Odds Of Treatment Response Research Articles

Nurse-Supported Self-Directed Cognitive Behavioral Therapy for Insomnia

Cognitive behavioral therapy for insomnia (CBTi) is the standard of care for treating insomnia disorder, but access is limited. Alternative approaches are needed to expand access to the standard of care. To examine the effectiveness of a nurse-supported, self-directed behavioral insomnia intervention for decreasing insomnia severity and improving sleep outcomes among veterans, a population with considerable mental health comorbidity. This randomized clinical trial included 178 patients with insomnia disorder who were recruited from a Veterans Affairs hospital (Durham VA Healthcare System) from September 2019 to April 2022 and randomized following baseline assessment; follow-ups were conducted at 8 weeks (primary end point) and 6 months. Data analysis was primarily conducted during the summer of 2023 and concluded in May 2024. Six weekly phone calls from a nurse interventionist plus assigned treatment manual readings covering CBTi treatment components. The health education manual focused on health topics but not sleep. The primary outcome was the Insomnia Severity Index (score range, 0-28; remission <8; differential improvement of 3 points targeted) score assessed at 8 weeks postrandomization. Secondary outcomes were sleep outcomes, depression, fatigue, treatment response, and remission. Of 178 study participants, the mean (SD) age was 55.1 (13.2) years, and 128 (71.9%) identified as men. At 8 weeks, Insomnia Severity Index scores decreased by an estimated mean (SE) of 5.7 (0.51) points in the intervention group and 2.0 (0.47) points in the control group, a differential mean improvement of 3.7 points (95% CI, -5.0 to -2.4; P < .001). Differences were sustained at 6 months (mean, -2.8; 95% CI, -4.4 to -1.3; P < .001). The intervention also resulted in greater improvements at 8 weeks postrandomization in diary sleep onset latency, wake after sleep onset, and sleep efficiency and actigraphy sleep efficiency; these differences were sustained at 6 months. At 8 weeks, depression and fatigue were significantly reduced, and the odds of treatment response and remission were greater in the intervention group compared with controls. This randomized clinical trial found that despite greater prevalence of mental health conditions and sleep difficulties among veterans, a nurse-supported self-directed CBTi was more effective than health education control for reducing insomnia severity and improving sleep outcomes. Although less effective than therapist-delivered CBTi, findings were comparable with other trials using modified CBTi protocols. ClinicalTrials.gov Identifier: NCT03727438.

P183 Disease activity, comorbidities and functional status predict treatment response to biologic and targeted synthetic disease-modifying anti-rheumatic drugs in psoriatic arthritis

Abstract Background/Aims Much discussion surrounds the optimal therapeutic treatment plan for biologic and targeted synthetic disease modifying anti-rheumatic drugs (bDMARDs/tsDMARDs) when treating psoriatic arthritis (PsA). The current study aims to identify predictors of treatment response among PsA patients initiating bDMARD/tsDMARD treatment, focusing on disease activity, functional status (Health Assessment Questionnaire, HAQ), and comorbidities. Methods The systematic review of clinical trials and observational studies used Medline, Embase and Cochrane databases. Eligible studies included full text papers with quantitative estimates of effect (or data to allow these to be computed). Papers also required a validated assessment of treatment response i.e., Minimal Disease Activity (MDA), or some other marker of treatment response such as treatment continuation. Case reports and conference abstracts were excluded. Results From 2824 articles identified, 27 were included. Across these, &amp;gt;15 different outcomes were used, and measured at &amp;gt; 10 different timepoints. There was consistent evidence to suggest that higher baseline disease activity was associated with a reduction in the likelihood of treatment response, see Table 1. Some studies reported up to 20% reduction in odds of LDA at 6 months associated with each 1 unit increase in DAPSA. Others demonstrated that patients with a high DAS28 (&amp;gt;3.2) experienced over a 90% reduction in the odds of MDA at 12 weeks. Eleven studies (from 15) demonstrated a significant association between baseline function and odds of treatment response. Each 1 unit increase in HAQ-DI decreased the odds of a good EULAR response at 3 months by up to 66%. The presence of comorbidities was also consistently associated with a decrease in treatment response. Studies showed that the presence of comorbidities at baseline lessened the odds of MDA at 6 months by up to 80%. Others reported that comorbidities were associated with a reduction in the odds of 5 year treatment persistence by up to 40%. Conclusion This review shows clear evidence of reduced bDMARD/tsDMARD response in PsA among patients with disease activity, poor function, and comorbidities. Clinicians should be aware of the reduced chances of treatment success and should consider early review of therapy, to consider whether treatment escalation or switching is required. Disclosure C. Addae-Kyereme: None. S. Lembke: None. G.J. Macfarlane: None. G.T. Jones: None.

