Development and validation of explicit criteria to identify potentially inappropriate prescribing for adults with type 2 diabetes mellitus

BackgroundEarly detection and timely resolution of potentially inappropriate prescribing (PIP) prevents adverse outcomes and improves patient care. An explicit tool specifically designed to detect PIP among people with Type 2 Diabetes Mellitus (T2DM) has not been published.ObjectivesThis study aims to develop and validate the Inappropriate Medication Prescribing Assessment Criteria for Type 2 Diabetes Mellitus (IMPACT2DM); an explicit tool that can be used to identify PIP for adults with T2DM.MethodsCurrent national and international guidelines for the management of T2DM and drug information software programs were used to generate potential items. The content of the IMPACT2DM was validated by 2 consecutive rounds of Delphi method. Physicians and clinical pharmacists experienced in providing care for people with diabetes and authors of selected diabetes guidelines were invited to participate in the Delphi panel. Consensus was assumed if 90% (first round) and 85% (second round) of expert panelists showed agreement to include or exclude an item.ResultsA total of 95 potential items were generated from selected diabetes guidelines and drug information software programs. After the first Delphi round 27 items had ≥90% agreement and were included in the tool; 19 items were considered not PIP and were excluded from the tool. The second round contained 49 items; of these 43 were included and 6 were excluded from the tool. The final IMPACT2DM contains 70 items categorized by type of PIP and arranged in terms of medical conditions and medication classes. IMPACT2DM can be applied using information on medical charts and requires minimal or no clinical knowledge to assess quality of diabetes care and improve medication selection.ConclusionsIMPACT2DM has been developed from current quality evidence and undergone content validation. It is the first explicit tool specifically designed to identify PIP for adults with T2DM.     

Development of a list of potentially inappropriate medications for patients with heart failure (PIMHF)

BackgroundSeveral medications are likely to be potentially inappropriate medications for patients with heart failure (PIMHF) as they may worsen heart failure (HF). A screening tool inclusive of PIMHF is lacking.ObjectiveTo develop an extensive list of PIMHF for HF patients.MethodsA list of PIMHF was developed using reviews of recent HF guidelines and literature and validated through a survey study of HF experts using a modified Delphi technique. The study participants were Thai HF experts with ≥ 5 years of practice experience in Thailand. To create an initial list of PIMHF, medications likely to be PIMHF were gathered from both HF guidelines and HF-related explicit criteria. A 3-round Delphi survey was conducted for 9 months, from January 1, 2019 to September 30, 2019. In the first round, medication items that ≥ 60% of the participants rated as “not PIMHF” were excluded. The two subsequent rounds were conducted to measure an agreement on PIMHF. To reach consensus, medication items in the PIMHF list had to meet the following pre-determined criteria: convergence (median ≥ 3.5 and interquartile range ≤ 1.5) and stability (marginal changes of medians between round 2 and round 3 < 15%).ResultsSeventeen eligible HF experts, including 10 cardiologists, 3 hospital pharmacists and 4 academic pharmacists, participated in the study. The initial list of PIMHF consisted of 100 medication items. From round 1, 8 medication items were excluded from the initial list. Thus, 92 medication items were considered in the second and the third round, respectively. After 3 surveys, 47 medication items reached the consensus and agreed as PIMHF.ConclusionThis Delphi survey on opinion about PIMHF among an HF expert panel produced a list of 47 medication items as PIMHF which may be used as a screening tool for PIMHF in Thai HF patients.     

Development of the adult complexity tool for pharmaceutical care (ACTPC) in hospital: A modified Delphi study

BackgroundHospital pharmacists play an essential role in patient care; however, a lack of resources means pharmacists are unable to review all patients daily. Consequently, there is a demand for reliable screening tools to allocate care to patients with urgent and/or complex pharmaceutical needs. Several tools have been developed, but no broad consensus exists on the design of a screening tool to be used in the adult hospital setting.ObjectiveTo obtain expert consensus on the design of a pharmaceutical care complexity screening tool for use on admission to hospital.MethodsTwo Delphi studies were conducted: the first sought to gain consensus from experts including pharmacists, academics and physicians on the components of a pharmaceutical complexity tool, the second to achieve consensus from UK chief pharmacists and clinical service pharmacy managers on the clinical appropriateness and practicality of the tool. Tool components and Delphi statements were identified and refined from our previous systematic review, UK survey and interview study of prioritisation tools. A valid definition for consensus was used.ResultsOver 300 components were extracted from the interview data and systematic review and then refined for inclusion in the first Delphi study. Thirty-three experts completed Delphi One and consensus was reached on 92 components. Components were grouped into demographic, clinical and medication components and condensed to 33 items, which were included in the first draft of the Adult Complexity Tool for Pharmaceutical Care (ACTPC). The tool stratified patients into highly, moderately or least complex. Forty expert panellists completed Delphi Two and consensus was reached on review frequency and experience of pharmacy practitioner at each level. These decisions were incorporated into the final version of the ACTPC.ConclusionsThe ACTPC is the first systematically designed and internationally agreed tool for use on medical admission to hospital. It has potential to enable the delivery of targeted patient-centred pharmaceutical care.     

