Recent publications
Background
Psychological safety is critical to early and continued engagement with healthcare providers, yet no studies have explored this concept in relationship to cancer care. Black/African American (“Black”) individuals experience disparities in breast and ovarian cancer beyond what can be explained biologically.
Aims
We explored factors influencing psychological safety among Black breast and ovarian cancer patients and their family members.
Methods
Socioeconomically diverse patients with a personal diagnosis or family history of breast and/or ovarian cancer were invited to complete a semi‐structured qualitative interview on their cancer and healthcare experiences between September 2020 and April 2021. Informed by principles of grounded theory, interview transcripts were qualitatively analyzed for thematic content related to psychological safety.
Results
Black breast and ovarian cancer patients and their family members described personal and community experiences and structural components of the healthcare system that suggested they may receive differential cancer care due to their race, placing them on guard. This posture was mediated by several self‐identified factors that added to or detracted from their comfort, including provider racial and gender concordance in healthcare, personalized care, and effective communication. The priorities and perceptions of care in participants receiving care in safety net clinics were more focused on what was feasible given resource limitations rather than what was ideally desired.
Conclusions
Implementation of strategies to promote psychological safety with Black cancer patients may foster improved patient experiences, as well as encourage early screening, patient engagement, and treatment continuation.
Learning from past pandemics is essential for addressing future threats. Our analysis of the coronavirus disease of 2019 (COVID-19) pandemic in Jordan highlights key epidemiological trends, government responses, and the impact of viral variants. Jordan experienced four significant epidemic waves, each with distinct patterns in daily cases and deaths influenced by viral evolution, vaccination efforts, and containment measures. The government’s early strict measures initially delayed community transmission, but later relaxations led to sustained spread. Vaccination began in January 2021, successfully including refugees, and significantly reduced deaths, though its effect on infection rates is still debated. Genomic analysis identified dominant variants, such as B.1.1.312 and B.1.617.2, throughout the waves. This study underscores the need to understand the role of viral variants in disease dynamics for effective pandemic preparedness and offers insights into best practices for managing future health crises.
Hepatitis D virus leads to a severe form of viral hepatitis and affects nearly 5% of people living with chronic hepatitis B. Chronic infection with hepatitis D virus leads to more rapid progression to cirrhosis, hepatocellular carcinoma and ultimately liver disease‐related death compared with hepatitis B monoinfection. Health outcomes and treatment adherence can be affected by patient perception of, engagement in, and satisfaction with care. Our objective was to better understand the experiences of people with chronic hepatitis D, identify their preferred sources of information, and recognise unmet needs from their perspectives. Sixty‐seven participants from the United States and the European Union took part in monthly, online, self‐guided surveys for a minimum of 3 months with an optional extension. Participants reported feeling anxious and scared at the time of diagnosis but over time came to accept living with chronic hepatitis D. They voiced a need for access to information from trusted sources, fewer barriers to care, and shorter wait times for provider visits and test results after diagnosis. Participants experienced both physical and psychological strain living with chronic hepatitis D. Although most participants reported the ability to continue their regular activities and employment, some stated such activities were done at a reduced pace. Self‐reported overall health appeared to be closely linked with emotional support. Understanding patient perspectives, with concurrent clinician perspectives, is crucial when working toward developing solutions to fulfil unmet patient needs associated with chronic hepatitis D management and advancing health equity.
In the Perspective, William Burman and colleagues advocate improving the safety and acceptability of treatment, rather than treatment-shortening, of rifampin-susceptible tuberculosis.
Background
Data on the incidence and risk of opportunistic fungal infections (OFIs), rare yet life-threatening infections in rheumatoid arthritis (RA) patients[1], remain scarce due to limited patient numbers and inconsistent case definitions.
Objectives
To investigate associations between demographic and clinical characteristics, treatment, and the development of OFI in RA patients.
Methods
Data were obtained from the German biologics register RABBIT, which includes adult RA patients starting a new treatment with a biologic (b) or targeted synthetic (ts) disease-modifying anti-rheumatic drug (DMARD) or a conventional synthetic (cs) DMARD after at least one csDMARD failure. Fungal infections reported between 05/2001 and 12/2022 were considered opportunistic when meeting the consensus definitions by Winthrop et al.[2] or when causing esophagitis. Patients who had developed an OFI were matched 1:5 to RA controls by age and enrolment year. Associations between OFI development and patient characteristics at last visit prior to mycosis onset (see Table 1) were assessed using multivariable logistic regression, analysing sex, smoking history, disease duration, glucocorticoid (GC) use, disease activity (DAS28-ESR), sum of comorbidities predisposing for infection (malignancies, diabetes mellitus, kidney disease, lung disease, autoimmune disease, liver disease, blood count disorder), therapy with b/tsDMARDs, number of previous DMARDs, and type of enrolling institution. Multiple imputation of missing values was performed.
