Patient characteristics of, and remedial interventions for, complaints and medico-legal claims against doctors: a rapid review of the literature.

BACKGROUND: It is uncertain if patient's characteristics are associated with complaints and claims against doctors. Additionally, evidence for the effectiveness of remedial interventions on rates of complaints and claims against doctors has not been synthesised. METHODS: We conducted a rapid review of recent literature to answer: Question 1 "What are the common characteristics and circumstances of patients who are most likely to complain or bring a claim about the care they have received from a doctor?" and Question 2 "What initiatives or interventions have been shown to be effective at reducing complaints and claims about the care patients have received from a doctor?". We used a systematic search (most recently in July 2023) of PubMed, Scopus, Web of Science and grey literature. Studies were screened against inclusion criteria and critically appraised in duplicate using standard tools. Results were summarised using narrative synthesis. RESULTS: From 8079 search results, we reviewed the full text of 250 studies. We included 25 studies: seven for Question 1 (6 comparative studies with controls and one systematic review) and 18 studies for Question 2 (14 uncontrolled pre-post studies, 2 comparative studies with controls and 2 systematic reviews). Most studies were set in hospitals across a mix of medical specialties. Other than for patients with mental health conditions (two studies), no other patient characteristics demonstrated either a strong or consistent effect on the rate of complaints or claims against their treating doctors. Risk management programs (6 studies), and communication and resolution programs (5 studies) were the most studied of 6 intervention types. Evidence for reducing complaints and medico-legal claims, costs or premiums and more timely management was apparent for both types of programs. Only 1 to 3 studies were included for peer programs, medical remediation, shared decision-making, simulation training and continuing professional development, with few generalisable results. CONCLUSION: Few patient characteristics can be reliably related to the likelihood of medico-legal complaints or claims. There is some evidence that interventions can reduce the number and costs of claims, the number of complaints, and the timeliness of claims. However, across both questions, the strength of the evidence is very weak and is based on only a few studies or study designs that are highly prone to bias.

Insights from a single centre implementation of a digitally-enabled atrial fibrillation virtual ward.

Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and poses a significant public health burden. Virtual wards are a novel approach utilising digital solutions to provide hospital-level care remotely; their rollout has become a key priority for the UK National Health Service to expand acute care capacity. We devised and implemented a digitally-enabled AF virtual ward to monitor patients being established onto medical therapy following an AF diagnosis or an AF-related hospitalisation. Patients were onboarded either as outpatients to avoid admission or on discharge after an acute AF hospitalisation. Remote monitoring was undertaken using a clinically validated photoplethysmography-based smartphone app. Over a 1-2 week period, patients performed twice daily measurements of heart rate and rhythm and provided corresponding symptoms. A traffic light system guided frequency of telephone assessments by specialist practitioners. Red flag symptoms or abnormal heart rate parameters prompted an urgent care escalation. We report our experience of the first 73 patients onboarded to the AF virtual ward from October 2022 to June 2023 (mean age 65 years, median 68 years, IQR range 27-101 years; 33 females). Thirty-nine (53%) patients had red flag features requiring care escalation, of whom 9 (23%) were advised to attend ED (emergency department) for urgent assessment, 10 (26%) attended for expedited review and 14 (36%) required medication changes. By 3 months post-monitoring, only 3 patients (4%) had re-attended ED with an arrhythmia-related presentation. Virtual ward patients had an average 3-day shorter inpatient stay (mean duration 4 days) compared with AF patients hospitalised prior to virtual ward implementation (mean duration 7 days). Overall, 22 arrhythmia-related readmissions were prevented via the virtual ward model. In this study, we present a novel implementation of a digitally-enabled virtual ward for the acute management of patients with newly diagnosed or poorly controlled AF. Our pilot data indicate that this model is feasible and is potentially cost-effective. Further longitudinal study is needed to definitively evaluate long-term clinical utility and safety.

Factors associated with radiological misstaging of pancreatic ductal adenocarcinoma: A retrospective observational study.