Development and content validation of an assessment tool for medicine compounding on hospital wards

Background Medicines should be compounded by using an aseptic technique to assure patient safety. The parenteral administration of microbiologically contaminated doses can result in bacteriaemia, other morbidity and even death. Objective The purpose was to develop and content validate an assessment tool for medicine compounding on hospital wards suitable for self-assessment and external audit to ensure the safety of medicine compounding on wards. Setting Finland as setting. Method The first draft of the tool was based on ISMP “Guidelines for safe preparation of sterile compounds” and a systematic literature search. The tool was validated by using a two-rounded Delphi-method with a panel of 19 experts. Suitability and feasibility of each item was evaluated. Main outcome measure An agreement of ≥70% on each item was required. Results The final tool comprises of 64 items under the following topics: (1) general principles of good compounding practices (23 items), (2) recording and confirming medicine orders on the wards (5 items), (3) storage of medicines on the wards (7), (4) aseptic compounding of intravenous medicines (25 items) and (5) quality assurance (4 items). Most items related to General principles of good compounding practices and Compounding of IV medicines (36 and 38% of the items, respectively). Conclusion It was possible to develop and content validate, by the Delphi method, an assessment tool for safe aseptic compounding on hospital wards. A two-round Delphi process yielded consensus on 64 items for this purpose.     

Diseño y validación de 2 instrumentos para analizar y evaluar la calidad formal en el proceso de consentimiento informado de ensayos clínicos con medicamentos

ObjectiveThe activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation.MethodDesign (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated.ResultsVery good concordance was obtained in both checklists (k ≥ 0.81, p < 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items.ConclusionThe instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.     

Identifying outcome measures for atrial fibrillation value-based contracting using the Delphi method

BackgroundValue-based contracts that tie payments for pharmaceuticals to predefined outcomes aim to promote value through shared risk and aligned incentives between manufacturers and payers.MethodsWe conducted a Delphi study among diverse stakeholders (patients, providers, payers, pharmacy benefits managers, pharmaceutical company representatives) to identify top meaningful outcomes for inclusion in value-based contracts for atrial fibrillation medications. The final panel (n = 55) rated the importance of each outcome on a 5-point Likert scale and selected their top 3 most meaningful outcomes. Non-patient participants rated the feasibility of collecting each outcome on a 5-point Likert scale. Consensus was defined as ≥75% agreement (Likert scores ≥4/5 or selection of an outcome as most meaningful). Differences between stakeholder groups were examined using Fisher's Exact Test.ResultsConsensus was achieved for importance of 10 outcomes (Likert scale), where “preventing stroke or mini-stroke” reached 100% agreement (55/55). Eighty-one percent (44/54) of participants selected “preventing stroke or mini-stroke” as the most meaningful outcome (rank order question). The measures rated as most feasibly collected were “reducing hospitalizations” (97%, 36/37) followed by “preventing stroke or mini-stroke” and “reducing emergency department visits” (both 92%, 34/37). There were statistically significant differences between patients and non-patients [0% (0/17) vs 22% (8/37), P = 0.047] and patients and providers [0% (0/17) vs 39% (7/18), P = 0.008] in selection of “improving health-related quality of life” as a most meaningful outcome.ConclusionsThese findings will inform the design of atrial fibrillation value-based pharmaceutical contracts and provide additional insight into preferences for outcomes which could be used to improve the quality of atrial fibrillation care.     

