Efficacy of anti-TNF dosing interval lengthening in adolescents and young adults with inflammatory bowel disease in sustained remission (FREE-study): protocol for a partially randomised patient preference trial

IntroductionAnti-tumour necrosis factor (TNF) therapy has greatly improved treatment outcomes in patients with inflammatory bowel disease (IBD), but long-term use is associated with cutaneous reactions, susceptibility to infections and frequent injections or hospital visits. Several non-controlled studies have demonstrated that dose reduction is feasible for a subset of patients, provided that early detection of a disease flare is possible. Here, we aim to compare the effectiveness of interval lengthening with standard dosing in maintaining remission in young patients with IBD.Methods and analysisIn this international, prospective, non-inferiority, partially randomised patient preference trial, we aim to recruit 148 patients aged 12–25 years with luminal Crohn’s disease or ulcerative colitis in sustained remission (ie, three consecutive in-range faecal calprotectin (FC) results or recently confirmed endoscopic remission). In the interventional arm, the dosing interval will be lengthened from 8 to 12 weeks for infliximab users and from 2 to 3 weeks for adalimumab users. In the control group, standard dosing will be continued. Rapid tests will be performed for FC every 4 weeks and for anti-TNF trough levels every 12 weeks. The primary outcome is the cumulative incidence of out-of-range FC results at 48-week follow-up. Secondary endpoints include time to get out-of-range FC results, cumulative incidence of adverse effects, proportion of patients progressing to loss of response and identification of predictors of successful interval lengthening.Ethics and disseminationThe protocol has been approved by the Medical Ethics Review Committee of the University Medical Centre Groningen and is pending at the other participating centres. Results will be disseminated in peer-reviewed journals and presented at scientific meetings.Trial registration numberEudraCT number: 2020-001811-26; ClinicalTrials.gov Identifier: NCT04646187. Protocol version 4, date 17 September 2021.

PSIV-B-18 Performance response of weanling and grower pigs fed graded levels of poultry byproduct meal (PBM) in the diet

Two experiments were conducted to investigate effects of feeding graded levels of PBM on performance of weanling pigs and to evaluate feed preference for PBM-based diets relative to spray-dried plasma protein (SDPP)-based diets. A third experiment evaluated PBM in grower diets on performance. In Exp. 1, 120 pigs [body weight (BW) 7.1 ± 0.6 kg] were randomly allotted to 1 of 5 treatments (0, 1, 2, 3, or 5% PBM) and housed 4 pigs/pen for a 28-d growth trial. In Exp. 2, 60 pigs (BW 6.7 ± 1.4 kg) were randomly allotted to 1 of 3 comparisons including: Comparison 1) 0% PBM vs. 2% PBM, Comparison 2) 0% PBM vs. 2% SDPP, and Comparison 3) 2% PBM vs. 2% SDPP and housed 4 pigs/pen for a 28-d preference trial; pigs were provided ad libitum access to feeders; feeder location was switched 3 times/wk. In Exp. 3, 120 pigs (BW 25.9 ± 2.1 kg) were randomly allotted to 1 of 4 treatments (0, 1.25, 2.5 or 5% PBM) and housed 5 pigs/pen for a 41-d growth trial. Increasing PBM from 0 to 5% in Exp. 1 resulted in no differences in ADG (398, 417, 424, 432, and 428 g) or G:F (0.675, 0.686, 0.733, 0.711, and 0.717). Feed preference results (Exp. 2) demonstrated that pigs consumed a higher percentage (76 vs. 24%, P < 0.01) of their total feed intake from the 2% PBM-based diet compared to the 2% SDPP-based diet (Comparison 3). In Exp. 3, increasing PBM for grower pigs resulted in no differences in ADG (1007, 1025, 1002, and 1025 g) or G:F (0.484, 0.472, 0.484, and 0.478). Thus, feeding PBM up to 5% of the diet had no effect on overall performance of nursery or grower pigs, indicating it is an acceptable option as a feed ingredient.

