Delphi Consensus Procedure Research Articles

Assessing Severity and Need for Delivery in Early Onset Preeclampsia Before 32 Weeks of Gestation: a Delphi Consensus Procedure.

Preeclampsia is a potentially life-threatening hypertensive pregnancy disorder that carries an acute risk of an unfavorable outcome of the pregnancy but also has consequences for the long-term health of the mother. Women who develop the early form of pre-eclampsia before the 32nd week of pregnancy have the highest risk and are also the most difficult to treat. The severity of pre-eclampsia is not characterized uniformly in Germany, so that the indication for delivery is rather individualized. The aim of this study was to reach a consensus on parameters that could serve as criteria for describing the severity of pre-eclampsia based on the urgency of delivery. To this end, a Delphi procedure was used to present a scenario in which a woman was admitted for preeclampsia before 32 gestational weeks and after completion of antenatal steroid therapy. Clinicians specialized in maternal-fetal medicine from German-speaking countries completed five rounds of a modified Delphi questionnaire. Presented parameters were selected by the section "Hypertensive Pregnancy Diseases and Fetal Growth Restriction" of the German Society of Gynecology and Obstetrics after reviewing the literature. These included objectifiable laboratory or clinical parameters as well as subjective symptoms of the patient. In addition, nine fetal parameters were taken into account. The clinicians were asked to rate presented parameters as an indication for delivery on a Likert scale from 0 to 4 (no indication to absolute indication without delay). For each item, the predefined cut-off for group consensus was ≥70% agreement. A total of 126 experts were approached. Sixty-nine experts (54.8%) took part in the first round; of those 50 completed the entire Delphi procedure. A consensus was reached on 14 parameters to be considered rapid preparation for delivery without delay (4 points on the Likert scale). These were among others hepatic hematoma or liver capsule rupture, acute liver failure with fulminant coagulation disorder or disseminated intravascular coagulation, eclampsia, pathologic findings in imaging (e.g. cMRI) or electrocardiogram arranged for new onset of headache or retrosternal pain, respectively. Twenty-six parameters were rated as factors that should be considered in the decision without being absolute (1 to 3 points), and 13 parameters should have no influence on the decision to deliver (0 points). No consensus on severe hypertension as an indication for delivery could be reached for blood pressure values below 220/140mmHg. A consensus was reached on whether to deliver in preeclampsia typic clinical findings and symptoms. The results can serve as guidance for current clinical practice and for the definition of clinical endpoints in intervention studies. Nevertheless, the isolated criteria are a theoretical construction since the combined deterioration or summation of several factors rather than a single factor most likely influences the decision to deliver and reflect the severity of preeclampsia. Moreover, the degree of hypertension as an indication for delivery remains controversial, unless the patient suffers additionally from complaints. Future research should be enforced to incorporate long-term risks for the mother into a decision aid.

Selection of proxy indicators estimating the appropriateness of antibiotic prescriptions in general practice: a national consensus procedure in France.

GPs are responsible for more than 70% of outpatient antibiotic prescriptions in France. Metrics are important antibiotic stewardship tools that can be used to set targets for improvement and to give feedback to professionals and stakeholders. The primary objective of the present study was to select a set of proxy indicators (PIs) based on 10 previously developed PIs, to estimate the appropriateness of antibiotic prescriptions by GPs. The secondary objective was to evaluate the clinimetric properties of the selected PIs. A RAND-modified Delphi consensus procedure was conducted with a multidisciplinary panel of stakeholders. This procedure consisted of two successive online surveys with a consensus meeting in between. Clinimetric properties (measurability, applicability and potential room for improvement) were evaluated for the PIs selected through the consensus procedure, using 2022 Regional Health Insurance data. Seventeen experts participated in the first-round survey and 14 in the second-round. A final set of 12 PIs was selected. Among the 10 initial PIs, 3 were selected without modification and 7 were modified and selected. Moreover, two newly suggested PIs were selected. Ten of the 12 PIs presented good clinimetric properties. The 12 selected PIs cover the main situations responsible for inappropriate and unnecessary use of antibiotics in general practice. These PIs, easily calculable using routinely collected health insurance reimbursement data, might be used to give feedback to prescribers and stakeholders and help improve antibiotic prescriptions in primary care.