Results
Among 20,907 RA patients contributing 101,778 patient-years (PY) to RABBIT, 105 developed an OFI (1.03/1,000 PY), caused by Candida ssp. (60 %), Pneumocystis jirovecii (20 %), Aspergillus ssp. (7 %), and unknown fungal genus (13 %). Nineteen patients died from or with infection (18 % of all OFIs and 34 % of 56 invasive OFIs). Higher disease activity (OR 1.18, 95% CI: 1.01 – 1.37 per point of DAS28-ESR), a daily prednisolone-equivalent dose of > 5 mg (OR 2.11, 95% CI:1.16 – 3.82), smoking history among men (OR 2.69, 95% CI:1.58 – 4.59), a higher number of relevant comorbidities (OR 1.62, 95% CI: 1.29 – 2.03 per additional comorbidity), and type of enrolling institution (OR for clinic vs. practice: 1.39, 95% CI: 1.00 – 1.92) were associated with a higher odds of OFIs (see Figure 1).
Conclusion
Our study underlines the rarity of OFIs in RA patients, yet revealing a notable mortality. The development of OFIs was associated with higher disease activity, GC use > 5 mg per day, smoking history among men, and a higher number of relevant comorbidities. Further research is essential to investigate the risk profile by DMARD class, enhancing our understanding of potential causal relationships.
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REFERENCES
[1] PMID: 27032792.[2] PMID: 26395500.
Acknowledgements
RABBIT is currently supported by a joint, unconditional grant from AbbVie, Amgen, BMS, Celltrion, Fresenius Kabi, Galapagos, Hexal, Lilly, MSD, Pfizer, Samsung Biogen, Sanofi, Biocon, UCB and previously by Roche.
Disclosure of Interests
Alina Purschke: None declared, Martin Schaefer: None declared, Bernhard Manger Abbvie, Alexion, Astra-Zeneca, EUSA, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Pharming, EUSA, Vifor, Matthias Schneider AstraZeneca, GSK, Pfizer, Abbvie, AstraZeneca, GSK, Otsuka, UCB, AstraZeneca, GSK, Martin Feuchtenberger Abbvie, Novartis, Rheumaakademie, Abbvie, Biogen, BMS, Boehringer, Lilly, MSD, Novartis, Pfizer, Charlotte Moebius UCB, Pfizer, Lilly, UCB, Pfizer, Lilly, Anja Strangfeld AbbVie, Biogen, Galapagos, Janssen, Lilly, Pfizer, Takeda.
Background
TNFi biosimilars are increasingly prescribed as treatments of rheumatoid arthritis (RA) in Germany. Reliable information on their efficacy and safety in everyday practice used to be sparse, but is now becoming increasingly available [1],[2].
Objectives
To compare drug retention between TNFi biosimilars (BS) and bio-originals (BO) for each active substance adalimumab (ADA), etanercept (ETN) and infliximab (IFX).
Methods
Data was used from the German biologics register RABBIT, including adult RA patients initiating a new biologic (b) or targeted synthetic (ts) disease-modifying anti-rheumatic drug (DMARD) or a conventional synthetic (cs) DMARD after at least one csDMARD failure. Treatment episodes of ADA, ETN and IFX were evaluated from the calendar year following EU marketing authorization of the first respective BS until June 2023 (Table 1). Drug retention was analyzed with Kaplan-Meier curves. Additionally, hazard ratios (HR) for treatment discontinuation were calculated with unadjusted and adjusted Cox-based regression (Andersen-Gill). Adjustment factors included age, sex, disease duration, DAS28-ESR, number of previous b/tsDMARDs, concomitant glucocorticoid (GC) use, sum of comorbidities, BMI, smoking, educational level and employment status. In the regression analysis, treatment discontinuation was only considered when resulting from adverse events (including death), treatment failure or non-compliance. Treatment episodes that terminated for other reasons were censored at the end of the episode. The respective BO treatment served as reference group for presenting HR.
