Empowering diabetes management: The impact of patient-provider collaboration on type 2 diabetes outcomes through autonomy support and shared decision-making.

OBJECTIVES: Through the lens of self-determination theory, this quantitative study investigates how patient-provider collaboration through perceived shared decision-making (SDM) and autonomy support impact type 2 diabetes (T2D) outcomes. METHODS: We sampled 474 individuals over 18 years old who self-identified as having T2D. Completed and valid responses were received from 378 participants from two separate groups in an online survey. Data was analyzed using the IBM Statistical Package for Social Sciences (SPSS), AMOS package, version 28, and Mplus, version 8.8. RESULTS: Patient-provider collaboration through autonomy support improved treatment satisfaction (ß = .16, ρ < .05) and self-management adherence (ß = .43, ρ < .001). While collaboration through SDM improved treatment satisfaction (ß = .25, ρ < .01), it worsened SM adherence (ß = -.31, ρ < .001). The negative impact of SDM on self-management adherence was mitigated by our moderator, coping ability. However, coping ability minimally impacted treatment satisfaction and SM adherence when autonomous support was provided. CONCLUSIONS: Autonomy support increases treatment satisfaction and self-management adherence. SDM enhances treatment satisfaction but may adversely affect self-management adherence. The study also suggests that coping ability can mitigate the negative effect of SDM on self-management adherence, although its influence is limited when autonomy support is provided by the provider. PRACTICAL IMPLICATIONS: For providers, SDM and autonomy support permits shared power over treatment decisions while fostering independence over self-management tasks. Providers should evaluate patients' coping ability and adapt their approach to care based on the patient's coping capacity.

Long-Term Outcome of Clozapine in Treatment-Resistant Schizophrenia.

PURPOSE/BACKGROUND: The favorable effect of clozapine on psychotic symptoms in patients with treatment-resistant (TR) schizophrenia (SCZ) in short-term studies is well established. However, prospective studies of the long-term outcome of clozapine treatment on psychopathology, cognition, quality of life, and functional outcome in TR-SCZ are limited. METHODS/PROCEDURES: Here, we have examined the long-term (mean duration of follow-up 14 years) effects of clozapine on those outcomes in a prospective, open label study in 54 TR-SCZ patients. Assessments were performed at baseline, 6 weeks, 6 months, and at the last follow-up. FINDINGS/RESULTS: Brief Psychiatric Rating Scale (BPRS) total, positive symptoms, and anxiety/depression at the last follow-up improved significantly from baseline, as well as from the 6-month evaluation ( P < 0.0001), with a 70.5% responder rate (≥20% improvement at the last follow-up from baseline). Quality of Life Scale (QLS) total improved by 72% at the last follow-up, with 24% of patients rated as having "good" functioning compared with 0% at baseline. Suicidal thoughts/behavior was significantly reduced at the last follow-up from the baseline. No significant change in negative symptoms was found at the last follow-up in the total sample. Short-term memory function declined at the last follow-up from baseline, but there was no significant change in processing speed. The QLS total showed a significant negative correlation with BPRS positive symptoms but not with cognitive measures, or negative symptoms, at the last follow-up. IMPLICATIONS/CONCLUSIONS: For patients with TR-SCZ, improving psychotic symptoms with clozapine seems to have a more significant impact than negative symptoms or cognition on improving psychosocial function.

Breaking Through Barriers: Factors That Influence Behavior Change Toward Leadership for Women in Academic Medicine.

