Treatment Completion Rates Research Articles

Advantage in privacy protection by using synchronous video observed treatment enhances treatment adherence among patients with latent tuberculosis infection

BackgroundTreatment of latent tuberculosis infection (LTBI) is an important strategy for active disease prevention. Conventional in-person DOT (CDOT) programs are challenged by patient dissatisfaction over problems of convenience and privacy. The present study assessed satisfaction to DOT program and treatment adherence of synchronous video observed treatment (SVOT) programs from patients’ perspectives. MethodsA two-part questionnaire was presented to 240 subjects with LTBI who received a 9-month isoniazid treatment regimen along with mandatory DOT monitoring during January 2014 to December 2017. ResultsSatisfactions with location arrangement (p<0.001), ensuring treatment adherence (p=0.027), and privacy issues (p=0.005) were superior in the SVOT group. The overall rate of LTBI treatment completion was 91.25%. One (1.25%) and 20 (12.50%) of the participants in the SVOT and CDOT groups, respectively, quit LTBI treatment (p=0.008). Development of adverse events [adjusted hazard ratio, aHR 8.01 (3.42–18.79)], and the concern of privacy infringement [aHR 5.86 (2.69–12.76)] by the DOT program independently increase the risk of withdrawal. SVOT program [aHR 0.21 (0.06–0.68)] and a belief in the importance of adherence on treatment efficacy [aHR 0.29 (0.08–0.98)] were independent predictors preventing patients from withdrawing from treatment. ConclusionsA comprehensive patient-centered DOT program enables high treatment adherence for the 9-month isoniazid LTBI treatment. Furthermore, SVOT was associated with superior patients’ satisfactions which translate into higher treatment completion rates. As treatment adherence is the key to the efficacy of LTBI treatment, SVOT should be a reasonable supplement for LTBI treatment.

Tuberculosis among First Nations, Inuit and Métis children and youth in Canada: Beyond medical management.

First Nations, Inuit and Métis people in Canada continue to be disproportionately affected by tuberculosis (TB), a disparity rooted primarily in factors such as poverty, crowded and inadequate housing, food insecurity, and inequitable health care access. Historical TB control practices in Canada have contributed to stigma and discrimination toward those with the disease, as well as fear and mistrust of the health system. These individual and system-level factors result in delays in TB diagnoses, ongoing transmission, poorer outcomes, and lower treatment completion rates. Children are especially vulnerable, as they are more likely to develop disease once infected with TB bacteria and to experience life-threatening conditions such as TB meningitis. Paediatric health professionals can help to increase TB awareness and literacy, reduce stigma and discrimination, and ultimately, improve the quality and uptake of services for treatment and prevention in families and communities at risk. They can also advocate for sustainable, community-driven TB elimination strategies that incorporate First Nations, Inuit and Métis principles of wellness, healing and self-determination.

Online Acceptance and Commitment Therapy for People with Painful Diabetic Neuropathy in the United Kingdom: A Single-Arm Feasibility Trial.

ObjectiveThis study aimed to assess the feasibility of online Acceptance and Commitment Therapy for painful diabetic neuropathy in the United Kingdom and to determine if a larger randomized controlled trial testing treatment efficacy is justified.MethodsParticipants with painful diabetic neuropathy were recruited online and from hospital services. This was a single-arm study in which all participants received online Acceptance and Commitment Therapy. Participants completed questionnaires at baseline and three months post-treatment. Primary feasibility outcomes were recruitment, retention, and treatment completion rates. Secondary outcomes were pre- to post-treatment effects on pain outcomes and psychological flexibility.ResultsOf 225 potentially eligible participants, 30 took part in this study. Regarding primary feasibility outcomes, the treatment completion and follow-up questionnaire completion rates were 40% and 100%, respectively. Generally, at baseline those who completed the treatment, compared with those who did not, had better daily functioning and higher psychological flexibility. With respect to secondary outcomes, results from the completers group showed clinically meaningful effects at post-treatment for 100% of participants for pain intensity and pain distress, 66.7% for depressive symptoms, 58.3% for functional impairment, 41.7% for cognitive fusion, 66.7% for committed action, 58.3% for self-as-context, and 41.7% for pain acceptance.ConclusionsThis preliminary trial suggests feasibility of recruitment and follow-up questionnaire completion rates, supporting planning for a larger randomized controlled trial. However, treatment completion rates did not achieve the prespecified feasibility target. Changes to the treatment content and delivery may enhance the feasibility of online Acceptance and Commitment Therapy for people with painful diabetic neuropathy on a larger scale.