Results
Patients with BS treatment were quite similar to patients with the respective BO, but had a shorter disease duration and less prior treatment failures (Table 1). No discernible differences were observed in the unadjusted Kaplan-Meier curves for ETN and IFX (Figure 1). For ADA BO, the drug retention probabilities seemed to be lower (Figure 1). Estimated HR for discontinuation from the unadjusted Cox regression, with the BO as reference, yielded similar results (ADA: 0.83 [0.69-0.99], ETN: 0.96 [0.82-1.12], IFX: 1.02 [0.71-1.46]). Using the adjusted model, no significant differences were found in any of the groups. HR for discontinuation were 0.92 [0.76-1.10] for ADA, 1.02 [0.86-1.20] for ETN and 1.12 [0.76-1.65] for IFX.
Conclusion
After adjusting for differences in patient characteristics, TNFi BS and BO do not show a significant difference in drug retention. These results are in line with the findings of other observational studies and strengthen the current perspective on the equivalence of BS with their BO. Possible limitations are the considerably lower numbers of treatment episodes in the BO groups compared to BS.
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Figure 1. Kaplan-Meier curves of bio-originals and biosimilars for adalimumab, etanercept and infliximab
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Table 1. Patient characteristics at start of bio-original (BO) or biosimilar (BS) treatment for adalimumab (ADA), etanercept (ETN) and infliximab (IFX), values are given as counts (%) or mean ± SD
REFERENCES
[1] PMID: 34919663[2] PMID: 36943379
Acknowledgements
RABBIT is currently supported by a joint, unconditional grant from AbbVie, Amgen, BMS, Celltrion, Fresenius Kabi, Galapagos, Hexal, Lilly, MSD, Pfizer, Samsung Biogen, Sanofi, Biocon, UCB and previously by Roche.
Disclosure of Interests
Franziska Frederking: None declared, Malte Kramer Bayer, Joern Kekow: None declared, Marc Schmalzing BMS, Novartis, AbbVie, AstraZeneca, Chugai/Roche, Janssen-Cilag, Gilead, Boehringer Ingelheim, Mylan, onkowissen.de, Galapagos, EUSA Pharma, Chugai/Roche, Hexal/Sandoz, Gilead, AbbVie, Janssen-Cilag, Boehringer Ingelheim, onkowissen.de, EUSA Pharma, Novartis, AstraZeneca, Amgen, medac, Lilly, Galapagos, UCB, Chugai, Novartis, Henry Fricke-Wagner: None declared, Anja Strangfeld AbbVie, Biogen, Galapagos, Janssen, Lilly, Pfizer, Takeda.
Background
Currently, there are more than two million people in prisons or jails, with nearly two-thirds meeting the criteria for a substance use disorder. Following these patterns, overdose is the leading cause of death following release from prison and the third leading cause of death during periods of incarceration in jails. Traditional quantitative methods analyzing the factors associated with overdose following incarceration may fail to capture structural and environmental factors present in specific communities. People with lived experiences in the criminal legal system and with substance use disorder hold unique perspectives and must be involved in the research process.
Objective
To identify perceived factors that impact overdose following release from incarceration among people with direct criminal legal involvement and experience with substance use.
Methods
Within a community-engaged approach to research, we used concept mapping to center the perspectives of people with personal experience with the carceral system. The following prompt guided our study: “What do you think are some of the main things that make people who have been in jail or prison more and less likely to overdose?” Individuals participated in three rounds of focus groups, which included brainstorming, sorting and rating, and community interpretation. We used the Concept Systems Inc. platform groupwisdom for our analyses and constructed cluster maps.
Results
Eight individuals (ages 33 to 53) from four states participated. The brainstorming process resulted in 83 unique factors that impact overdose. The concept mapping process resulted in five clusters: (1) Community-Based Prevention, (2) Drug Use and Incarceration, (3) Resources for Treatment for Substance Use, (4) Carceral Factors, and (5) Stigma and Structural Barriers.
Conclusions
Our study provides critical insight into community-identified factors associated with overdose following incarceration. These factors should be accounted for during resource planning and decision-making.
