By J. Tufail. Northwest Missouri State University.
Effectiveness of HeLP versus usual practice Data presented in Chapter 3 have reported that there is no evidence that HeLP is more effective than usual practice generic 250mg diamox mastercard. Table 9 reports no statistically significant differences between HeLP participants and controls at 24-month follow up on the primary outcome measure of BMI SDS order 250mg diamox fast delivery. The Exeter Obesity Model estimates cost-effectiveness with a starting premise that an intervention has shown a difference in effectiveness that can be translated to a reduction in the relative risk associated with being in BMI SDS weight status categories associated with overweight and/or obesity discount diamox 250mg amex, using the BMI centile categories applied in the base data drawn from Power et al. This model structure allows a comparison of a cohort of children over time, with and without the intervention. The results from the HeLP RCT do not show reductions in the relative risk for being in states aligned to overweight and/or obesity, finding no statistically significant difference between the intervention group and the control group (see Table 11). Cost-effectiveness of HeLP versus usual practice Given the effectiveness profile for the HeLP intervention, there is no expectation, using the Exeter Obesity Model framework, that there will be any improvements in the likely incidence of the weight-related health events (CHD, stroke, T2DM and CRC), or cost savings to the health and social care system associated with weight-related events. This profile, together with a certain expectation that the introduction of the HeLP intervention is associated with additional resource use and costs, in the short term, leads to the clear conclusion that HeLP is not considered to be a cost-effective alternative to usual practice. HeLP does not offer value for money to the UK health-care system, compared with usual practice. As this is a clear and unambiguous outcome, consistent with agreement with the TSC, no further detailed cost-effectiveness analysis is presented here. We have presented detailed cost analysis and results on the estimated expected mean incremental cost per child for delivery of the HeLP intervention, together with estimates of expected additional costs per school (per class). Exploratory cost-effectiveness analyses using the Exeter Obesity Model Predicted results for control participants In the HeLP RCT the distribution of children starting the trial and at 24-month follow-up by weight status categories, as centile categories used by Power et al. Outcome (HeLP) (usual practice) control) Mean BMI SDS (SD)a (n = 650) 0. TABLE 34 Summary of weight status profile by group at childhood and by adult predicted profile Group HeLP Control (usual practice) Weight status category Baseline 24 months Baseline 24 months BMI centile category (Power et al. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals 65 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. ECONOMIC EVALUATION When modelling the experiences of a cohort (n = 1000) of children defined using the weight status data for the control participants in the HeLP study, we predict that at age 33 years the cohort will result in an adult cohort with 49% overweight or obese adults and 51% healthy weight adults. These 252 events comprise 76 cases of CHD, 105 cases T2DM, 28 cases of CRC and 42 cases of stroke; 675 participants remain event free at age 62–63 years. The mean per participant cost associated with those events is estimated at £1140 (£6821 undiscounted; £3145 discounted at 1. Over the 30-year time horizon (30 adult-years) where events, costs and event related outcomes are estimated, in addition to all-cause mortality, the mean number of life-years per participant is 26. Of note, overall we are modelling life expectancy over a 50-year time horizon, with specific payoffs (future costs and outcomes for health events) captured in the latter 30 years. The modelling framework developed to assess the cost-effectiveness of interventions such as HeLP is dependent on identifying a beneficial (effective) intervention, with effectiveness reflected through an improved weight status profile in childhood. That mechanism of effect provides an opportunity to consider the future potential impact of a change in childhood weight status, into adult years, and the estimation of that effect over adult years through a reduction in future incidence of a core set of weight-related health events. When applying the data from the HeLP exploratory trial (crude unadjusted relative risks, by BMI SDS category), the modelling framework indicates that HeLP has the potential to be a cost-effective intervention (see scenario analyses E in Table 35). This is primarily due to the reduced number of participants in the HeLP exploratory trial intervention arm, compared with the number in the control arm, who ended up in the childhood weight status category associated with obesity. However, the sample size in the exploratory trial was very small, and