Defining off-label and unlicensed use of medicines for children: Results of a Delphi survey

The aim of this Delphi survey is to develop common definitions for unlicensed and off-label drug use in children to be used for research and regulatory purposes. After a literature review on the current status of unlicensed/off-label definitions, a two-stage, web-based Delphi survey was conducted among experts in Europe. Their opinion on concerns, rules and scenarios regarding the unlicensed and off-label use of medicines were obtained. Results were then consulted with the European Medicines Agency (EMEA) before the final proposal was circulated to participants. Eighty-four experts were invited to participate (scientists, health professionals, pharmaceutical companies, regulatory agencies), 34 responded to the first round questionnaire and participated in subsequent rounds. Consensus was reached for the majority of questions. The lowest level of consensus reached was for questions related to a different formulation or if a drug was given although contraindicated. At the final step, 85% of the responding experts agreed on the proposed definition for off-label (use of a drug already covered by a Marketing Authorisation, in an unapproved way) and 80% on the definition for unlicensed (use of a drug not covered by a Marketing Authorisation as medicinal for human use), respectively. Results will facilitate the conduct of pharmacoepidemiological studies and allow comparison between different countries. The Delphi panel agreed that the definitions should be circulated within the scientific community and recommended to be adopted by relevant regulatory authorities.     

What Should Junior Doctors Know about the Drugs they Frequently Prescribe? A Delphi Study among Physicians in the Netherlands

The aim of this study was to identify the information about commonly prescribed drugs that junior doctors should know in order to prescribe rationally in daily practice, defined as essential drug knowledge (EDK). A two‐round Internet Delphi study was carried out involving general practitioners from one practice cluster, and registrars and consultants from two Dutch academic and eight teaching hospitals. A preliminary list of 377 potential EDK items for three commonly prescribed drugs was assessed on a dichotomous scale; an item was considered EDK if at least 80% consensus was reached. The consensus list of EDK items was discussed by the research team to identify similarities between the three drugs, with a view to forming a list of general EDK items applicable to other commonly prescribed drugs. Sixty experts considered 93 of the 377 items (25%) as EDK. These items were then used to form a list of 10 general EDK items. The list of EDK items identified by primary and secondary care doctors could be used in medical curricula and training programmes and for assessing the prescribing competence of future junior doctors. Further research is needed to evaluate the generalizability of this list for other commonly prescribed drugs.     

[Translated article] Design and validation of two instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products

ObjectiveThe activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation.MethodsDesign (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated.ResultsVery good concordance was obtained in both checklists (k ≥ 0.81, p b 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items.ConclusionThe instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.     

Translation and cross-cultural adaptation of the ABC taxonomy for medication adherence into Portuguese – Updating patients into people

BackgroundThe Ascertaining Barriers to Compliance (ABC) taxonomy for describing medication adherence was created in 2012, aiming to standardize terms and definitions in research and practice. The taxonomy comprises seven terms and definitions. Originally developed in English, subsequently translated into French and German, is currently being translated to Portuguese, Spanish, Czech, Romanian and Italian, aiming to promote its global use and overcome cultural barriers.ObjectivesTo cross-culturally translate the ABC taxonomy into Portuguese for Portugal and Brazil.MethodsA systematic literature search was conducted to identify published taxonomy terms and definitions in Portuguese, and to identify panelists in medication adherence. Initial mapping of terms and definitions retrieved was scrutinized by the research team to build an e-survey. The e-survey was piloted and then sent to panelists in both countries seeking consensus using a three-round Delphi method. Consensus was defined as ≥ 85% for round 1 and ≥ 75% for round 2. Terms with agreement <10% were dropped between rounds. In round 3, terms and definitions reaching agreement between 50 and 75% were classified as moderate consensus,>75–95% as consensus and >95% as strong consensus.ResultsA total of 778 studies were identified and 84 included, enabling the extraction of 154 terms and 32 definitions. In round 1, 164 panelists participated, 115 in round 2 and 99 in the round 3. Consensus was achieved in both countries for all seven terms and definitions, although with varying intensity of agreement. The term “Management of adherence” and the definition of “Discontinuation” obtained moderate consensus in both countries.ConclusionsA unified and unique ABC taxonomy in Portuguese was possible to develop for use in Portugal and in Brazil. Its use will harmonize and standardize the terms and definitions used in clinical practice and research.     

