Routine Care Settings Research Articles

Cognitive behavioural therapy for mood and anxiety disorders delivered by mental health nurses: Outcomes and predictors of response in a real-world outpatient care setting

Objective: The need for mental health nurses (MHNs) to incorporate psychological techniques into their nursing practice has been recognised worldwide. Further evidence from real-world settings is necessary to demonstrate that MNH-led cognitive behavioural therapy (CBT) is an effective approach that can be used in clinical practice. This study aimed to explore the clinical effectiveness and predictors of MNH-led CBT for mood and anxiety disorders in routine outpatient care settings in Japan. Methods: This retrospective study collected data through a medical record review of 69 participants who underwent MHN-led CBT between January 2015 and December 2019. Results: Participants who received MHN-led CBT demonstrated significant improvements in depressive/anxiety symptoms, health-related quality of life and primary psychiatrists' impressions of condition severity (all p <.001). At the end of therapy, more than half of the participants (56.5%) showed positive clinical significance (recovered/improved) based on cutoff points and reliable change indices of validated depression and anxiety measurement scores. Furthermore, an increase in the baseline anxiety score predicted lower odds of achieving positive clinical significance (odds ratio = 0.87, 95% confidence interval = 0.79-0.96). Conclusions: Despite several limitations, mainly owing to its single-group retrospective design, this real-world evidence of MHN-led CBT bridges the gap between research and clinical practice, contributing to the widespread use of MHN-led CBT in mental health services worldwide.

Mindfulness-enhanced internet-based cognitive behavioural therapy for anxiety and depression: Outcomes in routine care

BackgroundClinical trials support the efficacy of mindfulness-enhanced, internet-based cognitive behavioural therapies (CBT) in reducing anxiety and depression symptom severity. However, it is unclear how effective these interventions are when delivered in routine clinical care settings. This study investigated the utilisation and treatment outcomes of an online mindfulness-enhanced CBT program in the general Australian community. MethodsOver a one-year study period, 2187 adults commenced the online mindfulness-enhanced CBT program. The program consisted of six sequential lessons to be completed within 90 days. Participants (mean age= 39 ± 14 years, 68 % female) completed measures of symptom severity for anxiety, depression, and psychological distress at pre-, mid- and post-treatment. Treatment effects were assessed via intention-to-treat linear mixed models with Hedges' g effect size calculations. ResultsFrom pre- to post-treatment, the mindfulness-enhanced CBT program was associated with medium and large effect sized reductions in generalised anxiety symptom severity (g = 0.80, 95%CI: 0.74–0.86), depression symptom severity (g = 0.74, 95%CI: 0.68–0.80), and psychological distress (g = 0.97, 95%CI: 0.90–1.03). Program adherence was modest with approximately 30 % of participants completing all six lessons of the program. LimitationsThis study is limited by its lack of a comparator condition, longer-term follow-up, and assessment of the reasons for participant non-adherence. The relative acceptability and effectiveness of mindfulness versus CBT components was not examined. ConclusionThis study supports the effectiveness of mindfulness-enhanced iCBT for symptoms of anxiety and depression when delivered in a routine care setting under the supervision of community health care practitioners.

Adaptive Nutrition Intervention Stabilizes Serum Phosphorus Levels in Hemodialysis Patients: A Multicenter Decentralized Clinical Trial Using Real-World Data

This study aims to evaluate the effect of an adaptive nutritional and educational intervention for patients on hemodialysis (HD) in a routine care setting, using real-world data from electronic health records. Decentralized clinical trial of seven HD facilities recruited patients who have been on HD for over 3months (N=153) for an 8-week adaptive intervention protocol. Patients were divided into four groups: (1) control (2) education intervention (3) meal intervention (4) education and meal interventions. Educational contents were digitally delivered via mobile phones and premade meals tailored on laboratory findings were home-delivered. Changes in serum electrolytes and malnutrition inflammation score (MIS) were analyzed. Meal intervention statistically significantly stabilized serum phosphorus level (β=-0.81mg/dL, 95% confidence interval=[-1.40, -0.22]) at week 8, with increased likelihood of being within target serum value range (odds ratio=1.21, 95% confidence interval=[1.04, 1.40]). Meal group showed better nutritional status (MIS=3.65) than the education group (MIS=5.10) at week 8 (adjusted p<.05). No significant changes were observed in serum potassium level, depression, and self-efficacy. It was demonstrated that an adaptive meal intervention in a real-world care setting may benefit serum phosphorus control and nutritional status of patients on HD, without negative effect on depression levels or self-efficacy. More work is needed to develop an effective educational intervention.

