Appraisal Program Research Articles

The Health Technology Assessment of Companion Diagnostics: Experience of NICE

Companion diagnostics are used to aid clinical decision making to identify patients who are most likely to respond to treatment. They are becoming increasingly important as more new pharmaceuticals receive licensed indications that require the use of a companion diagnostic to identify the appropriate patient subgroup for treatment. These pharmaceuticals have proven benefit in the treatment of some cancers and other diseases, and also have potential to precisely tailor treatments to the individual in the future. However, the increasing use of companion diagnostics could place a substantial burden on health system resources to provide potentially high volumes of testing. This situation, in part, has led policy makers and Health Technology Assessment (HTA) bodies to review the policies and methods used to make reimbursement decisions for pharmaceuticals requiring companion diagnostics. The assessment of a pharmaceutical alongside the companion diagnostic used in the clinical trials may be relatively straightforward, although there are a number of challenges associated with assessing pharmaceuticals where a range of alternative companion diagnostics are available for use in routine clinical practice. The UK HTA body, the National Institute for Health and Care Excellence (NICE), has developed policy for considering companion diagnostics using its Technology Appraisal and Diagnostics Assessment Programs. Some HTA bodies in other countries have also adapted their policies and methods to accommodate the assessment of companion diagnostics. Here, we provide insight into the HTA of companion diagnostics for reimbursement decisions and how the associated challenges are being addressed, in particular by NICE. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development."

The Impact of Land Property Rights Interventions on Investment and Agricultural Productivity in Developing Countries: a Systematic Review

We conducted a systematic review on the effects of land tenure recognition interventions on agricultural productivity, income, investment and other relevant outcomes. We synthesise findings from 20 quantitative studies and nine qualitative studies that passed a methodological screening. The results indicate substantial productivity and income gains from land tenure recognition, although gains differ markedly by region. We find that these effects may operate through gains in perceived tenure security and investment; we find no evidence for a credit mechanism. The qualitative synthesis highlights potential adverse effects. A conclusion emphasises the need for further research on inter-regional differences and on the role of customary tenure arrangements.

Building Goal Alignment in Federal Agencies’ Performance Appraisal Programs

Public managers wrestle with how to influence organizational performance. Results-based management approaches point to the goal alignment’s importance in performance management programs for meeting organizational goals. This research examines the extent to which federal agency organizational factors allow for performance appraisal goal alignment. Goal alignment is operationalized in two ways: embedding of strategic plan goals into employee performance plans and employee knowledge of how their work relates to the agency’s goals and priorities. Using data from U.S. Office of Personnel Management’s evaluation of federal agency appraisal programs, results indicate leadership support of the program is a determining factor of plan alignment. Communication of the organization’s goals, the climate fit for achieving results, and whether the strategic plan was written for the agency program level tend to predict employee alignment. Strategic plan level is particularly important for strategic management literature, which has limited empirical evidence for the effectiveness of program-level strategic plans.

Health technology assessments in England: an analysis of the NICE Medical Technologies Evaluation Programme