Stand Out in Class: restructuring the classroom environment to reduce sitting time \u2013 findings from a pilot cluster randomised controlled trial

BackgroundExcessive sedentary behaviour (sitting) is a risk factor for poor health in children and adults. Incorporating sit-stand desks in the classroom environment has been highlighted as a potential strategy to reduce children’s sitting time. The primary aim of this study was to examine the feasibility of conducting a cluster randomised controlled trial (RCT) of a sit-stand desk intervention within primary school classrooms.MethodsWe conducted a two-armed pilot cluster RCT involving 8 primary schools in Bradford, United Kingdom. Schools were randomised on a 1:1 basis to the intervention or usual practice control arm. All children (aged 9–10 years) in participating classes were eligible to take part. Six sit-stand desks replaced three standard desks (sitting 6 children) in the intervention classrooms for 4.5-months. Teachers were encouraged to use a rotation system to ensure all pupils were exposed to the sit-stand desks for > 1 h/day on average. Trial feasibility outcomes (assessed using quantitative and qualitative measures) included school and participant recruitment and attrition, intervention and outcome measure completion rates, acceptability, and preliminary effectiveness of the intervention for reducing sitting time. A weighted linear regression model compared changes in weekday sitting time (assessed using the activPAL accelerometer) between trial arms.ResultsSchool and child recruitment rates were 33% (n = 8) and 75% (n = 176). At follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63 to 97%. A preliminary estimate of intervention effectiveness revealed a mean difference in change in sitting of − 30.6 min/day (95% CI: − 56.42 to − 4.84) in favour of the intervention group, after adjusting for baseline sitting and wear time. Qualitative measures revealed the intervention and evaluation procedures were acceptable to teachers and children, except for some problems with activPAL attachment.ConclusionThis study provides evidence of the acceptability and feasibility of a sit-stand desk intervention and evaluation methods. Preliminary evidence suggests the intervention showed potential in reducing children’s weekday sitting but some adaptations to the desk rotation system are needed to maximize exposure. Lessons learnt from this trial will inform the planning of a definitive trial.Trial registrationISRCTN12915848 (registered: 09/11/16).

Factors affecting uptake and completion of isoniazid preventive therapy among HIV-infected children at a national referral hospital, Kenya: a mixed quantitative and qualitative study

BackgroundTuberculosis (TB) is the most common opportunistic infection and the leading cause of death in people living with HIV (PLHIV). HIV-infected children are at a higher risk of TB infection and disease compared to those without HIV. Isoniazid preventive therapy (IPT) is an effective intervention in preventing progression of latent TB infection to active TB. The World Health Organization (WHO) currently recommends that all children aged > 12 months and adults living with HIV in whom active TB has been excluded should receive a 6-months course of IPT as part of a comprehensive package of HIV care. Despite this recommendation, the uptake of IPT among PLHIV has been suboptimal globally. This study sought to determine the factors affecting IPT uptake and completion among HIV-infected children in a large HIV care centre in Nairobi, Kenya.MethodThis was a cross-sectional mixed methods study comprising of quantitative and qualitative study designs. Medical records of 225 HIV-infected children aged 1 to < 10 years, in care in the Kenyatta National Hospital Comprehensive Care Centre (KNH CCC) were retrospectively reviewed, and 8 purposively selected healthcare providers and 18 consecutively selected caregivers of children were interviewed.ResultsIPT uptake among CLHIV in care in the KNH CCC was 68% (152/225) while the treatment completion rate was 82% (94/115). IPT-related health education and counselling were the main facilitators of IPT uptake and completion, while fear of adverse drug reaction, pill burden and lack of an integrated monitoring and evaluation system for IPT were the major barriers.ConclusionThe IPT uptake in this study was low and fell short of the set global target of > 90%. The completion rate was however acceptable. There is an urgent need to address the identified barriers.

The value of moderate dose escalation for re-irradiation of recurrent or second primary head-and-neck cancer

