Treatment patterns in women with postmenopausal osteoporosis using abaloparatide: a real-world observational study.

Review of medical records from 173 women with osteoporosis who received abaloparatide treatment revealed that 96.0% had at least one visit for osteoporosis management and 55.5% had medication support group access. The most common reasons for discontinuing treatment were financial (31.2%) and tolerability (22.8%). Most patients (64.8%) completed treatment as prescribed. PURPOSE: Abaloparatide is approved for the treatment of women with postmenopausal osteoporosis at high risk for fracture. This study evaluated real-world treatment patterns for patients new to abaloparatide, regardless of osteoporosis treatment history. METHODS: Data for patients with ≥ 1 prescription for abaloparatide were collected retrospectively from six academic and clinical practice settings across the US. RESULTS: A total of 173 patients were enrolled (mean [SD] age, 69.8 [7.4] years). At the time of abaloparatide treatment initiation, 78.6% had received other osteoporosis medications. Mean (SD) time from discontinuation of osteoporosis medications prior to initiation of abaloparatide was 1.7 (3.2) years. Twenty-four months of follow-up data from the initiation date of abaloparatide was collected from 94.0% of patients and 6.0% of patients had 12-24 months of follow-up. During the follow-up period, 96.0% of patients had at least one visit for osteoporosis management and 55.5% had access to a medication support program. The median duration of therapy was 18.6 months and 105/162 (64.8%) completed abaloparatide treatment as prescribed. The most common reasons for treatment discontinuation were financial (31.2%) and tolerability (22.8%). Following completion of a course of treatment with abaloparatide, 82/162 (50.6%) patients transitioned to another osteoporosis medication. The median time between abaloparatide treatment course completion and the initiation of follow-on medication was 21 days. CONCLUSION: Most patients completed treatment with abaloparatide as prescribed, and over half continued with an antiresorptive agent. This favorable conduct may be the result of regular follow-up visits and accessibility to both medication and patient support services.

Magnetic Resonance Fingerprinting to Characterize Childhood and Young Adult Brain Tumors.

OBJECT: Magnetic resonance fingerprinting (MRF) allows rapid, simultaneous mapping of T1 and T2 relaxation times and may be an important diagnostic tool to measure tissue characteristics in pediatric brain tumors. We examined children and young adults with primary brain tumors to determine whether MRF can discriminate tumor from normal-appearing white matter and distinguish tumor grade. METHODS: MRF was performed in 23 patients (14 children and 9 young adults) with brain tumors (19 low-grade glioma, 4 high-grade tumors). T1 and T2 values were recorded in regions of solid tumor (ST), peritumoral white matter (PWM), and contralateral white matter (CWM). Nonparametric tests were used for comparison between groups and regions. RESULTS: Median scan time for MRF and a sequence for tumor localization was 11 min. MRF-derived T1 and T2 values distinguished ST from CWM (T1: 1,444 ± 254 ms vs. 938 ± 96 ms, p = 0.0002; T2: 61 ± 22 ms vs. 38 ± 9 ms, p = 0.0003) and separated high-grade tumors from low-grade tumors (T1: 1,863 ± 70 ms vs. 1,355 ± 187 ms, p = 0.007; T2: 90 ± 13 ms vs. 56 ± 19 ms, p = 0.013). PWM was distinct from CWM (T1: 1,261 ± 359 ms vs. 933 ± 104 ms, p = 0.0008; T2: 65 ± 51 ms vs. 38 ± 8 ms, p = 0.008), as well as from tumor (T1: 1,261 ± 371 ms vs. 1,462 ± 248 ms, p = 0.047). CONCLUSIONS: MRF is a fast sequence that can rapidly distinguish important tissue components in pediatric brain tumor patients. MRF-derived T1 and T2 distinguished tumor from normal-appearing white matter, differentiated tumor grade, and found abnormalities in peritumoral regions. MRF may be useful for rapid quantitative measurement of tissue characteristics and distinguish tumor grade in children and young adults with brain tumors.

Medication Decision-making in Osteoporosis: Can We Explain Why Patients Do Not Take Their Osteoporosis Medications?

Patients at high risk of fracture often do not take medication for osteoporosis. Recent literature may give us some insights into why patients at high risk of fracture do not take medications for osteoporosis.