Many countries undertaking health technology assessments (HTAs) to inform decisions on the reimbursement of technologies focus solely on the analysis of pharmaceuticals [1, 2]. In the UK, the responsibility for undertaking HTAs falls mainly to the National Institute for Health and Care Excellence (NICE). NICE is an independent organisation whose role is to provide guidance on health technologies and clinical practice for the National Health Service (NHS) in England and Wales [3], and it is regarded as a world leader in the HTA field. In contrast to HTA bodies in most other countries, NICE has been given a wider remit to assess the full range of technologies (i.e. not just pharmaceuticals) [4]. There are difficulties present when assessing non-pharmaceutical health technologies, which can reduce the applicability of methods routinely used in the assessment of pharmaceuticals. Nevertheless, it is important not to undertake HTAs only on those technologies where the assessment process is straightforward, otherwise the allocation of resources between the different types of technology may be distorted by an imbalance in the information supporting decisions [2]. In order to overcome the aforementioned difficulties and ensure that the assessments of all forms of health technology are useful in decision-making, NICE has developed four appraisal programmes that are each overseen by a separate committee (technology appraisals, medical technologies, diagnostics and public health). At this point a distinction needs to be made between two sections of the NICE decision process: assessment and appraisal. An assessment is the review and analysis of data and other evidence, whereas appraisal is the a priori consideration of the evidence on benefits and costs of different courses of action in order to distinguish which is superior. The assessment of technologies is undertaken by the NICE technical team and an independent review group, with the manufacturer of the technology also having a major role. The evidence generated from this process is then passed onto one of the NICE committees, who have to make a decision regarding the suitability of the technology for the NHS, the appraisal section of the process. There are four NICE committees, each of which is responsible for one of the four programmes discussed previously. The newest of them is the Medical Technologies Advisory Committee (MTAC). The MTAC assesses a specific subset of health technologies, which can loosely be defined as medical devices. A full description of the technologies that are assessed by the MTAC can be found in the Medical Technologies Evaluation Programme (MTEP) methods guide [5], referred to as ‘MTEP guidance’ in the remainder of this paper. This methods guide stipulates the methodology that manufacturers must follow when undertaking economic evaluations of medical devices that are to be assessed by the MTAC. NICE aims for consistency across its four committees. However, a comparison of the methodology outlined in the MTEP guidance with those used by the other NICE decision-making committees shows some significant differences. The possible W. Green (&) York Health Economics Consortium, University of York, Market Square, Heslington, York YO10 5NH, UK e-mail: william.green@york.ac.uk

PRM97 - Technical Errors in Cost-Effectiveness Models: Evidence from the Single Technology Appraisal Programme in England and Wales

PRM97 - Technical Errors in Cost-Effectiveness Models: Evidence from the Single Technology Appraisal Programme in England and Wales

Structural condition assessment and functional appraisal of a large basement affected by groundwater leakage

A systematic approach to assess the structural integrity and functional viability of the basement of a 40,000m2 building complex, which was affected by a 3m rise in groundwater level (GWL) after occupancy, is presented. Visual observations, in situ testing of structural components and analytical studies using commercially available finite element analysis programs were employed to implement the structural condition assessment and appraisal program. Functional viability of the basement, after being affected by groundwater, was carried out based on BS 8102 guidelines. It was concluded that the basement structure was to be strengthened for 25% of the plan area to withstand the applied hydrostatic pressure. In the meanwhile, functionality of the basement, after required strengthening, was also determined to be slightly impaired due to the revised loading conditions. Increased maintenance and periodic inspection were recommended for satisfactory operation of the basement.

Injectivity in the Surat Basin, Queensland, Australia: Likelihood and Uncertainty Evaluation

In the context of pre-tenement application studies, Monte Carlo simulations of steady state (initial) CO2 injectivity for the Precipice Sandstone in the Surat Basin have been used together with discrete dynamic models to assess injection rate uncertainty. Such uncertainty analyses are used to guide exploration work programs. This paper considers an analysis of steady state injection rates based on a modified form of Darcy's Law, using parameter probability probability density functions (PDF) for 4 different tenement areas. Uncertainty in absolute permeability and upscaled permeability (as seen in an injection well) typically accounted for around 70% of variation in estimated steady-state injectivity. Uncertainty in gross thickness and net-to-gross ratio accounted for most of the remaining variation.Due to changes in depositional setting and depth, the P50 initial injectivity estimates for the Precipice Sandstone varies by an order of magnitude from 0.2 to 2.4 megatonne per anum (Mt/a) across the 4 areas. P10/P90 ratios were between 10 and 20 and are indicative of the relative immaturity of the technical assessment. Concepts including several wells will likely be required for industrial scale, multi-Mt/a developments. Dynamic well testing specifically to determine compartmentalisation and heterogeneity and the departure from steady state will be essential in designing and costing any field development plan. Therefore such data will be essential in any exploration or appraisal program.

