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Purpose: Advances in patient treatment depend heavily on clinical trials (CTs). Patient volunteers for CT are tougher to recruit and retain. In order to administer CTs effectively, it is necessary to comprehend how the public views and perceives participating in them. The study assessed the perception and attitudes of patients and bystanders toward CTs in India. Methods: This was a multi-centric, cross-sectional study among patients and bystanders using a questionnaire that consisted of socio-demographic characteristics and questions on knowledge and attitude toward participation in CTs. The minimum sample size estimated for the survey was 750. Results: A total of 1260 respondents (patients and bystanders) had participated in the survey. 42% of total respondents were aware about CTs. Unawareness regarding (i) voluntary power of an individual to participate in a CT (only 47%), (ii) entitled benefits of free treatment and medical insurance during enrolment in a CT (only 47%), and (iii) only 16% of the respondents knew involvement of human subjects in CT were the major highlights among those who had prior knowledge about CTs. Education was the most pervasive factor in shaping positive perception among the respondents. Occupation was another ubiquitous factor in shaping their perception regarding CTs. Conclusion: The majority of respondents were not aware of CTs. The major concerns observed were time consumption and harmful nature of CTs that influenced their unwillingness to participate in CTs. Initiatives such as awareness campaigns and survey assessments that would result in scientifically effective health service policies would be strategic methods to enhance CT participation. [ABSTRACT FROM AUTHOR]

Background: Imatinib mesylate (IM) treatment adherence is a challenge, especially in an economic-social population neglected from developing countries. Objective: To create a new complementary audiovisual educational intervention model to improve IM treatment adherence of CML patients. Methods: Two adherence verification methods were applied before and after intervention: modified Morisky-Green test and molecular responses (BCR-ABL transcripts quantification). Adherence estimates were calculated using univariate and multivariate component analysis (MCA) for the socio-demographic and clinical characteristics of patients. Results: Modified Morisky-Green test results demonstrated a substantial increase of CML patient adherence from 23% (pre-film) to 65% (post-film). Greater improvement was obtained for patients presenting major molecular response (MMR) from 38% (pre-film) to 60% (post-film). Although slight gain for complete molecular response (CMR) from 23% (pre-film) to 26% (post-film) was achieved, it represents a total tumour regression. MCA identified that females <50 years-old, using less than two medications (no disease associated) and CMR condition were the most benefited with intervention. Conclusion: Audiovisual educational intervention was an effective complementary pro-adherence model, activating patient memory and improving IM treatment adherence. Although this intervention shows effective, not all patients responded as expected, being necessary a combination of educational and clinical interventions to improve IM adherence. [ABSTRACT FROM AUTHOR]

Purpose: To develop a new computer adaptive test that evaluates important aspects of medication adherence for persons with type 2 diabetes mellitus. Methods: Two hundred and twenty-five people with type 2 diabetes mellitus completed 41 items related to medication adherence. Results: Exploratory analysis supported the essential unidimensionality of the initial item pool. Five items were deleted due to low item-adjusted total score correlations (resulting in 36 items). Confirmatory factor analysis supported the retention of 27 items. A graded response model identified no items for exclusion, based on misfit. No items were flagged for meaningful differential item functioning (DIF). The final item bank is comprised of 27 items; an associated 6-item short form was constructed that balanced both psychometric factors (e.g., item information values) and clinical input. Initial analysis of the simulated CAT and static short form supported both the reliability (i.e., internal consistency and test–retest reliability) and validity (i.e., convergent, discriminant, and known groups) of both administration formats. Conclusions: The new medication adherence item bank provides a reliable and valid assessment of the ability to take medications accurately among people with T2DM; it will be available in early 2023 through healthmeasures.net. [ABSTRACT FROM AUTHOR]

A letter published in the Annals of Pharmacotherapy discusses the potential use of intranasal theophylline as a treatment for olfactory dysfunction (OD) associated with long COVID. The letter references a systematic review and meta-analysis that found a global prevalence of 3.7% for OD associated with the omicron variant of SARS-CoV-2. The letter also describes two randomized controlled trials investigating the efficacy and safety of intranasal theophylline saline irrigation for post-viral OD. While the studies found intranasal theophylline to be safe and tolerable, they did not provide sufficient evidence to support its use in patients with long COVID OD. Larger clinical trials are needed to determine the long-term safety and treatment effects of intranasal theophylline in individuals with confirmed long COVID OD. [Extracted from the article]