Improving the legibility of prescription medication labels for older adults and adults with visual impairment.

OBJECTIVES: Most current prescription labels fail to meet print guidelines, especially in print size. We therefore compared the legibility of current prescription medication labels against the legibility of prototype labels, based on current guidelines for legibility. METHOD: Sample medication labels were obtained from pharmacies, and prototype medication labels were developed according to legibility guidelines from nongovernmental organizations and pharmacy organizations. Three groups of participants, consisting of older adults with normal vision, older adults with visual impairment and younger adults with visual impairment (total N = 71) took part. Participants were asked to read and rank the labels. Reading speed and accuracy were determined. RESULTS: Accuracies were high (75%-100%), and there were no significant differences between samples or prototypes or between groups. Prototypes, however, were read faster than samples (p < 0.001). Subjectively, participants preferred the largest print option (p < 0.001) and instructions with the numbers written in highlighted uppercase words (p < 0.001). DISCUSSION: The results indicate that improvements to the label would include larger print size, a consistent layout with left justification and using upper case with highlighting for emphasis of the numbers in the instructions.

Coccidioidomycosis among Workers Constructing Solar Power Farms, California, USA, 2011-2014.

Coccidioidomycosis is associated with soil-disruptive work in Coccidioides-endemic areas of the southwestern United States. Among 3,572 workers constructing 2 solar power-generating facilities in San Luis Obispo County, California, USA, we identified 44 patients with symptom onset during October 2011-April 2014 (attack rate 1.2 cases/100 workers). Of these 44 patients, 20 resided in California outside San Luis Obispo County and 10 resided in another state; 9 were hospitalized (median 3 days), 34 missed work (median 22 days), and 2 had disseminated disease. Of the 25 patients who frequently performed soil-disruptive work, 6 reported frequent use of respiratory protection. As solar farm construction in Coccidioides-endemic areas increases, additional workers will probably be exposed and infected unless awareness is emphasized and effective exposure reduction measures implemented, including limiting dust generation and providing respiratory protection. Medical providers, including those in non-Coccidioides-endemic areas, should suspect coccidioidomycosis in workers with compatible illness and report cases to their local health department.

Fatal meningococcal disease in a laboratory worker--California, 2012.

Occupationally acquired meningococcal disease is rare. Adherence to recommendations for safe handling of Neisseria meningitidis in the laboratory greatly reduces the risk for transmission to laboratory workers. A California microbiologist developed fatal serogroup B meningococcal disease after working with N. meningitidis patient isolates in a research laboratory (laboratory A). The California Department of Public Health (CDPH), the local health department, the California Division of Occupational Safety and Health (CalOSHA), and the federal Occupational Safety and Health Administration (OSHA) collaborated on an investigation of laboratory A, which revealed several breaches in recommended laboratory practice for safe handling of N. meningitidis, including manipulating cultures on the bench top. Additionally, laboratory workers had not been offered meningococcal vaccine in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations and CalOSHA Aerosol Transmissible Diseases Standard requirements. In accordance with OSHA and CalOSHA regulations, laboratory staff members must receive laboratory biosafety training and use appropriate personal protective equipment, and those who routinely work with N. meningitidis isolates should receive meningococcal vaccine.

Validation of the Osteoporosis-Specific Morisky Medication Adherence Scale in long-term users of bisphosphonates.

PURPOSE: To examine the psychometric properties and validity of the 8-item Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS-8) in postmenopausal women prescribed bisphosphonates (BPs) for at least 15 months. METHODS: A random sample of women aged ≥55 years with osteoporosis prescribed daily or weekly BPs was identified. Pharmacy fill data were extracted to calculate the medication possession ratio (MPR). Eligible women were stratified by low (<0.50), medium (0.50-0.79), or high (≥0.80) MPR, with the a priori goal of recruiting 133 participants in each group. OS-MMAS-8 scores can range from 0 to 8 and were categorized as low (<6), medium (6 to <8), and high (8) adherence. Internal consistency reliability (Cronbach's alpha), test-retest reliability [intraclass correlation coefficients (ICCs)] and convergent validity (correlating OS-MMAS-8 with MPR and other self-reported measures) were assessed. RESULTS: A total of 400 women out of 449 respondents reported that they were still taking their BPs at the time of the survey and completed OS-MMAS-8. Overall, 38.5, 34.3, and 27.3% of participants had low, medium, and high OS-MMAS-8 scores, respectively. The mean (SD) MPRs according to OS-MMAS-8 scores (<6, 6 to <8 and 8) were 56.9 (22.6), 69.0 (24.9), and 76.7 (26.4), respectively. The correlation between OS-MMAS-8 and MPR was 0.36; p < 0.0001. Cronbach's alpha was 0.74, and the ICC was 0.83 (95% CI 0.76-0.88). CONCLUSIONS: OS-MMAS-8 has acceptable psychometric properties for assessing medication adherence in postmenopausal women prescribed therapy for osteoporosis. Additional studies are needed to investigate the psychometric properties of OS-MMAS-8 in other settings and populations.