BackgroundTreatment for local and locoregional recurrence or second head-and-neck (H&N) cancers after previous radiotherapy is challenging, and re-irradiation carries a significantly increased risk for radiotherapy-related normal tissue toxicities and treatment failure due to a radioresistant tumor phenotype. Here, we analyzed re-irradiation management and outcomes in patients with recurrent or second primary H&N carcinoma using state-of-the-art diagnostic procedures and radiotherapy techniques.MethodsBetween 2010 and 2019, 48 patients with recurrent or second primary H&N carcinoma received re-radiotherapy at the University of Freiburg Medical Center and were included in this study. Overall survival (OS) and progression-free survival (PFS) were calculated with the Kaplan-Meier method, and univariate Cox-regression analyses were performed to assess the effects of clinico-pathological factors on treatment outcomes. Acute and chronic treatment-related toxicities were quantified using the Common Terminology Criteria for Adverse Events (CTCAE v4.03).ResultsThirty-one patients (64.6%) received definitive and 17 (35.4%) adjuvant radiotherapy. Simultaneous chemotherapy was administered in 28 patients (58.3%) with cetuximab as the most commonly used systemic agent (n = 17, 60.7%). After a median time of 17 months (range 4 months to 176 months) between first and second radiotherapy, patients were re-irradiated with a median of 58.4 Gy and a treatment completion rate of 87.5% (n = 42). Median OS was 25 months with a 1-year OS amounting to 62.4%, and median PFS was 9 months with a 1-year PFS of 37.6%. Univariate analyses demonstrated that both a lower rT-status and a radiotherapy boost were associated with improved OS (p < 0.05). There was a trend towards superior OS for patients who received > 50 Gy (p = 0.091) and who completed the prescribed radiotherapy (p = 0.055). Five patients (10.4%) suffered from at least one grade 3 toxicities, while 9 patients (27.3%) experienced chronic higher-grade toxicities (≥ grade 3) with one (3.0%) grade 4 carotid blowout and one (3.0%) grade 4 osteoradionecrosis.ConclusionRe-irradiation of recurrent or second primary H&N cancer with modern radiation techniques such as intensity-modulated radiotherapy resulted in promising survival rates with acceptable toxicities compared to historical cohorts. Increased re-irradiation doses, utilization of a radiotherapy boost and completion of the re-irradiation treatment were found to result in improved survival.

Reducing Drinking Among People Experiencing Homelessness: Protocol for the Development and Testing of a Just-in-Time Adaptive Intervention.

BackgroundAdults who are homeless are more likely to have alcohol use disorders (AUDs) compared with domiciled adults. Although AUD treatments are commonly available, many factors (eg, transportation limitations and inability to schedule appointments) contribute to low treatment completion rates and low success rates of these interventions among adults experiencing homelessness. Most adults who are homeless own mobile phones; however, no interventions have been developed that use mobile devices to deliver and support AUD interventions for this population. Mobile phone–based AUD interventions may reduce barriers that have limited the use and utility of traditional interventions.ObjectiveThe aim of this study is to (1) identify variables (eg, affect, stress, geolocation, and cravings) that predict drinking among homeless adults (phase I), (2) develop a mobile intervention that utilizes an algorithm to identify moments of risk for drinking and deliver treatment messages that are tailored to the individual’s current needs in real time (phase II), and (3) pilot test the intervention app (phase III).MethodsIn phase I, adults experiencing homelessness with an AUD (N=80) will complete baseline, equipment, 2-week, and 4-week follow-up visits in person. Participants will be prompted to complete five daily ecological momentary assessments on a study-provided smartphone for 28 days. The smartphone app will collect GPS coordinates every 5 min for the entire 28-day study period. Participants will wear a transdermal alcohol sensor that will objectively measure alcohol use. In phase II, we will use phase I data to develop an algorithm that identifies moments of heightened risk for drinking and develop treatment messages that address risk factors for drinking. Phase III will pilot test the intervention in 40 adults experiencing homelessness with AUD.ResultsThis project was funded in June 2018. IRB approval was obtained in October 2018, and data collection for phase I began in February 2019. Phase III data collection is expected to conclude in 2020. To date, 80 participants have consented to the study, and data analysis for phase I will begin in early 2020.ConclusionsThis research will highlight intervention targets and develop a novel intervention for understudied and underserved adults experiencing homelessness with AUD.International Registered Report Identifier (IRRID)DERR1-10.2196/15610

Older-Adult Marijuana Users in Substance Use Treatment: Characteristics Associated with Treatment Completion

ABSTRACT More older adults are using marijuana and receiving substance use treatment. We used the 2015–2017 Treatment Episode Data Set-Discharges (TEDS-D) to identify characteristics associated with treatment discharge among those aged 50+ whose admission involved marijuana use. Among these discharges (N = 130,287), 7.0% had been admitted for marijuana use only and 93.0% for polysubstance use (13.0% marijuana-primary, 57.7% marijuana-secondary, and 22.3% marijuana-tertiary), and the overall treatment completion rate was 45%. Using logistic regression, we examined associations of detoxification, residential rehabilitation, and outpatient treatment completion with type of marijuana and other substance involvement. Compared to marijuana-only cases, marijuana-tertiary cases had higher odds of completing detoxification (AOR = 1.54, 95% CI = 1.16–2.03), marijuana-secondary cases had higher odds of completing residential rehabilitation (AOR = 1.19, CI = 1.01–1.40), and all polysubstance cases had lower odds of completing outpatient treatment. Of the polysubstance cases, treatment completion odds were higher for those with alcohol problems but lower for those with other illicit drug problems. Previous treatment, referral source, psychiatric problems, first age of marijuana use, and racial/ethnic minority status were significant factors in treatment completion. Better strategies are needed to promote treatment retention and completion among older adults admitted for marijuana use problems, especially those who also have other illicit drug problems.