Background: Slower than planned recruitment is a major factor contributing to the delay or failure of randomised controlled trials to report on time. There is a limited evidence base regarding the optimisation of recruitment strategies. Here we performed an observational review of our experience in recruitment for two large randomised controlled trials for people with secondary progressive multiple sclerosis. We aimed to explicitly determine those factors which can facilitate trial recruitment in progressive neurodegenerative disease.Methods: Recruitment data from the sequential MS-SMART [NCT01910259] and MS-STAT2 [NCT03387670] UK randomised controlled trials was reviewed from the largest recruiting site, University College London (UCL). The trial population was similar which allowed comparison over the two recruitment periods of 2015-2016 and 2018-2021. This included sources of referral, progress through stages of recruitment, reasons for participant ineligibility and the impact of publicity events upon recruitment.Results: In MS-SMART, 18% of patients contacted were enrolled, compared to 27% for MS-STAT2. Online registration of interest portals provided the greatest number of referrals (76% in MS-SMART, and 51% in MS-STAT2), with publicity in national media outlets producing a demonstrable increase in the number of potential participants. The introduction of an online self-screening questionnaire for MS-STAT2 resulted in 67% of potential participants (3080 of 4605) automatically determining their own ineligibility. In both studies, however, around 60% of those directly telephoned to discuss the study were not eligible, with difficulties related to travel to trial visits, or excluded medication, being the most common issues. Eighty-four percent of those deemed potentially eligible following telephone calls were enrolled in the MS-STAT2 study, compared to only 55% for MS-SMART.Conclusions: Through a detailed review of recruiting participants at the largest centre into two large randomised controlled trials with similar entry criteria, we have identified a number of approaches that may improve recruitment efficiency. We highlight here the importance of mandatory online self-screening questionnaires, a coordinated publicity campaign, and simple interventions such as eligibility checklists and appointment reminders. Recruitment approaches should be further assessed through a studies within a trial (SWAT) design.Trial Registration: MS-SMART: NCT01910259 ; registered July 2013 and MS-STAT2: NCT03387670 ; registered Jan 2018. [ABSTRACT FROM AUTHOR]

Despite efforts to increase the diversity of cancer clinical trial participants, African Americans are still underrepresented. While perceptions of participation have been studied, the objective of this study was to compare perceptions and decisional conflict towards clinical trials among African American cancer patients who have and have not participated in clinical trials to identify key areas for intervention. Post hoc analysis also looked at whether they had been asked to participate and how that group differed from those who did. Forty-one African American cancer patients were surveyed at two urban cancer centers and asked to agree/disagree to statements related to clinical trials perceptions (facilitators, barriers, beliefs, values, support, and helpfulness), and complete the O'Connor Decisional Conflict Scale. Independent-samples t tests compared participants by clinical trials participation status; 41% had participated in a clinical trial. Results revealed significant perceptual differences among the groups in three main areas: helpfulness of clinical trials, facilitators to participate in clinical trials, and barriers to participating in clinical trials. Post hoc analysis indicated that those who were not asked about clinical trials and had not participated differed significantly in all areas compared with participants. Additionally, clinical trial participants reported significantly lower decisional conflict in most items compared with both those who had and had not be asked to participate. These differences can give practitioners clues as to how to bridge the gap from non-participator to participator. Messages could then be infused in the clinician–patient dyad when introducing and discussing clinical trials, potentially providing a more effective strategy for communicating with African American patients. [ABSTRACT FROM AUTHOR]

Advances in cancer treatment are impeded by low accrual rates of patients to cancer clinical trials (CCTs). The national rates of recruitment of underserved groups, including racial/ethnic minorities, are limiting the generalizability of research findings and are likely to enhance inequities in cancer outcomes. The goal of this study was to examine willingness to participate (WTP) in CCTs and factors associated with this willingness among patients and caregivers attending a minority-serving university cancer center in the Southwest. A cross-sectional survey design was utilized (n = 236, 135 patients and 101 caregivers). Fear was the strongest predictor of WTP in CCTs. The only ethnic differences observed related to Spanish-speaking patients exhibiting increased WTP in CCTs, and Spanish-speaking caregivers' decreased WTP, compared to others. These results underscore the importance of future interventions to reduce CCT-related fear among patients and caregivers, with particular need for family-focused tailored interventions designed to meet the needs of Spanish-speaking patients and caregivers. [ABSTRACT FROM AUTHOR]

After a diagnosis of cancer (or other serious disease), patients may be asked to consider joining a clinical trial. Because most people are unfamiliar with the scientific concepts that are necessary to the provision of meaningful informed consent, patient education is necessary. Increasing knowledge alone is not sufficient; understanding how clinical trial participation aligns with personal circumstances and knowledge is central to the decision-making process. In this study, 302 cancer patients and survivors evaluated an interactive information aid (IA) designed to inform their decision to join a research study or clinical trial by providing tailored information to patients' responses to questions pertaining to seven key barriers or facilitators of clinical trial participation. The development of the IA was done with input from the authors' Clinical Translational Science Institute; linked components of the IA were vetted by members and leaders of the institution's NCI-designated comprehensive cancer center. Results of the study indicated that the information aid was successful in significantly reducing fears and increasing knowledge, attitudes, perceived behavioral control, and behavioral intentions about research participation relative to a control condition. Thus, an interactive information aid that provides information that is responsive to patients' values, knowledge, and personal circumstances can help patients to be better prepared to consider a decision about research participation. [ABSTRACT FROM AUTHOR]

Background: Failure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes.Methods: StAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals.Results: The trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (- 0.08% (- 0.31 to 0.16) (IFCC - 0.82 mmol/mol (- 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was - 0.71% (- 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful.Conclusions: Whilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes.Trial Registration: Trial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808. [ABSTRACT FROM AUTHOR]

The inclusion of diverse populations in clinical trial research is a social justice imperative. Creating the communicative tools that can support cancer patients across varied cultural backgrounds in processing complex clinical trial information, to achieve informed consent, has been a challenge. This study sought to evaluate specific clinical trial multimedia-a website, four animations, and a decision aid-to meet the decision-making and informational needs of Hispanic patients. The multimedia content was positively evaluated by Hispanic cancer patients. However, the discussions also yielded important steps for culturally adapting these tools to account for particular informational needs and cultural values that would be important to incorporate into these, and future, clinical trial multimedia interventions that target Hispanic populations. [ABSTRACT FROM AUTHOR]