Stellate Ganglion Block and Intraarterial Spasmolysis in Patients with Cerebral Vasospasm: A Retrospective Cohort Study

BackgroundIn patients with symptomatic cerebral vasospasm (CV) following aneurysmal subarachnoid hemorrhage who do not respond to medical therapy, urgent treatment escalation has been suggested to be beneficial for brain tissue at risk. In our routine clinical care setting, we implemented stellate ganglion block (SGB) as a rescue therapy with subsequent escalation to intraarterial spasmolysis (IAS) with milrinone for refractory CV.MethodsIn this retrospective analysis from 2012 to 2021, patients with CV following aneurysmal subarachnoid hemorrhage who received an SGB or IAS were identified. Patients were assessed through neurological examination and transcranial Doppler. Rescue therapy was performed in patients with mean cerebral blood flow velocity (CBFV) ≥ 120 cm/s and persistent neurological deterioration/intubation under induced hypertension. Patients were reassessed after therapy and the following day. The Glasgow Outcome Scale was assessed at discharge and 6-month follow-up.ResultsA total of 82 patients (mean age 50.16 years) with 184 areas treated with SGB and/or IAS met the inclusion criteria; 109 nonaffected areas were extracted as controls. The mean CBFV decrease in the middle cerebral artery on the following day was − 30.1 (± 45.2) cm/s with SGB and − 31.5 (± 45.2) cm/s with IAS. Mixed linear regression proved the significance of the treatment categories; other fixed effects (sex, age, aneurysm treatment modality [clipping or coiling], World Federation of Neurological Surgeons score, and Fisher score) were insignificant. In logistic regression, the presence of cerebral infarction on imaging before discharge from the intensive care unit (34/82) was significantly associated with unfavorable outcomes (Glasgow Outcome Scale ≤ 3) at follow-up.ConclusionsStellate ganglion block and IAS decreased CBFV the following 24 h in patients with CV. We suggest SGB alone for patients with mild symptomatic CV (CBFV < 180 cm/s), while subsequent escalation to IAS proved to be beneficial in patients with refractory CV and severe CBFV elevation (CBFV ≥ 180 cm/s).

Real-world outcomes of mepolizumab treatment in severe eosinophilic asthma patients - retrospective cohort study in Slovakia.

Mepolizumab, a fully-humanized recombinant IgG1 kappa monoclonal antibody directed against IL-5, has shown improved asthma control and lung function in randomised controlled trials. The aim of this study was to evaluate real-world clinical experience in patients with severe eosinophilic asthma treated with mepolizumab in Slovakia. A retrospective, non-interventional study based on medical records of all adult asthma patients initiating mepolizumab between November 1, 2017 and January 31, 2019, completing 12 months of treatment. At baseline, general and clinical profile data were recorded 12 months prior to treatment. Primary and secondary endpoints described the results of mepolizumab use at 2, 6, and 12 months after the initiation and compared to baseline. Statistical testing of individual change (in each patient) in selected parameters was performed. The cohort included 17 patients with particularly severe asthma at baseline, with frequent severe exacerbations (SE, median 5 [IQR 4-6]/patient/year), high blood eosinophil counts (median 0.6x109/L), frequent oral corticosteroid (OCS) dependence (82.35%), median dose 15 (IQR 7.5-20) mg/day, impaired lung function, and a spectrum of comorbidities. In a one-year follow-up, the data showed reductions in median SE (0 [IQR 0-1] patient/year, eosinophilia (median 0.175x109/L) and OCS maintenance dose (median 6.25 [IQR 2.5-20] mg/day), all statistically significant after 12 months on mepolizumab. Improved and stabilised lung functions throughout the cohort and a reduced incidence of nasal polyposis were observed. The results provide clinical evidence of mepolizumab efficacy in a real sample of patients with severe asthma when administered in routine care settings in Slovakia.

Rates of emergency department visits and acute-care hospital admissions after starting chemotherapy or having surgery across six community-based cancer centers.