Guidelines for the treatment of latent tuberculosis infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020

Comprehensive guidelines for treatment of latent tuberculosis infection (LTBI) among persons living in the United States were last published in 2000 (American Thoracic Society. Am J Respir Crit Care Med 161:S221-S247, 2000). Since then, several new regimens have been evaluated in clinical trials. To update previous guidelines, the National Tuberculosis Controllers Association (NTCA) and CDC convened a committee to conduct a systematic literature review and make new recommendations for the most effective and least toxic regimens for treatment of LTBI among persons who live in the United States. The systematic literature review included clinical trials of regimens to treat LTBI. Quality of evidence (high, moderate, low, or very low) from clinical trial comparisons was appraised using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. In addition, a network meta-analysis evaluated regimens that had not been compared directly in clinical trials. The effectiveness outcome was tuberculosis disease; the toxicity outcome was hepatotoxicity. Strong GRADE recommendations required at least moderate evidence of effectiveness and that the desirable consequences outweighed the undesirable consequences in the majority of patients. Conditional GRADE recommendations were made when determination of whether desirable consequences outweighed undesirable consequences was uncertain (eg with low-quality evidence). These updated 2020 LTBI treatment guidelines include the NTCA- and CDC-recommended treatment regimens that comprise three preferred rifamycin-based regimens and two alternative monotherapy regimens with daily isoniazid. All recommended treatment regimens are intended for persons infected with Mycobacterium tuberculosis that is presumed to be susceptible to isoniazid or rifampin. These updated guidelines do not apply when evidence is available that the infecting M tuberculosis strain is resistant to both isoniazid and rifampin; recommendations for treating contacts exposed to multidrug-resistant tuberculosis were published in 2019 (Nahid P, Mase SR Migliori GB, et al Treatment of drug-resistant tuberculosis. An official ATS/CDC/ERS/IDSA clinical practice guideline. Am J Respir Crit Care Med 2019;200:e93-e142). The three rifamycin-based preferred regimens are 3months of once-weekly isoniazid plus rifapentine, 4months of daily rifampin, or 3months of daily isoniazid plus rifampin. Prescribing providers or pharmacists who are unfamiliar with rifampin and rifapentine might confuse the two drugs. They are not interchangeable, and caution should be taken to ensure that patients receive the correct medication for the intended regimen. Preference for these rifamycin-based regimens was made on the basis of effectiveness, safety, and high treatment completion rates. The two alternative treatment regimens are daily isoniazid for 6 or 9months; isoniazid monotherapy is efficacious but has higher toxicity risk and lower treatment completion rates than shorter rifamycin-based regimens. In summary, short-course (3- to 4-month) rifamycin-based treatment regimens are preferred over longer-course (6-9month) isoniazid monotherapy for treatment of LTBI. These updated guidelines can be used by clinicians, public health officials, policymakers, health care organizations, and other state and local stakeholders who might need to adapt them to fit individual clinical circumstances.

A Feasibility and Acceptability Trial of Social Cognitive Therapy in Early Psychosis Delivered Through a Virtual World: The VEEP Study.

BackgroundAddressing specific social cognitive difficulties is an important target in early psychosis and may help address poor functional outcomes. However, structured interventions using standard therapy settings including groups suffer from difficulties in recruitment and retention.AimsTo address these issues, we aimed to modify an existing group social cognitive intervention entitled ‘Social Cognition and Interaction Training' (SCIT) to be delivered through a virtual world environment (Second Life ©).MethodsA single arm nonrandomized proof-of-concept trial of SCIT-VR was conducted. Five groups of three to five individuals per group were recruited over 6 months. Eight sessions of SCIT-VR therapy were delivered through the virtual world platform Second Life© over a 5-week intervention window. Feasibility was examined using recruitment rates and retention. Acceptability was examined using qualitative methods. Secondary outcomes including social cognitive indices, functioning, and anxiety were measured pre- and postintervention.ResultsThe SCIT-VR therapy delivered was feasible (36% consent rate and 73.3% intervention completion rate), acceptable (high overall postsession satisfaction scores) and safe (no serious adverse events), and had high levels of participant satisfaction. Users found the environment immersive. Prepost changes were found in emotion recognition scores and levels of anxiety. There were no signs of clinical deterioration on any of the secondary measures.ConclusionThis proof-of-concept pilot trial suggested that delivering SCIT-VR through a virtual world is feasible and acceptable. There were some changes in prepost outcome measures that suggest the intervention has face validity. There is sufficient evidence to support a larger powered randomized controlled trial.Clinical Trial RegistrationISRCTN, identifier 41443166

Efficacy and feasibility of S-1 plus oxaliplatin (C-SOX) for treating patients with stage III colon cancer (KSCC1303): final analysis of 3-year disease-free survival