Psychometric properties of the osteoporosis assessment questionnaire (OPAQ) 2.0: results from the multiple outcomes of raloxifene evaluation (MORE) study.

BACKGROUND: We explored psychometric properties of the Osteoporosis Assessment Questionnaire 2.0 in terms of reliability, validity, and responsiveness with generic, clinical, demographic, and preference-based data collected from a population of postmenopausal women with osteoporosis. METHODS: The Multiple Outcomes of Raloxifene Evaluation study was a randomized, placebo-controlled, multinational clinical trial evaluating efficacy and safety of raloxifene. The Osteoporosis Assessment Questionnaire 2.0, a generic quality of life measure (Nottingham Health Profile), and a preference-based measure (Health Utilities Index) were administered at baseline and annually. Psychometric properties of the 14 Osteoporosis Assessment Questionnaire 2.0 domains were evaluated by standard statistical techniques. RESULTS: This study included a subset of 1477 women from the Multiple Outcomes of Raloxifene Evaluation study population completing the questionnaires. Mean (standard deviation) age was 68.4 (6.8) years. Prevalent vertebral fractures were found in 70% (n =1038) of women. Internal consistency was >0.7 in 9 Osteoporosis Assessment Questionnaire 2.0 domains. Correlations were moderate and significant for similar Osteoporosis Assessment Questionnaire 2.0 domain scores, Nottingham Health Profile domains, and Health Utilities Index scores. All but 2 Osteoporosis Assessment Questionnaire 2.0 domains distinguished between patients with or without prevalent vertebral fractures and detected worsening with increased number of vertebral fractures. Women with ≥ 1 incident vertebral fracture generally had a greater worsening in Osteoporosis Assessment Questionnaire 2.0 scores (excluding social activity and support of family and friends) from baseline to study endpoint compared with women without incident vertebral fractures. CONCLUSIONS: Most domains in the Osteoporosis Assessment Questionnaire 2.0 demonstrated robust psychometric properties; however, several domains not showing these criteria may need to be reassessed and removed for a potentially shorter and validated version of the Osteoporosis Assessment Questionnaire.

The legibility of prescription medication labelling in Canada: Moving from pharmacy-centred to patient-centred labels.

INTRODUCTION: The legibility of medication labelling is a concern for all Canadians, because poor or illegible labelling may lead to miscommunication of medication information and poor patient outcomes. There are currently few guidelines and no regulations regarding print standards on medication labels. This study analyzed sample prescription labels from Ontario, Canada, and compared them with print legibility guidelines (both generic and specific to medication labels). METHODS: Cluster sampling was used to randomly select a total of 45 pharmacies in the tri-cities of Kitchener, Waterloo and Cambridge. Pharmacies were asked to supply a regular label with a hypothetical prescription. The print characteristics of patient-critical information were compared against the recommendations for prescription labels by pharmaceutical and health organizations and for print accessibility by nongovernmental organizations. RESULTS: More than 90% of labels followed the guidelines for font style, contrast, print colour and nonglossy paper. However, only 44% of the medication instructions met the minimum guideline of 12-point print size, and none of the drug or patient names met this standard. Only 5% of the labels were judged to make the best use of space, and 51% used left alignment. None of the instructions were in sentence case, as is recommended. DISCUSSION: We found discrepancies between guidelines and current labels in print size, justification, spacing and methods of emphasis. CONCLUSION: Improvements in pharmacy labelling are possible without moving to new technologies or changing the size of labels and would be expected to enhance patient outcomes.

