Lead aprons and thyroid collars: to be, or not to be?

Wearing lead aprons and thyroid collars for long periods of time has a subjective component: to balance the effective dose reduction with the effort of carrying a heavy load. Occupational radiation exposure has decreased dramatically in the last century within the health care system. During the same period the use of lead aprons and thyroid collars has also gone up. Therefore, a question that may be raised is: how safe is safe enough? In order to promote stakeholder involvement, the aim of the present study was to investigate staff's experience of discomforts associated with wearing lead aprons and thyroid collars for long periods of time, and also to investigate staff's willingness to tolerate personal dose equivalent (expressed as radiation dose) and the corresponding increase in future cancer risk to avoid wearing these protective tools. A questionnaire was developed and given to staff working in operating or angiography rooms at Skaraborg Hospital in Sweden. The results from the 245 respondents showed that 51% experienced bothersome warmth, 36% experienced fatigue and 26% experienced ache or pain that they believed was associated with wearing lead aprons. One third of the respondents would tolerate a personal dose equivalent of 1 mSv per year to avoid wearing lead aprons, but only a fifth would tolerate the corresponding increase in future cancer risk (from 43% to 43.2%). In conclusion, discomforts associated with wearing lead aprons and thyroid collars for long periods of time are common for the staff using them. At the same time, only a minority of the staff would tolerate a small increase in future cancer risk to avoid wearing them. The present study gives an example of stakeholder involvement and points at the difficulties in making reasonable decisions about the use of these protective tools.

A case study of cost-benefit analysis in occupational radiological protection within the healthcare system of Sweden.

The aim of the present study was to demonstrate cases of cost-benefit analysis within healthcare, of how economic factors can be considered in occupational radiological protection, in agreement with the as low as reasonably achievable principle and present Swedish legislations. In the first part of the present study, a comparison of examples within health economics used by authorities and institutes in Sweden was made. The comparison focused on value of a statistical life, quality-adjusted life year, and monetary cost assigned to a unit of collective dose for radiation protection purposes (α-value). By this comparison, an α-value was determined as an interval between $45 and $450 per man-mSv, for the Swedish society in 2021. The α-value interval can be interpreted as following: Less than $45 per man-mSv is a good investment. From $45 to $450 per man-mSv, other factors than costs and collective dose are important to consider. More than $450 per man-mSv is too expensive. In the second part of the present study, seven cases of cost-benefit analyses in occupational radiological protection were provided. The present study focused specifically on cases where the relevant factors were costs and collective dose. The present case study shows a large variation in costs per collective dose from different types of occupational radiological protection, used at Skaraborg Hospital in Sweden.

Exacerbations and healthcare resource utilization among COPD patients in a Swedish registry-based nation-wide study.

BACKGROUND: Exacerbations of chronic obstructive pulmonary disease (COPD) are an important measure of disease severity in terms of impaired disease progression, increased recovery time, healthcare resource utilization, overall morbidity and mortality. We aimed to quantify exacerbation and healthcare resource utilization rates among COPD patients in Sweden with respect to baseline treatments, exacerbation history, and comorbidities. METHODS: Patients with a COPD or chronic bronchitis (CB) diagnosis in secondary care at age of ≥40 years on 1.7.2009 were identified and followed until 1.7.2010 or death. Severe exacerbations were defined as hospitalizations due to respiratory disease, and healthcare resource utilization was measured by all-cause hospitalizations and secondary care visits. Poisson regression was used adjusting for age, gender, time since COPD/CB diagnosis, and Charlson comorbidity index. RESULTS: In 88,548 patients (54% females, mean age 72 years), previous respiratory hospitalizations and current high use of COPD medication (double or triple therapy) predicted an 8.3-fold increase in severe exacerbation rates and 1.8-fold increase in healthcare resource utilization rates in the following year, compared to patients without combination treatment and/or history of severe exacerbations. CONCLUSIONS: COPD/CB patients with history of severe exacerbations and high use of COPD medication experienced a significantly increased rate of severe exacerbations and healthcare resource utilization during the one-year follow-up.

A Cost-effectiveness Analysis of Brentuximab Vedotin in Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma.

Objective: To evaluate the cost-effectiveness of brentuximab vedotin in patients with R/R sALCL from a UK NHS perspective. Methods: A partitioned survival model used clinical outcomes for brentuximab vedotin from the pivotal phase-2 single-arm trial of brentuximab vedotin in 58 patients with R/R sALCL (SG035-0004; NCT00866047), over a lifetime (30-year) time horizon. Comparison with conventional chemotherapy was based on data from the Canadian British Columbia Cancer Agency registry from 40 patients starting salvage chemotherapy after front-line treatment between 1980 and 2012. Survival was extrapolated using parametric distributions, with brentuximab vedotin risk after the trial period assumed equal to conventional chemotherapy. Other modelling assumptions were based on a systematic literature review and clinical expert opinion. Results: Based on statistical extrapolation, brentuximab vedotin was associated with 3.1 years longer duration in the progression-free survival health state and an overall survival improvement of 5.4 years, prior to discounting. In addition, brentuximab vedotin was associated with 2.5 quality-adjusted life years (QALYs) gained at a total incremental cost of £88 556, resulting in an incremental cost-effectiveness ratio (ICER) of approximately £35 400. Sensitivity analyses of alternative model assumptions provided ICERs ranging from approximately £28 100 to £61 900. Comparing only first-line salvage patients reduced the ICER to £26 800 per QALY gained. Conversely, considering only patients with Eastern Corporative Oncology Group performance status of 0 or 1 increased the ICER to approximately £38 200. At a willingness-to-pay threshold of £50 000, the estimated probability that brentuximab vedotin is cost-effective compared with conventional chemotherapy was 86.5%. Conclusion: Compared to conventional chemotherapy, and considering the full survival period, brentuximab vedotin may provide a valuable treatment choice for patients with R/R sALCL, a population with limited therapeutic options.

