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.

The Impact of Incident Disclosure Behaviors on Medical Malpractice Claims.

OBJECTIVES: To provide preliminary estimates of incident disclosure behaviors on medical malpractice claims. METHODS: We conducted a descriptive analysis of data on medical malpractice claims obtained from the Controlled Risk Insurance Company and Risk Management Foundation of Harvard Medical Institutions (Cambridge, Massachusetts) between 2012 and 2013 (n = 434). The characteristics of disclosure and apology after medical errors were analyzed. RESULTS: Of 434 medical malpractice claims, 4.6% (n = 20) medical errors had been disclosed to the patient at the time of the error, and 5.9% (n = 26) had been followed by disclosure and apology. The highest number of disclosed injuries occurred in 2011 (23.9%; n = 11) and 2012 (34.8%; n = 16). There was no incremental increase during the financial years studied (2012-2013). The mean age of informed patients was 52.96 years, 58.7 % of the patients were female, and 52.2% were inpatients. Of the disclosed errors, 26.1% led to an adverse reaction, and 17.4% were fatal. The cause of disclosed medical error was improper surgical performance in 17.4% (95% confidence interval, 6.4-28.4). Disclosed medical errors were classified as medium severity in 67.4%. No apology statement was issued in 54.5% of medical errors classified as high severity. CONCLUSIONS: At the health-care centers studied, when a claim followed a medical error, providers infrequently disclosed medical errors or apologized to the patient or relatives. Most of the medical errors followed by disclosure and apology were classified as being of high and medium severity. No changes were detected in the volume of lawsuits over time.

A Longitudinal Investigation of Internalized Stigma, Constrained Disclosure, and Quality of Life Across 12 Weeks in Lung Cancer Patients on Active Oncologic Treatment.

INTRODUCTION: Internalized lung cancer stigma (i.e., feelings of regret, shame, and self-blame about one's lung cancer) is related to poorer psychological outcomes. Less is known about how internalized stigma relates to physical and functional outcomes or how constrained disclosure (i.e., avoidance of or discomfort about disclosing one's lung cancer status to others) relates to well-being. Furthermore, no study has examined whether internalized stigma and constrained disclosure predict changes in well-being for lung cancer patients. This longitudinal study characterized relationships of internalized stigma and constrained disclosure with emotional and physical/functional outcomes. METHODS: Participants (N = 101, 52.4% male, 63.4% currently/formerly smoked) were lung cancer patients on active medical treatment who completed questionnaires on stigma and well-being at study entry and at 6- and 12-week follow-up. Multivariable linear regressions characterized relationships of internalized stigma and constrained disclosure with emotional and physical/functional well-being at study entry and across time. RESULTS: Participants who currently or formerly smoked reported higher levels of internalized stigma (but not constrained disclosure), compared to never smokers (p < 0.001). Higher internalized stigma and constrained disclosure were uniquely associated with poorer emotional and physical/functional well-being at study entry (all p < 0.05), beyond sociodemographic characteristics, time elapsed since diagnosis, and smoking status. Higher internalized stigma predicted significant declines in emotional well-being across 6 and 12 weeks (all p < 0.01) and declines in physical/functional well-being across 6 weeks (p < 0.05). CONCLUSIONS: Internalized lung cancer stigma and constrained disclosure relate to emotional and physical/functional maladjustment. Findings carry implications for provider- and patient-focused interventions to reduce internalized stigma and promote well-being.

The impact of caregiver's role preference on decisional conflicts and psychiatric distresses in decision making to help caregiver's disclosure of terminal disease status.

PURPOSE: The objective of this study was to investigate the impact of caregivers' role preference in decision making on conflicts and psychiatric distresses. METHODS: The responses of 406 caregivers of terminal cancer patients enrolled in a trial determining the efficacy of a decision aid focused on the disclosure of terminal disease status were included in this secondary analysis. The outcomes include the change scores of the Decision Conflict Scale (DCS) and depression and anxiety subscales of the Hospital Anxiety and Depression Scale (HADS) at the 1 and 3 months from baseline. The linear mixed model was employed to discover the impact of caregivers' decisional role preference on the outcomes. FINDINGS: Of the 406, 137 (33.7%) showed an active role preference and 269 (66.3%) showed a passive role preference. In the post hoc analysis of the adjusted differences of change scores between passive caregivers who received decision aid (passive-decision aid) and active caregivers with decision aid (active-decision aid), non-significant differences were observed in the DCS. However, at the 3-month, the change scores of the HADS depression subscale increased by 4.43 (effect size, 0.71) and those of the HADS anxiety subscale increased by 4.14 (effect size, 0.61) in the passive-decision aid group than in active-decision aid group, showing moderate to large difference. CONCLUSIONS: These findings suggest that information might be ethically recommended in a format that is interactive and tailored to how much an individual wishes to be involved in the decision-making process.