Adjuvant chemotherapy is an accepted treatment to improve survival rates in patients with stage III colon cancer, and regimens including oxaliplatin have been shown to be superior to those containing 5-FU alone. The purpose of this study was to examine the efficacy and feasibility of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for patients with stage III colon cancer following curative resection. Patients with colon cancer who underwent curative resection were enrolled and received oral S-1 40-60mg twice daily on days 1-14 every 3weeks plus intravenous oxaliplatin 130mg/m2 on day 1 for eight courses. The primary endpoint was 3-year disease-free survival rate. Secondary endpoints were the rate of treatment completion, adverse events, relative dose intensity, and overall survival. Between February 2014 and December 2014, 89 patients were enrolled. One patient was excluded from the analysis because of ineligibility, and the remaining 88 patients were included. The rate of protocol treatment completion was 72.3%. The relative dose intensity of S-1 and oxaliplatin was 72% and 76.3%, respectively. Hematological severe adverse events (Grade 3/4) were neutropenia (21.3%) and thrombocytopenia (15.7%). The most frequent symptom was diarrhea (Grade 3/4: 5.6%). The incidence of grade 2 neuropathy has decreased from 8.1 to 2.7% after 3years of the therapy. Three-year disease-free survival rate was 73.9% (95% CI 63.8-81.9), and 3-year overall survival rate was 94.3% (95% CI 86.8-97.6) CONCLUSIONS: C-SOX is a safe and feasible adjuvant chemotherapy regimen in patients with stage III colon cancer undergoing curative resection.

Impact of setting insecurity on Cognitive Processing Therapy implementation and outcomes in eastern Democratic Republic of the Congo

ABSTRACT Background: While evidence is growing for the efficacy of trauma-focused mental health interventions in low- and middle-income countries, concerns have been raised about whether these types of interventions can be effectively delivered in contexts with ongoing conflict and violence. Cognitive Processing Therapy (CPT) has been shown to be effective in reducing sexual violence survivors’ psychological symptoms in eastern Democratic Republic of the Congo (DRC), a region with a history of chronic conflict. Objective: The purpose of the present study is to assess the degree to which exposure to different levels of ongoing insecurity impacts effectiveness of an evidence-based trauma-focused psychotherapy for sexual violence survivors. Method: Participants were 158 female sexual violence survivors receiving CPT in seven communities in South Kivu. Participants completed weekly assessments of their symptoms of PTSD and depression as part of CPT. Degree of site insecurity was categorized as high or low levels of ongoing insecurity based on information collected from supervisors and clinicians. Hierarchical linear modelling was used to examine change over time moderated by level of insecurity at the site. Results: Overall, women reported a significant reduction in psychological symptoms over time (b = −2.04, p <.001). Residing in a site of greater insecurity was associated with higher initial symptoms (b = 5.91, p <.01), but similar improvement over time (b = −0.30, p =.10) compared to women living in relatively more secure sites. High rates of attendance and treatment completion were observed. Conclusions: These results support the effectiveness of trauma-focused therapies when provided in a well-structured and well-supervised program even in contexts of ongoing conflict and violence.

Pharmacological Treatment of Methamphetamine/Amphetamine Dependence: A Systematic Review.

BackgroundStimulant drugs are second only to cannabis as the most widely used class of illicit drug globally, accounting for 68 million past-year consumers. Dependence on amphetamines (AMPH) or methamphetamine (MA) is a growing global concern. Yet, there is no established pharmacotherapy for AMPH/MA dependence. A comprehensive assessment of the research literature on pharmacotherapy for AMPH/MA dependence may inform treatment guidelines and future research directions.MethodsWe systematically reviewed the peer-reviewed literature via the electronic databases PubMed, EMBASE, CINAHL and SCOPUS for randomised controlled trials reported in the English language examining a pharmacological treatment for AMPH/MA dependence or use disorder. We included all studies published to 19 June 2019. The selected studies were evaluated for design; methodology; inclusion and exclusion criteria; sample size; pharmacological and (if included) psychosocial interventions; length of follow-up and follow-up schedules; outcome variables and measures; results; overall conclusions and risk of bias. Outcome measures were any reported impact of treatment related to AMPH/MA use.ResultsOur search returned 43 studies that met our criteria, collectively enrolling 4065 participants and reporting on 23 individual pharmacotherapies, alone or in combination. Disparate outcomes and measures (n = 55 for the primary outcomes) across studies did not allow for meta-analyses. Some studies demonstrated mixed or weak positive signals (often in defined populations, e.g. men who have sex with men), with some variation in efficacy signals dependent on baseline frequency of AMPH/MA use. The most consistent positive findings have been demonstrated with stimulant agonist treatment (dexamphetamine and methylphenidate), naltrexone and topiramate. Less consistent benefits have been shown with the antidepressants bupropion and mirtazapine, the glutamatergic agent riluzole and the corticotropin releasing factor (CRF-1) antagonist pexacerfont; whilst in general, antidepressant medications (e.g. selective serotonin reuptake inhibitors [SSRIs], tricyclic antidepressants [TCAs]) have not been effective in reducing AMPH/MA use.ConclusionsNo pharmacotherapy yielded convincing results for the treatment of AMPH/MA dependence; mostly studies were underpowered and had low treatment completion rates. However, there were positive signals from several agents that warrant further investigation in larger scale studies; agonist therapies show promise. Common outcome measures should include change in use days. Future research must address the heterogeneity of AMPH/MA dependence (e.g. coexisting conditions, severity of disorder, differences between MA and AMPH dependence) and the role of psychosocial intervention.Electronic supplementary materialThe online version of this article (10.1007/s40263-020-00711-x) contains supplementary material, which is available to authorized users.