Preventing Aerosol-Transmissible Diseases in Healthcare Settings: The Need for Protective Guidelines and Standards-Workshop Report.

There is an urgent need for stronger protection from aerosol-transmissible diseases in healthcare settings-for workers, patients, volunteers, and visitors. Concerned that the Centers for Disease Control and Prevention (CDC) Healthcare Infection Control Practices Advisory Committee (HICPAC) lacks diversity in expertise and experience and has not consulted widely with all concerned parties regarding a planned update to the 2007 Guideline for Isolation Precautions, a workshop was developed to consider the science and lessons learned before and during the COVID-19 pandemic. Sponsored by the New York/New Jersey Occupational Safety and Health Center, Preventing Aerosol-Transmissible Diseases in Healthcare Settings: The Need for Protective Guidelines and Standards was held on October 13, 2023, with these goals: describe current CDC/HICPAC infection prevention guidelines, review current scientific understanding of aerosol-transmissible pathogens, and consider perspectives from a wide range of groups currently excluded from the CDC HICPAC process.

Use of health-related quality of life measures to predict health utility in postmenopausal osteoporotic women: results from the Multiple Outcomes of Raloxifene Evaluation study.

BACKGROUND: The aim of this study is to examine the associations between health utility (HU), health-related quality of life (HRQoL), and patient characteristics in postmenopausal osteoporotic (PMO) women. METHODS: Baseline data from a subsample of 1,245 participants of the Multiple Outcomes of Raloxifene Evaluation study, a randomized, placebo-controlled, multinational clinical trial to evaluate the safety and efficacy of raloxifene, were analyzed. The study cohort included 694 participants from non-European Union (non-EU) countries and 551 participants from EU countries. All participants with complete baseline HU and HRQoL assessments were included in the following analyses: 1) HU (HUI or EQ-5D) and HRQoL (QualEFFO or OPAQ and NHP) associations; 2) HU variability explained by HRQoL domains; and 3) the percentage of HU variability explained by statistically significant (p < 0.05) HRQoL domains, after adjusting for baseline characteristics. RESULTS: Several domains were significantly associated with HU scores. HU variance was well explained (41% to 61%) by 4 to 6 (p < 0.05) significant HRQoL domains. After controlling for baseline characteristics, 48% to 64% of the HU variance was well explained by 5 to 7 significant (p < 0.05) HRQoL domains. Additional trend analyses detected statistically significant decreases in HRQoL and HU scores with an increased number of vertebral and non-vertebral fractures. CONCLUSIONS: Both disease-targeted and generic HRQoL domains were well correlated with HU. A large percentage (48% to 64%) of the HU variance was explained by HRQoL, after adjusting for baseline characteristics. Both disease-targeted and generic HRQoL measures were significant predictors of HU. HRQoL and HU scores decreased with increased vertebral and non-vertebral fractures.

Public Health Experts Ask CDC Director to Broaden Input on Revisions to Key Infection Control Guidelines.

On July 20, 2023 a letter was sent to the Director of the Centers for Disease Control and Prevention requesting the agency's Healthcare Infection Control Practice Advisory Committee seek input from more stakeholders and the public, recognize the importance of infectious disease transmission by inhalation of human-generated aerosols, and ensure the application of interventions from all levels of the control hierarchy.

