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Developing New Practice Model To Ensure Better Medication Concordance
A778
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1
Although patient engagement in health research is commonly recognized as a priority, there is a lack of guidance regarding appropriate and feasible methods for defining patient-centered outcomes. This is critical when developing both patientreported outcome measures (PROMs) and PRO-based performance measures (PRO-PMs). One area that has been particularly ignored is engaging patients in the creation of conceptual frameworks that define outcomes that matter to patients. Clinicians and researchers generally create these frameworks, relying on the incorporation of the patient voice through one-on-one interviews, surveys, and focus groups. However, each of these strategies are fraught with limitations, including patient response bias and potential limitations of generalizability. In addition, they do not leverage the potential of social research networks and group-based technological solutions to develop patient-centered conceptual frameworks. This presentation addresses the following objectives in PROM and PRO-PM development: (1) review of group concept mapping (GCM; Concept Systems®) as a viable method for engaging patients, (2) provision of examples of GCM applications in defining outcomes, and (3) discussion of strengths and limitations of this approach. GCM combines qualitative (statement generation and sorting) and quantitative (multidimensional scaling and cluster analysis) methods to generate visual maps depicting a conceptual model. This presentation will show examples of studies that have utilized GCM for the development of PROMs and a recent Robert Wood Johnson Foundation PRO-PM study to define patient perceptions of “good” healthcare. Strengths of GCM include evidence of validity and reliability, ability to incorporate multiple stakeholder views into a single conceptual framework, and the potential for application to measurement and evaluation. Potential limitations include problems with technical literacy, attrition, and managing response burden. Methods to address these limitations will be discussed. Overall, GCM represents a valuable participatory concept development strategy with the potential to enhance traditional researcher-driven methods in PROM and PRO-PM development. PRM263 Using A Mixed Methods Approach To Determine The Item-Scale Structure and Scoring for Clinical Outcome Assessments Williamson N, Johnson C, Cocks K, Bennett B, Tolley C, Simpson S Adelphi Values Ltd, Bollington, Cheshire, UK
Background: Factor analysis is a widely accepted approach to assess the suitability of an instrument structure and can be used in the content and psychometric validation of clinical outcome assessments (COAs). Qualitative insights into the importance of items and concepts should also be considered when developing a scoring algorithm, outlining how to combine individual items into a score in a meaningful way. Objectives: This study outlines quantitative methods to define a suitable item-scale factor structure for COAs and qualitative approaches to develop a scoring algorithm to weight items by importance. Results: Factor analysis is used to assess the suitability of a hypothesized conceptual framework for a COA (confirmatory factor analysis) or to identify a suitable item-scale structure in the absence of a pre-defined conceptual framework (exploratory factor analysis). First or second-order confirmatory factor analysis can be used depending on the hierarchy and structure of the concept of interest. Once the item-scale factor structure is finalized a scoring algorithm can be developed. Many COAs are scored by assigning an equal weight to all items and summing or averaging items to form domain and total scores. Qualitative ranking exercises with patients and clinical experts can determine the relative importance of items. Weighting can then provide the percentage that each item should contribute towards an overall score. This can provide insights into which items are of greater relevance to a condition, and highlight concepts that are crucial or less critical to a health condition. Factor analysis and qualitative approaches to develop scoring algorithms should be used in combination to ensure that item-scale structures of COAs are both quantitatively and qualitatively valid. Conclusions: When developing a COA factor analysis and qualitative weighting or ranking exercises can be used in combination to determine item-scale structures and scoring for COAs.