Background: The misuse of and addiction to opioids is a national crisis that affects public health as well as social and economic welfare. There is an urgent need for strategies to improve opioid use disorder treatment quality (e.g., 6-month retention). Substance use disorder treatment programs are challenged by limited resources and a workforce that does not have the requisite experience or education in quality improvement methods. The purpose of this study is to test a multicomponent clinic-level intervention designed to aid substance use disorder treatment clinics in implementing quality improvement processes to improve high-priority indicators of treatment quality for opioid use disorder.Methods: A stepped-wedge randomized controlled trial with 30 outpatient treatment clinics serving approximately 2000 clients with opioid use disorder each year will test whether a clinic-level measurement-driven, quality improvement intervention, called Coaching for Addiction Recovery Enhancement (CARE), improves (a) treatment process quality measures (use of medications for opioid use disorder, in-treatment symptom and therapeutic progress, treatment retention) and (b) recovery outcomes (substance use, health, and healthcare utilization). The CARE intervention will have the following components: (1) staff clinical training and tools, (2) quality improvement and change management training, (3) external facilitation to support implementation and sustainability of quality improvement processes, and (4) an electronic client-reported treatment progress tool to support data-driven decision making and clinic-level quality measurement. The study will utilize multiple sources of data to test study aims, including state administrative data, client-reported survey and treatment progress data, and staff interview and survey data.Discussion: This study will provide the field with a strong test of a multicomponent intervention to improve providers' capacity to make systematic changes tied to quality metrics. The study will also result in training and materials that can be shared widely to increase quality improvement implementation and enhance clinical practice in the substance use disorder treatment system.Trial Registration: Trial # NCT04632238NCT04632238 registered at clinicaltrials.gov on 17 November 2020. [ABSTRACT FROM AUTHOR]

Despite the promise of clinical trials for improving cancer care, less than 5% of all cancer patients participate. Racial/ethnic minorities continue to be underrepresented in cancer clinical trials (CCTs). To address this gap, we developed a plain language, web-based decision support tool (CHOICES DST) in English and Spanish to support decision-making about CCTs among Blacks and Hispanics. In phase 1 (information collection), we conducted qualitative interviews with 45 cancer patients, completed a thorough literature review, and reviewed results from a telephone survey of 1100 cancer patients. In phase 2 (content generation), we created the first iteration of the CHOICES DST. In phase 3 (usability testing), we gathered user experience and acceptability data from a small sample of cancer survivors (n = 9). The Knowledge, Empowerment, and Values Clarification (KEV) model of decision-making was developed based on data from phase 1. The KEV model and other phase 1 data allowed us to create the CHOICES DST platform. Usability testing of the CHOICES DST showed highly favorable responses from users, satisfaction with content, ease of navigation, and a desire to use the tool. Qualitative results identified addressable points that would benefit from content and navigation-related alterations. The final version of the CHOICES DST was well received and understood by Black and Hispanic participants, and adheres to the mandates for plain language communication. This research provides preliminary data that CHOICES DST holds promise for improving knowledge of CCTs and potentially improving informed decision-making about participation in trials. [ABSTRACT FROM AUTHOR]

Introduction: Pharmacological intervention is an important component of patient care. However, drugs are often inappropriately used. It is necessary for countries to implement strategies to improve the rational use of drugs, including independent information for healthcare professionals and the public, which must be supported by well-trained staff. The primary objectives of the EDU.RE.DRUG (Effectiveness of informative and/or educational interventions aimed at improving the appropriate use of drugs designed for general practitioners and their patients) study are the retrospective evaluation of rates of appropriate prescribing indicators (APIs) and the assessment of the effectiveness of informative and/or educational interventions addressed to general practitioners (GPs) and their patients, aimed at improving prescribing quality and promoting proper drug use. Methods and analysis: This is a prospective, multicentre, open-label, parallel-arm, controlled, pragmatic trial directed to GPs and their patients in two Italian regions (Campania and Lombardy). The study data are retrieved from administrative databases (Demographic, Pharmacy-refill, and Hospitalization databases) containing healthcare information of all beneficiaries of the National Health Service in the Local Health Units (LHUs) involved. According to LHU, the GPs/patients will be assigned to one of the following four intervention arms: (1) intervention on GPs and patients; (2) intervention on GPs; (3) intervention on patients; and (4) no intervention (control). The intervention designed for GPs consists of reports regarding the status of their patients according to the APIs determined at baseline and in two on-line Continuous Medical Education (CME) courses. The intervention designed for patients consists in flyers and posters distributed in GPs ambulatories and community pharmacies, focusing on correct drug use. A set of indicators (such as potential drug–drug interactions, unnecessary duplicate prescriptions, and inappropriate prescriptions in the elderly), adapted to the Italian setting, has been defined to determine inappropriate prescription at baseline and after the intervention phase. The primary outcome was a composite API. Ethics and dissemination: The study was approved by the Ethics Committee of the University of Milan on 7th June 2017 (code 15/17). The investigators will communicate trial results to stakeholders, collaborators, and participants via appropriate presentations and publications. Registration details: NCT04030468. EudraCT number 2017-002622-21 [ABSTRACT FROM AUTHOR]