HIV pre-exposure prophylaxis and its implementation in the PrEP Impact Trial in England: a pragmatic health technology assessment.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV acquisition. To enable routine commissioning of PrEP in England, we aimed to establish population need, duration of need, PrEP uptake, and duration of use in attendees of sexual health services (SHS) in England. METHODS: The Impact Trial was a prospective, open-label, single-arm, multicentre trial conducted at 157 SHS across England between Oct 13, 2017, and July 12, 2020. Clinicians assessed HIV-negative attendees for their risk of HIV acquisition to identify those who were eligible to participate and receive either daily or event-based oral PrEP (tenofovir disoproxil maleate with emtricitabine), as appropriate. Eligible participants were aged 16 years or older, considered HIV-negative on the day of enrolment, and willing to adhere to the trial procedures. Non-trial attendees are mutually exclusive of trial participants and included SHS attendees who were not recruited to the Impact Trial at any point. They include HIV-negative individuals aged 16 years or older who attended a participating SHS at least once after recruitment at that SHS had begun and before Feb 29, 2020. The main outcomes assessed were PrEP need, uptake, and use, and HIV and sexually transmitted infection (STI) incidence. Data are presented up to Feb 29, 2020, before the introduction of COVID-19 control measures. The study is registered with ClinicalTrials.gov, NCT03253757. FINDINGS: In this analysis, we include 21 356 of 24 268 participants enrolled before Feb 29, 2020. 20 403 participants (95·5%) were men who have sex with men (MSM). Uptake of PrEP among SHS attendees clinically assessed and coded as eligible was 21 292 (57·1%) of 37 289. 18 400 trial participants had at least one post-enrolment visit and a median of 361 days of follow-up (IQR 143-638); 14 039 (75·9%) of these had enough PrEP prescribed to provide protection for 75% of their follow-up time. Among MSM, HIV incidence was 0·13 (95% CI 0·08-0·19) per 100 person-years in trial participants (27 seroconversions) and 0·95 (95% CI 0·88-1·03) per 100 person-years in non-trial attendees (587 seroconversions; proportionate reduction of 86·8%, 95% CI 80·2-91·6). 18 607 bacterial STIs were recorded (incidence 68·1 per 100 person-years in trial participants who were MSM). 4343 (24·4%) MSM participants were diagnosed with two or more STIs, accounting for 14 800 (79·5%) of all 18 607 diagnoses. INTERPRETATION: PrEP need was higher than initially estimated by an expert stakeholder group. The high proportion of follow-up time protected by PrEP suggests that the need for protection persisted throughout trial participation for most participants. HIV incidence among MSM trial participants was low. The large unmet need for PrEP suggests that greater provision is required to maximise the potential of a national programme. The high incidence of bacterial STIs among participants, concentrated within a subgroup of PrEP users, presents an opportunity for tailored STI control measures. FUNDING: NHS England.

Recommendations for defining preventable HIV-related mortality for public health monitoring in the era of Getting to Zero: an expert consensus.

Getting to Zero is a commonly cited strategic aim to reduce mortality due to both HIV and avoidable deaths among people with HIV. However, no clear definitions are attached to these aims with regard to what constitutes HIV-related or preventable mortality, and their ambition is limited. This Position Paper presents consensus recommendations to define preventable HIV-related mortality for a pragmatic approach to public health monitoring by use of national HIV surveillance data. These recommendations were informed by a comprehensive literature review and agreed by 42 international experts, including clinicians, public health professionals, researchers, commissioners, and community representatives. By applying the recommendations to 2019 national HIV surveillance data from the UK, we show that 30% of deaths among people with HIV were HIV-related or possibly HIV-related, and at least 63% of these deaths were preventable or potentially preventable. The application of these recommendations by health authorities will ensure consistent monitoring of HIV elimination targets and allow for the identification of inequalities and areas for intervention.

Psychometric properties of the Osteoporosis-specific Morisky Medication Adherence Scale in postmenopausal women with osteoporosis newly treated with bisphosphonates.

BACKGROUND: Poor adherence to oral osteoporosis medications is common. Strategies for improving adherence begin with identification of the problem. The 8-item Morisky Medication Adherence Scale for self-reported adherence to antihypertensive medications was modified for assessing adherence to oral osteoporosis medications. An evaluation of the measurement properties of the Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS) was needed. OBJECTIVE: To examine the psychometric properties of the OS-MMAS in women with postmenopausal osteoporosis. METHODS: Five hundred women aged 55 years and older with osteoporosis who were newly prescribed daily or weekly oral bisphosphonates between May 15, 2010, and August 15, 2010, were randomly selected from Kaiser Permanente Southern California, a large integrated health care delivery system, and mailed a self-administered survey that included the 8-item OS-MMAS, Self-Efficacy for Appropriate Medication Use Scale (SEAMS), Beliefs about Medicines Questionnaire (BMQ), Treatment Satisfaction Questionnaire for Medication (TSQM), Gastrointestinal Symptom Rating Scale (GSRS), and 12-item Short-Form Health Survey (SF-12v2). OS-MMAS scores can range from 0 to 8, with higher scores indicating better medication adherence. Internal consistency reliability was evaluated using Cronbach α coefficient. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs) in a subset of 102 participants. Construct validity was assessed using confirmatory factor analysis and correlations between OS-MMAS and related measures. RESULTS: Of 197 participants, 150 reported that they were still taking their bisphosphonate at the time of the survey and completed the OS-MMAS. Overall, 30.7%, 32.7%, and 36.7% had low, medium, and high OS-MMAS scores (<6, 6 to <8, and 8, respectively). Cronbach α was 0.82 and the ICC was 0.77. Convergent validity was supported by significant correlations with SEAMS, BMQ necessity, and TSQM scores. In confirmatory factor analysis, a single-factor scale was supported. CONCLUSIONS: The OS-MMAS showed strong psychometric properties with good reliability and construct validity and may provide a valuable assessment of self-reported medication adherence in women newly prescribed oral osteoporosis medications.

