The Efficacy of a New AMCOP® Elastodontic Protocol for Orthodontic Interceptive Treatment: A Case Series and Literature Overview

Background: Elastodontics is a specific interceptive orthodontic treatment that uses removable elastomeric appliances. They are functional appliances that produce neuromuscular, orthopedic and dental effects. Thus, these devices are useful in the developmental age, when skeletal structures are characterized by important plasticity and adaptation capacity, allowing to remove factors responsible for malocclusions. Elastomeric devices are generally well tolerated by patients requiring simple collaboration and management. This work can be useful to update all orthodontists already adopting these appliances or for those who want to approach them for the first time. This study aimed to describe four cases treated with new elastomeric devices called AMCOP Bio-Activators and to provide an overview of elastodontics, its evolution, indications and limits. Methods: A total of four clinical cases were presented after a treatment period of 16–20 months to evaluate the clinical and radiological effects of the elastodontic therapy. Results: The effectiveness of Bio-Activators on clinical cases was evidenced with a significant improvement in skeletal and dentoalveolar relationship, and malocclusion correction in a limited treatment period (16–20 months). Conclusions: The Bio-Activators showed clinical effectiveness to achieve therapeutic targets according to a low impact on the patient’s compliance.

A qualitative analysis of dental professionals’ beliefs and concerns about providing aerosol generating procedures early in the COVID-19 pandemic

Introduction In response to the COVID-19 pandemic, the Scottish Dental Clinical Effectiveness Programme (SDCEP) initiated a rapid review of the evidence related to the generation and mitigation of aerosols in dental practice. To support this review, a survey was distributed to better understand the provision of aerosol generating procedures (AGPs) in dentistry. Methods An online questionnaire was distributed to dental professionals asking about their current practice and beliefs about AGPs. Data were analysed using qualitative content analysis. Results Analysis revealed confusion and uncertainty regarding mitigation of AGPs. There was also frustration and scepticism over the risk of SARS-COV-2 transmission within dental settings, the evidence underpinning the restrictions and the leadership and guidance being provided, as well as concern over financial implications and patient and staff safety. Discussion The frustration and concerns expressed by respondents mirrored findings from other recent studies and suggest there is a need for reflection within the profession so that lessons can be learned to better support staff and patients. Conclusion Understanding the profession’s views about AGP provision contributed to the SDCEP rapid review and provides insights to help inform policymakers and leaders in anticipation not only of future pandemics but in considering the success of any large scale and/or rapid organisational change.

Tucatinib (Tukysa)

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec. This review assesses tucatinib (Tukysa), 50 mg and 150 mg tablets, orally. Tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and T-DM1 separately or in combination.

Azacitidine (Onureg)

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec. This review assesses azacitidine (Onureg), tablet 300 mg, oral. Indication: Maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation.

Intense Pulsed Light Combined With Meibomian Gland Massage for Recurrent Corneal Erosion: a Review of Clinical Effectiveness

Purpose: To observe the therapeutic effect on recurrent corneal erosion syndrome (RCES) by intense pulsed light (IPL) combined with meibomian gland massage. Methods: We recruited 30 patients (30 eyes) with RCES as the RCES group and 31 patients (31 eyes) as the control group. Both the groups received eyelash sampling, Demodex count, meibomian gland infrared photography, and the blepharolipin score. The RCES group was divided into the treatment group and the observation group again. Results: Parameters in the RCES group were higher than those in the control group. The parameters of the treatment group were decreased compared with the observation group. During the follow-up period, one patient in the treatment group relapsed. Conclusion: Meibomian gland dysfunction and Demodex infection may be associated with RCES. IPL combined with meibomian gland massage can significantly improve meibomian gland function, reduce the number of Demodex, and effectively control the relapse of RCES.