An International Expert-Based CONsensus on Indications and Techniques for aoRtic balloOn occLusion in the Management of Ruptured Abdominal Aortic Aneurysms (CONTROL-RAAA)

Objective: To report on the recommendations of an expert-based consensus on the indications, timing, and techniques of aortic balloon occlusion (ABO) in the management of ruptured abdominal aortic aneurysms (rAAA). Methods: Eleven facilitators created appropriate statements regarding the study issues that were voted on using a 4-point Likert scale with open-comment fields, by a selected panel of international experts (vascular surgeons and interventional radiologists) using a 3-round modified Delphi consensus procedure (study period: January-April 2023). Based on the experts’ responses, only the statements reaching grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final study report. The consistency of each round’s answers was also graded using Cohen’s kappa, the intraclass correlation coefficient, and, in case of double resubmission, Fleiss kappa. Results: Sixty-three experts were included in the final analysis and voted on 25 statements related to indication and timing (n=6), and techniques (n=19) of ABO in the setting of rAAA. Femoral sheath or ABO should be preferably placed in the operating room, via a percutaneous transfemoral access, on a stiff wire (grade B, consistency I), ABO placement should be suprarenal and last less than 30 minutes (grade B, consistency II), postoperative peripheral vascular status (grade A, consistency II) and laboratory testing every 6 to 12 hours (grade B, consistency) should be assessed to detect complications. Formal training for ABO should be implemented (grade B, consistency I). Most of the statements in this international expert-based Delphi consensus study might guide current choices for indications, timing, and techniques of ABO in the management of rAAA. Clinical practice guidelines should incorporate dedicated statements that can guide clinicians in decision-making. Conclusions: At arrival and during both open or endovascular procedures for rAAA, selective use of intra-aortic balloon occlusion is recommended, and it should be performed preferably by the treating physician in aortic pathology. Clinical Impact This is the first consensus study of international vascular experts aimed at defining the indications, timing, and techniques of optimal use of ABO in the clinical setting of rAAA. Aortic occlusion by endovascular means (or ABO) is a quick procedure in properly trained hands that may play an important role as a temporizing measure until the definitive aortic repair is achieved, whether by endovascular or open means. Since data on its use in hemodynamically unstable patients are limited in the literature, owing to practical challenges in the performance of well-conducted prospective studies, understanding real-world use by experts is of importance in addressing critical issues and identifying main gaps in knowledge.

64 The Biomarker-Based Etiological Diagnosis of Neurocognitive Disorders: the European Inter-Societal Delphi Consensus

Objective:In the field of neurocognitive disorders, the perspective offered by new disease-modifying therapy increases the importance of etiological diagnosis. The prescription of cerebrospinal fluid analysis (CSF) and imaging biomarkers is a common practice in the clinic but is often driven more by personal expertise and local availability of diagnostic tools than by evidence of efficacy and cost-effectiveness analysis. This leads to a widely heterogeneous dementia care across Europe. Therefore, a European initiative is currently being conducted to establish a consensus for biomarker-based diagnosis of patients with mild cognitive impairment (MCI) and mild dementia.Participants and Methods:Since November 2020, a European multidisciplinary task force of 22 experts from 11 scientific societies have been defining a diagnostic workflow for the efficient use of biomarkers. The Delphi consensus procedure was used to bridge the gaps of incomplete scientific evidence on biomarker prioritization. The project has been in two phases. During Phase 1, we conducted a literature review on the accuracy of imaging, CSF, neurophysiological and blood biomarkers in predicting the clinical progression or in defining the underpinning aetiology of main neurocognitive disorders. Evidence was provided to support the panelists’ decisions. In phase 2, a modified Delphi procedure was implemented, and consensus was reached at a threshold of 70% agreement, or 50%+1 when a question required rediscussion.Results:In phase 1, 167 out of 2,200 screened papers provided validated measures of biomarker diagnostic accuracy compared with a gold standard or in predicting progression or conversion of MCI to the dementia stage (i.e., MRI, CSF, FDG-PET, DaT-imaging, amyloid-PET, tau-PET, and myocardial MIBG-scintigraphy and EEG). During phase 2, panelists agreed on the clinical workspace of the workflow, the stage of application, and the patient age window. The workflow is patient-centered and features three levels of assessment (W): W1 defines eleven clinical profiles based on integrated results of neuropsychology, MRI atrophy patterns, and blood tests; W2 describes the first-line biomarkers according to W1 versus clinical suspicion; and W3 suggests the second-line biomarkers when the results of first-line biomarkers are inconsistent with the diagnostic hypothesis, uninformative or inconclusive. CSF biomarkers are first-line in the suspect of Alzheimer’s disease (AD) and when inconsistent neuropsychological and MRI findings hinder a clear diagnostic hypothesis; dopamine SPECT/PET for those leading to suspect Lewy body spectrum. FDG-PET is first-line for the clinical profiles leading to suspect frontotemporal lobar degeneration and motor tauopathies and is followed by CSF biomarkers in the case of atypical metabolic patterns, when an underlying AD etiology is conceivable.Conclusions:The workflow will promote consistency in diagnosing neurocognitive disorders across countries and rational use of resources. The initiative has some limitations, mainly linked to the Delphi procedure (e.g., kickoff questions were driven by the moderators, answers are driven by the Delphi panel composition, a subtle phrasing of the questions may drive answers, and 70% threshold for convergence is conventional). However, the diagnostic workflow will be able to help clinicians achieve an early and sustainable etiological diagnosis and enable the use of disease-modifying drugs as soon as they become available.