Brentuximab vedotin in relapsed/refractory Hodgkin lymphoma post-autologous stem cell transplant: a cost-effectiveness analysis in Scotland.

OBJECTIVE: To evaluate cost-effectiveness of brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma who have received autologous stem cell transplantation, from a Scottish healthcare payer perspective. METHODS: A Microsoft Excel-based partitioned survival model comprising three health states (progression-free survival [PFS], post-progression survival, and death) was developed. Relevant comparators were chemotherapy with or without radiotherapy (C/R) and C/R with intent to allogeneic hematopoietic stem cell transplantation (alloSCT). Data were obtained from the pivotal phase II single-arm trial in 102 patients (SG035-0003; NCT00848926), a systematic literature review and clinical expert opinions (where empirical evidence was unavailable). PFS and overall survival for brentuximab vedotin were estimated using 5-year follow-up data from SG035-0003, and extrapolated using event rates observed for comparator treatments from published survival data. Resource use included drug acquisition and administration; alloSCT; treatment of adverse events; and long-term follow-up. Deterministic and probabilistic sensitivity analyses were conducted to evaluate the impact of uncertainty. RESULTS: In the base case, the incremental cost-effectiveness ratio (ICER) for brentuximab vedotin was £38,769 per quality-adjusted life year (QALY) vs C/R, whereas C/R with intent to alloSCT was dominated by brentuximab vedotin. ICERs for brentuximab vedotin generated by the deterministic sensitivity analysis ranged between £32,000-£54,000 per QALY. Including productivity benefits reduced the ICER to £28,881 per QALY. LIMITATIONS: Limitations include lack of comparative data from this single arm study and the heterogeneous population. Inconsistent baseline characteristic reporting across studies prevented complete assessment of heterogeneity and the extent of potential bias in clinical and cost-effectiveness estimates. CONCLUSIONS: Although the base case ICER is above the threshold usually applied in Scotland, it is relatively low compared with other orphan drugs, and lower than the ICER generated using a previous data cut of SG035-0003 that informed a positive recommendation from the Scottish Medicines Consortium, under its decision-making framework for assessment of ultra-orphan medicines.

Fetal growth, cognitive function, and brain volumes in childhood and adolescence.

OBJECTIVE: To evaluate the association between fetal growth pattern and cognitive function at 5 and 9 years and regional brain volumes at 15 years. METHODS: Eighty-three term-born small-for-gestational-age (SGA) neonates and 105 non-SGA neonates in a control group were available for follow-up. Based on serial fetal ultrasound measurements from gestational weeks 25-37, SGA neonates were classified with fetal growth restriction (n=13) or non-fetal growth restriction (n=36). Cognitive function was assessed at 5 and 9 years, and brain volumes were estimated with cerebral magnetic resonance imaging at 15 years. RESULTS: Small-for-gestational-age children had lower performance intelligence quotient at 5 years compared with those in a control group (107.3 compared with 112.5, P<.05). Although there were no differences between the SGA non-fetal growth restriction and control groups, the SGA fetal growth restriction group had significantly lower performance intelligence quotient at 5 years (103.5 compared with 112.5, P<.05) and 9 years (96.2 compared with 107.5, P<.05) compared with those in the control group. There were some brain volume differences at 15 years between SGA children and those in the control group, but after adjustment for total intracranial volume, age at examination, and sex, there were only significant differences between the SGA fetal growth restriction and control groups for thalamic (17.4 compared with 18.6 cm, P<.01) and cerebellar white matter volumes (21.5 compared with 24.3 cm, P<.01). CONCLUSION: Small-for-gestational-age children had lower intelligence quotient scores at 5 and 9 years and smaller brain volumes at 15 years compared with those in the control group, but these findings were only found in those with fetal growth restriction, indicating a possible relationship to decelerated fetal growth. LEVEL OF EVIDENCE: II.

Examining the quality of health economic analyses submitted to the Pharmaceutical Benefits Board in Sweden. The first year.

This study assessed the quality of health economic documentation submitted to the Pharmaceutical Benefits Board (PBB) in Sweden. Two different instruments were used in the evaluation: the PBB checklist, which was constructed by the authors from the PBB guidelines for health economic evaluations, and the QHES, a validated quality assessment instrument. Some areas that seem especially problematic, or where the quality was particularly low are identified and discussed. Also, we present the cost per quality-adjusted life-year that the companies have presented and how this related to the PBBs decisions.