Aleksandra E. Zgierska

Background: Chronic low back pain (CLBP) is common and often refractory to existing treatments, necessitating long‐term opioid therapy, which has substantial risks. Mindfulness‐based (MBT) and cognitive behavioral (CBT) therapies are safe and can be effective for CLBP. Aims: To better understand how MBT and CBT may help improve opioid‐treated CLBP: Methods: This qualitative study involved a subgroup of participants with opioid‐treated CLBP who completed a 12‐month randomized clinical trial comparing the effects of MBT versus CBT. Participants who reported improvements at 12 months, compared to baseline, in main outcomes (assessed with validated “quantitative” questionnaires) and experience with the study intervention, and who attended the intervention sessions were invited to in‐depth exit interviews. The interviews achieved thematic saturation. Thematic analysis of transcribed interviews summarized qualitative findings. Results: Fifty participants (26 MBT, 24 CBT) were interviewed. They were, on average, 58.5 (SD = 10.0) years old. Most were female (60.0%), non‐Hispanic (94.0%), and White (82.0%). At baseline, both groups were, on average, moderately‐to‐severely impacted by CLBP and treated with moderate‐to‐high daily opioid doses; at 12 months, they quantitatively reported improved pain, function and QoL scores and reduced daily opioid dose. In their qualitative responses, these participants corroborated the quantitative findings, reporting reductions in back pain (98.0% of interviewed participants), functional limitations (100.0%), and opioid dose (98.0%), with the majority attributing these changes to the study intervention they had received (98.0%, 94.0%, and 90.0%, respectively). Participants also reported the interventions helped them cope with emotional challenges and life stressors, and opioid‐related adverse effects. Participants did not raise concerns about interventions' safety. Qualitative themes identified intervention‐taught techniques participants most frequently used to manage their symptoms. Conclusion: MBT and CBT can improve health and QoL and reduce opioid dose in adults with opioid‐treated refractory CLBP, calling for improved access to these safe treatments.

Digital twins have rapidly entered healthcare discourse, accompanied by ambitious claims regarding personalization, prediction, and decision support. Originating in engineering domains characterized by well-observed, controllable, and mechanistically understood systems, the concept is increasingly being applied to biological, clinical, and organizational settings whose underlying assumptions differ substantially. As a result, the term now encompasses a heterogeneous collection of models, simulations, and artificial intelligence (AI) systems, often without clear specification of what is being represented, what can be inferred, or what actions can legitimately be justified.This review develops a scale-aware framework for evaluating healthcare digital twins. Through a structured analysis spanning cardiovascular disease, diabetes, Alzheimer's disease, maternal–fetal health, addiction, radiology, and hospital operations, we argue that the scientific validity and practical utility of a digital twin depend fundamentally on scale. As applications move from mechanistic physiological systems to individual patients, coupled human systems, sociotechnical settings, and healthcare organizations, the central challenges shift from model fidelity and state estimation to non-identifiability, behavioral adaptation, contested objectives, and governance.Across domains, recurring failure modes arise less from insufficient computational capability than from misalignment among state definitions, uncertainty representation, causal support, decision authority, and governance. We examine the roles of AI in state estimation, prediction, uncertainty quantification, and decision support while highlighting its limits in addressing poorly defined state spaces, non-identifiability, causal ambiguity, and normative questions regarding acceptable actions. We further argue that governance is not an external constraint but a foundational component of healthcare digital twins, shaping accountability, lifecycle oversight, data stewardship, and the legitimacy of decisions informed by digital twin outputs.This review reframes healthcare digital twins not as a single technology but as a family of computational representations whose validity depends on scale, context, purpose, and governance. Future progress will depend less on increasingly sophisticated models than on maintaining alignment among representation, evidence, intervention, and accountability, and on ensuring digital twin ambitions remain commensurate with the epistemic conditions and institutional constraints of the systems they seek to represent. Building on this analysis, the review offers complementary research roadmaps for AI and governance that emphasize explicit state semantics, uncertainty-aware inference, decision-centered evaluation, adaptive oversight, and governance-by-design.

Background: Acute rhinosinusitis is one of the most common conditions seen in primary care. One in seven adults are diagnosed with ARS annually, resulting in one in five of all antibiotic prescriptions. Yet there has been limited research comparing the effectiveness of widely used treatments such as antibiotics and nasal steroids. Conducting such a trial in the context of decades of established practice poses unique challenges. Methods: A feasibility phase was conducted with continuing feedback to provide refinement and guidance regarding the design of a large-scale, pragmatic randomized controlled trial. The pilot trial assessed the ability to enroll, retain, and evaluate adherence to the intervention and assessment protocols. Results: The feasibility phase allowed us to seek input from patients and experts. This resulted in changes pre and post pilot that will impact the full study. A priori enrollment targets for the pilot were achieved, and with high adherence rates. In total, 373 patients were pre-screened and 140 patients were enrolled participants. Adherence to data collection via the daily diary was 93% throughout the study, with 95% completing their diary on the day of the primary outcome, 3 post-randomization. Conclusion: Expert panels and a patient advisory committee recommended critical changes to our study design. Stakeholder engagement is a key component of this funding source and was widely used throughout the 18-months. An achieved primary goal of the feasibility phase was to evaluate recruitment and study methods prior to implementing a large clinical trial that requires significant resources.