6621 Background: Cancer patients who start chemotherapy or have surgery are at risk for serious adverse events, which can include emergency department visits (EDV) and acute-care hospital admissions (ADM). These events are relevant to patients, clinicians, health systems, and policy makers. Few studies have described the frequency and predictors of EDVs and ADMs in the routine care setting. We sought to address this knowledge gap, and to describe the impact of the COVID pandemic on these events, using data from the SIMPRO consortium of six US-based health systems. Methods: In 2019, SIMPRO started a phased deployment of an electronic health record-integrated symptom management program (eSyM) as part of the routine care provided to patients with a suspected or confirmed gastrointestinal, thoracic, and gynecologic malignancy. eSyM prompts patients to complete symptom questionnaires and provides symptom management resources for 180 days after starting chemotherapy and 60 days following surgery. This analysis includes all patients, whether they used eSyM resources or not. Outcomes, which were measured using EHR-based encounter data, included the rates of EDVs and ADMs at 30 and 90-days after starting chemotherapy or following discharge from surgery. To account for potential confounding, we used multivariable logistic regression for the 30-day outcomes and Cox regression for the 90-day outcomes. Results: From September 2019-December 2022, 8664 patients started chemotherapy and 11,578 had surgery, with 3075 and 2587 patients, respectively, experiencing at least one outcome event (Table). 90-day outcomes varied significantly across health systems for chemotherapy (EDV 2-21%, ADM 5-28%) and surgery (EDV 7-14%, ADM 9-18%) patients. In multivariable analyses, patients who reported an employment status of disabled were more likely to report an EDV (OR 1.73-1.96) and an ADM (ORs 1.52-1.96). Widowed status was associated with greater odds of having an ADM (ORs 1.29-1.30), but not an EDV. Cox regression found chemotherapy recipients experienced lower hazards of an EDV, but not an ADM, during 2020 (coinciding with the start of the COVID pandemic). For surgery patients, there was no significant association between calendar year and EDVs or ADMs. [p&lt;0.001 for all reported values]. Conclusions: A meaningful proportion of patients who started chemotherapy or had surgery for a suspected or confirmed malignancy in the routine-care setting had an EDV or ADM within 90 days. Most events occurred within 30 days. Further work is required to ascertain how many of these encounters are avoidable and what structural or procedural interventions could improve outcomes. Clinical trial information: NCT03850912 . [Table: see text]

Phenotypic differences related to homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) treated in routine care settings in the United States (US).

e17047 Background: Recent evidence suggests mutations in HRR genes predict clinical benefit from treatment with PARP inhibitors in patients (pts) with mCRPC. Little is known about the prevalence, clinical and prognostic phenotypes associated with HRR-mutated (HRRm) mCRPC pts receiving routine oncology care in the US. We assessed HRRm positivity rate and described difference in phenotypic factors between HRRm+ and HRRm- mCRPC patients receiving routine care in community oncology settings. Methods: In this retrospective cohort study, we identified biologically male pts with mCRPC, ≥18 years, who received HRRm testing and on systemic anti-cancer treatment from 5/1, 2020 – 3/31, 2022, from the Integra Connect database, an electronic medical record (EMR) and claims database of US cancer pts in community oncology. We defined 2 cohorts based on their HRRm status (defined by the presence of an alteration in at least 1 of the following genes: BRCA1/2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L). We described age and race (at diagnosis), cancer stage and Gleason score (at staging), and line of therapy (LOT), Eastern Cooperative Oncology Group (ECOG) performance status, prostate-specific antigen (PSA) values and microsatellite instability (MSI) status using values closest to mCRPC diagnosis. HRR tests were stratified by germline, ctDNA, and solid tumor. Results: The study cohort comprised 376 HRRm-tested pts: by ctDNA only – 29%, germline only – 16.2%, solid tissue only – 18.4% and &gt; 2 testing types – 33.5%. 96 had HRRm+ mCRPC (25.5%). Median (IQR) age at diagnosis for both cohorts was 67 (43-89) years and there were no statistically significant differences in age, race, stage, Gleason score, PSA value, LOT or ECOG by HRRm status. HRRm+ rates by ctDNA, germline, and solid tissue testing were 26.6%, 13.1% and 21.7%, respectively. Of the 126 patients with &gt; 2 testing types, HRRm+ rate was 30.9%. A higher, but not statistically significant, proportion of HRRm+ pts had Gleason scores 9-10 compared to HRRm- pts (54.8% vs 48.6%). Of HRRm- pts, 10.2% had MSI-H status compared to 6.5% in HRRm+ pts. Conclusions: In this real-world cohort of HRR gene-tested pts with mCRPC, we observed a 25.5% HRRm+ rate, which suggests the prevalence for HRR mutation is significant enough to warrant testing for all pts with mCRPC. Further research is needed to examine the impact of these findings on overall survival and other clinical outcomes.

Use of statistical process control charts to identify impactful implementation strategies for an ePRO-based symptom management program across the SIMPRO Consortium.