Consulting the oracle: a Delphi Study to determine the content of a postgraduate distance learning course in therapeutics

Aims To determine the content of a distance learning course in therapeutics for general practitioners (GPs).
Methods This paper reports the results of a three-round Delphi study. The respondent group comprised 21 GPs who were expert in their field. In the first round, the experts were interviewed to determine the knowledge, skills, competencies and attitudes required by GPs to prescribe effectively; the justification for, and scope of a distance learning course; and the preferred learning methods, format and methods of assessment. The first round generated 251 statements, which were collapsed into 108 statements covering thirteen domains. In the second and third rounds, a questionnaire was posted to the GPs. 95% responded to the second round questionnaire and agreed upon 86 statements, which were then collated into four domains. In the third round, 19 GPs rated each of the 86 statements on a five point scale. Consensus was reached for 99% of statements: 40 on the aims, design, format, organization and assessment of the course; and 45 on the knowledge and skills to be acquired by GPs who complete the course.
Results The results revealed a consensus in favour of:
• modules at regular intervals
• some flexibility in meeting deadlines
• interaction among students for mutual support
• easy access to course tutors
• some face-to-face contact to complement distance learning material
• clear guidance on effective and safe prescribing
• emphasis on importance of 'people skills'
Conclusions The Delphi process can be used to determine the competencies required for continuing medical education in therapeutics.     

医疗机构中成药品种遴选与临床应用评价指标体系构建江苏专家共识

中成药是我国医药产品的重要组成部分。为加快建立行之有效、符合中医药特色的中成药品种遴选与临床应用评价指标体系,以便科学地进行药品遴选,规范合理地开展中成药临床应用评价工作,江苏省中医药学会和南京药学会中药专业委员会组织了本次专家共识的制定。共识专家采用文献研究法、头脑风暴法、层次分析法、德尔菲法等,从安全性、有效性、经济性、创新性、适宜性、可及性、临床应用7个维度(一级指标),构建了包含24个二级指标、102个三级指标的中成药品种遴选与临床应用评价指标体系,以期为医疗机构药事管理与药物治疗学委员会(组)中成药品种的遴选和评价工作提供决策依据,推动各级医疗机构不断优化用药目录和用药结构,加快形成以基本药物为主导的"1+X"("1"为基本药物",X"为非基本药物)用药模式,促进医疗机构科学、合理、安全地使用中成药,从而提高药事服务质量,控制不合理药品的使用和费用支出,更高质量地满足人民群众的用药需求。     

Spanish translation of the ABC taxonomy for medication adherence

BackgroundThe Ascertaining Barriers to Compliance (ABC) taxonomy was developed aiming at systematizing definitions and operationalizations of medication adherence. Its translation is crucial to improve the generalizability, application and comparison of study findings.ObjectiveTo provide a consensus translation of the ABC taxonomy from English to Spanish.MethodsA two-phased approach was used, according to the Preferred Methods for the Translation of the ABC Taxonomy for Medication Adherence. Two literature reviews were conducted: to identify Spanish synonyms and definitions of the ABC taxonomy, and to identify a panel of Spanish-speaking experts in medication adherence. A Delphi survey was designed based on the synonyms and definitions found. The experts previously identified were invited to participate in the Delphi. A consensus of ≥85% was established for the first round. A moderate consensus (50–75%), a consensus (75–95%) or a strong consensus (>95%) were considered to be necessary in the second round.ResultsForty potential synonyms of the ABC taxonomy terms were identified from a total of 270 papers. The response rate during the first Delphi round was 32% (63/197) and in the second round 86% (54/63). A strong consensus was reached for the term “inicio del tratamiento” (96%) and consensus for the term “implementación” (83%). A moderate consensus was obtained for “adherencia a la medicación” (70%), “interrupción del tratamiento” (52%), “manejo de la adherencia” (54%) and “disciplinas relacionadas con la adherencia” (74%). No consensus was reached for the term persistence. Five out of the seven definitions reached a consensus in the first round, and two definitions a moderate consensus after the second round.ConclusionThe adoption of the Spanish taxonomy will increase transparency, comparability and transferability of results in the field of medication adherence. This may facilitate benchmarking of adherence strategies between Spanish-speaking researchers and practitioners, and other language speakers.     