Translation of Two Healthy Eating and Active Living Support Programs for Parents of 2–6-Year-Old Children: Outcomes of the ‘Time for Healthy Habits’ Parallel Partially Randomised Preference Trial

This translation study assessed the effectiveness of two remotely delivered healthy eating and active living interventions for parents of 2- to 6-year-old children in improving child fruit and vegetable intake, non-core food intake, body mass index (BMI), physical activity, screen time, and sleep. Parents (n = 458) were recruited to a partially randomised preference trial comprising three intervention groups. Healthy Habits Plus comprised six telephone calls, Time2bHealthy comprised six online modules, and the active control comprised ten information sheets and a summary booklet. Data were collected from parents via a telephone questionnaire at baseline and nine months post-baseline. Data were analysed for randomised participants alone (n = 240), preference participants alone (n = 218), and all participants combined (n = 458). There was no significant improvement in fruit and vegetable intake (primary outcome) when comparing the telephone and online interventions to the control. In both the randomised only and all participants combined analyses, there was a significant improvement in non-core food intake for the telephone intervention compared to the control (p < 0.001). Differences between interventions for other outcomes were small. In conclusion, the telephone and online interventions did not improve child fruit and vegetable intake relative to written materials, but the telephone intervention did improve non-core food intake.

The Effectiveness of the Digital Care Platform CMyLife for Patients With Chronic Myeloid Leukemia: Patient-Preference Trial (Preprint)

BACKGROUND The two most important factors determining treatment success in chronic myeloid leukemia (CML) are adequate medication compliance and molecular monitoring, but both are still suboptimal. The CMyLife platform is an eHealth innovation, co-created with and for CML patients. CMyLife aims to provide these patients with tools and knowledge to have more control over their disease process and improve medication compliance and molecular monitoring. This could eventually lead to an increased quality of life and the opportunity of hospital-free care. OBJECTIVE The aim of this study was to explore the effectiveness of CMyLife in terms of information provision, patient empowerment, medication compliance, molecular monitoring, and quality of life. METHODS The effectiveness of CMyLife was explored using a patient-preference trial. Participants received a written baseline questionnaire by mail. Upon completion of the baseline questionnaire, participants actively used (intervention group) or did not actively use (questionnaire group) the CMyLife platform for at least six months, after which they completed the post-intervention questionnaire. The scores between the intervention group and the questionnaire group were compared with regard to the within-subject change between baseline and post-measurement using Generalized Estimating Equation models. RESULTS At baseline, 33 patients were enrolled in the questionnaire group and 75 in the intervention group. After six months, 29 patients filled in the post-intervention questionnaire in the questionnaire group and 57 patients filled in the post-intervention questionnaire in the intervention group. Online health information knowledge improved significantly when actively using CMyLife and patients felt more empowered. No significant improvements were found regarding medication compliance and molecular monitoring, which were already outstanding. However, self-reported effectiveness showed that patients experienced that using CMyLife improved their medication compliance and helped them to oversee their molecular monitoring. Patients using CMyLife reported more symptoms but were better able to manage these. CONCLUSIONS In the future, an iterative process of assessing patients’ needs and further adjustment of CMyLife is required, to keep care patient-centered and put patients in lead of their disease process. Since hospital-free care has shown to be feasible in time of the COVID-19 pandemic, eHealth-based innovations such as CMyLife could be a solution to maintain the quality of care and make current oncological health care services more sustainable. CLINICALTRIAL ClinicalTrials.gov NCT04595955

Influence of preferences in intervention research: A scoping review

Introduction: Accounting for treatment preferences is beneficial in practice, it increases adherence to treatment and improves health outcomes. The randomized controlled trial (RCT) is considered the most robust in generating valid evidence on effectiveness, yet it ignores participants’ preferences for treatment. This scoping review addressed three questions: 1) How are treatment preferences conceptualized in intervention research? 2) To what extent do treatment preferences affect participants’ enrollment in trials, withdrawal from the study, adherence to treatment, and outcomes? And 3) What designs are used to account for treatment preferences in intervention evaluation research? Methods: The first five steps of the scoping review methodology framework were applied: 1) identifying the research questions; 2) searching the literature; 3) selecting articles; 4) charting data; and 5) summarizing findings. Results: Treatment preferences refer to choice treatment; they are shaped by participants’ beliefs and appraisal of the interventions. Evidence from reviews and primary studies indicated that offering participants the opportunity to choose and receive the preferred treatment enhances enrollment and reduces withdrawal in trials; however, the evidence regarding the influence of treatment preferences on adherence to treatment and improvement in outcomes is inconclusive. Designs that account for treatment preferences include: RCT, RCT with a comprehensive cohort, partially randomized preference trial, and two-stage partially randomized trial. Conclusion: The pattern of results may be attributed to the methods for assessing treatment preferences. A systematic method for assessing preferences is recommended.