Cost and Toxicity Comparisons of Two IMRT Techniques for Prostate Cancer: A Micro-Costing Study and Weighted Propensity Score Analysis Based on a Prospective Study

BackgroundIntensity modulated radiation therapy (IMRT) combined with androgen deprivation therapy (ADT) has become the standard treatment for patients with high-risk prostate cancer. Two techniques of rotational IMRT are commonly used in this indication: Volumetric Modulated Arc Therapy (VMAT) and helical tomotherapy (HT). To the best of our knowledge, no study has compared their related costs and clinical effectiveness and/or toxicity in prostate cancer. We aimed to assess differences in costs and toxicity between VMAT and HT in patients with high-risk prostate cancer with pelvic irradiation.Material and MethodsWe used data from the “RCMI pelvis” prospective multicenter study (NCT01325961) including 155 patients. We used a micro-costing methodology to identify cost differences between VMAT and HT. To assess the effects of the two techniques on total actual costs per patient and on toxicity we used stabilized inverse probability of treatment weighting.ResultsThe mean total cost for HT, €2019 3,069 (95% CI, 2,885–3,285) was significantly higher than the mean cost for VMAT €2019 2,544 (95% CI, 2,443–2,651) (p <.0001). The mean ± SD labor and accelerator cost for HT was €2880 (± 583) and €1978 (± 475) for VMAT, with 81 and 76% for accelerator, respectively. Acute GI and GU toxicity were more frequent in VMAT than in HT (p = .021 and p = .042, respectively). Late toxicity no longer differed between the two groups up to 24 months after completion of treatment.ConclusionUse of VMAT was associated with lower costs for IMRT planning and treatment than HT. Similar stabilized long-term toxicity was reported in both groups after higher acute GI and GU toxicity in VMAT. The estimates provided can benefit future modeling work like cost-effectiveness analysis.

Systematic review and meta-analysis of clinical effectiveness of self-management interventions in Parkinson’s disease

Background Parkinson’s disease is a complex neurodegenerative condition with significant impact on quality of life (QoL), wellbeing and function. The objective of this review is to evaluate the clinical effectiveness of self-management interventions for people with Parkinson’s disease, taking a broad view of self-management and considering effects on QoL, wellbeing and function. Methods Systematic searches of four databases (MEDLINE, Embase, PsycINFO, Web of Science) were conducted for studies evaluating self-management interventions for people with Parkinson’s disease published up to 16th November 2020. Original quantitative studies of adults with idiopathic Parkinson’s disease were included, whilst studies of atypical Parkinsonism were excluded. Full-text articles were independently assessed by two reviewers, with data extracted by one reviewer and reliability checked by a second reviewer, then synthesised through a narrative approach and, for sufficiently similar studies, a meta-analysis of effect size was conducted (using a random-effects meta-analysis with restricted maximum likelihood method pooled estimate). Interventions were subdivided into self-management components according to PRISMS Taxonomy. Risk of bias was examined with the Cochrane Risk of Bias 2 (RoB2) tool or ROBIN-I tool as appropriate. Results Thirty-six studies were included, evaluating a diverse array of interventions and encompassing a range of study designs (RCT n = 19; non-randomised CT n = five; within subject pre- and post-intervention comparisons n = 12). A total of 2884 participants were assessed in studies across ten countries, with greatest output from North America (14 studies) and UK (six studies). Risk of bias was moderate to high for the majority of studies, mostly due to lack of participant blinding, which is not often practical for interventions of this nature. Only four studies reported statistically significant improvements in QoL, wellbeing or functional outcomes for the intervention compared to controls. These interventions were group-based self-management education and training programmes, either alone, combined with multi-disciplinary rehabilitation, or combined with Cognitive Behaviour Therapy; and a self-guided community-based exercise programme. Four of the RCTs evaluated sufficiently similar interventions and outcomes for meta-analysis: these were studies of self-management education and training programmes evaluating QoL (n = 478). Meta-analysis demonstrated no significant difference between the self-management and the control groups with a standardised mean difference (Hedges g) of − 0.17 (− 0.56, 0.21) p = 0.38. By the GRADE approach, the quality of this evidence was deemed “very low” and the effect of the intervention is therefore uncertain. Components more frequently observed in effective interventions, as per PRISMS taxonomy analysis, were: information about resources; training or rehearsing psychological strategies; social support; and lifestyle advice and support. The applicability of these findings is weakened by the ambiguous and at times overlapping nature of self-management components. Conclusion Approaches and outcomes to self-management interventions in Parkinson’s disease are heterogenous. There are insufficient high quality RCTs in this field to show effectiveness of self-management interventions in Parkinson’s disease. Whilst it is not possible to draw conclusions on specific intervention components that convey effectiveness, there are promising findings from some studies, which could be targeted in future evaluations.

