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Collaborative risk assessment and management planning in secure mental health services in England: protocol for a realist review.

INTRODUCTION: Secure mental health pathways are complex. They are typically based around secure hospitals, but also interface with justice agencies and other clinical services, including in the community. Consideration of risk is fundamental to clinical care and to decisions relating to a patient's stepwise journey through the pathway. Patient autonomy and involvement in decision-making are policy priorities for health services. However, improving collaboration in risk-related decisions in secure services is complicated by potential issues with insight and capacity and the necessary involvement of other agencies. In addition, although some collaborative approaches are feasible and effective, their impact, mechanisms and the contexts in which they work are not well understood. Therefore, using realist methodology, this review will outline what works, for whom, why and under what circumstances in terms of collaborative risk assessment and management in secure services. METHODS AND ANALYSIS: The review will consist of four stages: (1) Development of an initial programme theory to explain how and why collaborative risk assessment and management works for different groups of people, (2) search for evidence, (3) data selection and extraction and (4) evidence synthesis and development of a final programme theory. Our initial programme theory will be informed by an informal search of the literature and consultation with experts and patient and public involvement and engagement representatives. Following this, our formal literature search will include both the published and unpublished literature. During full text screening, each document will be assessed according to the principles of rigour and relevance and, if included, data will be extracted and synthesised to refine the programme theory. ETHICS AND DISSEMINATION: This protocol is for a review of published literature and so does not require ethical approval. The main output will be the final programme theory. Remaining gaps will inform planned future work to further refine the theory using mixed methods. Our dissemination strategy will be codeveloped with our public and patient involvement group and will include publishing findings in a peer-reviewed journal and presenting findings at relevant professional conferences, as well as engaging patient, carer and clinician groups directly.

Enhancing learning from evaluations in newborn and child health.

Social demographics and clinical characteristics of referred adult mental health patients to an Australian secure extended care unit: A 5-year retrospective study

The importance of experience: insights into optimal home-blood pressure monitoring regimens from the TASMINH4 Trial.

OBJECTIVES: This study investigates how prior home blood pressure monitoring (HBPM) experience affects blood pressure variability and evaluates if reduced HBPM regimens could be recommended for experienced patients. METHODS: This posthoc analysis of the TASMINH4 trial included self-monitored blood pressure (BP) data from 225 patients. The standard deviation of systolic BP recordings was calculated for each patient-week to assess how BP variability changes with HBPM duration. A subgroup of 84 patients, who submitted at least 1 reading a day for 7 days at months 1, 3, and 6, was analysed to assess the impact of reduced HBPM regimens on BP estimates. RESULTS: Day 1 readings were significantly higher than day 2-7 in the first 3 months of HBPM: 1.1 (95% CI 1.8, 0.4) day 1 vs. day 2. This effect diminished after 6 months: 1.0 (95% CI -0.8, 2.8) day 1 vs. 2. Long term monitoring significantly reduced intra-week BP variability, with the standard deviation of systolic BP recordings within each patient-week significantly reduced after 6 months. After 6 months of HBPM, the inclusion of day 1 readings or use of an abbreviated monitoring regimen had a reduced impact on estimates of mean systolic and diastolic blood pressure. CONCLUSIONS: Long-term HBPM reduces intra-week BP variability, making day 1 readings insignificantly raised after 6 months of HBPM. This provides rationale for different HBPM recommendations: longer regimes, excluding day one readings, for diagnosis and short-term monitoring; and abbreviated regimes including day 1 for longer term monitoring in those with HBPM experience.

The value of mental science: we publish what matters.

Recent changes to US research funding are having far-reaching consequences that imperil the integrity of science and the provision of care to vulnerable populations. Resisting these changes, the BJPsych Portfolio reaffirms its commitment to publishing mental science and advancing psychiatric knowledge that improves the mental health of one and all.

Mechanisms through which exercise reduces symptom severity and/or functional impairment in posttraumatic stress disorder (PTSD): Protocol for a living systematic review of human and non-human studies.

