Methodological Research Priorities Research Articles

PCR76 Do We Really Need a Study Looking at That? A Best-Worst Scaling Study Assessing Methodological Research Priorities According to the Patient Preference Research Community

PCR76 Do We Really Need a Study Looking at That? A Best-Worst Scaling Study Assessing Methodological Research Priorities According to the Patient Preference Research Community

An international, Delphi consensus study to identify priorities for methodological research in behavioral trials in health research

BackgroundNon-communicable chronic diseases are linked to behavioral risk factors (including smoking, poor diet and physical inactivity), so effective behavior change interventions are needed to improve population health. However, uptake and impact of these interventions is limited by methodological challenges. We aimed to identify and achieve consensus on priorities for methodological research in behavioral trials in health research among an international behavioral science community.MethodsAn international, Delphi consensus study was conducted. Fifteen core members of the International Behavioral Trials Network (IBTN) were invited to generate methodological items that they consider important. From these, the research team agreed a “long-list” of unique items. Two online surveys were administered to IBTN members (N = 306). Respondents rated the importance of items on a 9-point scale, and ranked their “top-five” priorities. In the second survey, respondents received feedback on others’ responses, before rerating items and re-selecting their top five.ResultsNine experts generated 144 items, which were condensed to a long-list of 33 items. The four most highly endorsed items, in both surveys 1 (n = 77) and 2 (n = 57), came from two thematic categories:“Intervention development” (“Specifying intervention components” and “Tailoring interventions to specific populations and contexts”) and “Implementation” (“How to disseminate behavioral trial research findings to increase implementation” and “Methods for ensuring that behavioral interventions are implementable into practice and policy”). “Development of novel research designs to test behavioral interventions” also emerged as a highly ranked research priority.ConclusionsFrom a wide array of identified methodological issues, intervention development, implementation and novel research designs are key themes to drive the future behavioral trials’ research agenda. Funding bodies should prioritize these issues in resource allocation.

An international, Delphi consensus study to identify priorities for methodological research in behavioural trials: A study protocol

Background: Effective behaviour change interventions are needed to impact important health outcomes, including morbidity and mortality. However, the uptake and impact of behavioural interventions have been limited by methodological challenges. The International Behavioural Trials Network (IBTN) was established in 2013 to facilitate global improvement in methodological quality of behavioural trials. There has been no formal process, within the network or in the broader literature, to define the most important research priorities to achieve this aim. In this project, we will conduct an international, Delphi consensus study to identify and achieve consensus on priorities for methodological research in behavioural trials among IBTN members. Methods: Fifteen core members of IBTN, who are experts in the field of behavioural intervention research, will be invited to generate a list of all items they consider priority areas for methodological research in trials of behavioural interventions. The IBTN Research Prioritisation team (the authors) will review all items generated, removing duplicates and merging similar topics, and generate a ‘long-list’ of items. This long-list will be sent to the 15 IBTN core members for approval. We will then administer two online Delphi surveys to all IBTN members. In the first survey, respondents will be asked to rate the importance of each item on a nine-point scale and rank their top five priorities. In the second survey, respondents will receive feedback on others’ responses and a reminder of their own responses in survey 1, and will be asked to re-rate items and re-select their ‘top five’. Discussion: Findings from the project will be used to inform the research agenda of the IBTN and to make recommendations for future research.

An international, Delphi consensus study to identify priorities for methodological research in behavioural trials: A study protocol

