Does Hospital Operative Volume Influence the Outcomes of Patients After Heated Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis?

BACKGROUND: For some cancer operations, center volume is associated with improved patient outcomes. Whether this association is true for cytoreductive surgery/heated intraperitoneal chemotherapy (CRS/HIPEC) is unclear. Given the rapidly expanding use of CRS/HIPEC, the aim of this analysis was to determine whether a volume-outcome relationship exists for this strategy. METHODS: The Vizient Clinical Database® was queried for CRS/HIPEC cases from January 2020 through December 2022. Low-, medium-, and high-volume designations were made by sorting hospitals by case volume and creating equal tertiles based on total number of cases. Analysis was performed via one-way ANOVA with post-hoc Tukey test, as indicated. RESULTS: In the 36-month study period, 5165 cases were identified across 149 hospitals. Low- (n = 113), medium- (n = 25), and high-volume (n = 11) centers performed a median of 4, 21, and 47 cases per annum, respectively. Most cases were performed for appendiceal (39.3%) followed by gynecologic neoplasms (20.4%). Groups were similar with respect to age, gender, race, comorbidities, and histology. Low-volume centers were more likely to utilize the ICU post-operatively (59.6% vs. 40.5% vs. 36.3%; p = 0.02). No differences were observed in morbidity (9.4% vs. 7.1% vs. 9.0%, p = 0.71), mortality (0.9% vs. 0.6% vs. 0.7%, p = 0.93), length of stay (9.3 vs. 9.4 vs. 10 days, p = 0.83), 30-day readmissions (5.6% vs. 5.6% vs. 5.6%, p = 1.0), or total cost among groups. CONCLUSIONS: No association was found between CRS/HIPEC hospital volume and post-operative outcomes. These data suggest that in academic medical centers with HIPEC programs, outcomes for commonly treated cancers are not associated with hospital volume.

Moderators of Loneliness Trajectories in People with Systemic Sclerosis During the COVID-19 Pandemic: A SPIN COVID-19 Cohort Longitudinal Study.

BACKGROUND: Many individuals with systemic sclerosis (SSc) are at heightened risk for COVID-19 related morbidity and isolation due to interstitial lung disease, frailty, and immunosuppressant use. Minimal research has explored loneliness predictors in individuals with chronic illnesses during COVID-19. This study evaluated moderators of loneliness trajectories in individuals with SSc during COVID-19. METHODS: Longitudinal data were analyzed across 30 timepoints from April 2020 to May 2022 from 775 adults in the Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Cohort. Hierarchical linear modeling evaluated cross-level moderators of loneliness trajectories, including marital status, baseline number of household members, number of virtual or telephone one-on-one or virtual group conversations, number of hours spent enjoying in-person household conversations or activities, and satisfaction with quality of in-person household conversations (all in the past week). Level-1 moderation analyses assessed effects of conversation, activity, and satisfaction means and slopes over time. RESULTS: Baseline values were not statistically significant moderators of loneliness trajectories. Higher mean (averaged over time) virtual or telephone one-on-one and in-person household conversations, in-person household activity, and in-person household conversation satisfaction were associated with lower loneliness trajectories (ps < .05). The relationship between in-person household conversation satisfaction and loneliness trajectory was statistically significantly but minimally attenuated over time (p < .001). CONCLUSIONS: For people with SSc, higher mean conversation, activity, and satisfaction variables were associated with lower levels of loneliness during the pandemic, but changes in these social variables were generally not predictive of changes in loneliness.

Mental health symptoms in scleroderma during COVID-19: a Scleroderma Patient-centred Intervention Network (SPIN) cohort longitudinal study.

OBJECTIVES: People with systemic sclerosis (SSc) are vulnerable in COVID-19 and face challenges related to shifting COVID-19 risk and protective restrictions. We evaluated mental health symptom trajectories in people with SSc through March 2022. METHODS: The longitudinal Scleroderma Patient-centred Intervention Network (SPIN) COVID-19 cohort was launched in April 2020 and included participants from the ongoing SPIN Cohort and external enrolees. Analyses included estimated means with 95% CIs for anxiety and depression symptoms pre-COVID-19 for ongoing SPIN Cohort participants and anxiety, depression, loneliness, and fear of COVID-19 for all participants across 28 COVID-19 assessments up to March 2022. We conducted sensitivity analyse including estimating trajectories using only responses from participants who completed >90% of items for ≥21 of 28 possible assessments ("completers") and stratified analyses for all outcomes by sex, age, country, and SSc subtype. RESULTS: Anxiety symptoms increased in early 2020 but returned to pre-COVID-19 levels by mid-2020 and remained stable through March 2022. Depression symptoms did not initially change but were slightly lower by mid-2020 compared to pre-COVID-19 and were stable through March 2022. COVID-19 fear started high and decreased. Loneliness did not change across the pandemic. Results were similar for completers and for all subgroups. CONCLUSIONS: People with SSc continue to face COVID-19 challenges related to ongoing risk, the opening of societies, and removal of protective restrictions. People with SSc, in aggregate, appear to be weathering the pandemic well, but health care providers should be mindful that some individuals may benefit from mental health support.