A Study of Job Stress on Job Satisfaction among the Employees of Small Scale Industries

The purpose of this study is to examine the impact of job stress on job satisfaction among the employees of small scale industries in Madurai. The correlation analysis indicates that the employee job satisfaction is negatively and significantly associated with work load and role conflict, while the employee job satisfaction is positively and significantly correlated with physical environment in small scale industries. The regression analysis shows that the job stress factors of workload and role conflict have the negative impact on employee job satisfaction while, the job stress factor of physical environment have the positive impact on employee job satisfaction at one per cent level of significance. It is very important that the small scale industries understands the needs of its employees and provide what is best for the employees. Constant appraisal programmes and appreciation should be given to reinstate and motivate the employees. In order to enhance the satisfaction of their jobs and lives of employees should compensate with equitable incentives.

Evaluation of a Critical Appraisal Program for Clinical Nurses: A Controlled Before-and-After Study

Evidence-based practice is important to.clinical health care professionals. Clinical nurses can make informed decisions by applying the best evidence to their care. However, standardized curricula on evidence-based medicine are lacking in nursing education programs. This study evaluated a critical appraisal education program and assessed its value in increasing nurses' knowledge of critical appraisal and confidence in their critical appraisal skills. A controlled before-and-after study design was used. The education program integrated lectures,practice, and group discussion. A questionnaire was used to evaluate participants' knowledge and confidence in critical appraisal pre- and postintervention. Participants' knowledge and confidence in critical appraisal improved significantly postintervention(both p < .001 ). A 1-day, small group discussion education program can effectively improve nurses' knowledge and confidence in critical appraisal. Educators and administrators may replicate this education program to improve the quality of nursing care

Building Goal Alignment in Federal Agencies' Performance Appraisal Programs

Public managers wrestle with how to increase organizational performance in public organizations. Proponents of results-based management approaches point to the importance of goal alignment in organ...

Intelligent Exploration and Appraisal Program for a Multiprospect Development

Summary While many companies are hunting for elephants, exploration results in deep offshore plays over the past years show the increasing trend away from giant-field discoveries toward smaller fields in the 50-100 million bbl range, which tend to be geographically dispersed. These resources need to accumulate to a critical mass, a global threshold, to justify an economically viable development. This is not only a question of volume but also of geographic location of the discoveries, and the threshold, of course, also depends on economic factors. A methodology is proposed to evaluate the potential of a block to lead to a multiprospect development and to optimize exploration and appraisal. It is illustrated by a real deepwater case study including five discoveries and four prospects, 10-30 km apart. The practical approach taken is to define circles or ellipses on a map representing potential hubs and their catchment areas. For each area, a global resource threshold is defined by analogy with other regional developments or by a detailed economic study of representative cases (not discussed in the paper). A probabilistic model of the resource base is derived from the geological assessments of discoveries and prospects. It is entered into Monte Carlo simulation to generate a large number of scenarios representing exploration outcomes and discovery volumes, which are stored in a scenario database. This allows a probabilistic evaluation of the performance of an exploration and appraisal program, using specially developed indicators such as the cumulative discovered P50. Intelligence is introduced in the process by evaluating after each well the probability of meeting the threshold with the remaining wells. If it is low (10% or less) the program is stopped, which has a great impact on risked economics. The main results of the analysis are the economic decision tree with the probability of a development decision and the P90/ P50/P10 of the developed resources; the number of wells in the dry branch of the tree, which actually is not a fixed number but a probability distribution; the definition of a firm and contingent well program; and an optimum drilling order, which may also reduce the well count.

Research on Quality Measuring of CMMI Cyclic Implementation in Software Process

Based on the specific elements in terms of process area, project, practice and relevant methodologies, which were adopted from Capability Maturity Model Integration(CMMI), this paper studied feasible appraisal program that combined the CMMI implementation cycle model into entire software process, therefore, the index system and measurement model in measuring the quality of software developing process were built and the barrier of CMMI model could only be used in enterprise CMMI certification was broken down.

