Dietary intake of low-income adults in South Africa: ultra-processed food consumption a cause for concern.

OBJECTIVE: Given the rapidly changing food environment and proliferation of ultra-processed foods (UPF) in South Africa (SA), this study aimed to critically evaluate dietary quality and adequacy of low-income adults using the Nova classification system and WHO and World Cancer Research Fund dietary guidelines. DESIGN: Secondary household data and 1-d 24-h recalls were analysed from two cross-sectional studies conducted in 2017-2018. Foods consumed were classified according to the Nova classification system. Compliance with WHO dietary guidelines and UPF consumption trends were evaluated. SETTING: Three low-income areas (Langa, Khayalitsha and Mount Frere) in SA were included. PARTICIPANTS: In total, 2521 participants (18-50 years) were included in the study. RESULTS: Participants had a mean energy intake of 7762 kJ/d. Most participants were within the acceptable WHO guideline range for saturated fat (80·4 %), total fat (68·1 %), Na (72·7 %) and free sugar (57·3 %). UPF comprised 39·4 % of diets among the average adult participant. Only 7·0 % of all participants met the WHO guideline for fruit and vegetables and 18·8 % met the guideline for fibre. Those within the highest quartile of share of energy from UPF consumed statistically higher amounts of dietary components to limit and were the highest energy consumers overall. CONCLUSIONS: Low-income adults living in SA are consuming insufficient protective dietary components, while UPF consumption is prevalent. Higher UPF consumers consume larger amounts of nutrients linked to increased chronic disease risk. Policy measures are urgently needed in SA to protect against the proliferation of harmful UPF and to promote and enable consumption of whole and less UPF.

Background commentary on the Researching the Obesogenic Food Environment (ROFE) project.

OBJECTIVE: The objective of this commentary is to provide an overview of the rationale and objectives of the Researching the Obesogenic Food Environment (ROFE) project that was conducted in Ghana and South Africa. DESIGN: Narration has been used to describe the main objectives, phases as well as the methods used for the conduct of this project. SETTING: The project described in this commentary was conducted in Khayelitsha and Mount Frere in South Africa and Ahodwo and Ejuratia for Ghana. PARTICIPANT: Participants of the study described here include households in South Africa and Ghana, stakeholders and policymakers, and various actors within the food chain in both countries. RESULTS: The ROFE findings provide a good understanding of the extent of the impact of the food environment on consumption, characteristics of value chains of healthy and unhealthy foods, as well as the potential for improved governance and policy that is relevant to the region. The supplement provides the opportunity to share the extensive findings of the ROFE project. Nine papers that describe the process and findings of the three phases of the ROFE project have been presented. Some of the papers focus on phases of the ROFE, while others cut across different phases and explore the linkages between the phases. Briefly descriptions of key findings of some of the papers in the supplement are provided. CONCLUSION: Together, the findings of the ROFE study presented in this supplement have increased understanding of how communities in SA and Ghana interact with their food supplies and have led to identification of specific opportunities to improve food supply policies, in ways that create incentives for the production and consumption of healthy, relative to unhealthy foods.

Are intentions to change, policy awareness, or health knowledge related to changes in dietary intake following a sugar-sweetened beverage tax in South Africa? A before-and-after study.

BACKGROUND: In April 2018, South Africa implemented the Health Promotion Levy (HPL), one of the first sugar-sweetened beverage (SSB) taxes to be based on each gram of sugar (beyond 4 g/100mL). The objectives of this study were to examine whether the psychological constructs tax awareness, SSB knowledge, SSB risk perception, and intentions to reduce SSB intake were associated with taxed beverage intake, whether they changed from pre- to post-tax, and whether they modified the effect of the HPL. METHODS: We collected single day 24-hour dietary recalls surveyed from repeat cross-sectional surveys of adults aged 18-39 years in Langa, South Africa. Participants were recruited in February-March 2018 (pre-tax, N = 2,481) and February-March 2019 (post-tax, N = 2,507) using door-to-door sampling. Surveys measured tax awareness, SSB knowledge, SSB risk perception, and intention to reduce SSB intake. SSB intake was estimated using a two-part model. To examine changes over time, logistic regression models were used for binary outcomes (tax awareness and intention to reduce SSB consumption) and linear regression models for continuous outcomes (SSB knowledge SSB risk perceptions). Effect modification was tested using interaction terms for each psychological construct with time. RESULTS: No constructs were associated with SSB intake at baseline. At post-tax, the predicted probability to consume taxed beverages was 33.5% (95% CI 28.5-38.5%) for those who expressed an intention to reduce SSB intake compared to 45.9% (95% CI 43.7-48.1%) for those who did not. Among consumers, intending to reduce SSB intake was associated with 55 (95% CI 28 to 82) kcal/capita/day less SSBs consumed. Tax awareness, SSB knowledge, and SSB risk perception increased by a small amount from pre- to post-tax. Intentions to reduce SSB intake was lower in the post-tax period. The tax effect on SSB intake was modified by SSB knowledge and intention to reduce SSB intake, with higher levels of each associated with lower SSB intake. CONCLUSION: After the South African SSB tax was implemented, SSB knowledge and risk perception increased slightly, tax awareness remained low, and only SSB knowledge and behavioral intention to change were significantly associated with taxed beverage intake among participants recruited from a low-income South African township.