Magnesium-Based Trigger Point Infiltrations Versus Local Anaesthetic Infiltrations in Chronic Pelvic Myofascial Pain: A Randomized, Double-Blind, Controlled Study.

OBJECTIVE: To determine if a novel, magnesium-based trigger point infiltration formulation is more effective in treating chronic myofascial pelvic pain than lidocaine-only infiltration. METHODS: This was a single-centre, double-blind, randomized controlled trial of women diagnosed with chronic pelvic myofascial pain associated with trigger points. We compared a novel magnesium-based infiltration formulation with lidocaine infiltration of trigger points and with a control group of participants who were waitlisted for a chronic pain clinic. Treatment groups completed a 12-week program that included 8 trigger point injection treatments and 9 visits during which pain scores were recorded and questionnaires administered. The primary outcome measure was change in mean pain score between baseline and the final visit. Secondary outcomes included pain with function scores, scores on the World Health Organization Quality of Life questionnaire, procedural pain, concomitant medication use, and complications. RESULTS: We assigned 44 women diagnosed with chronic myofascial pelvic pain associated with trigger points to either the magnesium-based infiltrate (n = 15), lidocaine infiltrate (n = 17), or waitlist (n = 12) group. In the intent-to-treat analysis, a clinically relevant decrease in mean pain score out of 10 was observed in the magnesium-based (-2.6 ± 3.2) and lidocaine (-2.9 ± 3.1) infiltration groups, but not in the waitlist group (-0.5 ± 2.3). The per protocol analysis post-hoc tests, adjusted for multiple comparisons, found a significant difference in the average change in pain score between the magnesium-based infiltrate and the waitlist groups (P = 0.045), while differences between the lidocaine infiltrate and waitlist groups approached statistical significance (P = 0.052). Both treatment groups saw improvements in pain with function and quality of life scores. CONCLUSION: While this study is underpowered, it does not support the use of a magnesium-based trigger point infiltrate in the treatment of chronic myofascial pelvic pain over lidocaine-only infiltration. Nonetheless, these results are consistent with current management recommendations and suggest improvements in pain, pain with function, and quality of life scores with either magnesium-based or lidocaine-only infiltration. We outline an approach to assessment and treatment that can be adopted by general gynaecologists.

Transfusion-associated adverse events and implementation of blood safety measures - findings from the 2017 National Blood Collection and Utilization Survey.

BACKGROUND: Serious transfusion-associated adverse events are rare in the United States. To enhance blood safety, various measures have been developed. With use of data from the 2017 National Blood Collection and Utilization Survey (NBCUS), we describe the rate of transfusion-associated adverse events and the implementation of specific blood safety measures. STUDY DESIGN AND METHODS: Data from the 2017 NBCUS were used with comparison to already published estimates from 2015. Survey weighting and imputation were used to obtain national estimates of transfusion-associated adverse events, and the number of units treated with pathogen reduction technology (PRT), screened for Babesia, and leukoreduced. RESULTS: The rate of transfusion-associated adverse events requiring any diagnostic or therapeutic interventions was stable (275 reactions per 100,000 transfusions in 2015 and 282 reactions per 100,000 transfusions in 2017). In 2017 among US blood collection centers, 16 of 141 (11.3%) reported screening units for Babesia and 28 of 144 (19.4%) reported PRT implementation; 138 of 2279 (6.1%) hospitals reported transfusing PRT-treated platelets. In 2017, 134 of 2336 (5.7%) hospitals reported performing secondary bacterial testing of platelets (50,922 culture-based and 63,220 rapid immunoassay tests); in 2015, 71 of 1877 (3.8%) hospitals performed secondary testing (87,155 culture-based and 21,779 rapid immunoassay tests). Nearly all whole blood/red blood cell units and platelet units were leukoreduced. CONCLUSIONS: Besides leukoreduction, implementation of most blood safety measures reported in this study remains low. Nationally, hospitals might be shifting from culture-based secondary bacterial testing to rapid immunoassays.