PRM265 Developing New Practice Model To Ensure Better Medication Concordance Amir M Ziauddin Univeristy, Karach, Pakistan
Introduction: Tremendous research has been carried out relating nonadherence and its interventions since 1950. Interventions developed were found not to be effective in clinical scenario. We intended to develop a model or conceptual framework to incorperate medication adherence in clinical scenario. Methodology: 5 steps process by Yosef Jabareen for conceptual framework analysis was used 1: Extensive literature search was carried out to identify types of model were used for developing interventions. 2: Reviewing result to find the deficiencies in the model and rationale their impact on medication non-adherence. 3: Survey was conducted. 4: Model was developed. 5: Appraisal by different health care professionals. Result: Model “practice model for medication concordance” is based on closed environment based on two dynamics: health related and patient related. Health dynamic comprises of two participants and patient dynamics have one participant. All information remains within these three active participants. Participants are initiator, mediator and recipient . Initiator may be a physician or pharmacist who initiates the concordance pathway by assessing patient, medication regimen, documents and monitor patient adherence with mutual agreement of patient. Initiator takes the responsibility of creating the environment of concordance. Mediator is another health professional who is responsible to support both initiator and recipient. Once the initiator has assessed recipient, mediator may assist the Initiator by providing supplies (medications or other), technical support (education, reminder aids) and follow up. Information about recipient will be provided to initiator for further evaluation. Mediator shares equal responsibility with initiator to achieve the outcome as set in goals. Recipient usually is one who receives the services from health professionals. Recipient can be patient himself or care taker of the patient which is the focus of the model hence the represent the major part of it. Conclusion: Model allows health professionals and patient parallel in terms of information, responsibility and accountability. PRM266 Measuring Changes In Patterns of Tobacco Product Use Over Time: Transition Probability Approaches Afolalu EF1, Prieto L1, de La Bourdonnaye G1, Sponsiello-Wang Z1, Weitkunat R2 R&D, Philip Morris Products S.A, Neuchâtel, Switzerland, 2PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland 1PMI
Measuring patterns of tobacco use has typically involved assessing number of units and frequency of use of cigarettes. With the emergence of new types of products (e.g. e-cigarettes, water-pipes, heat-not-burn products), use of more than one tobacco product is increasing in popularity, and therefore quantifying the overall tobacco consumption of individuals is becoming more challenging. Novel products are different in design and consumption to cigarettes and their availability results in multiple and complex combinations that make the measurement of exposure to tobacco and nicotine containing products intricate. Moreover, these complex patterns of use present a challenge when assessing changes over time and evaluating their subsequent impact on health outcomes. Changes in patterns of tobacco product use over time (i.e. moving between different tobacco use status and combinations, the possibilities of single, dual or poly product use, progression from occasional to regular use, initiation, cessation, switching, and re-initiation between products) can be characterized by estimating the probabilities of transition between one tobacco-use state and another. This contribution presents an overview of analytical approaches to assess transitions in complex patterns of tobacco use. It addresses the practical implications of applying these analytical approaches across existing epidemiological surveys and datasets to characterize patterns and determine probabilities of changes in tobacco use status. In addition, it considers the utility of transition probability methods to provide a snapshot into changes in the patterns of tobacco use and how this can be used to inform future tobacco use trajectories, associated health outcomes, and tobacco harm reduction efforts.
PRM264 Conceptual Modeling Framework for Global Functioning of Adhd Patients Freriks RD1, Cao Q1, van der Schans J1, Dijk HH1, Groenman AP2, Hoekstra PJ2, Postma MJ1, Buskens E2, Mierau JO1 1University of Groningen, Groningen, The Netherlands, 2University Medical Center Groningen, Groningen, The Netherlands
State-Transitions Models (STMs) in Attention-Deficit Hyperactivity Disorder (ADHD) are often in discrete time following a standard Markov process. Consequently, transitioning from one health state to another can only take place at the start or end of a predefined time interval and depends only on the present state. As a results, patient history is ignored. In addition, the utility measures related to the states of existing models are often based on Health Related Quality of Life (HRQoL) measures such as the EuroQol five dimensions questionnaire (EQ5D). However, it has been called into question whether measures such as the EQ5D can adequately capture the wellbeing and the level of functioning of children and adolescents with ADHD. Therefore, we propose a new approach for differentiating between the states by focusing on impairment. We use the Global Assessment of Functioning (GAF) - scores, obtained from real-world data, to model the disease progression of children and adolescents with ADHD. In addition, contrary to current studies, we choose to use continuous time semi-Markov modeling to deal with the limiting assumptions of existing STMs in ADHD as stated above. The methods will be illustrated using an applied example for ADHD. We aim to investigate whether the proposed conceptual modeling framework based on global functioning fits the observed real-world process better than the existing models. Sensitivity analyses will be performed to determine the impact of difference in goodness-of-fit on the long-term cost-effectiveness estimates comparing a Markov and semi-Markov approach in both discrete and continuous time.