[Evaluation of physians, patients, relatives and society of opinions on the told lung cancer diagnosis]. / Hekimlerin, hasta yakinlarinin ve toplumun akciger kanseri tanisinin söylenmesine iliskin görüslerinin degerlendirilmesi.

INTRODUCTION: In our country, this is usually done by patient relatives. In this study, we aimed to investigate the thought of doctors who done the diagnosis, doctors who arrange the treatment, first degree relatives of patients with lung cancer, and population as a control. MATERIALS AND METHODS: 310 subjects (100 doctors, 110 first degree realtives of patients, and 100 subjects as a control) were included to the study. The mean age was 39.77 ± 11.44 years and there was 170 females. 46% of doctors were giving cancer treatment (chemotheraphy/radiotheraphy). RESULT: 84.5% of subjects were answered the question (Do you want to know the diagnosis of lung cancer if you are lung cancer?) as "yes" and the answers were not different between groups (p> 0.05). 72 of doctors were giving information about diagnosis of patients. This ratio was 89.1% in doctors who arrange lung cancer treatment whereas it was 57.4% in doctors who do not arrange cancer treatment. The percent age of learning of diagnosis of lung cancer throughout the time in doctors, population, and patient's relatives were 19%, 34%, and 59% respectively (p< 0.05). Information about quality of life was more important in relatives of patients (87%) than population (65%) and doctors (63%) (p< 0.05). Quality of life was more important for doctors who arrange lung cancer treatment (76.7)% than doctors who did not (48.8%) (p< 0.05). Patients who were more children wanted to stay with their family at end stage of disease (p< 0.05). CONCLUSIONS: According to this study we think that doctors should say the diagnosis of lung cancer in the form of they understand, inform the patients and relatives about treatment, and quality of life and this can increase patient trust to doctor and compliance of patients to the treatment.

Disclosing and reporting medical errors: Cross-sectional survey of Swiss anaesthesiologists.

BACKGROUND: There is limited research on anaesthesiologists' attitudes and experiences regarding medical error communication, particularly concerning disclosing errors to patients. OBJECTIVE: To characterise anaesthesiologists' attitudes and experiences regarding disclosing errors to patients and reporting errors within the hospital, and to examine factors influencing their willingness to disclose or report errors. DESIGN: Cross-sectional survey. SETTING: Switzerland's five university hospitals' departments of anaesthesia in 2012/2013. PARTICIPANTS: Two hundred and eighty-one clinically active anaesthesiologists. MAIN OUTCOME MEASURES: Anaesthesiologists' attitudes and experiences regarding medical error communication. RESULTS: The overall response rate of the survey was 52% (281/542). Respondents broadly endorsed disclosing harmful errors to patients (100% serious, 77% minor errors, 19% near misses), but also reported factors that might make them less likely to actually disclose such errors. Only 12% of respondents had previously received training on how to disclose errors to patients, although 93% were interested in receiving training. Overall, 97% of respondents agreed that serious errors should be reported, but willingness to report minor errors (74%) and near misses (59%) was lower. Respondents were more likely to strongly agree that serious errors should be reported if they also thought that their hospital would implement systematic changes after errors were reported [(odds ratio, 2.097 (95% confidence interval, 1.16 to 3.81)]. Significant differences in attitudes between departments regarding error disclosure and reporting were noted. CONCLUSION: Willingness to disclose or report errors varied widely between hospitals. Thus, heads of department and hospital chiefs need to be aware of the importance of local culture when it comes to error communication. Error disclosure training and improving feedback on how error reports are being used to improve patient safety may also be important steps in increasing anaesthesiologists' communication of errors.

[Informed consent of the surgical patient]. / Tájékozott beleegyezés a sebészetben.

The article analyses the consequences of the paradigm shift in the surgical practice in the last fifty years. The earlier, paternalistic physician-patient relationship has been replaced by an equal one, which is based on informing the patient and involving him or her in the treatment decisions. This shift did not happen uniformly in various medical subspecialties. In this respect, surgery is more conservative than general medicine. The article analyses the most frequent problems of informing patients, and examines the major elements of information, together with their technical conditions in surgery. It reflects on specifics of surgical information disclosure and conditions of refusing medical interventions.