South Africa's Health Promotion Levy on Pricing and Acquisition of Beverages in Local Spazas and Supermarkets.

OBJECTIVE: In response to concern over rising sugar-sweetened beverage (SSB) consumption, in April 2018, South Africa became the first Sub-Saharan African country to implement an SSB tax. We assess changes in pricing and acquisition of beverages from local supermarkets and small stores among 18-39 year old adults living in one township in the Western Cape, before and after tax implementation. This study is among the first evaluations of an SSB tax on the local food environment in a low-income township. DESIGN: Store beverage pricing and participant surveys were cross-sectional, analyzed 1 month before and 11 months after implementation of the tax (March 2018 and March 2019). SETTING: Langa, Western Cape, South Africa. PARTICIPANTS: Surveyed participants were residents of Langa between 18-39 years old (N=2,693 in 2018 and N=2,520 in 2019). RESULTS: Prices of taxed SSBs increased significantly among small shops and supermarkets between 2018 and 2019. There were non-significant decreases in prices of untaxed beverages in small shops, but prices of untaxed beverages increased in supermarkets. Across all store types, there was a 9 percentage point decrease in the probability of purchasing regular soda weekly pre/post-implementation. Reductions in purchasing were larger in small shops than supermarkets. CONCLUSIONS: We found some differential impacts of the levy on pricing and acquisition of beverages by retailer type in one low-income township. As other Sub-Saharan African countries consider similar fiscal policies to curb soda consumption, obesity and related diseases, this work can be used to understand the implications of these policies in the retail setting.

Applying and comparing various nutrient profiling models against the packaged food supply in South Africa.

OBJECTIVE: This study aimed to apply the newly developed Chile Adjusted Model (CAM) nutrient profiling model (NPM) to the food supply in South Africa (SA) and compare its performance against existing NPMs as an indication of suitability for use to underpin food policies targeted at discouraging consumption of products high in nutrients associated with poor health. DESIGN: Cross-sectional analysis of the SA packaged food supply comparing the CAM to three other NPMs: SA health and nutrition claims (SA HNC), Chilean warning octagon (CWO) 2019, and Pan-American Health Organization (PAHO) NPM. SETTING: The SA packaged food supply based on products stocked by supermarkets in Cape Town, SA. PARTICIPANTS: Packaged foods and beverages (N=6474) available in 2018 were analyzed. RESULTS: 49% of products contained excessive amounts of nutrients of concern (considered non-compliant) according to the criteria of all four models. Only 10.9% of products were not excessive in any nutrients of concern (considered compliant) according to all NPMs evaluated. The CAM had an overall non-compliance level of 73.2%, and was comparable to the CWO 2019 for foods (71.2% and 71.1% respectively). The CAM was the strictest NPM for beverages (80.4%) due to the criteria of non-sugar sweeteners and free sugars. The SA HNC was the most lenient with non-compliance at 52.9%. This was largely due to the inclusion of nutrients to encourage, which is a criterion for this NPM. CONCLUSION: For the purpose of discouraging products high in nutrients associated with poor health in SA, the CAM is a suitable NPM.

Effect of Social Determinants of Health Interventions on Adults Living With Disabilities: A Scoping Review.

OBJECTIVE: To investigate social determinants of health (SDoH) interventions on individual health outcomes, population health, and cost for persons in the United States over age 18 living with disabilities and receiving long-term services and supports (LTSS) in noninstitutional settings. DATA SOURCES: A review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted of literature from PubMed, PsycINFO, REHABDATA, and Web of Science Core Collection published between January 1997 and July 2020. STUDY SELECTION: Search terms were based on the primary SDoH domains identified by the Centers for Medicare and Medicaid's Accountable Health Communities Model. A total of 5082 abstracts were screened based on identification criteria of persons age 18 and above living in non-institutional, community-based settings receiving LTSS. DATA EXTRACTION: During Level 2 review, articles were reviewed based on population focus, type of LTSS (personal assistance services, home care, adult day care, home modification, durable medical equipment, community transition services, caregiver supports and/or prevention services related to home- and community-based care), SDoH intervention and association with health outcomes, population health and/or cost. A total of 1037 abstracts underwent Level 2 review, yielding 131 publications or 1.3% for full review. DATA SYNTHESIS: Studies (n=33) designed a priori to test outcomes of interventions were rated according to Grading Recommendations Assessment Development and Evaluation (GRADE) criteria. Qualifying articles that did not include interventions (n=98) were included in our summary of the literature but were not assessed by GRADE. CONCLUSIONS: The preponderance of research surrounding SDoH and health outcomes has focused on older adults living with disabilities, and most interventions scored low or very low using GRADE criteria. Evidence is limited to the extent SDoH interventions are measured against outcomes for persons of all ages living with disabilities. Robust evaluation of models that feature SDoH interventions in partnership with community-based organizations is recommended as home and community-based care infrastructure expands in response to the American Rescue Plan Act of 2021.