Developing Core Elements and Checklist Items for Implementing Antimicrobial Stewardship Programs in Korean General Hospitals: A Modified Delphi Survey.

Antimicrobial stewardship programs (ASPs) aim to optimize antimicrobial use by minimizing the spread of antimicrobial resistance. The core elements for implementing ASPs in healthcare facilities have been developed by the World Health Organization, international research group and government agencies of various countries. However, to date, there is no documented core elements for implementation of ASP in Korea. This survey aimed to establish a national consensus on a set of core elements and their related checklist items for the implementation of ASPs in Korean general hospitals. The survey was conducted from July 2022 to August 2022 by the Korean Society for Antimicrobial Therapy with support from the Korea Disease Control and Prevention Agency. A literature review was conducted by searching Medline and relevant websites to retrieve a list of core elements and checklist items. These core elements and checklist items were evaluated by a multidisciplinary panel of experts using a structured modified Delphi consensus procedure, using two-step survey included online in-depth questionnaires and in-person meeting. The literature review identified 6 core elements (Leadership commitment, Operating system, Action, Tracking, Reporting, and Education) and 37 related checklist items. Fifteen experts participated in the consensus procedures. Ultimately, all 6 core elements were retained, and 28 checklist items were proposed, all with ≥80% agreement; in addition 9 items were merged into 2 items, 2 items were deleted, and 15 items were rephrased. This Delphi survey provides useful indicators for the implementation of ASP in Korea and suggests national policy improvement about the barriers (e.g., shortage of staffing and financial support) existing in Korea for optimal implementation of ASPs.

European Academy of Neurology guidance for developing and reporting clinical practice guidelines on rare neurological diseases.

Rare diseases affect up to 29million people in the European Union, and almost 50% of them affect the nervous system or muscles. Delays in diagnosis and treatment onset and insufficient treatment choices are common. Clinical practice guidelines (CPGs) may improve the diagnosis and treatment of patients and optimize care pathways, delivering the best scientific evidence to all clinicians treating these patients. Recommendations are set for developing and reporting high-quality CPGs on rare neurological diseases (RNDs) within the European Academy of Neurology (EAN), through a consensus procedure. A group of 27 experts generated an initial list of items that were evaluated through a two-step Delphi consensus procedure and a face-to-face meeting. The final list of items was reviewed by an external review group of 58members. The consensus procedure yielded 63 final items. Items are listed according to the domains of the AGREE instruments and concern scope and purpose, stakeholder involvement, rigour of development, and applicability. Additional items consider reporting and ethical issues. Recommendations are supported by practical examples derived from published guidelines and are presented in two tables: (1) items specific to RND CPGs, and general guideline items of special importance for RNDs, or often neglected; (2) items for guideline development within the EAN. This guidance aims to provide solutions to the issues specific to RNDs. This consensus document, produced by many experts in various fields, is considered to serve as a starting point for further harmonization and for increasing the quality of CPGs in the field of RNDs.