Diet Quality as a Moderator of Response to Multinutrients for ADHD and Emotional Dysregulation: The MADDY RCT

ObjectivesThe Micronutrients for ADHD in Youth (MADDY) study was an 8-week double-blind RCT of broad spectrum multinutrients (BSMN) for ADHD with emotional dysregulation in children ages 6–12. Primary outcome Clinical Global Impressions-Improvement (CGI-I) showed 3 times as many responders with BSMN (54%) as placebo (18%). Since diet is the primary source of nutrients intake, and diet quality corresponds with nutritional outcomes, this study seeks to determine the role of baseline diet quality as a moderator of treatment response to test the hypothesis that those with poor diet quality should benefit more. Methods124 children (69 BSMN, 55 placebo) in the intent-to-treat analysis had diet quality assessed by Healthy Eating Index-2015 (HEI-2015) component and total scores from the VioscreenTM FFQ. Primary outcome was odds of treatment response, defined by a rating of 1 or 2 (very much or much improved) on CGI-I at week 8. Sensitivity analysis used CGI-I at week 8 as a dimensional outcome (from 1 = very much improved to 7 = very much worse). Logistic regressions were conducted for the primary analysis and linear regressions for the sensitivity analysis, with HEI scores entered as potential moderators. ResultsTotal HEI-2015 score did not moderate treatment response [odds ratio = 1.00 (95% CI: 0.90,1.10), p = 0.994] or improvement [β= –0.01 (95% CI: –0.06,0.04), p = 0.655]. HEI component scores also did not moderate treatment response, though total vegetable intake moderated level of improvement [β= –0.48 (95% CI: –0.82, –0.13), p = 0.007]: those with higher vegetable intake showed greater improvement with BSMN but not with placebo. ConclusionsBSMN may benefit children with ADHD and irritability regardless of diet quality. The finding that higher baseline vegetable intake possibly predisposes to improvement with BSMN is puzzling and worth further exploration of potential mechanisms such that a higher vegetable intake may promote the absorption or utilization of the multinutrients. Funding SourcesThis study was funded by Foundation for Excellence in Mental Health Care, Wells Fargo/Gratis Foundation, and CTSA award #s UL1TR002733, UL1TR002369.

Transforming Population-Based Depression Care: a Quality Improvement Initiative Using Remote, Centralized Care Management.

With the growing prevalence of value-based contracts, health systems are incentivized to consider population approaches to service delivery, particularly for chronic conditions like depression. To this end, UW Medicine implemented the Depression-Population Approach to Health (PATH) program in primary care (PC) as part of a system-wide Center for Medicare and Medicaid Innovation (CMMI) quality improvement (QI) initiative. To examine the feasibility of a pilot PATH program and its impact on clinical and process-of-care outcomes. A large, diverse, geographically disparate academic health system in Western Washington State including 28 PC clinics across five networks. The PATH program was a population-level, centralized, measurement-based care intervention that utilized a clinician to provide remote monitoring of treatment progress via chart review and facilitate patient engagement when appropriate. The primary goals of the program were to improve care engagement and increase follow-up PHQ-9 assessments for patients with depression and elevated initial PHQ-9 scores. We employed a prospective, observational study design, including commercially insured adult patients with new depression diagnoses and elevated initial PHQ-9 scores. The pilot intervention group, consisting of accountable care network (ACN) self-enrollees (N = 262), was compared with a similar commercially insured cohort (N = 2527) using difference-in-differences analyses adjusted for patient comorbidities, initial PHQ-9 score, and time trends. The PATH program was associated with three times the odds of PHQ-9 follow-up (OR 3.28, 95% CI 1.79-5.99), twice the odds of a follow-up PC clinic visit (OR 1.74, 95% CI 0.99-3.08), and twice the odds of treatment response, defined as reduction in PHQ-9 score by ≥ 50% (OR 2.02, 95% CI 0.97-4.21). Our results demonstrate that a centralized, remote care management initiative is both feasible and effective for large academic health systems aiming to improve depression outcome ascertainment, treatment engagement, and clinical care.

Differences in treatment response to a total diet replacement intervention versus a food-based intervention: A secondary analysis of the OPTIWIN trial.

SummaryObjectiveFor every weight loss treatment, there are usually groups of people who lose less than expected. This study sought to determine if response rates to a total diet replacement (TDR) differed from those of a calorie‐restricted, food‐based (FB) diet.MethodsData from OPTIWIN, a 12‐month multicenter trial in adults with a BMI of 30–55 kg/m2, with 26‐week weight‐loss and weight‐maintenance phases, were utilized. Participants (n = 330) were randomized to the OPTIFAST programme (OP) or to a reduced‐energy FB diet. Treatment non‐responders were defined as those who lost <3% of initial weight at months 6 or 12.ResultsThere were 103 (76%) responders in the OP compared with 78 (57%) in the FB group at 12 months. The odds of treatment response at 12 months among participants who were non‐responders at 3 months was not significantly different between the OP and FB groups (p = 0.64). Race, type 2 diabetes status and previous weight loss attempts were significantly associated with responder status. OP responders had higher meal plan adherence and non‐caloric fluid intake compared with FB responders.ConclusionEarly treatment response is more likely and better sustained with TDR compared with an FB diet. Individual and treatment level factors appear to influence early treatment response to behavioural interventions for weight reduction.

