A patient centered assessment of the 2016 ACR-EULAR Myositis Response Criteria: evaluating the meaningfulness of response.

OBJECTIVES: The ACR-EULAR Myositis Response Criteria (Total Improvement Score [TIS]) is a composite measure calculated using changes in myositis core set measures. It is unclear if achieving improvement per TIS reflects improvement in any symptoms of myositis patients. In this study, we examined the association between achieving TIS improvement and patient-centered outcome measures (PCOMs). METHODS: Adults with myositis were enrolled in a prospective study with baseline and 6-month visits. Six core set measures were collected at each visit along with the following PCOMs: Fatigue (visual analogue scale [VAS] and short form 36 [SF36]), pain (VAS, SF36), health-related quality of life (SF-36), physical function (PROMIS-physical function, SF36, sit-to-stand, timed up-and-go, and six-min walk) and physical activity (actigraphy). Mann-Whitney U was used to compare PCOMs between improvement groups. Spearman correlation and regression models were used for correlation and association between TIS and PCOMs, respectively. RESULTS: Of 50 patients (six polymyositis, 24 dermatomyositis, 9 necrotizing myopathy, 11 anti-synthetase syndrome) enrolled (mean age: 52, 60% female), 21 patients satisfied the TIS improvement criteria at 6-months. PCOMs including fatigue, pain, quality of life, physical activity and physical function demonstrated significantly greater improvement in patients who had minimal TIS improvement compared with those with no improvement. Greater PCOM improvements were seen with moderate-major TIS improvement. TIS correlated moderately-strongly with most PCOMs. CONCLUSION: Achieving improvement criteria was accompanied by significant clinical improvements in fatigue, pain, health-related quality of life, physical function, and physical activity. These results support the use of TIS as a clinically meaningful metric of improvement.

A checklist for a consistent, comprehensive medication review.

INTRODUCTION: Medicare Advantage Part D plans and stand-alone Part D prescription drug plans are required by the Centers for Medicare and Medicaid Services to have qualified providers, including pharmacists, and offer annual comprehensive medication reviews (CMRs) for eligible Medicare beneficiaries. Although guidance on the components of a CMR is available, providers have flexibility in how to deliver the CMR to patients and which content to cover. With the variety of patient needs, CMR content is not always consistently delivered in practice. Our research group performed an extensive evaluation to create and test an ideal CMR content coverage checklist for CMR provision. CMR CONTENT CHECKLIST: The CMR Content Checklist can be used for quality improvement purposes to evaluate the comprehensiveness of pharmacist services-to assess either within pharmacist variation across patients or within organization variations between pharmacists or sites. INCORPORATING THE CMR CONTENT CHECKLIST INTO PRACTICE: Testing in a real-world setting demonstrated where gaps in service coverage existed. The CMR Content Checklist could be used as the first step for quality improvement given that it provides details on the key aspects of the service that can inform quality measure development.

It is time for a new comprehensive medication review quality measure.

Medication therapy management (MTM) services include comprehensive medication reviews (CMRs), which have been completed with millions of patients since their inception in the United States. The current MTM quality measure focuses on whether CMRs were completed (ie, the CMR completion rate). However, this process measure does not assess quality of care, or patient-reported or other outcomes of CMRs, and, therefore, does not reward MTM providers for improving health outcomes. In this viewpoint article, we present 3 reasons that shape our argument for new MTM quality measures and offer recommendations on next steps to achieve this. DISCLOSURES: Dr Vaffis is an employee of Clinical Outcomes Solutions and discloses this was work was completed previously during her employment at the University of Arizona. Dr Dhatt is an employee of Janssen and discloses this was work was completed previously during her employment at the University of Arizona. Dr Anderson is an employee of The Freedom Fund and discloses this was work was completed previously during her employment at the University of Arizona. Dr Black is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Dr Campbell received funding from Pharmacy Quality Alliance, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and SinfoniaRx and discloses this work was completed previously during his employment at the University of Arizona. Dr Kolobova is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Dr Hines is an employee of Pharmacy Quality Alliance. Dr Castora-Binkley is an employee of Pharmacy Quality Alliance. Dr Nelson is an employee of Pharmacy Quality Alliance. Dr Axon received funding from Pharmacy Quality Alliance, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and SinfoniaRx. Dr Warholak received funding from Pharmacy Quality Alliance, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and SinfoniaRx and discloses this was work was completed previously during her employment at the University of Arizona.

Qualitative analysis of telephonic comprehensive medication review content and delivery.

