Comparisons of clinical trial findings in systematic reviews can be hindered by the heterogeneity of the outcomes reported. Moreover, the outcomes that matter most to patients might be underreported. ...A core outcome set can address these issues, as it defines a minimum set of outcomes that should be reported in all clinical trials in a particular area of research. The objective in this study was to develop a core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy.
Firstly, eligible outcomes were identified through a systematic review of trials of medication review in older patients (≥65 years) and interviews with 15 older patients. Secondly, an international three-round Delphi survey in four countries involving patients, healthcare professionals, and experts was conducted to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results.
Of the 164 participants invited to take part in the Delphi survey, 150 completed Round 1, including 55 patients or family caregivers, 55 healthcare professionals, and 40 experts. A total of 129 participants completed all three rounds. Sixty-four eligible outcomes were extracted from 47 articles, 32 clinical trial protocols, and patient interviews. Thirty outcomes were removed and one added after Round 1, 18 outcomes were removed after Round 2, and seven after Round 3. Results were discussed during consensus meetings. Consensus was reached on seven outcomes, which constitute the core outcome set: drug-related hospital admissions; drug overuse; drug underuse; potentially inappropriate medications; clinically significant drug-drug interactions; health-related quality of life; pain relief.
We developed a core outcome set of seven outcomes which should be used in future trials of medication review in multi-morbid older patients with polypharmacy.
Background
Fatty liver disease in the absence of excessive alcohol consumption is an increasingly common condition with a global prevalence of ~ 25–30% and is also associated with cardiovascular ...disease (CVD). Since systemic metabolic dysfunction underlies its pathogenesis, the term metabolic (dysfunction)-associated fatty liver disease (MAFLD) has been proposed for this condition. MAFLD is closely intertwined with obesity, type 2 diabetes mellitus and atherogenic dyslipidemia, which are established cardiovascular risk factors. Unlike CVD, which has received attention in the literature on fatty liver disease, the CVD risk associated with MAFLD is often underestimated, especially among Cardiologists.
Methods and results
A multidisciplinary panel of fifty-two international experts comprising Hepatologists, Endocrinologists, Diabetologists, Cardiologists and Family Physicians from six continents (Asia, Europe, North America, South America, Africa and Oceania) participated in a formal Delphi survey and developed consensus statements on the association between MAFLD and the risk of CVD. Statements were developed on different aspects of CVD risk, ranging from epidemiology to mechanisms, screening, and management.
Conculsions
The expert panel identified important clinical associations between MAFLD and the risk of CVD that could serve to increase awareness of the adverse metabolic and cardiovascular outcomes of MAFLD. Finally, the expert panel also suggests potential areas for future research.
Management of patients with interstitial lung disease (ILD) requires subspecialized, comprehensive, multidisciplinary care. The Pulmonary Fibrosis Foundation established the Care Center Network (CCN) ...in 2013 with identified criteria to become a designated CCN site. Despite these criteria, the essential components of an ILD clinic remain unknown.
How are ILD clinics within the CCN structured? What are the essential components of an ILD clinic according to ILD physician experts, patients, and caregivers?
This study had three components. First, all 68 CCN sites were surveyed to determine the characteristics of their current ILD clinics. Second, an online, three-round modified Delphi survey was conducted between October and December 2019 with 48 ILD experts participating in total. Items for round 1 were generated using expert interviews. During rounds 1 and 2, experts rated the importance of each item on a 5-point Likert scale. The a priori threshold for consensus was more than 75% of experts rating an item as important or very important. In round 3, experts graded items that met consensus and ranked items deemed essential for an ILD clinic. Third, ILD patient and caregiver focus groups were conducted and analyzed for content to determine their perspectives of an ideal ILD clinic.
Forty items across four categories (members, infrastructure, resources, and multidisciplinary conference) achieved consensus as essential to an ILD clinic. Patient and caregiver focus groups identified three major themes: comprehensive, patient-centered medical care; expanded access to care; and comprehensive support for living and coping with ILD.
The essential components of an ILD clinic are well-aligned between physician experts and patients. Future research can use these findings to evaluate the impact of these components on patient outcomes and to inform best practices for ILD clinics throughout the world.
To establish consensus practices among a panel of national experts for the discharge of premature infants with bronchopulmonary dysplasia (BPD) from the hospital to home.
We conducted a Delphi study ...that included US neonatologists and pediatric pulmonologists from the Bronchopulmonary Dysplasia Collaborative to establish consensus practices—defined as recommendations with at least 80% agreement—for infants with BPD being discharged from the hospital. Specifically, we evaluated recommendations for diagnostic tests to be completed around discharge, follow-up respiratory care, and family education.