Multimodal Residential Treatment for Adolescent Anxiety: Outcome and Associations with Pre-treatment Variables

This study aimed to determine the effect of a multimodal residential treatment program for severe adolescent anxiety, and examine whether treatment outcome was associated with pre-treatment anxiety, comorbid disorders, or participant age or gender. Participants were 70 adolescents (61.4% female, mean age = 15.4years) with a primary anxiety disorder who received residential treatment involving cognitive behavioral therapy and medication management. Treatment outcome was assessed both as the change in adolescent-reported anxiety symptoms, and using treatment response criteria. Results indicated a strong effect of the intervention on symptoms of anxiety, depression, and anxiety-related life interference. Most pre-treatment variables were not associated with treatment outcome. However, higher adolescent-reported pre-treatment anxiety was associated with a greater reduction in anxiety at post-treatment, and the presence of a comorbid anxiety disorder was associated with poorer odds of treatment response. Findings indicate that residential treatment is a robust intervention for adolescent anxiety.

Longer-term treatment of patients with bipolar disorder: a 9-month observational study in Central and Eastern Europe, the Middle East and Africa

ABSTRACTObjective: To compare the longer-term outcomes of pharmacological treatment of patients with a diagnosis of bipolar affective disorder currently suffering a manic or hypomanic episode prescribed olanzapine or non-olanzapine medication in naturalistic, clinical practice settings in Bosnia-Herzegovina, Slovakia, Slovenia, Turkey, Saudi Arabia and Egypt.Research design and methods: Prospective, observational, non-interventional study conducted over 9 months. Inpatients or outpatients who initiated or changed oral bipolar mania medication were grouped into (1) those prescribed olanzapine at baseline (n = 569) and (2) those not prescribed olanzapine (n = 325).Main outcome measure(s): The change from baseline in the Clinical Global Impression Severity scale for bipolar disorder (CGI-BP-S), the rates of symptomatic response and remission (based on CGI-BP-S) and the frequency and nature of treatment-emergent adverse events. Analyses included (1) linear or logistic regression, with adjustment for confounders, based on the last observation carried forward and (2) weighted repeated measures models that adjusted for treatment switching and patient drop-out.Results: When results were adjusted for treatment switching and patient drop-out, patients prescribed olanzapine had significantly better CGI-BP-S scores (mean difference = −0.24; 95% confidence interval [CI] −0.33, −0.16; p < 0.001) and significantly greater odds of treatment response (odds ratio [OR] = 1.86; 95% CI 1.31, 2.65; p < 0.001) and symptom remission (OR = 1.65; 95% CI 1.18–2.32; p = 0.003) than those not prescribed olanzapine. The frequency of most adverse events decreased in both groups. Patients prescribed olanzapine had significantly greater weight gain from baseline (mean increase = 2.66 kg; 95% CI 2.35, 2.98) compared with those not prescribed olanzapine (mean increase = 1.85 kg; 95% CI 1.51, 2.19; p < 0.001).Conclusions: Inclusion of olanzapine is of benefit for pharmacological treatment of patients with bipolar disorder. However, the favourable outcomes observed cannot be directly attributed to olanzapine alone because of the high prevalence of polypharmacy in the patient population.

Third-generation drugs in the chemoradiation of stage III non-small cell lung cancer (NSCLC): A meta-analysis of efficacy and toxicity parameters

7536 Background: The role of third generation drugs (paclitaxel, docetaxel, gemcitabine and vinorelbine) in the chemoradiotherapy to maximize survival and decrease toxicity in NSCLC is unclear. We performed a meta-analysis of published randomized controlled trials (RCT) comparing third generation drugs. Methods: We searched MEDLINE, EMBASE, CENTRAL, proceedings of ASCO and other Cancer Congresses to December 08 for RCTs comparing chemoradiation treatment (CRT) including any type of third generation drugs in stage III NSCLC patients who had not been treated surgically. Standard meta-analysis techniques, using random effects model, were used to compare study arms with regards to treatment response, survival and toxicity data. For treatment response odds ratio (OR), to reach complete response and overall response were calculated. For survival data, hazard ratios (HR) and confidence intervals (CI) of individual studies were calculated based on survival curves-published in the manuscript (Parmar MKB, 1998). Basically two types of comparisons were performed: (1) subgroups defined by the type of CRTs, (2) subgroups defined by the type of drugs administered. Results: We found 18 RCTs including 2725 patients. Concurrent CRT was superior to the pool of other types of CRT (overall survival [OAS] HR 0.76, 95%CI 0.6–0.96, p=0.021) and sequential CRT (OAS HR 0.59, 95%CI 0.39–0.88, p=0.01). CRT with paclitaxel was superior to CRT without paclitaxel or with another type of third generation drug with regard to complete response (OR 1.93, 95%CI 1.02–3.67, p=0.044), with no significant difference in OAS (HR 0.94, 95%CI 0.56–1.57, p=0.799). CRT with paclitaxel was less toxic to CRTs without paclitaxel or with another type of third generation drug with regard to the incidence of grade III and IV anemia (OR 0.1, 95%CI 0.03–0.36, p&lt;0.001) and febrile neutropenia (OR 0.22, 95%CI 0.1–0.49, p&lt;0.001). Conclusions: Paclitaxel has less haematologic toxicity when compared with the other drugs without any significant survival difference. No significant financial relationships to disclose.