Identifying potential indicators to measure the outcome of translational cancer research: a mixed methods approach

International audienceAbstractBackgroundIn a context where there is an increasing demand to evaluate the outcome of bio-medical research, our work aims to develop a set of indicators to measure the impact of translational cancer research. The objective of our study was to explore the scope and issues of translational research relevant to evaluation, explore the views of researchers on the evaluation of oncological translational research, and select indicators measuring the outcomes and outputs of translational research in oncology by consensus.MethodsSemi-structured interviews amongst 23 researchers involved in translational cancer research were conducted and analysed using thematic analysis. A two-round modified Delphi survey of 35 participants with similar characteristics was then performed followed by a physical meeting. Participants rated the feasibility and validity of 60 indicators. The physical meeting was held to discuss the methodology of the new indicators.ResultsThe main themes emerging from the interviews included a common definition for translational research but disagreements about the exact scope and limits of this research, the importance of multidisciplinarity and collaboration for the success of translational research, the disadvantages that translational research faces in current evaluation systems, the relative lack of pertinence of existing indicators, and propositions to measure translational cancer research in terms of clinical applications and patient outcomes. A total of 35 participants took part in the first round survey and 12 in the second round. The two-round survey helped us select a set of 18 indicators, including four that seemed to be particularly adapted to measure translational cancer research impact on health service research (number of biomarkers identified, generation of clinical guidelines, citation of research in clinical guidelines, and citation of research in public health guidelines). The feedback from participants helped refine the methodology and definition of indicators not commonly used.ConclusionIndicators need to be accepted by stakeholders under evaluation. This study helped the selection and refinement of indicators considered as the most relevant by researchers in translational cancer research. The feasibility and validity of those indicators will be tested in a scientometric study

Use of chicken eggshell to improve dietary calcium intake in rural sub-Saharan Africa

Undernutrition resulting from inadequate access to high‐quality, nutritious food is a widespread issue in sub‐Saharan Africa impacting the health and survival of mothers and their children. Inadequate dietary intake leads to a deficiency in nutrients including calcium, required for growth and physiological functioning. This study investigated the potential of increasing dietary calcium intake by the addition of heat‐treated ground eggshell to locally prepared food. A mixed methods approach of literature review, Delphi expert survey and focus group discussions with women of childbearing age in rural Tanzania, were used to assess the practicality, safety, and acceptability of consumption of ground eggshell. Chicken eggshell has high calcium content (380 mg of calcium/gram) and bioavailability comparable to calcium carbonate (~39%) with 1 g sufficient to provide one half of a sub‐Saharan African adult female's dietary calcium needs. Salmonella was indicated as the most likely threat to human health through eggshell consumption. Experts agreed that eggshells boiled for 10 min when preparing hard‐boiled eggs with a further 20 min cooking of crushed eggshell in staple foods would eliminate identified egg‐associated pathogens. Five focus groups (n = 46) indicated eggshells were perceived as waste. However, there was an indication of general acceptance of the approach and a willingness to consider the incorporation of ground eggshells into their diets. Development of suitable communication methods are required to convey benefits and safe preparation methods. Ground eggshell could be a highly equitable method of increasing calcium intakes across rural sub‐Saharan Africa where calcium intake is low and village poultry ownership common

A Delphi process to optimize quality and performance of drug evaluation in neonates

Background Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently. Methodology and Main Findings This Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, selected to be part of two committees (a scientific committee and an expert committee), in order to validate criteria required to perform drug evaluation in neonates. Eighty six items were initially selected and classified under 7 headings: “NICUs description - Level of care” (21), “Ability to perform drug trials: NICU organization and processes (15), “Research Experience” (12), “Scientific competencies and area of expertise” (8), “Quality Management” (16), “Training and educational capacity” (8) and “Public involvement” (6). Sixty-one items were retained and headings were rearranged after the first round, 34 were selected after the second round. A third round was required to validate 13 additional items. The final set includes 47 items divided under 5 headings. Conclusion A set of 47 relevant criteria will help to NICUs that want to implement, conduct or participate in drug trials within a neonatal network identify important issues to be aware of. Summary Points 1) Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. 2) The present Delphi study was conducted with an international multidisciplinary panel of 25 experts from 13 countries and aims to identify the major criteria considered necessary for selecting neonatal intensive care units (NICUs) that are able to perform drug evaluations competently. 3) Of the 86 items initially selected and classified under 7 headings - “NICUs description - Level of care” (21), “Ability to perform drug trials: NICU organization and processes (15), “Research Experience” (12), “Scientific competencies and area of expertise” (8), “Quality Management” (16), “Training and educational capacity” (8) and “Public involvement” (6) - 47 items were selected following a three rounds Delphi process. 4) The present consensus will help NICUs to implement, conduct or participate in drug trials within a neonatal network