PURPOSE: Accurate staging of disease is vital in determining appropriate care for patients with pancreatic ductal adenocarcinoma (PDAC). It has been shown that the quality of scans and the experience of a radiologist can impact computed tomography (CT) based assessment of disease. The aim of the current study was to evaluate the impact of the rereading of outside hospital (OH) CT by an expert radiologist and a repeat pancreatic protocol CT (PPCT) on staging of disease. METHODS: Patients evaluated at the our institute's pancreatic multidisciplinary clinic (2006 to 2014) with OH scan and repeat PPCT performed within 30 days were included. In-house radiologists staged disease using OH scans and repeat PPCT, and factors associated with misstaging were determined. RESULTS: The study included 100 patients, with a median time between OH scan and PPCT of 19 days (IQR: 13-23 days.) Stage migration was mostly accounted for by upstaging of disease (58.8 % to 83.3 %) in all comparison groups. When OH scans were rereviewed, 21.5 % of the misstaging was due to missed metastases, however, when rereads were compared to the PPCT, occult metastases accounted for the majority of misstaged patients (62.5 %). Potential factors associated with misstaging were primarily related to imaging technique. CONCLUSION: A repeat PPCT results in increased detection of metastatic disease that rereviews of OH scans may otherwise miss. Accessible insurance coverage for repeat PPCT imaging even within 30 days of an OH scan could help optimize delivery of care and alleviate burdens associated with misstaging.

Community health navigator-assisted transition of care from hospital to community: protocol for a randomised controlled trial.

INTRODUCTION: The objective of this parallel group, randomised controlled trial is to evaluate a community health navigator (CHN) intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes. Unplanned hospital readmissions are costly for the health system and negatively impact patients. METHODS AND ANALYSIS: Patients are randomised post hospital discharge to the CHN intervention or usual care. A comparison of outcomes between intervention and control groups will use multivariate regression techniques that adjust for age, sex and any independent variables that are significantly different between the two groups, using multiple imputation for missing values. Time-to-event analysis will examine the relationship between seeing a CHN following discharge from the index hospitalisation and reduced rehospitalisations in the subsequent 60 days and 6 months. Secondary outcomes include medication adherence, health literacy, quality of life, experience of healthcare and health service use (including the cost of care). We will also conduct a qualitative assessment of the implementation of the navigator role from the viewpoint of stakeholders including patients, health professionals and the navigators themselves. ETHICS APPROVAL: Ethics approval was obtained from the Research Ethics and Governance Office, Sydney Local Health District, on 21 January 2022 (Protocol no. X21-0438 and 2021/ETH12171). The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations. Data will be deposited in an institutional data repository at the end of the trial. This is subject to Ethics Committee approval, and the metadata will be made available on request. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN 12622000659707). ARTICLE SUMMARY: The objective of this trial is to evaluate a CHN intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes.

A case of mosaic deletion of paternally-inherited PLAGL1 and two cases of upd(6)mat add to evidence for PLAGL1 under-expression as a cause of growth restriction.

PLAGL1 is one of a group of imprinted genes, whose altered expression causes imprinting disorders impacting growth, development, metabolism, and behavior. PLAGL1 over-expression causes transient neonatal diabetes mellitus (TNDM type 1) and, based on murine models, under-expression would be expected to cause growth restriction. However, only some reported individuals with upd(6)mat have growth restriction, giving rise to uncertainty about the role of PLAGL1 in human growth. Here we report three individuals investigated for growth restriction, two with upd(6)mat and one with a mosaic deletion of the paternally-inherited allele of PLAGL1. These cases add to evidence of its involvement in pre- and early post-natal human growth.

[Planning, Reflecting and Evaluating Participatory Health Research: Adaptation and Piloting of the "Community Based Participatory Research (CBPR) Model" for German-Speaking Countries]. / Partizipative Gesundheitsforschung planen, reflektieren und evaluieren: Die Adaption und Erprobung des "Community Based Participatory Research (CBPR) Model" für den deutschsprachigen Raum.