Introduction: Lack of reliable, affordable transportation is a common barrier to clinical research participation, potentially contributing to health disparities. Insufficient and/or nonexistent institutional policies on research-related transportation make it challenging for research teams to effectively overcome transportation barriers and promote research participation among people from disadvantaged backgrounds. This study’s goal was to review research-related transportation policies across clinical research-involved institutions and propose recommendations for what such policies should address to help promote research engagement among diverse, representative populations. Methods: We surveyed 28 recruitment sites, members of the National Institutes of Health-funded Healthy Brain and Child Development Consortium, poised to recruit over 7000 families, and completed an online search for each site’s policies relevant to research-related transportation (i.e., transportation of participants or research staff travel to/from research activities). We identified, reviewed, and thematically described content of the relevant policies and developed summary recommendations for institutional guidance components. Results: We identified seven policies (from five sites) on research-related transportation; four provided guidance on research-related transportation services; two on reimbursement; and one on when research staff transports participants. The online search identified publicly available business travel policies for 22 sites. No policy addressed research staff travel specifically for “study business” or research personnel transporting children for research purposes. Conclusions: Few institutions involved in clinical research have policies guiding research-related transportation. Such policies, if adopted, could help support research-related transportation and, thus, participation of individuals from disadvantaged backgrounds, increasing generalizability of research results and contributing toward reducing social and health disparities.

Importance: Chronic low back pain (CLBP) can necessitate opioid therapy. Effective approaches to reduce CLBP’s symptoms and opioid-related harms are needed. Cognitive behavioral (CBT) and mindfulness-based (MBT) therapies may be useful but have not been well-studied for opioid-treated CLBP.Objective: To compare the effectiveness of MBT vs CBT in opioid-treated CLBP, hypothesizing MBT’s superiority.Design, Setting, and Participants: In this 12-month community partner–informed, partially masked, multisite, randomized clinical trial, participants at primary and specialty care clinics and community settings were randomly assigned (1:1) to MBT or CBT groups. Participants included English-fluent adults (21 years or older), without prior MBT or CBT training, and with moderate-to-severe CLBP (average score ≥3 on the Brief Pain Inventory [BPI]; functional limitation score ≥20 on the Oswestry Disability Index [ODI]), treated with an opioid dosage of at least 15 mg/d of morphine milligram equivalents (MME) for at least 3 months. Outcome data were collected from July 1, 2017, to November 23, 2022. Analysis used the intention-to-treat approach.Interventions: Manual-based MBT or CBT interventions consisting of 8 weekly therapist-led group sessions and at-home practice.Outcomes and Measures: Self-reported coprimary (average pain severity, 0-10 [BPI]; functional limitations, 0-100 [ODI]) and secondary (mental and physical health–related quality of life [QOL] on the Medical Outcomes Study 12-Item Short Form Health Survey and opioid dose in MME per day, Timeline Followback) outcomes compared at 6 and 12 months.Results: Among 6024 screened individuals, 2926 were ineligible, 2328 were eligible, and 770 were enrolled, including 385 in the MBT and 385 in the CBT groups. Of these, 434 participants (56.4%) were female, 647 (84.0%) identified as non-Hispanic ethnicity, and 630 (81.8%) identified as White race; mean (SD) age was 57.8 (11.3) years. The mean (SD) BPI average pain score was 6.1 (1.6) (moderate pain) and the mean (SD) ODI functional limitation score was 47.2 (14.0) (moderate functional limitations), with reduced physical (mean [SD], 28.5 [8.3]) and mental (mean [SD], 42.5 [11.8]) health–related QOL on the SF-12 and high opioid dosage (mean [SD], 177 [1041] MME/d). Over time, each group significantly improved their outcomes, without serious adverse effects. The intention-to-treat linear mixed-effects model analysis did not detect significant between-group differences at 6 and 12 months for pain (0.21 [95% CI, −0.05 to 0.48; P = .12] and 0.13 [95% CI, −0.13 to 0.40; P = .33], respectively) or function (0.07 [95% CI, −1.80 to 1.93; P = .94], and 0.27 [95% CI, −1.59 to 2.12; P = .78], respectively) and indicated MBT’s noninferiority relative to CBT on primary outcomes.Conclusions and Relevance: In this large trial, CLBP-related symptoms improved, while opioid dosage decreased in both MBT and CBT groups at 6 and 12 months. Increasing availability of these safe psychological therapies could help reduce individual and societal burdens of refractory, opioid-treated CLBP.Trial Registration: ClinicalTrials.gov Identifier: NCT03115359