6579 Background: Collecting electronic patient reported outcomes (ePROs) reduces the burden of cancer and prevents acute care hospitalizations. However, broad implementation in the routine care setting remains challenging, partly because the optimal implementation strategies – actions that are most likely to encourage adoption and use – are not known. Since 2019, the SIMPRO Consortium has deployed an ePRO-based symptom management program (eSyM) across 6 community-based cancer centers. Methods: We used statistical process control (SPC) charts to identify variation due to special versus common causes (random variation) for one key performance indicator (KPI) – the weekly ePROs response rate. All 6 SIMPRO sites contributed data for this analysis: 3 for chemotherapy patients and 3 for surgery patients. Sites had to have at least 18 months of KPI data; information from the first 4 months after eSyM rollout were excluded to account for program ramp-up. The KPI was calculated as the number of patients who submitted an ePRO questionnaire divided by the number eligible to submit a questionnaire each week. The upper and lower confidence limits were set at +/- 2 sigma to allow for 95% of observations to fall within the limits. Three rules were applied to identify special cause variation: 1) astronomical points (outside sigma limits), 2) shifts (8 or more points above or below a center line), and 3) trends (6 or more points consecutively ascending or descending). Implementation strategies that mapped to special cause variations were selected as those most likely to impact the KPI. Results: Across the 6 sites that deployed eSyM, the mean KPI performance ranged from 19.7%-35.7%. SPC charts detected multiple special cause variations in the KPI at all 6 sites, though the patterns varied by site. All sites demonstrated positive and negative astronomical variations as well as positive and negative shifts. Three sites demonstrated negative trends; no sites demonstrated positive trends. Direct patient outreach was the implementation strategy most frequently associated with special cause variation, followed by changes in promoting the ePRO program to clinical staff. Positive changes were associated with strategy initiation; negative changes were associated with strategy discontinuation. Conclusions: Applying SPC charts to a KPI from the eSyM deployment highlighted the effect of personal communication with patients and providers, suggesting that these implementation strategies could offer value to other sites deploying eSyM. The absence of positive trends early in eSyM program deployment underscores the need to identify better implementation strategies and allocate more resources to foster program adoption and sustainability. Applying SPCs to other KPIs, such as symptom severity and healthcare utilization, could improve eSyM deployment and impact.

Implementation of point-of-care testing of C-reactive protein concentrations to improve antibiotic targeting in respiratory illness in Vietnamese primary care: a pragmatic cluster-randomised controlled trial

In previous trials, point-of-care testing of C-reactive protein (CRP) concentrations safely reduced antibiotic use in non-severe acute respiratory infections in primary care. However, these trials were done in a research-oriented context with close support from research staff, which could have influenced prescribing practices. To better inform the potential for scaling up point-of-care testing of CRP in respiratory infections, we aimed to do a pragmatic trial of the intervention in a routine care setting. We did a pragmatic, cluster-randomised controlled trial at 48 commune health centres in Viet Nam between June 1, 2020, and May 12, 2021. Eligible centres served populations of more than 3000 people, handled 10-40 respiratory infections per week, had licensed prescribers on site, and maintained electronic patient databases. Centres were randomly allocated (1:1) to provide point-of-care CRP testing plus routine care or routine care only. Randomisation was stratified by district and by baseline prescription level (ie, the proportion of patients with suspected acute respiratory infections to whom antibiotics were prescribed in 2019). Eligible patients were aged 1-65 years and visiting the commune health centre for a suspected acute respiratory infection with at least one focal sign or symptom and symptoms lasting less than 7 days. The primary endpoint was the proportion of patients prescribed an antibiotic at first attendance in the intention-to-treat population. The per-protocol analysis included only people who underwent CRP testing. Secondary safety outcomes included time to resolution of symptoms and frequency of hospitalisation. This trial is registered with ClinicalTrials.gov, NCT03855215. 48 commune health centres were enrolled and randomly assigned, 24 to the intervention group (n=18 621 patients) and 24 to the control group (n=21 235). 17 345 (93·1%) patients in the intervention group were prescribed antibiotics, compared with 20 860 (98·2%) in the control group (adjusted relative risk 0·83 [95% CI 0·66-0·93]). Only 2606 (14%) of 18 621 patients in the intervention group underwent CRP testing and were included in the per-protocol analysis. When analyses were restricted to this population, larger reductions in prescribing were noted in the intervention group compared with the control group (adjusted relative risk 0·64 [95% CI 0·60-0·70]). Time to resolution of symptoms (hazard ratio 0·70 [95% CI 0·39-1·27]) and frequency of hospitalisation (nine in the intervention group vs 17 in the control group; adjusted relative risk 0·52 [95% CI 0·23-1·17]) did not differ between groups. Use of point-of-care CRP testing efficaciously reduced prescription of antibiotics in patients with non-severe acute respiratory infections in primary health care in Viet Nam without compromising patient recovery. The low uptake of CRP testing suggests that barriers to implementation and compliance need to be addressed before scale-up of the intervention. Australian Government, UK Government, and the Foundation for Innovative New Diagnostics.

