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Background HIV self-testing (HIVST) has been found to be highly effective, but no cost analysis has been undertaken to guide the design of affordable and scalable implementation strategies. Methods Consecutive HIV self-testers and facility-based testers were recruited from participants in a community cluster-randomised trial ( ISRCTN02004005 ) investigating the impact of offering HIVST in addition to facility-based HIV testing and counselling (HTC). Primary costing studies were undertaken of the HIVST service and of health facilities providing HTC to the trial population. Costs were adjusted to 2014 US$ and INT$. Recruited participants were asked about direct non-medical and indirect costs associated with accessing either modality of HIV testing, and additionally their health-related quality of life was measured using the EuroQol EQ-5D. Results A total of 1,241 participants underwent either HIVST (n = 775) or facility-based HTC (n = 446). The mean societal cost per participant tested through HIVST (US$9.23; 95 % CI: US$9.14-US$9.32) was lower than through facility-based HTC (US$11.84; 95 % CI: US$10.81-12.86). Although the mean health provider cost per participant tested through HIVST (US$8.78) was comparable to facility-based HTC (range: US$7.53-US$10.57), the associated mean direct non-medical and indirect cost was lower (US$2.93; 95 % CI: US$1.90-US$3.96). The mean health provider cost per HIV positive participant identified through HIVST was higher (US$97.50) than for health facilities (range: US$25.18-US$76.14), as was the mean cost per HIV positive individual assessed for anti-retroviral treatment (ART) eligibility and the mean cost per HIV positive individual initiated onto ART. In comparison to the facility-testing group, the adjusted mean EQ-5D utility score was 0.046 (95 % CI: 0.022-0.070) higher in the HIVST group. Conclusions HIVST reduces the economic burden on clients, but is a costlier strategy for the health provider aiming to identify HIV positive individuals for treatment. The provider cost of HIVST could be substantially lower under less restrictive distribution models, or if costs of oral fluid HIV test kits become comparable to finger-prick kits used in health facilities.

Background Postoperative delirium is a frequent complication with negative consequences for neurosurgical patients. Recorded music has been shown to reduce the incidence of delirium, however its economic benefit remains unclear. This study aimed to investigate the cost-effectiveness of perioperative music in preventing postoperative delirium. Methods This study used data from a randomized controlled trial (Clinical Trials.gov; NCT04649450) that compared the effect of perioperative music with standard of clinical care on the occurrence of postoperative delirium in patients undergoing craniotomy at the Erasmus Medical Centre. The primary outcome of this study is the cost-effectiveness of the music intervention. A trial-based cost-effectiveness analysis (CEA) was conducted from a societal perspective. Mean costs were calculated using bootstrapping with 95% confidence intervals. Secondary outcomes included postoperative complications, mortality, cognitive functioning, and quality of life. Costs and patient outcomes were assessed separately for the initial hospital admission and long-term follow-up until 6 months after discharge. Results This study included 91 patients in the intervention group and 93 in the control group. On average, medical costs during initial admission were lower, albeit not statistically significant, in the music group compared to the control group (€ 11,819 vs. € 13,106), mostly due to a shorter length of stay. Total costs over the 6-month period were nearly identical between the groups, at € 18,587 and € 18,571 in the music and control group, respectively. Conclusions Pre-recorded perioperative music may be a cost-effective intervention for reducing postoperative delirium in neurosurgical patients, possibly by decreasing healthcare utilization and costs during primary admission. Further studies are needed to confirm its potential as a cost-effective intervention.