BACKGROUND: Exercise can play an important role in reducing symptom severity and improving functional impairment in patients with posttraumatic stress disorder (PTSD). However, the precise mechanisms underpinning the effect of exercise in PTSD management are not fully understood. This living systematic review aims to synthesize and triangulate the evidence from non-human and human studies to gain insight into the biopsychosocial mechanisms through which exercise reduces symptom severity and functional impairment. METHODS: Independent searches will be conducted in electronic databases to identify eligible studies. Two reviewers will independently conduct the study selection, data extraction, and risk of bias assessment. We will extract outcome data and variables that can act as effect modifiers or as mediators of the effect of exercise. For the non-human studies, outcome data will include the non-human equivalents of PTSD symptom clusters. For human studies, the primary outcome will be PTSD symptom severity. The secondary outcomes will be avoidance symptom severity, reexperiencing symptom severity, hyperarousal symptom severity, negative cognitions and mood severity, functional impairment, loss of PTSD diagnosis, and dropout rates.To explain the biopsychosocial mechanisms through which exercise affects the outcome of interest, we will extract effects that relate to the impact of exercise on potential mediating variables and the effect of the later outcomes. Comparison of within-study direct and indirect effects obtained from mediation analysis, when reported, will provide insight into the importance of the examined mediator.If appropriate, we will synthesize study results using meta-analyses. We will examine potential effect modifiers of the total exercise effect to understand better the impact of exercise on PTSD symptoms and function impairment (when possible). The evidence about the potential mediators of the association between exercise and PTSD-related outcomes will be considered in a consensus meeting when sufficient evidence is available. PROTOCOL REGISTRATION: PROSPERO-ID: 453615.

A Cluster Randomized Controlled Trial of Social Workers in Schools (SWIS) in England

Purpose: “Social Workers in Schools” (SWIS) is a school-based intervention aiming to reduce the need for children to receive child protection services in England. This article reports the findings of a randomized controlled trial (RCT) designed to evaluate SWIS. Method: The study was a two-arm pragmatic cluster RCT with an embedded process and economic evaluation. The intervention physically located social workers within schools. The primary outcome was the rate of child protection inquiries and secondary outcomes included care entry and educational outcomes. Results: 278,858 students in 268 schools were randomized to the intervention (136 schools) or control arm (132 schools). We found no statistically significant effects on primary or secondary outcomes. SWIS was implemented well and positively perceived. Discussion: SWIS appears ineffective in reducing the need for statutory services. The study demonstrates it is possible to conduct a large-scale school-based social work RCT. The study was registered at https://www.isrctn.com/, ref: ISRCTN90922032.

Heart failure and major haemorrhage in people with atrial fibrillation

Developing prediction models for electrolyte abnormalities in patients indicated for antihypertensive therapy: evidence-based treatment and monitoring recommendations.

OBJECTIVES: Evidence from clinical trials suggests that antihypertensive treatment is associated with an increased risk of common electrolyte abnormalities. We aimed to develop and validate two clinical prediction models to estimate the risk of hyperkalaemia and hyponatraemia, respectively, to facilitate targeted treatment and monitoring strategies for individuals indicated for antihypertensive therapy. DESIGN AND METHODS: Participants aged at least 40 years, registered to an English primary care practice within the Clinical Practice Research Datalink (CPRD), with a systolic blood pressure reading between 130 and 179 mmHg were included the study. The primary outcomes were first hyperkalaemia or hyponatraemia event recorded in primary or secondary care. Model development used a Fine-Gray approach with death from other causes as competing event. Model performance was assessed using C-statistic, D-statistic, and Observed/Expected (O/E) ratio upon external validation. RESULTS: The development cohort included 1 773 224 patients (mean age 59 years, median follow-up 6 years). The hyperkalaemia model contained 23 predictors and the hyponatraemia model contained 29 predictors, with all antihypertensive medications associated with the outcomes. Upon external validation in a cohort of 3 805 366 patients, both models calibrated well (O/E ratio: hyperkalaemia 1.16, 95% CI 1.13-1.19; hyponatraemia 1.00, 95% CI 0.98-1.02) and showed good discrimination at 10 years (C-statistic: 0.69, 95% CI 0.69-0.69; 0.80, 95% CI 0.80-0.80, respectively). CONCLUSION: Current clinical guidelines recommend monitoring serum electrolytes after initiating antihypertensive treatment. These clinical prediction models predicted individuals' risk of electrolyte abnormalities associated with antihypertensive treatment and could be used to target closer monitoring for individuals at a higher risk, where resources are limited.

Development and external validation of a risk prediction score (DASHI) for cardiovascular events following acute respiratory infections: derivation and validation retrospective cohort study

Practitioners' views on the measurement and management of postural hypotension in general practice: a qualitative inquiry.

