Open Access Policy Deposits

This series is automatically populated with publications deposited by UCSF Department of Epidemiology and Biostatistics researchers in accordance with the University of California’s open access policies. For more information see Open Access Policy Deposits and the UC Publication Management System.

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Caring for providers to improve patient experience (CPIPE): intervention development process.

(2023)

A growing body of research has documented disrespectful, abusive, and neglectful treatment of women in facilities during childbirth, as well as the drivers of such mistreatment. Yet, little research exists on effective interventions to improve Person-Centred Maternal Care (PCMC)-care that is respectful and responsive to individual women's preferences, needs, and values. We sought to extend knowledge on interventions to improve PCMC, with a focus on two factors - provider stress and implicit bias - that are driving poor PCMC and contributing to disparities in PCMC. In this paper we describe the process towards the development of the intervention. The intervention design was an iterative process informed by existing literature, behaviour change theory, formative research, and continuous feedback in consultation with key stakeholders. The intervention strategies were informed by the Social Cognitive Theory, Trauma Informed System framework, and the Ecological Perspective. This process resulted in the 'Caring for Providers to Improve Patient Experience (CPIPE)' intervention, which has 5 components: provider training, peer support, mentorship, embedded champions, and leadership engagement. The training includes didactic and interactive content on PCMC, stress, burnout, dealing with difficult situations, and bias, with some content integrated into emergency obstetric and neonatal care (EmONC) simulations to enable providers apply concepts in the context of managing an emergency. The other components create an enabling environment for ongoing individual behavior and facility culture change. The pilot study is being implemented in Migori County, Kenya. The CPIPE intervention is an innovative theory and evidence-based intervention that addresses key drivers of poor PCMC and centers the unique needs of vulnerable women as well as that of providers. This intervention will advance the evidence base for interventions to improve PCMC and has great potential to improve equity in PCMC and maternal and neonatal health.

An evidence double standard for pharmacological versus non-pharmacological interventions: Lessons from the COVID-19 pandemic.

(2023)

Cover page of Prostate-specific Membrane Antigen Positron Emission Tomography in the Staging of Newly Diagnosed Prostate Cancer: Is More Sensitivity Always Better?

Prostate-specific Membrane Antigen Positron Emission Tomography in the Staging of Newly Diagnosed Prostate Cancer: Is More Sensitivity Always Better?

(2023)

Higher diagnostic accuracy, even if desirable, is not automatically associated with better outcomes. If used in settings validated with less sensitive imaging modalities, it is of paramount importance to prospectively ascertain that the higher sensitivity of prostate-specific antigen membrane-based imaging will benefit patients, and will probably not do harm.

Female reproductive health impacts of Long COVID and associated illnesses including ME/CFS, POTS, and connective tissue disorders: a literature review

(2023)

Long COVID disproportionately affects premenopausal women, but relatively few studies have examined Long COVID's impact on female reproductive health. We conduct a review of the literature documenting the female reproductive health impacts of Long COVID which may include disruptions to the menstrual cycle, gonadal function, ovarian sufficiency, menopause, and fertility, as well as symptom exacerbation around menstruation. Given limited research, we also review the reproductive health impacts of overlapping and associated illnesses including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), postural orthostatic tachycardia syndrome (POTS), connective tissue disorders like Ehlers-Danlos syndrome (EDS), and endometriosis, as these illnesses may help to elucidate reproductive health conditions in Long COVID. These associated illnesses, whose patients are 70%–80% women, have increased rates of dysmenorrhea, amenorrhea, oligomenorrhea, dyspareunia, endometriosis, infertility, vulvodynia, intermenstrual bleeding, ovarian cysts, uterine fibroids and bleeding, pelvic congestion syndrome, gynecological surgeries, and adverse pregnancy complications such as preeclampsia, maternal mortality, and premature birth. Additionally, in Long COVID and associated illnesses, symptoms can be impacted by the menstrual cycle, pregnancy, and menopause. We propose priorities for future research and reproductive healthcare in Long COVID based on a review of the literature. These include screening Long COVID patients for comorbid and associated conditions; studying the impacts of the menstrual cycle, pregnancy, and menopause on symptoms and illness progression; uncovering the role of sex differences and sex hormones in Long COVID and associated illnesses; and addressing historical research and healthcare inequities that have contributed to detrimental knowledge gaps for this patient population.