Under-representation of women in leadership at Academic Medical Centers (AMCs) is a known challenge such that, in 2021, women made up only 28% of department chairs. AMCs are addressing the dearth of women leaders through targeted programming to create leadership pipelines of qualified women. The FLEX Leadership Development Program at the Case Western Reserve University (CWRU) School of Medicine prepares women faculty for increased leadership opportunities. FLEX includes the opportunity to leverage executive coaching to accomplish individual goals. The FLEX program has the explicit goal of increasing the number of women in visible leadership positions in academic medicine and health sciences. Semi-structured interviews were conducted with 25 graduates from seven FLEX cohorts (2012-2018). Participants reflected diversity in academic rank, terminal degree, racial/ethnic background, years of employment, and institutional affiliation. Interviews consisted of eight questions with additional probes to elicit lived experiences. Analysis consisted of two-stage open- and axial-coding of interview transcripts to understand: What factors facilitated behavior change following FLEX training? The analysis revealed five overarching themes: (1) Communication skills; (2) Self-Efficacy; (3) Networking; (4) Situational Awareness; and (5) Visioning. FLEX graduates reported achieving both personal and professional growth by drawing upon peer networks to proactively seek new leadership opportunities. These results suggest that the enduring benefits of the FLEX Program include improved communication skills, expanded situational awareness and relational capacity, greater self-efficacy and self-confidence, improved networking with an understanding of the value of networking. All these factors led FLEX graduates to have greater visibility and to engage with their colleagues more effectively. Similarly, FLEX graduates could better advocate for themselves and for others as well as paying it forward to mentor and train the next generation of faculty. Finally, participants learned to re-evaluate their goals and their career vision to be able to envision themselves in greater leadership roles. The five factors that strongly influenced behavior change provide valuable constructs for other programs to examine following leadership development training. Ongoing studies include examining successful leadership position attainment, personal goal attainment, and measuring changes in leadership self-efficacy.

Discovering Factors that Influence Physician Scientist Success in Academic Medical Centers.

This study investigated factors influencing success of physician scientists in Academic Medical Centers. These organizations and individuals drive healthcare in the United States. Translation of scientific discovery to medical practice moves at an astoundingly slow and ineffective rate. We must understand what contributes to physician scientist success to speed up translation. Through a lens of dialectic process theory, a grounded theory approach identified emergent factors from lived experiences of 31 individuals, at various experience levels, with MD and PhD degrees. Role balance, autonomy, organizational support, teamwork, life-cycle mentorship, and relational capacity were relevant factors impacting success. Role balance was important for success. Teamwork, organizational support, and life-cycle mentorship helped individuals grow, achieve balance, and respect, but relational capacity emerged as a critical driver for realizing both individual and organizational success. One person cannot execute these complex roles on their own, but development of deep and meaningful relationships through teamwork, collaboration, and life-cycle mentorship are essential for life satisfaction and success.

Scientific Review Committees as part of institutional review of human participant research: Initial implementation at institutions with Clinical and Translational Science Awards.

INTRODUCTION: Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs). METHODS: SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations. RESULTS: Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3 weeks. For the 60% under review after 3 weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures. CONCLUSIONS: The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.

Perspectives of individuals with multiple sclerosis on discontinuation of disease-modifying therapies.

BACKGROUND: Therapeutic research in multiple sclerosis (MS) has focused on the development of treatments with little investigation regarding the possibility of discontinuation of disease-modifying therapies (DMTs). OBJECTIVE: To understand the opinion of individuals with MS concerning stopping DMTs and the factors that influence the decision-making process. METHODS: A mixed method approach was used starting with three focus groups from which a survey was developed. This survey was sent to 1000 participants in the North American Research Committee on Multiple Sclerosis registry who met inclusion criteria (age ⩾45 years; on most recent DMT for ⩾5 years). Descriptive analysis and structural equation modeling were used. RESULTS: Of 1000 participants receiving the survey, 377 provided complete responses and met inclusion criteria. Only 11.9% of participants reported that if their disease was considered stable, they would consider coming off medications. A high level of external locus of control in influential others such as physicians significantly decreased the likelihood of considering discontinuation. CONCLUSIONS: Most individuals with MS report being unlikely to consider stopping MS therapy if their disease was considered "non-active." As the results of studies concerning DMT discontinuation are obtained, information from providers will be an important part of individuals' decision-making process.