Trends in utilization and costs of migraine medications, 2017-2020.

OBJECTIVE: This study examines changes in utilization and costs trends associated with migraine medications. BACKGROUND: Migraine attacks are a burden to many patients. There are many pharmacotherapy options available with newer migraine drug classes entering the market in the past decade. Little is known about the use, associated costs, and the impact of the newer agents. METHODS: This retrospective, cross-sectional study examined 2017-2020 administrative claims from a large national pharmacy benefits manager. Patients aged ≥ 18 years enrolled in commercial, Medicare, Medicaid, or health insurance exchange insurance plans who filled ≥ 2 prescription claims for triptans, ergotamines, isometheptenes, gepants, ditans, and CGRP mABs were included. A two-sample t-test was conducted to estimate whether differences in mean utilization and costs between 2017 and 2020 were statistically significant for migraine drug classes, except for CGRP mABs, which were estimated between 2018 and 2020. RESULTS: The sample ranged from 161,369 (2017) to 240,330 (2020) patients. 84.5% (n = 203,110; 2020) of patients were women. The number of 30-day adjusted prescription fills for prophylaxis remained stable over the four-year period, except for CGRP mABs, which increased from 0.5% (n = 0.007; 2018) to 5.3% (n = 0.075; 2020). Antiepileptics, antidepressants and beta blockers were the most common prophylaxes, while triptans, non-steroidal anti-inflammatory drugs/non-narcotic analgesics and opioids were the most common treatments utilized. CGRP mABs were the most expensive, while utilization of triptans were the highest. CGRP mABs had the largest increase in utilization (177.5%) and costs (166.3%) PPPM in 2020 ($291.17) compared to 2018 ($109.35), the year they were first available (p < 0.001). Between 2018 and 2020, costs increased overall and for commercial and Medicare enrollees, but remained unchanged for Medicaid and HIX members. CONCLUSION: Our study demonstrates a shift in migraine medication utilization from 2017-2020, where increased use of CGRP mABs had a significant contribution to increased costs. These increased pharmacy costs must be weighed against the improved tolerability of these agents likely resulting in other healthcare and indirect cost savings.

Taxed and untaxed beverage intake by South African young adults after a national sugar-sweetened beverage tax: A before-and-after study.

BACKGROUND: In an effort to prevent and reduce the prevalence rate of people with obesity and diabetes, South Africa implemented a sugar-content-based tax called the Health Promotion Levy in April 2018, one of the first sugar-sweetened beverage (SSB) taxes to be based on each gram of sugar (beyond 4 g/100 ml). This before-and-after study estimated changes in taxed and untaxed beverage intake 1 year after the tax, examining separately, to our knowledge for the first time, the role of reformulation distinct from behavioral changes in SSB intake. METHODS AND FINDINGS: We collected single-day 24-hour dietary recalls from repeat cross-sectional surveys of adults aged 18-39 years in Langa, South Africa. Participants were recruited in February-March 2018 (pre-tax, n = 2,459) and February-March 2019 (post-tax, n = 2,489) using door-to-door sampling. We developed time-specific food composition tables (FCTs) for South African beverages before and after the tax, linked with the diet recalls. By linking pre-tax FCTs only to dietary intake data collected in the pre-tax and post-tax periods, we calculated changes in beverage intake due to behavioral change, assuming no reformulation. Next, we repeated the analysis using an updated FCT in the post-tax period to capture the marginal effect of reformulation. We estimated beverage intake using a 2-part model that takes into consideration the biases in using ordinary least squares or other continuous variable approaches with many individuals with zero intake. First, a probit model was used to estimate the probability of consuming the specific beverage category. Then, conditional on a positive outcome, a generalized linear model with a log-link was used to estimate the continuous amount of beverage consumed. Among taxed beverages, sugar intake decreased significantly (p < 0.0001) from 28.8 g/capita/day (95% CI 27.3-30.4) pre-tax to 19.8 (95% CI 18.5-21.1) post-tax. Energy intake decreased (p < 0.0001) from 121 kcal/capita/day (95% CI 114-127) pre-tax to 82 (95% CI 76-87) post-tax. Volume intake decreased (p < 0.0001) from 315 ml/capita/day (95% CI 297-332) pre-tax to 198 (95% CI 185-211) post-tax. Among untaxed beverages, sugar intake increased (p < 0.0001) by 5.3 g/capita/day (95% CI 3.7 to 6.9), and energy intake increased (p < 0.0001) by 29 kcal/capita/day (95% CI 19 to 39). Among total beverages, sugar intake decreased significantly (p = 0.004) by 3.7 (95% CI -6.2 to -1.2) g/capita/day. Behavioral change accounted for reductions of 24% in energy, 22% in sugar, and 23% in volume, while reformulation accounted for additional reductions of 8% in energy, 9% in sugar, and 14% in volume from taxed beverages. The key limitations of this study are an inability to make causal claims due to repeat cross-sectional data collection, and that the magnitude of reduction in taxed beverage intake may not be generalizable to higher income populations. CONCLUSIONS: Using a large sample of a high-consuming, low-income population, we found large reductions in taxed beverage intake, separating the components of behavioral change from reformulation. This reduction was partially compensated by an increase in sugar and energy from untaxed beverages. Because policies such as taxes can incentivize reformulation, our use of an up-to-date FCT that reflects a rapidly changing food supply is novel and important for evaluating policy effects on intake.