DISEASE- SPECIFIC STUDIES
INFECTION – Clinical Outcomes Studies PIN1 Case Fatality Rate of Enteric Fever: A Systematic Review and MetaAnalysis Pieters Z1, Saad NJ2, Antillon M2, Pitzer VE2, Bilcke J1 of Antwerp, Wilrijk, Belgium, 2Yale University, New Haven, CT, USA
1University
Objectives: Enteric fever, caused by S. Typhi and S. Paratyphi, is a febrile illness. It can present as a severe disease with complications including intestinal perforations and death. Reliable estimates of disease burden are needed to inform decision makers in the implementation of new control strategies. Until now, no meta-analysis has been conducted to summarize mortality from enteric fever. Therefore, we aimed to collect all studies reporting a case fatality rate (CFR) for enteric fever. Methods: For this systematic review and meta-analysis, we searched Embase, Medline, WoS, and PMC for articles published between January 1, 1970 and January 11, 2017 reporting mortality from enteric fever. Studies had to diagnose cases via serology or culture, be conducted in an endemic country, and include all ages. We used a random effects model to combine the estimates. The protocol was registered in PROSPERO (CRD42017057428). Results: We identified 40 eligible articles, which resulted in 44 outcomes. The average CFR was estimated to be 2.49% (95% CI: 1.65%3.75%). The odds of dying from enteric fever is lower in children compared to adults
VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1
Although patient engagement in health research is commonly recognized as a priority, there is a lack of guidance regarding appropriate and feasible methods for defining patient-centered outcomes. This is critical when developing both patientreported outcome measures (PROMs) and PRO-based performance measures (PRO-PMs). One area that has been particularly ignored is engaging patients in the creation of conceptual frameworks that define outcomes that matter to patients. Clinicians and researchers generally create these frameworks, relying on the incorporation of the patient voice through one-on-one interviews, surveys, and focus groups. However, each of these strategies are fraught with limitations, including patient response bias and potential limitations of generalizability. In addition, they do not leverage the potential of social research networks and group-based technological solutions to develop patient-centered conceptual frameworks. This presentation addresses the following objectives in PROM and PRO-PM development: (1) review of group concept mapping (GCM; Concept Systems®) as a viable method for engaging patients, (2) provision of examples of GCM applications in defining outcomes, and (3) discussion of strengths and limitations of this approach. GCM combines qualitative (statement generation and sorting) and quantitative (multidimensional scaling and cluster analysis) methods to generate visual maps depicting a conceptual model. This presentation will show examples of studies that have utilized GCM for the development of PROMs and a recent Robert Wood Johnson Foundation PRO-PM study to define patient perceptions of “good” healthcare. Strengths of GCM include evidence of validity and reliability, ability to incorporate multiple stakeholder views into a single conceptual framework, and the potential for application to measurement and evaluation. Potential limitations include problems with technical literacy, attrition, and managing response burden. Methods to address these limitations will be discussed. Overall, GCM represents a valuable participatory concept development strategy with the potential to enhance traditional researcher-driven methods in PROM and PRO-PM development. PRM263 Using A Mixed Methods Approach To Determine The Item-Scale Structure and Scoring for Clinical Outcome Assessments Williamson N, Johnson C, Cocks K, Bennett B, Tolley C, Simpson S Adelphi Values Ltd, Bollington, Cheshire, UK
Background: Factor analysis is a widely accepted approach to assess the suitability of an instrument structure and can be used in the content and psychometric validation of clinical outcome assessments (COAs). Qualitative insights into the importance of items and concepts should also be considered when developing a scoring algorithm, outlining how to combine individual items into a score in a meaningful way. Objectives: This study outlines quantitative methods to define a suitable item-scale factor structure for COAs and qualitative approaches to develop a scoring algorithm to weight items by importance. Results: Factor analysis is used to assess the suitability of a hypothesized conceptual framework for a COA (confirmatory factor analysis) or to identify a suitable item-scale structure in the absence of a pre-defined conceptual framework (exploratory factor analysis). First or second-order confirmatory factor analysis can be used depending on the hierarchy and structure of the concept of interest. Once the item-scale factor structure is finalized a scoring algorithm can be developed. Many COAs are scored by assigning an equal weight to all items and summing or averaging items to form