Integrating Acupuncture into a Dialysis Center.

A growing interest in integrating traditional Chinese medicine (TCM) and conventional medicine (CM) to create a more comprehensive approach to healthcare has been verified. Scientific evidence supports acupuncture as an integrative treatment for specific health conditions. The aim of this study was to assess the acceptance and feasibility by patients and healthcare professionals of integrating acupuncture in a dialysis center. Individuals undergoing hemodialysis (HD) who participated in a patient-assessor-blinded randomized controlled trial that evaluated the effect of acupuncture on functional capacity and quality of life were included. Acceptance was measured by adherence (percentage of patients who completed treatments and dropouts) and patients' and healthcare professionals' opinions toward acupuncture (pre- and pro-intervention questionnaires). Feasibility was measured by safety (number of reported adverse events) and effectiveness (changes in functional capacity, peripheral muscle strength, and health-related quality of life scores after treatment). Forty-eight patients were included, and forty-five (93.8%) were analyzed. No adverse events were reported. All patients completed the treatment, and only three patients (6.2%) were lost to the 12-week post-treatment follow-up. The attitudes of patients and health professionals were favorable to acupuncture, namely in relation to its use, degree of discomfort, recommendation to others, and interference with routine care and clinical setting. Integrating acupuncture into a dialysis center seems viable and well-accepted by patients with kidney failure on maintenance HD, doctors and nurses.

Major Update: Masks for Prevention of SARS-CoV-2 in Health Care and Community Settings-Final Update of a Living, Rapid Review.

Optimal use of masks for preventing COVID-19 is unclear. To update an evidence synthesis on N95, surgical, and cloth mask effectiveness in community and health care settings for preventing SARS-CoV-2 infection. MEDLINE, EMBASE, medRxiv (3 June 2022 to 2 January 2023), and reference lists. Randomized trials of interventions to increase mask use and risk for SARS-CoV-2 infection and observational studies of mask use that controlled for potential confounders. Two investigators sequentially abstracted study data and rated quality. Three randomized trials and 21 observational studies were included. In community settings, mask use may be associated with a small reduced risk for SARS-CoV-2 infection versus no mask use, on the basis of 2 randomized trials and 7 observational studies. In routine patient care settings, surgical masks and N95 respirators may be associated with similar risk for SARS-CoV-2 infection, on the basis of 1 new randomized trial with some imprecision and 4 observational studies. Evidence from observational studies was insufficient to evaluate other mask comparisons due to methodological limitations and inconsistency. Few randomized trials, studies had methodological limitations and some imprecision, suboptimal adherence and pragmatic aspects of randomized trials potentially attenuated benefits, very limited evidence on harms, uncertain applicability to Omicron variant predominant era, meta-analysis not done due to heterogeneity, unable to formally assess for publication bias, and restricted to English-language articles. Updated evidence suggests that masks may be associated with a small reduction in risk for SARS-CoV-2 infection in community settings. Surgical masks and N95 respirators may be associated with similar infection risk in routine patient care settings, but a beneficial effect of N95 respirators cannot be ruled out. None.

Feasibility and Acceptability of Group Compassion-Focused Therapy to Treat the Consequences of Childhood Maltreatment in People With Psychiatric Disorders in France.

Childhood maltreatment contributes to the development of psychiatric disorders. Shame appears to be an important mediating factor. Compassion-focused therapy (CFT) targets shame and seems relevant for adults with hard-to-treat psychiatric disorders associated with childhood maltreatment. Nevertheless, few studies have examined the feasibility and relevance of group CFT for this population and none in a French routine care setting. The aim of our study was to evaluate the feasibility and acceptability of group CFT for psychiatric disorders associated with childhood maltreatment. Eight adult patients with a history of childhood maltreatment participated in the 12-session group CFT. Feasibility and acceptability were assessed via a standardized satisfaction questionnaire, dropout rates, and attendance. Clinical benefits were assessed via changes in scores on scales of self-compassion, shame, and psychopathological dimensions. Adherence to therapy (75%) and attendance (88.3%) were high, and all participants reported high satisfaction. Posttreatment, self-compassion significantly increased (p = 0.016), and depression, anxiety, and posttraumatic scores decreased. Our study is the first to show that transdiagnostic group CFT (difficult-to-treat psychiatric disorders associated with a history of child maltreatment) is feasible in a French routine care setting. Changes in clinical scale scores after the intervention suggest the clinical value of the intervention and encourage further research of its effectiveness.

BiomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis): A protocol for a multicentre randomised controlled trial.

To describe the protocol for a multi-centre randomised controlled trial to determine whether treatment protocols monitoring daily CRP (C-reactive protein) or PCT (procalcitonin) safely allow a reduction in duration of antibiotic therapy in hospitalised adult patients with sepsis. Multicentre three-arm randomised controlled trial. UK NHS hospitals. Hospitalised critically ill adults who have been commenced on intravenous antibiotics for sepsis. Three protocols for guiding antibiotic discontinuation will be compared: (a) standard care; (b) standard care + daily CRP monitoring; (c) standard care + daily PCT monitoring. Standard care will be based on routine sepsis management and antibiotic stewardship. Measurement of outcomes and costs. Outcomes will be assessed to 28 days. The primary outcomes are total duration of antibiotics and safety outcome of all-cause mortality. Secondary outcomes include: escalation of care/re-admission; infection re-lapse/recurrence; antibiotic dose; length and level of critical care stay and length of hospital stay. Ninety-day all-cause mortality rates will also be collected. An assessment of cost effectiveness will be performed. In the setting of routine NHS care, if this trial finds that a treatment protocol based on monitoring CRP or PCT safely allows a reduction in duration of antibiotic therapy, and is cost effective, then this has the potential to change clinical practice for critically ill patients with sepsis. Moreover, if a biomarker-guided protocol is not found to be effective, then it will be important to avoid its use in sepsis and prevent ineffective technology becoming widely adopted in clinical practice.

P010 Real world experience of switching to an adalimumab biosimilar; different outcomes for axial spondylitis, psoriatic and rheumatoid arthritis

Abstract Background/Aims Adalimumab is licenced to treat a variety of autoimmune conditions including inflammatory arthropathies. Switching stable patients from the bio-originator Humira to biosimilars has been strongly promoted on economic grounds and presumed equitable interchangeability regarding efficacy and tolerance across all disease indications. Our aims were to assess adalimumab biosimilar retention rates up to 1 year in patients with axial spondylitis (AS), psoriatic (PsA) and rheumatoid arthritis (RA) in a routine care setting and to determine by disease subtype reasons for switching back to Humira. Methods Retrospective observational study, utilising data from the St. George’s Hospital Rheumatology Biologics Database. Demographic details, retention duration and reasons for discontinuation for all patients switched from Humira to an adalimumab biosimilar were recorded up to 1 year. Results 238 patients (female 54.5%) were switched from Humira to an adalimumab biosimilar: AS n = 95, PsA n = 82, RA n = 61. Overall, 53% patients switched back to Humira over a 1-year period, female 57%. By disease subtype, the biosimilar retention rate at 1 year was AS 36%, PsA 61%, RA 46%. Overall, the reason for switching back to Humira was an adverse effect or device specific problem (AE) in 59% and loss of efficacy (IR) in 41%. AEs in 98% were pain and other injection site reactions. By disease subtype, the reason for switching back was: AS 59% IR, 41% AE, PsA 22% IR, 78% AE, RA 27% IR, 73% AE. Conclusion Projected cost savings from the adalimumab biosimilar switch programme were not achieved, with 53% returning to Humira up to 1 year later. By disease indication patients with AS had the lowest retention on the biosimilar, in whom loss of efficacy was more likely than an AE to trigger the switch, and over twice as prevalent than in patients with RA and PsA. AEs were the most prevalent reason for PsA and RA patients to switch back, and citrate in the biosimilar buffer solution was the likely reason for this. The loss of efficacy, particularly prevalent in AS patients, implies that equitable interchangeability between Humira and biosimilar products cannot be assumed, and projected cost saving advantages may be overestimated. Disclosure F.A.A. Holden: None. D. Hill: None. P. Kiely: None.