Summary: Background: The last decade has seen a rapid growth in the number of clinical trials enrolling patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NASH). Due to the underlying chronic liver disease, patients with NASH often require different approaches to the assessment and management of suspected drug‐induced liver injury (DILI) compared to patients with healthy livers. However, currently no regulatory guidelines or position papers systematically address best practices pertaining to DILI in NASH clinical trials. Aims: This publication focuses on best practices concerning the detection, monitoring, diagnosis and management of suspected acute DILI during clinical trials in patients with NASH. Methods: This is one of several papers developed by the IQ DILI Initiative, comprised of members from 15 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. This paper is based on extensive literature review, and discussions between industry members with expertise in drug safety and DILI experts from outside industry to achieve consensus on common questions related to this topic. Results: Recommended best practices are outlined pertaining to hepatic inclusion and exclusion criteria, monitoring of liver tests, DILI detection, approach to a suspected DILI signal, causality assessment and hepatic discontinuation rules. Conclusions: This paper provides a framework for the approach to assessment and management of suspected acute DILI during clinical trials in patients with NASH. [ABSTRACT FROM AUTHOR]

Purpose: The treatment decisions of melanoma patients are poorly understood. Most research on cancer patient decision-making focuses on limited components of specific treatment decisions. This study aimed to holistically characterize late-stage melanoma patients' approaches to treatment decision-making in order to advance understanding of patient influences and supports.Methods: (1) Exploratory analysis of longitudinal qualitative data to identify themes that characterize patient decision-making. (2) Pattern analysis of decision-making themes using an innovative method for visualizing qualitative data: a hierarchically-clustered heatmap. Participants were 13 advanced melanoma patients at a large academic medical center.Results: Exploratory analysis revealed eight themes. Heatmap analysis indicated two broad types of patient decision-makers. "Reliant outsiders" relied on providers for medical information, demonstrated low involvement in decision-making, showed a low or later-in-care interest in clinical trials, and expressed altruistic motives. "Active insiders" accessed substantial medical information and expertise in their networks, consulted with other doctors, showed early and substantial interest in trials, demonstrated high involvement in decision-making, and employed multiple decision-making strategies.Conclusion: We identified and characterized two distinct approaches to decision-making among patients with late-stage melanoma. These differences spanned a wide range of factors (e.g., behaviors, resources, motivations). Enhanced understanding of patients as decision-makers and the factors that shape their decision-making may help providers to better support patient understanding, improve patient-provider communication, and support shared decision-making. [ABSTRACT FROM AUTHOR]

Background: Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial.Methods/design: Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the interventions on African-American versus White men; and 3) examine the extent to which patient-physician communication mediates the effect of the interventions on the outcomes.Discussion: PACCT has the potential to identify ways to increase clinical trial rates in a diverse patient population. The research can also improve access to high quality clinical care for African American men bearing the disproportionate burden of disparities in prostate and other cancers.Trial Registration: Clinical Trials.gov registration number: NCT02906241 (September 8, 2016). [ABSTRACT FROM AUTHOR]

Background: The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women's views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial.Methods: We conducted a qualitative study using semi-structured interviews. A total of 179 participants in the Cord Pilot Trial were sent a postal invitation to take part in interviews. Women who agreed were interviewed in person or by telephone to explore their experiences of two consent pathways for a preterm intrapartum trial. Data were analysed using inductive systematic thematic analysis.Results: Twenty-three women who gave either written consent (n = 18) or oral assent followed by written consent (n = 5) to participate in the trial were interviewed. Five themes were identified: (1) understanding of the implications of randomisation, (2) importance of staff offering participation, (3) information about the trial and time to consider participation, (4) trial secondary in women's minds and (5) reasons for agreeing to take part in the trial. Experiences were similar for the two consent pathways. Women recruited by the oral assent pathway reported being given less information about the trial but felt it was sufficient to make a decision regarding participation. There were gaps in women's understanding of the trial and intervention, regardless of the consent pathway.Conclusions: Overall, women were positive about their experiences of being invited to participate in the trial. The oral assent pathway seems an acceptable option for women if the intervention is low-risk and time is limited.Trial Registration: ISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013. [ABSTRACT FROM AUTHOR]

Background: More patient-specific medical care is expected as more is learned about variations in patient responses to medical treatments. Analytical tools enable insights by linking treatment responses from different types of studies, such as randomized controlled trials (RCTs) and observational studies. Given the importance of evidence from both types of studies, our goal was to integrate these types of data into a single predictive platform to help predict response to pregabalin in individual patients with painful diabetic peripheral neuropathy (pDPN).Methods: We utilized three pivotal RCTs of pregabalin (398 North American patients) and the largest observational study of pregabalin (3159 German patients). We implemented a hierarchical cluster analysis to identify patient clusters in the Observational Study to which RCT patients could be matched using the coarsened exact matching (CEM) technique, thereby creating a matched dataset. We then developed autoregressive moving average models (ARMAXs) to estimate weekly pain scores for pregabalin-treated patients in each cluster in the matched dataset using the maximum likelihood method. Finally, we validated ARMAX models using Observational Study patients who had not matched with RCT patients, using t tests between observed and predicted pain scores.Results: Cluster analysis yielded six clusters (287-777 patients each) with the following clustering variables: gender, age, pDPN duration, body mass index, depression history, pregabalin monotherapy, prior gabapentin use, baseline pain score, and baseline sleep interference. CEM yielded 1528 unique patients in the matched dataset. The reduction in global imbalance scores for the clusters after adding the RCT patients (ranging from 6 to 63% depending on the cluster) demonstrated that the process reduced the bias of covariates in five of the six clusters. ARMAX models of pain score performed well (R 2 : 0.85-0.91; root mean square errors: 0.53-0.57). t tests did not show differences between observed and predicted pain scores in the 1955 patients who had not matched with RCT patients.Conclusion: The combination of cluster analyses, CEM, and ARMAX modeling enabled strong predictive capabilities with respect to pain scores. Integrating RCT and Observational Study data using CEM enabled effective use of Observational Study data to predict patient responses. [ABSTRACT FROM AUTHOR]

