A methodological guide for implementing and interpreting results of probabilistic analysis.

Introduction: Probabilistic analysis, also referred to as probabilistic sensitivity analysis (PSA), is used extensively in cost-effectiveness evaluations of health technologies. We present methodological guidance for implementing probabilistic analysis and interpreting its results for policy and decision-making.

Methods: We review the methodological issues related to common practices in probabilistic analysis, explore aspects that are currently not widely addressed in the health economics literature, and provide an overview of recent methodological developments.

Evaluating the correlations of cost and utility parameters from summary statistics for probabilistic analysis in economic evaluations.

Objectives: The correlations between economic modeling input parameters directly impact the variance and may impact the expected values of model outputs. However, correlation coefficients are not often reported in the literature. We aim to understand the correlations between model inputs for probabilistic analysis from summary statistics.

Examining the correlation between treatment effects in clinical trials and economic modeling.

Introduction: Many diseases have a sequential treatment pathway. Compared with patients without previous treatment, patients who fail initial treatment may have lower success rates with a second treatment. This phenomenon can be explained by a correlation between treatment effects.

Cost-effectiveness of noninvasive fetal RhD blood group genotyping in nonalloimmunized and alloimmunized pregnancies.

Background: We sought to determine the cost-effectiveness of noninvasive fetal RhD blood group genotyping in nonalloimmunized and alloimmunized pregnancies in Canada.

Study Design And Methods: We developed two probabilistic state-transition (Markov) microsimulation models to compare fetal genotyping followed by targeted management versus usual care (i.e.

Noninvasive Fetal RhD Blood Group Genotyping: A Systematic Review of Economic Evaluations.

Objective: Noninvasive fetal rhesus D (RhD) blood group genotyping may prevent unnecessary use of anti-D immunoglobulin (RhIG) in non-alloimmunized RhD-negative pregnancies and can guide management of alloimmunized pregnancies. We conducted a systematic review of the economic literature to determine the cost-effectiveness of this intervention over usual care.

Data Sources: Systematic literature searches of bibliographic databases (Ovid MEDLINE, Embase, and Cochrane) until February 26, 2019, and auto-alerts until October 30, 2020, and of grey literature sources were performed to retrieve all English-language studies.

A Non-inferiority Framework for Cost-Effectiveness Analysis.

Background: Traditional decision rules have limitations when a new technology is less effective and less costly than a comparator. We propose a new probabilistic decision framework to examine non-inferiority in effectiveness and net monetary benefit (NMB) simultaneously. We illustrate this framework using the example of repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT) for treatment-resistant depression.

Comparison of the expected rewards between probabilistic and deterministic analyses in a Markov model.

: In Markov models that evaluate the cost-effectiveness of health-care technologies, it is generally recommended to use probabilistic analysis instead of deterministic analysis. We sought to compare the performance of probabilistic and deterministic analysis in estimating the expected rewards in a Markov model.: We applied Jensen's inequality to compare the expected Markov rewards between probabilistic and deterministic analysis and conducted a simulation study to compare the bias and accuracy between the two approaches.

Incident Fragility Fractures Have a Long-Term Negative Impact on Health-Related Quality of Life of Older People: The Canadian Multicentre Osteoporosis Study.

Although the short-term impact of incident fragility fractures on health-related quality of life (HRQL) of older people has been confirmed, we lack long-term evidence. We explored the impact of incident fragility fractures on HRQL, among people aged 50 years and older, using 10-year prospective data from the Canadian Multicentre Osteoporosis Study (CaMos). This study was based on data from 7753 (2187 men and 5566 women) participants of CaMos.

Cost-Effectiveness of Magnetic Resonance-Guided Focused Ultrasound for Essential Tremor.

Background: Radiofrequency thalamotomy and deep brain stimulation are current treatments for moderate to severe medication-refractory essential tremor. However, they are invasive and thus carry risks. Magnetic resonance-guided focused ultrasound is a new, less invasive surgical option.

Getting fit for hip and knee replacement: a protocol for the Fit-Joints pilot randomized controlled trial of a multi-modal intervention in frail patients with osteoarthritis.

Background: Joint replacement provides significant improvements in pain, physical function, and quality of life in patients with osteoarthritis. With a growing body of evidence indicating that frailty can be treated, it is important to determine whether targeting frailty reduction in hip and knee replacement patients improves post-operative outcomes.

Objectives: The primary objective is to examine the feasibility of a parallel group RCT comparing a preoperative multi-modal frailty intervention to usual care in pre-frail/frail older adults undergoing elective unilateral hip or knee replacements.

The reporting quality of abstracts of stepped wedge randomized trials is suboptimal: A systematic survey of the literature.

Background: The stepped wedge trial (SWT) design is a type of the randomized clinical trial (RCT) design in which clusters or individuals are randomly and sequentially crossed over from control to intervention over a number of time periods. Trials using SWT design have become increasingly popular in medical, behavioral and social sciences research. Therefore, complete and transparent reporting of these studies is crucial.