Baclofen and the Risk of Encephalopathy: A Real-World, Active-Comparator Cohort Study

ObjectiveTo quantify the risk of encephalopathy associated with oral baclofen compared with other muscle relaxants—tizanidine or cyclobenzaprine. Patients and MethodsWe conducted a new-user, active-comparator study of 2 pairwise cohorts using tertiary health system data from Geisinger Health in Pennsylvania (January 1, 2005, through December 31, 2018). Adults (aged ≥18 years) newly treated with baclofen or tizanidine were included in cohort 1. Adults newly treated with baclofen or cyclobenzaprine were included in cohort 2. Propensity score–based inverse probability of treatment weighting (IPTW) was used to balance the respective cohorts on 45 patient characteristics. Fine-Gray competing risk regression was used to estimate the risk of encephalopathy. ResultsCohort 1 included 16,192 new baclofen users and 9782 new tizanidine users. The 30-day risk of encephalopathy was higher in patients treated with baclofen vs tizanidine (IPTW incidence rate, 64.7 vs 28.3 per 1000 person-years) with an IPTW subdistribution hazard ratio (SHR) of 2.29 (95% CI, 1.43 to 3.67). This risk persisted through 1 year (SHR, 1.32 [95% CI, 1.07 to 1.64]). Similarly in cohort 2, baclofen vs cyclobenzaprine was associated with a greater risk of encephalopathy at 30 days (SHR, 2.35 [95% CI, 1.59 to 3.48]) that persisted through the first year of treatment (SHR, 1.94 [95% CI, 1.56 to 2.40]). ConclusionThe risk of encephalopathy was greater with baclofen vs tizanidine or cyclobenzaprine use. The elevated risk was apparent as early as 30 days and persisted through the first year of treatment. Our findings from routine care settings may inform shared treatment decisions between patients and prescribers.

Short term results in a population based study indicate advantage for laparoscopic colon cancer surgery versus open

The aim of this study was to compare LAP with OPEN regarding short-term mortality, morbidity and completeness of the cancer resection for colon cancer in a routine health care setting using population based register data. All 13,683 patients who were diagnosed 2012–2018 and underwent elective surgery for right-sided or sigmoid colon cancer were included from the Swedish Colorectal Cancer Registry and the National Patient Registry. Primary outcome was 30-day mortality. Secondary outcomes were 90-day mortality, length of hospital stay, reoperation, readmission and positive resection margin (R1). Weighted and unweighted multi regression analyses were performed. There were no difference in 30-day mortality: LAP (0.9%) and OPEN (1.3%) (OR 0.89, 95% CI 0.62–1.29, P = 0.545). The weighted analyses showed an increased 90-day mortality following OPEN, P < 0.001. Re-operations and re-admission were more frequent after OPEN and length of hospital stay was 2.9 days shorter following LAP (P < 0.001). R1 resections were significantly more common in the OPEN group in the unweighted and weighted analysis with P = 0.004 and P < 0.001 respectively. Therefore, the favourable short-term outcomes following elective LAP versus OPEN resection for colon cancer in routine health care indicate an advantage of laparoscopic surgery.

Beyond State of the Art: Digital psychiatry is coming of age!

Abstract Digital interventions for common mental disorders are coming of age. The uptake of evidence-based self-guided and guided (a-synchronic in time) cognitive behavioural digital interventions for depression and anxiety in routine care is however low. Blended treatment formats appear an attractive alternative for routine care settings as these combine face-to-face sessions with digital ones in integrated treatment protocols. Yet little is known about the clinical and cost-effectiveness of blended CBT (bCBT). In this presentation I will touch upon the current state of the art of digital interventions for depression and anxiety disorders, including blended formats in routine care and I will go beyond that state by addressing new developments. I will illustrate these new developments by virtue of several studies (RCT’s) we conducted on the clinical and cost-effectiveness of blended CBT interventions (and their implementation) in routine care settings. A specific focus will be put on blending digital phenotyping in CBT treatment which includes mobile ecological momentary assessment tools and AI algorithms. Conclusion While digital mental health for depression and anxiety in routine care was boosted through the Covid-19 pandemic, the question remains whether the current knowledge base will leveraging digital mental health research and services to the next level. Implications for future research on blended treatments and clinical applications in routine care will be discussed. Disclosure of Interest None Declared

Apremilast for biologic-naïve, peripheral psoriatic arthritis, including patients with early disease: results from the APROACH observational prospective study