PROTOCOL: The Impact of Land Property Rights Interventions on Agricultural Productivity in Developing Countries: A Systematic Review

PROTOCOL: The Impact of Land Property Rights Interventions on Agricultural Productivity in Developing Countries: A Systematic Review

The Effect of Performance Appraisal in an Organizatin

This study is on the effects of performance appraisal on productivity in an organization and it is geared towards examining the effects of performance appraisal on the productivity of employees in organization. The objective of this study is to investigate the performance appraisal techniques adopted in an organization, to examine the usefulness of performance appraisal programme in an organization, to find out the various environmental variables affecting performance appraisal programs in an organization, to identify the pitfall associated with performance appraisal exercise and provide solutions to them. In the course of this study, data were collected from primary and secondary sources and it was analyzed. The researcher made use of survey design. In view of the findings, it was discovered that participation of employees in appraisal exercise and the use of performance appraisal resulted to an increase in output to the organization and higher standard of living to the employee because of promotion given and other necessary reward that motivated the employee to work hard. At the end of this work the researcher was able to conclude that problem with the organization’s appraisal system lies with implementation rather than method. Consequently, since the intention of the research is not to recommend an entirely new method but to enhance the relationship between the currently used method and its objectives, the researcher conclusion is there summed up in the phrase. Better implementation of the organization’s appraisal method is needed so as to be able to match practice with purpose on an intensive advice that the organization should provide an intensive training programme for appraisal. my final conclusion draws on the major highlight of the study of the revelation that subordinates are not involved in setting goals and objectives on which they are appraisal.

PCN178 Reimbursement of Cancer Drugs in the UK: New Approach to End-of-Llife Treatments and the Technology Appraisal Programme of NICE

PCN178 Reimbursement of Cancer Drugs in the UK: New Approach to End-of-Llife Treatments and the Technology Appraisal Programme of NICE

Cautions Regarding the Fitting and Interpretation of Survival Curves

The UK National Institute for Health and Clinical Excellence (NICE) has used its Single Technology Appraisal (STA) programme to assess several drugs for cancer. Typically, the evidence submitted by the manufacturer comes from one short-term randomized controlled trial (RCT) demonstrating improvement in overall survival and/or in delay of disease progression, and these are the pre-eminent drivers of cost effectiveness. We draw attention to key issues encountered in assessing the quality and rigour of the manufacturers' modelling of overall survival and disease progression. Our examples are two recent STAs: sorafenib (Nexavar®) for advanced hepatocellular carcinoma, and azacitidine (Vidaza®) for higher-risk myelodysplastic syndromes (MDS). The choice of parametric model had a large effect on the predicted treatment-dependent survival gain. Logarithmic models (log-Normal and log-logistic) delivered double the survival advantage that was derived from Weibull models. Both submissions selected the logarithmic fits for their base-case economic analyses and justified selection solely on Akaike Information Criterion (AIC) scores. AIC scores in the azacitidine submission failed to match the choice of the log-logistic over Weibull or exponential models, and the modelled survival in the intervention arm lacked face validity. AIC scores for sorafenib models favoured log-Normal fits; however, since there is no statistical method for comparing AIC scores, and differences may be trivial, it is generally advised that the plausibility of competing models should be tested against external data and explored in diagnostic plots. Function fitting to observed data should not be a mechanical process validated by a single crude indicator (AIC). Projective models should show clear plausibility for the patients concerned and should be consistent with other published information. Multiple rather than single parametric functions should be explored and tested with diagnostic plots. When trials have survival curves with long tails exhibiting few events then the robustness of extrapolations using information in such tails should be tested.