Improving disclosure and management of medical error - an opportunity to transform the surgeons of tomorrow.

INTRODUCTION: Human error is the major causal factor of industrial and transportation accidents and healthcare is not immune to the effects of human error. Medical error can be defined as the failure of the planned action to be completed as intended or the use of a wrong plan to achieve an aim. AIM: The objective of this literature review was to explore the practices of medical error management and disclosure by surgical trainees and to examine how to better prepare and educate the surgeons of tomorrow. METHODS: PubMed was searched to identify available literature. Preliminary search criteria included medical error and junior doctors, management and prevention of medical error. RESULTS: Fifty-two papers were included for review. Medical error is common and junior doctors are more vulnerable to err. Most serious errors occur in the emergency department, operating rooms and the intensive care unit. Improvements in patient safety result primarily from organizational and individual learning, particularly with reference to trainee doctors who present an enhanced level of risk. CONCLUSION: Junior doctors are a unique population, with a higher propensity to medical error. A transition from the current culture of 'name, blame and shame' is required. We need to ensure that the 'learning moment' is seized and that mistakes are learned from and not simply forgotten. Surgery has an opportunity to learn from high risk-industries and incorporate human factors training, into surgical training programs in order to better manage and prevent medical error.

American Society of Clinical Oncology policy for relationships with companies: background and rationale.

The American Society of Clinical Oncology's (ASCO's) new conflict of interest policy reflects a commitment to transparency and independence in the development and presentation of scientific and educational content. ASCO supports thorough and accessible disclosure of financial relationships with companies at institutional and individual levels and calls for rigorous evaluation of content in light of the information disclosed. For abstracts and articles presenting original research, ASCO holds first, last, and corresponding authors to a clear standard of independence. In imposing restrictions, the new policy focuses on the role of these authors rather than of the principal investigator(s) as in the previous policy. ASCO remains actively engaged with the broader scientific community in seeking and implementing efficient, effective approaches to conflict of interest management.

Facing the truth about nanotechnology in drug delivery.

Nanotechnology in drug delivery has been manifested into nanoparticles that can have unique properties both in vitro and in vivo, especially in targeted drug delivery to tumors. Numerous nanoparticle formulations have been designed and tested to great effect in small animal models, but the translation of the small animal results to clinical success has been limited. Successful translation requires revisiting the meaning of nanotechnology in drug delivery, understanding the limitations of nanoparticles, identifying the misconceptions pervasive in the field, and facing inconvenient truths. Nanoparticle approaches can have real impact in improving drug delivery by focusing on the problems at hand, such as enhancing their drug loading capacity, affinity to target cells, and spatiotemporal control of drug release.

The impact of information disclosure on quality of care in HMO markets.

OBJECTIVE: To examine the impact of voluntary information disclosure on quality of care in Health Maintenance Organization (HMO) markets in the USA. SETTING: Commercial HMOs that collected a set of standardized quality meausures, Health Plan Employer Data and Information Set (HEDIS), between 1997 and 2000 in the USA (1062 HMO-years). After collecting the HEDIS data, some HMOs disclosed their HEDIS-quality scores to the public (disclosing HMOs), whereas some HMOs declined to disclose the information (non-disclosing HMOs). DESIGN: A secondary data analysis based on 4 years of quality scores of HMOs. The study uses non-disclosing plans as a control group. A treatment-effects model is used to address a potential bias associated with voluntary disclosure decisions by HMOs. MAIN OUTCOME MEASURE(S): The study focuses on 13 HEDIS clinical indicators. On the basis of these indicators, a plan-level composite score and four domain scores were constructed. The four domains are childhood immunizations, treatments/exams for chronic conditions, screening tests and maternity services. RESULTS: Public disclosure leads to an increase of 0.72 composite score units, which corresponds to ∼7% points in original quality scale (0-100%). The degree of quality improvement differed by the type of services. CONCLUSIONS: Public release of quality information had a significant and positive effect on quality in HMO markets during the earlier years of the voluntary disclosure program; however, the improvement was not universal across all quality measures.

Disclosure of research results from cancer genomic studies: state of the science.