Changes in Type 2 Diabetes Medication Utilization and Costs in the United States, 2014-2019.

OBJECTIVE: The objective of this study was to describe national changes in utilization and associated costs of antidiabetic medications in the United States from 2014 to 2019, across different drug classes and insurance plans. RESEARCH DESIGN AND METHODS: This retrospective, cross-sectional study examined administrative claims from a large national pharmacy benefits manager from January 1, 2014, to December 31, 2019. Patients aged 18 years and above enrolled in commercial, Medicare, or Medicaid health plans who filled ≥1 prescription claim for an antidiabetic medication(s) during the 6-year period were included. Utilization was examined as the total number of 30-day adjusted prescription fills per user per month (PUPM). Gross costs were calculated as the sum of plan costs (net of rebates) and member out-of-pocket costs. Differences in mean utilization and costs PUPM between 2014 and 2019 for each medication class were calculated. RESULTS: The final analytic sample increased from 745,290 patients in 2014 to 1,596,006 in 2019. Antidiabetic medication utilization increased by 8.8% from 2014 to 2019, driven by increases in sodium-glucose cotransporter 2 inhibitor (48.7%; P<0.001), glucagon-like peptide 1 receptor agonist (11.8%; P<0.001), insulin (8.1%; P<0.001), and metformin (2.9%; P<0.05) utilization. Average costs PUPM rose 47.5% (P<0.001), from $126.52 in 2014 to $186.58 in 2019. Sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and combination drugs contributed significantly to these increased costs, with 6-year cost differences of 57.3%, 46.9%, and 47.2%, respectively (all P<0.001). CONCLUSION: Our study demonstrates a shift in antidiabetic medication class utilization from 2014 to 2019, where associated costs net of rebates significantly increased to a disproportionately greater extent than the significant increase in utilization PUPM.

Impact of Marijuana Legalization on Opioid Utilization in Patients Diagnosed with Pain.

BACKGROUND: Given efforts to reduce opioid use, and because marijuana potentially offers a lower-risk alternative for treating chronic pain, there is interest in understanding the public health impact of marijuana legalization on opioid-related outcomes. OBJECTIVE: Assess the impact of recreational and medical marijuana legalization on opioid utilization among patients receiving pharmacotherapy for pain. DESIGN: Retrospective claims-based study of commercially insured patients continuously eligible for pharmacy and medical benefits from July 8, 2014 to June 30, 2017. Index pain prescription period was defined between January 8, 2015 and June 30, 2015, and longer-term opioid use examined during 2-year follow-up. Marijuana state policy on July 1, 2015, was assigned: none; medical only; or medical and recreational. PARTICIPANTS: Patients aged 18-62 without cancer diagnosis. MAIN MEASURES: Patient receiving (1) opioid at index; (2) > 7 days' supply of index opioid; (3) opioid during follow-up; and (4) ≥ 90 days' opioid supply during follow-up. Multivariable regression assessed associations between opioid utilization and state marijuana policy, adjusting for age, gender, overall disease burden, mental health treatment, concomitant use of benzodiazepine or muscle relaxant, and previous pain prescription. KEY RESULTS: Of 141,711 patients, 80,955 (57.1%) resided in states with no policy; 56,494 (39.9%) with medical-only; and 4262 (3.0%) with medical and recreational. Patients in states with both policies were more likely to receive an index opioid (aOR = 1.72, 95% CI = 1.61-1.85; aOR = 1.90, 95% CI = 1.77-2.03; P < 0.001) but less likely to receive > 7 days' index supply (aOR = 0.84, 95% CI = 0.77-0.91; aOR = 0.76, 95% CI = 0.70-0.83; P < 0.001) than patients in states with no policy or medical-only, respectively. Those in states with both policies were more likely to receive a follow-up opioid (aOR = 1.87, 95% CI = 1.71-2.05; aOR = 2.20, 95% CI = 2.01-2.42; P < 0.001) than those in states with no policy or medical-only, respectively, and more likely to receive ≥ 90 cumulative follow-up opioid days' supply (aOR = 1.18, 95% CI = 1.07-1.29; P < 0.001) than those in states with no policy. CONCLUSIONS: Our analysis does not support the supposition that access to marijuana lowers use of chronic opioids for pain.