the distributions by weights status in the intervention and control arms were not balanced at baseline, given that the study design was for an exploratory trial, and feasibility research. Here, to illustrate the use of the modelling framework, and to illustrate the potential scenarios in which an intervention such as HeLP may be considered cost-effective, we present a series of scenario analyses in Table 35 describing alternative weight status profiles for a potential hypothetical treatment group, compared with the data reported for the HeLP control participants (standardised to a cohort of n = 1000). In these exploratory analyses we have used the inputs on expected additional costs for the HeLP intervention, and the data on the weight status of the control participants in HeLP at 24-month follow-up, to explore the cost-effectiveness of the HeLP intervention at hypothetical scenarios on intervention effectiveness [i. We use hypothetical estimates of the relative risk, between controls and intervention, and we present data on predicted distribution by adult weight status, and summary data on weight related events, cost per life-year saved and cost per QALY gained. The exploratory results demonstrate that when the relative risks are ≥ 0. We therefore suggest that relatively modest effectiveness results may lead to a scenario in which an intervention is cost-effective, regardless of the apparent magnitude of the estimated relative risk (for small proportions of the cohort). We advise that the exploratory results presented here should not be interpreted in a way that indicates that interventions may be cost-effective only when dramatic effects are seen. The exploratory results also illustrate that when considering the impacts of such a public health intervention over time, the mean incremental costs and outcomes are very small, and the cost per life-year gained, and cost per QALY gained, 66 NIHR Journals Library www. N te B as e line / s tarting d is tribution ( s tand ard is e d to coh ort, M I S D S ce ntile s t, M I S D S ce ntile s t to th M I S D S ce ntile th to th M I S D S ce ntile th ECONOMIC EVALUATION estimates are very sensitive to small changes in the mean incremental inputs to the cost-effectiveness ratios. Furthermore, the exploratory results highlight that the results are sensitive to the parameter used to discount future costs and outcomes, with cost-effectiveness estimates markedly different (more attractive) when using a discount rate of 1.
Inclusion and Exclusion Criteria The PICOTS (Populations cheap diamox online visa, Interventions purchase 250mg diamox otc, Comparators purchase diamox 250 mg otc, Outcomes, Timings, and Settings of interest) criteria used to screen articles for inclusion/exclusion at both the title-and-abstract and full-text screening stages are detailed in Table 1. Inclusion and exclusion criteria PICOTS Element Inclusion Criteria Exclusion Criteria Populations • Humans • Patients who have known • Adults (age ≥ 18 years of age) reversible causes of AF (including • Patients with AF (includes atrial flutter) but not limited to postoperative, o Paroxysmal AF (recurrent episodes that self- postmyocardial infarction, terminate in less than 7 days) hyperthyroidism) o Persistent AF (recurrent episodes that last more • All subjects are <18 years of age, than 7 days) or some subjects are under <18 o Permanent AF (an ongoing, long-term episode) years of age but results are not • Subgroups of potential interest include: broken down by age o Patients stratified by age (≤ 40, 41–64, 65–74, 75–84, 85+) o Patients with different types of AF (paroxysmal, persistent, permanent) o Patients with specific comorbidities (heart failure, coronary artery disease, kidney disease, hypertrophic cardiomyopathy, thyroid disease, pulmonary disease) o Patients for whom a prior rate- (KQ 3) or rhythm- control (KQ 5) pharmacological strategy was ineffective o Women o Patients with an enlarged left atrium o Patients at high risk for stroke and bleeding events (patients with diabetes, heart failure, and hypertension) 8 Table 1. Inclusion and exclusion criteria (continued) PICOTS Element Inclusion Criteria Exclusion Criteria Interventions • Pharmacological agents for rate control (KQ 1, KQ 2, • Studies comparing different KQ 3, KQ 6): imaging or mapping techniques o Beta blockers (e. Inclusion and exclusion criteria (continued) PICOTS Element Inclusion Criteria Exclusion Criteria Outcomes Study assesses a patient-centered outcome of interest: Study does not include any outcomes • Intermediate outcomes: of interest o Restoration of sinus rhythm (conversion) o Maintenance of sinus rhythm o Recurrence of AF at 12 months o Ventricular rate control o Development of cardiomyopathy a • Final outcomes: o Mortality (all-cause, cardiovascular) o Myocardial infarction o Cardiovascular hospitalizations (including AF hospitalizations) o Heart failure symptoms o Control of AF symptoms (e. Abbreviations: AF=atrial fibrillation; AVN=atrioventricular node; CRT=cardiac resynchronization therapy; KQ=Key