Validation of Claims-Based Algorithm for Lyme Disease, Massachusetts, USA.

Compared with notifiable disease surveillance, claims-based algorithms estimate higher Lyme disease incidence, but their accuracy is unknown. We applied a previously developed Lyme disease algorithm (diagnosis code plus antimicrobial drug prescription dispensing within 30 days) to an administrative claims database in Massachusetts, USA, to identify a Lyme disease cohort during July 2000-June 2019. Clinicians reviewed and adjudicated medical charts from a cohort subset by using national surveillance case definitions. We calculated positive predictive values (PPVs). We identified 12,229 Lyme disease episodes in the claims database and reviewed and adjudicated 128 medical charts. The algorithm's PPV for confirmed, probable, or suspected cases was 93.8% (95% CI 88.1%-97.3%); the PPV was 66.4% (95% CI 57.5%-74.5%) for confirmed and probable cases only. In a high incidence setting, a claims-based algorithm identified cases with a high PPV, suggesting it can be used to assess Lyme disease burden and supplement traditional surveillance data.

Reliability and validity testing of the medicines related - consultation assessment tool for assessing pharmacists' consultations.

BACKGROUND: Demonstrating a person-centred approach in a consultation is a key component of delivering high-quality healthcare. To support development of such an approach requires training underpinned by valid assessment tools. Given the lack of a suitable pharmacy-specific tool, a new global consultation skills assessment tool: the medicines related-consultation assessment tool (MR-CAT) was designed and tested. AIM: This study aimed to test the validity and reliability of the MR-CAT using psychometric methods. METHOD: Psychometric testing involved analysis of participants' (n = 13) assessment of fifteen pre-recorded simulated consultations using the MR-CAT. Analysis included discriminant validity testing, intrarater and interrater reliability testing for each of the five sections of the MR-CAT and for the overall global assessment of the consultation. Analysis also included internal consistency testing for the whole tool. RESULTS: Internal consistency for the overall global assessment of the consultation was good (Cronbach's alpha = 0.97). The MR-CAT discriminated well for the overall global assessment of the consultation (p < 0.001). Moderate to high intrarater reliability was observed for the overall global assessment of the consultation and for all five sections of the MR-CAT (rho = 0.64-0.84) in the test-retest analysis. Moderate to good interrater reliability (Kendall's W = 0.68-0.90) was observed for the overall global assessment of the consultation and for all five sections of the MR-CAT. CONCLUSION: The MR-CAT is a valid and reliable tool for assessing person-centred pharmacist's consultations. Moreover, its unique design means that the MR-CAT can be used in both formative and summative assessment.

Healthcare claims-based Lyme disease case-finding algorithms in the United States: A systematic literature review.

BACKGROUND AND OBJECTIVE: Lyme disease (LD) is the fifth most commonly reported notifiable infectious disease in the United States (US) with approximately 35,000 cases reported in 2019 via public health surveillance. However, healthcare claims-based studies estimate that the number of LD cases is >10 times larger than reported through surveillance. To assess the burden of LD using healthcare claims data and the effectiveness of interventions for LD prevention and treatment, it is important to use validated well-performing LD case-finding algorithms ("LD algorithms"). We conducted a systematic literature review to identify LD algorithms used with US healthcare claims data and their validation status. METHODS: We searched PubMed and Embase for articles published in English since January 1, 2000 (search date: February 20, 2021), using the following search terms: (1) "Lyme disease"; and (2) "claim*" or "administrative* data"; and (3) "United States" or "the US*". We then reviewed the titles, abstracts, full texts, and bibliographies of the articles to select eligible articles, i.e., those describing LD algorithms used with US healthcare claims data. RESULTS: We identified 15 eligible articles. Of these, seven studies used LD algorithms with LD diagnosis codes only, four studies used LD diagnosis codes and antibiotic dispensing records, and the remaining four studies used serologic test order codes in combination with LD diagnosis codes and antibiotics records. Only one of the studies that provided data on algorithm performance: sensitivity 50% and positive predictive value 5%, and this was based on Lyme disease diagnosis code only. CONCLUSIONS: US claims-based LD case-finding algorithms have used diverse strategies. Only one algorithm was validated, and its performance was poor. Further studies are warranted to assess performance for different algorithm designs and inform efforts to better assess the true burden of LD.

Cost-effectiveness of alternative minimum recall intervals between whole blood donations.