Examining the news media reaction to a national sugary beverage tax in South Africa: a quantitative content analysis.

BACKGROUND: South Africa was the first sub-Saharan African country to implement a sugar-sweetened beverage (SSB) tax called the Health Promotion Levy (HPL) in April 2018. Given news media can increase public awareness and sway opinions, this study analyzed how the media represented the HPL, including expressions of support or challenge, topics associated with the levy, and stakeholder views of the HPL. METHODS: We performed a quantitative content analysis of online South African news articles related to the HPL published between January 1, 2017 and June 30, 2019. We coded the presence or absence of mentions related to health and economic effects of the HPL and HPL support or opposition. Prevalence of these mentions, overall and by source (industry, government, academics, other), were analyzed with Pearson χ2 and post-hoc Fisher exact tests. RESULTS: Across all articles, 81% mentioned health, and 65% mentioned economics topics. 54% of articles expressed support, 26% opposition, and 20% a balanced view of the HPL. All sources except industry expressed majority support for the HPL. Health reasons were the most common justifications for support, and economic harms were the most common justifications for opposition. Statements that sugar intake is not related to obesity, the HPL will not reduce SSB intake, and the HPL will cause industry or economic harm were all disproportionately high in industry sources (92, 80, and 81% vs 25% prevalence in total sample) (p < 0.001). Statements that sugar intake is related to obesity and non-communicable diseases were disproportionately high in both government (46 and 54% vs 31% prevalence in total sample) (p < 0.001) and academics (33 and 38% vs 25% prevalence in total sample) (p < 0.05). Statements that the HPL will improve health and the HPL will reduce health care costs were disproportionately high in government (47% vs 31% prevalence in total sample) (p < 0.001) and academics (44% vs 25% prevalence in total sample) (p < 0.05), respectively. CONCLUSIONS: Industry expressed no support for the HPL, whereas academics, government, and other sources mainly expressed support. Future studies would be improved by linking news media exposure to SSB intake data to better understand the effects news media may have on individual behavior change.

Impact of Healthcare Delivery System Type on Clinical, Utilization, and Cost Outcomes of Patient-Centered Medical Homes: a Systematic Review.

BACKGROUND: As healthcare reimbursement shifts from being volume to value-focused, new delivery models aim to coordinate care and improve quality. The patient-centered medical home (PCMH) model is one such model that aims to deliver coordinated, accessible healthcare to improve outcomes and decrease costs. It is unclear how the types of delivery systems in which PCMHs operate differentially impact outcomes. We aim to describe economic, utilization, quality, clinical, and patient satisfaction outcomes resulting from PCMH interventions operating within integrated delivery and finance systems (IDFS), government systems including Veterans Administration, and non-integrated delivery systems. METHODS: We searched PubMed, the Cochrane Library, and Embase from 2004 to 2017. Observational studies and clinical trials occurring within the USA that met PCMH criteria (as defined by the Agency for Healthcare Research and Quality), addressed ambulatory adults, and reported utilization, economic, clinical, processes and quality of care, or patient satisfaction outcomes. RESULTS: Sixty-four studies were included. Twenty-four percent were within IDFS, 29% were within government systems, and 47% were within non-IDFS. IDFS studies reported decreased emergency department use, primary care use, and cost relative to other systems after PCMH implementation. Government systems reported increased primary care use relative to other systems after PCMH implementation. Clinical outcomes, processes and quality of care, and patient satisfaction were assessed heterogeneously or infrequently. DISCUSSION: Published articles assessing PCMH interventions generally report improved outcomes related to utilization and cost. IDFS and government systems exhibit different outcomes relative to non-integrated systems, demonstrating that different health systems and populations may be particularly sensitive to PCMH interventions. Both the definition of PCMH interventions and outcomes measured are heterogeneous, limiting the ability to perform direct comparisons or meta-analysis.

Identifying Outcome Measures for Migraine Value-Based Contracting Using the Delphi Method.