Clinical impact of baseline renal function on the safety of radiotherapy with concurrent docetaxel for esophageal cancer in elderly patients.

We aimed to compare the safety of radiotherapy with concurrent docetaxel (DOC-RT) for esophageal cancer (EC) in elderly patients who were divided into a creatinine clearance (Ccr) < 60mL/min (Ccr-L) group and a Ccr ≥ 60mL/min (Ccr-H) group. Eligible patients included those aged ≥ 76years who were diagnosed with esophageal squamous cell carcinoma. The patients received radiotherapy (60Gy in 30 fractions) and concurrent docetaxel (10mg/m2 weekly for six cycles), after which toxicity and treatment completion rates were retrospectively evaluated. The 73 elderly EC patients receiving DOC-RT were divided into two groups for evaluation: the Ccr-L group (49 patients) and the Ccr-H group (24 patients). The median survival time for patients in the Ccr-L and Ccr-H groups was 21 and 20months, respectively (p = 0.2). The incidence of grade 1 acute kidney injury was 8% vs. 8% (p = 1) in the Ccr-L and Ccr-H groups, respectively. No other hematological or nonhematological toxicities differed between patients in the two groups. No grade 4 or 5 toxicities were observed in the two groups. No significant difference was observed in the treatment completion rates (88% vs. 92%, p = 1) between patients in the Ccr-L and Ccr-H groups. Regardless of baseline renal function, DOC-RT is a safe regimen for elderly patients with EC.

ITTREAT (Integrated Community Test - Stage - TREAT) Hepatitis C service for people who use drugs: Real-world outcomes.

Direct-acting antivirals (DAAs) provide an unprecedented opportunity for a "find-and-treat strategy." We aimed to report real-world clinical, patient reported and health economic outcomes of community-based hepatitis C virus (HCV) screening/treatment in people who use drugs (PWUDs). Project ITTREAT (2013-2021), established at a drug and alcohol treatment centre, offered a comprehensive service. Generic (SF-12v2 and EQ-5D-5L) and liver-specific (SFLDQoL) health-related quality of life (HRQoL) were assessed before and after HCV treatment. Costs/case detected and cured were calculated. Primary outcome measure was sustained virological response (SVR) (intention to treat). Till March 2018, 573 individuals recruited, 462 (81%) males, mean age 40.5±10.0years. Of the 125 treated, 115 (92%) had past/current history of injecting drug use, 88 (70%) were receiving opioid agonist treatment and 50 (40%) were homeless. Twenty-six per cent received interferon-based and 74% DAA-only regimens. SVR (ITT) was 87% (90% with DAAs). Service uptake/HCV treatment completion rates were >95%, HCV reinfection being 2.63/100 person years (95% CI 0.67-10.33). HRQoL improved significantly at end of treatment (EOT) in those with SVR: SFLDQoL (symptoms, memory, distress, loneliness, hopelessness, sleep and stigma) (P</=.011); SF-12 v2 physical and mental health domains (P<.001); and EQ-5D-5L composite profile score (P=.009) and visual analogue scale, P<.001. Cost (British pounds 2018) per case detected was £171; mean cost per cure (excluding medication) was £702±188. Excellent real-world SVRs in PWUDs with significant improvement in HRQoL can be achieved at modest costs. Project ITTREAT endorses community-based integrated services to help achieve HCV elimination.

Improving Quality of Life in Hematopoietic Stem Cell Transplantation Survivors Through a Positive Psychology Intervention.