Background: Discussing randomized clinical trials (RCTs) with cancer patients is one of the most challenging communication tasks a physician faces. Only two prior Communication Skills Trainings (CSTs) focused on RCTs in oncology have been reported. Their results demonstrated the need for further improvement. We developed and evaluated an enhanced, individually-tailored CST focused on improving physicians' communication during discussions of RCTs.Methods: The CST focused on personal learning goals derived from video pre-assessment that were addressed in a 1.5-day group workshop and one-on-one coaching sessions. Forty physicians were recruited and randomly assigned to intervention and control groups. Video-recorded standardized consultations with actor-patients were utilized. As a primary outcome (1), training success was evaluated by blinded raters using a previously developed checklist. Change in checklist items was evaluated between pre- and post-training assessment and compared against control group results. As a secondary outcome (2), the physicians' feeling of confidence was assessed by a questionnaire.Results: (1) Significant improvements in the intervention group were observed for the score on all items (p = 0.03), for the subgroup of content-specific items (p = 0.02), and for the global rating of communication competence (p = 0.04). The improvement observed for the subgroup of general communication skill items did not achieve significance (p = 0.20). (2) The feeling of confidence improved in nine out of ten domains.Conclusion: While the individually-tailored CST program significantly improved the physicians' discussions of RCTs, specifically related to discussion content, what remains unknown is the influence of such programs in practice on participant recruitment rates. The study was registered retrospectively in 2010/07/22 under DRKS-ID: DRKS00000492 . [ABSTRACT FROM AUTHOR]

Aim: To evaluate tolerability of a new extended-release acetylsalicylic acid (ER-ASA).Materials& Methods: Daily ER-ASA (162.5-1300 mg) for up to 6 weeks was evaluated (four studies; n = 565). Safety of ER-ASA, immediate-release (IR; 150-1200 mg) ASA and enteric-coated ASA (75 mg) was assessed.Results: Forty-three out of 184 (23.4%) patients with atherosclerosis (ER-ASA 162.5 mg group) experienced adverse events versus 51/195 (26.2%) patients receiving IR-ASA 150 mg. Overall, 48.7 and 51.3% of patients in the ER-ASA group experienced no gastrointestinal discomfort or any gastrointestinal symptoms, respectively, versus 42.1 and 57.9% of patients in the IR-ASA group, respectively. In healthy volunteers, adverse event incidence was comparable between ER-ASA and IR-ASA and between ER-ASA and enteric-coated ASA.Conclusion: Safety of the new ER-ASA formulation was consistent with other ASA formulations. [ABSTRACT FROM AUTHOR]

Background: Pragmatic randomised controlled trials (RCTs) are considered essential to determine effective interventions for routine clinical practice, but many fail to recruit participants efficiently, and some really important RCTs are not undertaken because recruitment is thought to be too difficult. The 'QuinteT Recruitment Intervention' (QRI) aims to facilitate informed decision making by patients about RCT participation and to increase recruitment. This paper presents the development and implementation of the QRI.Methods: The QRI developed iteratively as a complex intervention. It emerged from the National Institute for Health Research (NIHR) ProtecT trial and has been developed further in 13 RCTs. The final version of the QRI uses a combination of standard and innovative qualitative research methods with some simple quantification to understand recruitment and identify sources of difficulties.Results: The QRI has two major phases: understanding recruitment as it happens and then developing a plan of action to address identified difficulties and optimise informed consent in collaboration with the RCT chief investigator (CI) and the Clinical Trials Unit (CTU). The plan of action usually includes RCT-specific, as well as generic, aspects. The QRI can be used in two ways: it can be integrated into the feasibility/pilot or main phase of an RCT to prevent difficulties developing and optimise recruitment from the start, or it can be applied to an ongoing RCT experiencing recruitment shortfalls, with a view to rapidly improving recruitment and informed consent or gathering evidence to justify RCT closure.Conclusions: The QRI provides a flexible way of understanding recruitment difficulties and producing a plan to address them while ensuring engaged and well-informed decision making by patients. It can facilitate recruitment to the most controversial and important RCTs. QRIs are likely to be of interest to the CIs and CTUs developing proposals for 'difficult' RCTs or for RCTs with lower than expected recruitment and to the funding bodies wishing to promote efficient recruitment in pragmatic RCTs. [ABSTRACT FROM AUTHOR]

The article talks about the importance of patient adherence to antihypertensive therapy in the effectiveness of hypertension treatment. Topics discussed include the benefits of adherence to dietary approach to stop hypertension (DASH) diet; the clinical trials with antihypertensive therapy; and the use of high-performance liquid chromatography tandem mass spectrometry to monitor the therapeutics.

