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BACKGROUND: The Dutch Committee for the Evaluation of Oncological Agents (cieBOM) assesses the clinical benefit of systemic anti-cancer treatments (SACTs). For SACTs tested in non-randomized trials (NRTs), cieBOM primarily utilizes response-related thresholds as assessment criteria. As sufficiency of NRT-based evidence for benefit assessments is questionable, this study investigated whether and how NRTs can be used to assess the clinical benefit of new SACTs initially appraised by cieBOM based on randomized controlled trials (RCTs). METHODS: Using the RCTs underpinning cieBOM recommendations issued between 2015 and 2017, we searched for matching NRTs and applied the NRT-related assessment criteria by cieBOM to them. We then compared the assessment outcomes to the respective RCT-based cieBOM recommendations. Further, we investigated how the assessments would change when applying different response-related thresholds and adding a progression-free survival (PFS) threshold. RESULTS: For 13 of the 37 eligible recommendations, a matching NRT was found. Two treatments were assessed positively and six negatively; five treatments were non-assessable. Two positive recommendations matched a positive NRT-based assessment; one matching negative assessment was found, and one treatment could not be assessed based on either trial results. Adding a > 6 months PFS threshold decreased the number of non-assessable NRTs (five to two). CONCLUSIONS: Limited publications and inconsistent data reporting hampered the viability of NRTs for clinical benefit assessments of SACTs beyond the scope of rare indications. Further, response-related assessment criteria alone might not fully grasp the clinical benefit of novel SACTs. NRT-based assessments should be considered with caution due to uncertainty of the trial results.

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BACKGROUND: Risky driving behaviour including anger while driving has led to millions of global road traffic crashes, thousands of mortalities and injuries. These losses are much more in middle-income countries, such as Iran. This paper explains methods of data collection in a controlled trial study for evaluating the effect of psychosocial interventions on risky driving by using simulated and real driving. METHODS: This non-randomised controlled trial study will include 180 offender drivers. They will refer to the simulation laboratory by traffic police after their driving licences were suspended. At baseline, all participants will fill five questionnaires including demographic, Driving Anger Scale, Driving Anger Expression Scale, Spielberger's Anger and Manchester Driving Behavioural, and then they will be tested with a driving simulator. Afterwards, they will be allocated to one of three-intervention training arms (mindfulness, meta-cognition and social marketing) or a control arm without any training. Risky driving behaviours will be assessed in three follow-ups after intervention. The primary outcome of interest will be driving offences, recorded by traffic police in two time points: at 6 months and 1 year after the intervention. DISCUSSION: This study examines the effect of three interventions in reducing driving offence. The results can end in a new therapeutic training or a new legislation that should be added to current obligatory training for getting driving licence and can lead to long-term safe driving among Iranian drivers. Future research is recommended to study the cost-effectiveness of these interventions in actual driving in Iran. TRIAL REGISTRATION NUMBER: UMIN000039493.

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BACKGROUND: Speed calming interventions have been employed globally as a road safety measure to curb outcomes of RTCs such as injuries and deaths. In Ghana, few studies have reported on the effect of speed calming measures on the severity of road traffic injuries. This study examined the effect of speed humps on the severity of injuries during RTCs on trunk roads passing through towns in Ghana from 2011 to 2020. METHODS: The study employed a quasi-experimental before-and-after study with controls design to answer the research questions. The study used both primary and secondary sources of data. Univariable and multivariable ordered logistic regression was used to examine the effect of speed humps on the severity of injuries during RTCs. RESULTS: The mean height, length and spacing of the speed humps were 10.9 cm, 7.67 m and 207.17 m, respectively. Fatal/serious/minor injuries were 35% higher at the intervention than the control settlements prior to installation of speed humps though not significant (adjusted OR (aOR)=1.35, 95% CI 0.85 to 2.14). A significant change in injury severity occurred after the installation of the speed hump devices. There was a reduction of 77% in fatal/serious/minor injuries at the intervention towns compared with the control towns (aOR=0.23, 95% CI 0.11 to 0.47). CONCLUSION: The findings present evidence suggesting that speed hump is an effective road safety measure in reducing the severity of road traffic injuries on trunk roads.

