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.

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.

Short-term intestinal lipase inhibition in normal-weight individuals does not affect postprandial peptide YY3-36 and glucagon-like peptide-1 levels, hunger or satiety.

Fat malabsorption associated with Roux-en-Y gastric bypass (RYGB) may contribute to elevated postprandial glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) after the procedure, leading to sustained weight loss and appetite reduction. This study investigated whether fat malabsorption via orlistat increases GLP-1 and PYY and if these increases would be proportional to changes in hunger and satiety. Five healthy participants received standardized meals with 120 mg orlistat or placebo in a randomized, double-blinded, crossover design for 3 days. On the final day, glucose, insulin, GLP-1, PYY3-36 and visual analogue scores for hunger and satiety were measured over a 14-hour period that included three meals. Fasting, 14-hour area under the curve (AUC) and meal-related AUC for glucose and insulin were similar, although postprandial increases in peak insulin and glucose were greater with orlistat. PYY3-36 , GLP-1, hunger and satiety were not different. In conclusion, short-term orlistat administration does not enhance postprandial GLP-1 or PYY3-36 or affect hunger or satiety in normal-weight individuals. Furthermore, fat malabsorption from RYGB is unlikely to mediate subsequent postprandial increases in GLP-1 and PYY.

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.

Vaccine uptake and barriers to vaccination among at-risk adult populations in the US.

To reduce morbidity and mortality associated with vaccine-preventable diseases (VPD), it is imperative that vaccination programs are implemented and prioritized throughout all stages of life across all populations. This study aimed to determine vaccine uptake and barriers to vaccination against VPDs among at-risk adult populations in the United States. We conducted a systematic literature review for articles published between January 2010 and June 2020 and identified 153 publications. The review identified 17 at-risk populations. Vaccine uptake was suboptimal among many populations, with factors including age, gender, and disease severity, associated with uptake. This review identified several barriers that impact vaccine uptake among at-risk populations, with concerns over safety, vaccine costs, lack of insurance, and lack of provider recommendation commonly reported across populations. Embracing a national life-course immunization framework that integrates developing policies, guidelines, and education would be a step to addressing these barriers.

Burden of vaccine-preventable diseases among at-risk adult populations in the US.

Life-course immunization holds significant benefit for population health by reducing the burden of vaccine-preventable diseases (VPD) through vaccinating individuals at different stages and circumstances in life. The study aimed to determine the epidemiologic, clinical, economic, and societal burden of VPDs among at-risk adult subpopulations in the United States. A systematic literature review was conducted for articles published between January 2010 and June 2020, which identified 72 publications. There was heterogeneity in available epidemiology data, with the prevalence of VPDs ranging from 1.1% to 68.7%. Where the disease burden was described, outcomes were typically worse among high-risk subpopulations than in the general population. Several VPDs, including herpes zoster, meningococcal, and pneumococcal infections were associated with increased costs. This review suggests that subpopulations may not frequently interact with the healthcare system, or their risk factors may not be recognized by healthcare providers, and therefore individuals may not be appropriately targeted for vaccination.

Making Sense of Family Medicine Resident Wellness Curricula: A Delphi Study of Content Experts.

BACKGROUND AND OBJECTIVES: The Association of Family Medicine Residency Directors (AFMRD) Physician Wellness Task Force released a comprehensive Well-Being Action Plan as a guide to help programs create a culture of wellness. The plan, however, does not offer a recommendation as to which elements may be most important, least resource intensive, or most feasible. This study sought to identify the most essential components of the AFMRD's Well-Being Action Plan, as rated by expert panelists using a modified Delphi technique. METHODS: Sixty-eight selected experts were asked to participate; after three rounds of surveys, the final sample included 27 participants (7% residents, 38% MD faculty, 54% behavioral science faculty). RESULTS: Fourteen elements were rated as essential by at least 80% of the participants. These components included interventions at both the system and individual level. Of those elements ranked in the top five by a majority of the panel, all but one do not mention specific curricular content, but rather discusses the nature of a wellness curriculum. CONCLUSIONS: The expert consensus was that an essential curriculum should begin early, be longitudinal, identify a champion, and provide support for self-disclosure of struggles.

Effects of Altering Levothyroxine Dose on Energy Expenditure and Body Composition in Subjects Treated With LT4.

Background: It is unclear whether variations in thyroid status within or near the reference range affect energy expenditure, body mass, or body composition. Methods: 138 subjects treated with levothyroxine (LT4) for hypothyroidism with normal TSH levels underwent measurement of total, resting, and physical activity energy expenditure; thermic effect of food; substrate oxidation; dietary intake; and body composition. They were assigned to receive an unchanged, higher, or lower LT4 dose in randomized, double-blind fashion, targeting one of three TSH ranges (0.34 to 2.50, 2.51 to 5.60, or 5.61 to 12.0 mU/L). The doses were adjusted every 6 weeks to achieve target TSH levels. Baseline measures were reassessed at 6 months. Results: At study end, the mean LT4 doses and TSH levels were 1.50 ± 0.07, 1.32 ± 0.07, and 0.78 ± 0.08 µg/kg (P < 0.001) and 1.85 ± 0.25, 3.93 ± 0.38, and 9.49 ± 0.80 mU/L (P < 0.001), respectively, in the three arms. No substantial metabolic differences in outcome were found among the three arms, although direct correlations were observed between decreases in thyroid status and decreases in resting energy expenditure for all subjects. The subjects could not ascertain how their LT4 dose had been adjusted but the preferred LT4 dose they perceived to be higher (P < 0.001). Conclusions: Altering LT4 doses in subjects with hypothyroidism to vary TSH levels in and near the reference range did not have major effects on energy expenditure or body composition. Subjects treated with LT4 preferred the perceived higher LT4 doses despite a lack of objective effect. Our data do not support adjusting LT4 doses in patients with hypothyroidism to achieve potential improvements in weight or body composition.