Coping with diabetes: Provider attributes that influence type 2 diabetes adherence.

Diabetes, a chronic disease affecting over 29 million people in the United States, requires the integration of complex medical tasks into a person's daily life. Patient-centered care and compassion are recognized as essential dimensions of the quality care experience. This research examined provider attributes that influence adherence to type 2 diabetes mellitus (T2DM) regimens and sought to understand the phenomena of provider attributes, treatment adherence, and their relationship to coping ability and treatment outcomes. This quantitative study sampled 474 people with T2DM using a 62-item online survey administered to three different groups. The sample population included people over age 18 diagnosed with T2DM. The first group included 91 persons with T2DM identified through a Facebook group and personal social media connections, the second group included 120 Amazon Mechanical Turk participants with T2DM, and the third group included 263 respondents from a Qualtrics panel who had T2DM. Results indicated that perceived provider compassion (ß = .41, ρ < .001) and optimism (ß = .48, ρ < .001) positively affected coping ability. Additionally, full mediation effects for self-management were revealed, with coping ability positively mediating the effect of compassion on self-management and the effects of optimism on self-management. Furthermore, full mediation effects were found for treatment satisfaction, with coping ability positively mediating the effect of compassion on treatment satisfaction and the effects of optimism on treatment satisfaction. This research has implications for patients, healthcare professionals, and leaders suggesting that providers who communicate with optimism and compassion positively affect coping ability. As a result, healthcare providers and professionals have an opportunity to enhance self-management adherence by helping their patients cope with the burdens of diabetes. In addition, this study has implications for developing provider communication tools aimed at assessing patients' coping capacity and increasing compassionate communication.

Research participant-centered outcomes at NIH-supported clinical research centers.

BACKGROUND: Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants' experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants. METHODS: Survey questions addressed core aspects of the research participants' experience, including their overall rating, motivation, trust, and informed consent. We describe participant characteristics, responses to individual questions, and correlations among responses. RESULTS: Respondents broadly represented the research population in sex, race, and ethnicity. Seventy-three percent awarded top ratings to their overall research experience and 94% reported no pressure to enroll. Top ratings correlated with feeling treated with respect, listened to, and having access to the research team (R(2) = 0.80-0.96). White participants trusted researchers more (88%) than did nonwhite participants collectively (80%; p < 0.0001). Many participants felt fully prepared by the informed consent process (67%) and wanted to receive research results (72%). CONCLUSIONS: Our survey demonstrates that a majority of participants at NIH-supported clinical research centers rate their research experience very positively and that participant-centered outcome measures identify actionable items for improvement of participant's experiences, research protections, and the conduct of clinical investigation.

Evaluating various areas of process improvement in an effort to improve clinical research: discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management workshop.

Emphasis has been placed on assessing the efficiency of clinical and translational research as part of the National Institutes of Health (NIH) goal to "improve human health." Improvements identified and implemented by individual organizations cannot address the research infrastructure needs of all clinical and translational research conducted. NIH's National Center for Advancing Translational Sciences (NCATS) has brought together 61 Clinical and Translational Science Award (CTSA) sites creating a virtual national laboratory that reflects the diversity and breadth of academic medical centers to collectively improve clinical and translational science. The annual Clinical Research Management workshop is organized by the CTSA consortium with participation from CTSA awardees, NIH, and others with an interest in clinical research management. The primary objective of the workshop is to disseminate information that improves clinical research management although the specific objectives of each workshop evolve within the consortium. The fifth annual workshop entitled "Learning by doing; applying evidence-based tools to re-engineer clinical research management" took place in June 2012. The primary objective of the 2012 workshop was to utilize data to evaluate, modify, and improve clinical research management. This report provides a brief summary of the workshop proceedings and the major themes discussed among the participants.