Background: Effective behaviour change interventions are needed to impact important health outcomes, including morbidity and mortality. However, the uptake and impact of behavioural interventions have been limited by methodological challenges. The International Behavioural Trials Network (IBTN) was established in 2013 to facilitate global improvement in methodological quality of behavioural trials. There has been no formal process, within the network or in the broader literature, to define the most important research priorities to achieve this aim. In this project, we will conduct an international, Delphi consensus study to identify and achieve consensus on priorities for methodological research in behavioural trials among IBTN members. Methods: Fifteen core members of IBTN, who are experts in the field of behavioural intervention research, will be invited to brainstorm a complete list of all items they consider priority areas for methodological research in trials of behavioural interventions. The IBTN Research Prioritisation team (the authors) will review all items generated, removing duplicates and merging similar topics, and generate a ‘long-list’ of items. This long-list will be sent to the 15 IBTN core members for approval. We will then administer two online Delphi surveys to all IBTN members. In the first survey, respondents will be asked to rate the importance of each item on a nine-point scale and rank their top five priorities. In the second survey, respondents will receive feedback on others’ responses and a reminder of their own responses in survey 1, and will be asked to re-rate items and re-select their ‘top five’. Discussion: Findings from the project will be used to develop the research agenda of the IBTN and to make recommendations for future research.

Global health trials methodological research agenda: results from a priority setting exercise

BackgroundMethodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists in the field have established a set of top priorities in aid of this research. These priorities, however, may not be reflected in the needs of similar research in low- to middle-income countries (LMICs) with different healthcare provision, resources and research infrastructure. The aim of the study was to identify the top priorities for methodological research in LMICs to inform further research and ultimately to improve clinical trials in these regions.MethodsAn online, two-round survey was conducted from December 2016 to April 2017 amongst researchers and methodologists working on trials in LMICs. The first round required participants to suggest between three and six topics which they felt were priorities for trial methodological research in LMICs. The second round invited participants to grade the importance of a compulsory list of topics suggested by four or more individuals, and an optional list of the remaining topics.FindingsRounds 1 and 2 were completed by 412 and 314 participants, respectively. A wide spread of years of experience, discipline, current country of residence, origin of trials training and area of involvement in trials was reported. The topics deemed most important for methodological research were: choosing appropriate outcomes to measure and training of research staff.ConclusionBy presenting these top priorities we have the foundations of a global health trials methodological research agenda which we hope will foster future research in specific areas in order to increase and improve trials in LMICs.

Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

BackgroundDespite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials.ObjectiveTo identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials.DesignA modified Delphi process including a two round online survey and a stakeholder consensus meeting.ParticipantsIn total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty‐seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting.ResultsRound 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants.ConclusionsThe prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

Methodological research priorities for data sciences: Report from The International Methodology Consortium for Coded Health Information (IMECCHI)

ABSTRACT
 ObjectivesThe vast amount of data produced by healthcare systems both structured and unstructured, termed ‘Big Data’ have the potential to improve the quality of healthcare through supporting a wide range of medical and healthcare functions, including clinical decision support, disease surveillance, and population health management. As the field of big data in healthcare is rapidly expanding, methodology to understand and analyze thereby enhancing and optimizing the use of this data is needed. We present priorities determined for future work in this area.
 ApproachAn international collaboration of health services researchers who aim to promote the methodological development and use of coded health information to promote quality of care and quality health policy decisions known as IMECCHI –proposes areas of development and future priorities for use of big data in healthcare. Thematic areas were determined through discussion of potential projects related to the use and evaluation of both structured /codeable and unstructured health information, during a recent meeting in October 2015
 ResultsSeveral themes were identified. The top priorities included: 1) electronic medical record data exploration and utilization; 2) developing common data models and multimodal /multi-source databases from disparate sources development; 3) data quality assessment including developing indicators, automated logic checks and international comparisons; 4) the translation of ICD-10 to ICD-11 through field-testing 5) Exploration of non-physician produced/coded data; and 6) Patient safety and quality measure development.
 ConclusionsA list of expert views on critical international priorities for future methodological research relating to big data in healthcare were determined. The consortium's members welcome contacts from investigators involved in research using health data, especially in cross-jurisdictional collaborative studies.

PRIORITIES FOR HEALTH ECONOMIC METHODOLOGICAL RESEARCH: RESULTS OF AN EXPERT CONSULTATION.