Background Recruitment is a major challenge for many trials; just over half reach their targets and almost a third resort to grant extensions. The economic and societal implications of this shortcoming are significant. Yet, we have a limited understanding of the processes that increase the probability that recruitment targets will be achieved. Accordingly, there is an urgent need to bring analytical rigour to the task of improving recruitment, thereby increasing the likelihood that trials reach their recruitment targets. This paper presents a conceptual framework that can be used to improve recruitment to clinical trials. Methods Using a case-study approach, we reviewed the range of initiatives that had been undertaken to improve recruitment in the txt2stop trial using qualitative (semi-structured interviews with the principal investigator) and quantitative (recruitment) data analysis. Later, the txt2stop recruitment practices were compared to a previous model of marketing a trial and to key constructs in social marketing theory. Results Post hoc, we developed a recruitment optimisation model to serve as a conceptual framework to improve recruitment to clinical trials. A core premise of the model is that improving recruitment needs to be an iterative, learning process. The model describes three essential activities: i) recruitment phase monitoring, ii) marketing research, and iii) the evaluation of current performance. We describe the initiatives undertaken by the txt2stop trial and the results achieved, as an example of the use of the model. Conclusions Further research should explore the impact of adopting the recruitment optimisation model when applied to other trials. [ABSTRACT FROM AUTHOR]

Background: Non-adherence to antidepressants generates higher costs for the treatment of depression. Little is known about the cost-effectiveness of pharmacist's interventions aimed at improving adherence to antidepressants. The study aimed to evaluate the cost-effectiveness of a community pharmacist intervention in comparison with usual care in depressed patients initiating treatment with antidepressants in primary care. Methods: Patients were recruited by general practitioners and randomized to community pharmacist intervention (87) that received an educational intervention and usual care (92). Adherence to antidepressants, clinical symptoms, Quality-Adjusted Life-Years (QALYs), use of healthcare services and productivity losses were measured at baseline, 3 and 6 months. Results: There were no significant differences between groups in costs or effects. From a societal perspective, the incremental cost-effectiveness ratio (ICER) for the community pharmacist intervention compared with usual care was €1,866 for extra adherent patient and €9,872 per extra QALY. In terms of remission of depressive symptoms, the usual care dominated the community pharmacist intervention. If willingness to pay (WTP) is €30,000 per extra adherent patient, remission of symptoms or QALYs, the probability of the community pharmacist intervention being cost-effective was 0.71, 0.46 and 0.75, respectively (societal perspective). From a healthcare perspective, the probability of the community pharmacist intervention being cost-effective in terms of adherence, QALYs and remission was of 0.71, 0.76 and 0.46, respectively, if WTP is €30,000. Conclusion: A brief community pharmacist intervention addressed to depressed patients initiating antidepressant treatment showed a probability of being cost-effective of 0.71 and 0.75 in terms of improvement of adherence and QALYs, respectively, when compared to usual care. Regular implementation of the community pharmacist intervention is not recommended. Trial Registration: ClinicalTrials.gov NCT00794196 [ABSTRACT FROM AUTHOR]

PurposeTo evaluate the impact of individualised patient care, as an adjunct to standard care, on adherence to ocular hypotensive therapy.MethodsA two-arm, single-masked exploratory randomised controlled trial recruited patients newly prescribed ocular hypotensive therapy. The intervention involved an individual assessment of health-care needs and beliefs and a 1-year follow-up period according to need. The primary outcome was refill adherence, measured by collating prescription and dispensing data for 12 months. Secondary outcomes included self-reported adherence, glaucoma knowledge, beliefs about illness and medicines, quality of care, intraocular pressure (IOP) fluctuation, and changes in clinical management assessed at 12 months. The strength of the intervention was measured following withdrawal by reviewing clinical outcomes for a further 12 months.ResultsIn all, 127 patients were recruited (91% response rate). Intervention-arm patients collected significantly more prescriptions than control-arm patients. Self-report adherence was significantly better in the intervention-arm for patients who forgot drops and those who intentionally missed drops. The intervention group demonstrated significantly more glaucoma knowledge, expressed a significantly stronger belief in the necessity of eye drops and believed that they had more personal control over managing their condition. Control-arm patients had more IOP fluctuation and changes in clinical management. However, this finding only reached significance at 24 months.ConclusionModelling patient care according to health-care needs and beliefs about illness and medicines can have a significant impact on improving adherence to therapy for this patient group, with the potential benefit of improving clinical outcomes. [ABSTRACT FROM AUTHOR]