OBJECTIVE: To identify meaningful migraine outcome measures among key stakeholders to inform value-based contracts for migraine medications. BACKGROUND: Value-based contracts linking medication payments to predefined performance metrics aim to promote value through aligned incentives and shared risk between manufacturers and payers. The emergence of new and expensive pharmaceuticals for migraine presents an opportunity for value-based contract development. However, uncertainty remains around which outcomes are most meaningful to all migraine stakeholders. METHODS: This study utilized a Delphi survey to incorporate views from 82 stakeholders, including patients (n = 21), providers (n = 23), payers (n = 10), employers (n = 18), and pharmaceutical company representatives (n = 10). A list of 15 migraine-related outcomes was created from a literature review and subject matter expert consultation. Stakeholders reported on the value of these outcomes through a 5-point Likert scale and selection of their top 3 most meaningful outcomes. All participants except patients and employers also used a 5-point Likert scale to rate the feasibility of collecting each outcome measure. Consensus was defined as ≥75% agreement on the importance and feasibility of an outcome (Likert scores ≥4/5 or selection of an outcome as most meaningful). RESULTS: After 2 rounds, consensus was achieved for importance of 9 outcomes on the Likert scale. "Decrease in migraine frequency" reached 100% agreement (82/82), followed by "increased ability to resume normal activities" (96%, 79/82). When asked to choose the 3 most meaningful outcomes, stakeholders selected "decrease in migraine frequency" (88%, 72/82) followed by "decrease in migraine severity" (80%, 66/82). The 2 measures rated as most feasibly collected were "decrease in emergency department/urgent care visits" (95%, 40/42) and "decrease in migraine frequency" (90%, 38/42). There were statistically significant differences between non-patient and patient stakeholders in selection of "decrease in emergency department/urgent care visits" [20% (12/61) vs 0% (0/21), P = .031]; and employer and patient stakeholders in selection of "decrease in work days missed" [44% (8/18) vs 5% (1/21), P = .006] and "decrease in emergency department/urgent care visits" [22% (4/18) vs 0% (0/21), P = .037] as most meaningful outcomes. CONCLUSIONS: The measures "decrease in migraine frequency" followed by "decrease in migraine severity" were identified as top priority migraine outcome measures.

Impact of community pharmacist-provided preventive services on clinical, utilization, and economic outcomes: An umbrella review.

Preventable diseases and late diagnosis of disease impose great clinical and economic burden for health care systems, especially in the current juncture of rising medical expenditures. Under these circumstances, community pharmacies have been identified as accessible venues to receive preventive services. This umbrella review aims to examine existing evidence on the impact of community pharmacist-provided preventive services on clinical, utilization, and economic outcomes in the United States (US). We included systematic reviews, narrative reviews and meta-analyses published in English between January 2007 and October 2017. Of 2742 references identified by our search strategy, a total of 13 research syntheses met our inclusion criteria. Included reviews showed that community pharmacists are effective at increasing immunization rates, supporting smoking cessation, managing hormonal contraception therapies, and identifying patients at high risk for certain diseases. Moreover, evidence suggests that community pharmacies are especially well-positioned for the provision of preventive services due to their convenient location and extended hours of operation. There is general agreement on the positive impact of community pharmacists in increasing access to preventive health, particularly among patients who otherwise would not be reached by other healthcare providers. The provision of preventive services at US community pharmacies is feasible and effective, and has potential for improving patient outcomes and health system efficiency. However, high-quality evidence is still lacking. As the healthcare landscape shifts towards a value-based framework, it will be important to conduct robust studies that further evaluate the impact of community pharmacist-provided preventive services on utilization and economic outcomes.

Disease-Modifying Medications in Patients with Rheumatoid Arthritis in the USA: Trends from 2016 to 2021.

BACKGROUND: Disease-modifying anti-rheumatic drugs (DMARDs), since their introduction in 1990, have revolutionized the management of rheumatoid arthritis. Newer DMARDs have recently been approved, influencing treatment patterns and clinical guidelines. OBJECTIVE: To update the current prescribing patterns of DMARDs in the pharmacotherapy of rheumatoid arthritis (RA) to include the pandemic era. METHODS: This was a retrospective cross-sectional multi-year study. Using Optum's Clinformatics® Data Mart Database, we summarized trends in the prevalence of DMARD use in the USA from 2016 to 2021 by year for adult patients ≥ 18 years old with at least one medical RA claim and one pharmacy/medical claim of a DMARD medication. Trends included type of DMARD, class of DMARD (conventional (csDMARDs), biologics [tumor necrosis factor (TNFi) and Non-TNFi), and Janus kinase inhibitors (JAKs)], and triple therapy [methotrexate (MTX), hydroxychloroquine (HCQ), sulfasalazine (SUL)] used. RESULTS: The total sample from 2016 to 2021 was 670,679 commercially insured patients. The average age was 63.7 years (SD 13.6), and 76.7% were female and 70% were White. csDMARDs remain the most prescribed (ranging from 77.2 to 79.2%). Although JAKs were the least prescribed DMARD class, their proportion more than doubled from 2016 (1.5%) to 2021 (4%). MTX utilization declined from 40% in 2016 to 34% in 2021. In contrast, HCQ use increased during the pandemic era from < 25% in 2018 to 30% in 2021. Although there is evidence of the therapeutic benefit of triple therapy, its use was very low (~ 1%) compared to biologics only (~ 17%) or biologics+MTX (~ 10%). CONCLUSION: About half of patients with RA were on DMARDs. As expected, csDMARDs were highly used consistently. The COVID-19 pandemic might have influenced the use of HCQ and infusion DMARDs. Triple therapy use remains low.