BACKGROUND: The INTERVAL trial showed shorter inter-donation intervals could safely increase the frequency of whole-blood donation. We extended the INTERVAL trial to consider the relative cost-effectiveness of reduced inter-donation intervals. METHODS: Our within-trial cost-effectiveness analysis (CEA) used data from 44,863 whole-blood donors randomly assigned to 12, 10 or 8 week (males), and 16, 14 or 12 week inter-donation intervals (females). The CEA analysed the number of whole-blood donations, deferrals including low- haemoglobin deferrals, and donors' health-related quality of life (QoL) to report costs and cost-effectiveness over two years. FINDINGS: The mean number of blood donation visits over two years was higher for the reduced interval strategies, for males (7.76, 6.60 and 5.68 average donations in the 8-, 10- and 12- week arms) and for females (5.10, 4.60 and 4.01 donations in the 12-, 14- and 16- week arms). For males, the average rate of deferral for low haemoglobin per session attended, was 5.71% (8- week arm), 3.73% (10- week), and 2.55% (12- week), and for females the rates were: 7.92% (12-week), 6.63% (14- week), and 5.05% (16- week). Donors' QoL was similar across strategies, although self-reported symptoms were increased with shorter donation intervals. The shorter interval strategies increased average cost, with incremental cost-effectiveness ratios of £9.51 (95% CI 9.33 to 9.69) per additional whole-blood donation for the 8- versus 12- week interval for males, and £10.17 (95% CI 9.80 to 10.54) for the 12- versus 16- week interval arm for females. CONCLUSIONS: Over two years, reducing the minimum donation interval could provide additional units of whole-blood at a small additional cost, including for those donor subgroups whose blood type is in relatively high demand. However, the significance of self-reported symptoms needs to be investigated further before these policies are expanded.

Risk management of teratogenic medicines: A systematic review.

AIM: To systematically identify studies of implementing risk management measures when prescribing teratogenic medicines for women of childbearing age and studies reporting risk perceptions of teratogenic medications. METHODS: MEDLINE, CINAHL, Scopus, EMBASE, and International Pharmaceutical Abstracts were searched. Studies were included in the risk management section if they reported any of the following risk management measures: teratogenic counseling, contraceptive counseling, pregnancy testing before starting treatment, pregnancy testing during treatment, use of contraception before starting treatment, and use of contraception during treatment. Studies were included in the perceptions section if they reported perceived teratogenic risk as numerical value. RESULTS: Fifty-five studies were included in the risk management section and seven studies were included in the perceptions sections. Prevalence of risk management measures varied as follows: teratogenic counseling (9.5%-99.3%), contraceptive counseling (6.1%-98%), pregnancy testing before starting treatment (0%-95.1%), pregnancy testing during treatment (12.7%-100%), contraception use before starting treatment (15.7%-94%), and contraception use during treatment (1.7%-100%). A proper estimation of the teratogenic risk was reported for thalidomide (by general practitioners and obstetric/gynecologists), for etretinate (by pregnant women), and for misoprostol (by pregnant and nonpregnant women). An under-estimation was reported for warfarin and retinoids (by general practitioners and obstetric/gynecologists). And over-estimation was reported for thalidomide, valproate, lithium, isotretinoin, phenytoin, warfarin and etretinate by different populations. CONCLUSION: Considerable variation in the implementation of risk management measures when prescribing teratogenic medicines to women of childbearing age is reported in the literature. A common tendency to over-estimate the risk of teratogenic medications was evident.

Supporting patients with long-term conditions in the community: Evaluation of the Greater Manchester Community Pharmacy Care Plan Service.

The Greater Manchester Community Pharmacy Care Plan (GMCPCP) service provided tailored care plans to help adults with one or more qualifying long-term condition (hypertension, asthma, diabetes and COPD) to achieve health goals and better self-management of their long-term conditions. The service ran between February and December 2017. The aim of this study was to investigate the impact of the service on patient activation, as measured by the PAM measure (primary outcome). Secondary outcomes included quality of life (EQ-5D-5L, EQ-VAS), medication adherence (MARS-5), NHS resource use and costs, systolic and diastolic blood pressure, HDL cholesterol ratio levels and body mass index (BMI). A before and after design was used, with follow-up at 6-months. A questionnaire was distributed at follow-up and telephone interviews with willing participants were used to investigate patient satisfaction with the service. The study was approved by the University of Manchester Research Ethics Committee. Quantitative data were analysed in SPSS v22 (IBM). A total of 382 patients were recruited to the service; 280 (73%) remained at follow-up. Ten patients were interviewed and 43 completed the questionnaire. A total of 613 goals were set; mean of 1.7 goals per patient. Fifty percent of goals were met at follow-up. There were significant improvements in PAM, EQ-5D-5L and EQ-VAS scores and significant reductions in systolic blood pressure, BMI and HDL cholesterol ratio at follow-up. Mean NHS service use costs were significantly lower at follow-up; with a mean decrease per patient of £236.43 (±SD £968.47). The mean cost per patient for providing the service was £203.10, resulting in potential cost-savings of £33.33 per patient (SD ± 874.65). Questionnaire respondents reported high levels of satisfaction with the service. This study suggests that the service is acceptable to patients and may lead to improvements in health outcomes and allows for modest cost savings. Limitations of the study included the low response rate to the patient questionnaire.