The objective of the study was to show the clinical performance and cost‐effectiveness of a Silicone foam dressing with 3DFit™ Technology compared to current standard of care. This was an open‐labelled, two‐arm, randomised controlled multicentre study conducted from February to December 2023. One hundred and two participants with an exuding, non‐infected and chronic ulcer were randomised in a 1:1 fashion and treated with either a Silicone foam with 3DFit™ Technology or standard of care (a filler combined with a secondary dressing), stratified by venous leg ulcers and diabetic foot ulcers. After a 4‐week study period, wound size and total costs were evaluated. After 4 weeks of treatment, a comparable percentage in wound area reduction was observed in both treatment arms with mean and 95% confidence interval of 54.3% (37.1%; 71.5%) and 43.0% (26.5%; 59.6%) for the investigational and comparator dressing, respectively. This corresponded to a mean difference of 11.3% ([−10.22; 32.86], p = 0.299). Total mean estimated costs were significantly lower for the investigational dressing (£14.3, 95% confidence interval [£9.6; £19.0]) compared to the two‐dressing regime (£21.4 [£16.9; £26.0]), corresponding to a 33% price reduction (p = 0.033) after 4 weeks of treatment. With this RCT, a conforming Silicone foam dressing with 3DFit™ Technology was shown to be clinically comparable and a cost‐effective alternative to using a filler and a secondary dressing at a significantly lower cost in both venous leg ulcers and diabetic foot ulcers up to 2 cm in depth.

Link4Health, a cluster-RCT, demonstrated the effectiveness of a combination strategy targeting barriers at various HIV continuum steps on linkage to and retention in care; showing effectiveness in achieving linkage to HIV care within 1 month plus retention in care at 12 months after HIV testing for people living with HIV (RR 1.48, 95% CI 1.19-1.96, p = 0.002). In addition to standard of care, Link4Health included: 1) Point-of-care CD4+ count testing; 2) Accelerated ART initiation; 3) Mobile phone appointment reminders; 4) Care and prevention package including commodities and informational materials; and 5) Non-cash financial incentive. Our objective was to evaluate the cost-effectiveness of a scale-up of the Link4Health strategy in Swaziland. We incorporated the effects and costs of the Link4Health strategy into a computer simulation of the HIV epidemic in Swaziland, comparing a scenario where the strategy was scaled up to a scenario with no implementation. The simulation combined a deterministic compartmental model of HIV transmission with a stochastic microsimulation of HIV progression calibrated to Swaziland epidemiological data. It incorporated downstream health costs potentially saved and infections potentially prevented by improved linkage and treatment adherence. We assessed the incremental cost-effectiveness ratio of Link4Health compared to standard care from a health sector perspective reported in US$2015, a time horizon of 20 years, and a discount rate of 3% in accordance with WHO guidelines.[1] Our results suggest that scale-up of the Link4Health strategy would reduce new HIV infections over 20 years by 11,059 infections, a 7% reduction from the projected 169,019 cases and prevent 5,313 deaths, an 11% reduction from the projected 49,582 deaths. Link4Health resulted in an incremental cost per infection prevented of $13,310 and an incremental cost per QALY gained of $3,560/QALY from the health sector perspective. Using a threshold of <3 x per capita GDP, the Link4Health strategy is likely to be a cost-effective strategy for responding to the HIV epidemic in Swaziland.

IntroductionThe most effective duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer (EBC) patients is unknown. Despite significant differences in cost and toxicity, no prospective trial has been performed to optimize practice. We assessed the feasibility of using a novel pragmatic trial model to compare the most commonly used schedules of filgrastim.MethodsEarly breast cancer patients receiving chemotherapy were randomized to 5, 7, or 10 days of filgrastim as primary FN prophylaxis. The trial methodology integrated broad eligibility criteria, simply defined endpoints, an integrated consent model incorporating oral consent, and web-based randomization in the clinic. Feasibility was reflected through a combination of primary endpoints including patient and physician engagement (if > 50% of appropriate patients approached agree to participate, and if > 50% of physicians approached patients for the study). Secondary endpoints included the first occurrence rates of FN, treatment-related hospital admission, or chemotherapy dose reductions/delays/discontinuation.ResultsFrom May 2015 to August 2016, 142/149 (95.3%) patients approached agreed to participate and were randomized. Seventeen of 24 (70.8%) medical oncologists approached and randomized patients. The 142 patients received a total of 495 cycles of chemotherapy. Aggregate incidences of a first event by patient were FN (8/142, 5.6%), treatment-related hospitalization (6/142, 4.2%), chemotherapy discontinuation (7/142, 4.9%), chemotherapy delays (5/142, 3.5%), and chemotherapy dose reduction (18/142, 12.7%). Overall, 31.7% (45/142) of patients and 9.0% (45/495) of chemotherapy cycles were associated with one of these first events.ConclusionThis study met its feasibility endpoints. This novel pragmatic trial approach offers a means of comparing standard of care treatments in a practical and cost-effective manner. The trial will now be expanded to compare rates of FN between the three filgrastim schedules.Trial registrationClinicalTrials.gov: NCT02428114.

