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Nevin Manimala Statistics

Patient and public involvement in preclinical and medical research: Evaluation of an established programme in a Discovery-Based Medical Research Institute

Health Expect. 2024 Feb;27(1):e13968. doi: 10.1111/hex.13968.

ABSTRACT

BACKGROUND AND CONTEXT: Involving people with lived experience of health conditions and the public (consumers) in health research is supported by policy, practice and research funding schemes. However, consumer involvement programmes in discovery-based preclinical research settings are uncommon. Few formal evaluations of these programmes are reported in the literature.

OBJECTIVE: This study aimed to evaluate an established patient and public involvement programme operating in a major Australian Discovery-Based Medical Research Institute (DBMRI) to inform programme development and the wider field.

DESIGN AND PARTICIPANTS: A multimethods programme evaluation incorporating demographic, descriptive and qualitative data obtained through consumer/researcher co-developed online surveys and semistructured virtual interviews. Programme participants (n = 111) were invited to complete an online survey seeking feedback on their experience of involvement, programme processes and perceived impacts. A purposive sample of 25 participants was interviewed. Descriptive data were analysed using explanatory statistics and qualitative data from surveys and interviews were thematically analysed.

RESULTS: This consumer involvement programme was found to be useful and meaningful for most participants, with specific examples of perceived added value. Consumers most commonly engaged with researchers to inform research development, prepare funding applications or strengthen lay communication of science. Genuine consumer-researcher interactions, relationship development and mutual respect were key elements in a positive experience for participants. Opportunities to ‘give back’, to learn and to ground research in lived experience were identified programme strengths and benefits. Developing researcher training in how to work with consumers, increasing the diversity of the consumer group membership and expanding the range of consumer activities were identified opportunities for improvement. Organisational support and adequate programme resourcing were identified as key enablers.

CONCLUSION: Discovery-based preclinical research is often viewed as being distant from clinical application; therefore, consumer involvement may be considered less relevant. However this study identified value in bringing a strong consumer voice to the discovery-based research process through a coordinated, organisation-wide approach with the potential for application in similar preclinical research settings.

PATIENT OR PUBLIC CONTRIBUTION: Four consumer partners from the DBMRI Consumer Advisory Panel were actively engaged in developing this programme evaluation. Specifically, these consumer partners co-developed and pilot-tested surveys and interview guides, reviewed and commented on project data analysis and reporting and also contributed as co-authors by editing the manuscript.

PMID:39102693 | DOI:10.1111/hex.13968

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Nevin Manimala Statistics

Using Wearables to Study Biopsychosocial Dynamics in Couples Who Cope With a Chronic Health Condition: Ambulatory Assessment Study

JMIR Mhealth Uhealth. 2024 Aug 5;12:e49576. doi: 10.2196/49576.

ABSTRACT

BACKGROUND: Technology has become an integral part of our everyday life, and its use to manage and study health is no exception. Romantic partners play a critical role in managing chronic health conditions as they tend to be a primary source of support.

OBJECTIVE: This study tests the feasibility of using commercial wearables to monitor couples’ unique way of communicating and supporting each other and documents the physiological correlates of interpersonal dynamics (ie, heart rate linkage).

METHODS: We analyzed 617 audio recordings of 5-minute duration (384 with concurrent heart rate data) and 527 brief self-reports collected from 11 couples in which 1 partner had type II diabetes during the course of their typical daily lives. Audio data were coded by trained raters for social support. The extent to which heart rate fluctuations were linked among couples was quantified using cross-correlations. Random-intercept multilevel models explored whether cross-correlations might differ by social contexts and exchanges.

RESULTS: Sixty percent of audio recordings captured speech between partners and partners reported personal contact with each other in 75% of self-reports. Based on the coding, social support was found in 6% of recordings, whereas at least 1 partner self-reported social support about half the time (53%). Couples, on average, showed small to moderate interconnections in their heart rate fluctuations (r=0.04-0.22). Couples also varied in the extent to which there was lagged linkage, that is, meaning that changes in one partner’s heart rate tended to precede changes in the other partner’s heart rate. Exploratory analyses showed that heart rate linkage was stronger (1) in rater-coded partner conversations (vs moments of no rater-coded partner conversations: rdiff=0.13; P=.03), (2) when partners self-reported interpersonal contact (vs moments of no self-reported interpersonal contact: rdiff=0.20; P<.001), and (3) when partners self-reported social support exchanges (vs moments of no self-reported social support exchange: rdiff=0.15; P=.004).