More young people are living in the world than ever before, 90% of whom reside in low and middle income countries (LMICs). To address their needs, it is critical to have sustainable youth engagement when determining policy and to advance effective implementation of youth-focused interventions. Youth Community Advisory Boards (CABs) are a sustainable mechanism to achieve this goal. This paper describes engagement with youth CAB members across four locations in Tanzania. To set youth CAB meeting agendas and priorities, we asked youth CAB members to write (using free text) the top five challenges faced by young people in their communities (highest to lower priority). The Google Forms survey link was presented at the May 2023 youth CAB meeting and disseminated through WhatsApp. The survey was completed by smartphone, tablet, or paper provided to the youth liaison for data entry. Results were translated from Swahili to English and coded using excel. Findings were then presented back to the youth CABs at the September 2023 meeting. At that meeting, youth CAB members were then asked to write (free text) potential solutions to the most commonly described challenges. The surveys had response rates of 90% (84/93) for challenges and 78% (71/93) for solutions. The number one reported challenge was unemployment and financial instability (45%). Gender based violence (13%), sexual reproductive health issues (8%), and alcohol and drug use (8%) were in the top four both by priority and frequency of report. Other important challenges included physical and mental health, malnutrition, relationships, education, and societal and environmental norms, among others. Solutions included job creation, improved education, expanded legal systems, youth-friendly health care services, and increased social support through peer networks and community support. The National Accelerated Action and Investment Agenda for Adolescent Health and Wellbeing (NAIA-AHW) 2021/22-2024/25 includes most, but not all, of these top challenges and solutions. Ensuring young people have a seat at the policy table is critical to effective youth-empowerment in health and other related programs. Including a youth CAB member to represent this collective in youth-related government activities is a sustainable model to achieve this goal.
Background
Care complexity can occur when patients experience health challenges simultaneously with social barriers including food and/or housing insecurity, lack of transportation or other factors that impact care and patient outcomes. People with rheumatoid arthritis (RA) may experience care complexity due to the chronicity of their condition and other biopsychosocial factors. There are few standardised instruments that measure care complexity and none that measure care complexity specifically in people with RA.
Objectives
We assessed the content validity of the INTERMEDS Self‐Assessment (IMSA) instrument that measures care complexity with a sample of adults with RA and rheumatology healthcare providers (HCPs). Cognitive debriefing interviews utilising a reparative framework were conducted.
Methods
Patient participants were recruited through two existing studies where participants agreed to be contacted about future studies. Study information was also shared through email blasts, posters and brochures at rheumatology clinic sites and trusted arthritis websites. Various rheumatology HCPs were recruited through email blasts, and divisional emails and announcements. Interviews were conducted with nine patients living with RA and five rheumatology HCPs.
Results
Three main reparative themes were identified: (1) Lack of item clarity and standardisation including problems with item phrasing, inconsistency of the items and/or answer sets and noninclusive language; (2) item barrelling, where items asked about more than one issue, but only allowed a single answer choice; and (3) timeframes presented in the item or answer choices were either too long or too short, and did not fit the lived experiences of patients. Items predicting future healthcare needs were difficult to answer due to the episodic and fluctuating nature of RA.
Conclusions
Despite international use of the IMSA to measure care complexity, patients with RA and rheumatology HCPs in our setting perceived that it did not have content validity for use in RA and that revision for use in this population under a reparative framework was unfeasible. Future instrument development requires an iterative cognitive debriefing and repair process with the population of interest in the early stages to ensure content validity and comprehension.
Patient or Public Contribution
Patient and public contributions included both patient partners on the study team and people with RA who participated in the study. Patient partners were involved in study design, analysis and interpretation of the findings and manuscript preparation. Data analysis was structured according to emergent themes of the data that were grounded in patient perspectives and experiences.
In the United States, 21 million adults are diagnosed with depression. Couple therapy effectively treats depression, however, couples encounter access barriers. The Relationship Checkup is an assessment and feedback intervention delivered in participants' homes. The current study examines changes in relationship satisfaction and depressive symptoms, and moderators and mechanisms of change in a community sample ( N = 85 couples). Changes in depressive symptoms and satisfaction, and the association between changes in satisfaction and depressive symptoms were examined with multilevel modeling. Depressive symptoms (Cohen's d = 0.36) and satisfaction ( d = 1.43) improved from baseline to 1‐month follow‐up, with greater declines in depression ( d = 0.44) for those with more severe symptoms. Increases in satisfaction were associated with decreases in depressive symptoms ( d = 0.23), and decreases in depressive symptoms were associated with increases in satisfaction ( d = 0.33). Individuals with depression and relationship distress may be well served by this intervention.