Isokinetic hamstring and quadriceps strength interpretation guideline for football (soccer) players with ACL reconstruction: a Delphi consensus study in the Netherlands

ABSTRACT Strength testing is a key part of rehabilitation and return to sport (RTS) decision making for football players after anterior cruciate ligament reconstruction (ACLR). Isokinetic testing has been the gold standard for strength measurement for decades, but a uniform protocol and clinical implications of test results are lacking. Therefore, this study aimed to 1) develop a uniform protocol for football players based on knowledge and experience from experts in the field of ACL rehabilitation and 2) clarify the clinical interpretation of different isokinetic test outcomes. In a structured Delphi consensus procedure 42 experts (98% full response rate) fulfilled three rounds that involved a survey, content analysis and anonymised feedback report for each round. Surveys addressed the isokinetic protocol, evaluation report and torque–angle curve of the isokinetic test for strength evaluation in football players after ACLR. The final protocol consisted of concentric knee flexion and extension isokinetic testing with 5 repetitions at 60°/sec, 20 repetitions at 180°/sec and 15 repetitions at 300°/sec and 60 seconds rest between sets. All parameters were deemed valuable, with Peak Torque, Max Rep Total Work, Total Work, Range of Motion and Agonist to Antagonist ratio being considered key for clinical interpretation. For qualitative assessment, it was advised to assess the shape, course, volume, potential dips, peak, and build-up to the peak of the parabola. This Delphi consensus study provided a guideline for data collection and clinical interpretation of isokinetic strength testing in football players after ACLR.

Patient voice in core outcome sets: are we hearing but not listening?

The article by Kgosidialwa O. et al. is a good example of the process of uniformization of research1 . In the absence of unambiguous empirical evidence, a (modified) Delphi consensus procedure is the method of choice to develop agreement on definitions, core outcome sets, and other sets of relevant items. The Delphi procedure taps into the contemporary knowledge and values of individual participants, including layexperts and patient representatives2 . Patient involvement is advocated because they are the primary stakeholders and best informed about what outcomes are most important to them. An example: the perception of the importance of breast feeding as an outcome of obstetric intervention studies may differ between patients and health care providers.

Sustainable Neonatal CLABSI Surveillance: Consensus Toward New Criteria in the Netherlands

Group Name: Working Group on Neonatal Infectious Diseases of the Section of Neonatology of the Dutch Paediatric SocietyBackground: Central-line–associated bloodstream infections (CLABSIs) are a main focus of infection prevention and control initiatives in neonatal care. Standardized surveillance of neonatal CLABSI enables intra- and interfacility comparisons, which can contribute to quality improvement. To date, there is no national registration system for CLABSI in neonatal care in the Netherlands. Across neonatal intensive care units (NICUs), several different sets of CLABSI criteria and surveillance methods are used for local monitoring of CLABSI incidence rates. To achieve standardized CLABSI surveillance, we conducted a consensus procedure with regard to nationwide neonatal CLABSI surveillance criteria. Method: A modified Delphi consensus procedure for the development of nationwide neonatal CLABSI surveillance criteria was performed between January 2016 and January 2017 in the Netherlands. An expert panel was formed by members of the Working Group on Neonatal Infectious Diseases of the Section of Neonatology of the Dutch Paediatric Society. The consensus procedure consisted of 3 expert panel rounds. Figure 1 shows a detailed description of the consensus procedure. Result: The expert panel achieved consensus on Dutch neonatal CLABSI surveillance criteria, which are summarized in Figure 2. Neonatal CLABSI is defined as a bloodstream infection occurring >72 hours after birth, associated with an indwelling central venous or arterial line and laboratory confirmed by 1 or more blood cultures. In addition, the blood culture finding should not be related to an infection at another site and one of the following criteria can be applied: (1) a bacterial or fungal pathogen is identified from 1 or more blood cultures; (2) the patient has clinical symptoms of sepsis and (2A) a common commensal is identified in 2 separate blood cultures or (2B) a common commensal is identified by 1 blood culture and C-reactive protein (CRP) level is >10 mg/L in the first 36 hours following blood culture collection. Conclusion: The newly developed Dutch neonatal CLABSI surveillance criteria are concise, are specific to the neonatal population, and comply with a single blood-culture policy in actual neonatal clinical practice. International agreement upon neonatal CLABSI surveillance criteria is needed to identify best practices for infection prevention and control.Funding: NoDisclosures: None