To evaluate the effect of the phosphodiesterase 4 inhibitor apremilast in biologic-naïve patients with early peripheral PsA in terms of disease activity, clinical manifestations, patient-perceived outcomes, as well as apremilast’s safety profile in routine care settings of Greece. Non-interventional, multicenter, 52-week prospective cohort study, enrolling biologic-naïve patients with early active peripheral PsA who started apremilast after intolerance or inadequate response (within the first 12 months of treatment) to an initial conventional synthetic (cs)DMARD treatment. Non-responder imputation was applied for missing data.In total, 167 consecutive patients (mean age: 52.5 years; median PsA duration: 0.9 years) were analyzed. At baseline, the median (interquartile range) clinical Disease Activity in Psoriatic Arthritis (cDAPSA) score was 22.0 (16.0–29.0), with 86.8% of patients having at least moderate (29.3% high) disease activity; 87.4% had skin psoriasis, 37.7% nail psoriasis, 30.7% enthesitis, and 12.4% dactylitis. At 16, 24, and 52 weeks, 28.7, 42.5, and 48.5% of patients, achieved ≥ 50% improvement in their baseline cDAPSA score, respectively. At week 52, 55.6, 50, and 26.8% of evaluable patients achieved complete resolution of enthesitis, dactylitis and nail psoriasis, respectively. Improvements were also observed in patient’s health state assessed by the Psoriatic Arthritis Impact of Disease 12-item questionnaire, and health-related quality of life. The 52-week drug survival rate was 75%, while 13.8% of patients experienced at least one adverse drug reaction.Biologic-naïve patients with early PsA, treated with apremilast experienced significant improvements in disease activity, extra-articular manifestations and patient-centered outcomes, accompanied by a favorable tolerability profile.

Therapist perceptions of experiential training for exposure therapy.

Despite evidence for its efficacy, exposure therapy for anxiety is rarely used in routine care settings. Efforts to address one major barrier to its use - therapists' negative beliefs about exposure - have included therapist-level implementation strategies, such as training and consultation. Experiential training, in which therapists themselves undergo exposures, has recently demonstrated feasibility, acceptability and preliminary effectiveness for increasing exposure use. This study aimed to assess: (1) therapists' perceptions of experiential training and (2) barriers and facilitators to implementing exposure following training. Therapists who underwent experiential training (n=12) completed qualitative interviews and quantitative questionnaires. Interviews were coded using an integrated approach, combining both inductive and deductive approaches. Mixed methods analyses examined how themes varied by practice setting (community mental health versus private practice) and exposure use. Results highlight how therapist-level factors, such as clinician self-efficacy, interact with inner- and outer-setting factors. Participants reported positive perceptions of exposure after training; they noted that directly addressing myths about exposure and experiencing exposures themselves improved their attitudes toward exposure. Consistent with prior literature, issues such as insufficient supervisory support, organizational constraints, and client characteristics made it challenging to implement exposures. Results highlight the benefits of experiential training, while also highlighting the need to consider contextual determinants. Differences in responses across practice settings highlight areas for intervention and the importance of tailoring implementation strategies. Barriers that were specific to therapists who did not use exposure (e.g. hesitancy about its appropriateness for most clients) point to directions for future implementation efforts.

Adherence and effectiveness of an emotion-based psychodynamic online self-help during and after inpatient and day-care psychotherapy: Results of a naturalistic study.

Internet-based mental health interventions are considered effective in providing low-threshold support for people with mental health disorders. However, there is a lack of research investigating the transferability of such online programs into routine care settings. Low treatment adherence and problems with technical implementation often limit a successful transfer into clinical routines. This naturalistic study aims to identify influencing factors on program adherence in patients who participated in an online intervention during inpatient or day-clinic psychotherapeutic treatment. In a naturalistic study, we investigated the transferability of the transdiagnostic psychodynamic online self-help program KEN-Online, which includes eight consecutive units. Between May 2017 and October 2018, patients who received inpatient or day-clinic psychotherapeutic treatment at the Department of Psychosomatic Medicine and Psychotherapy in the University Medical Center Mainz have been offered to use KEN-Online. Of the n = 749 patients who were admitted to the clinic, n = 239 patients (32%) registered for participation in KEN-Online. While 46.9% of the participants did not complete any unit (inactive participants), 53.1% completed at least the first unit (active participants). Age, number of diagnoses, and symptom severity were associated with (in)active participation. Adherence decreased over time resulting in only 17 participants (7.6%) who completed all units. None of the sociodemographic and medical characteristics proved to be significant predictors of adherence. Analyses of effectiveness showed a significant reduction of anxiety and depression in active participants in the course of participation, with higher improvements in participants that completed more than half of the units. Adherence to the online self-help program KEN-Online was lower in the naturalistic setting than in a previous clinical trial, but was still associated with greater program effectiveness. Adherence-promoting measures are crucial to increase the effectiveness of such interventions in clinical settings.