Long-term health and developmental impact after in utero opioid and other substance exposures is unclear. There is an urgent need for well-designed, prospective, long-term observational studies. The HEALthy Brain and Child Development Study aims to address this need. It will require optimizing recruitment and retention of caregivers and young children in long-term research. Therefore, a scoping review of original research articles, indexed in the PubMed database and published in English between January 1, 2010, and November 23, 2023, was conducted on recruitment and retention strategies of caregiver–child (≤6 years old) dyads in observational, cohort studies. Among 2,902 titles/abstracts reviewed, 37 articles were found eligible. Of those, 29 (78%) addressed recruitment, and 18 (49%) addressed retention. Thirty-four (92%) articles focused on strategies for facilitating recruitment and/or retention, while 18 (49%) described potentially harmful approaches. Recruitment and retention facilitators included face-to-face and regular contact, establishing a relationship with study personnel, use of technology and social platforms, minimizing inconveniences, and promoting incentives. This review demonstrates that numerous factors can affect engagement of caregivers and their children in long-term cohort studies. Better understanding of these factors can inform researchers about optimal approaches to recruitment and retention of caregiver–child dyads in longitudinal research.

Objective: The purpose of this qualitative analysis was to better understand what pain management strategies adults with opioid-treated chronic low back pain (CLBP) found most helpful. Design: A subgroup of participants from a larger randomized control trial of two psychological interventions were asked: “What helps your back pain?” at baseline and 12 months (exit) in brief, video-recorded interviews. Videos were analyzed using qualitative thematic content analysis utilizing Transana™. Setting: Participants were recruited from the community and outpatient clinics in three United States sites. Participants: Seventy-nine adults with long-term (≥3 months) opioid-treated (≥15 mg/day morphine equivalent) CLBP. Main outcome measure(s): Participants' baseline and exit qualitative responses to the question “What helps your back pain?” Results: At baseline, participants identified medication (n = 63), body position (n = 59), thermal application (n = 50), physical activity (n = 49), and stretching (n = 24) as the CLBP management strategies they found helpful. At exit, the reports of medication (n = 55), physical activity (n = 41), and stretching (n = 21) were often considered helpful for CLBP and remained relatively stable, while position (n = 36) and thermal application (n = 35) strategies were mentioned less frequently and psychological strategies (n = 29) were mentioned more frequently (up from n = 5) compared to baseline. Conclusions: Over time, the reports of medication and active pain management strategies, eg, physical activity, remained stable, while the reports of some passive pain management strategies, eg, position and thermal, declined over time. Increased use of psychological strategies implies that study interventions were incorporated as useful pain self-management strategies.

Objective: Early work suggests the type of subjective experiences upon first opioid use may predict opioid use disorder (OUD) risk. This study developed and pilot-tested a brief survey to evaluate the “first response” to opioids. Design: A cross-sectional survey research study. The survey was administered to a subsample for the second time to assess test–retest reliability. Setting: Outpatient. Participants: Convenience sample of adults treated for OUD at an opioid treatment program. Main outcome measures: A seven-question First Response to Opioids Survey Tool (FROST), developed based on the existing questionnaires and stakeholder-advisor feedback, was evaluated. Results: Participants (N = 157) were 36.8 (standard deviation [SD] = 9.4) years old, with 79.6 percent identifying as Caucasian and 56.7 percent male. They reported opioid initiation at 20.6 (SD = 8.8) years old, with a prescription-based (78.3 percent), orally administered (66.2 percent), and illicitly procured (51.0 percent) opioids. Upon opioid initiation, positive-valence, euphoria-like subjective experiences of feeling “comfortable” (65.0 percent), “happy” (61.1 percent), “euphoria” (58.6 percent), and “energized” (44.6 percent) were common, and different (p < 0.05) from other types of subjective experiences. Among 64 individuals who answered a question about “drug-liking,” 50 (78.1 percent) reported drug-liking. Among 31 respondents who completed the survey a second time, the test–retest consistency was 78.2 percent for subjective experience characteristics and 72 percent for drug-liking responses. Qualitative results corroborated quantitative findings. Conclusion: These results suggest that euphoria-type experiences and drug-liking upon opioid initiation are common among adults with OUD and FROST's promising psychometric properties. Future research should assess clinical utility of this brief survey, which could be applied at bedside and help identify those at risk for OUD, guide safer opioid prescribing, and reduce opioid-related harm.

Sustained widespread deployment of clinically and cost-effective models of integrated pain care could be bolstered by optimally aligning shared stakeholder values.