Most ongoing and planned TB therapeutic trials are focused on shortening the duration of treatment while giving less consideration to other aspects of TB care that are important to people with TB. Here we argue that other variables besides duration of TB treatment should also be considered when developing new TB treatment regimens, including drug toxicity, time spent in monitoring and overall quality of life while on therapy. We examine the specific use of linezolid in treatment-shortening trials for drug-susceptible TB and propose additional endpoints that should be prioritised in TB treatment studies.
Background: Cisgender women represent over half of people living with HIV globally. However, current research efforts toward a cure for HIV focus predominantly on cisgender men. The under-representation of women in HIV cure clinical studies is particularly problematic given data suggesting that sex-dependent phenotypes
limit scientific discovery.
Objective: We aimed to generate considerations to increase the meaningful involvement of women in HIV cure-related research.
Materials and methods: We conducted in-depth interviews with biomedical researchers and community members to better understand factors that could increase the meaningful involvement of women in HIV cure clinical trials. Participants were affiliated with academia, industry, community advisory boards, and community-based organizations, and were identified using listings from the AIDS Clinical Trials Group and the Martin Delaney Collaboratories. We used conventional content analysis to analyze the qualitative data.
Results: We recruited 27 participants, of whom 11 were biomedical researchers and 16 were community members. Participants included 25 cisgender women, 1 transgender woman, and 1 cisgender man. Key considerations emerged, including the need to ensure that HIV cure studies reflect HIV epidemiologic trends and having accurate representation by sex and gender in HIV cure research. To increase the meaningful involvement of women, recommendations included instituting intentional enrollment goals, frequent and mandatory reporting on enrollment, and incentives for sites to enroll women. Additional themes included the need for agency and self-determination, attention to lived experiences, trauma and healing, and
adequate support for women (e.g. logistical, psychosocial, mental, emotional, and physical). Participants noted that women would be willing to participate in HIV cure trials, related procedures (e.g. biopsies), and analytical treatment interruptions. They also expressed a desired for women-centered and holistic clinical trial
designs that account for intersectionality.
Conclusions: Our empirical inquiry extends recent calls to action to increase diversity of people involved in HIV cure research. Redressing the under-inclusion of women in HIV cure research is an urgent imperative. The entire field must mobilize and reform to achieve this goal. Meaningfully involving women across the gender
spectrum in HIV cure research is needed to ensure that interventions are safe, effective, scalable, and acceptable for all people with HIV.
Importance:
Black men have a higher risk of prostate cancer compared with White men, but Black adults are underrepresented in online content about prostate cancer. Across racial groups, the internet is a popular source of health information; Black adults are more likely to trust online health information, yet have more medical mistrust than White adults.
Objective:
To evaluate the association between racial representation in online content about prostate cancer and trust in the content and identify factors that influence trust.
Design, setting, and participants:
A randomized clinical trial was conducted from August 18, 2021, to January 7, 2022, consisting of a 1-time online survey. Participants included US men and women aged 40 years and older. Data were analyzed from January 2022 to June 2023.
Interventions:
Participants were randomized to watch the same video script about either prostate cancer screening or clinical trials presented by 1 of 4 speakers: a Black physician, a Black patient, a White physician, or a White patient, followed by a questionnaire.
Main outcomes and measures:
The primary outcome was a published scale for trust in the information. χ2 tests and multivariable logistic regression were used to compare trust according to the video's speaker and topic.
Results:
Among 2904 participants, 1801 (62%) were men, and the median (IQR) age was 59 (47-69) years. Among 1703 Black adults, a greater proportion had high trust in videos with Black speakers vs White speakers (72.7% vs 64.3%; adjusted odds ratio [aOR], 1.62; 95% CI, 1.28-2.05; P < .001); less trust with patient vs physician presenter (64.6% vs 72.5%; aOR, 0.63; 95% CI, 0.49-0.80; P < .001) and about clinical trials vs screening (66.3% vs 70.7%; aOR, 0.78; 95% CI, 0.62-0.99; P = .04). Among White adults, a lower proportion had high trust in videos featuring a patient vs physician (72.0% vs 78.6%; aOR, 0.71; 95% CI, 0.54-0.95; P = .02) and clinical trials vs screening (71.4% vs 79.1%; aOR, 0.57; 95% CI, 0.42-0.76; P < .001), but no difference for Black vs White presenters (76.8% vs 73.7%; aOR, 1.11; 95% CI, 0.83-1.48; P = .49).