BACKGROUND: Postural hypotension (PH) is associated with cognitive decline, falls and allcause mortality, representing a substantial burden on the NHS. PH is often asymptomatic, making detection and treatment difficult. Currently, there is no systematic approach to measuring and managing PH in UK general practice. AIM: To explore barriers and facilitators to improving PH measurement and management. DESIGN AND SETTING: Qualitative interview study with healthcare practitioners in general practices in England. METHODS: We conducted individual, remote, semi-structured interviews with a range of healthcare practitioners (HCPs) who measure blood pressure (BP) in general practice, to explore their views and experiences of measuring and managing PH. Participants were identified from expressions of interest during a national survey. Interviews were video and audio-recorded, transcribed verbatim and analysed thematically. RESULTS: 26 HCPs in 24 practices across nine Clinical Research Networks in England were interviewed between March and July 2023. HCPs checked for PH when patients were older, reported dizziness, fatigue or had chronic conditions. Despite awareness of clinical guidelines, various diagnostic definitions were provided and measurement protocols varied between participants. Sit-to-stand rather than supine-to-stand measurements were considered more feasible due to time constraints and patient mobility. Education and training, as well as incentives and specialist clinics, were suggested as methods to improve PH measurement and management. CONCLUSIONS: This is the first study to explore barriers to, and facilitators of, PH measurement in English general practice. Findings suggest a more systematic approach to measurement is needed to improve detection and management of PH in general practice.

Screening for atrial fibrillation with or without general practice involvement: a controlled study.

BACKGROUND: There has been a drive to increase atrial fibrillation (AF) detection in general practice. However, one-off, opportunistic testing can miss paroxysmal AF and requires significant resource. Paroxysmal AF can be detected through screening that involves repeated ECGs over a period of time, although it is unclear whether screening would need to be led by general practice, and how much support participants require. We aimed to investigate whether AF screening can be delivered remotely by a centralised administration instead of general practice, and to determine the level of support required. METHODS: We undertook a controlled comparator study with secondary randomisation in three English general practices. We invited people aged ≥ 70 years to use a hand-held ECG device four times daily for three weeks. Participants were allocated to practice-led or administrator-led screening, with administrator-led support randomised to three different levels. We compared quantity and quality of ECGs obtained in each arm. The primary outcome was proportion of screened participants who recorded ≥ 56 adequate-quality ECGs (2/3 of possible ECGs). RESULTS: Of 288 screened participants, 59 participants received practice-led screening with a telephone consultation to explain the device. The remainder received administrator-led screening: 81 were automatically given a consultation; 74 were offered a consultation, and 74 were not offered a consultation. Most screened participants (280/288, 97.2%) recorded ≥ 56 adequate-quality ECGs. This proportion did not vary significantly between practice-led and administrator-led screening (100.0% vs. 98.8%), or between support levels (94.6% to 98.8%). Practice-led screening led to slightly more adequate-quality ECGs (mean: 83.9 vs 78.3, p 

Analysis of factors influencing tacrolimus levels and immunoassay bias in renal transplantation

The magnitude and time course of changes in mycophenolic acid 12-hour predose levels during antibiotic therapy in mycophenolate mofetil-based renal transplantation

There is increasing evidence that monitoring predose plasma levels of mycophenolic acid (MPA) is of benefit in renal transplant recipients treated with mycophenolate mofetil (MMF). Concomitant treatment with oral antibiotics leads to a 10% to 30% reduction in MPA area under the curve (AUC)0-12, probably by reducing enterohepatic recirculation (EHR). Because of the timing of EHR (6 to 12 hours postdose), the magnitude of predose MPA level reduction may be disproportionately larger than that of AUC0-12. However, changes in predose MPA levels and the time course over which these changes occur and resolve during antibiotic treatment have not been studied. The purpose of this study was to define the extent and time course of MPA predose level reduction during antibiotic therapy. A total of 64 MMF-treated renal transplant recipients (with tacrolimus cotherapy) were prospectively studied. Clinically indicated cotherapy with either oral ciprofloxacin or amoxicillin with clavulanic acid resulted in a reduction in 12 hour predose MPA level to 46% of baseline within 3 days of antibiotic commencement. No demographic or biochemical variables were associated with the magnitude of MPA level reduction. No further fall in MPA level was seen by day 7, but MPA levels recovered spontaneously to 79% of baseline after 14 days of antibiotics. Levels normalized within 3 days of antibiotic cessation. No changes in daily MMF dose (normalized for body weight) were made during antibiotic treatment. This data should help the clinician to recognize the extent of MPA predose level reduction during antibiotic therapy, and to avoid inappropriate MMF dose escalation and potential risk of toxicity. © 2007 Lippincott Williams & Wilkins, Inc.