A Qualitative Study to Assess US Patient Preferences between new Transdermal System and Injectable Anabolic Therapies for Osteoporosis Treatment.

US patients with osteoporosis included in three focus groups identified efficacy, safety, cost, and convenience as important attributes of treatment when choosing between anabolic therapies with high stated preference for the solid Microstructured Transdermal System. OBJECTIVE: The current study evaluated patient perspective and relative importance of treatment attributes of in-home daily self-administration of abaloparatide-solid Microstructured Transdermal System (sMTS) compared with other anabolic agents (i.e. in-home daily subcutaneous self-injections, and monthly subcutaneous injections at doctor office) among a group of US patients with osteoporosis. METHODS: The current study included systematic literature reviews, experts' consultation and three online patients focus groups (n=27), including patients ≥50 years of age at high risk for fracture. Nominal Group Technique was used by asking patients to (1) Individually identify characteristics that would be important for them when choosing between anabolic treatments, (2) Share ideas and discuss perspectives with other patients, (3) Review additional attributes generated from a systematic literature review, (4) Select and rank individually the 7 most important characteristics from the list and (5) Report their acceptability and stated preference ranking between the three treatment options. RESULTS: Twenty women and 7 men with a mean age of 65 (range 51-85 years) participated in the focus groups. Twenty-four treatment characteristics were identified through focus groups and literature review. Efficacy, safety, out-of-pocket costs, strength of evidence and the option to self-administer were ranked as the most important attributes. The majority of patients stated preference for a daily sMTS if prescribed by their doctor. CONCLUSIONS: This study revealed that efficacy, safety, costs, and convenience are important attributes of osteoporosis treatment for US patients at high risk for fractures when choosing between anabolic therapies, with a high stated preference for sMTS.

Keepers of the House: A documentary.

BACKGROUND: Our documentary, Keepers of the House, highlights ways that hospital housekeepers, typically unnoticed care team members, provide emotional support for patients and their families. This film addresses a gap in education by emphasizing the importance of valuing and reflecting on the unique lived experiences of others. APPROACH: We created this documentary to expose students to the experiences and perceptions of hospital housekeepers. A focus group with six hospital housekeepers informed an interview script for the film's creation. Nine additional housekeepers were then interviewed, which developed into a 15-min documentary. Healthcare students and educators from five disciplines viewed the documentary during their institution's Medical Education Day. EVALUATION: To expose students and educators to housekeepers' experiences, we designed our post-viewing survey to address whether the housekeepers' stories impacted their understanding of the role and value of these workers. Viewers were surprised by the depth and breadth of patient-housekeeper interactions, the trauma housekeepers experienced from patient loss and the pride housekeepers take in their work. The stories that touched the viewers varied but centred on connections between housekeepers and patients. Lessons learned focused on recognizing the contributions of unseen team members. IMPLICATIONS: This innovative documentary amplifies the perspectives of voices rarely heard in healthcare. We aim to use this film, alongside its associated learning session, in education and grand round settings to foster discussion around empathy, valuing underrecognised team members and applying these insights in practice. This work can be disseminated to other institutions, further amplifying underrepresented narratives in healthcare.

Development, reliability, and validity of a new Preference and Satisfaction Questionnaire.

