How does evidence based guidance influence determinations of medical negligence?
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ABSTRACT:
SUBMITTER: Hurwitz B
PROVIDER: S-EPMC524559 | biostudies-literature | 2004 Oct
REPOSITORIES: biostudies-literature
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How does evidence based guidance influence determinations of medical negligence?
BMJ (Clinical research ed.) 20041001 7473
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Project description:BackgroundProfessional communities such as the medical community are acutely concerned with negligence: the category of misconduct where a professional does not live up to the standards expected of a professional of similar qualifications. Since science is currently strengthening its structures of self-regulation in parallel to the professions, this raises the question to what extent the scientific community is concerned with negligence, and if not, whether it should be. By means of comparative analysis of medical and scientific codes of conduct, we aim to highlight the role (or lack thereof) of negligence provisions in codes of conduct for scientists, and to discuss the normative consequences for future codes of conduct.MethodsWe collected scientific and medical codes of conduct in a selection of OECD countries, and submitted each code of conduct to comparative textual analysis.ResultsNegligence is invariably listed as an infraction of the norms of integrity in medical codes of conduct, but only rarely so in the scientific codes. When the latter list negligence, they typically do not provide any detail on the meaning of 'negligence'.DiscussionUnlike codes of conduct for professionals, current codes of conduct for scientists are largely silent on the issue of negligence, or explicitly exclude negligence as a type of misconduct. In the few cases where negligence is stipulated to constitute misconduct, no responsibilities are identified that would help prevent negligence. While we caution against unreasonable negligence provisions as well as disproportionate sanctioning systems, we do argue that negligence provisions are crucial for justified trust in the scientific community, and hence that there is a very strong rationale for including negligence provisions in codes of conduct.
| S-EPMC8046265 | biostudies-literature
Project description:BackgroundThe coronavirus disease (COVID-19) presents unique challenges in health care, including mental health care provision. Telepsychiatry can provide an alternative to face-to-face assessment and can also be used creatively with other technologies to enhance care, but clinicians and patients may feel underconfident about embracing this new way of working.ObjectiveThe aim of this paper is to produce an open-access, easy-to-consult, and reliable source of information and guidance about telepsychiatry and COVID-19 using an evidence-based approach.MethodsWe systematically searched existing English language guidelines and websites for information on telepsychiatry in the context of COVID-19 up to and including May 2020. We used broad search criteria and included pre-COVID-19 guidelines and other digital mental health topics where relevant. We summarized the data we extracted as answers to specific clinical questions.ResultsFindings from this study are presented as both a short practical checklist for clinicians and detailed textboxes with a full summary of all the guidelines. The summary textboxes are also available on an open-access webpage, which is regularly updated. These findings reflected the strong evidence base for the use of telepsychiatry and included guidelines for many of the common concerns expressed by clinicians about practical implementation, technology, information governance, and safety. Guidelines across countries differ significantly, with UK guidelines more conservative and focused on practical implementation and US guidelines more expansive and detailed. Guidelines on possible combinations with other digital technologies such as apps (eg, from the US Food and Drug Administration, the National Health Service Apps Library, and the National Institute for Health and Care Excellence) are less detailed. Several key areas were not represented. Although some special populations such as child and adolescent, and older adult, and cultural issues are specifically included, important populations such as learning disabilities, psychosis, personality disorder, and eating disorders, which may present particular challenges for telepsychiatry, are not. In addition, the initial consultation and follow-up sessions are not clearly distinguished. Finally, a hybrid model of care (combining telepsychiatry with other technologies and in-person care) is not explicitly covered by the existing guidelines.ConclusionsWe produced a comprehensive synthesis of guidance answering a wide range of clinical questions in telepsychiatry. This meets the urgent need for practical information for both clinicians and health care organizations who are rapidly adapting to the pandemic and implementing remote consultation. It reflects variations across countries and can be used as a basis for organizational change in the short- and long-term. Providing easily accessible guidance is a first step but will need cultural change to implement as clinicians start to view telepsychiatry not just as a replacement but as a parallel and complementary form of delivering therapy with its own advantages and benefits as well as restrictions. A combination or hybrid approach can be the most successful approach in the new world of mental health post-COVID-19, and guidance will need to expand to encompass the use of telepsychiatry in conjunction with other in-person and digital technologies, and its use across all psychiatric disorders, not just those who are the first to access and engage with remote treatment.