domain and total scores. Qualitative ranking exercises with patients and clinical experts can determine the relative importance of items. Weighting can then provide the percentage that each item should contribute towards an overall score. This can provide insights into which items are of greater relevance to a condition, and highlight concepts that are crucial or less critical to a health condition. Factor analysis and qualitative approaches to develop scoring algorithms should be used in combination to ensure that item-scale structures of COAs are both quantitatively and qualitatively valid. Conclusions: When developing a COA factor analysis and qualitative weighting or ranking exercises can be used in combination to determine item-scale structures and scoring for COAs.
PRM265 Developing New Practice Model To Ensure Better Medication Concordance Amir M Ziauddin Univeristy, Karach, Pakistan
Introduction: Tremendous research has been carried out relating nonadherence and its interventions since 1950. Interventions developed were found not to be effective in clinical scenario. We intended to develop a model or conceptual framework to incorperate medication adherence in clinical scenario. Methodology: 5 steps process by Yosef Jabareen for conceptual framework analysis was used 1: Extensive literature search was carried out to identify types of model were used for developing interventions. 2: Reviewing result to find the deficiencies in the model and rationale their impact on medication non-adherence. 3: Survey was conducted. 4: Model was developed. 5: Appraisal by different health care professionals. Result: Model “practice model for medication concordance” is based on closed environment based on two dynamics: health related and patient related. Health dynamic comprises of two participants and patient dynamics have one participant. All information remains within these three active participants. Participants are initiator, mediator and recipient . Initiator may be a physician or pharmacist who initiates the concordance pathway by assessing patient, medication regimen, documents and monitor patient adherence with mutual agreement of patient. Initiator takes the responsibility of creating the environment of concordance. Mediator is another health professional who is responsible to support both initiator and recipient. Once the initiator has assessed recipient, mediator may assist the Initiator by providing supplies (medications or other), technical support (education, reminder aids) and follow up. Information about recipient will be provided to initiator for further evaluation. Mediator shares equal responsibility with initiator to achieve the outcome as set in goals. Recipient usually is one who receives the services from health professionals. Recipient can be patient himself or care taker of the patient which is the focus of the model hence the represent the major part of it. Conclusion: Model allows health professionals and patient parallel in terms of information, responsibility and accountability. PRM266 Measuring Changes In Patterns of Tobacco Product Use Over Time: Transition Probability Approaches Afolalu EF1, Prieto L1, de La Bourdonnaye G1, Sponsiello-Wang Z1, Weitkunat R2 R&D, Philip Morris Products S.A, Neuchâtel, Switzerland, 2PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland 1PMI
Measuring patterns of tobacco use has typically involved assessing number of units and frequency of use of cigarettes. With the emergence of new types of products (e.g. e-cigarettes, water-pipes, heat-not-burn products), use of more than one tobacco product is increasing in popularity, and therefore quantifying the overall tobacco consumption of individuals is becoming more challenging. Novel products are different in design and consumption to cigarettes and their availability results in multiple and complex combinations that make the measurement of exposure to tobacco and nicotine containing products intricate. Moreover, these complex patterns of use present a challenge when assessing changes over time and evaluating their subsequent impact on health outcomes. Changes in patterns of tobacco product use over time (i.e. moving between different tobacco use status and combinations, the possibilities of single, dual or poly product use, progression from occasional to regular use, initiation, cessation, switching, and re-initiation between products) can be characterized by estimating the probabilities of transition between one tobacco-use state and another. This contribution presents an overview of analytical approaches to assess transitions in complex patterns of tobacco use. It addresses the practical implications of applying these analytical approaches across existing epidemiological surveys and datasets to characterize patterns and determine probabilities of changes in tobacco use status. In addition, it considers the utility of transition probability methods to provide a snapshot into changes in the patterns of tobacco use and how this can be used to inform future tobacco use trajectories, associated health outcomes, and tobacco harm reduction efforts.