Effects of Altering Levothyroxine (L-T4) Doses on Quality of Life, Mood, and Cognition in L-T4 Treated Subjects.

Background: The brain is a critical target organ for thyroid hormone, but it is unclear whether variations in thyroid function within and near the reference range affect quality of life, mood, or cognition. Methods: A total of 138 subjects with levothyroxine (L-T4)-treated hypothyroidism and normal thyrotropin (TSH) levels underwent measures of quality of life (36-Item Short Form Health Survey, Underactive Thyroid-Dependent Quality of Life Questionnaire), mood (Profile of Mood States, Affective Lability Scale), and cognition (executive function, memory). They were then randomly assigned to receive an unchanged, higher, or lower L-T4 dose in double-blind fashion, targeting one of three TSH ranges (0.34 to 2.50, 2.51 to 5.60, or 5.61 to 12.0 mU/L). Doses were adjusted every 6 weeks based on TSH levels. Baseline measures were reassessed at 6 months. Results: At the end of the study, by intention to treat, mean L-T4 doses were 1.50 ± 0.07, 1.32 ± 0.07, and 0.78 ± 0.08 µg/kg (P < 0.001), and mean TSH levels were 1.85 ± 0.25, 3.93 ± 0.38, and 9.49 ± 0.80 mU/L (P < 0.001), respectively, in the three arms. There were minor differences in a few outcomes between the three arms, which were no longer significant after correction for multiple comparisons. Subjects could not ascertain how their L-T4 doses had been adjusted (P = 0.55) but preferred L-T4 doses they perceived to be higher (P < 0.001). Conclusions: Altering L-T4 doses in hypothyroid subjects to vary TSH levels in and near the reference range does not affect quality of life, mood, or cognition. L-T4-treated subjects prefer perceived higher L-T4 doses despite a lack of objective benefit. Adjusting L-T4 doses in hypothyroid patients based on symptoms in these areas may not result in significant clinical improvement.

Thyroid Function Variation in the Normal Range, Energy Expenditure, and Body Composition in L-T4-Treated Subjects.

Purpose: It is not clear whether upper limits of the thyrotropin (TSH) reference range should be lowered. This debate can be better informed by investigation of whether variations in thyroid function within the reference range have clinical effects. Thyroid hormone plays a critical role in determining energy expenditure, body mass, and body composition, and therefore clinically relevant variations in these parameters may occur across the normal range of thyroid function. Methods: This was a cross-sectional study of 140 otherwise healthy hypothyroid subjects receiving chronic replacement therapy with levothyroxine (L-T4) who had TSH levels across the full span of the laboratory reference range (0.34 to 5.6 mU/L). Subjects underwent detailed tests of energy expenditure (total and resting energy expenditure, thermic effect of food, physical activity energy expenditure), substrate oxidation, diet intake, and body composition. Results: Subjects with low-normal (≤2.5 mU/L) and high-normal (>2.5 mU/L) TSH levels did not differ in any of the outcome measures. However, across the entire group, serum free triiodothyronine (fT3) levels were directly correlated with resting energy expenditure, body mass index (BMI), body fat mass, and visceral fat mass, with clinically relevant variations in these outcomes. Conclusions: Variations in thyroid function within the laboratory reference range have clinically relevant correlations with resting energy expenditure, BMI, and body composition in L-T4-treated subjects. However, salutary effects of higher fT3 levels on energy expenditure may be counteracted by deleterious effects on body weight and composition. Further studies are needed before these outcomes should be used as a basis for altering L-T4 doses in L-T4-treated subjects.

Effects of Levothyroxine Replacement or Suppressive Therapy on Energy Expenditure and Body Composition.