| S-EPMC7485934 | biostudies-literature
Project description:ObjectiveTo understand the association between medical negligence claims and doctors' sex, age, specialty, working hours, work location, personality, social supports, family circumstances, self-rated health, self-rated life satisfaction and presence of recent injury or illness.Design and settingProspective cohort study of Australian doctors.Participants12 134 doctors who completed the Medicine in Australia: Balancing Employment and Life survey between 2013 and 2019.Primary outcome measureDoctors named as a defendant in a medical negligence claim in the preceding 12 months.Results649 (5.35%) doctors reported being named in a medical negligence claim during the study period. In addition to previously identified demographic factors (sex, age and specialty), we identified the following vocational and psychosocial risk factors for claims: working full time (OR=1.48, 95% CI 1.13 to 1.94) or overtime hours (OR 1.70, 95% CI 1.29 to 2.23), working in a regional centre (OR 1.69, 95% CI 1.37 to 2.08), increasing job demands (OR 1.16, 95% CI 1.04 to 1.30), low self-rated life satisfaction (OR 1.43, 95% CI 1.08 to 1.91) and recent serious personal injury or illness (OR 1.40, 95% CI 1.13 to 1.72). Having an agreeable personality was mildly protective (OR 0.91, 95% CI 0.83 to 1.00). When stratified according to sex, we found that working in a regional area, low self-rated life satisfaction and not achieving work-life balance predicted medical negligence claims in male, but not female, doctors. However, working more than part-time hours and having a recent personal injury or illness predicted medical negligence claims in female, but not male, doctors. Increasing age predicted claims more strongly in male doctors. Personality type predicted claims in both male and female doctors.ConclusionsModifiable risk factors contribute to an increased risk of medical negligence claims among doctors in Australia. Creating more supportive work environments and targeting interventions that improve doctors' health and well-being could reduce the risk of medical negligence claims and contribute to improved patient safety.
| S-EPMC9171255 | biostudies-literature
Project description:Circulating cell-free DNA (cfDNA) is rapidly transitioning from discovery research to an important tool in clinical decision making. However, the lack of harmonization of preanalytic practices across institutions may compromise the reproducibility of cfDNA-derived data and hamper advancements in cfDNA testing in the clinic. Differences in cellular genomic contamination, cfDNA yield, integrity, and fragment length have been attributed to different collection tube types and anticoagulants, processing delays and temperatures, tube agitation, centrifugation protocols and speeds, plasma storage duration and temperature, the number of freeze-thaw events, and cfDNA extraction and quantification methods, all of which can also ultimately impact subsequent downstream analysis. Thus, there is a pressing need for widely applicable standards tailored for cfDNA analysis that include all preanalytic steps from blood draw to analysis. The NCI's Biorepositories and Biospecimen Research Branch has developed cfDNA-specific guidelines that are based upon published evidence and have been vetted by a panel of internationally recognized experts in the field. The guidelines include optimal procedures as well as acceptable alternatives to facilitate the generation of evidence-based protocols by individual laboratories and institutions. The aim of the document, which is entitled "Biospecimen Evidence-based Best Practices for Cell-free DNA: Biospecimen Collection and Processing," is to improve the accuracy of cfDNA analysis in both basic research and the clinic by improving and harmonizing practices across institutions.
| S-EPMC7334102 | biostudies-literature
Project description:Urban overheating is an increasing threat to people, infrastructure, and the environment. Common heat mitigation strategies, such as green infrastructure, confront space limitations in current car-centric cities. In 2020, the City of Phoenix, Arizona, piloted a "cool pavement" program using a solar reflective pavement seal on 58 km of residential streets. Comprehensive micrometeorological observations are used to evaluate the cooling potential of the reflective pavement based on three heat exposure metrics-surface, air, and mean radiant temperatures-across three residential reflective pavement-treated and untreated neighborhoods. In addition, the solar reflectivity of reflective pavement is observed over 7 months across eight residential neighborhoods. Results are synthesized with the literature to provide context-based reflective pavement implementation guidelines to mitigate urban overheating where common strategies cannot be applied. The three most important contextual factors to consider for effective implementation include urban location, background climate type, and heat exposure metric of interest.