Indications for Hematopoietic Stem Cell Transplantation in Patients with Waldenstrom's Macroglobulinemia: A Consensus Project of the EBMT Lymphoma Working Party (LWP)/ European Consortium for Waldenstrom's Macroglobulinemia (ECWM)/International Waldenstrom's Macroglobulinemia Foundation (IWMF)

Indications for Hematopoietic Stem Cell Transplantation in Patients with Waldenstrom's Macroglobulinemia: A Consensus Project of the EBMT Lymphoma Working Party (LWP)/ European Consortium for Waldenstrom's Macroglobulinemia (ECWM)/International Waldenstrom's Macroglobulinemia Foundation (IWMF)

Selecting a Contextualized Set of Urban Quality of Life Indicators: Results of a Delphi Consensus Procedure

Although indicators are commonly used to measure/assess urban quality of life (QOL), there is no consensus in the literature on the core indicators of urban QOL. This paper aims to identify a set of key indicators that will be used to assess/measure urban QOL in the Saudi Arabia (SA) context. For this purpose, a three-round online Delphi procedure is used. A group of 92 local experts were asked to rate the importance of a set of pre-defined indicators in assessing/measuring urban QOL. The results reveal that the panel of experts reached consensus and agreed on the high importance of 53 indicators for assessing/measuring urban QOL. These indicators provide appropriate coverage of the three core dimensions of urban QOL: environmental, social and economic. However, the results also show that the social indicators are perceived as more essential than economic and environmental indicators. This finding has practical implications for designing and developing QOL assessment tools to better capture and measure urban QOL in the SA context. Furthermore, research findings also identified some methodological limitations associated with using the Delphi approach, which need to be addressed to ensure the development of comprehensive QOL assessment tools.

Sustainable neonatal CLABSI surveillance: consensus towards new criteria in the Netherlands

BackgroundCentral line-associated bloodstream infections (CLABSI) are a main focus of infection prevention and control initiatives in neonatal care. Standardised surveillance of neonatal CLABSI enables intra- and interfacility comparisons which can contribute to quality improvement. To date, there is no national registration system for CLABSI in neonatal care in the Netherlands and several criteria are used for local monitoring of CLABSI incidence rates. To achieve standardised CLABSI surveillance we conducted a consensus procedure with regard to nationwide neonatal CLABSI surveillance criteria (SC).MethodsA modified Delphi consensus procedure for the development of nationwide neonatal CLABSI SC was performed between January 2016 and January 2017 in the Netherlands. An expert panel was formed by members of the Working Group on Neonatal Infectious Diseases of the Section of Neonatology of the Dutch Paediatric Society. The consensus procedure consisted of three expert panel rounds.ResultsThe expert panel achieved consensus on Dutch neonatal CLABSI SC. Neonatal CLABSI is defined as a bloodstream infection occurring more than 72 h after birth, associated with an indwelling central venous or arterial line and laboratory confirmed by one or more blood cultures. In addition, the blood culture finding should not be related to an infection at another site and one of the following criteria can be applied: 1. a bacterial or fungal pathogen is identified from one or more blood cultures; 2. the patient has clinical symptoms of sepsis and 2A) a common commensal is identified in two separate blood cultures or 2B) a common commensal is identified by one blood culture and C-reactive protein level is above 10 mg/L in the first 36 h following blood culture collection.ConclusionsThe newly developed Dutch neonatal CLABSI SC are concise, specified to the neonatal population and comply with a single blood culture policy in actual neonatal clinical practice. International agreement upon neonatal CLABSI SC is needed to identify best practices for infection prevention and control.

Consensus Parameter: Research Methodologies to Evaluate Neurodevelopmental Effects of Pubertal Suppression in Transgender Youth.