Survival Time Outcomes in Randomized, Controlled Trials and Meta-Analyses: The Parallel Universes of Efficacy and Cost-Effectiveness

ObjectivesMany regulatory agencies require that manufacturers establish both efficacy and cost-effectiveness. The statistical analysis of the randomized, controlled trial (RCT) outcomes should be the same for both purposes. The question addressed by this article is the following: for survival outcomes, what is the relationship between the statistical analyses used to support inference and the statistical model used to support decision making based on cost-effectiveness analysis (CEA)? MethodsWe performed a review of CEAs alongside trials and CEAs based on a synthesis of RCT results, which were submitted to the National Institute for Health and Clinical Excellence (NICE) Technology Appraisal program and included survival outcomes. We recorded the summary statistics and the statistical models used in both efficacy and cost-effectiveness analyses as well as procedures for model diagnosis and selection. ResultsIn no case was the statistical model for efficacy and CEA the same. For efficacy, relative risks or Cox regression was used. For CEA, the common practice was to fit a parametric model to the control arm, then to apply the hazard ratio from the efficacy analysis to predict the treatment arm. The proportional hazards assumption was seldom checked; the choice of model was seldom based on formal criteria, and uncertainty in model choice was seldom addressed and never propagated through the model. ConclusionsBoth inference and decisions based on CEAs should be based on the same statistical model. This article shows that for survival outcomes, this is not the case. In the interests of transparency, trial protocols should specify a common procedure for model choice for both purposes. Further, the sufficient statistics and the life tables for each arm should be reported to improve transparency and to facilitate secondary analyses of results of RCTs.

Non-clinical interventions that increase the uptake and success of vaginal birth after caesarean section: a systematic review

The aim of this study was to review non-clinical interventions that increase the uptake and/or the success rates of vaginal birth after caesarean section. Increases in rates of caesarean section are largely due to repeat caesarean section in a subsequent pregnancy. Concerns about vaginal birth after caesarean section have centred on the risk of uterine rupture. Nonetheless, efforts to increase the vaginal birth rate in these women have been made. This study reviews these in relation to non-clinical interventions. Literature was searched up until December 2008 from five databases and a number of relevant professional websites. A systematic review of quantitative studies that evaluated a non-clinical intervention for increasing the uptake and/or the success of vaginal birth after caesarean section was undertaken. Only study designs that involved a comparison group were included. Further exclusions were imposed for quality using the Critical Skills Appraisal Programme. National guidelines influence vaginal birth after caesarean section rates, but a greater effect is seen when institutions develop local guidelines, adopt a conservative approach to caesarean section, use opinion leaders, give individualized information to women, and give feedback to obstetricians about mode of birth rates. Individual clinician characteristics may impact on the number of women choosing and succeeding in vaginal birth after caesarean section. There is inconsistent evidence that having private health insurance may be a barrier to the uptake and success of vaginal birth after caesarean section. Non-clinical factors can have a significant impact on vaginal birth after caesarean section uptake and success.

Evaluating Hydraulic-Fracture Effectiveness in a Coal-Seam-Gas Reservoir From Surface Tiltmeter and Microseismic Monitoring