Question; ICD=implantable cardioverter defibrillator; PICOTS=Populations, Interventions, Comparators, Outcomes, Timing, Settings; RCTs=randomized controlled trials 10 Study Selection Using the prespecified inclusion and exclusion criteria described in Table 1, two investigators independently reviewed titles and abstracts for potential relevance to the KQs. Articles included by either reviewer underwent full-text screening. At the full-text review stage, paired researchers independently reviewed the articles and indicated a decision to “include” or “exclude” the article for data abstraction. When the two reviewers arrived at different decisions about whether to include or exclude an article, they reconciled the difference through review and discussion, or through a third-party arbitrator if needed. Full-text articles meeting our eligibility criteria were included for data abstraction. Relevant systematic review articles, meta-analyses, and methods articles were flagged for manual searching of references and cross-referencing against the library of citations identified through electronic database searching. For citations retrieved by searching the grey literature, the above-described procedures were modified such that a single screener initially reviewed all search results; final eligibility of citations for data abstraction was determined by duplicate screening review. All screening decisions were made and tracked in a Distiller SR database (Evidence Partners Inc. Data Extraction The research team created data abstraction forms and evidence table templates for abstracting data for each KQ. Based on clinical and methodological expertise, a pair of investigators was assigned to abstract data from each eligible article. One investigator abstracted the data, and the second reviewed the completed abstraction form alongside the original article to check for accuracy and completeness. To aid in both reproducibility and standardization of data collection, researchers received data abstraction instructions directly on each form created specifically for this project within the DistillerSR database. We designed the data abstraction forms to collect the data required to evaluate the specified eligibility criteria for inclusion in this review, as well as demographic and other data needed for determining outcomes (intermediate, final, and adverse events outcomes). We paid particular attention to describing the details of treatment (e. In addition, we described comparators carefully, as treatment standards may have changed during the period covered by this review. The safety outcomes were framed to help identify adverse events, including those from drug therapies (e. Data necessary for assessing quality and applicability, as described in the 22 Methods Guide, were abstracted. Before the data abstraction form templates were used, they were pilot-tested with a sample of included articles to ensure that all relevant data elements were captured and that there was consistency/reproducibility between abstractors. Forms were revised as necessary before full abstraction of all included articles. In these instances, we used the web-based software, EnGauge Digitizer (http://digitizer. Appendix B provides a detailed listing of the elements included in the data abstraction forms. We applied criteria for each study type derived from core elements described in the Methods Guide. Criteria of interest for all studies included similarity of groups at baseline, extent to which outcomes were described, blinding of subjects and providers, blinded assessment of the outcome(s), intention-to-treat analysis, and differential loss to followup between the compared groups or overall high loss to followup. Criteria specific to RCTs included methods of randomization and allocation concealment. For observational studies, additional elements such as methods for selection of participants, measurement of interventions/exposures, addressing any design-specific issues, and controlling for confounding were considered. To indicate the summary judgment of the quality of individual studies, we used the summary ratings of good, fair, or poor based on the classification scheme presented in Table 2. Definitions of overall quality ratings Quality Rating Description Good A study with the least bias; results are considered valid. A good study has a clear description of the population, setting, interventions, and comparison groups; uses a valid approach to allocate patients to alternative treatments; has a low dropout rate; and uses appropriate means to prevent bias, measure outcomes, and analyze and report results. Fair A study that is susceptible to some bias but probably not enough to invalidate the results. The study may be missing information, making it difficult to assess limitations and potential problems. As the fair-quality category is broad, studies with this rating vary in their strengths and weaknesses. The results of some fair-quality studies are possibly valid, while others are probably valid. Poor A study with significant bias that may invalidate the results.