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BACKGROUND AND AIMS: A proportion of chronic heart failure (CHF) patients will experience regurgitation secondary to ventricular remodeling in CHF, known as functional mitral (MR) or tricuspid (TR) regurgitation. Its presence adversely impacts the prognosis and healthcare utilization in CHF patients. The advent of interventional devices for both atrioventricular valves modifies both aspects. We present an economic model structure suitable for comparing interventions used in MR and TR, and assess the cost-effectiveness of transcatheter mitral valve repair (TMVr) plus guideline directed medical therapy (GDMT) compared with GDMT alone in people with MR.
METHODS: An economic model with a lifetime time horizon was developed based on extrapolated survival data and using New York Heart Association classifications to describe disease severity in people with functional MR at high risk of surgical mortality or deemed inoperable. Cost and utility values (describing health-related quality-of-life) were assigned to patients dependent on their disease severity. The analysis was conducted from a UK National Health Service perspective. An incremental cost per additional quality-adjusted life year (QALY) was estimated, and sensitivity (one-way and probabilistic) and scenario analyses conducted.
RESULTS AND COMPARISONS:
Compared with GDMT, the use of TMVr results in an additional 1.07 QALYs and an increase in costs of £32,267 per patient over a lifetime time horizon. The estimated incremental cost per QALY gained is £30,057 and would therefore be on the threshold of cost-effectiveness at £30,000 per quality adjusted life year. Thus, from a UK reimbursement perspective, in patients with severe functional MR who are at high risk of surgical mortality or deemed inoperable with conventional surgery, TMVr plus medical therapy is likely to represent a cost-effective treatment option compared with GDMT alone. The choice of device (MitraClip or PASCAL) will need to be confirmed once further clinical data are reported.
The purpose of economic evaluation is to inform decisions as to the relative value of different courses of action, in a systematic, transparent way. Cost-effectiveness analysis involves assessing the costs and effects of two or more competing, alternative interventions against other uses if the same resources were used elsewhere. Applied to the social care context, a commissioner with a constrained budget might use this information to consider whether to invest public funds in a new intervention, programme or service or whether standard care represents the optimal choice of provision.
In the context of the UK, the National Institute for Health and Care Excellence (NICE) has provided methods guidance for the economic evaluation of social care interventions (NICE, 2013 & 2014). In practice, there remains considerable uncertainty on methods for social care economic evaluation; for example, in the relevant perspective, inclusion of informal care, appropriate cost-effectiveness threshold, etc. To help resolve this uncertainty, NICE commissioned a scoping review to support developing a long-term strategy for how to consider social care economics in NICE guidelines. Full details for this study are available online (see Weatherly et al., 2017). This article summarises the methods used in published economic evaluations of social care interventions, briefly noting some recent methods developments, and it highlights key methods issues and gaps for addressing in the future.
OBJECTIVES: To assess the comparative efficacy and safety of lurasidone, brexpiprazole and cariprazine in the treatment of schizophrenia in a network meta-analysis.
METHODS: A systematic review was conducted to identify randomised controlled trials comparing lurasidone, brexpiprazole and cariprazine with each other or placebo in patients with schizophrenia. Searches were carried out in a range of bibliographic databases and other information sources. The key outcomes included effect on Positive and Negative Syndrome Scales (PANSS) and Clinical Global Impression-Severity (CGI-S) scores; and cardiovascular and metabolic parameters. A feasibility assessment evaluated the trials' suitability for inclusion in a Bayesian Network Meta Analysis. Random effects models were used, with half-Cauchy priors for the between-study variance term for the continuous outcomes and informative priors from Turner et al. (2015) for the binomial outcomes. Uninformative priors were used for the treatment effects. Each drug and dose combination was considered as a separate node in the networks.
RESULTS: Searches conducted in February 2020 identified 1,138 records; 19 RCTs contributed to the NMA. There was evidence that lurasidone doses of 40mg/d and above performed better than placebo in terms of change in PANSS and CGI-S scores at 6 weeks, with increasing dose leading to higher effect estimates. The lowest doses of all treatments were not found to be better than placebo. When comparing brexpiprazole and cariprazine against lurasidone 40 mg/d, the 95% credible interval contained 'no difference' regardless of dose. The safety outcomes were relatively variable; for all treatments, the 95% credible intervals usually contained 'no difference'. Active treatments were generally associated with lower odds of discontinuation due to any cause, and higher odds of experiencing any adverse event.
CONCLUSIONS: Lurasidone was found to be comparable to brexpiprazole and cariprazine for the efficacy and safety outcomes assessed at 6 weeks.