Clinical outcomes of renal transplantation using liquid chromatographic monitoring of tacrolimus

It is suggested that specific methods of Tacrolimus monitoring rather than immunoassays which over-estimate Tacrolimus levels, should be used in transplant recipients. There is limited data, however, comparing clinical outcomes of renal transplantation using each of these techniques. In this study, 40 renal transplant recipients with Tacrolimus monitoring by Microparticle Enzyme Immunoassay (MEIA; target trough level 10-15 ng/ml) were compared with 40 patients monitored by High Performance Liquid Chromatography with Tandem Mass Spectrometry (HPLC-MS; target trough level 8-13 ng/ml). All received anti CD25 antibody induction and Mycophenolate Mofetil in a steroid sparing protocol. No demographic differences were seen between MEIA and HPLC-MS groups. All patients were followed for 6 months. Patient survival was 100% in both groups; graft survival was 100% in the MEIA group and 97.5% in the HPLC-MS group. The groups did not differ in the number of dose changes required in the first 6 months or in the number of patients displaying Tacrolimus levels within target range at three and six months. Delayed graft function occurred in 14 patients in the MEIA group and 12 patients in the HPLC-MS group (P=NS). Biopsy-proven acute rejection occurred in 4 patients in the MEIA group and 1 patient in the HPLC-MS group (P=0.17). Biopsy proven acute Tacrolimus nephrotoxicity occurred in 6 patients in the MEIA group, and 7 in the HPLC-MS group (P=NS). No difference was seen in serum creatinine or estimated creatinine clearance at 3 or 6 months. No difference between groups was seen in systolic or diastolic blood pressure, or total cholesterol at 3 or 6 months. 2 patients in the MEIA group developed CMV disease and 1 developed posttransplantation diabetes mellitus. CMV and posttransplantation diabetes were not seen in the HPLC-MS group. 2 patients in each group developed reversible tremor. This study suggests that renal transplantation with HPLC-MS monitoring of Tacrolimus is safe and effective. Copyright © 2006 by Lippincott Williams & Wilkins.

Mycophenolic acid 12-h trough level monitoring in renal transplantation: Association with acute rejection and toxicity

Studies of renal transplantation utilizing trough plasma level monitoring of mycophenolic acid (MPA) have shown inconsistent associations with toxicity and rejection. In this study, 5600 12-h trough MPA samples from 121 renal transplant recipients immunosuppressed with mycophenolate mofetil (MMF) and tacrolimus in a steroid sparing protocol (steroids for 7 days only) were sequentially analyzed. Higher MPA levels were associated with lower hemoglobin concentrations and anemia (hemoglobin <10 g/dL). Similarly, higher MPA levels were associated with lower total white cell counts and an increased incidence of leucopenia (total white cell count <4.0 × 109/L). Hypoalbuminemia and renal impairment were also associated with hemotoxicity. MMF-associated diarrhea and viral infection were associated with higher MPA levels. Conversely, biopsy-proven acute rejection within the first month post-transplantation was associated with lower MPA levels. Anti-CD25 antibody induction was also associated with reduced rejection rates. No association was seen between MPA levels and platelet count, thrombocytopenia or bacterial infection. An MPA level of 1.60 mg/L early post-transplantation best discriminated patients with and without rejection, and an MPA level of 2.75 mg/L best discriminated patients with and without toxicity later post-transplantation. © 2005 The American Society of Transplantation and the American Society of Transplant Surgeons.

Determinants of mycophenolic acid levels after renal transplantation

There are data suggesting an association between mycophenolic acid (MPA) levels and acute rejection and toxicity in renal transplant recipients treated with mycophenolate mofetil (MMF), and therefore, knowledge of factors determining MPA levels may aid in accurate adjustment of MMF dosage. A total of 4970 samples taken 12 hours postdose were analyzed for MPA by immunoassay at regular intervals from the first week posttransplantation in 117 renal transplant patients immunosuppressed with MMF and tacrolimus in a steroid-sparing regimen (prednisolone for the first 7 days only). MPA levels rose in the first 3 months and stabilized thereafter; dose-normalized MPA levels rose throughout the first 12 months and subsequently stabilized. Multivariate analysis by means of a population-averaged linear regression showed positive associations between MPA level and total daily dose (P < 0.001) but not individual dose or total daily dose corrected for body weight. Positive associations were also seen with serum albumin (P = 0.01), tacrolimus trough level (P = 0.01), and female gender (P = 0.002). The association with tacrolimus levels diminished with time. Negative associations were seen between MPA level and higher estimated creatinine clearance (P < 0.001), and also with increasing alanine transaminase levels (P = 0.002), the use of oral antibiotics (P < 0.001), and infective diarrhea (P < 0.001). The latter findings may be related to changes in enterohepatic recirculation of MPA. Many clinical variables show associations with trough MPA levels. An understanding of these factors may aid therapeutic monitoring of MMF. Copyright © 2005 by Lippincott Williams & Wilkins.