CONCLUSIONS: Our study provides initial evidence for the utility of using wearables to collect biopsychosocial data in couples managing a chronic health condition in daily life. Specifically, heart rate linkage might play a role in fostering chronic disease management as a couple. Insights from collecting such data could inform future technology interventions to promote healthy lifestyle engagement and adaptive chronic disease management.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13685.

PMID:39102683 | DOI:10.2196/49576

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Nevin Manimala Statistics

Evaluating patient participation in value-based healthcare: Current state and lessons learned

Health Expect. 2024 Feb;27(1):e13945. doi: 10.1111/hex.13945.

ABSTRACT

INTRODUCTION: Value-based healthcare (VBHC) focusses on increasing value for patients. Hospitals aim to implement VBHC via value improvement (VI) teams for medical conditions. To determine the patient’s perspective on value, collective patient participation is important in these teams. We therefore evaluated the current state of patient participation in VI teams and share lessons learned.

METHODS: This mixed-methods study was conducted at seven collaborating hospitals in the Netherlands. A questionnaire (the public and patient engagement evaluation tool) was tailored to the study’s context, completed by VI team members (n = 147 from 76 different VI teams) and analysed with descriptive statistics. In addition, 30 semistructured interviews were held with VI team members and analysed through thematic analysis. Data were collected between February 2022 and January 2023 and were triangulated by mapping the quantitative results to the interview themes.

RESULTS: Thirty-eight of the 76 included VI teams reported using a form of patient participation. Many respondents (71%) indicated a lack of a clear strategy and goal for patient participation. Multiple VI team members believed that specific knowledge and skills are required for patients to participate in a VI team, but this led to concerns regarding the representativeness of participating patients. Furthermore, while patients indicated that they experienced some level of hierarchy, they also stated that they did not feel restricted hereby. Lastly, patients were satisfied with their participation and felt like equal VI team members (100%), but they did mention a lack of feedback from the VI team on their input.

CONCLUSION: The results imply the lack of full implementation of patient participation within VI teams. Guidelines should be developed that provide information on how to include a representative group of patients, which methods to use, how to evaluate the impact of patient participation, and how to give feedback to participating patients.

PATIENT AND PUBLIC CONTRIBUTION: Two patient advisors were part of the research team and attended the research team meetings. They were involved as research partners in all phases of the study, including drafting the protocol (e.g., drafting interview guides and selecting the measurement instrument), interpreting the results and writing this article.

PMID:39102682 | DOI:10.1111/hex.13945

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Nevin Manimala Statistics

Preoperative chemotherapy with Gemcitabine for pancreatic cancer causes zinc deficiency

Pancreas. 2024 Aug 6. doi: 10.1097/MPA.0000000000002396. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of this study was to investigate how preoperative chemotherapy affected the serum zinc concentrations in patients with pancreatic cancer (PC).

METHODS: Two hundreds and thirty-one patients with PC who underwent pancreatectomy at our department from 2013 to 2019 were enrolled in this study and measured for the serum zinc concentrations before pancreatectomy. Patient characteristics, course of treatment, and laboratory data were analyzed.

RESULTS: One hundred thirty-five patients underwent upfront pancreatectomy and 58 received preoperative Gemcitabine + S1 (GEM + S1) and 29 received Gemcitabine + nab-Paclitaxel (GEM + nab-PTX). Comparing the serum zinc concentrations before and after preoperative treatment, it was found to decrease after treatment with statistical difference (79.3 μg/dl vs. 68.7 μg/dl, p < 0.001). The result was consistent with the investigation for both the patients who received GEM + S1 and those who received GEM + nab-PTX (p = 0.019, p < 0.001, respectively).

CONCLUSIONS: The preoperative chemotherapy consistently reduced the serum zinc concentrations in the PC patients, regardless of their regimen such as GEM + S1 and GEM + nab-PTX. Monitoring the serum zinc concentration and appropriate zinc supplementation may be essential for PC patients undergoing preoperative chemotherapy and pancreatectomy.

PMID:39102680 | DOI:10.1097/MPA.0000000000002396

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Nevin Manimala Statistics

Virtual Clinic Telehealth Abortion Services in the United States One Year After Dobbs: Landscape Review

J Med Internet Res. 2024 Aug 5;26:e50749. doi: 10.2196/50749.