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BACKGROUND: Compliant flooring may prevent fall injuries in residential care, but evidence is inconclusive. We investigate compliant sports floors and fall-related injuries in a residential care setting and update a meta-analysis from a recent systematic review on compliant flooring. METHODS: A non-randomised study comparing outcomes in a residential care unit that installed sports flooring in bedrooms with four units with regular flooring in a Norwegian municipality (n=193). Data on falls were collected for a period of 46 months (323 falls on sports flooring; 414 on regular flooring). Outcomes were injurious falls per person bed-day, falls per person bed-day and injury risks per fall. Confounding was adjusted for using Andersen-Gill proportional hazards and log-binomial regression models. Random-effects inverse variance models were used to pool estimates. RESULTS: Injurious fall rates were 13% lower in the unit with sports flooring (adjusted HR (aHR): 0.87 (95% CI: 0.55 to 1.37)). There was limited evidence of adverse effects on fall rates (aHR: 0.93 (95% CI: 0.63 to 1.38)) and the injury risk per fall was lower in fall events that occurred on sports floors (adjusted relative risk (RR): 0.75 (95% CI: 0.53 to 1.08)). Pooling these estimates with previous research added precision, but the overall pattern was the same (pooled RR for injurious falls: 0.66 (95% CI: 0.39 to 1.12); fall rates: 0.87 (95% CI: 0.68 to 1.12); injury risks per fall: 0.71 (95% CI: 0.52 to 0.97)). CONCLUSION: Sports floors may be an alternative to novel shock-absorbing floors in care settings; however, more research is needed to improve precision.

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BACKGROUND: Since March 2020, COVID-19 has disproportionately impacted communities of color within the United States. As schools have shifted from virtual to in-person learning, continual guidance is necessary to understand appropriate interventions to prevent SARS-CoV-2 transmission. Weekly testing of students and staff for SARS-CoV-2 within K-12 school setting could provide an additional barrier to school-based transmission, especially within schools unable to implement additional mitigation strategies and/or are in areas of high transmission. This study seeks to understand the role that weekly SARS-CoV-2 testing could play in K-12 schools. In addition, through qualitative interviews and listening sessions, this research hopes to understand community concerns and barriers regarding COVID-19 testing, COVID-19 vaccine, and return to school during the COVID-19 pandemic. METHODS/DESIGN: Sixteen middle and high schools from five school districts have been randomized into one of the following categories: (1) Weekly screening + symptomatic testing or (2) Symptomatic testing only. The primary outcome for this study will be the average of the secondary attack rate of school-based transmission per case. School-based transmission will also be assessed through qualitative contact interviews with positive contacts identified by the school contact tracers. Lastly, new total numbers of weekly cases and contacts within a school-based quarantine will provide guidance on transmission rates. Qualitative focus groups and interviews have been conducted to provide additional understanding to the acceptance of the intervention and barriers faced by the community regarding SARS-CoV-2 testing and vaccination. DISCUSSION: This study will provide greater understanding of the benefit that weekly screening testing can provide in reducing SARS-CoV-2 transmission within K-12 schools. Close collaboration with community partners and school districts will be necessary for the success of this and similar studies. TRIAL REGISTRATION: NCT04875520 . Registered May 6, 2021.

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OBJECTIVE: To elucidate the performance of a shock-absorbing floor material with a mechanical metamaterial (MM-flooring) structure and its effect on the gait and balance of older adults. METHODS: The drop-weight impact was applied to evaluate the shock-absorbing performance. The falling weight was adjusted equivalent to the energy exerted on the femur of an older woman when she falls, which was evaluated on the MM-flooring and six other flooring materials.Nineteen healthy people over the age of 65 years participated in the gait and balance evaluations. The timed up and go and two-step tests were adopted as gait performance tests, and the sway-during-quiet-balance test with force plates and the functional reach test (FRT) were adopted as balance tests. All the participants underwent these tests on the MM-flooring, shock-absorbing mat and rigid flooring. RESULTS: The shock-absorbing performance test revealed that MM-flooring has sufficient shock-absorbing performance, and suggesting that it may reduce the probability of fractures in the older people when they fall. The results of the gait performance test showed that the participants demonstrated the same gait performance on the MM-flooring and the rigid floor. In the quiet standing test, MM-flooring did not affect the balance function of the participants to the same extent as the rigid floor, compared with the shock-absorbing mat. In the FRT, no significant differences were found for any of the flooring conditions. CONCLUSIONS: MM-flooring has the potential to prevent fractures attributed to falls and does not affect the gait or balance of older adults.

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Convalescent plasma therapy has shown controversial results in coronavirus disease-19 (COVID-19) patients. We performed a non-randomized case-control study with contemporaneous controls in a hospital in southern Brazil. Patients were selected for treatment with convalescent plasma by medical decision and compared with patients who did not receive plasma and were hospitalized due to COVID-19 at the same time. The outcomes of interest were intensive care unit (ICU) admission and in-hospital death. Patients that received convalescent plasma had lower in-hospital mortality than patients that did not receive plasma (relative risk (RR) 0.48; 95% confidence interval (CI) 0.29 to 0.79) and these results were consistent after changing the subset of control patients. There were no differences regarding ICU admission between groups (RR=0.80; 95%CI: 0.47 to 1.35). In this study, patients that received convalescent plasma for COVID-19 had lower in-hospital mortality, but this finding requires further confirmation given the retrospective nature of the study.