Surgical site infections (SSI) substantially increase costs for healthcare providers because of additional treatments and extended patient recovery. The objective of this study was to assess the cost and health-related quality of life impact of SSI, from the perspective of a large teaching hospital in England. Data were available for 144 participants undergoing clean or clean-contaminated vascular surgery. SSI development, length of hospital stay, readmission, and antibiotic use were recorded over a 30-day period. Patient-reported EQ-5D scores were obtained at baseline, day 7 and day 30. Linear regressions were used to control for confounding variables. A mean SSI-associated length of stay of 9.72 days resulted in an additional cost of £3776 per patient (including a mean antibiotic cost of £532). Adjusting for age, smoking status, and procedure type, SSI was associated with a 92% increase in length of stay (P < 0.001). The adjusted episode cost was £3040. SSI reduced patient utility between baseline and day 30 by 0.156 (P = 0.236). Readmission rates were higher with SSI (P = 0.017), and the rate to return to work within 90 days was lower. Therefore, strategies to reduce the risk of surgical site infection for high-risk vascular patients should be investigated.
OBJECTIVES: Screening can detect cancer earlier. Uptake of breast, cervical, and bowel cancer screening in England is below 75%. This study identifies the barriers and facilitators underpinning HCP screening behaviours which can support screening uptake, and reviews the design of real-world interventions targeting these, assessing for congruence between the two. The aim was to provide recommendations to improve the design of interventions.
DESIGN AND METHODS: Barriers/facilitators were identified by a literature review and qualitatively coded using the theoretical domains framework (TDF). Interventions were identified by stakeholders and coded using the behaviour change wheel and the taxonomy of behaviour change techniques. Congruence was assessed through comparing the intervention designs with behavioural science experts' recommendations which link the TDF domains to intervention design. Recommendations targeted missed opportunities.
RESULTS: Barriers/facilitators were extracted from 60 papers and most frequently coded to the TDF domains: environmental context and resources, knowledge and beliefs about consequences. Thirty-one interventions were identified, most frequently education, training or enablement functions, delivered via communication/marketing or service provision, and using BCTs designed to shape knowledge or highlight the consequences of or antecedents to screening. Intervention design was largely congruent with recommendations. However, there was less use of persuasion and modelling intervention functions and a reliance on BCTs such as providing instruction when other BCTs could be considered.
CONCLUSIONS: Recommendations include to consider a broader range of intervention functions and BCTs, particularly for training interventions which should make use of recommended BCTs such as 'graded tasks'.
OBJECTIVE: To assess the relative safety of oral tapentadol PR and other opioid analgesics for moderate or severe chronic pain in adults, we conducted a systematic review and network meta-analysis (NMA).
METHODS: A systematic review was conducted to identify randomized controlled trials (RCTs) and randomized withdrawal trials of tapentadol with other WHO stage II and III opioid analgesics in patients with moderate or severe chronic pain. Searches were conducted in MEDLINE, EMBASE, PubMed, Cochrane databases and trial registries. Feasibility assessment evaluated the trials' suitability for NMA. Outcomes assessed were overall AEs, overall serious adverse events, constipation, nausea, dizziness, somnolence, headache, and discontinuation due to AEs. Randomized withdrawal trials were analyzed separately to other RCTs.
RESULTS: Searches conducted in April 2019 identified 16,604 records. Following screening and feasibility assessment, 29 RCTs and 19 randomized withdrawal trials were identified and included in the NMA. Consistent with existing research, evidence from RCTs suggested that tapentadol is associated with relatively lower odds of adverse events occurring than most active comparators. The withdrawal trial data were less clear, with higher uncertainty around the results, and results that appear to contradict the RCT evidence. There are a number of trial design factors that may be affecting these results.
CONCLUSIONS: RCT evidence suggests that tapentadol can be a useful treatment option for patients suffering from chronic pain and in need of an opioid analgesic. Opioids should be prescribed by a qualified physician only after other analgesics have been considered, taking side effects and misuse risk into account.
We investigated the impact of appropriate versus inappropriate initial antimicrobial therapy on the clinical outcomes of patients with severe bacterial infections as part of a systematic review and meta-analyses assessing the impact of delay in appropriate antimicrobial therapy. Literature searches of MEDLINE and Embase, conducted on 24 July 2018, identified studies published after 2007 reporting the impact of delay in appropriate antibiotic therapy for hospitalised adult patients with bacterial infections. Results were statistically pooled for outcomes including mortality, hospital length of stay (LOS) and treatment failure. Subgroup analyses were explored by site of infection where data permitted. Inclusion criteria were met by 145 studies, of which 114 reported data on the impact of appropriate versus inappropriate initial therapy. In the pooled analysis, rates of mortality were significantly in favour of appropriate therapy [odds ratio (OR) = 0.44, 95% CI 0.38-0.50]. Across eight studies, LOS was shorter with appropriate therapy compared with inappropriate therapy [mean difference (MD) -2.54 days (95% CI -5.30 to 0.23)], but not significantly so. The incidence of treatment failure was significantly lower in patients who received appropriate therapy compared with patients who received inappropriate therapy (six studies: OR = 0.33, 95% CI 0.16-0.66) as was mean hospital costs (four studies: MD -7.38 thousand US$ or Euros, 95% CI -14.14 to -0.62). Initiation of appropriate versus inappropriate antibiotics can reduce mortality, reduce treatment failure and decrease LOS, highlighting the importance of broad-spectrum empirical therapy and rapid diagnostics for early identification of the causative pathogen. [Study registration: PROSPERO: CRD42018104669]