Cost-effectiveness of the anti-fibrotics for the treatment of idiopathic pulmonary fibrosis in the United States

Background The anti-fibrotic medications nintedanib and pirfenidone were approved in the United States for use in patients with idiopathic pulmonary fibrosis several years ago. While there is a growing body of evidence surrounding their clinical effectiveness, these medications are quite expensive and no prior cost-effectiveness analysis has been performed in the United States. Methods A previously published Markov model performed in the United Kingdom was replicated using United States data to project the lifetime costs and health benefits of treating idiopathic pulmonary fibrosis with: (1) symptom management; (2) pirfenidone; or (3) nintedanib. For the cost-effectiveness analysis, strategies were ranked by increasing costs and then checked for dominating treatment strategies. Then an incremental cost-effectiveness ratio was calculated for the dominant therapy. Results The anti-fibrotic medications were found to cost more than $110,000 per year compared to $12,291 annually for symptom management. While pirfenidone was slightly more expensive than nintedanib and provided the same amount of benefit, neither medication was found to be cost-effective in this U.S.-based analysis, with an average cost of $1.6 million to gain one additional quality-adjusted life year over symptom management. Conclusions Though the anti-fibrotics remain the only effective treatment option for patients with idiopathic pulmonary fibrosis and the data surrounding their clinical effectiveness continues to grow, they are not considered cost-effective treatment strategies in the United States due to their high price.

Preemptive pharmacogenetic testing to guide chemotherapy dosing in patients with gastrointestinal malignancies: a qualitative study of barriers to implementation

Background Pharmacogenetic (PGx) testing for germline variants in the DPYD and UGT1A1 genes can be used to guide fluoropyrimidine and irinotecan dosing, respectively. Despite the known association between PGx variants and chemotherapy toxicity, preemptive testing prior to chemotherapy initiation is rarely performed in routine practice. Methods We conducted a qualitative study of oncology clinicians to identify barriers to using preemptive PGx testing to guide chemotherapy dosing in patients with gastrointestinal malignancies. Each participant completed a semi-structured interview informed by the Consolidated Framework for Implementation Research (CFIR). Interviews were analyzed using an inductive content analysis approach. Results Participants included sixteen medical oncologists and nine oncology pharmacists from one academic medical center and two community hospitals in Pennsylvania. Barriers to the use of preemptive PGx testing to guide chemotherapy dosing mapped to four CFIR domains: intervention characteristics, outer setting, inner setting, and characteristics of individuals. The most prominent themes included 1) a limited evidence base, 2) a cumbersome and lengthy testing process, and 3) a lack of insurance coverage for preemptive PGx testing. Additional barriers included clinician lack of knowledge, difficulty remembering to order PGx testing for eligible patients, challenges with PGx test interpretation, a questionable impact of preemptive PGx testing on clinical care, and a lack of alternative therapeutic options for some patients found to have actionable PGx variants. Conclusions Successful adoption of preemptive PGx-guided chemotherapy dosing in patients with gastrointestinal malignancies will require a multifaceted effort to demonstrate clinical effectiveness while addressing the contextual factors identified in this study.

Safety, Effectiveness, and Professional Judgment: A Survey of Training-Related Perspectives Among Physiotherapists Who Practise Acupuncture in Ontario

Purpose: Physiotherapists practise various forms of acupuncture worldwide, but no international consensus exists as to the appropriate duration of related training programs. In this cross-sectional study, we aimed to characterize the training-related backgrounds and views of acupuncture-practising physiotherapists. Method: A total of 426 physiotherapists who practised acupuncture in Ontario completed an online survey that included training-related items and an open-ended question (39 provided training-related responses). Statistical analyses included multivariate and multinomial logistical regression models. Thematic analysis was used to interpret respondents’ textual responses to the open-ended question. Results: Respondents, who practised predominantly Western medical acupuncture, dry needling, or both, had completed acupuncture-related training programs ranging from < 25 to ≥ 300 hours. Those who had completed programs lasting > 100 hours were significantly more likely to self-report excellent clinical results and an enhanced ability both to recruit and retain patients and to earn a higher income. They were also more likely to endorse longer trainings as necessary for safe and effective patient care. Respondents to the open-ended question expressed a range of views, including the need for more stringent training requirements. Conclusions: PT regulatory requirements for longer (>100 hour) acupuncture trainings may better support clinical effectiveness and safety, patient satisfaction, and professional outcomes.