Background The healthy user bias is usually overlooked as an explanation in studies in which a strong association is found between poor patient medication adherence and worse disease outcomes. Such studies are increasing in frequency across disease states and influence clinical practice. Adherence to antihypertensive medications was studied to illustrate confounding in such studies. Methods Using data from veterans with hypertension starting antihypertensive treatment, causal models were developed that predicted the risks of hospitalisation, myocardial infarction (MI) and death associated with poor adherence (<80%) while adjusting for patient demographics, baseline disease severity and disease comorbidity. In a second set of otherwise identical models, adjustment was made for time-varying blood pressure (BP), thus controlling for adherence effects that were mediated through the main pharmacological effects of the drugs. It was hypothesised that the second set of models would reveal a positive association between poor adherence and adverse disease outcomes that is largely explained by unmeasured confounders, including healthrelated behaviours. Results The models that did not adjust for time-varying BP levels showed that patients with poor adherence had statistically significantly increased risks of 3.7% for hospitalisation, 28.1% for MI and 23.3% for death. These estimates exceed the benefits of these drugs demonstrated by clinical trials. When controlling for timevarying BP, the increased risks were similar (3.4% for hospitalisation, 27.7% for MI and 23.4% for death). The findings were consistent across a range of adherence thresholds (50-90%) and when allowing disease status variables to vary. Conclusions The associations between poor adherence and outcomes are largely independent of the pharmacological effects of the drugs on BP control as well as commonly measured patient covariates. This finding suggests that even carefully designed observational adherence studies using rich clinical data are impossibly confounded and probably overestimate the true magnitude of the effect. Clinical practice guidelines based on reported adherence effects should be reconsidered. [ABSTRACT FROM AUTHOR]

Background: Poor adherence is estimated to cause 125 thousand deaths per year and is linked to 10% of all hospital stays in the U.S. Up to one third of elderly hypertensive patients don't have adherence, which is responsible for high proportion of hospitalizations. Hypertension is also related to poor performance in tests that assess cognitive functions. On the other hand, poor cognitive performance is associated with low adherence to treatment. Objective: To assess the association between cognitive function, anxiety and psychiatric disorders with adherence to drug treatment in patients with hypertension. Methodology and Principal Findings: This a cohort studies with 56 adult patients with uncontrolled hypertension who participated of all meetings of a pharmaceutical intervention in a randomized clinical trial of pharmaceutical care. Cognitive function was measured by the Mini Mental State Examination (Mini-mental). The memory was measured by digit and word spans, tower and church shadow test, short story test and metamemory. Anxiety and psychiatric disorders were evaluated by the State Trace Anxiety Inventory and the Self-Report Questionnaire, respectively. The participants were classified as adherent or non-adherent to the drug treatment, according to the identification of plasma levels of hydrochlorothiazide. All non-adherent patients (n = 12) and 35 out 44 (79.5%) patients with adherence to treatment had at least one memory test with an altered score (P = 0.180). Participants with an unsatisfactory score in the Mini-mental had six-fold higher risk of non-adherence to treatment when compared to those with a normal score (RR = 5.8; CI 95%: 1.6-20.8; P = 0.007). The scores of anxiety and psychiatric disorders were not associated with adherence to the pharmacological treatment. Conclusion: Cognitive deficit impairs adherence to drug therapy and should be screened as part of a program of pharmaceutical care to improve adherence to treatment. [ABSTRACT FROM AUTHOR]

Objective: The primary objective of this study was to evaluate the effect of a pharmaceutical care program on pharmacotherapy adherence in elderly diabetic and hypertensive patients. The clinical outcomes of this pharmacotherapy adherence approach were the secondary objective of the study. Setting: Public Primary Health Care Unit in a municipality in the Brazilian State of Sao Paulo. Method: A 36-month randomized, controlled, prospective clinical trial was carried out with 200 patients divided into two groups: control (n = 100) and intervention (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultancies). The patients randomized into the intervention group received pharmaceutical care intervention besides the usual care offered. Main outcome measure: Pharmacotherapy adherence (Morisky-Green test translated into Portuguese and computerized dispensed medication history) and clinical measurements (blood pressure, fasting glucose, A1C hemoglobin, triglycerides and total cholesterol) were evaluated at the baseline and up to 36 months. A P value <0.05 was considered statistically significant. Results: A total of 97 patients from the intervention group and 97 patients from the control group completed the study (n = 194). Significant improvements in the pharmacotherapy adherence were verified for the intervention group according to the Morisky-Green test (50.5% of adherent patients at baseline vs. 83.5% of adherent patients after 36 months; P < 0.001) and the computerized dispensed medication history (52.6% of adherent patients at baseline vs. 83.5% of adherent patients after 36 months; P < 0.001); no significant changes were verified in the control group. Significant improvements in the number of patients reaching adequate values for their blood pressure (26.8% at baseline vs. 86.6% after 36-months; P < 0.001), fasting glucose (29.9% at baseline vs. 70.1% after 36 months; P < 0.001), A1C hemoglobin (3.3% at baseline vs. 63.3% after 36 months; P < 0.001), triglycerides (47.4% at baseline vs. 74.2% after 36 months; P < 0.001) and total cholesterol (59.8% at baseline vs. 80.4% after 36 months; P = 0.002) were verified in the intervention group, but remained unchanged in the control group. Conclusion: These results indicated the effectiveness of pharmaceutical care in improving pharmacotherapy adherence, with positive effects in the clinical outcomes of the patients studied. [ABSTRACT FROM AUTHOR]