Independent prescribing in primary care: A survey of patients', prescribers' and colleagues' perceptions and experiences.

Besides doctors and dentists, an increasing range of healthcare professionals, such as nurses, pharmacists and podiatrists, can become independent prescribers (IPs). As part of an evaluation for independent prescribing funded training, this study investigated views and experiences of IPs, their colleagues and patients about independent prescribing within primary care. Questionnaires capturing quantitative and qualitative data were developed for IPs, their colleagues and patients, informed by existing literature and validated instruments. IPs were identified following independent prescribing training funded by Health Education England Northwest in 2015-2017. Quantitative data were analysed using descriptive statistics and qualitative data were analysed thematically. Twenty-four patients, 20 IPs and 26 colleagues responded to the questionnaires. Most patient respondents had a long-term medical condition (n = 17) and had regular medicines prescribed (n = 21). IPs were nurses (n = 14), pharmacists (n = 4), one podiatrist (n = 1) and one was unknown. Half of the IPs were current prescribers (n = 10), the other half were still training (to become) IPs (n = 10). Colleague respondents were doctors and nurses (n = 15) other healthcare professionals (n = 8) and practice managers (n = 3). Both current IPs (n = 9) and colleague respondents (n = 25) (strongly) agreed that independent prescribing improved the quality of care provided for patients. Nearly all colleagues were supportive of independent prescribing and believed that they worked well with IPs (n = 25). Patients' perceptions and experiences of their consultations with the IP were mostly positive with the vast majority of respondents (strongly) agreeing that they were very satisfied with their visit to the IP (n = 23). Key barriers and enablers to independent prescribing were centred on IPs' knowledge, competence and organisational factors such as workload, effective teamwork and support from their colleagues. Findings from this study were mainly positive but indicate a need for policy strategies to tackle longstanding barriers to independent prescribing. However, a larger sample size is needed to confirm findings.

Extending the scope of community pharmacists' practice to patients requiring urgent care - An evaluation of a training programme using the Theoretical Domains Framework.

Redesigned health systems could meet the rising demand for healthcare, with community pharmacy currently an underused resource for the treatment and management of patients requiring urgent care. This study aimed to investigate whether a training intervention delivered over 2 days to community pharmacists resulted in behaviour and practice change. Validated measures of psychological motivation and capability factors relevant to understanding behaviour and behaviour change were collected 1 week before, 1 week after and 2 months after training in a non-controlled before and after study design. Two targeted behaviours of the intervention were the primary outcome measures: taking a structured history and applying clinical examination techniques to patients requiring urgent care. Secondary outcomes measured participants' reported patient management behaviours to investigate possible bridging of gaps in the health system. Training was provided in 14 locations in the UK to 258 community pharmacists, with data collection occurring from July 2015 to September 2016. In total, 81 participants completed all three rounds of data collection (31.4%). Findings suggest that 1-week post-training significant changes in psychological capability had taken place, and that these were sustained 2 months later: of the eight domains influencing behaviour and stimulating behaviour change, knowledge, skills, professional role, beliefs about capabilities and goals all increased significantly between T1 and T2, and T1 and T3 (all p < 0.0001). At T3, participants were more likely to have taken a structured history than performed a clinical examination, and reported both managing patients themselves and changing referral practices to other healthcare providers. Participants reported workload and the need for liability insurance as structural and contextual barriers to implementation. While findings suggest the potential to transform models of care through training to extend community pharmacists' practice these barriers to successful implementation of the urgent care service would need to be addressed if this service is rolled out nationally.

Level Versus Uphill Economy and Mechanical Responses in Elite Ultra-Trail Runners.