BACKGROUND: Comprehensive medication reviews (CMRs) are offered to eligible Medicare beneficiaries to improve patient medication knowledge, identify, and address medication concerns, and empower medication self-management. However, the specific content of real-world CMRs is unclear. OBJECTIVE: To qualitatively assess CMR content and delivery among telephonic CMR providers. METHODS: This qualitative thematic analysis used transcriptions of audio-recorded patient interactions during CMRs from 3 telephonic medication therapy management provider organizations. Data were qualitatively analyzed using the inductive saturation model to code emergent themes by independent reviewers who met to agree themes through consensus. Intercoder reliability was calculated using Krippendorf alpha. RESULTS: Overall, 32 CMR transcripts from 3 organizations were analyzed in 13 rounds of coding. Intercoder reliability was >95%. A total of 21 themes were identified across 4 stages: call opening (4 themes), medication reconciliation (5 themes), clinical assessments and guidance (8 themes), and call closing (4 themes). The call opening stage included: service explanation; insurance coverage/cost; identity/privacy/recording; and patient's medication management. Medication reconciliation included: drug name, dose, frequency, and indication; medication deletion and addition; over-the-counter and vaccination assessment; drug efficacy assessment; and prescribing provider assessment. Clinical assessments and guidance included 4 core clinical assessments: allergy assessment; drug therapy problem assessment; drug-related adverse events; and medication modification; and 4 additional assessments: clinical/therapeutic guidance; cost savings guidance; diet/exercise/lifestyle guidance; and optional clinical and behavioral assessments. Call closing included: documentation; primary care provider confirmation; patient satisfaction; and call transfer. There were variations among organizations in the depth that CMR components were covered. CONCLUSION: These findings suggest provider organizations are including components that meet Centers for Medicare and Medicaid Services goals for CMRs. Yet, variations among organizations indicate a need for standardization and patient-centered measures to ensure appropriate CMR components are covered, while maintaining flexibility for pharmacists to provide patient-oriented CMRs that meet patients' clinical needs.

Trends in telephonic comprehensive medication review in the United States from 2000 to present: a scoping literature review.

BACKGROUND: Although comprehensive medication review (CMR) services have been shown to provide value to patients and payers, the extent of uniformity in service delivery is unknown. A variety of standards and recommendations are available from academic and professional sources, but variation in service provision is an important consideration when attempting to measure or compare service quality nationally. OBJECTIVE: This study aimed to identify and summarize trends in the peer-reviewed and gray literature describing telephonic CMR delivery and content. METHODS: A scoping review of peer-reviewed and gray literature was conducted to quantify and qualify trends in CMR service. Two independent reviewers screened abstracts from 9 bibliographic databases and selected gray literature sources in accordance with the Joanna Briggs Institute guidelines and an internally developed protocol. Inclusion criteria for the review were English language; discussion of telephonic CMR service in the United States; research, legislation, or guidelines that describe CMR content coverage requirements for payment; and publication from the year 2000 to the present. Data relating to publication type, study design, setting, region, and themes of CMR content were collated into a Microsoft Excel data extraction form. Qualitative thematic analysis was conducted, and key findings and concepts were reported contextually. RESULTS: Of 374 identified documents screened, 15 were included in this scoping review and thematic analysis. The following characteristics of CMRs were identified: content, coverage, eligibility, frequency, process, and responsiveness. All published documents (n = 15, 100%) included a discussion of CMR content, and 14 sources (93%) addressed process elements of providing a CMR. Discussion of other themes varied in frequency across documents, ranging from 3 articles (20%) addressing organizational goals for CMR to 12 articles (80%) including elements of responsiveness. Within-theme variation was also observed for several CMR content areas. CMR process was the most heterogeneous theme with topics ranging from access to patient health records to pharmacist training. CONCLUSIONS: Assessment of telephonic CMR comprised a small but steadily increasing portion of the medication therapy management literature. Publications since 2015 have shown an increasing consensus of CMR content and purpose. Per the identified literature, there is an ongoing demand for higher-quality, more holistic CMRs, but there is no consensus on how to measure CMR quality. Future work should include engaging with CMR experts to understand variability in measures of CMR success.

Key informant perspectives about telephonic comprehensive medication review services in the United States.