Slowing decline in blood collection and transfusion in the United States - 2017.

INTRODUCTION: The National Blood Collection and Utilization Survey (NBCUS) has demonstrated declines in blood collection and transfusion in the United States since 2008, including declines of 11.6% in red blood cell (RBC) collections and 13.9% in RBC transfusions during 2013-2015. This study described the 2017 NBCUS results. METHODS: The 2017 NBCUS was distributed to all US blood collection centers, all hospitals performing at least 1000 surgeries annually, and a 40% random sample of hospitals performing 100 to 999 surgeries annually. Weighting and imputation were used to generate national estimates for units of blood and components collected, deferred, distributed, transfused, and outdated. RESULTS: Response rates for the 2017 NBCUS were 88% for blood collection centers and 86% for transfusing hospitals. Compared with 2015, the number of RBC units collected during 2017 (12,211,000; 95% confidence interval [CI], 11,680,000-12,742,000) declined by 3.0%, and transfused RBC units (10,654,000, 95% CI, 10,314,000-10,995,000) declined by 6.1%. Distributed platelet (PLT) units (2,560,000; 95% CI, 2,391,000-2,730,000 units) increased by 5.1%, and transfused PLT units (1,937,000, 95% CI, 1,794,000-2,079,000) declined by 2.3%. Distributed plasma units (3,209,000; 95% CI, 2,879,000-3,539,000) declined by 13.6%, and transfused plasma units (2,374,000; 95% CI, 2,262,000-2,487,000) declined by 12.9%. CONCLUSION: The 2017 NBCUS suggests a continued but slowing decline in demand for RBCs. The decline in blood collection and use will likely continue. Despite decreasing demand and increasing manufacturing costs of blood products, the US blood industry has met the regular and emergent needs of the country.

Social determinants of sleep disturbance in safety-net primary care: unmet needs, classist discrimination, and anxiety.

BACKGROUND: The 3P model proposes that predisposing, precipitating, and perpetuating factors all play a role in sleep disturbance. OBJECTIVE: The purpose of the current study is to investigate social determinants of sleep disturbance by applying the 3P model to a safety-net primary care setting, specifically by evaluating the role of classism and unmet needs as precipitating factors for sleep disturbance, and anxiety as a perpetuating factor for sleep disturbance. METHODS: Participants (N = 210) were a convenience sample of racially/ethnically diverse adults over the age of 18 (age M = 44.7 years) recruited from a safety-net primary care clinic in an urban area. The study employed a cross-sectional design. Participants completed a survey assessing sleep disturbances, anxiety, unmet needs, classism, social support, and a researcher-generated demographic form. RESULTS AND CONCLUSIONS: The unmet need for affordable long-term housing and greater experiences of classism were associated with more sleep disturbance, suggesting that both acted as precipitating factors. In a structural equation model with adequate fit indices, anxiety mediated the relationships with sleep disturbance for both the unmet need for affordable long-term housing and classism, suggesting that it serves as a perpetuating factor. Medical providers are recommended to explore these potential needs in safety-net primary care when patients present with sleep disturbance or anxiety. Assisting with connections to long-term housing and helping patients counteract and cope with classist discrimination may be effective in improving sleep in safety-net primary care.

The minority strengths model: Development and initial path analytic validation in racially/ethnically diverse LGBTQ individuals.

OBJECTIVE: The minority stress model and much research based upon it tend to adopt and reinforce a deficit-based approach. This study created and initially validated the minority strengths model, which by contrast outlines how personal and collective strengths in minority populations create resilience and positive mental and physical health. MATERIALS AND METHOD: A sample of 317 lesbian, gay, bisexual, transgender, and queer individuals from diverse racial/ethnic backgrounds completed a national online survey. RESULTS: A minority strengths path model was generated with statistically significant paths and good fit indices, including all possible significant indirect effects. The model explained 16.8% of the variance in identity pride, 19.7% in self-esteem, 32.9% in resilience, 41.6% in mental health, and 13.0% in positive health behaviors. CONCLUSIONS: The minority strengths model holds promise to stimulate research on the personal and collective strengths of minority populations and the ways in which strengths generate resilience and positive mental and physical health.

Cost projections for implementation of safety interventions to prevent transfusion-transmitted Zika virus infection in the United States.