Background There is a growing interest in using negative pressure wound therapy in closed surgical incision to prevent wound complications which continue to persist following surgery despite advances in infection measures. Objectives To estimate the cost-effectiveness of single use negative pressure wound therapy (sNPWT) compared to standard of care in patients following coronary artery bypass grafting surgery (CABG) procedure to reduce surgical site complications (SSC) defined as dehiscence and sternotomy infections. Method A decision analytic model was developed from the Germany Statutory Health Insurance payer’s perspective over a 12-week time horizon. Baseline data on SSC, revision operations, length of stay, and readmissions were obtained from a prospective observational study of 2621 CABG patients in Germany. Effectiveness data for sNPWT was taken from a randomised open label trial conducted in Poland which randomised 80 patients to treatment with either sNPWT or standard care. Cost data (in Euros) were taken from the relevant diagnostic related groups and published literature. Results The clinical study reported an increase in wounds that healed without complications 37/40 (92.5%) in the sNPWT compared to 30/40 (75%) patients in the SC group p  = 0.03. The model estimated sNPWT resulted in 0.989 complications avoided compared to 0.952 and the estimated quality adjusted life years were 0.8904 and 0.8593 per patient compared to standard care. The estimated mean cost per patient was €19,986 for sNPWT compared to €20,572 for SC resulting in cost-saving of €586. The findings were robust to a range of sensitivity analyses. Conclusion The sNPWT can be considered a cost saving intervention that reduces surgical site complications following CABG surgery compared to standard care. We however recommend that additional economic studies should be conducted as new evidence on the use of sNPWT in CABG patients becomes available to validate the results of this economic analysis.

A cost-effectiveness analysis was conducted during a 3-year randomized controlled clinical trial in a general dental practice in the Netherlands in which 230 6-year-old children (± 3 months) were assigned to either regular dental care, an increased professional fluoride application (IPFA) programme or a non-operative caries treatment and prevention (NOCTP) programme. Information on resource use during the 3-year period was documented by the dental nurse at every patient visit, such as treatment time, travel time and travel distance. Caries increment scores (at D 3 MFS level) were used to assess effectiveness. Cost calculations were performed using bottom-up micro-costing. Incremental cost-effectiveness ratios (ICERs) were expressed as additional average costs per prevented DMFS. The ICERs compared with regular dental care from a health care system perspective and societal perspective were, respectively, EUR 269 and EUR 1,369 per prevented DMFS in the IPFA programme, and EUR 30 and EUR 100 in the NOCTP programme. The largest investments for the NOCTP group were made in the first year of the study; they decreased in the second and equalled the costs of control group in third year of the study. From both medical and economic points of view, the NOCTP strategy may be considered the preferred strategy for caries prevention.

