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.

Emergency department crowding: prioritising quantified crowding measures using a Delphi study.

AimsEmergency department (ED) crowding has been associated with a number of negative health outcomes, including unnecessary deaths, increased waiting times and a decrease in care quality. Despite the seriousness of this issue, there is little agreement on appropriate crowding measures to assess crowding effects on ED operations. The objective of this study was to prioritise a list of quantified crowding measures that would assess the current state of a department.MethodsA three round Delphi study was conducted via email and an Internet based survey tool. The panel consisted of 40 professionals who had exposure to and expertise in crowding. Participants submitted quantified crowding measures which, through three rounds, were evaluated and ranked to assess participant agreement for inclusion.ResultsThe panel identified 27 measures of which eight (29.6%) reached consensus at the end of the study. These measures comprised: (1) ability of ambulances to offload; (2) patients who leave without being seen or treated; (3) time until triage; (4) ED occupancy rate; (5) patients' total length of stay in the ED; (6) time to see a physician; (7) ED boarding time; and (8) number of patients boarding in the ED.ConclusionsThis study resulted in the identification of eight quantified crowding measures, which present a comprehensive view of how crowding is affecting ED operations, and highlighted areas of concern. These quantified measures have the potential to make a considerable contribution to decision making by ED management and to provide a basis for learning across different departments.

Designing for resilience: Using a Delphi study to identify resilience issues for hospital designs in a changing climate

Hospitals are facing a triple challenge - meeting mandatory climate change targets and refurbishing aging infrastructure while simultaneously providing quality of care. With the potential of more frequent disruptive weather events, a UK government-funded project was launched in 2009 to investigate practical strategies for the National Health Service to increase its resilience to climate change. This paper presents the process of defining resilience by using the Delphi method and demonstrates its applicability within healthcare design. A Delphi survey is nearing completion which has determined the significant resilience issues and temperature ranges for ideal and critical conditions. Our preliminary findings identified six priorities that lead towards increasing resilience. Using the Delphi method can be a useful tool in clarifying the focus for healthcare design considerations. Copyright © 2002-2012 The Design Society. All rights reserved.

Padronização da codificação programas em Borland Delphi: experiência no projeto SIGI.

Regras gerais para formatação de código fonte: idioma dos nomes; identação; margens; comentários. Linguagem Object Pascal. Tratamento de exceções estruturado. Classes: nomenclatura; atributos; propriedades. Arquivos: arquivos de projeto (project); Arquivos de formulários (Forms); Arquivos de units; Units de formulários; Units dos módulos de dados (data module); Units de propósito geral. Formulários (Forms) e Módulo de dados (Data Modules).

Quality of care for cancer patients on home parenteral nutrition: Development of key interventions and outcome indicators using a two-round Delphi approach

Purpose: Clear recommendations on how to guide patients with cancer on home parenteral nutrition (HPN) are lacking as the use of HPN in this population remains a controversial issue. Therefore, the aims of this study were to rank treatment recommendations and main outcome indicators to ensure high-quality care and to indicate differences in care concerning benign versus malignant patients. Methods: Treatment recommendations, identified from published guidelines, were used as a starting point for a two-round Delphi approach. Comments and additional interventions proposed in the first round were reevaluated in the second round. Ordinal logistic regression with SPSS 2.0 was used to identify differences in care concerning benign versus malignant patients. Results: Twenty-seven experts from five European countries completed two Delphi rounds. After the second Delphi round, the top three most important outcome indicators were (1) quality of life (QoL), (2) incidence of hospital readmission and (3) incidence of catheter-related infections. Forty-two interventions were considered as important for quality of care (28/42 based on published guidelines; 14/42 newly suggested by Delphi panel). The topics 'Liver disease' and 'Metabolic bone disease' were considered less important for cancer patients, together with use of infusion pumps (p = 0.004) and monitoring of vitamins and trace elements (p = 0.000). Monitoring of QoL is considered more important for cancer patients (p = 0.03). Conclusion: Using a two-round Delphi approach, we developed a minimal set of 42 interventions that may be used to determine quality of care in HPN patients with malignancies. This set of interventions differs from a similar set developed for benign patients. © 2012 Springer-Verlag Berlin Heidelberg.

Research priorities of adult intensive care nurses in 20 European countries: a Delphi study.

Aims: This paper is a report of a three round Delphi study of intensive care nursing research priorities in Europe (October 2006–April 2009).

Background: Internationally, priorities for research in intensive care nursing have received some attention focusing on healthcare interventions and patient needs. Studies as early as the 1980s identified priorities in the United States, United Kingdom, Hong Kong and Australia. Research priorities of intensive care nurses across the European Union are unknown.