Conclusions and relevance:
In this randomized clinical trial, prostate cancer information was considered more trustworthy when delivered by a physician, but racial concordance was significantly associated with trust only among Black adults. These results highlight the importance of physician participation and increasing racial diversity in public dissemination of health information and an ongoing need for public education about clinical trials.
Trial registration:
ClinicalTrials.gov Identifier: NCT05886751.
Background:
Advancing health equity requires innovative patient education approaches for adapting English-language evidence-based interventions (EBIs) to resonate with multicultural, multilingual audiences.
Objective:
Examine the benefit, functionality, and practical considerations of transcreation (translation + cultural adaptation) as a critical and salient learner-centric process for developing a Spanish-language intervention (photonovella + video): Un examen sencillo para un colon saludable (A simple test for a healthy colon).
Patient/community involvement:
We involved patients/community members in a participatory reflective process, from problem identification to intervention design, development, delivery, and impact measurement.
Methods:
A community-based participatory research (CBPR) approach involving formative research plus systematic iterative pretesting and learner verification checks augmented by a community advisory board guided the transcreation processes.
Results:
Data collected using a learner-centric approach effectively produced a new Spanish-language EBI and substantiated the value of co-learner/co-design methods. Learner-centric methods identified cultural nuances that were treated as knowledge and integrated into the intervention materials and study design. Pilot testing of the intervention among Latinos receiving care at community clinics demonstrated improved initial colorectal cancer screening uptake, awareness, and perceived susceptibility.
Discussion:
Inherent in the transcreation process was learner involvement that informed essential modification and adaptation of the materials. The transcreation methods led to the development of a culturally salient intervention that maintained theoretical integrity and message intent as well as behavioral activation. Findings have broad implications for the creation and transfer of EBIs to new audiences for greater adoption, engagement, and 'reach' of interventions.
Practical value:
Transcreation aligns with a growing paradigm shift in health communication science that brings to light the beneficial effect that construction and application of cultural knowledge has on patient education toward health equity.
Background
Interstitial lung disease (ILD) is one of the most common extra-articular manifestations of rheumatoid arthritis (RA) with a high mortality risk. Only few studies examined the association between RA treatment and mortality in patients with RA-ILD, and these studies do not include all available DMARDs and tend to be of poor quality [1].
Objectives
To investigate the impact of treatment on all-cause mortality in patients with RA-ILD taking inflammation, traditional risk factors and comorbidities into account.
Methods
RA patients enrolled and observed in the biologics register RABBIT between 01/2007 and 10/2021 with an ILD, reported either at enrolment or during follow-up, were selected for the analysis. Observation started at the time of ILD reporting (= baseline) death, dropout or end of follow-up, whichever came first. Time-varying cox regression (= main model) was applied, taking into account all treatment exposures and covariates on a monthly basis (Figure 1). Sensitivity analyses comprised two alternative treatment exposures: a cumulative model (calculated as cumulative exposure in months for every treatment divided by total months of observation time), and an intention-to-treat model (treatment at baseline as exposure). Missing data was imputed 10 times. All models were adjusted by inverse probability weighting and number of comorbidities as covariate.
Results
Out of 15,566 cohort participants, 381 patients were identified as prevalent ILD cases. The total observed time was 1,258 person years, and 97 patients (25 %) died.Patients exposed to T cell co-stimulation modulator (T cell), B cell targeted therapy (B cell), and Janus kinase inhibitors (JAKi) had higher RA disease scores and multiple comorbidities (Table 1). In contrast, patients with csDMARD therapy or tumour necrosis factor inhibitor (TNFi) were less affected overall. Those receiving interleukin-6 inhibitors (IL6i) were the youngest and had a comparable number of comorbidities as patients with csDMARDs or TNFi. Patients not exposed to any DMARD differed from the other treatment groups in having lower disease activity, but a higher number of comorbidities and prior treatments.
The main Cox regression model showed a 2.8-fold higher mortality risk for patients receiving no DMARD treatment compared to TNFi (Figure 1). Numerically, hazard ratios < 1 were observed for IL6i, T cell, B cell, JAKi and csDMARD in reference to TNFi but without statistical significance. The results of the sensitivity analyses pointed in the same direction.