Purpose: Pubertal suppression is standard of care for early pubertal transgender youth to prevent the development of undesired and distressing secondary sex characteristics incongruent with gender identity. Preliminary evidence suggests pubertal suppression improves mental health functioning. Given the widespread changes in brain and cognition that occur during puberty, a critical question is whether this treatment impacts neurodevelopment.Methods: A Delphi consensus procedure engaged 24 international experts in neurodevelopment, gender development, puberty/adolescence, neuroendocrinology, and statistics/psychometrics to identify priority research methodologies to address the empirical question: is pubertal suppression treatment associated with real-world neurocognitive sequelae? Recommended study approaches reaching 80% consensus were included in the consensus parameter.Results: The Delphi procedure identified 160 initial expert recommendations, 44 of which ultimately achieved consensus. Consensus study design elements include the following: a minimum of three measurement time points, pubertal staging at baseline, statistical modeling of sex in analyses, use of analytic approaches that account for heterogeneity, and use of multiple comparison groups to minimize the limitations of any one group. Consensus study comparison groups include untreated transgender youth matched on pubertal stage, cisgender (i.e., gender congruent) youth matched on pubertal stage, and an independent sample from a large-scale youth development database. The consensus domains for assessment includes: mental health, executive function/cognitive control, and social awareness/functioning.Conclusion: An international interdisciplinary team of experts achieved consensus around primary methods and domains for assessing neurodevelopmental effects (i.e., benefits and/or difficulties) of pubertal suppression treatment in transgender youth.

Uniform Registration Agreements on Cholesteatoma Care: A Nationwide Consensus Procedure.

Background:To coordinate and align the content for registration of cholesteatoma care.Methods:Systematic Delphi consensus procedure, consisting three rounds: two written sessions followed by a face-to-face meeting. Before this procedure, input on important patient outcomes was obtained. Consensus was defined as at least 80% agreement by participants. Hundred-thirty-six adult patients who had undergone cholesteatoma surgery and all ENT surgeons of the Dutch ENT Society were invited. The consensus rounds were attended by ENT surgeons with cholesteatoma surgery experience. Feasibility and acceptability of outcome measures and reporting agreements were assessed in round 1 by 150 ENT surgeons. In round 2 definitions were narrowed and context information to interpret outcome measure were questioned. In round 3, the results, amendments, and the open-ended points were discussed to reach agreement.Results:Most important outcome measures are: 1) the presence or absence of a cholesteatoma in the first 5 years after surgical removal of cholesteatoma, 2) hearing level after surgical removal of cholesteatoma, and 3) the documented assessment of patient's complaints with a validated patient reported outcome measures questionnaire (PROM). Furthermore, consensus was reached on the registration of cholesteatoma type (residual/recurrent), localization of cholesteatoma, and reporting of the presence of cholesteatoma in the follow-up.Conclusion:Consensus was reached on the content and method of registration of cholesteatoma care based on patient's and ENT surgeons input. Three outcome measures were defined. National agreements on the method and content of registration will facilitate monitoring and feedback to the ENT surgeon about the cholesteatoma care.

Developing consensus description of group music therapy characteristics for persons with dementia

ABSTRACT Introduction Group music therapy (GMT) represents a promising person-centered approach facilitating emotional and social interaction and alleviating behavioral and psychological symptoms in people with dementia. The aim of this study is to produce a consensus statement that can inform provision of and research on person-centered group music therapy (GMT) for persons with dementia. Method We used a Delphi consensus procedure of two iterations in which music therapists rated their agreement with predefined statements about descriptions of GMT in structured questionnaires. Music therapists from eight countries (Austria, Australia, Denmark, Germany, Italy, Netherlands, Norway and UK) participated in the Delphi iterations. Results In the first iteration 57 music therapists participated and 34 in the second iteration. Consensus was reached on 75 out of 91 statements covering five themes: (1) People who can benefit from GMT, (2) Short and long-term goals, (3) Therapy frame & Assessment (4) Therapeutic approaches within GMT and (5) Therapists’ qualities and attitudes. Discussion This consensus statement provides therapists and researchers with practical information to which music therapists agree on an international level. It may serve as a foundation for developing more extensive and in-depth guidelines and fidelity measures. The statements underlinethat the music therapist must adapt therapy to the needs and wishes of persons with dementia, which can be seen in the consensus statements about group size, group dynamics, distractions and interruptions during the therapy.

