Abstract Objective Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis health outcomes have improved. This paper evaluates the costs and the health-related quality of life implications of these guidelines. Design and setting A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015. Study participants Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months. Primary and secondary outcome measures Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS), and the EuroQoL; health care costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life years (QALYs) were calculated from the EQ-5D utility scores. Cost-utility analysis was performed using the NHS and Social Scare perspective. Results A total of 49 patients were included, 35 treated within 48 hours “early” (median [IQR] 8.25 [3.7-20.5]) and 14 treated after 48 hours (median [IQR] 93.9 [66.7 - 100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared to 4 (29%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p<0.000). After adjusting for age and symptom duration at admission, early treatment incurred a lower average cost at discharge, £23,086 (95% CI: £15,186 to £30,987) vs £42,405 (95% CI: £25,457 to £59,354) [p<0.04]. A -£20,218 (95% CI: -£52,173 to £11,783) cost difference was observed at 12-month follow-up post discharge. Conclusions This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment. Article Summary Strengths and limitations of this study - Admissions to acute hospitals with suspected encephalitis, using predetermined inclusion criteria were recruited across 29 hospitals in the UK within a 3-year period, giving the largest cohort of prospectively recruited HSV encephalitis cases in the UK to date. - Precise definitions to characterise those individuals with proven HSV encephalitis were applied thus ensuring accurate diagnoses. - Individuals were followed up systematically for 12 months after discharge for clinical, and quality of life data providing the first study to assess the effect of treatment delays on health care resources, costs and health related quality of life. - The analysis is limited by its relatively small sample size due to it being a rare disease, and the case record forms although thorough may not capture all health care costs incurred. This is particularly so for primary care and community care contact outside of the study hospitals.
Anaemia is a common side effect of cancer treatments and can lead to a reduction in quality of life. Erythropoiesis-stimulating agents (ESAs) are licensed for use in conjunction with red blood cell transfusions to improve cancer treatment-induced anaemia (CIA). To investigate the effectiveness and cost-effectiveness of ESAs in anaemia associated with cancer treatment (specifically chemotherapy). The following databases were searched from 2004 to 2013: The Cochrane Library, MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Web of Science, Cumulative Index to Nursing and Allied Health Literature, British Nursing Index, Health Management Information Consortium, Current Controlled Trials and ClinicalTrials.gov. The US Food and Drug Administration and European Medicines Agency websites were also searched. Bibliographies of included papers were scrutinised for further potentially includable studies. The clinical effectiveness review followed principles published by the NHS Centre for Reviews and Dissemination. Randomised controlled trials (RCTs), or systematic reviews of RCTs, of ESAs (epoetin or darbepoetin) for treating people with CIA were eligible for inclusion in the review. Comparators were best supportive care, placebo or other ESAs. Anaemia- and malignancy-related outcomes, health-related quality of life (HRQoL) and adverse events (AEs) were evaluated. When appropriate, data were pooled using meta-analysis. An empirical health economic model was developed comparing ESA treatment with no ESA treatment. The model comprised two components: one evaluating short-term costs and quality-adjusted life-years (QALYs) (while patients are anaemic) and one evaluating long-term QALYs. Costs and benefits were discounted at 3.5% per annum. Probabilistic and univariate deterministic sensitivity analyses were performed. Of 1457 titles and abstracts screened, 23 studies assessing ESAs within their licensed indication (based on start dose administered) were included in the review. None of the RCTs were completely aligned with current European Union licenses. The results suggest a clinical benefit from ESAs for anaemia-related outcomes and an improvement in HRQoL scores. The impact of ESAs on AEs and survival remains highly uncertain, although point estimates are lower, confidence intervals are wide and not statistically significant. Base-case incremental cost-effectiveness ratios (ICERs) for ESA treatment compared with no ESA treatment ranged from £ 19,429 to £ 35,018 per QALY gained, but sensitivity and scenario analyses demonstrate considerable uncertainty in these ICERs, including the possibility of overall health disbenefit. All ICERs were sensitive to survival and cost. The relative effectiveness of ESAs was not addressed; all ESAs were assumed to have equivalent efficacy. No studies were completely aligned with their European labelling beyond the starting dose evaluated. There is questionable generalisability given that the included trials were published >20 years ago and there have been many changes to chemotherapy as well as to the quality of supportive treatment. Trial quality was moderate or poor and there was considerable unexplained heterogeneity for a number of outcomes, particularly survival, and evidence of publication bias. Adjustments were not made to account for multiple testing. ESAs could be cost-effective when used closer to licence, but there is considerable uncertainty, mainly because of unknown impacts on overall survival. This study is registered as PROSPERO CRD42013005812. The National Institute for Health Research Health Technology Assessment programme.