Conclusion
To our knowledge, this is the first study to investigate the risk of all-cause mortality in RA-ILD for all available DMARD treatments jointly, using month-level data. In accordance with the few existing recommendations and studies, all non-TNFi-biologics as well as JAKi showed a protective signal compared to TNFi in all three regression models. Furthermore, patients who did not receive any DMARD had an increased risk of mortality. However, the study sample size was small, the results should thus be interpreted with caution.
Reference
[1]PMID: 36064885View this table:
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Table 1. Characteristics by treatment group at time of ILD reporting
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Figure 1. Hazard ratios of inverse probability weighted. * Cox regression models
Acknowledgements
RABBIT is currently supported by a joint, unconditional grant from AbbVie, Amgen, BMS, Celltrion, Fresenius Kabi, Galapagos, Hexal, Lilly, MSD, Pfizer, Samsung Bioepis, Sanofi Aventis, VIATRIS SANTE and UCB and previously by Roche.
Disclosure of Interests
Tatjana Rudi: None declared, Vera Zietemann: None declared, Martin Schaefer: None declared, Yvette Meissner Speakers bureau: Pfizer, Angela Zink Grant/research support from: Previously, but not during last three years, Andreas Krause Speakers bureau: AbbVie, BMS, Boehringer Ingelheim, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, BMS, Boehringer Ingelheim, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Grant/research support from: UCB, Anja Strangfeld Speakers bureau: AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, Pfizer, Roche, Sanofi, UCB. Non-personal, joint grant from a consortium of 14 pharmaceutical companies for the biologics register RABBIT to my institute., Grant/research support from: Non-personal, joint grant from a consortium of 14 pharmaceutical companies for the biologics register RABBIT to my institute.
Background
In 2019, 2020 and 2021, the European and US-American regulatory agencies issued warnings about venous thromboembolism, major cardiovascular events and malignancy risks associated with the Janus kinase inhibitor (JAKi) tofacitinib and required changes in labelling.
Objectives
To investigate whether characteristics of patients with rheumatoid arthritis receiving a JAKi versus biologic therapy differed before and after the safety warnings.
Methods
Data from patients who started with any JAKi or biologics treatment in the German biologics register RABBIT between 01/2017 and 04/2022 were included. Multivariate logistic regression analyses were used to understand differences in characteristics of patients starting a JAKi treatment versus a biologic treatment in three annual cohorts: 2017 the year JAKis became available in Germany, 2019 before the EMA safety warnings and 2021. In each year, only the first treatment episodes of each JAKi, TNF inhibitor, interleukin-6 inhibitor or B/T-cell targeted therapy were considered. Prior treatment episodes were possible. The logistic regressions were corrected for clustering at the patient level. In 2017, we included 549 JAKi versus 2510 bDMARD treatment episodes, in 2019 674 versus 2233 and in 2021 700 versus 1296 episodes.
Results
Patient characteristics at treatment start have changed over time. In 2017, compared to patients receiving a biologic, patients starting a JAKi had been treated with a higher number of therapies, had a higher (worse) physician reported heath and were more likely to have comorbidities such as hypertension, coronary heart disease, diabetes, hyperlipoproteinaemia, thrombosis, malignancy or lymphoma. In 2019, patients initiating a JAKi therapy compared to a biologic were less likely to be women, had a worse physician reported health and were more likely to receive a dose of less than 10mg glucocorticoids than none. In 2021, after the safety warnings, compared to patients receiving a biologic, those who started a JAKi were older, had a worse physician reported health, had received a higher number of previous therapies, had poorer self-reported health and were less likely to receive a high dose of glucocorticoids. Although not significant, patients with comorbidities were less likely to receive a JAKi.
Conclusion
The analyses show that after the launch of JAKi treatment in 2017, comorbidities increased the likelihood to receive JAKis as a new treatment option. In 2021, patients with a high disease burden and with many other previous therapies were more likely to receive JAKis, but not those with comorbidities. This development shows that rheumatologists in Germany follow the safety recommendations and consider the patients’ disease burden and risk factors when prescribing JAKis.View this table:
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Table 1. Odds Ratios of the logistic regressions for treatment start of a JAKi compared to a bDMARD in 2017, 2019, 2021
Acknowledgements
RABBIT is currently supported by a joint, unconditional grant from AbbVie, Amgen, BMS, Celltrion, Fresenius Kabi, Galapagos, Hexal, Lilly, MSD, Pfizer, Samsung Bioepis, Sanofi, VIATRIS SANTE and UCB and previously by Roche.