The response rate by tumour type for tissue-agnostic approved drugs.

(2023)

Cover page of Clinical Trials Portfolio and Regulatory History of Idelalisib in Indolent Non-Hodgkin Lymphoma: A Systematic Review and Meta-analysis.

Clinical Trials Portfolio and Regulatory History of Idelalisib in Indolent Non-Hodgkin Lymphoma: A Systematic Review and Meta-analysis.

(2023)

Importance

Idelalisib is a first-in-class phosphatidylinositol 3-kinase inhibitor that received US Food and Drug Administration accelerated approval in July 2014 as a single-agent treatment for relapsed follicular lymphoma (FL) and small lymphocytic lymphoma (SLL). Serious adverse effects were reported in 2016 leading to termination of postmarketing registry trials. However, idelalisib remained on the market until 2022 when Gilead voluntarily withdrew the drug for the accelerated approval indication.

Objective

Evaluate the regulatory oversight of the accelerated approval pathway and evidence generation for idelalisib during premarketing (2008-2014), postmarketing (2014-2016), and premarketing withdrawal periods (2016-2022).

Data sources

ClinicalTrials.gov, FDA.gov, PubMed database.

Study selection

Clinical trials investigating the safety and effectiveness of idelalisib.

Data extraction and synthesis

Study characteristics and relative risk (RR) of safety outcomes were abstracted. Data were pooled using random effects meta-analysis. The analysis was performed in October of 2022.

Main outcomes and measures

Trial status, recruitment status, publication status, serious adverse events (SAEs), fatal adverse events (FAEs), and all-cause mortality.

Results

Overall, 31 idelalisib trials met selection criteria. In total, 20 of 30 (65%) included SLL and/or FL; 13 (42%) trials were completed, 13 (42%) had published results, and 7 (23%) were randomized clinical trials (RCTs). Overall, 6 RCTs of idelalisib had publicly available data on safety outcomes. By the initial postmarketing period (2016), the cumulative RR for SAEs was 1.86 (95% CI, 1.63-2.11), for FAEs was 3.30 (95% CI, 1.56-7.00), and for death was 1.35 (95% CI, 0.85-2.12). In the premarketing withdrawal period, only a single phase 3 trial was enrolling patients for FL and was terminated. However, idelalisib was not withdrawn from the market until 2022. Gilead reported cumulative sales revenue of $842 million during market authorization (2014-2022) and annual sales had a steady decline from $168 million to $62 million during the premarketing withdrawal period (2016-2021).

Conclusions and relevance

Findings of this systematic review and meta-analysis show that serious risks of SAE, FAE, and death with idelalisib treatment were evident by 2016. However, idelalisib remained on the market for another 6 years, with minimal evidence generation. It was voluntarily withdrawn for FL and SLL accelerated approval indications coinciding with decreasing revenue generation. Closer attention for safety and effectiveness of drugs reaching market by accelerated approval is needed.

Financial conflicts of interest of physicians followed by neurosurgical journals on Twitter.

(2023)

Background

Social media, particularly Twitter, has played an increasing role in networking and the dissemination of neurosurgical research. Despite extensive study on financial conflicts of interest (FCOI) influencing medical research, little is known about the function of conflicts of interest on social media and the influence they may have. In this study, we sought to evaluate the FCOI of physicians followed on Twitter by the top three neurosurgical journals.

Materials and methods

We analysed the FCOI of United States (US) physicians followed by the top three neurosurgical journals (Journal of Neurosurgery, World Neurosurgery, Neurosurgery) on Twitter. We determined the FCOIs of each physician using the Open Payments Search Tool located at https://openpaymentsdata.cms.gov and summed the data between 2014 and 2021.

Results

We examined 2651 Twitter accounts followed by the top three neurosurgical journals on Twitter and determined 705 (26.6%) belonged to US physicians. Of the 705 US physicians, 577 (81.8%) received general payments between 2014 and 2021. After excluding US physicians currently in residency or fellowship (n = 157), this percentage increased to 93.2% (n = 511/548). In total, nearly $70 million in general payments were made between 2014 and 2021.

Conclusion

These findings raise questions regarding the interaction between neurosurgical journals and the medical community on Twitter. This study may serve as the basis for future work on best practices for medical journals navigating their affiliations on Twitter.