The importance of economic evaluation in decision making is growing with increasing budgetary pressures on health systems. Diverse economic evidence is available for a range of interventions across national contexts within Europe, but little attention has been given to identifying evidence gaps that, if filled, could contribute to more efficient allocation of resources. One objective of the Research Agenda for Health Economic Evaluation project is to determine the most important methodological evidence gaps for the ten highest burden conditions in the European Union (EU), and to suggest ways of filling these gaps. The highest burden conditions in the EU by Disability Adjusted Life Years were determined using the Global Burden of Disease study. Clinical interventions were identified for each condition based on published guidelines, and economic evaluations indexed in MEDLINE were mapped to each intervention. A panel of public health and health economics experts discussed the evidence during a workshop and identified evidence gaps. The literature analysis contributed to identifying cross-cutting methodological and technical issues, which were considered by the expert panel to derive methodological research priorities. The panel suggests a research agenda for health economics which incorporates the use of real-world evidence in the assessment of new and existing interventions; increased understanding of cost-effectiveness according to patient characteristics beyond the "-omics" approach to inform both investment and disinvestment decisions; methods for assessment of complex interventions; improved cross-talk between economic evaluations from health and other sectors; early health technology assessment; and standardized, transferable approaches to economic modeling.

Methodological Research Priorities in Palliative Care and Hospice Quality Measurement

Quality measurement is a critical tool for improving palliative care and hospice, but significant research is needed to improve the application of quality indicators. We defined methodological priorities for advancing the science of quality measurement in this field based on discussions of the Technical Advisory Panel of the Measuring What Matters consensus project of the American Academy of Hospice and Palliative Medicine and Hospice and Palliative Nurses Association and a subsequent strategy meeting to better clarify research challenges, priorities, and quality measurement implementation strategies. In this article, we describe three key priorities: 1) defining the denominator(s) (or the population of interest) for palliative care quality indicators, 2) developing methods to measure quality from different data sources, and 3) conducting research to advance the development of patient/family-reported indicators. We then apply these concepts to the key quality domain of advance care planning and address relevance to implementation of indicators in improving care. Developing the science of quality measurement in these key areas of palliative care and hospice will facilitate improved quality measurement across all populations with serious illness and care for patients and families.

Infusion of statistical science in comparative effectiveness research

We present a general introduction to comparative effectiveness research (CER) from a statistician's viewpoint and focus on how statisticians can contribute to the methodology of CER. The statistical science community needs to determine the priorities for methodological research in CER, in collaboration with our colleagues in the aligned medical fields. CER requires that we apply a new paradigm - a focus on the patient. The emphasis on the patient is driven by patients themselves, the federal government, and private payers, in addition to the fact that there is a rising chronic disease burden that is making patient populations more heterogeneous. The availability of new technology and data sources introduces not only complexity but also opportunity. Statistical scientists should rise to meet these new demands and develop optimal, statistically valid approaches to CER, just as they have in agriculture and clinical trials.

RISKS OF DISADAPTATION OF A YOUNG FAMILY IN RUSSIA

This article attempts to identify risky factors in the process of social adaptation of young families to the conditions of Russian reality from the standpoint of the adaptation approach. It identifies methodological research priorities, which are the provisions of structural-activity paradigm to study adaptive processes Furthermore research methodological priorities are identified, which are presented by provisions of structural-activity paradigm to study adaptive processes. Developed by its researchers specifically to study the transforming Russian society, this paradigm allows us to consider the social adaptation of young families in the context of their resource potential as reflecting the subjective nature of adaptation activities. However, being the subject of the adaptation process, the young family is dependent on the macro environment objective factors, which defines the institutional background of the family-marriage relations development in the Russian society and the nature of state policy on support and development of the institution of the family, including a young family. The author considers micro and macro-social factors of influence on the efficiency of social adaptation of young families and the conclusion about a high degree of riskogenics of this institutional sector in the sphere of the family, as evidenced by the high conflict potential of young families and the divorce rate. An important aspect is emphasized due to the forced nature of the social adaptation of young families to the conditions of Russian reality, in which there are no conditions for a life of self-fulfillment needs of young families for proper self-fulfillment of young family living needs. On the background of the family culture crisis in the society, the risk factors of the young family social exclusion are automatically altered into its collapse factors.