Despite advances in transplantation medicine, psychological distress and quality of life and functional deficits continue to compromise survivorship after hematopoietic stem cell transplantation (HSCT). With increasing numbers of HSCT survivors, supportive oncology interventions that target health-related outcomes in HSCT survivorship are needed. Here we aimed to test the feasibility and acceptability of a group format phone-delivered positive psychology (PP) intervention in HSCT survivors. This is a one-arm pilot study design that adapted and tested an individual PP intervention used in cardiac disease to a phone-delivered group-based program for HSCT survivors who were .4 to 39 years post-transplantation. All participants received an 8-session weekly PP intervention. We assessed feasibility by the enrollment and intervention completion rates. We examined acceptability on a 10-point Likert scale of ease and utility. Unstructured qualitative interviews were used to obtain participant feedback on the intervention for future application in a larger trial. Self-reported assessments on psychological, functional, and quality of life outcomes were administered at baseline and at follow-up (the end of the intervention). Of 64 eligible participants, 29 (45%) enrolled in the study. For the main aim of intervention feasibility and acceptability, participants completed 96% of all PP sessions and rated the ease (7.6 ± 1.7) and utility (8.1 ± 1.1) of sessions highly. Of the self-reported assessments obtained, the PP intervention resulted in improvements in the resilience scale (mean difference, 2.4 ± 5.4; P=.03). From unstructured qualitative interviews, participants reported the PP exercises and intervention helped them to focus on positive emotions and the group format fostered a sense of community and social support. An 8-week phone-delivered group format PP intervention is feasible and acceptable in HSCT survivors. The piloted intervention could be tested with minor modifications in a randomized study to definitively examine the impact of the group format PP intervention on health-related outcomes.

Adding mitomycin to Bacillus Calmette-Guérin as adjuvant intravesical therapy for high-risk, nonmuscle-invasive urothelial bladder cancer (BCGMM; ANZUP 1301).

TPS602 Background: Adjuvant intravesical bacillus Calmette-Guérin (BCG) decreases disease recurrence and progression in people with high-risk, non-muscle invasive urothelial bladder cancer (NMIBC), however recurrence occurs in 30% despite optimal therapy. Recent meta-analyses evaluating addition of intravesical mitomycin (MM) to BCG showed lower rates of recurrence and cancer-specific mortality in people with NMIBC who received combination regimens. Good quality randomized trials to definitively test this combination are lacking. The BCGMM trial (NCT02948543) will be the largest study to date evaluating this approach in people with high-risk NMIBC. Methods: This open-label phase 3 trial aims to randomize 500 participants, stratified by stage, site of disease, and presence of carcinoma in-situ, to Arm A (BCG induction weekly x6 then monthly x10) or Arm B (BCG + MM weekly x9 then monthly x9). This study is powered to detect a 10% improvement in 2-year disease free survival (DFS) at 5% level of significance with 85% power. Stage 1 of this study, designed to recruit 130 patients to determine rates of treatment completion, activity reflected by cystoscopic findings at 3 months, adverse events, resource use, and health related quality of life, has completed enrolment and successfully established feasibility of this trial protocol. Stage 2, aiming for a further 370 patients, will inform on additional endpoints including differences in DFS, time to recurrence and progression, overall survival, and potential predictive biomarkers, is estimated to complete accrual in December 2020. Successful treatment completion, defined as 75% or more of planned treatment doses, has been achieved in 76% of patients treated in the experimental arm of Stage 1, compared to 60% in those allocated BCG alone. Clinical trial information: NCT02948543.

Guidelines for the Treatment of Latent Tuberculosis Infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020.