Osteoporotic fractures and obesity affect frailty progression: a longitudinal analysis of the Canadian multicentre osteoporosis study.

Background: Despite knowing better how to screen older adults, understanding how frailty progression might be modified is unclear. We explored effects of modifiable and non-modifiable factors on changes in frailty in community-dwelling adults aged 50+ years who participated in the Canadian Multicentre Osteoporosis Study (CaMos).

Methods: Rates of change in frailty over 10 years were examined using the 30-item CaMos Frailty Index (CFI).

Reporting quality of stepped wedge design randomized trials: a systematic review protocol.

Background: Stepped wedge design (SWD) is a cluster randomized controlled trial (RCT) design that sequentially rolls out intervention to all clusters at varying time points. Being a relatively new design method, reporting quality has yet to be explored, and this review will seek to fill this gap in knowledge.

Objectives: The objectives of this review are: 1) to assess the quality of SWD trial reports based on the CONSORT guidelines or CONSORT extension to cluster RCTs; 2) to assess the completeness of reporting of SWD trial abstracts using the CONSORT extension for abstracts; 3) to assess the reporting of sample size details in SWD trial reports or protocols; 4) to assess the completeness of reporting of SWD trial protocols according to SPIRIT guidelines; 5) to assess the consistency between the trial registration information and final SWD trial reports; and 6) to assess the consistency of what is reported in the abstracts and main text of the SWD trial reports.

Effects of Long-Term Low-Molecular-Weight Heparin on Fractures and Bone Density in Non-Pregnant Adults: A Systematic Review With Meta-Analysis.

Background: Adults who require long-term anticoagulation with low-molecular-weight heparin (LMWH) such as cancer patients or the elderly may be at increased risk of fractures.

Objective: To determine the effects of LMWH therapy of at least 3 months' duration on fractures and bone mineral density (BMD) in non-pregnant adult populations.

Methods: We systematically reviewed electronic databases (e.

A tutorial on Bayesian bivariate meta-analysis of mixed binary-continuous outcomes with missing treatment effects.

Bivariate random-effects meta-analysis (BVMA) is a method of data synthesis that accounts for treatment effects measured on two outcomes. BVMA gives more precise estimates of the population mean and predicted values than two univariate random-effects meta-analyses (UVMAs). BVMA also addresses bias from incomplete reporting of outcomes.

Odanacatib for the treatment of osteoporosis.

Introduction: Osteoporosis and fragility fractures are important public health concerns. Cathepsin K inhibitors, including odanacatib , are a novel class of medications for osteoporosis whose mechanism of action is to directly inhibit bone resorption without killing osteoclasts, thereby permitting the complex coupling between bone resorption and formation to continue.

Areas Covered: The physiological basis for the mechanism of action of cathepsin K inhibitors is covered in addition to a review of the preclinical, Phase I, Phase II and preliminary Phase III trial data of odanacatib.

Effect of odanacatib on BMD and fractures: estimates from Bayesian univariate and bivariate meta-analyses.

Context: Odanacatib (ODN), a selective cathepsin-K inhibitor, was found to increase bone mineral density (BMD); the effect on fractures is based on adverse event reports.

Objective: To estimate current effects and predict future effects of ODN on BMD and fractures.

Data Sources: Electronic databases (Medline, EMBASE, Cochrane Library), conference proceedings, and bibliographies.

Vitamin K and bone health.

Vitamin K has been purported to play an important role in bone health. It is required for the gamma-carboxylation of osteocalcin (the most abundant noncollagenous protein in bone), making osteocalcin functional. There are 2 main forms (vitamin K1 and vitamin K2), and they come from different sources and have different biological activities.

The choice of a noninformative prior on between-study variance strongly affects predictions of future treatment effect.

Purpose: Bayesian random-effects meta-analyses require the analyst to specify the prior distribution for between-study variance of the treatment effect. We assessed the sensitivity of prediction and other outputs of the meta-analysis to the choice of this prior.

Methods: We reanalyzed 7 published meta-analyses (5-14 trials) with rare (event rates <5%), moderate (15%-50%), and frequent binary outcomes (>50%).

Women trafficked into prostitution: determinants, human rights and health needs.

Human trafficking is an international challenge that increasingly affects industrialized countries. It represents a gross violation of a person's right to liberty and freedom of movement, and is often accompanied by violence and degrading treatment which can have detrimental effects on health. In this article, we review the definition and extent of human trafficking, and focus on the human rights abuses and determinants of trafficking in women.

[Analysis of mortality in cancer of the large intestine in a cohort group in Serbia from 1971 to 1996].

Colorectal cancer is one of the most frequent malignant neoplasms in both sexes within developed countries. In the Republic of Serbia(Serbia), colorectal cancer mortality in 1971 range 5 in females, and 4 in males; it became the second leading malignancy in 1982 in females (after breast cancer), and in 1992 in males (after lung cancer). The objective of this descriptive-epidemiological study was to examine colorectal cancer mortality in Serbian population, particularly the effect of cohort variations on death rates in defined age groups over the period 1971-1996.