Associations of the glycaemic index and the glycaemic load with risk of type 2 diabetes in 127 594 people from 20 countries (PURE): a prospective cohort study.

BACKGROUND: The association between the glycaemic index and the glycaemic load with type 2 diabetes incidence is controversial. We aimed to evaluate this association in an international cohort with diverse glycaemic index and glycaemic load diets. METHODS: The PURE study is a prospective cohort study of 127 594 adults aged 35-70 years from 20 high-income, middle-income, and low-income countries. Diet was assessed at baseline using country-specific validated food frequency questionnaires. The glycaemic index and the glycaemic load were estimated on the basis of the intake of seven categories of carbohydrate-containing foods. Participants were categorised into quintiles of glycaemic index and glycaemic load. The primary outcome was incident type 2 diabetes. Multivariable Cox Frailty models with random intercepts for study centre were used to calculate hazard ratios (HRs). FINDINGS: During a median follow-up of 11·8 years (IQR 9·0-13·0), 7326 (5·7%) incident cases of type 2 diabetes occurred. In multivariable adjusted analyses, a diet with a higher glycaemic index was significantly associated with a higher risk of diabetes (quintile 5 vs quintile 1; HR 1·15 [95% CI 1·03-1·29]). Participants in the highest quintile of the glycaemic load had a higher risk of incident type 2 diabetes compared with those in the lowest quintile (HR 1·21, 95% CI 1·06-1·37). The glycaemic index was more strongly associated with diabetes among individuals with a higher BMI (quintile 5 vs quintile 1; HR 1·23 [95% CI 1·08-1·41]) than those with a lower BMI (quintile 5 vs quintile 1; 1·10 [0·87-1·39]; p interaction=0·030). INTERPRETATION: Diets with a high glycaemic index and a high glycaemic load were associated with a higher risk of incident type 2 diabetes in a multinational cohort spanning five continents. Our findings suggest that consuming low glycaemic index and low glycaemic load diets might prevent the development of type 2 diabetes. FUNDING: Full funding sources are listed at the end of the Article.

Scoping review protocol exploring the relationship between food insecurity, mental health and diet intake among adolescents across the globe.

INTRODUCTION: Studies, exploring the effect of food insecurity on physical and mental health, have shown that food insecurity is associated with lower self-reports of physical and mental health. With the COVID-19 pandemic, food insecurity has increased leading to higher risks of poor mental health. Despite evidence of the negative implications of food insecurity on mental health, there is a paucity of research on these variables for adolescents specifically. The current evidence shows there is a gap in adolescent centred research linking mental health and food insecurity globally. Adolescence is a crucial period of development where habits, nutritional inadequacies linked to food insecurity and mental health problems formed due to these inadequacies can be conveyed into adulthood. The aim of this study is to systematically scope the literature exploring the relationship between mental health, food (in)security and/or diet intake of adolescents. METHODS: This review will be guided by Arksey and O'Malley's extended framework. The search strategy was developed by two of the authors and will be used to search literature from January 2012 to December 2022 in PubMed, Academic search complete, PsychARTICLES, Google, ScienceDirect, Scopus and Web of science core collection. Searching published and unpublished literature will be done in the chosen databases. References used in included literature will be reviewed for additional studies/sources. Articles will be assessed for eligibility by two reviewers, and any discrepancies reviewed by a third reviewer. The inclusion and exclusion criteria will be used for screening. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram will be used to document the selection process. A narrative summary and descriptive analysis will be used to summarise and report the extracted data. ETHICS AND DISSEMINATION: Approval for this study has been granted by the University of the Western Cape Biomedical Research Ethics Committee (BM21/8/3). Strict measures will be followed to ensure methodological rigour.

Real-world impact of empagliflozin on total cost of care in adults with type 2 diabetes: Results from an outcomes-based agreement.