Thirty-one expert participants completed 3 rounds of surveys, with a 99% response rate (92 of 93). Consensus was established that infants with moderate-severe BPD (ie, those who remain on respiratory support at 36 weeks) and those discharged on oxygen should be targeted for in-person pulmonary follow-up within 1 month of hospital discharge. Specialized neonatal follow-up is an alternative for infants with mild BPD. Infants with moderate or severe BPD should have an echocardiogram performed after 36 weeks to screen for pulmonary hypertension. Infants with BPD warrant additional evaluations if they have growth restriction or poor growth, pulmonary hypertension, or tachypnea and if they are discharged to home on oxygen, diuretics, or nonoral feeds.
This Delphi survey establishes expert consensus around best practices for follow-up respiratory management and routine evaluation for infants with BPD surrounding neonatal discharge. Areas of disagreement for which consensus was not established are discussed.
In 2016, the National Academies of Sciences, Engineering, and Medicine issued a report calling for a National Trauma Research Action Plan (NTRAP) requiring a resourced, coordinated, joint approach to ...trauma care research. The National Academies of Sciences, Engineering, and Medicine report recommended the identification of regulatory barriers to trauma research. The NTRAP Regulatory Challenges Panel of trauma researchers and regulatory professionals was convened to identify the most challenging aspects of regulatory processes involved in conducting research.
Trauma researchers and regulatory experts were recruited to identify and rate challenging regulatory issues in 2021 to 2022. Challenge statements were developed from a comprehensive scoping review. Panelists rated the challenge level for each statement on a 9-point Likert scale. The Delphi survey was conducted over three online rounds. Consensus was defined a priori as ≥60% agreement. Results of the Delphi survey were presented to the panel during a webinar. Panel participants then participated in breakout sessions to strategize solutions, share lessons learned, and identify where more regulatory guidance is needed.
Thirty-eight subject matter experts rated 175 regulatory challenges, of which 141 (81%) reached the consensus threshold. Of the consensus-reaching challenge statements, 42 had a challenge rating of 6 or higher. Among the highest-rated challenges were issues pertaining to conducting prehospital research, exception from informed consent, mistrust of research among various racial and ethnic groups, and issues specific to conducting pediatric trauma research.
This Delphi survey rated challenges culled from a regulatory literature scoping review. The panel identified the most challenging aspects of human subjects protection while conducting trauma research and recommended strategies and best practices to address them. The findings from this study were used to develop the NTRAP Investigator Toolkit, which is available on the internet as a resource for trauma researchers.
Prognostic and Epidemiological; Level IV.
Introduction:
Nasal irrigation is regularly used in infants to relieve upper airway symptoms. However, because there is no consensus on good practice, nasal irrigation in infants is described and ...applied heterogeneously among clinicians and between clinical trials.
Objective:
The aim of this study was to establish consensus regarding the use of nasal irrigation in infants.
Methods:
A panel of Belgian physiotherapists and physicians experienced in performing nasal irrigation in infants were surveyed using the Delphi technique. Three survey rounds were used. Participants rated their level of (dis)agreement to each statement in each round using a 6-point Likert scale. Consensus was defined for statements which collected at least 75% of responses in agreement or disagreement. The questionnaire of Round 1 was built on nasal irrigation practice habits previously collected from parents, childcare workers, and healthcare professionals. Questionnaires from rounds 2 and 3 were amended based on experts written feedback.
Results:
Thirty experts (12 physicians and 18 physiotherapists) completed all 3 questionnaires. Consensus was achieved for 47 of 75 statements (63%) distributed over the following domains: “contraindications,” “indications and frequency of use,” “irrigation means,” “solution preparation,” “solution volume,” “realization of the technique,” and “assessment of the efficacy of nasal irrigation.”
Conclusion:
This study provides the first well-constructed consensus on good practice on nasal irrigation in infants. Consensus on several statements across different domains were established but require validation in future trials. This study also proposes direction for future research focusing on statements that did not reach consensus.
Introduction
This survey of international experts in obesity management was conducted to achieve consensus on standardized definitions and to identify areas of consensus and non-consensus in ...metabolic bariatric surgery (MBS) to assist in an algorithm of clinical practice guidelines for the management of obesity.