AIM: The purpose of this brief report was to examine the net oxygen cost, oxygen kinetics, and kinematics of level and uphill running in elite ultra-trail runners. METHODS: Twelve top-level ultra-distance trail runners performed two 5-minute stages of treadmill running (level, 0%, men 15 km·h-1, women 13 km·h-1; and uphill, 12%, men 10 km·h-1, women 9 km·h-1). Gas exchanges were measured to obtain the net oxygen cost and assess oxygen kinetics. Additionally, running kinematics were recorded with inertial measurement unit motion sensors on the wrist, head, belt, and foot. RESULTS: Relationships resulted between level and uphill running regarding oxygen uptake, respiratory exchange ratio, net energy and oxygen cost, as well as oxygen kinetics parameters of amplitude and time delay of the primary phase, and time to reach V̇O2 steady state. Of interest, net oxygen cost demonstrated a significant correlation between level and uphill conditions (r=0.826, p<0.01). Kinematics parameters demonstrated relationships between level and uphill running as well (including contact time, aerial time, stride frequency, and stiffness; all p<0.01). CONCLUSION: This study indicated strong relationships between level and uphill values of net oxygen cost, the time constant of the primary phase of oxygen kinetics, and biomechanical parameters of contact and aerial time, stride frequency, and stiffness in elite mountain ultra-trail runners. These results show that these top-level athletes are specially trained for uphill locomotion at the expense of their level running performance and suggest that uphill running is of utmost importance for success in mountain ultra-trail races.

What's Important to the Patient? Informational Needs of Patients Making Decisions About Hepatitis C Treatment.

BACKGROUND AND OBJECTIVES: Multiple treatment options with direct-acting antivirals are now available for hepatitis C virus (HCV). Study aims were to understand (1) the informational topics patients want to have to make informed treatment decisions; (2) the importance patients place on each topic; and (3) the topics patients prioritize as most important. METHODS: We used a mixed-methods study of two samples recruited from an academic liver center. Participants were not currently on treatment. Sample I (n = 45) free listed all informational topics deemed important to decision making. Raw responses were coded into several broad and subcategories. Sample II (n = 38) rated the importance of the subcategories from Sample I and ranked their highest priorities on two surveys, one containing topics for which sufficient research existed to inform patients ('static'), and the other containing topics that would require additional research. RESULTS: The topics listed by Sample I fell into six broad categories with 17 total subcategories. The most oft-cited informational topics were harms of treatment (100%), treatment benefits (62%), and treatment regimen details (84%). Sample II rated 16 of 17 subcategories as "pretty important' or "extremely important". Sample II prioritized (1) viral cure, (2) long-term survival, and (3) side effects on the survey of topics requiring additional research, and (1) liver disease, (2) lifestyle changes, and (3) medication details on the second survey of the most important static topics patients needed. CONCLUSIONS: Patients weighed several informational topics to make an informed decision about HCV treatment. These findings lay the groundwork for future patient-centered outcomes research in HCV and patient-provider communication to enhance patients' informed decision making regarding direct-acting antiviral treatment options.

A review of economic evaluations of diagnostic strategies using imaging in men at risk of prostate cancer.

PURPOSE OF REVIEW: The role of imaging, particularly MRI, in diagnosing clinically significant prostate cancer is the focus of a rapidly developing body of clinical research. We identified five economic evaluations of multiparametric magnetic resonance imaging (mpMRI) for diagnosing prostate cancer which report very different results. This review aims to explain why the reported cost-effectiveness of mpMRI varies so widely. FINDINGS: The studies evaluate the cost-effectiveness of mpMRI within different clinical pathways; before biopsy and after a negative biopsy. Although there were important differences in the questions posed, the studies also employed different assumptions about the impact of prostate cancer and its treatment on survival and quality of life. SUMMARY: This review highlights the need for a better standard of reporting around key modelling assumptions. Also, a wider range of sensitivity analyses should explore the impact of these structural assumptions on the model results, in addition to the more commonly acknowledged uncertainty around data inputs for the model parameters.

Alterations in aerobic energy expenditure and neuromuscular function during a simulated cross-country skiathlon with the skating technique.