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OBJECTIVES: For the first time to present a systematic review of observational studies on the efficiency of lithium monotherapy in comparison with other maintenance mood stabilizers in monotherapy and in combination. METHODS: As part of the International Society for Bipolar Disorders (ISBD) Task Force on Lithium Treatment, we undertook a systematic literature search of non-randomized controlled observational studies on (i) lithium monotherapy vs treatment with another maintenance mood stabilizer in monotherapy and (ii) lithium in combination with other mood stabilizers vs monotherapy. RESULTS: In eight out of nine identified studies including a total of < 14 000 patients, maintenance lithium monotherapy was associated with improved outcome compared with another mood stabilizer in monotherapy, including valproate, lamotrigine, olanzapine, quetiapine, unspecified anticonvulsants, carbamazepine/lamotrigine, unspecified atypical antipsychotics and unspecified antipsychotics. Among the four identified studies including a total of > 4000 patients comparing maintenance combination therapy with maintenance monotherapy, a few combination therapies were found to be superior to monotherapy in some analyses, but many were not. CONCLUSIONS: The results show the superiority in real life of lithium monotherapy compared with monotherapy with other maintenance mood stabilizers. The four largest register-based studies largely addressed confounding, but, as ever, residual confounding cannot be excluded. Nevertheless, the observational findings substantially add to the findings from randomized controlled trials, whose designs often limit the validity of comparison between medicines.

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The objective of this study was to quantify the efficacy of using individual calving pens (ICP) from which manure was removed between successive calving compared with group calving pens (GCP) for limiting transmission of Mycobacterium avium subsp paratuberculosis (MAP) in Holstein calves. Every other pregnant cow in three Minnesota MAP endemic herds was assigned to calve in either the ICP or the GCP within 48-72 h prior to expected calving. Heifer calves born in the ICP were assigned to the intervention group (n=238) while heifer calves born in the GCP were considered controls (n=211). Calves were separated from their dams as soon as was possible once the calf was found. The intervention within the ICP relative to the GCP was the removal of fecal material in the ICP immediately after each birth. Upon enrollment in 2005, calves were monitored into adulthood. Of the original animals enrolled, 318 were tested for MAP at least once in 2007, 2009, or 2010 using serum ELISA (ICP, n=165; GCP, n=141) and bacterial culture of feces (ICP, n=173; GCP, n=145) tests. Cox regression analysis was performed to evaluate the time until MAP test positivity. Cows born in the ICP had a hazard ratio of 0.37 (95% CI=0.34-0.4) for testing MAP serum ELISA positive, compared with cows born in GCP. Similarly, cows born in the ICP had a hazard ratio of 0.09 (95% CI=0.06-0.14) for testing MAP fecal culture positive, compared with cows born in GCP. The Cox proportional-hazard assumption was violated in both models such that differences observed in the instantaneous hazards of MAP positive outcomes between groups (ICP vs. GCP) subsequently diminished overtime. These findings indicate that using ICP for calving delays exposure to MAP in calves and provides an effective strategy for reducing peripartum MAP transmission risks in herds attempting to limit the impact of paratuberculosis.

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BACKGROUND: Since the Korean Journal of Family Medicine (KJFM) started publishing in 1980, randomized controlled trials (RCTs) and non-randomized controlled studies (NRSs) consistently have increased in quality and quantity. Although there have been several studies on the quality assessment of RCTs in Korea, there has been no study on quality assessment of NRSs. Thus, this study evaluated NRS in the KJFM to assess the quantity and quality. METHODS: Upon extracting NRSs for assessing the intervention effects from all the articles published in the KJFM from 1980 to 2006, assessments were made on methodological index for non-randomized studies (MINORS). Also, the analysis were made upon the proportion of NRSs within original articles according to two categories (comparative study, noncomparative study). The mean scores by research methods and years, and total scores and mean scores of yearly research methods were analyzed. RESULTS: A total of 34 trials on NRSs were selected. In 1980s, 0.65% of the total selected original articles, in 1990s, 1.54%, and in 2000s 5.11% were NRSs. According to the research designs, the mean scores of MINORS were before and after study 8.5, interrupted Time Series 9.7 (out of 16), controlled before and after 13.5, quasi randomized trial 12.6, and non randomized trial 13 (out of 24). Before and after design was the most frequently used (55.9%). CONCLUSION: Although NRSs consistently increased in quantity, the assessed mean scores were low and most articles used before and after design. Thus, there should be studied using appropriate research methods in the future.

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