This article, written by Senior Technology Editor Dennis Denney, contains highlights of paper SPE 133063, ’Evaluating Hydraulic-Fracture Effectiveness in a Coal-Seam-Gas Reservoir From Surface Tiltmeter and Microseismic Monitoring,’ by Raymond L. Johnson Jr., SPE, and Michael P. Scott, SPE, QGC; R.G. Jeffrey, SPE, and Zuorong Chen, SPE, CSIRO Earth Science and Resource Engineering; Les Bennett SPE, and Craig Vandenborn, SPE, Schlumberger; and Sergei Tcherkashnev, ASTO Geophysical Consulting, prepared for the 2010 SPE Annual Technical Conference and Exhibition, Florence, Italy, 19-22 September. The paper has not been peer reviewed. In developing coalbed-methane or coal-seam-gas (CSG) fields or reservoirs, the effects of many parameters are important in understanding the success or potential improvement of hydraulic-fracturing treatments. Estimating fracture geometry relative to reservoir architecture is critical in understanding production variability. An outline for steps used to plan the monitoring program is presented along with a description of how geological data were integrated to better understand the results observed during the treatments. A logical framework was developed to evaluate and integrate these technologies for use in future CSG-well stimulation. Introduction The wells in this study are in the Walloon coal measures of the Surat basin of eastern Queensland, Australia. The Walloon subgroup (WSG) is Middle Jurassic, comprising fluvial deposition dominated by definable transgressive events of peat-swamp deposition. It can be divided further into the Juandah and Taroom coal measures, which comprise 10 regionally correlatable coal packages with interbedded sandstone, silt-stone, and carbonaceous-shale intervals. Typically, the WSG is 1,000 to 1,200 ft thick, with net coal thickness ranging from 65 to 120 ft. There can be more than 50 plies of coal throughout these 10 coal packages, with average ply thickness of 1 to 2 ft and the maximum typically between 7 and 10 ft. Generally, hydraulic fracturing resulted in low-productivity wells in the early pilot areas of the Surat basin and resulted in wellbore failures in the Undulla Nose area, which led to an underreamed, openhole completion as the primary completion method for WSG wells. As appraisal programs moved away from the more prolific Undulla Nose area, areas having variable and lower permeability were encountered. These areas required reevaluating the traditional WSG completion method and considering implementation of hydraulic fracturing to improve production. On the basis of past wellbore failures, it was suspected that fracture complexity may be developing as a result of interaction of the created hydraulic fracture with the natural fractures and with the overall stress environment. When a program to incorporate hydraulic fracturing was considered, it was decided that an integrated diagnostics program would be essential in understanding the fracture geometry and overall stress environment to improve treatment designs and to help understand past-treatment results.

Technology Focus: Well Testing (February 2011)

Technology Focus Often, the trial-and-error method is viewed as an imperfect surrogate for systematic scientific research. Yet, great advances never would have taken place without such an approach. Take shale gas, for example. Despite scarce research conducted by only a few companies, shale-gas plays have undergone massive development and have progressed techniques (e.g., horizontal drilling and multistage fracturing) that enabled resources unavailable less than a decade ago. According to a US Department of Energy report, US shale-gas production is expected to increase from 1.4 Tcf in 2007 to 4.8 Tcf in 2020. That same year, 64% of the total US gas production will come from unconventional gas. Well testing is no exception. Although transient-linear-fluid-flow and dual-porosity concepts for fractured horizontal wells have been available for many years, painstaking trial and error has been the key to accommodating such extremely-low-permeability ranges in current prefracture- and post-fracture-well-test designs. Similarly, many if not all operators have diligently re-evaluated their appraisal programs in an effort to collect data needed for critical parameters (e.g., gas-in-place and initial pressure) in a cost-effective manner while accounting for varying relationships between matrix and natural- and hydraulic-fracture networks. It is undeniable that trial and error should not be used to replace the rigor and thoroughness of systematic scientific research. However, the expanded range of environments that we encounter (from unconventional, to multilayered, to high-pressure/high-temperature reservoirs) requires rapid learning and adaptation, and, therefore, experimentation. The papers selected for this issue are clear examples of best-in-class knowledge development in well testing through first principles and an old familiar approach—trial and error. Well Testing additional reading available at OnePetro: www.onepetro.org IPTC 13912 “A Novel Analysis Procedure for Estimating Thickness-Independent Horizontal and Vertical Permeabilities From Pressure Data at an Observation Probe Acquired by Packer/Probe Wireline Formation Testers” by M. Onur, Istanbul Technical University, et al. (See JPT, September 2010, page 56.) SPE 134534 “Practical Use of Well-Test Deconvolution” by A.C. Gringarten, SPE, Imperial College, London. SPE 131675 “Pressure-Falloff-Test Interpretation for Leakage Detection During CO2 Injection in a Deep Saline Aquifer” by C.A. Ehlig-Economides, Texas A&amp;M University, et al.