ABSTRACT

BACKGROUND: Telehealth abortion has taken on a vital role in maintaining abortion access since the Dobbs v. Jackson Women’s Health Organization Supreme Court decision. However, little remains known about the landscape of new telehealth-only virtual clinic abortion providers that have expanded since telehealth abortion first became widely available in the United States in 2021.

OBJECTIVE: This study aimed to (1) document the landscape of telehealth-only virtual clinic abortion care in the United States, (2) describe changes in the presence of virtual clinic abortion services between September 2022, following the Dobbs decision, and June 2023, and (3) identify structural factors that may perpetuate inequities in access to virtual clinic abortion care.

METHODS: We conducted a repeated cross-sectional study by reviewing web search results and abortion directories to identify virtual abortion clinics in September 2022 and June 2023 and described changes in the presence of virtual clinics between these 2 periods. In June 2023, we also described each virtual clinic’s policies, including states served, costs, patient age limits, insurance acceptance, financial assistance available, and gestational limits.

RESULTS: We documented 11 virtual clinics providing telehealth abortion care in 26 states and Washington DC in September 2022. By June 2023, 20 virtual clinics were providing services in 27 states and Washington DC. Most (n=16) offered care to minors, 8 provided care until 10 weeks of pregnancy, and median costs were US $259. In addition, 2 accepted private insurance and 1 accepted Medicaid, within a limited number of states. Most (n=16) had some form of financial assistance available.

CONCLUSIONS: Virtual clinic abortion providers have proliferated since the Dobbs decision. We documented inequities in the availability of telehealth abortion care from virtual clinics, including age restrictions that exclude minors, gestational limits for care, and limited insurance and Medicaid acceptance. Notably, virtual clinic abortion care was not permitted in 11 states where in-person abortion is available.

PMID:39102679 | DOI:10.2196/50749

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Predictors of Health Care Practitioners’ Intention to Use AI-Enabled Clinical Decision Support Systems: Meta-Analysis Based on the Unified Theory of Acceptance and Use of Technology

J Med Internet Res. 2024 Aug 5;26:e57224. doi: 10.2196/57224.

ABSTRACT

BACKGROUND: Artificial intelligence-enabled clinical decision support systems (AI-CDSSs) offer potential for improving health care outcomes, but their adoption among health care practitioners remains limited.

OBJECTIVE: This meta-analysis identified predictors influencing health care practitioners’ intention to use AI-CDSSs based on the Unified Theory of Acceptance and Use of Technology (UTAUT). Additional predictors were examined based on existing empirical evidence.

METHODS: The literature search using electronic databases, forward searches, conference programs, and personal correspondence yielded 7731 results, of which 17 (0.22%) studies met the inclusion criteria. Random-effects meta-analysis, relative weight analyses, and meta-analytic moderation and mediation analyses were used to examine the relationships between relevant predictor variables and the intention to use AI-CDSSs.

RESULTS: The meta-analysis results supported the application of the UTAUT to the context of the intention to use AI-CDSSs. The results showed that performance expectancy (r=0.66), effort expectancy (r=0.55), social influence (r=0.66), and facilitating conditions (r=0.66) were positively associated with the intention to use AI-CDSSs, in line with the predictions of the UTAUT. The meta-analysis further identified positive attitude (r=0.63), trust (r=0.73), anxiety (r=-0.41), perceived risk (r=-0.21), and innovativeness (r=0.54) as additional relevant predictors. Trust emerged as the most influential predictor overall. The results of the moderation analyses show that the relationship between social influence and use intention becomes weaker with increasing age. In addition, the relationship between effort expectancy and use intention was stronger for diagnostic AI-CDSSs than for devices that combined diagnostic and treatment recommendations. Finally, the relationship between facilitating conditions and use intention was mediated through performance and effort expectancy.

CONCLUSIONS: This meta-analysis contributes to the understanding of the predictors of intention to use AI-CDSSs based on an extended UTAUT model. More research is needed to substantiate the identified relationships and explain the observed variations in effect sizes by identifying relevant moderating factors. The research findings bear important implications for the design and implementation of training programs for health care practitioners to ease the adoption of AI-CDSSs into their practice.

PMID:39102675 | DOI:10.2196/57224

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Nevin Manimala Statistics

Beyond 5-year survival. A report from the Cooperative Osteosarcoma Study Group (COSS)

Cancer Med. 2024 Jan;13(1):e6893. doi: 10.1002/cam4.6893.