Participatory research approaches are becoming increasingly established in both academic and practice settings. The participation of people with varied lived experiences and professional backgrounds can help academia and practitioners to learn from and empower each other. In the exchange of different perspectives, needs and ideas, it is possible to plan, reflect on, implement and evaluate projects in the health sector jointly and with attention to the needs of all stakeholders. The Community Based Participatory Research (CBPR) Model is often used internationally to guide participatory processes. However, an accessible translation has been lacking for application in German-speaking countries. To address this problem, a multidisciplinary working group composed of academic researchers and practitioners came together within the German-speaking Participatory Health Research Network (PartNet) to adapt the CBPR model for German-speaking countries and to test the adapted version with potential users. The adaptation was more than a translation, as the four model components "Contexts", "Partnership Processes", "Intervention & Research" and "Outcomes" as well as their associated contents are not directly applicable to the socio-structural and political contexts of the German-speaking countries. This article describes the process of adapting the model. This includes how translation drafts for German-speaking countries were first discussed in detail and then agreed upon as an initial template for testing in practice. Subsequently, various users reflected on the German-language model based on their experience of testing it in different projects, focusing on accuracy, comprehensibility and applicability. At the same time, the model was presented and discussed at conferences. The diverse feedback was incorporated into further revisions of the model. The result is a German-language version called "Modell für partizipative Gesundheitsforschung (PGF-Modell)".

Discovery of ginisortamab, a potent and novel anti-gremlin-1 antibody in clinical development for the treatment of cancer.

Gremlin-1, a high-affinity antagonist of bone morphogenetic proteins (BMP)-2, -4, and -7, is implicated in tumor initiation and progression. Increased gremlin-1 expression, and therefore suppressed BMP signaling, correlates with poor prognosis in a range of cancer types. A lack of published work using therapeutic modalities has precluded the testing of the hypothesis that blocking the gremlin-1/BMP interaction will provide benefits to patients. To address this shortfall, we developed ginisortamab (UCB6114), a first-in-class clinical anti-human gremlin-1 antibody, currently in clinical development for the treatment of cancer, along with its murine analog antibody Ab7326 mouse immunoglobulin G1 (mIgG1). Surface plasmon resonance assays revealed that ginisortamab and Ab7326 mIgG1 had similar affinities for human and mouse gremlin-1, with mean equilibrium dissociation constants of 87 pM and 61 pM, respectively. The gremlin-1/Ab7326 antigen-binding fragment (Fab) crystal structure revealed a gremlin-1 dimer with a Fab molecule bound to each monomer that blocked BMP binding. In cell culture experiments, ginisortamab fully blocked the activity of recombinant human gremlin-1, and restored BMP signaling pathways in human colorectal cancer (CRC) cell lines. Furthermore, in a human CRC - fibroblast co-culture system where gremlin-1 is produced by the fibroblasts, ginisortamab restored BMP signaling in both the CRC cells and fibroblasts, demonstrating its activity in a relevant human tumor microenvironment model. The safety and efficacy of ginisortamab are currently being evaluated in a Phase 1/2 clinical trial in patients with advanced solid tumors (NCT04393298).

Balancing care and responsibility: The role of the general practitioner in specialist referrals.

BACKGROUND: Referrals are a critical component of the Australian healthcare system, with referrals from general practitioners (GPs) to non-GP specialists making up the majority of medical referrals. Given the key role referrals have in primary healthcare, it is important that GPs understand their legal and professional responsibilities when providing a referral and ensure they refer appropriately and effectively to provide the best health outcomes for patients. OBJECTIVE: This article explores GP referrals to other health professionals and aims to describe a doctor's medicolegal obligations and responsibilities when making a referral. DISCUSSION: The responsibility of GPs in the referral process reflects their central coordinating role as providers of primary care, and the reliance patients place upon them to advise and recommend treatment and investigations. Understanding the medicolegal obligations and responsibilities when writing a referral can help GPs find the right balance between respecting patient autonomy and the professional obligation to take reasonable steps to ensure referrals and investigations are acted upon appropriately. The key to an effective referral process is clear communication between practitioners and patients, to help align the expectations of all involved so they can agree and implement a shared treatment plan in the interests of the patient.