BACKGROUND: Comprehensive medication reviews (CMRs) are provided by providers such as pharmacists to eligible beneficiaries. Although CMRs have been shown to provide value to patients, little is known about the service uniformity, quality, and content of CMRs. OBJECTIVE: This study aimed to characterize the current state of CMR services from diverse stakeholder perspectives and describe variation in responses to content and delivery of telephonic CMR services. METHODS: Semistructured interviews were conducted with 10 key informants. The interview guide contained 6 key questions with additional probing questions. Transcripts were analyzed using the inductive saturation model and phenomenological approach to code emergent themes, which were iteratively refined until saturation was achieved. RESULTS: Key informants included CMR payers (n = 3), providers (n = 5), and standards-setting organizations (n = 2). Ten themes about CMRs emerged from qualitative analysis: (1) definition, (2) organizational goals, (3) content, (4) eligibility, (5) frequency, (6) acceptance and completion, (7) process and personnel, (8) quality assurance, (9) preparation, and (10) future directions. CMR content descriptions were consistent across perspectives. Key informants described scenarios appropriate for expanded CMR eligibility criteria, although none were consistently reported. Providers emphasized patient CMR acceptance rates whereas payers and standard-setting organizations emphasized completion rates. Completion rates and adherence to Centers for Medicare and Medicaid Services standards were characterized as core organizational goals (n = 8), whereas patient satisfaction was less frequently identified (n = 4). A lack of incentive for CMR providers to follow-up with patients was a barrier to expanded services. Overall, key informants were dissatisfied with the CMR completion rate measure and would prefer measures focused on service quality and outcomes. CONCLUSIONS: CMR services largely met perceived guidelines, with variation in value-added services. Key informants desired adoption of an actionable measure that is focused on quality rather than completion rate. To inform a quality measure, future research should analyze completed CMRs to determine the extent of variation in content and delivery.

Evaluation of a Novel Pharmacist-Delivered Adherence Improvement Service via Telehealth.

Nearly half of all patients prescribed a chronic medication do not adhere to their regimen. Conversion from a 30- to 90-day medication refill is associated with improved adherence. The objective of the study was to assess the change in proportion of days covered (PDC) in those who converted to a 90-day fill and those who did not after a telehealth pharmacist-delivered, medication adherence intervention. This retrospective review involved data collected between May and December 2018. Patients with ≤85% baseline PDC rates were targeted. One group included patients who converted to a 90-day fill after the pharmacist intervention. The comparator group did not convert to a 90-day fill. Differences in median end-of-year (EOY) PDC rates for each medication class were compared between groups. An alpha level of 0.05 was set a priori. Overall, 237 patients converted to a 90-day fill and 501 did not. There was no significant difference in age, sex, and total number of drugs per patient. A Mann-Whitney U test revealed statistically significant improvements in median EOY PDC in the group that converted to a 90-day fill (+9% vs. -3%, p < 0.001). Pharmacist-delivered telehealth interventions were associated with improved PDC rates in those who converted to a 90-day fill.

Evaluating the role and value of a clinical pharmacist in a concierge primary care clinic.

OBJECTIVE: To understand the perceived role and value of the clinical pharmacist in a southern Arizona concierge primary care practice (CPCP) by employees. METHODS: Semistructured face-to-face interviews were conducted with health care team members employed by the CPCP site in December 2019 and January 2020 for this study. The interviews were audio recorded, transcribed, and thematically analyzed using an inductive approach with ATLAS.ti (version 7). A qualitative assessment was performed by 2 independent reviewers to identify the themes, which included clinical, economic, and humanistic outcomes. RESULTS: Eleven CPCP employees were interviewed: physicians (n = 2), a nurse practitioner (n = 1), medical assistants (n = 4), and administrative staff (n = 4). The perceived role and value of the clinical pharmacist in this CPCP varied by employee position; yet, all expressed the pharmacist's positive impact on patient care. Five themes were identified. The most common pharmacist roles identified included providing medication knowledge to providers, preventing abuse of controlled substances, monitoring clinical response to medications and adverse drug events, aiding in prior authorizations, educating patients, and providing patient-centered care. CONCLUSION: These results demonstrate that the integration of a clinical pharmacist into a CPCP can be valuable. This study highlights that the pharmacist was positively received by the physicians and staff. This further supports the value of the pharmacist as a key interprofessional health care team member. Further study is warranted to assess the longitudinal impact of pharmacists' services in a CPCP.

A motivational factors assessment instrument for medication management center employees providing medication therapy management services: A Rasch analysis.