ABSTRACT

PURPOSE: Prognostic factors have been well described for osteosarcoma, but analyses evaluating the further course of long-term survivors are lacking. We used the large database of the Cooperative Osteosarcoma Study Group (COSS) to perform such an analysis.

PATIENTS AND METHODS: The COSS database 1980-04/2019 was searched for 5-year survivors of primary high-grade central osteosarcoma of the extremities or trunk. Identified patients were analyzed for their further survival outcomes, assessing potentially prognostic and predictive factors already evident at initial disease presentation and treatment as well as their disease course during the first 5 years of follow-up.

RESULTS: Two thousand and nine former eligible patients were identified (median age at initial diagnosis 15.1 (2.5-63.0) years; male vs. female 1149 (57.2%) vs. 860 (42.8%); extremities vs. trunk 1927 (95.9%) vs. 82 (4.1%); extremity primaries <1/3 vs. ≥1/3 of the involved bone 997 (67.8%) vs. 474 (32.2%) (456 unknown); localized vs. primary metastatic 1881 (93.6%) vs. 128 (6.4%); osteosarcoma as a secondary malignancy 41/2009 (2.0%)). Therapy starting by chemotherapy versus primary surgery 1860 (92.6%) versus 149 (7.4%); definitive tumor surgery by limb salvage versus ablative 1347 (67.0%) versus 659 (1 no surgery, 2 unknown); tumor response to preoperative chemotherapy documented for 1765 (94.9%) patients receiving neoadjuvant chemotherapy, good (<10% viable tumor) versus poor 1130 (64.0%) versus 635 (36.0%), local radiotherapy documented for 19 (0.9%) tumors. Recurrence during preceding 5 years no versus yes 1681 (83.7%) versus 328 (16.3%). Median follow-up starting 5 years after initial diagnosis 6.1 (0.002-32.2) years; 1815 survivors and 194 deaths. Overall survival after another 5/10/15/20 years 91.7%/88.9%/85.8%/83.4% for all patients; 97.5%/95.2%/92.4%/89.9% if in remission years 1-5 versus 62.7%/57.3%/53.0%/51.2% if recurrence year 1-5 (p < 0.001). Significant predictors of survival for all patients age at diagnosis (p = 0.038), tumor site (p = 0.030), having experienced the osteosarcoma as secondary malignancy (p < 0.001), tumor response to preoperative chemotherapy (p = 0.002). Multivariate Cox regression testing possible for 1759 (87.6%) patients with complete dataset: Having had a recurrence in years 1-5 (p < 0.001), older age at diagnosis (p = 0.009), and osteosarcoma as secondary malignancy (p = 0.013) retained significance.

DISCUSSION: Highly important predictors of death such as the extent of tumor response to chemotherapy no longer remain valid after 5-year survival. The individual history of malignancies and their outcomes seems to gain pivotal importance.

CONCLUSION: This benchmark analysis clearly defined risk factors for the further course of 5-year survivors from osteosarcoma. It argues for large disease-oriented databases as well as for very long follow-up periods. Novel findings will most likely require innovative statistical models to analyze such cohorts.

PMID:39102672 | DOI:10.1002/cam4.6893

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Nevin Manimala Statistics

Help-Seeking Behaviors in a Community Experiencing Multiple, Concurrent Natural Disasters. Lessons from a Greater Houston Community

Issues Ment Health Nurs. 2024 Aug 5:1-8. doi: 10.1080/01612840.2024.2373257. Online ahead of print.

ABSTRACT

Previous disaster research exploring mental health consequences has been conducted after a single disaster. Community mental health nurses offer critical support in the aftermath of a disaster through complex assessments, psychosocial education and treatment. This research examines help-seeking behaviors in a Greater Houston community struggling with two simultaneous disasters, a historic winter freeze amidst the COVID-19 pandemic. Three Mental Health Crisis clinics, staffed by an interdisciplinary team, offered walk-in crisis services. The study characterizes adults who accessed services and describes those who accepted follow-up, subsidized behavioral health therapy or case management, including populations experiencing health disparities. Statistical analysis included descriptive and inferential statistics. Those who recognized the need for behavioral health care and accessed episodic care differed from those who accepted follow-up care. The population that was more likely to accept follow up care largely consisted of females, individuals without a previously existing mental health condition, those who reported trauma exposure, and young adults of Hispanic/Latino origin. Nurses can leverage female support to inspire male adults to seek care and advocate for increased resources and training to support culturally relevant care. Nurses and the interdisciplinary team need to assess for trauma exposure, as it influences care decisions.