Managing patient complaints to improve your practice.

BACKGROUND: Increasing numbers of patient complaints to regulators suggest practices need effective systems to manage and address patient concerns. Many patient complaints can often be dealt with at a practice level, but patients can have difficulty reporting negative experiences directly. OBJECTIVE: This article explores the benefits of having a system to accept and deal with patient feedback within a practice and identifies barriers preventing patients from raising their concerns directly. DISCUSSION: Managing patient complaints well at a practice level can prevent them escalating, as well as offering insights to reduce risk and improve patient care. Understanding factors that inhibit patients from raising concerns, or prevent staff from being able to accept and deal with complaints, allows an opportunity for practices to implement strategies to address these barriers and support patients and staff. Effective strategies include process improvements, as well as cultural changes and support for those managing a complaint process.

Optimal binary gratings for multi-wavelength magneto-optical traps.

Grating magneto-optical traps are an enabling quantum technology for portable metrological devices with ultracold atoms. However, beam diffraction efficiency and angle are affected by wavelength, creating a single-optic design challenge for laser cooling in two stages at two distinct wavelengths - as commonly used for loading, e.g., Sr or Yb atoms into optical lattice or tweezer clocks. Here, we optically characterize a wide variety of binary gratings at different wavelengths to find a simple empirical fit to experimental grating diffraction efficiency data in terms of dimensionless etch depth and period for various duty cycles. The model avoids complex 3D light-grating surface calculations, yet still yields results accurate to a few percent across a broad range of parameters. Gratings optimized for two (or more) wavelengths can now be designed in an informed manner suitable for a wide class of atomic species enabling advanced quantum technologies.

Clinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised controlled trial protocol.

INTRODUCTION: Low back pain (LBP) is commonly treated with opioid analgesics despite evidence that these medicines provide minimal or no benefit for LBP and have an established profile of harms. International guidelines discourage or urge caution with the use of opioids for back pain; however, doctors and patients lack practical strategies to help them implement the guidelines. This trial will evaluate a multifaceted intervention to support general practitioners (GPs) and their patients with LBP implement the recommendations in the latest opioid prescribing guidelines. METHODS AND ANALYSIS: This is a cluster randomised controlled trial that will evaluate the effect of educational outreach visits to GPs promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids, on GP prescribing of opioids medicines dispensed. At least 40 general practices will be randomised in a 1:1 ratio to either the intervention or control (no outreach visits; GP provides usual care). A total of 410 patient-participants (205 in each arm) who have been prescribed an opioid for LBP will be enrolled via participating general practices. Follow-up of patient-participants will occur over a 1-year period. The primary outcome will be the cumulative dose of opioid dispensed that was prescribed by study GPs over 1 year from the enrolment visit (in morphine milligram equivalent dose). Secondary outcomes include prescription of opioid medicines, benzodiazepines, gabapentinoids, non-steroidal anti-inflammatory drugs by study GPs or any GP, health services utilisation and patient-reported outcomes such as pain, quality of life and adverse events. Analysis will be by intention to treat, with a health economics analysis also planned. ETHICS AND DISSEMINATION: The trial received ethics approval from The University of Sydney Human Research Ethics Committee (2022/511). The results will be disseminated via publications in journals, media and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12622001505796.

Bacterial second messenger cyclic di-AMP in streptococci.