BACKGROUND: Telephonic medication management centers (MMCs) provide medication therapy management services to help alleviate medication-related issues and improve health outcomes. Motivation factors driving the performance of MMC personnel are key components in achieving these goals. Yet, published literature is limited on how motivation affects MMC personnel performance. OBJECTIVE: To assess validity and reliability of the employee motivation questionnaire (EMQ), a 19-item measure of barriers and facilitators to motivation associated with MMC employees' work performance. METHODS: Pharmacist, nurse, pharmacy technician, and intern employees (N = 534) from 5 telephonic-based U.S. MMCs were invited to complete the electronic EMQ. Rasch analysis was conducted in Winsteps software using a rating scale model. Construct and content validity and reliability were analyzed with employee and item separation index (SI) and reliability coefficient (RC). Linear regression was conducted to test the association of employee characteristics with individual work performance motivation. RESULTS: A total of 319 employees completed the EMQ, 59.7% response rate. Principal components analysis suggested a unidimensional construct. Employee and item infit and outfit mean squared values met recommended fit criteria (0.5-1.5), suggesting that the data fit the model. An item-person map identified items that were easiest (joy of helping patients) and most difficult (motivated to work harder if incentives were tied to goal achievements) to agree with. Mismatch of employee motivation and item difficulty level on the measurement continuum (-1 to 0.92 logits) indicated a need for additional items that employees perceive as more difficult to agree with. The employee RC was 0.81 and the SI was 2.04; whereas, the item RC was 0.97 and the SI was 5.94. None of the variables tested illustrated statistically significant associations with the person motivation measure. CONCLUSIONS: The EMQ illustrated reasonable content validity, good construct validity, and reliability evidence when used to measure motivation factors among MMC employees. Consideration of employee motivation factors may help to better meet MMC program goals and improve patient outcomes.

Qualitative modification and development of patient- and caregiver-reported outcome measures for iron chelation therapy.

BACKGROUND: Compliance, palatability, gastrointestinal (GI) symptom, and treatment satisfaction patient- and observer-reported outcome (PRO, ObsRO) measures were developed/modified for patients with transfusion-dependent anemias or myelodysplastic syndrome (MDS) requiring iron chelation therapy (ICT). METHODS: This qualitative cross-sectional observational study used grounded theory data collection and analysis methods and followed PRO/ObsRO development industry guidance. Patients and caregivers of patients with transfusion-dependent anemias or MDS were individually interviewed face-to-face to cognitively debrief the Compliance, Palatability, GI Symptom Diary, and Modified Satisfaction with Iron Chelation Therapy (SICT) instruments presented electronically. Interviews were conducted in sets. Interviews began open-endedly to spontaneously elicit ICT experiences. Item modifications were debriefed during the later interviews. Interviews were audio recorded, transcribed, and coded. Data was analyzed using ATLAS.ti qualitative research software. RESULTS: Twenty-one interviews were completed (Set 1: 5 patients, 6 caregivers; Set 2: 6 patients, 4 caregivers) in 6 US cities. Mean age was 43 years for patients and 9 years for children of caregivers. Conditions requiring ICT use across groups included transfusion-dependent anemias (85.7%) and MDS (14.3%). Concepts spontaneously reported were consistent with instruments debriefed. Interview analysis resulted in PRO and ObsRO versions of each instrument: Compliance (2 items), Palatability (4 items), GI Symptom Diary (6 items), and Modified SICT (PRO = 13, ObsRO = 17 items). CONCLUSION: Qualitative research data from cognitive interviews supports the content validity and relevance of the instruments developed/modified. Quantitative validation of these PRO and ObsRO measures is needed testing for validity, reliability, and responsiveness for future research use with new formulations of oral ICT.

Economic evaluation of urgent-start peritoneal dialysis versus urgent-start hemodialysis in the United States.

Patients presenting late in the course of kidney disease who require urgent initiation of dialysis have traditionally received temporary vascular catheters followed by hemodialysis. Recent changes in Medicare payment policy for dialysis in the USA incentivized the use of peritoneal dialysis (PD). Consequently, the use of more expeditious PD for late-presenting patients (urgent-start PD) has received new attention. Urgent-start PD has been shown to be safe and effective, and offers a mechanism for increasing PD utilization. However, there has been no assessment of the dialysis-related costs over the first 90 days of care. The objective of this study was to characterize the costs associated with urgent-start PD, urgent-start hemodialysis (HD), or a dual approach (urgent-start HD followed by urgent-start PD) over the first 90 days of treatment from a provider perspective. A survey of practitioners from 5 clinics known to use urgent-start PD was conducted to provide inputs for a cost model representing typical patients. Model inputs were obtained from the survey, literature review, and available cost data. Sensitivity analyses were also conducted. The estimated per patient cost over the first 90 days for urgent-start PD was $16,398. Dialysis access represented 15% of total costs, dialysis services 48%, and initial hospitalization 37%. For urgent-start HD, total per patient costs were $19,352, and dialysis access accounted for 27%, dialysis services 42%, and initial hospitalization 31%. The estimated cost for dual patients was $19,400. Urgent-start PD may offer a cost saving approach for the initiation of dialysis in eligible patients requiring an urgent-start to dialysis.