A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

PURPOSE: The "card study," in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks. Because an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study institutional review board (IRB) approval. METHODS: We developed a protocol for a study of the card study method, allowing new card study proposals of specific research questions to be submitted as addenda to the approved Card Study Protocol. RESULTS: Seven card studies were proposed and approved under the Card Study Protocol during the first year after implementation, contrasted with one-card study proposed in the previous year. New card study ideas submitted as addenda to an approved protocol appeared to increase IRB comfort with the card study as a minimal risk method while reducing the hurdles to developing new study ideas. CONCLUSIONS: A Card Study Protocol allowing new study questions to be submitted as addenda decreases time between idea generation and IRB approval. Shortened turn-around times may be useful for translating ideas into action while reducing regulatory burden.

A randomized trial comparing clozapine and typical neuroleptic drugs in non-treatment-resistant schizophrenia.

Clozapine has been shown to be superior to typical neuroleptic drugs for treating positive symptoms in treatment-resistant (TR) schizophrenia. Long-term data from randomized clinical trials comparing clozapine with typical neuroleptics in non-TR schizophrenia are rare. We previously reported that clozapine was superior to typical neuroleptic drugs in some domains of cognition in recent onset non-TR schizophrenia. We now present data on psychopathology and quality of life from this randomized, flexibly dosed, 24-month study of clozapine vs. typical neuroleptics in non-TR schizophrenia patients. Both treatments produced significant improvement in measures of psychopathology, quality of life, and global function, with minor exceptions. There was no difference in extrapyramidal side effects between the patients treated with clozapine or typical neuroleptics. However, significantly more relapse/rehospitalization drop-outs occurred in the typical neuroleptic group. Two patients treated with typical neuroleptics, but none treated with clozapine, became non-responsive to treatment. Clozapine was associated with significantly greater weight gain. Clozapine and typical neuroleptic drugs appear to produce equivalent improvement in psychopathology in patients with non-TR schizophrenia. Clozapine may be more effective than typical neuroleptics for treatment retention and prevention of relapse, but it produces more severe metabolic side effects. These considerations should be taken into account in decisions of how best to utilize clozapine in the treatment of schizophrenia.

A genome-wide investigation of SNPs and CNVs in schizophrenia.

We report a genome-wide assessment of single nucleotide polymorphisms (SNPs) and copy number variants (CNVs) in schizophrenia. We investigated SNPs using 871 patients and 863 controls, following up the top hits in four independent cohorts comprising 1,460 patients and 12,995 controls, all of European origin. We found no genome-wide significant associations, nor could we provide support for any previously reported candidate gene or genome-wide associations. We went on to examine CNVs using a subset of 1,013 cases and 1,084 controls of European ancestry, and a further set of 60 cases and 64 controls of African ancestry. We found that eight cases and zero controls carried deletions greater than 2 Mb, of which two, at 8p22 and 16p13.11-p12.4, are newly reported here. A further evaluation of 1,378 controls identified no deletions greater than 2 Mb, suggesting a high prior probability of disease involvement when such deletions are observed in cases. We also provide further evidence for some smaller, previously reported, schizophrenia-associated CNVs, such as those in NRXN1 and APBA2. We could not provide strong support for the hypothesis that schizophrenia patients have a significantly greater "load" of large (>100 kb), rare CNVs, nor could we find common CNVs that associate with schizophrenia. Finally, we did not provide support for the suggestion that schizophrenia-associated CNVs may preferentially disrupt genes in neurodevelopmental pathways. Collectively, these analyses provide the first integrated study of SNPs and CNVs in schizophrenia and support the emerging view that rare deleterious variants may be more important in schizophrenia predisposition than common polymorphisms. While our analyses do not suggest that implicated CNVs impinge on particular key pathways, we do support the contribution of specific genomic regions in schizophrenia, presumably due to recurrent mutation. On balance, these data suggest that very few schizophrenia patients share identical genomic causation, potentially complicating efforts to personalize treatment regimens.