Cyclic dimeric adenosine monophosphate (c-di-AMP) has been well studied in bacteria, including those of the genus Streptococcus, since the first recognition of this dinucleotide in 2008. Streptococci possess a sole diadenylate cyclase, CdaA, and distinct c-di-AMP phosphodiesterases. Interestingly, cdaA is required for viability of some streptococcal species but not all when streptococci are grown in standard laboratory media. Bacteria of this genus also have distinct c-di-AMP effector proteins, diverse c-di-AMP-signaling pathways, and subsequent biological outcomes. In streptococci, c-di-AMP may influence bacterial growth, morphology, biofilm formation, competence program, drug resistance, and bacterial pathogenesis. c-di-AMP secreted by streptococci has also been shown to interact with the mammalian host and induces immune responses including type I interferon production. In this review, we summarize the reported c-di-AMP networks in seven species of the genus Streptococcus, which cause diverse clinical manifestations, and propose future perspectives to investigate the signaling molecule in these streptococcal pathogens.

Accuracy of pharmacy student self-assessment of a single sterile compounding technique following didactic training.

INTRODUCTION: The primary objective was to determine pharmacy students' ability to self-assess sterile compounding technique in a single evaluation three semesters after training in the curriculum. METHODS: School of pharmacy (SOP) students were trained and assessed on sterile compounding technique during their second year of school, with no additional formal assessments provided later in the curriculum. From 2016 to 2018, 262 students were asked to compound a simulated sterile product in their third year of pharmacy school and self-evaluate their technique, which was compared to an instructor evaluation with both people using the same rubric. RESULTS: Two thresholds were used to define successful assessment: strict (ability to detect ideal technique) and lenient (ability to detect harmful technique). The average match rate was 70.2% and 87.6% in the strict and lenient analyses, respectively, with outcomes varying between categories. In the product preparation and inspecting product categories, students who disagreed with assessors tended to misidentify their incorrect technique as correct. CONCLUSIONS: Pharmacy students who assessed themselves on sterile compounding technique three semesters after formal sterile compounding training were able to accurately self-assess in most cases, but when disagreeing with an assessor, commonly identified their incorrect technique as correct. Most students demonstrated the ability to self-assess sterile compounding technique and are prepared to assess their own sterile compounding in practice. SOPs could consider whether sterile compounding training coupled with self-assessment throughout the curriculum would be beneficial to further improve students' sterile compounding ability and accuracy of self-assessment.

Diverse and vulnerable: experiences of private allied health practices managing through the coronavirus (COVID-19) pandemic. Implications for the financial viability of Australian primary care.

Background The majority of allied health services are delivered by small, private practices in the primary care setting with limited government funding. During the coronavirus disease 2019 (COVID-19) lockdowns these practices were subject to the same health orders as any other private business with only 'essential services' permitted to remain open. Research aim We set out to understand the impact of the COVID-19 pandemic, and associated public health measures, on the financial viability of private allied health practices. Methods Thirteen semi-structured interviews were conducted with primary care allied health practice owners and managers in Sydney. Data were analysed thematically. Findings All of the interviewees reported experiencing the stress of balancing precarious finances caused by reduced and/or fluctuating patient demand. Patients' reluctance to seek care was compounded by ambiguity around whether allied health services were 'essential'. Manual therapies were particularly vulnerable to financial stress because their capacity to transition to telehealth and access to government funding were limited. Conversely, psychologists reported demand for their services exceeded what they could provide. Study implications The findings are indicative of primary care allied health's peripheral status in Australia's primary care landscape. Greater priority to the funding and integration of primary care allied health is needed in primary care policy.

Models of KPTN-related disorder implicate mTOR signalling in cognitive and overgrowth phenotypes.