Methods: The participants, invited in 2006, included 110 intensive care nurses, managers, educators and researchers from 20 European Critical Care Nursing Associations. Delphi round one was an emailed questionnaire inviting participants to list important areas for research. The list was content analysed and developed into an online questionnaire for rounds two and three. In round two, participants ranked the topics on a scale of 1–6 (not important to extremely important). Mean scores of round two were added to the questionnaire of round three and participants ranked the topics again.

Results: There were 52 research topics in 12 domains. There was a dominance of priorities in five main areas: patient safety; impact of evidence based practice on outcomes; impact of workforce on outcomes; well being of patients and relatives; and impact of end-of-life care on staff and practice.

Conclusions: The results reflect worldwide healthcare concerns and objectives and highlight topics that nurses view as fundamental to the care of critically ill patients. These topics provide a platform for future research efforts to improve clinical practice and care of patients in intensive care.

Consensus statements for management of Barrett's dysplasia and early-stage esophageal adenocarcinoma, based on a Delphi process

Esophageal adenocarcinoma (EA) is increasingly common among patients with Barrett's esophagus (BE). We aimed to provide consensus recommendations based on the medical literature that clinicians could use to manage patients with BE and low-grade dysplasia, high-grade dysplasia (HGD), or early-stage EA.

Developing the specifications of an open angle glaucoma screening intervention in the United Kingdom: a Delphi approach.

Abstract
BACKGROUND:
Glaucoma is a leading cause of blindness. Early detection is advocated but there is insufficient evidence from randomized controlled trials (RCTs) to inform health policy on population screening. Primarily, there is no agreed screening intervention. For a screening programme, agreement is required on the screening tests to be used, either individually or in combination, the person to deliver the test and the location where testing should take place. This study aimed to use ophthalmologists (who were experienced glaucoma subspecialists), optometrists, ophthalmic nurses and patients to develop a reduced set of potential screening tests and testing arrangements that could then be explored in depth in a further study of their feasibility for evaluation in a glaucoma screening RCT.
METHODS:
A two-round Delphi survey involving 38 participants was conducted. Materials were developed from a prior evidence synthesis. For round one, after some initial priming questions in four domains, specialists were asked to nominate three screening interventions, the intervention being a combination of the four domains; target population, (age and higher risk groups), site, screening test and test operator (provider). More than 250 screening interventions were identified. For round two, responses were condensed into 72 interventions and each was rated by participants on a 0-10 scale in terms of feasibility.
RESULTS:
Using a cut-off of a median rating of feasibility of =5.5 as evidence of agreement of intervention feasibility, six interventions were identified from round 2. These were initiating screening at age 50, with a combination of two or three screening tests (varying combinations of tonometry/measures of visual function/optic nerve damage) organized in a community setting with an ophthalmic trained technical assistant delivering the tests. An alternative intervention was a 'glaucoma risk score' ascertained by questionnaire. The advisory panel recommended that further exploration of the feasibility of screening higher risk populations and detailed specification of the screening tests was required.
CONCLUSIONS:
With systematic use of expert opinions, a shortlist of potential screening interventions was identified. Views of users, service providers and cost-effectiveness modeling are now required to identify a feasible intervention to evaluate in a future glaucoma screening trial.

BOB CAT: a Large-Scale Review and Delphi Consensus for Management of Barrett’s Esophagus With No Dysplasia, Indefinite for, or Low-Grade Dysplasia

OBJECTIVES: Barrett’s esophagus (BE) is a common premalignant lesion for which surveillance is recommended. This strategy is limited by considerable variations in clinical practice. We conducted an international, multidisciplinary, systematic search and evidence-based review of BE and provided consensus recommendations for clinical use in patients with nondysplastic, indefinite, and low-grade dysplasia (LGD). METHODS: We defined the scope, proposed statements, and searched electronic databases, yielding 20,558 publications that were screened, selected online, and formed the evidence base. We used a Delphi consensus process, with an 80% agreement threshold, using GRADE (Grading of Recommendations Assessment, Development and Evaluation) to categorize the quality of evidence and strength of recommendations. RESULTS: In total, 80% of respondents agreed with 55 of 127 statements in the final voting rounds. Population endoscopic screening is not recommended and screening should target only very high-risk cases of males aged over 60 years with chronic uncontrolled reflux. A new international definition of BE was agreed upon. For any degree of dysplasia, at least two specialist gastrointestinal (GI) pathologists are required. Risk factors for cancer include male gender, length of BE, and central obesity. Endoscopic resection should be used for visible, nodular areas. Surveillance is not recommended for <5 years of life expectancy. Management strategies for indefinite dysplasia (IND) and LGD were identified, including a de-escalation strategy for lower-risk patients and escalation to intervention with follow-up for higher-risk patients. CONCLUSIONS: In this uniquely large consensus process in gastroenterology, we made key clinical recommendations for the escalation/de-escalation of BE in clinical practice. We made strong recommendations for the prioritization of future research.

Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study

Background
Among clinical trials of interventions that aim to modify time spent on mechanical ventilation for critically ill patients there is considerable inconsistency in chosen outcomes and how they are measured. The Core Outcomes in Ventilation Trials (COVenT) study aims to develop a set of core outcomes for use in future ventilation trials in mechanically ventilated adults and children.

Methods/design
We will use a mixed methods approach that incorporates a randomised trial nested within a Delphi study and a consensus meeting. Additionally, we will conduct an observational cohort study to evaluate uptake of the core outcome set in published studies at 5 and 10 years following core outcome set publication. The three-round online Delphi study will use a list of outcomes that have been reported previously in a review of ventilation trials. The Delphi panel will include a range of stakeholder groups including patient support groups. The panel will be randomised to one of three feedback methods to assess the impact of the feedback mechanism on subsequent ranking of outcomes. A final consensus meeting will be held with stakeholder representatives to review outcomes.

Discussion
The COVenT study aims to develop a core outcome set for ventilation trials in critical care, explore the best Delphi feedback mechanism for achieving consensus and determine if participation increases use of the core outcome set in the long term.

Consensus on Outcome Measures for Glaucoma Effectiveness Trials: Results From a Delphi and Nominal Group Technique Approaches

PURPOSE: Comparing the relative effectiveness of interventions across glaucoma trials can be problematic due to differences in definitions of outcomes. We sought to identify a key set of clinical outcomes and reach consensus on how best to measure them from the perspective of glaucoma experts.

METHODS: A 2-round electronic Delphi survey was conducted. Round 1 involved 25 items identified from a systematic review. Round 2 was developed based on information gathered in round 1. A 10-point Likert scale was used to quantify importance and consensus of outcomes (7 outcomes) and ways of measuring them (44 measures). Experts were identified through 2 glaucoma societies membership-the UK and Eire Glaucoma Society and the European Glaucoma Society. A Nominal Group Technique (NGT) followed the Delphi process. Results were analyzed using descriptive statistics.

RESULTS: A total of 65 participants completed round 1 out of 320; of whom 56 completed round 2 (86%). Agreement on the importance of outcomes was reached on 48/51 items (94%). Intraocular pressure (IOP), visual field (VF), safety, and anatomic outcomes were classified as highly important. Regarding methods of measurement of IOP, "mean follow-up IOP" using Goldmann applanation tonometry achieved the highest importance, whereas for evaluating VFs "global index mean deviation/defect (MD)" and "rate of VF progression" were the most important. Retinal nerve fiber layer (RNFL) thickness measured by optical coherence tomography (OCT) was identified as highly important. The NGT results reached consensus on "change of IOP (mean of 3 consecutive measurements taken at fixed time of day) from baseline," change of VF-MD values (3 reliable VFs at baseline and follow-up visit) from baseline, and change of RNFL thickness (2 good quality OCT images) from baseline.

CONCLUSIONS: Consensus was reached among glaucoma experts on how best to measure IOP, VF, and anatomic outcomes in glaucoma randomized controlled trials.

Defining consensus norms for palliative care of people with intellectual disabilities in Europe using Delphi methods: A White Paper from the European Association of Palliative care

Background: People with intellectual disabilities often present with unique challenges that make it more difficult to meet their
palliative care needs.
Aim: To define consensus norms for palliative care of people with intellectual disabilities in Europe.
Design: Delphi study in four rounds: (1) a taskforce of 12 experts from seven European countries drafted the norms, based on available empirical knowledge and regional/national guidelines; (2) using an online survey, 34 experts from 18 European countries evaluated the draft norms, provided feedback and distributed the survey within their professional networks. Criteria for consensus
were clearly defined; (3) modifications and recommendations were made by the taskforce; and (4) the European Association for
Palliative Care reviewed and approved the final version.
Setting and participants: Taskforce members: identified through international networking strategies. Expert panel: a purposive sample identified through taskforce members’ networks.
Results: A total of 80 experts from 15 European countries evaluated 52 items within the following 13 norms: equity of access, communication, recognising the need for palliative care, assessment of total needs, symptom management, end-of-life decision making, involving those who matter, collaboration, support for family/carers, preparing for death, bereavement support, education/training
and developing/managing services. None of the items scored less than 86% agreement, making a further round unnecessary. In light of respondents’ comments, several items were modified and one item was deleted.
Conclusion: This White Paper presents the first guidance for clinical practice, policy and research related to palliative care for people with intellectual disabilities based on evidence and European consensus, setting a benchmark for changes in policy and practice.