Effects of Treatment Preference on Adherence, Attrition, and Process Measures Among Older Adult Worriers

Patient preference may be related to treatment outcomes through decreased rates of attrition and higher rates of adherence and patient satisfaction. We present findings from a 2-stage randomized preference trial of cognitive-behavioral therapy (CBT) and yoga for the treatment of late-life worry. We examine rates of preference for CBT and yoga, as well as the stability of these preferences over time. We also examine the impact of preference on adherence, attrition, and process measures (satisfaction, treatment expectancies, and working alliance). Five hundred participants were randomized to either the randomized controlled trial (RCT; N=250) or the preference trial (participants chose the treatment; N=250). All participants received 10 weeks of an intervention. Among those in the preference trial, 48% chose CBT and 52% chose yoga (p&gt;.05). Strength of preference was similar between the groups; 73.3% and 76.2% reported a strong preference for CBT and yoga, respectively (p&gt;.05). Fourteen percent of those who preferred CBT at baseline preferred yoga upon completion of the intervention, while 12.2% of those who preferred yoga at baseline preferred CBT upon completion of the intervention (p&gt;.05). There were no significant differences between participants in the RCT and preference trial on intervention adherence, attrition, satisfaction, or working alliance (p’s&gt;.05). Treatment expectancies were higher for the preferred intervention (p’s&lt;.0001). Results suggest that older adults prefer CBT and yoga at similar rates, and these preferences are stable. Receiving a preferred treatment had no effect on adherence, attrition, satisfaction, or working alliance.

The Effect of Patient’s Choice of Cognitive Behavioural or Psychodynamic Therapy on Outcomes for Panic Disorder: A Doubly Randomised Controlled Preference Trial

<b><i>Introduction:</i></b> It remains unclear whether offering psychiatric patients their preferred treatment influences outcomes at the symptom level. <b><i>Objective:</i></b> To assess whether offering patients with panic disorder with/without agoraphobia (PD/A) a choice between 2 psychotherapies yields superior outcomes to random assignment. <b><i>Methods:</i></b> In a doubly randomised, controlled preference trial (DRCPT), 221 adults with PD/A were randomly assigned to: choosing panic-focused psychodynamic therapy (PFPP) or panic control treatment (PCT; a form of cognitive behavioural therapy); random assignment to PFPP or PCT; or waiting list control. Primary outcomes were PD/A severity, work status and work absences at post-treatment assessment. Outcomes at post-treatment assessment, 6-, 12-, and 24-month follow-ups were assessed using segmented multilevel linear growth models. <b><i>Results:</i></b> At post-treatment assessment, the choice and random conditions were superior to the control for panic severity but not work status/absences. The choice and random conditions did not differ during treatment or follow-up for the primary outcomes. For panic severity, PCT was superior to PFPP during treatment (standardised mean difference, SMD, –0.64; 95% confidence interval, CI, –1.02 to –0.25); PFPP was superior to PCT during follow-up (SMD 0.62; 95% CI 0.27–0.98). There was no allocation by treatment type interaction (SMD –0.57; 95% CI –1.31 to 0.17). <b><i>Conclusions:</i></b> Previous studies have found that offering patients their preferred treatment yields small to moderate effects but have not employed designs that could rigorously test preference effects. In this first DRCPT of 2 evidence-based psychotherapies, allowing patients with PD/A to choose their preferred treatment was not associated with improved outcomes. Further DRCPTs are needed.