and 96% had blunt injury. In 315 patients, there were 523 IFs (1.7 per patient); the most common were lung (17.5%), kidney (13%), and liver (11%). Radiology report compliance rate was 84% (210 of 249 patients). There were 66 studies from outside facilities. Sixteen IFs were suspicious for malignancy. A total of 151 patients needed no follow-up and 148 patients needed future follow-up evaluation. Predischarge IF disclosure compliance rate was 90.1% (286 patients); 25 were post discharge. Four patients remained undisclosed. Compared with our previous report, clearer reporting and electronic medical records prompts increased predischarge disclosure from 63.5% to 90.1% (p < 0.01, chi-square test) and decreased days to notification from 29.5 (range 0 to 277) to 5.2 (range 0 to 59) (p < 0.01, Mann-Whitney U test). CONCLUSIONS: Timely, complete disclosure of IFs improves patient outcomes and reduces medicolegal risk. Collaboration among trauma, radiology, and information technology promotes improved disclosure in trauma populations.

Regulatory landscape of providing information on newborn screening to parents across Europe.

Newborn screening (NBS) is an important part of public healthcare systems in many countries. The provision of information to parents about NBS is now recognised as an integral part of the screening process. Informing parents on all aspects of screening helps to achieve the benefits, promote trust and foster support for NBS. Therefore, policies and guidelines should exist to govern how the information about NBS is provided to parents, taking into account evidence-based best practices. The purpose of our survey was to explore whether any legally binding provisions, guidelines or recommendations existed pertaining to the provision of information about NBS to parents across Europe. Questions were designed to determine the regulatory process of when, by whom and how parents should be informed about screening. Twenty-seven countries participated in the survey. The results indicated that most countries had some sort of legal framework or guidelines for the provision of information to parents. However, only 37% indicated that the provision of information was required prenatally. The majority of countries were verbally informing parents with the aid of written materials postnatally, just prior to sample collection. Information was provided by a neonatologist, midwife or nurse. A website dedicated to NBS was available for 67% of countries and 89% had written materials about NBS for parents. The survey showed that there is a lack of harmonisation among European countries in the provision of information about NBS and emphasised the need for more comprehensive guidelines at the European level.

Chronic groin pain following open inguinal hernia repair: has consenting practice improved?

INTRODUCTION: Chronic groin pain following inguinal hernia surgery is a common and potentially debilitating complication, and yet patients are infrequently informed of this risk. This leaves surgeons open to negligence claims, especially given recent changes to case law, which for the first time highlighted the need for a more patient-centred approach to risk disclosure. We investigated how these changes have influenced our consenting practice with respect to the disclosure of this risk. METHODS: We compared how often surgeons discussed the risk of chronic groin pain with adults undergoing elective open unilateral inguinal hernia mesh repairs in 2019 and 2009. The first 50 patients in each of these two years were retrospectively compared. Discussions during the initial consultation and on the day of surgery were assessed by reviewing clinic letters, medical notes and consent forms. FINDINGS: The risk of chronic pain was discussed with significantly more patients in 2019 than in 2009 (96% v 54%, p<0.0001). Most of these discussions occurred on the day of surgery (92% v 54%, p<0.0001). Only a few patients had these discussions during their initial consultation (18% v 4%, p<0.025). CONCLUSIONS: Discussing the risk of chronic groin pain has improved significantly over the past 10 years. However, these discussions occur mostly on the day of surgery, which gives patients very little time to weigh up the risk. This potentially invalidates the consent they give for surgery. Patients should be given an opportunity to discuss their operative risks in advance of their operation.