BACKGROUND: In August 2016, the Food and Drug Administration advised US blood centers to screen all whole blood and apheresis donations for Zika virus (ZIKV) with an individual-donor nucleic acid test (ID-NAT) or to use approved pathogen reduction technology (PRT). The cost of implementing this guidance nationally has not been assessed. STUDY DESIGN AND METHODS: Scenarios were constructed to characterize approaches to ZIKV screening, including universal ID-NAT, risk-based seasonal allowance of minipool (MP) NAT by state, and universal MP-NAT. Data from the 2015 National Blood Collection and Utilization Survey (NBCUS) were used to characterize the number of donations nationally and by state. For each scenario, the estimated cost per donor ($3-$9 for MP-NAT, $7-$13 for ID-NAT) was multiplied by the estimated number of relevant donations from the NBCUS. Cost of PRT was calculated by multiplying the cost per unit ($50-$125) by the number of units approved for PRT. Prediction intervals for costs were generated using Monte Carlo simulation methods. RESULTS: Screening all donations in the 50 states and DC for ZIKV by ID-NAT would cost $137 million (95% confidence interval [CI], $109-$167) annually. Allowing seasonal MP-NAT in states with lower ZIKV risk could reduce NAT screening costs by 18% to 25%. Application of PRT to all platelet (PLT) and plasma units would cost $213 million (95% CI, $156-$304). CONCLUSION: Universal ID-NAT screening for ZIKV will cost US blood centers more than $100 million annually. The high cost of PRT for apheresis PLTs and plasma could be mitigated if, once validated, testing for transfusion transmissible pathogens could be eliminated.

Continued decline in blood collection and transfusion in the United States-2015.

BACKGROUND: In 2011 and 2013, the National Blood Collection and Utilization Survey (NBCUS) revealed declines in blood collection and transfusion in the United States. The objective of this study was to describe blood services in 2015. STUDY DESIGN AND METHODS: The 2015 NBCUS was distributed to all US blood collection centers, all hospitals performing at least 1000 surgeries annually, and a 40% random sample of hospitals performing 100 to 999 surgeries annually. Weighting and imputation were used to generate national estimates for units of blood and components collected, deferred, distributed, transfused, and outdated. RESULTS: Response rates for the 2015 NBCUS were 78.4% for blood collection centers and 73.9% for transfusing hospitals. In 2015, 12,591,000 units of red blood cells (RBCs) (95% confidence interval [CI], 11,985,000-13,197,000 units of RBCs) were collected, and 11,349,000 (95% CI, 10,592,000-11,747,000) were transfused, representing declines since 2013 of 11.6% and 13.9%, respectively. Total platelet units distributed (2,436,000; 95% CI, 2,230,000-2,642,000) and transfused (1,983,000; 95% CI, 1,816,000 = 2,151,000) declined by 0.5% and 13.1%, respectively, since 2013. Plasma distributions (3,714,000; 95% CI, 3,306,000-4,121,000) and transfusions (2,727,000; 95% CI, 2,594,000-2,859,000) in 2015 declined since 2013. The median price paid per unit in 2015-$211 for leukocyte-reduced RBCs, $524 for apheresis platelets, and $54 for fresh frozen plasma-was less for all components than in 2013. CONCLUSIONS: The 2015 NBCUS findings suggest that continued declines in demand for blood products resulted in fewer units collected and distributed Maintaining a blood inventory sufficient to meet routine and emergent demands will require further monitoring and understanding of these trends.

Ensuring cancer nursing is up to date.

Richard Henry, Lecturer in Cancer Nursing, School of Nursing and Midwifery, Queen's University Belfast and President, UK Oncology Nursing Society.

Foreword.

There is a significant body of evidence describing the benefits of using systemic anti-cancer therapy (SACT) agents, such as chemotherapy, biological, hormone and antibiotics, to treat people diagnosed with cancer (Cancer Research UK, 2017). However, the potential improvements in survival outcomes must be regularly weighed against the risk of adverse health effects associated with exposure to them. For patients, the risks are balanced against the need to treat the cancer. For health professionals, the risks simply result from the occupational exposure that can occur when caring for patients receiving these drugs. Collectively referred to as cytotoxic agents, SACTs are known to be toxic; they are considered carcinogenic to humans, and are classified as hazardous (National Institute for Occupational Safety and Health (NIOSH), 2010).

Population genetics identifies challenges in analyzing rare variants.