Agency in Contraceptive Decision-Making in Patient Care: a Psychometric Measure.

(2023)

Background

Patient agency in contraceptive decision-making is an essential component of reproductive autonomy.

Objective

We aimed to develop a psychometrically robust measure of patient contraceptive agency in the clinic visit, as a measure does not yet exist.

Design

For scale development, we generated and field tested 54 questionnaire items, grounded in qualitative research. We used item response theory-based methods to select and evaluate scale items for psychometric performance. We iteratively examined model fit, dimensionality, internal consistency, internal structure validity, and differential item functioning to arrive at a final scale.

Participants

A racially/ethnically diverse sample of 338 individuals, aged 15-34 years, receiving contraceptive care across nine California clinics in 2019-2020.

Main measures

Contraceptive Agency Scale (CAS) of patient agency in preventive care.

Key results

Participants were 20.5 mean years, with 36% identifying as Latinx, 26% White, 20% Black, 10% Asian/Native Hawaiian/Pacific Islander. Scale items covered the domains of freedom from coercion, non-judgmental care, and active decision-making, and loaded on to a single factor, with a Cronbach's α of 0.80. Item responses fit a unidimensional partial credit item response model (weighted mean square statistic within 0.75-1.33 for each item), met criteria for internal structure validity, and showed no meaningful differential item functioning. Most participants expressed high agency in their contraceptive visit (mean score 9.6 out of 14). One-fifth, however, experienced low agency or coercion, with the provider wanting them to use a specific method or to make decisions for them. Agency scores were lowest among Asian/Native Hawaiian/Pacific Islander participants (adjusted coefficient: -1.5 [-2.9, -0.1] vs. White) and among those whose mothers had less than a high school education (adjusted coefficient; -2.1 [-3.3, -0.8] vs. college degree or more).

Conclusions

The Contraceptive Agency Scale can be used in research and clinical care to reinforce non-coercive service provision as a standard of care.

“It Was Definitely like an Altered Social Scene”: Effects of the COVID-19 Pandemic Restrictions on U.S. Adolescents’ Social Relationships

(2023)

Pandemic restrictions aiming to curb the spread of COVID-19 in the U.S. impacted the quality, quantity and tenor of adolescents’ social relationships and shifted the context in which sensitive social learning is occurring. We conducted in-depth semi-structured interviews with 47 adolescents (ages 10–24) from December 2020–February 2021, coded them using ATLAS.ti, and employed qualitative, grounded theory methodology to explore the impact of COVID-19 pandemic restrictions on adolescents’ social relationships with peers and family members. Overall, the impact of the pandemic restrictions on young people’s social relationships was multidimensional and complex. Many participants experienced benefits to relationships with family members. In contrast, their relationships with peers were more negatively impacted by severe social distancing measures. Young people who underwent significant social transitions and those who identified as people of color or LGBTQ+ described more negative effects on their social relationships.

Cover page of Respondent- Driven Sampling to Assess Cumulative Lifetime Incidence of Abortion in Soweto, South Africa: A Methodological Assessment.

Respondent- Driven Sampling to Assess Cumulative Lifetime Incidence of Abortion in Soweto, South Africa: A Methodological Assessment.

(2023)

Respondent-driven sampling (RDS) is a potential strategy for addressing challenges in accurate abortion incidence estimation, but relies on often untested assumptions. We conducted an RDS study to estimate the cumulative lifetime abortion incidence in Soweto, South Africa, evaluate whether RDS assumptions were met, and compare RDS estimates of incidence to estimates adjusted for employment and age based on census data. A total of 849 participants were recruited from 11 seeds between April and December 2018. The assumptions that individuals can identify target population members and approximation of sampling with replacement was met. There were minor violations of the assumptions of seed independence from the final sample, and reciprocity of ties. Assumptions of accurate degree reporting and random recruitment were not met. Failure to meet assumptions yielded a sample with different employment characteristics than the target population, which was not resolved by standard RDS methods. The RDS estimate of cumulative lifetime abortion incidence was 12.1% (95% CI: 9.8%, 14.3%), and the employment-adjusted estimate was 16.9% (95% CI: 12.8%, 22.1%). We caution researchers in using RDS for representative estimates of abortion incidence. Post-survey weights to adjust for differences in characteristics between the sample and target population may yield more representative results.