| S-EPMC10020537 | biostudies-literature
Project description: Not available
| S-EPMC11328562 | biostudies-literature
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| S-EPMC10436180 | biostudies-literature
Project description:ObjectiveTo assess the association between medical negligence claims and doctors' self-rated health and life satisfaction.DesignProspective cohort study.ParticipantsRegistered doctors practising in Australia who participated in waves 4 to 11 of the Medicine in Australia: Balancing Employment and Life (MABEL) longitudinal survey between 2011 and 2018.Primary and secondary outcome measuresSelf-rated health and self-rated life satisfaction.ResultsOf the 15 105 doctors in the study, 885 reported being named in a medical negligence claim. Fixed-effects linear regression analysis showed that both self-rated health and self-rated life satisfaction declined for all doctors over the course of the MABEL survey, with no association between wave and being sued. However, being sued was not associated with any additional declines in self-rated health (coef.=-0.02, 95% CI -0.06 to 0.02, p=0.39) or self-rated life satisfaction (coef.=-0.01, 95% CI -0.08 to 0.07, p=0.91) after controlling for a range of job factors. Instead, we found that working conditions and job satisfaction were the strongest predictors of self-rated health and self-rated life satisfaction in sued doctors. In analyses restricted to doctors who were sued, we observed no changes in self-rated health (p=0.99) or self-rated life satisfaction (p=0.59) in the years immediately following a claim.ConclusionsIn contrast to prior overseas cross-sectional survey studies, we show that medical negligence claims do not adversely affect the well-being of doctors in Australia when adjusting for time trends and previously established covariates. This may be because: (1) prior studies failed to adequately address issues of causation and confounding; or (2) legal processes governing medical negligence claims in Australia cause less distress compared with those in other jurisdictions. Our findings suggest that the interaction between medical negligence claims and poor doctors' health is more complex than revealed through previous studies.
| S-EPMC9121477 | biostudies-literature
Project description:The Centers for Medicare & Medicaid Services (CMS) relies on public comments submitted in response to proposed national coverage determinations to assist the agency in determining the coverage of items and services for Medicare beneficiaries. In a cross-sectional study, we characterized the cited evidence and what funding supported the cited evidence submitted in public comments to CMS for all therapeutic medical device national coverage determinations finalized between June 2019 and June 2022. Of 681 public comments, 159 (23%) cited at least 1 identifiable published scientific journal article. Within these 159 public comments, 198 unique articles were cited, 170 (86%) of which included funding statements or author disclosures. Among these, 96 (56%) disclosed funding from manufacturers that would benefit from Medicare coverage and/or were written by author(s) who received funding from these manufacturers. In summary, most public commenters for national coverage determinations did not cite published scientific journal articles to support their positions. Among those who did, more than half of articles were directly funded by manufacturers that would benefit from coverage. Greater funding of independent, non-industry-supported research may help provide unbiased evaluations of benefits and harms to support Medicare coverage decisions.
| S-EPMC11196998 | biostudies-literature
Project description:IntroductionMucopolysaccharidosis (MPS) IVA or Morquio A syndrome is an autosomal recessive lysosomal storage disorder (LSD) caused by deficiency of the N-acetylgalactosamine-6-sulfatase (GALNS) enzyme, which impairs lysosomal degradation of keratan sulphate and chondroitin-6-sulphate. The multiple clinical manifestations of MPS IVA present numerous challenges for management and necessitate the need for individualised treatment. Although treatment guidelines are available, the methodology used to develop this guidance has come under increased scrutiny. This programme was conducted to provide evidence-based, expert-agreed recommendations to optimise management of MPS IVA.MethodsTwenty six international healthcare professionals across multiple disciplines, with expertise in managing MPS IVA, and three patient advocates formed the Steering Committee (SC) and contributed to the development of this guidance. Representatives from six Patient Advocacy Groups (PAGs) were interviewed to gain insights on patient perspectives. A modified-Delphi methodology was used to demonstrate consensus among a wider group of healthcare professionals with experience managing patients with MPS IVA and the manuscript was evaluated against the validated Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument by three independent reviewers.ResultsA total of 87 guidance statements were developed covering five domains: (1) general management principles; (2) recommended routine monitoring and assessments; (3) disease-modifying interventions (enzyme replacement therapy [ERT] and haematopoietic stem cell transplantation [HSCT]); (4) interventions to support respiratory and sleep disorders; (5) anaesthetics and surgical interventions (including spinal, limb, ophthalmic, cardio-thoracic and ear-nose-throat [ENT] surgeries). Consensus was reached on all statements after two rounds of voting. The overall guideline AGREE II assessment score obtained for the development of the guidance was 5.3/7 (where 1 represents the lowest quality and 7 represents the highest quality of guidance).ConclusionThis manuscript provides evidence- and consensus-based recommendations for the management of patients with MPS IVA and is for use by healthcare professionals that manage the holistic care of patients with the intention to improve clinical- and patient-reported outcomes and enhance patient quality of life. It is recognised that the guidance provided represents a point in time and further research is required to address current knowledge and evidence gaps.
| S-EPMC6567385 | biostudies-literature