KPTN-related disorder is an autosomal recessive disorder associated with germline variants in KPTN (previously known as kaptin), a component of the mTOR regulatory complex KICSTOR. To gain further insights into the pathogenesis of KPTN-related disorder, we analysed mouse knockout and human stem cell KPTN loss-of-function models. Kptn -/- mice display many of the key KPTN-related disorder phenotypes, including brain overgrowth, behavioural abnormalities, and cognitive deficits. By assessment of affected individuals, we have identified widespread cognitive deficits (n = 6) and postnatal onset of brain overgrowth (n = 19). By analysing head size data from their parents (n = 24), we have identified a previously unrecognized KPTN dosage-sensitivity, resulting in increased head circumference in heterozygous carriers of pathogenic KPTN variants. Molecular and structural analysis of Kptn-/- mice revealed pathological changes, including differences in brain size, shape and cell numbers primarily due to abnormal postnatal brain development. Both the mouse and differentiated induced pluripotent stem cell models of the disorder display transcriptional and biochemical evidence for altered mTOR pathway signalling, supporting the role of KPTN in regulating mTORC1. By treatment in our KPTN mouse model, we found that the increased mTOR signalling downstream of KPTN is rapamycin sensitive, highlighting possible therapeutic avenues with currently available mTOR inhibitors. These findings place KPTN-related disorder in the broader group of mTORC1-related disorders affecting brain structure, cognitive function and network integrity.

"Ngany Kamam, I Speak Truly": First-Person Accounts of Aboriginal Youth Voices in Mental Health Service Reform.

Aboriginal young people are experts in their own experience and are best placed to identify the solutions to their mental health and wellbeing needs. Given that Aboriginal young people experience high rates of mental health concerns and are less likely than non-Indigenous young people to access mental health services, co-design and evaluation of appropriate mental health care is a priority. Increasing Aboriginal young people's participation in mental health service reform is key to ensuring services are culturally secure, relevant and accessible. This paper presents first-person accounts from three Aboriginal young people who worked alongside their Elders and in a positive and constructive partnership with mainstream mental health services on a three-year participatory action research project in Perth, Western Australia, in Whadjuk Nyoongar boodja (Country). The young people recount their experiences as participants and co-researchers on a systems change mental health research project and share their views on the importance of privileging Aboriginal youth voices. Their accounts highlight that Aboriginal young people's participation and leadership must be understood through a decolonising lens and that working in genuine partnership with the community is key to increasing their contact and engagement with mental health care and improving mental health and wellbeing outcomes.

Does It par-Tickle?: Investigating the Relationship Between Mid-Air Haptics and Visual Representations of Surface Textures.

Mid-air haptic feedback technology produces tactile sensations that are felt without the need for physical interactions. However, mid-air haptic experiences need to be congruent with visual cues to reflect user expectations. To overcome this, we investigate how to visually present properties of objects, so that what one feels is a more accurate prediction of what one sees. Specifically, this paper investigates the relationship between 8 visual parameters of a point-cloud representation of a surface (particle color, size, distribution, etc.) and 4 mid-air haptic spatial modulation frequencies (20, 40, 60 and 80 Hz). Our results and analysis reveal a statistical significance between low and high-frequency modulations and particle density, particle bumpiness (depth) and particle arrangement (randomness).

Successional dynamics of the cultivated kelp microbiome.

Kelp are important primary producers that are colonized by diverse microbes that can have both positive and negative effects on their hosts. The kelp microbiome could support the burgeoning kelp cultivation sector by improving host growth, stress tolerance, and resistance to disease. Fundamental questions about the cultivated kelp microbiome still need to be addressed before microbiome-based approaches can be developed. A critical knowledge gap is how cultivated kelp microbiomes change as hosts grow, particularly following outplanting to sites that vary in abiotic conditions and microbial source pools. In this study we assessed if microbes that colonize kelp in the nursery stage persist after outplanting. We characterized microbiome succession over time on two species of kelp, Alaria marginata and Saccharina latissima, outplanted to open ocean cultivation sites in multiple geographic locations. We tested for host-species specificity of the microbiome and the effect of different abiotic conditions and microbial source pools on kelp microbiome stability during the cultivation process. We found the microbiome of kelp in the nursery is distinct from that of outplanted kelp. Few bacteria persisted on kelp following outplanting. Instead, we identified significant microbiome differences correlated with host species and microbial source pools at each cultivation site. Microbiome variation related to sampling month also indicates that seasonality in host and/or abiotic factors may influence temporal succession and microbiome turnover in cultivated kelps. This study provides a baseline understanding of microbiome dynamics during kelp cultivation and highlights research needs for applying microbiome manipulation to kelp cultivation.