BACKGROUND: Value-based health care is expanding through payment models such as outcomes-based agreements between manufacturers and payers. OBJECTIVE: To describe the total-cost-of-care outcomes of an outcomes-based agreement evaluating the real-world impact of empagliflozin vs other type 2 diabetes mellitus (T2DM) drugs among all patients with T2DM, with and without cardiovascular disease (within and beyond the requirement of the agreement). METHODS: In this prospective real-world analysis, members from the health plan of an integrated health care delivery system from the commercial and Medicare Advantage lines of business, who qualify under the confines of the contract, were included for analysis. Thus, members aged 18 years and older who were continuously enrolled in the identification (January 1, 2018, to December 31, 2018) and measurement periods (≤1 year post-index) with a T2DM diagnosis were retained. Patients using empagliflozin and empagliflozin-combination drugs constituted the empagliflozin group; those using all other antihyperglycemics, the nonempagliflozin group. Patients with type 1 diabetes, or those using metformin or insulin monotherapy, at index were excluded. Eligible members were followed for up to the earliest occurrence of disenrollment date, discontinuation (60-day medication fill gap allowed) of empagliflozin (or nonempagliflozin containing) medication, or the end of the measurement period. We compared, using Student's t-test and summary statistics (for reporting the outcomes agreement) and a propensity-matched difference-in-difference model (for the followup evaluation beyond the requirement of the agreement), the mean all-cause total cost of care (pharmacy plus medical) per patient per month (PPPM) between the 2 groups, including a subgroup of members with a baseline cardiovascular disease diagnosis. RESULTS: There were 4,577 (3,069 and 1,508 in the commercial and Medicare) and 33,712 (15,571 and 18,141 in the commercial and Medicare) in the empagliflozin and nonempagliflozin groups, respectively. The difference in mean total cost PPPM was $75 lower for empagliflozin vs nonempagliflozin groups, driven mainly by lower medical costs in the empagliflozin group (-$465 PPPM). However, the difference was not statistically significant in the propensity score-matched model. CONCLUSIONS: Although empagliflozin had higher pharmacy costs, the total cost of care for patients with T2DM and with established cardiovascular disease were comparable to the group of patients with all other T2DM, driven mainly by lower medical costs. DISCLOSURES: The authors report no conflicts of interest beyond being employees of the 2 organizations involved in this outcomes-based agreement. Ms. Palli is a former employee of Boehringer Ingelheim Pharmaceuticals, Inc., who was affiliated at the time of study conduct.

Comparing estimates of household expenditures between pictorial diaries and surveys in three low- and middle-income countries.

In most low- and middle-income countries (LMICs), household out-of-pocket (OOP) health spending constitutes a major source of healthcare financing. Household surveys are commonly used to monitor OOP health spending, but are prone to recall bias and unable to capture seasonal variation, and may underestimate expenditure-particularly among households with long-term chronic health conditions. Household expenditure diaries have been developed as an alternative to overcome the limitations of surveys, and pictorial diaries have been proposed where literacy levels may render traditional diary approaches inappropriate. This study compares estimates for general household and chronic healthcare expenditure in South Africa, Tanzania and Zimbabwe derived using survey and pictorial diary approaches. We selected a random sub-sample of 900 households across urban and rural communities participating in the Prospective Urban and Rural Epidemiology study. For a range of general and health-specific categories, OOP expenditure estimates use cross-sectional survey data collected via standardised questionnaire, and data from these same households collected via two-week pictorial diaries repeated four times over 2016-2019. In all countries, average monthly per capita expenditure on food, non-food/non-health items, health, and consequently, total household expenditure reported by pictorial diaries was consistently higher than that reported by surveys (each p<0.001). Differences were greatest for health expenditure. The share of total household expenditure allocated to health also differed by method, accounting for 2% in each country when using survey data, and from 8-20% when using diary data. Our findings suggest that the choice of data collection method may have significant implications for estimating OOP health spending and the burden it places on households. Despite several practical challenges to their implementation, pictorial diaries offer a method to assess potential bias in surveys or triangulate data from multiple sources. We offer some practical guidance when considering the use of pictorial diaries for estimating household expenditure.

Overweight among children decreased, but obesity prevalence remained high among women in South Africa, 1999-2005.

OBJECTIVE: The aim of the present study was to assess anthropometric status in South African children and women in 2005 in order to document temporal trends in selected anthropometric parameters. DESIGN: Heights and weights were measured in a cross-sectional study of children aged 1-9 years and women aged 16-35 years. The WHO reference values and BMI cut-off points were used to determine weight status. SETTING: South Africa, representative sample based on census data. SUBJECTS: Children (n 2157) and women (n 2403). RESULTS: Stunting was the most common nutritional disorder affecting 21·7% of children in 1999 and 20·7% in 2005. The difference was not statistically significant. Underweight prevalence remained unchanged, affecting 8·1% of children, whereas wasting affected 5·8% of children nationally, a significant increase from 4·3% of children in 1999. Rural children were most severely affected. According to the international BMI cut-off points for overweight and obesity, 10% of children nationally were classified as overweight and 4% as obese. The national prevalence of overweight and obesity combined for women was 51·5%. The prevalence of overweight in children based on weight-for-height Z-score did not change significantly (8·0% to 6·8%, P = 0·138), but the combined overweight/obesity prevalence based on BMI cut-off points (17·1% to 14·0%, P = 0·02) decreased significantly from 1999 to 2005. CONCLUSIONS: The double burden of undernutrition in children and overweight among women is evident in South Africa and getting worse due to increased childhood wasting combined with a high prevalence of obesity among urban women, indicating a need for urgent intervention.