In bipolar spectrum disorder, some individuals experience ongoing, frequent fluctuations in mood outside of affective episodes. There are currently no evidence-based psychological interventions designed to address this. This feasibility study is a phase II evaluation of a dialectical behavioural therapy-informed approach (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). It seeks to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Patients will be randomised 1:1 to either treatment as usual only (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points will be at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point for the candidate primary outcome measures. We aim to recruit 48 individuals meeting diagnostic criteria for a bipolar spectrum disorder and reporting frequent mood swings outside of acute episodes, through primary and secondary care services and self-referral. To evaluate feasibility and acceptability, we will examine recruitment and retention rates, completion rates for study measures and feedback from participants on their experience of study participation and therapy. Proceeding to a definitive trial will be indicated if the following criteria are met: (1) trial participation does not lead to serious negative consequences for our participants; (2) any serious concerns about the acceptability and feasibility of the trial procedures can be rectified prior to a definitive trial; (3) follow-up data at 9 months are available for at least 60% of participants; (4) at least 60% of patients in the ThrIVe-B arm complete treatment. ISRCTN, ISRCTN54234300 . Registered on 20 July 2017.
Background Little is known about the social validity of self-harm prevention apps for young adolescents with severe mental health problems who repeatedly self-harm. Objective We assessed the acceptability, use and safety of BlueIce, a self-harm prevention app for young adolescents who self-harm. Methods Mixed methods study involving a content analysis of postuse interviews. Participants were a clinical group of 60 UK adolescents aged 12–17 with repeated self-harm, randomised to receive BlueIce. Findings BlueIce was used by 57/60 (95%) respondents with 47/57 (82%) using BlueIce when thinking about self-harm. 17/47 (36%) who were thinking about self-harm used it on more than six occasions with 36/47 (77%) reporting that BlueIce prevented at least one episode of self-harm. 33/47 (70%) reported occasions when they used the app but still went on to self-harm. Reasons why the app was not used or not helpful included feeling too distressed, a negative mindset, prior decision to self-harm or forgetting. BlueIce was rated 4.09 (SD=0.75) out of 5 stars, with high mean ratings out of 10 for ease of use (8.70, SD=1.37) and good for acceptability (7.68, SD=2.05) and helpfulness (6.77, SD=1.72). No respondent identified BlueIce as triggering any episode of self-harm. Conclusion These findings are consistent with previous evaluations and highlight the acceptability, use and safety of BlueIce. Self-reports indicate that BlueIce prevented some episodes of self-harm. Clinical implications Our results highlight the acceptability of the BlueIce self-harm app for young adolescents who repeatedly self-harm.
Abstract Background Currently ∼50% of people with dementia experience behavioural symptoms linked to unmanaged distress. Effective and safe management of these symptoms is critical to maintain the quality of life and overall care of people with dementia. Technological solutions have the potential to help with research into these symptoms. Milbotix are a health tech start‐up who are developing ‘SmartSocks®, a sock‐based wearable that provides wellbeing insights: notably by continually monitoring the physiological state of the wearer to recognise early signs of distress. In this study we will assess the acceptability and feasibility of SmartSocks® for clinical research in dementia in a care home environment. Method 30 people with dementia living in care homes in the UK will be asked to wear the SmartSocks®. We will conduct a survey of care home staff to assess the acceptability of the SmartSocks® so that we can ensure the socks are suitable for the care home environment. We will then carry out a focus group with care home staff to evaluate the integration of the SmartSocks® into care planning so that we can determine how care homes use the socks alongside best practice in care. We will determine the concurrent validity of SmartSocks® data with established measures of agitation and pain so that we can evaluate the potential of the socks to be used to deliver better care and used as objective outcome measures in clinical trials. Finally, we will estimate the cost of providing the socks and will assess if there are differences between the groups in resource use utilization and health related quality of life data. Result We present a protocol for feasibility and acceptability study of a novel wearable technology. Conclusion The study will start recruiting in July 2024 and finish in December 2024. Results will be used to inform the design of larger substantive studies that will test the efficacy of SmartSocks® in managing and measuring agitation and distress in care homes.
Abstract Background A subgroup of those with bipolar spectrum disorders experience ongoing mood fluctuations outside of full episodes. We conducted a randomised, controlled feasibility study of a Dialectical Behavioural Therapy-informed approach for bipolar mood fluctuations (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). Our study aimed to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Participants were required to meet diagnostic criteria for a bipolar spectrum disorder and report frequent mood swings outside of acute episodes. They were randomised to treatment as usual (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points were at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point. To evaluate feasibility and acceptability we examined recruitment and retention rates, completion rates for study measures, adverse events and feedback from participants on their experience of study participation and therapy. Results Of the target 48 participants, 43 were recruited (22 in the intervention arm; 21 in the control arm), with a recruitment rate of 3.9 participants per month. At 9 months 74% of participants engaged in research follow-up assessment, exceeding the pre-specified criterion of 60%. There were no serious concerns about the safety of the research procedures or the intervention. On one of the four candidate primary outcome measures, the 95% CI for the between-group mean difference score excluded the null effect and included the minimal clinically important difference, favouring the intervention arm, whilst on no measure was there evidence of deterioration in the intervention arm relative to the control arm. Attendance of the intervention (50% attending at least half of the mandatory sessions) was below the pre-specified continuation criterion of 60%, and qualitative feedback from participants indicated areas that may have hampered or facilitated engagement. Conclusions It is broadly feasible to conduct a trial of this design within the population of people with frequent bipolar mood swings. Changes should be made to the therapy to increase uptake, such as simplifying content and considering individual rather than group delivery. Trial registration ISRCTN: ISRCTN54234300. Registered 14th July 2017, http://www.isrctn.com/ISRCTN54234300
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