Geneticists have, for years, understood the nature of genome-wide association studies using common genomic variants. Recently, however, focus has shifted to the analysis of rare variants. This presents potential problems for researchers, as rare variants do not always behave in the same way common variants do, sometimes rendering decades of solid intuition moot. In this paper, we present examples of the differences between common and rare variants. We show why one must be significantly more careful about the origin of rare variants, and how failing to do so can lead to highly inflated type I error. We then explain how to best avoid such concerns with careful understanding and study design. Additionally, we demonstrate that a seemingly low error rate in next-generation sequencing can dramatically impact the false-positive rate for rare variants. This is due to the fact that rare variants are, by definition, seen infrequently, making it hard to distinguish between errors and real variants. Compounding this problem is the fact that the proportion of errors is likely to get worse, not better, with increasing sample size. One cannot simply scale their way up in order to solve this problem. Understanding these potential pitfalls is a key step in successfully identifying true associations between rare variants and diseases.

Declining blood collection and utilization in the United States.

BACKGROUND: The Department of Health and Human Services National Blood Collection and Utilization Survey (NBCUS) has been conducted biennially since 1997. Data are used to estimate national blood collection and utilization. STUDY DESIGN AND METHODS: The 2013 Department of Health and Human Services NBCUS is a cross-sectional survey of all US blood collection centers and hospitals as listed in the 2012 American Hospital Association Annual Survey database that perform at least 100 inpatient surgical procedures annually. The study objective was to estimate, with 95% confidence intervals (CIs), the number of blood and blood components collected and transfused in the United States. RESULTS: In 2013, a total of 14,237,000 whole blood and apheresis red blood cell (RBC) units (95% CI, 13,639,000-14,835,000) were collected with 13,395,000 available for transfusion. Of these, 13,180,000 (95% CI, 12,389,000-13,972,000) whole blood and RBC units were transfused. This represented a 4.4% decline in the number of transfused units compared to 2011. Outdated (i.e., expired without being transfused) whole blood and RBC units declined by 17.3%. Apheresis (2,318,000; 95% CI, 2,154,000-2,482,000) and whole blood-derived platelet (PLT; 130,000; 95% CI, 23,000-237,000) distribution declined in 2013. Total PLT transfusions increased in 2013 (2,281,000) in comparison to 2011 (2,169,000). Total plasma units distributed (4,338,000) and transfused (3,624,000) declined. CONCLUSION: Both blood collection and utilization have declined, but the gap between collection and utilization is narrowing. As collections decline further and hospitals decrease transfusions and manage products more efficiently, the decline in surplus inventory may be a concern for disaster preparedness or other unexpected utilization needs.

Dietary changes in migrant adolescents with increasing length of stay in Australia and associated risk of wheeze--a retrospective, cross sectional study.

BACKGROUND: Recent studies have reported that asthma prevalence increases on migration to Australia. We hypothesised that changes in dietary intake contribute to this phenomenon. The aim of this study was to assess dietary intake in relation to migration status, length of stay in Australia and the association with self-reported wheeze. METHODS: Students (n = 144) in a multicultural high school in Western Sydney completed the asthma symptoms ISAAC video questionnaire (AVQ3.0), spirometry and allergy skin prick tests. A dietitian administered a'Food Frequency' and 'Food Habits' questionnaire and a dietary history interview. RESULTS: Students who spoke a language other than English, consumed a traditional or mixed dietary pattern, with lower consumption of saturated fat, compared to students who spoke English only. Saturated fat intake increased and fibre intake decreased with length of time in Australia. Intake of foods high in saturated or trans fatty acids were positively associated with length of stay in Australia. No associations between nutrient intake or whole food intake and self-reported wheeze were observed. CONCLUSION: As time progressed, dietary intake of immigrant children changed. While this was not associated with the development of wheeze in the students in this cohort, these changes are likely to have negative health consequences.

Acute pain services following surgery for colorectal cancer.

This paper evaluates the pain management provided to patients following surgery for colorectal cancer. These patients were part of an enhanced recovery after surgery (ERAS) programme, which among other goals, aims to reduce length of hospital stay. The aim of the service evaluation was to investigate the success of the pain service in meeting the needs of the patients in relation to provision of analgesia for their postoperative recovery, ensuring that the ERAS programme wasn't compromising patient satisfaction. Findings demonstrate high levels of satisfaction with pain management and the approach of staff. The study also reinforces findings that there is a paradoxical link between pain intensity and patient satisfaction. However, despite advances in care, treatments and services, patients continue to experience high levels of pain after surgery and recommendations are made on how pain management services provided to patients after surgery might be enhanced.