PRM264 Conceptual Modeling Framework for Global Functioning of Adhd Patients Freriks RD1, Cao Q1, van der Schans J1, Dijk HH1, Groenman AP2, Hoekstra PJ2, Postma MJ1, Buskens E2, Mierau JO1 1University of Groningen, Groningen, The Netherlands, 2University Medical Center Groningen, Groningen, The Netherlands
State-Transitions Models (STMs) in Attention-Deficit Hyperactivity Disorder (ADHD) are often in discrete time following a standard Markov process. Consequently, transitioning from one health state to another can only take place at the start or end of a predefined time interval and depends only on the present state. As a results, patient history is ignored. In addition, the utility measures related to the states of existing models are often based on Health Related Quality of Life (HRQoL) measures such as the EuroQol five dimensions questionnaire (EQ5D). However, it has been called into question whether measures such as the EQ5D can adequately capture the wellbeing and the level of functioning of children and adolescents with ADHD. Therefore, we propose a new approach for differentiating between the states by focusing on impairment. We use the Global Assessment of Functioning (GAF) - scores, obtained from real-world data, to model the disease progression of children and adolescents with ADHD. In addition, contrary to current studies, we choose to use continuous time semi-Markov modeling to deal with the limiting assumptions of existing STMs in ADHD as stated above. The methods will be illustrated using an applied example for ADHD. We aim to investigate whether the proposed conceptual modeling framework based on global functioning fits the observed real-world process better than the existing models. Sensitivity analyses will be performed to determine the impact of difference in goodness-of-fit on the long-term cost-effectiveness estimates comparing a Markov and semi-Markov approach in both discrete and continuous time.
DISEASE- SPECIFIC STUDIES
INFECTION – Clinical Outcomes Studies PIN1 Case Fatality Rate of Enteric Fever: A Systematic Review and MetaAnalysis Pieters Z1, Saad NJ2, Antillon M2, Pitzer VE2, Bilcke J1 of Antwerp, Wilrijk, Belgium, 2Yale University, New Haven, CT, USA
1University
Objectives: Enteric fever, caused by S. Typhi and S. Paratyphi, is a febrile illness. It can present as a severe disease with complications including intestinal perforations and death. Reliable estimates of disease burden are needed to inform decision makers in the implementation of new control strategies. Until now, no meta-analysis has been conducted to summarize mortality from enteric fever. Therefore, we aimed to collect all studies reporting a case fatality rate (CFR) for enteric fever. Methods: For this systematic review and meta-analysis, we searched Embase, Medline, WoS, and PMC for articles published between January 1, 1970 and January 11, 2017 reporting mortality from enteric fever. Studies had to diagnose cases via serology or culture, be conducted in an endemic country, and include all ages. We used a random effects model to combine the estimates. The protocol was registered in PROSPERO (CRD42017057428). Results: We identified 40 eligible articles, which resulted in 44 outcomes. The average CFR was estimated to be 2.49% (95% CI: 1.65%3.75%). The odds of dying from enteric fever is lower in children compared to adults