Here, we tested the hypothesis that aerobic energy expenditure (AEE) is higher during a simulated 6-km (2 loops of 3-km each) "skiathlon" than during skating only on a treadmill and attempted to link any such increase to biomechanical and neuromuscular responses. Six elite male cross-country skiers performed two pre-testing time-trials (TT) to determine their best performances and to choose an appropriate submaximal speed for collection of physiological, biomechanical and neuromuscular data during two experimental sessions (exp). Each skier used, in randomized order, either the classical (CL) or skating technique (SK) for the first 3-km loop, followed by transition to the skating technique for the second 3-km loop. Respiratory parameters were recorded continuously. The EMG activity of the triceps brachii (TBr) and vastus lateralis (VLa) muscles during isometric contractions performed when the skiers were stationary (i.e., just before the first loop, during the transition, and after the second loop); their corresponding activity during dynamic contractions; and pole and plantar forces during the second loop were recorded. During the second 3-km of the TT, skating speed was significantly higher for the SK-SK than CL-SK. During this second loop, AEE was also higher (+1.5%) for CL-SKexp than SK-SKexp, in association with higher VLa EMG activity during both isometric and dynamic contractions, despite no differences in plantar or pole forces, poling times or cycle rates. Although the underlying mechanism remains unclear, during a skiathlon, the transition between the sections of classical skiing and skating alters skating performance (i.e., skiing speed), AEE and neuromuscular function.

Multiparametric MRI followed by targeted prostate biopsy for men with suspected prostate cancer: a clinical decision analysis.

OBJECTIVE: To compare the diagnostic outcomes of the current approach of transrectal ultrasound (TRUS)-guided biopsy in men with suspected prostate cancer to an alternative approach using multiparametric MRI (mpMRI), followed by MRI-targeted biopsy if positive. DESIGN: Clinical decision analysis was used to synthesise data from recently emerging evidence in a format that is relevant for clinical decision making. POPULATION: A hypothetical cohort of 1000 men with suspected prostate cancer. INTERVENTIONS: mpMRI and, if positive, MRI-targeted biopsy compared with TRUS-guided biopsy in all men. OUTCOME MEASURES: We report the number of men expected to undergo a biopsy as well as the numbers of correctly identified patients with or without prostate cancer. A probabilistic sensitivity analysis was carried out using Monte Carlo simulation to explore the impact of statistical uncertainty in the diagnostic parameters. RESULTS: In 1000 men, mpMRI followed by MRI-targeted biopsy 'clinically dominates' TRUS-guided biopsy as it results in fewer expected biopsies (600 vs 1000), more men being correctly identified as having clinically significant cancer (320 vs 250), and fewer men being falsely identified (20 vs 50). The mpMRI-based strategy dominated TRUS-guided biopsy in 86% of the simulations in the probabilistic sensitivity analysis. CONCLUSIONS: Our analysis suggests that mpMRI followed by MRI-targeted biopsy is likely to result in fewer and better biopsies than TRUS-guided biopsy. Future research in prostate cancer should focus on providing precise estimates of key diagnostic parameters.

Linkage, engagement, and viral suppression rates among HIV-infected persons receiving care at medical case management programs in Washington, DC.

BACKGROUND: The District of Columbia Department of Health funds facilities to provide HIV medical case management (MCM), inclusive of linkage, engagement in care, and treatment adherence support. The objective of this analysis was to identify the differences in the clinical outcomes among HIV-infected persons receiving care at MCM-funded facilities compared with those in nonfunded facilities. METHODS: Newly diagnosed and prevalent HIV-infected persons were identified from the District of Columbia Department of Health surveillance system. Clinical outcomes of interest were linkage, retention in care, and viral suppression. Bivariate analyses and random effects logistic regression were used to examine the differences in demographics and clinical outcomes of persons receiving care at MCM-funded and nonfunded facilities. RESULTS: Among 5631 prevalent cases, 56.7% received care at MCM-funded facilities of which 76.2% were retained in care, and 70.6% achieved viral suppression. Those receiving care in MCM-funded facilities were significantly more likely to be retained in care [adjusted odds ratio (aOR) 4.13; 95% confidence interval (CI): 1.93 to 8.85] and as likely (aOR 1.06; 95% CI: 0.68 to 1.62) to be virally suppressed than persons receiving care in nonfunded facilities. Among 789 newly diagnosed persons, those diagnosed in MCM-funded facilities were not significantly more likely to be linked to care within 3 months (aOR 0.50; 95% CI: 0.21 to 1.18) than those diagnosed in nonfunded facilities. DISCUSSION: This study provides evidence that MCM may be beneficial to HIV-infected persons in DC by improving retention in care. Further identification of the specific services providing the most benefit to clients is needed, including a better understanding of the complex relationship between retention and viral suppression.