Can we optimise doxorubicin treatment regimens for children with cancer? Pharmacokinetic simulations and a Delphi consensus procedure

BackgroundDespite its cardiotoxicity doxorubicin is widely used for the treatment of paediatric malignancies. Current treatment regimens appear to be suboptimal as treatment strategies vary and do not follow a clear pharmacological rationale. Standardisation of dosing strategies in particular for infants and younger children is required but is hampered by scarcely defined exposure-response relationships. The aim is to provide a rational dosing concept allowing for a reduction of variability in systemic therapy intensity and subsequently unforeseen side effects.MethodsDoxorubicin plasma concentrations in paediatric cancer patients were simulated for different treatment schedules using a population pharmacokinetic model which considers age-dependent differences in doxorubicin clearance. Overall drug exposure and peak concentrations were assessed. Simulation results were used to support a three round Delphi consensus procedure with the aim to clarify the pharmacological goals of doxorubicin dosing in young children. A group of 28 experts representing paediatric trial groups and clinical centres were invited to participate in this process.ResultsPharmacokinetic simulations illustrated the substantial differences in therapy intensity associated with current dosing strategies. Consensus among the panel members was obtained on a standardised a priori dose adaptation that individualises doxorubicin doses based on age and body surface area targeting uniform drug exposure across children treated with the same protocol. Further, a reduction of peak concentrations in very young children by prolonged infusion was recommended.ConclusionsAn approach to standardise current dose modification schemes in young children is proposed. The consented concept takes individual pharmacokinetic characteristics into account and involves adaptation of both the dose and the infusion duration potentially improving the safety of doxorubicin administration.

The FORTA (Fit fOR The Aged)-EPI (Epidemiological) Algorithm: Application of an Information Technology Tool for the Epidemiological Assessment of Drug Treatment in Older People.

To improve drug treatment in older people, who often present with multimorbidity and related polypharmacy, the FORTA (Fit fOR The Aged) List was developed via a Delphi consensus procedure. As a patient-in-focus listing approach (PILA), it has been clinically validated (VALFORTA trial). Unlike drug-oriented listing approaches (DOLAs), its application requires knowledge of patients' characteristics, including diagnoses and other details. As a drug list with discrete labels, application of FORTA seems particularly amenable to electronic support. An information technology (IT) algorithm was developed to analyze bulk data on International Classification of Diseases (ICD)-coded diseases and Anatomical Therapeutic Chemical (ATC)-coded drugs. FORTA-labeled diagnoses and drugs were used to compute the FORTA score, an automatically generated score that describes medication quality by adding up points assigned for errors related to over- and under-treatment. The algorithm detects mismatches between diagnoses and drugs, suboptimal drugs, omitted drugs, and deficient medication escalation schemes. The read-out produces explanations for each error point. A total of 5603 and 7954 patients ≥ 65years were included from two claims datasets (> 30,000 patients each, public health insurance). The FORTA scores were comparable (mean ± standard deviation 4.29 ± 3.37 vs. 4.17 ± 3.16), and similar to that determined in VALFORTA (pre-intervention 3.5 ± 2.7). Under-treatment was two times more prevalent than over-treatment. The main areas of under-treatment were pain, type 2 diabetes mellitus, and depression, and the main areas of over-treatment were gastrointestinal (proton pump inhibitors), pain (non-steroidal anti-inflammatory drugs), and arterial hypertension (β-blockers). The FORTA score is positively correlated with higher age, a higher Charlson Comorbidity Index, and more frequent hospitalizations. Patients in disease management programs run by public health insurers had higher scores than comparators. The algorithm produces plausible analyses of medication errors in older people, pointing to established areas of therapeutic deficiencies. Though individual recommendations exist, the algorithm cannot employ the full potential of FORTA as important details (e.g., blood pressure values, pain intensity) are not (yet) included. However, it seems capable of detecting medication problems in large cohorts-FORTA-EPI (Epidemiological) is designed to support epidemiological analyses, e.g., on comparisons of large cohorts, interventional impact, or longitudinal trends.