Methods
A three-round Delphi survey with 136 statements was conducted by 43 experts in obesity management comprising 26 bariatric surgeons, 4 endoscopists, 8 endocrinologists, 2 nutritionists, 2 counsellors, an internist, and a pediatrician spanning six continents over a 2-day meeting in Hamburg, Germany. To reduce bias, voting was unanimous, and the statements were neither favorable nor unfavorable to the issue voted or evenly balanced between favorable and unfavorable. Consensus was defined as ≥ 70% inter-voter agreement.
Results
Consensus was reached on all 15 essential definitional and reporting statements, including initial suboptimal clinical response, baseline weight, recurrent weight gain, conversion, and revision surgery. Consensus was reached on 95/121 statements on the type of surgical procedures favoring Roux-en-Y gastric bypass, sleeve gastrectomy, and endoscopic sleeve gastroplasty. Moderate consensus was reached for sleeve gastrectomy single-anastomosis duodenoileostomy and none on the role of intra-gastric balloons. Consensus was reached for MBS in patients > 65 and < 18 years old, with a BMI > 50 kg/m
2
, and with various obesity-related complications such as type 2 diabetes, liver, and kidney disease.
Conclusions
In this survey of 43 multi-disciplinary experts, consensus was reached on standardized definitions and reporting standards applicable to the whole medical community. An algorithm for treating patients with obesity was explored utilizing a thoughtful multimodal approach.
Graphical Abstract
Until recently, survival has been the main outcome measure for injury research. Given the impact of injury on quality of life, the National Academies of Science, Engineering, and Medicine has called ...for advancing the science of research evaluating the long-term outcomes of trauma survivors. This is necessary so that treatments and interventions can be assessed for their impact on a trauma patients' long-term functional and psychosocial outcomes. We sought to propose a set of core domains and measurement instruments that are best suited to evaluate long-term outcomes after traumatic injury with a goal for these measures to be adopted as a national standard.
As part of the development of a National Trauma Research Action Plan, we conducted a two-stage, five-round modified online Delphi consensus process with a diverse panel of 50 key stakeholders including clinicians, researchers, and trauma survivors from more than 9 professional areas across the United States. Before voting, panelists reviewed the results of a scoping review on patient-reported outcomes after injury and standardized information on measurement instruments following the Consensus-based Standards for the Selection of Health Measurement Instruments guidelines.
The panel considered a preliminary list of 74 outcome domains (patient-reported outcomes) and ultimately reached the a priori consensus criteria for 29 core domains that encompass aspects of physical, mental, social, and cognitive health. Among these 29 core domains, the panel considered a preliminary list of 199 patient-reported outcome measures and reached the a priori consensus criteria for 14 measures across 13 core domains. Participation of panelists ranged from 65% to 98% across the five Delphi rounds.
We developed a core outcome measurement set that will facilitate the synthesis, comparison, and interpretation of long-term trauma outcomes research. These measures should be prioritized in all future studies in which researchers elect to evaluate long-term outcomes of traumatic injury survivors.
Diagnostic Test or Criteria, Level IV.
The National Academies of Sciences, Engineering, and Medicine 2016 report on the trauma care system recommended establishing a National Trauma Research Action Plan to strengthen and guide future ...trauma research. To address this recommendation, the Department of Defense funded a study to generate a comprehensive research agenda spanning the trauma and burn care continuum. Panels were created to conduct a gap analysis and identify high-priority research questions. The National Trauma Research Action Plan panel reported here addressed trauma systems and informatics.
Experts were recruited to identify current gaps in trauma systems research, generate research questions, and establish the priorities using an iterative Delphi survey approach from November 2019 through August 2020. Panelists were identified to ensure heterogeneity and generalizability, including military and civilian representation. Panelists were encouraged to use a PICO format to generate research questions: patient/population, intervention, compare/control, and outcome. In subsequent surveys, panelists prioritized each research question on a 9-point Likert scale, categorized as low-, medium-, and high-priority items. Consensus was defined as ≥60% agreement.
Twenty-seven subject matter experts generated 570 research questions, of which 427 (75%) achieved the consensus threshold. Of the consensus reaching questions, 209 (49%) were rated high priority, 213 (50%) medium priority, and 5 (1%) low priority. Gaps in understanding the broad array of interventions were identified, including those related to health care infrastructure, technology products, education/training, resuscitation, and operative intervention. The prehospital phase of care was highlighted as an area needing focused research.
This Delphi gap analysis of trauma systems and informatics research identified high-priority research questions that will help guide investigators and funding agencies in setting research priorities to continue to work toward Zero Preventable Deaths after trauma.
Therapeutic/Care Management; Level IV.
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