Retail clinics colocated with pharmacies: A Delphi study of pharmacist impacts and recommendations for optimization

ObjectivesTo identify workforce issues likely to affect pharmacists working in retail clinics (RCs) colocated with community pharmacies and to generate recommendations for optimizing health, cost, and operations outcomes.Design and participantsA Delphi expert panel process using researchers with pharmacist workforce research experience was used. Panelists responded to 2 surveys of 3 rounds each. In survey 1, panelists used a 4-point linear numeric scale to rate the importance of 15 impact factors on pharmacists working in the RC/pharmacy setting. In survey 2, panelists used a 3-point linear numeric scale to rate the importance of recommendations for optimal outcomes. Recommendations were structured around elements from collaboration theory, a framework for evaluating critical areas for success in merged operations.Main outcome measuresConsensus was defined as ≥ 80% rating an impact “very” or “moderately” important (survey 1) and “very” important (survey 2). Impact factors were rank-ordered by ratings and numeric scoring. Selected comments about consensus items were reported.ResultsThe 8-person panel had 100% response rates for both surveys. 12 of the 15 impact variables achieved consensus (survey 1). The highest ranking impacts were ability to establish collaborative relationships, relationships with coworkers, including nurse practitioners, and location of the RC relative to the pharmacy. Of 15 recommendations (survey 2), 5 achieved consensus and focused heavily on information sharing and early and ongoing collaboration among all stakeholders.ConclusionClinical, economic, health care quality, and patient preference data suggest that RCs colocated with pharmacies are likely to play a permanent role in U.S. health care. RCs can affect pharmacists and pharmacies positively or negatively. Positive impacts are most likely where establishing collaborative partnerships with all stakeholders, including patients, throughout planning, implementation, and operation are emphasized. With only about 3% of pharmacy operations colocated with RCs now, attention and resources should be devoted to developing and testing models based on collaboration principles.     

Identifying Priority Student Leadership and Professionalism Attributes Among Faculty,Preceptors, and Students via Modified Delphi

Objective. To identify and build consensus on priority leadership and professionalism attributes for pharmacy student development among faculty, preceptors, and students.Methods. One hundred individuals (27 faculty members, 30 preceptors, 43 students) were invited to participate in a three-round, modified Delphi. Published literature on leadership and professionalism informed the initial attribute list. In the first round, participants reviewed and provided feedback on this list. In the second round, participants prioritized attributes as highly important, important, or less important for pharmacy student development. Leadership and professionalism attributes that achieved an overall consensus (a priori set to ≥80.0%) of being highly important or important for pharmacy student development were retained. In the third round, participants rank ordered priorities for leadership and professionalism attributes.Results. Fifteen leadership and 20 professionalism attributes were included in round one while 21 leadership and 21 professionalism attributes were included in round two. Eleven leadership and 13 professionalism attributes advanced to round three. Consensus was reached on the top four leadership attributes (adaptability, collaboration, communication, integrity) and five professionalism attributes (accountability, communication, honor and integrity, respect for others, trust). Differences were observed for certain attributes between faculty members, preceptors, and/or students.Conclusion. The modified Delphi technique effectively identified and prioritized leadership and professionalism attributes for pharmacy student development. This process facilitated consensus building and identified gaps among stakeholders (ie, faculty, preceptors, students). Identified gaps may represent varying priorities among stakeholders and/or different opportunities for emphasis and development across classroom, experiential, and/or cocurricular settings.     

Drug information centre queries and responses about drug interactions over 10 years—A descriptive analysis

Many people are treated with ≥1 drug, implying that risks of drug interactions need to be considered. The aim of this study was to describe drug interaction queries from healthcare professionals to a drug information centre in Sweden over 10 years focusing on drugs frequently asked about and the advice provided. Advice was recorded in mutually exclusive groups: Avoid, Adjust dose, Separate intake, Vigilance or No problem. For queries with Avoid, Adjust dose or Separate intake advice, alerts were extracted from an interaction database (Janusmed). Of 4335 queries to the centre in 2008‐2017, 589 (14%) concerned interactions. Most were posed by physicians (91%) and concerned a specific patient (83%) before treatment initiation (76%). Sertraline, warfarin and methotrexate were the most frequently asked about, whereas queries about cyclophosphamide and rifampicine occurred most often in relation to the number of exposed patients. Advice provided in 557 (95%) replies comprised Avoid: n = 85 (15%), Adjust dose: n = 57 (10%), Separate intake: n = 17 (3%), Vigilance: n = 235 (42%) or No problem: n = 163 (29%). In all, 113 (71%) of 159 queries with Avoid/Adjust dose/Separate intake advice elicited an action alert on Janusmed, whereas 31 (20%) did not result in any alert at all. Summarized, seven in ten replies from the drug information centre recommended an explicit drug treatment action, regarding either specific prescribing aspects, for instance dose adjustments, or active follow‐up including monitoring potential adverse reactions and/or laboratory results. Readily accessible decision support regarding drug interactions often provides relevant action alerts, but cannot be solely relied on.