SummaryComprehensive guidelines for treatment of latent tuberculosis infection (LTBI) among persons living in the United States were last published in 2000 (American Thoracic Society. CDC targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med 2000;161:S221–47). Since then, several new regimens have been evaluated in clinical trials. To update previous guidelines, the National Tuberculosis Controllers Association (NTCA) and CDC convened a committee to conduct a systematic literature review and make new recommendations for the most effective and least toxic regimens for treatment of LTBI among persons who live in the United States.The systematic literature review included clinical trials of regimens to treat LTBI. Quality of evidence (high, moderate, low, or very low) from clinical trial comparisons was appraised using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. In addition, a network meta-analysis evaluated regimens that had not been compared directly in clinical trials. The effectiveness outcome was tuberculosis disease; the toxicity outcome was hepatotoxicity. Strong GRADE recommendations required at least moderate evidence of effectiveness and that the desirable consequences outweighed the undesirable consequences in the majority of patients. Conditional GRADE recommendations were made when determination of whether desirable consequences outweighed undesirable consequences was uncertain (e.g., with low-quality evidence).These updated 2020 LTBI treatment guidelines include the NTCA- and CDC-recommended treatment regimens that comprise three preferred rifamycin-based regimens and two alternative monotherapy regimens with daily isoniazid. All recommended treatment regimens are intended for persons infected with Mycobacterium tuberculosis that is presumed to be susceptible to isoniazid or rifampin. These updated guidelines do not apply when evidence is available that the infecting M. tuberculosis strain is resistant to both isoniazid and rifampin; recommendations for treating contacts exposed to multidrug-resistant tuberculosis were published in 2019 (Nahid P, Mase SR Migliori GB, et al. Treatment of drug-resistant tuberculosis. An official ATS/CDC/ERS/IDSA clinical practice guideline. Am J Respir Crit Care Med 2019;200:e93–e142). The three rifamycin-based preferred regimens are 3 months of once-weekly isoniazid plus rifapentine, 4 months of daily rifampin, or 3 months of daily isoniazid plus rifampin. Prescribing providers or pharmacists who are unfamiliar with rifampin and rifapentine might confuse the two drugs. They are not interchangeable, and caution should be taken to ensure that patients receive the correct medication for the intended regimen. Preference for these rifamycin-based regimens was made on the basis of effectiveness, safety, and high treatment completion rates. The two alternative treatment regimens are daily isoniazid for 6 or 9 months; isoniazid monotherapy is efficacious but has higher toxicity risk and lower treatment completion rates than shorter rifamycin-based regimens.In summary, short-course (3- to 4-month) rifamycin-based treatment regimens are preferred over longer-course (6–9 month) isoniazid monotherapy for treatment of LTBI. These updated guidelines can be used by clinicians, public health officials, policymakers, health care organizations, and other state and local stakeholders who might need to adapt them to fit individual clinical circumstances.

Equine-Assisted Therapy for Veterans with PTSD: Manual Development and Preliminary Findings.

IntroductionEquine-assisted therapy (EAT) for post-traumatic stress disorder (PTSD) has attracted great interest despite lacking empirical support, a manual, and a standardized protocol. Our team of experts in EAT and PTSD developed an eight-session group EAT treatment protocol for PTSD (EAT-PTSD) and administered it to two pilot groups of military veterans to assess initial effects.Materials and MethodsWe describe the development of the treatment manual, which was used with two pilot groups of veterans. Protocol safety, feasibility, and acceptability were assessed by reported adverse events, treatment completion rates, and self-rated patient satisfaction. Preliminary data on PTSD, depressive, and anxiety symptoms and quality of life were collected pretreatment, midpoint, post-treatment, and at 3-month follow up.ResultsNo adverse events were recorded. All patients completed treatment, reporting high satisfaction. Preliminary data showed decreases in clinician-assessed PTSD and depressive symptoms from pre to post-treatment and follow-up (medium to large effect sizes, d = .54–1.8), with similar trends across self-report measures (d = 0.72–1.6). In our pilot sample, treatment response and remission varied; all patients showed some benefit post-treatment, but gains did not persist at follow-up.ConclusionsThis article presents the first standardized EAT protocol. Highly preliminary results suggest our new manualized group EAT-PTSD appears safe, well-regarded, and well-attended, yielding short-term benefits in symptomatology and quality of life if unclear length of effect. Future research should test this alternative treatment for PTSD more rigorously.

Preliminary analysis of total neoadjuvant therapy for patients with locally advanced gastric (G) and gastroesophageal (GE) adenocarcinoma.

393 Background: Nearly half of patients with G/GE cancer do not receive or complete post-operative chemotherapy and/or chemoradiation (CRT). Total neoadjuvant therapy (TNT) is as an emerging alternate treatment strategy. We have previously reported a 28% pCR with FOLFIRINOX followed by CRT. However, TNT outcomes with FLOT or FOLFOX followed by CRT are lacking. Methods: We retrospectively analyzed patients after resection of locally advanced G/GE after receiving TNT. Patient received neoadjuvant FOLFOX or FLOT x 8 cycles, CRT (G 45 Gy, GE 50.4 Gy) with concurrent chemotherapy (5FU, carboplatin/paclitaxel). The primary aim was to explore TNT completion rates. Secondary aims included pCR and toxicity. We performed descriptive statistics, t-test, chi-squared, and Fisher’s exact tests as appropriate. Results: From 12/2015 to 8/2019, 57.1% (40/70) completed TNT and resection (15.7% active treatment, 15.7% progressive disease, 11% treated elsewhere). Median age was 66.0 (range:27-79) and 73% male. Tumor locations included 57.5% G, 30.0% GE, and 12.5% overlapping. Neoadjuvant chemotherapy included FLOT 22.5% (n = 9) or FOLFOX 77.5% (n = 31). Overall we found a 25% pCR without significant differences between type of neoadjuvant chemotherapy. Conclusions: TNT followed by resection is feasible with acceptable rates of treatment completion and toxicity. Notable limitations include the retrospective analysis, small sample size, and heterogenous treatment. The pCR rate is promising and warrants further prospective study to optimize TNT approaches. [Table: see text]