Semantic and cultural equivalence of the working alliance inventory short-revised scale for therapeutic alliance in family medicine: Lessons learned in Slovenia

IntroductionTherapeutic alliance is a term most commonly associated with psychotherapeutic treatment, but recently its use has become increasingly significant in the other fields of medicine. An increasing amount of evidence implies that the quality of the therapeutic alliance between the doctor and patient substantially affects treatment outcomes. A European consensus chose the Working Alliance Inventory – Short Revised (WAI-SR) scale as the most efficient for European primary care. This paper presents the process of establishing the semantic and cultural equivalence of the two WAI-SR scales in Slovene.MethodAs a part of a larger international project, a group of four experts translated the two WAI SR scales (physician and patient versions) from English into Slovene. Twenty-six Slovenian family medicine doctors participated in the process of obtaining semantic, idiomatic, experiential and conceptual equivalence in translation using a Delphi consensus procedure. Afterward, a cultural equivalence was made to adapt the translations within the national context.ResultsAgreement on translation was achieved after two Delphi rounds. The back-translation and cultural equivalence were accomplished without major problems, with some minor additional linguistic corrections.ConclusionA Slovene version of the WAI-SR scale was successfully adapted and is available for further scale validation and research on therapeutic alliance.

What matters most to sepsis survivors: a qualitative analysis to identify specific health-related quality of life domains.

It is unknown how sepsis survivors conceptualize health-related quality of life (HRQL). We aimed to identify important HRQL domains for this population. A literature search was performed to inform an interview guide. Open-ended interviews were held with 15 purposefully sampled sepsis survivors. Interview transcripts were analyzed by interpretative phenomenological analysis to allow themes to develop organically. Resulting codes were reviewed by an independent expert. The preliminary list of domains was rated in a two-round Delphi consensus procedure with therapists and survivors. Eleven domains emerged as critically important: Psychological impairment, Fatigue, Physical impairment, Coping with daily life, Return to normal living, Ability to walk, Cognitive impairment, Self-perception, Control over one's life, Family support, and Delivery of health care. Sepsis survivors want a "normal life," to walk again, and to regain control without cognitive impairment. Family support is essential to overcome sepsis aftermaths. Survivors described many HRQL domains which are not captured by the QoL instruments that have traditionally been used to study ICU survivorship (i.e., SF-36 and EQ-5D). Future studies of QoL in ICU survivors should consider using both a traditional instrument so that results are comparable to previous research, as well as a more holistic QoL measurement instrument like the WHOQOL-BREF.

The Development of a Decision Tool for the Empiric Treatment of Suspected Urinary Tract Infection in Frail Older Adults: A Delphi Consensus Procedure

ObjectivesNonspecific signs and symptoms combined with positive urinalysis results frequently trigger antibiotic therapy in frail older adults. However, there is limited evidence about which signs and symptoms indicate urinary tract infection (UTI) in this population. We aimed to find consensus among an international expert panel on which signs and symptoms, commonly attributed to UTI, should and should not lead to antibiotic prescribing in frail older adults, and to integrate these findings into a decision tool for the empiric treatment of suspected UTI in this population. DesignA Delphi consensus procedure. Setting and ParticipantsAn international panel of practitioners recognized as experts in the field of UTI in frail older patients. MeasuresIn 4 questionnaire rounds, the panel (1) evaluated the likelihood that individual signs and symptoms are caused by UTI, (2) indicated whether they would prescribe antibiotics empirically for combinations of signs and symptoms, and (3) provided feedback on a draft decision tool. ResultsExperts agreed that the majority of nonspecific signs and symptoms should be evaluated for other causes instead of being attributed to UTI and that urinalysis should not influence treatment decisions unless both nitrite and leukocyte esterase are negative. These and other findings were incorporated into a decision tool for the empiric treatment for suspected UTI in frail older adults with and without an indwelling urinary catheter. ConclusionsA decision tool for suspected UTI in frail older adults was developed based on consensus among an international expert panel. Studies are needed to evaluate whether this decision tool is effective in reaching its aim: the improvement of diagnostic evaluation and treatment for suspected UTI in frail older adults.