OBJECTIVES: Existing questionnaires that assess preference and/or satisfaction with postmenopausal bone loss treatments were reviewed and determined to be inadequate for the assessment of an oral pill versus a subcutaneous injection. The Preference and Satisfaction Questionnaire (PSQ) was developed to assess preference, satisfaction, and bother with a weekly oral tablet versus a once every 6 months subcutaneous injection for treatment of postmenopausal bone loss. METHODS: Questions were developed based on literature review and expert input. Content validity of the PSQ in this patient population was assessed among current or previous bisphosphonate users in group interviews, and item comprehension and readability were also evaluated. Reliability, validity, and structure of the questionnaire were assessed in two phase 3 randomized clinical trials. RESULTS: Twenty-four women participated in cognitive interviews and found the PSQ understandable and acceptable. Subsequently, 1583 trial participants took the PSQ. Interitem correlations, ranging from 0.50 to 0.97 for preference items, 0.85 to 0.94 for pill-satisfaction items, and 0.84 to 0.92 for injection-satisfaction items, and a well-fitting confirmatory factor analysis (root mean square error of approximation 0.04, nonnormed fit index 0.99, and root mean square residual 0.08) supported the structure of the instrument. Cronbach's alpha reliability values for pill satisfaction, injection satisfaction, pill bother, and injection bother were 0.93, 0.89, 0.82, and 0.61, respectively. Discriminative validity was indicated with better satisfaction and bother scores being related to adherence and the absence of adverse events. CONCLUSIONS: The PSQ is a valid and reliable measure and may be a valuable tool to assess patient preference and satisfaction with a weekly oral tablet and 6-month subcutaneous injection for postmenopausal bone loss.

Growing up with sickle cell disease: a pilot study of a transition program for adolescents with sickle cell disease.

We implemented the Duke Sickle Cell Disease (SCD) Transition Program for adolescents with SCD and investigated the knowledge about SCD; concerns and emotions about transitioning; and the initial impact of the Transition Program. Thirty-three adolescents participated in the initial study. Gaps in knowledge included ethnicities affected by SCD and inheritance of SCD. Adolescents were primarily concerned about transferring to a new medical team. There was a mix of both positive and negative emotions that varied over time. Overall, we have identified educational gaps and concerns and emotions about transitioning, which we will address through the Duke SCD Transition Program.

Abaloparatide Real-World Patient Experience Study.

Despite the availability of various osteoporosis treatments, adherence remains suboptimal. One contributing factor may be patient experience with therapy. This US, multicenter, combined retrospective chart review and patient questionnaire study included postmenopausal women at high risk for fracture and is the first study to describe real-world patient experience with abaloparatide (ABL) injection. Eight geographically diverse secondary care sites in the United States participated (n = 193). Mean ± SD age was 67.4 ±8.62 years. Most patients (86%) were satisfied with the ABL regimen, especially with ease of preparation (82%), ease of storage (87%), and storage convenience (89%), an attribute 83% of the patients thought was important. The majority of patients reported complete satisfaction with the ABL regimen allowing for their ability to conduct daily activities (85%) and convenience to fit into their daily schedule (84%). All reported taking ABL as directed, by injection in the lower abdomen, and 83% of patients reported medium or high adherence. Patients were satisfied with the needle size (76% completely satisfied), and 93% reported never deliberately missing a dose. Although injecting medication (18%) and higher out-of-pocket costs (17%) were deemed the most bothersome attributes, the majority (69%) noted their healthcare team understands how osteoporosis impacts their lives. In multivariable analyses, ease of preparation (OR = 2.62; 95% CI, 1.01-6.81; p = 0.048) and fracture history (OR = 1.72; 95% CI, 1.03-2.86; p = 0.037) were significantly associated with overall satisfaction. Ease of preparation was a predictor of higher satisfaction with treatment convenience (coefficient = 13.60; 95% CI, 8.08-19.12; p = 0.00). Remembering to take the medication was a significant predictor of self-reported adherence (OR = 16.66; 95% CI, 3.30-84.24; p = 0.001). In conclusion, the majority of patients were satisfied with ABL and found it convenient/easy to prepare and store. High self-reported adherence may be associated with positive patient experience including ease of use and adequate support from healthcare providers. © 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC. on behalf of American Society for Bone and Mineral Research.