Disclosure of Interests
Doreen Huschek Grant/research support from: Non-personal, joint grant from a consortium of 14 pharmaceutical companies for the biologics register RABBIT to my institute., Peter Herzer Speakers bureau: ABBVIE, NOVARTIS, JANSSEN-CILAG, Angela Zink Grant/research support from: Previously, but not during last three years, Martin Feuchtenberger Speakers bureau: Martin Feuchtenberger reports fees from AbbVie, personal fees from Novartis, personal fees from Roche, and personal fees from UCB outside of the submitted work., Consultant of: Martin Feuchtenberger reports fees from AbbVie outside of the submitted work., Anja Strangfeld Speakers bureau: AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, Pfizer, Roche, Sanofi, UCB. Non-personal, joint grant from a consortium of 14 pharmaceutical companies for the biologics register RABBIT to my institute., Grant/research support from: Non-personal, joint grant from a consortium of 14 pharmaceutical companies for the biologics register RABBIT to my institute.
Black women experience disproportionate rates of advanced breast cancer diagnoses and mortality. Mammography is a proven and effective tool in early breast cancer detection and impacts patient outcomes. We interviewed Black women with a personal or family history of breast and/or ovarian cancer to understand their screening experiences and views. N = 61 individuals completed an interview. Interview transcripts were qualitatively analyzed for themes regarding clinical experiences, guideline adherence, and family sharing specific to Black women and their families. Most participants were college educated with active health insurance. Women in this cohort were knowledgeable about the benefits of mammography and described few barriers to adhering to annual mammogram guidelines. Some with first-degree family history were frustrated at insurance barriers to mammography before the age of 40. Participants were generally comfortable encouraging family and friends to receive mammograms and expressed a desire for a similar screening tool for ovarian cancer. However, they expressed concern that factors such as screening awareness and education, lack of insurance coverage, and other systematic barriers might prevent other Black women from receiving regular screening. Black women in this cohort reported high adherence to mammography guidelines, but expressed concern about cultural and financial barriers that may impact cancer screening access in the population more generally and contribute to disparities. Participants noted the importance of frank and open discussions of breast cancer screening in their families and community as a means of improving awareness.
This study provides a comparative analysis of the success factors of equity and reward‐based crowdfunding. We find that information signals related to venture/project quality are important determinants of both equity‐based and reward‐based crowdfunding success. However, signals on founder information matter only for equity‐based but not for reward‐based crowdfunding. Our study exemplifies the varying role of success factors that depend on the type of crowdfunding projects and provides a basis for further research to compare different forms of crowdfunding.
Background
The Housing Collaborative project at Eastern Virginia Medical School has developed a method of adapting public health guidance from public housing communities, which face tremendous health challenges in cardiometabolic health, cancer, and other major health conditions. In this paper, we describe how academic and community partners in the Housing Collaborative came together to do this work with a focus on COVID-19 testing in the context of the emerging pandemic.
Methods
The academic team used virtual community engagement methods to interact with the Housing Collaborative Community Advisory Board (HCCAB) and a separate cohort of research participants (N = 102) recruited into a study of distrust in COVID-19 guidance. We conducted a series of 44 focus group interviews with participants on related topics. Results from these interviews were discussed with the HCCAB. We used the collaborative intervention planning framework to inform adaptation of public health guidance on COVID-19 testing delivered in low-income housing settings by including all relevant perspectives.
Results
Participants reported several important barriers to COVID-19 testing related to distrust in the tests and those administering them. Distrust in housing authorities and how they might misuse positive test results seemed to further undermine decision making about COVID-19 testing. Pain associated with testing was also a concern. To address these concerns, a peer-led testing intervention was proposed by the Housing Collaborative. A second round of focus group interviews was then conducted, in which participants reported their approval of the proposed intervention.
Conclusion
Although the COVID-19 pandemic was not our initial focus, we were able to identify a number of barriers to COVID-19 testing in low-income housing settings that can be addressed with adapted public health guidance. We struck a balance between community input and scientific rigor and obtained high quality, honest feedback to inform evidence-based recommendations to guide decisions about health.
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