PMID:39102666 | DOI:10.1080/01612840.2024.2373257

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Nevin Manimala Statistics

Short and Long-term Effects of Cognitive Behavioral Therapy on Sleep Problems and Psychotic Symptoms in Patients with Psychotic Disorders: A Meta-Analysis Study

Braz J Psychiatry. 2024 Aug 5. doi: 10.47626/1516-4446-2024-3623. Online ahead of print.

ABSTRACT

OBJECTIVE: Sleep problems are common in patients with psychotic disorders, especially schizophrenia. Although pharmacological methods are at the forefront of treatment, this method has some drawbacks. Cognitive behavioral therapy for insomnia (CBT-I) is an option for the treatment of individuals with insomnia. In recent years, there has been an increasing interest in its use in patients with psychotic disorders. This meta-analysis aims to evaluate the effectiveness of CBT-I on sleep problems in patients with psychotic disorders.

METHODS: A systematic search was conducted using PubMed, Scopus, and EBSCO (MEDLINE) databases to identify relevant studies. The study included RCTs and uncontrolled studies that focused on participants diagnosed with schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorders, or unipolar depression with psychotic features, who had sleep problems for at least one month, and who were receiving treatment. The initial search yielded 246 studies, and eight studies were selected for the meta-analysis after screening and applying inclusion and exclusion criteria.The statistical analysis was conducted using the R software.

RESULTS: CBT-I significantly ameliorates insomnia and sleep quality in patients with psychotic disorders during short and long-term periods. In addition to this, CBT-I leads to a significant improvement in psychotic symptoms in the short-term period and contributes significantly to the improvement in mental well-being in both short and long-term periods.

CONCLUSIONS: CBT-I is an effective and valuable method for sleep problems in patients with psychotic disorders and its use is recommended to be widespread.

PMID:39102660 | DOI:10.47626/1516-4446-2024-3623

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Does outcome expectancy predict outcomes in online depression prevention? Secondary analysis of randomised-controlled trials

Health Expect. 2024 Feb;27(1):e13951. doi: 10.1111/hex.13951.

ABSTRACT

BACKGROUND: Evidence shows that online interventions could prevent depression. However, to improve the effectiveness of preventive online interventions in individuals with subthreshold depression, it is worthwhile to study factors influencing intervention outcomes. Outcome expectancy has been shown to predict treatment outcomes in psychotherapy for depression. However, little is known about whether this also applies to depression prevention. The aim of this study was to investigate the role of participants’ outcome expectancy in an online depression prevention intervention.

METHODS: A secondary data analysis was conducted using data from two randomised-controlled trials (N = 304). Multilevel modelling was used to explore the effect of outcome expectancy on depressive symptoms and close-to-symptom-free status postintervention (6-7 weeks) and at follow-up (3-6 months). In a subsample (n = 102), Cox regression was applied to assess the effect on depression onset within 12 months. Explorative analyses included baseline characteristics as possible moderators. Outcome expectancy did not predict posttreatment outcomes or the onset of depression.

RESULTS: Small effects were observed at follow-up for depressive symptoms (β = -.39, 95% confidence interval [CI]: [-0.75, -0.03], p = .032, padjusted = .130) and close-to-symptom-free status (relative risk = 1.06, 95% CI: [1.01, 1.11], p = .013, padjusted = 0.064), but statistical significance was not maintained when controlling for multiple testing. Moderator analyses indicated that expectancy could be more influential for females and individuals with higher initial symptom severity.

CONCLUSION: More thoroughly designed, predictive studies targeting outcome expectancy are necessary to assess the full impact of the construct for effective depression prevention.

PATIENT OR PUBLIC CONTRIBUTION: This secondary analysis did not involve patients, service users, care-givers, people with lived experience or members of the public. However, the findings incorporate the expectations of participants using the preventive online intervention, and these exploratory findings may inform the future involvement of participants in the design of indicated depression prevention interventions for adults.

CLINICAL TRIAL REGISTRATION: Original studies: DRKS00004709, DRKS00005973; secondary analysis: osf.io/9xj6a.

PMID:39102655 | DOI:10.1111/hex.13951