Association of COVID-19 vaccination and anxiety symptoms: A Scleroderma Patient-centered Intervention Network (SPIN) Cohort longitudinal study.

OBJECTIVE: Symptoms of anxiety increased early in the COVID-19 pandemic among people with systemic sclerosis (SSc) then returned to pre-pandemic levels, but this was an aggregate finding and did not evaluate whether vaccination may have contributed to reduced anxiety symptom levels. We investigated whether being vaccinated for COVID-19 was associated with reduced anxiety symptoms among people with SSc. METHODS: The longitudinal Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Cohort was launched in April 2020 and included participants from the ongoing SPIN Cohort and external enrollees. Participants completed measures bi-weekly through July 2020, then every 4 weeks afterwards through August 2022 (32 assessments). We used linear mixed models to evaluate longitudinal trends of PROMIS Anxiety 4a v1.0 anxiety domain scores and their association with vaccination. RESULTS: Among 517 participants included in analyses, 489 (95%) were vaccinated by September 2021, and no participants were vaccinated subsequently. Except for briefly at the beginning, when few had received a vaccine, and end, when only 28 participants remained unvaccinated, anxiety symptom trajectories were largely overlapping. Participants who were never vaccinated had higher anxiety symptoms by August 2022, but there were no other differences, and receiving a vaccination did not appear to change anxiety symptom trajectories meaningfully. CONCLUSION: Vaccination did not appear to influence changes in anxiety symptoms among vulnerable people with SSc during the COVID-19 pandemic. This may be due to people restricting their behavior when they were unvaccinated and returning to more normal social engagement once vaccinated to maintain a steady level of anxiety symptoms.

Development and Evaluation of a Digital App for Patient Self-Management of Opioid Use Disorder: Usability, Acceptability, and Utility Study.

BACKGROUND: Self-management of opioid use disorder (OUD) is an important component of treatment. Many patients receiving opioid agonist treatment in methadone maintenance treatment settings benefit from counseling treatments to help them improve their recovery skills but have insufficient access to these treatments between clinic appointments. In addition, many addiction medicine clinicians treating patients with OUD in a general medical clinic setting do not have consistent access to counseling referrals for their patients. This can lead to decreases in both treatment retention and overall progress in the patient's recovery from substance misuse. Digital apps may help to bridge this gap by coaching, supporting, and reinforcing behavioral change that is initiated and directed by their psychosocial and medical providers. OBJECTIVE: This study aimed to conduct an acceptability, usability, and utility pilot study of the KIOS app to address these clinical needs. METHODS: We developed a unique, patient-centered computational software system (KIOS; Biomedical Development Corporation) to assist in managing OUD in an outpatient, methadone maintenance clinic setting. KIOS tracks interacting self-reported symptoms (craving, depressed mood, anxiety, irritability, pain, agitation or restlessness, difficulty sleeping, absenteeism, difficulty with usual activities, and conflicts with others) to determine changes in both the trajectory and severity of symptom patterns over time. KIOS then applies a proprietary algorithm to assess the individual's patterns of symptom interaction in accordance with models previously established by OUD experts. After this analysis, KIOS provides specific behavioral advice addressing the individual's changing trajectory of symptoms to help the person self-manage their symptoms. The KIOS software also provides analytics on the self-reported data that can be used by patients, clinicians, and researchers to track outcomes. RESULTS: In a 4-week acceptability, usability (mean System Usability Scale-Modified score 89.5, SD 9.2, maximum of 10.0), and utility (mean KIOS utility questionnaire score 6.32, SD 0.25, maximum of 7.0) pilot study of 15 methadone-maintained participants with OUD, user experience, usability, and software-generated advice received high and positive assessment scores. The KIOS clinical variables closely correlated with craving self-report measures. Therefore, managing these variables with advice generated by the KIOS software could have an impact on craving and ultimately substance use. CONCLUSIONS: KIOS tracks key clinical variables and generates advice specifically relevant to the patient's current and changing clinical state. Patients in this pilot study assigned high positive values to the KIOS user experience, ease of use, and the appropriateness, relevance, and usefulness of the specific behavioral guidance they received to match their evolving experiences. KIOS may therefore be useful to augment in-person treatment of opioid agonist patients and help fill treatment gaps that currently exist in the continuum of care. A National Institute on Drug Abuse-funded randomized controlled trial of KIOS to augment in-person treatment of patients with OUD is currently being conducted.