Although the cancer research community has supported a "nondisclosure" position about the return of individual results to research subjects, new technologies, such as genome wide association studies, will reveal clinically relevant findings, some of which cannot be ignored. What recommendations exist that can guide researchers and Institutional Review Boards (IRBs) about this issue? This article summarizes the relevant public documents about the disclosure of individual research results to inform policy development. Four stakeholder groups were selected to make this comparison: federal, professional, advisory, and advocacy groups. Regardless of a group's position on disclosure, there was consensus that if research results were to be disclosed under any condition, the results must be analytically and clinically validated and that the researcher should not make this decision alone, but in conjunction with the IRB. There was no consensus, however, on the specific determinants for disclosure or what constitutes clinical validity. Although sufficient agreement exists to begin developing general guidelines about the process for disclosure of individual research results, the actual determinants with which to guide this decision remain challenging. An alternate framework that addresses the threshold of uncertainty a stakeholder is willing to accept, the positive predictive value of the research finding, and the magnitude of harm of returning results may be more effective to guide decision making. These assessments, along with what is considered useful information, requires the involvement of the research subject community to inform decision-making and move the policy process forward.

A turning point for conflicts of interest: the controversy over the National Academy of Sciences' first conflicts of interest disclosure policy.

Conflicts of interest policies have become a part of the fabric of the conduct of biomedical research, yet such concerns are relatively recent history. Until the 1960s, concerns about conflicts of interest were confined to scientists who served as government advisors and contractors. However, in the 1970s, as a range of environmental and consumer safety issues gained public attention, the conclusions of researchers frequently came under attack because of concerns about experts' financial ties to private industry. These debates typically focused on evaluating potential carcinogens in the environment. In response, the National Academy of Sciences (NAS) developed its first conflict of interest policy, requiring committee members to disclose any "potential sources of bias" that "others might deem prejudicial." Scientists universally opposed the policy, however, for a range of reasons--while some argued that all experienced and knowledgeable experts were inherently conflicted, others were offended at the suggestion that any expert could be biased. Despite the controversy, the disclosure policy remained in place and became a model for subsequent professional and institutional policies in the biomedical sciences. However, although disclosure policies have become standard at academic medical centers and for publications in scientific journals, clinical researchers have continued to debate the content of these policies and the need for additional protections beyond disclosure. In the absence of a definitive standard, this historical case study can substantially inform ongoing discussion on conflicts of interest in clinical research.

The student and the ovum: the lack of autonomy and informed consent in trading genes for tuition.

Rising tuition costs have forced university students to become creative in finding ways to fund their education. Some female university students have decided that ova donation may be an acceptable alternative in which to pay for their tuition. This alternative presents itself because of the insufficient number of ova available for assisted reproduction and emerging stem cell technologies. Young female university students are encouraged by Internet sources and respectable electronic and print media to donate their ova in the cause of assisted reproduction for monetary compensation. While university students generally exhibit autonomy, the constraining influence of their financial predicament compromises the elements of informed consent (voluntariness, competence, capacity, understanding, and disclosure) as to their making an autonomous decision in regard to egg donation. Thus, any moral possibility of giving informed consent is negated. Informed consent can only occur through autonomy. A female university student in need of financial resources to pay for her education cannot make an autonomous choice to trade her genes for tuition. Donated ova are not only needed for assisted reproduction, but for stem cell technologies. While the long-term health of women who donate their ova is of concern (a potential risk of cancer after long term use of ovulation induction), of equal concern is the possibility of a growth in the trade of ova targeting third world and Eastern European women where the precedence for autonomy and informed consent is not well established.

Pesticide exports from U.S. ports, 1997-2000.

U.S. Customs records reveal that 3.2 billion pounds of pesticide products were exported in 1997-2000, an average rate of 45 tons per hour. Nearly 65 million pounds of the exported pesticides were either forbidden or severely restricted in the United States; however, no banned pesticide export was recorded for the year 2000. 2.2 million pounds of pesticides regulated under a treaty on persistent organic pollutants (POPs) were exported between 1997 and 1999, with no such export in 2000. Exports of pesticides subject to the prior informed consent (PIC) treaty decreased 97% from the 1997 total of nearly 3 million pounds. Thus, international efforts to reduce the trade in hazardous pesticides may be bearing fruit. However, they are balanced by high rates of export of pesticides designated "extremely hazardous" by the WHO (89 million pounds), pesticides associated with cancer (170 million pounds), and pesticides associated with endocrine disrupting effects (368 million pounds), mostly to developing countries. These findings point in two directions: first, progress is possible, and second, the focus of international efforts should be expanded. From public health and environmental protection perspectives, exports of hazardous pesticides remain unacceptably high.