BACKGROUND: Thyrotropin (TSH)-suppressive doses of levothyroxine (LT4) have adverse effects on bone and cardiac function, but it is unclear whether metabolic function is also affected. The objective of this study was to determine whether women receiving TSH-suppressive LT4 doses have alterations in energy expenditure or body composition. METHODS: This study was a cross-sectional comparison between three groups of women: 26 women receiving chronic TSH-suppressive LT4 doses, 80 women receiving chronic replacement LT4 doses, and 16 untreated euthyroid control women. Subjects underwent measurements of resting energy expenditure (REE), substrate oxidation, and thermic effect of food by indirect calorimetry; physical activity energy expenditure by accelerometer; caloric intake by 24-hour diet recall; and body composition by dual X-ray absorptiometry. RESULTS: REE per kilogram lean body mass in the LT4 euthyroid women was 6% lower than that of the LT4-suppressed group, and 4% lower than that of the healthy control group (p = 0.04). Free triiodothyronine (fT3) levels were directly correlated with REE, and were 10% lower in the LT4 euthyroid women compared with the other two groups (p = 0.007). The groups of subjects did not differ in other measures of energy expenditure, caloric intake, or body composition. CONCLUSIONS: LT4 suppression therapy does not adversely affect energy expenditure or body composition in women. However, LT4 replacement therapy is associated with a lower REE, despite TSH levels within the reference range. This may be due to lower fT3 levels, suggesting relative tissue hypothyroidism may contribute to impaired energy expenditure in LT4 therapy.

Effect of Thyroid Function Variations Within the Laboratory Reference Range on Health Status, Mood, and Cognition in Levothyroxine-Treated Subjects.

BACKGROUND: There has been recent debate within the thyroid field regarding whether current upper limits of the thyrotropin (TSH) reference range should be lowered. This debate can be better informed by investigation of whether variations in thyroid function within the reference range have clinical effects. One important target organ for thyroid hormone is the brain, but little is known about variations in neurocognitive measures within the reference range for thyroid function. METHODS: This was a cross-sectional study of 132 otherwise healthy hypothyroid subjects receiving chronic replacement therapy with levothyroxine (LT4) who had TSH levels across the full span of the laboratory reference range (0.34-5.6 mU/L). Subjects underwent detailed tests of health status, mood, and cognitive function, with an emphasis on memory and executive functions. RESULTS: Subjects with low-normal (≤2.5 mU/L) and high-normal (>2.5 mU/L) TSH levels did not differ on most tests of health status, mood, or cognitive function, and there were no correlations between TSH, free T4, or free T3 levels and most outcomes. There was, however, a suggestion that thyroid function affected performance on the Iowa Gambling Task, which mimics real life decision-making. Subjects with low-normal TSH levels made more advantageous decisions than those with high-normal TSH levels. CONCLUSIONS: Variations in thyroid function within the laboratory reference range do not appear to have clinically relevant effects on health status, mood, or memory in LT4 treated subjects. However, decision making, which encompasses many executive functions, may be affected. Unless further studies strengthen this finding, these data do not support narrowing the TSH reference range.

Exploring the phenomenon of spiritual care between hospital chaplains and hospital based healthcare providers.

Hospital chaplaincy and spiritual care services are important to patients' medical care and well-being; however, little is known about healthcare providers' experiences receiving spiritual support. A phenomenological study examined the shared experience of spiritual care between hospital chaplains and hospital-based healthcare providers (HBHPs). Six distinct themes emerged from the in-depth interviews: Awareness of chaplain availability, chaplains focus on building relationships with providers and staff, chaplains are integrated in varying degrees on certain hospital units, chaplains meet providers' personal and professional needs, providers appreciate chaplains, and barriers to expanding hospital chaplains' services. While HBHPs appreciated the care received and were able to provide better patient care as a result, participants reported that administrators may not recognize the true value of the care provided. Implications from this study are applied to hospital chaplaincy clinical, research, and training opportunities.

The effects of levothyroxine replacement or suppressive therapy on health status, mood, and cognition.

CONTEXT: TSH-suppressive doses of levothyroxine (L-T4) have adverse effects on bone and cardiac function, but it is unclear whether central nervous system function is also affected. OBJECTIVE: The aim of the study was to determine whether women receiving TSH-suppressive L-T4 doses have decrements in health status, mood, or cognitive function. DESIGN AND SETTING: A cross-sectional comparison was made among three groups of women in an academic medical center research clinic. PATIENTS: Twenty-four women receiving chronic TSH-suppressive L-T4 doses, 35 women receiving chronic replacement L-T4 doses, and 20 untreated control women participated in the study. INTERVENTIONS: Subjects underwent testing at a single outpatient visit. MAIN OUTCOME MEASURES: We measured health status (SF-36), mood (Profile of Mood States, Symptom Checklist 90-R, Affective Lability Scale), and cognitive function (declarative memory [Paragraph Recall], working memory [N-back, Subject Ordered Pointing], motor learning [Pursuit Rotor, Motor Sequence Learning Test], and executive function [Letter Cancellation Test, Trail Making Test, Iowa Gambling Test]). RESULTS: Women receiving TSH-suppressive or replacement L-T4 doses had decrements in health status and mood compared to healthy controls. These decrements were more pronounced in women receiving replacement, rather than suppressive, L-T4 doses. Memory and executive function were not affected in either treated group, compared to healthy controls. CONCLUSIONS: Women receiving TSH-suppressive doses of L-T4 do not have central nervous system dysfunction due to exogenous subclinical thyrotoxicosis, but TSH-suppressed and L-T4-replaced women have slight decrements in health status and mood that may be related to self-knowledge of the presence of a thyroid condition or other uncharacterized factors. These mood alterations do not impair cognitive function.