ObjectivesTo explore differences in mean costs (from a UK National Health Service perspective) and effects of pharmacist-led management of chronic pain in primary care evaluated in a pilot randomised controlled trial (RCT), and to estimate optimal sample size for a definitive RCT.DesignRegression analysis of costs and effects, using intention-to-treat and expected value of sample information analysis (EVSI).SettingSix general practices: Grampian (3); East Anglia (3).Participants125 patients with complete resource use and short form-six-dimension questionnaire (SF-6D) data at baseline, 3 months and 6 months.InterventionsPatients were randomised to either pharmacist medication review with face-to-face pharmacist prescribing or pharmacist medication review with feedback to general practitioner or treatment as usual (TAU).Main outcome measuresDifferences in mean total costs and effects measured as quality-adjusted life years (QALYs) at 6 months and EVSI for sample size calculation.ResultsUnadjusted total mean costs per patient were £452 for prescribing (SD: £466), £570 for review (SD: £527) and £668 for TAU (SD: £1333). After controlling for baseline costs, the adjusted mean cost differences per patient relative to TAU were £77 for prescribing (95% CI −82 to 237) and £54 for review (95% CI −103 to 212). Unadjusted mean QALYs were 0.3213 for prescribing (SD: 0.0659), 0.3161 for review (SD: 0.0684) and 0.3079 for TAU (SD: 0.0606). Relative to TAU, the adjusted mean differences were 0.0069 for prescribing (95% CI −0.0091 to 0.0229) and 0.0097 for review (95% CI −0.0054 to 0.0248). The EVSI suggested the optimal future trial size was between 460 and 690, and between 540 and 780 patients per arm using a threshold of £30 000 and £20 000 per QALY gained, respectively.ConclusionsCompared with TAU, pharmacist-led interventions for chronic pain appear more costly and provide similar QALYs. However, these estimates are imprecise due to the small size of the pilot trial. The EVSI indicates that a larger trial is necessary to obtain more precise estimates of differences in mean effects and costs between treatment groups.Trial registration numberISRCTN06131530.

In a randomized clinical trial of early versus standard antiretroviral therapy (ART) in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm³ in Haiti, early ART decreased mortality by 75%. We assessed the cost-effectiveness of early versus standard ART in this trial. Trial data included use of ART and other medications, laboratory tests, outpatient visits, radiographic studies, procedures, and hospital services. Medication, laboratory, radiograph, labor, and overhead costs were from the study clinic, and hospital and procedure costs were from local providers. We evaluated cost per year of life saved (YLS), including patient and caregiver costs, with a median of 21 months and maximum of 36 months of follow-up, and with costs and life expectancy discounted at 3% per annum. Between 2005 and 2008, 816 participants were enrolled and followed for a median of 21 months. Mean total costs per patient during the trial were US$1,381 for early ART and US$1,033 for standard ART. After excluding research-related laboratory tests without clinical benefit, costs were US$1,158 (early ART) and US$979 (standard ART). Early ART patients had higher mean costs for ART (US$398 versus US$81) but lower costs for non-ART medications, CD4 cell counts, clinically indicated tests, and radiographs (US$275 versus US$384). The cost-effectiveness ratio after a maximum of 3 years for early versus standard ART was US$3,975/YLS (95% CI US$2,129/YLS-US$9,979/YLS) including research-related tests, and US$2,050/YLS excluding research-related tests (95% CI US$722/YLS-US$5,537/YLS). Initiating ART in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm³ in Haiti, consistent with World Health Organization advice, was cost-effective (US$/YLS <3 times gross domestic product per capita) after a maximum of 3 years, after excluding research-related laboratory tests. ClinicalTrials.gov NCT00120510.

Purpose: Implementation of novel genetic diagnostic tests is generally driven by technological advances because they promise shorter turnaround times and/or higher diagnostic yields. Other aspects, including impact on clinical management or cost-effectiveness, are often not assessed in detail prior to implementation. Methods: We studied the clinical utility of whole-exome sequencing (WES) in complex pediatric neurology in terms of diagnostic yield and costs. We analyzed 150 patients (and their parents) presenting with complex neurological disorders of suspected genetic origin. In a parallel study, all patients received both the standard diagnostic workup (e.g., cerebral imaging, muscle biopsies or lumbar punctures, and sequential gene-by-gene–based testing) and WES simultaneously. Results: Our unique study design allowed direct comparison of diagnostic yield of both trajectories and provided insight into the economic implications of implementing WES in this diagnostic trajectory. We showed that WES identified significantly more conclusive diagnoses (29.3%) than the standard care pathway (7.3%) without incurring higher costs. Exploratory analysis of WES as a first-tier diagnostic test indicates that WES may even be cost-saving, depending on the extent of other tests being omitted. Conclusion: Our data support such a use of WES in pediatric neurology for disorders of presumed genetic origin. Genet Med advance online publication 23 March 2017