An expert consensus definition of failure of a treatment to provide adequate relief (F-PAR) for chronic constipation - an international Delphi survey

BACKGROUND: As treatments for constipation become increasingly available, it is important to know when to progress along the treatment algorithm if the patient is not better. AIM: To establish the definition of failure of a treatment to provide adequate relief (F-PAR) to support this management and referral process in patients with chronic constipation. METHODS: We conducted an international Delphi Survey among gastroenterologists and general practitioners with a special interest in chronic constipation. An initial questionnaire based on recognised rating scales was developed following a focus group. Data were collected from two subsequent rounds of questionnaires completed by all authors. Likert scales were used to establish a consensus on a shorter list of more severe symptoms. RESULTS: The initial focus group yielded a first round questionnaire with 84 statements. There was good consensus on symptom severity and a clear severity response curve, allowing 67 of the symptom-severity pairings to be eliminated. Subsequently, a clear consensus was established on further reduction to eight symptom statements in the final definition, condensed by the steering committee into five diagnostic statements (after replicate statements had been removed). CONCLUSIONS: We present an international consensus on chronic constipation, of five symptoms and their severities, any of which would be sufficient to provide clinical evidence of treatment failure. We also provide data representing an expert calibration of commonly used rating scales, thus allowing results of clinical trials expressed in terms of those scales to be converted into estimates of rates of provision of adequate relief

Indicators to assess the functionality of clubfoot clinics in low-resource settings: a Delphi consensus approach and pilot study.

Background: This study aims to determine the indicators for assessing the functionality of clubfoot clinics in a low-resource setting. Methods: The Delphi method was employed with experienced clubfoot practitioners in Africa to rate the importance of indicators of a good clubfoot clinic. The consistency among the participants was determined with the intraclass correlation coefficient. Indicators that achieved strong agreement (mean≥9 [SD <1.5]) were included in the final consensus definition. Based on the final consensus definition, a set of questions was developed to form the Functionality Assessment Clubfoot Clinic Tool (FACT). The FACT was used between February and July 2017 to assess the functionality of clinics in the Zimbabwe clubfoot programme. Results: A set of 10 indicators that includes components of five of the six building blocks of a health system-leadership, human resources, essential medical equipment, health information systems and service delivery-was produced. The most common needs identified in Zimbabwe clubfoot clinics were a standard treatment protocol, a process for surgical referrals and a process to monitor dropout of patients. Conclusions: Practitioners had good consistency in rating indicators. The consensus definition includes components of the World Health Organization building blocks of health systems. Useful information was obtained on how to improve the services in the Zimbabwe clubfoot programme

Developing a national musculoskeletal core capabilities framework for first point of contact practitioners

Objective We aimed to support service transformation by developing a core capabilities framework for first contact practitioners working with people who have musculoskeletal (MSK) conditions. Methods We conducted a modified three-round Delphi study with a multi-professional panel of 41 experts nominated through 18 national professional and patient organisations. Qualitative data from an open-ended question in round one was analysed using a thematic approach and combined with existing literature to shape a draft framework. Participants rated their agreement with each of the proposed 142 outcomes within 14 capabilities on a 10-point Likert scale in round two. The final round combined round two results with a wider online survey. Results Rounds two and three of the Delphi survey were completed by 37 and 27 participants respectively. 90 practitioners responded to the wider online survey. The final framework contains 105 outcomes within 14 capabilities, separated into 4 domains (Person-centred approaches; Assessment, investigation and diagnosis; Condition management, intervention and prevention; Service and professional development). Median agreement for all 105 outcomes was ≥ 9 on the 10-point Likert scale in the final round. Conclusion The framework outlines the core capabilities required for practitioners working as the first point of contact for people with MSK conditions. It provides a standard structure and language across professions; greater consistency and portability of MSK core capabilities. Agreement on each of the 105 outcomes was universally high amongst the expert panel and the framework is now being disseminated by Health Education England, NHS England and Skills for Health