Preferences for multi-cancer tests (MCTs) in primary care: discrete choice experiments of general practitioners and the general public in England.

BACKGROUND: Multi-Cancer tests (MCTs) hold potential to detect cancer across multiple sites and some predict the origin of the cancer signal. Understanding stakeholder preferences for MCTs could help to develop appealing MCTs, encouraging their adoption. METHODS: Discrete Choice Experiments (DCEs) conducted online in England. RESULTS: GPs (n = 251) and the general public (n = 1005) preferred MCTs that maximised negative predictive value, positive predictive value, and could test for a larger number of cancer sites. A reduction of the NPV of 4.0% was balanced by a 12.5% increase in the PPV for people and a 32.5% increase in PPV for GPs. People from ethnic minority backgrounds placed less importance on whether MCTs can detect multiple cancers. People with more knowledge and experience of cancer placed substantial importance on the MCT being able to detect cancer at an early stage. Both GPs and members of the public preferred the MCT reported in the SYMPLIFY study to FIT, PSA, and CA125, and preferred the SYMPLIFY MCT to 91% (GPs) and 95% (people) of 2048 simulated MCTs. CONCLUSIONS: These findings provide a basis for designing clinical implementation strategies for MCTs, according to their performance characteristics.

A prospective study of risk factors and new prediction model for inpatient aggression in a Turkish forensic psychiatric cohort with psychotic illness

Background: Aggression among psychiatric inpatients causes harm and disrupts care. While often linked to modifiable risk factors, their role remains unclear, and many prediction tools overlook them. This study aimed to assess the relationship between risk factors and inpatient aggression among forensic patients with psychotic disorders in Turkiye and to develop a population-specific prediction model. Methods: Eight static and ten dynamic risk factors were assessed. Dynamic factors were collected fortnightly, with the outcome defined as any physical or verbal aggression between assessment rounds. Multilevel logistic regression analyses assessed the association between dynamic risk factors and outcomes. A new population-specific prediction model was developed by refitting the previously developed elsewhere (FOxWeb). Models incorporating fixed effects were used to assess predictive performance. Results: Over four months, 102 forensic psychiatric inpatients underwent 811 dynamic risk assessments, with 603 aggressive incidents recorded. Forty-two patients were involved in at least one incident. Many dynamic factors were significantly associated with outcomes in both univariable and multivariable analyses. The total dynamic score was a significant predictor, improving the discrimination of the fixed-effects model (AUC = 0.84, 95 % CI: 0.81–0.87) compared to the model using static factors alone (AUC=0.73, 95 % CI: 0.69–0.77). Conclusion: Combining dynamic and static factors in the prediction model showed strong performance for assessing aggression risk. Refitting existing prediction models to specific populations may offer enhanced performance, but this requires external validation in independent samples as development models may be overfitted. Highly quality predicative models could enhance interventions, optimize resource use, and improve clinical decision-making.

What do people do in the aftermath of healthcare-related harm? A qualitative study on experiences and factors influencing decision-making.

OBJECTIVES: To capture experiences of people self-reporting harm and contrast responses and actions between those who do or do not take formal action. DESIGN: Semi-structured qualitative interview study. SETTING: People self-reporting harm experienced in the National Health Service (NHS) or their family/friends identified from a general Great British population survey. PARTICIPANTS: 49 participants. RESULTS: There were commonalities in experiences after harm whether formal action (including making a formal complaint or litigation) was taken or not. Many participants reported raising concerns informally with NHS staff, trying to access explanations or support, but were usually unsuccessful. Decision-making on action was complex. There were multiple reasons for not pursuing formal action, including fears of damaging relationships with clinicians, being occupied coping with the consequences of the harm or not wanting to take action against the NHS. NHS advocacy services were not regarded as helpful. Knowledge of how to proceed and feeling entitled to do so, along with proactive social networks, could facilitate action, but often only after people were spurred on by anger and frustration about not receiving an explanation, apology or support for recovery from the NHS. Those from marginalised groups were more likely to feel disempowered to act or be discouraged by family or social contacts, which could lead to self-distancing and reduced trust in services. CONCLUSIONS: People actively seek resolution and recovery after harm but often face multiple barriers in having their needs for explanations, apologies and support addressed. Open and compassionate engagement, especially with those from more marginalised communities, plus tailored support to address needs, could promote recovery, decrease compounded harm and reduce use of grievance services where other provision may be more helpful.