Seeking a practical definition of stable glaucoma: a Delphi consensus survey of UK glaucoma consultants

© 2019, The Author(s), under exclusive licence to The Royal College of Ophthalmologists. Background: To generate a practical and clinically useful consensus definition of ‘stable glaucoma’ to aid provision of glaucoma services in the UK and to provide guidance for the criteria that should be used for monitoring of glaucoma patients in primary care services. Methods: A Delphi exercise was undertaken to derive consensus through an online questionnaire. Participants were asked to score their strength of agreement for a series of clinical parameters. Results and comments from each round were used to inform subsequent rounds. A total of 3 rounds were undertaken. Results: Thirty-two glaucoma experts participated in the study with over 90% completion rate achieved over three rounds. The consensus was reached for the following parameters: IOP levels to be used for defining stability, visual field-testing techniques to define stability, the number of medication changes acceptable to define stability and the number of treatment medications allowed to define stability. No consensus was reached on the period of time over which stability was defined, however, there was considerable agreement that longer durations of follow up (36–48 months) were required. A combination of optic disc photos and ocular coherence topography (OCT) retinal nerve fibre layer (RNFL) assessment/ OCT disc structural evaluation are the preferred imaging methods for the assessment of structural stability. Oversight by a glaucoma consultant was considered important for glaucoma monitoring schemes. Conclusion: The consensus definition of glaucoma stability generated through this Delphi exercise provides guidance for allocation of patients suitable for monitoring in primary care glaucoma monitoring schemes

The respiratory research agenda in primary care in Portugal: a Delphi study

Background: A research agenda can help to stimulate and guide research. The International Primary Care Respiratory Group (IPCRG) published a Research Needs Statement (RNS) in 2010 in which 145 research questions were identified. In 2012, priorities for respiratory research were established, based on these questions. To date, there has been no statement on primary care respiratory research needs in Portugal. The aim of the study was to develop a national consensus on research priorities in respiratory diseases in primary care in Portugal and to assess the applicability of the priorities for respiratory research set by the IPCRG. Method: We conducted a Delphi study by electronic mail with a panel of experts on respiratory disease from primary and secondary care in Portugal. In the first round, the research needs in respiratory disease in Portugal were identified. In the second round, 196 research questions in six disease areas, derived from the first round and from the IPCRG Respiratory needs statement, were prioritised on a five-point Likert-type scale. In the third round, the questions were prioritized again with feed-back provided on the median scores for each item in the second round. Consensus was considered to have been reached when 80 % of the participants gave a score of 4 or 5 out of five on a given item. Results: The 40 experts identified 121 respiratory research questions in Round 1 and expressed their views on 196 questions in Rounds 2 and 3. Twelve research questions (6 %) reached consensus. There were five questions in the asthma domain on early diagnosis, pulmonary function tests, the use of inhalers, and adherence to treatment. There were four questions in the chronic obstructive pulmonary disease domain on vaccinations, on routine monitoring and evaluation of treatment, on diagnosis, and on adherence to treatments. There was one question in the smoking domain on the effects of brief counselling. There were two questions on respiratory tract infections on the treatment of children and on the prescription of antibiotics. An additional 23 research questions (12 %) achieved consensus between 75 and 79 %. Conclusion: The results reflect the Portuguese reality in response the international agenda for research on respiratory diseases published by the IPCRG. They can support the development of future respiratory disease research in Portugal.Financial support for this work was provided by FEDER funds through the Operational Programme Competitiveness Factors - COMPETE and National Funds through FCT - Foundation for Science and Technology under the project POCI-01-0145-FEDER-007038; and by the project NORTE-01-0145-FEDER-000013, supported by Norte Portugal Regional Operational Programme (NORTE 2020), under the PORTUGAL 2020 Partnership Agreement, through the European Regional Development Fund (ERDF). PMT is partially supported by a grant from the International Primary Care Respiratory Group