This article deals with the question of how to handle costs to enhance medication adherence in trial-based pharmacoeconomic analyses. It argues that resources to improve patient adherence have a clearly distinguishable impact on costs and utility and thus are relatively easy to exclude when transferring trial-based pharmacoeconomic analyses to clinical practice. It proposes a model that adjusts trial-based incremental costs and effectiveness for lower medication adherence in clinical practice. It shows that, contrary to conventional wisdom, drug cost effectiveness in clinical practice can be better than in clinical trials. This may have implications for policy recommendations, depending on how close trial-based cost effectiveness is to the maximum willingness to pay. In many situations, the adjustment may not result in a change in policy recommendations. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to validate the effects of a simplified, gentle form of t'ai chi chuan in patients with type 2 diabetes and who are also obese. Design: The study was designed to be a randomized controlled trial. Setting: This study was conducted in the department of metabolism and endocrinology at Cheng Ching Hospital, in Taichung, Taiwan. Subjects: The study subjects were hospital-based patients with type 2 diabetes and who were also obese (ages 40-70, with a body-mass index [BMI] range of 30-35). The patients were randomly selected and grouped into t'ai chi exercise (TCE) and conventional exercise (CE) groups. Interventions: After receiving instruction in t'ai chi, the TCE group and the CE group practiced three times per week, including one practice session lasting up to 1 hour, for 12 weeks. Outcome measures: Hemoglobin A1C, serum lipid profile, serum malondialdehyde, and C-reactive protein were measured. Physical parameters of body weight and BMI were also measured. Diet and medications of participants were monitored carefully while biochemical and physical conditions were analyzed. Results: After 12 weeks, hemoglobin A1C values of the TCE group did not decrease (8.9 ± 2.7% : 8.3 ± 2.2%; p = 0.064). BMI (33.5 ± 4.8 : 31.3 ± 4.2; p = 0.038) and serum lipids, including triglyceride (214 ± 47 mg/dL : 171 ± 34 mg/dL; p = 0.012) and high density lipoprotein cholesterol (38 ± 16 mg/dL : 45 ± 18 mg/dL; p = 0.023) had significant improvements. Serum malondialdehyde tended to decrease from baseline (2.66 ± 0.78 μmol/L : 2.31 ± 0.55 μmol/L; p = 0.035), and C-reactive protein also decreased (0.39 ± 0.19 mg/dL : 0.22 ± 0.15 mg/dL; p = 0.014). No improvements occurred in BMI, lipids, and oxidative stress profiles in the CE group. Conclusions: T'ai chi exercise practiced by patients who are obese and have type 2 diabetes is efficient and safe when supervised by professionals and helps improve parameters, such as BMI, lipid profile, C-reactive protein, and malondialdehyde. Periodic monitoring of blood glucose, blood pressure, heart rate, breathing, physical fitness, and symptoms of discomfort of patients who exercise helps prevent injury. Simple, gentle TCE can be applied as regular daily exercise for patients with type 2 diabetes even when such patients are obese. [ABSTRACT FROM AUTHOR]

Over 485,000 people in the United States have chronic kidney disease, a progressive kidney disease that may lead to hemodialysis. Hemodialysis involves a complex regimen of treatment, medication, fluid, and diet management. In 2005, over 312,000 patients were undergoing hemodialysis in the United States. Dialysis nonadherence rates range from 8.5% to 86%. Dialysis therapy treatment nonadherence, including treatment, medication, fluid, and diet nonadherence, significantly increases the risk of morbidity and mortality. The purpose of this paper is to systematically review randomized-controlled trial intervention studies designed to increase treatment, medication, fluid, and diet adherence in adult hemodialysis patients. A search of Cumulative Index of Nursing and Allied Health Literature (CINAHL) (1982 to May 2008), MEDLINE (1950 to May 2008), PsycINFO (1806 to May 2008), and all Evidence-Based Medicine (EBM) Reviews (Cochran DSR, ACP Journal Club, DARE, and CCTR) was conducted to identify randomized-controlled studies that tested the efficacy of interventions to improve adherence in adult hemodialysis patients. Eight randomized-controlled trials met criteria for inclusion. Six of the 8 studies found statistically significant improvement in adherence with the intervention. Of these 6 intervention studies, all studies had a cognitive component, with 3 studies utilizing cognitive/behavioral intervention strategies. Based on this systematic review, interventions utilizing a cognitive or cognitive/behavioral component appear to show the most promise for future study. [ABSTRACT FROM AUTHOR]

Reports of interventions to improve adherence to medical regimens in solid organ transplant recipients are scarce. A systematic review identified 12 intervention studies. These studies focused on renal, heart, and liver transplant recipients. Five reports used randomized controlled trial (RCT) designs. Sample sizes varied between 18 and 110 subjects. The interventions are difficult to evaluate and categorize because of brief descriptions of intervention details. Of the 12 studies identified in this review, only five studies found a statistically significant improvement in at least one medication-adherence outcome with the intervention. In general, most included a combination of patient-focused cognitive/educational, counseling/behavioral, and psychologic/affective dimensions. Eight studies intervened at the healthcare provider, healthcare setting or healthcare system level, but showed a limited improvement in adherence. No single intervention proved to be superior at increasing medication-adherence in organ transplantation, but a combination of interventions in a team approach for the chronic disease management of organ transplant patients may be effective in a long-term perspective. In conclusion, finding the most effective combination of interventions to enhance adherence is vital. Utilizing an RCT design and adhering to the CONSORT guidelines can lead to higher quality studies and possibly more effective intervention studies to enhance medication-adherence. [ABSTRACT FROM AUTHOR]

There are inadequate data on the outcomes of patients who declined to participate in randomised clinical trials as compared with those of participants. We retrospectively reviewed the patient characteristics and treatment outcomes of both participants and non-participants in the two randomised trials for chemotherapy-naive advanced non-small-cell lung cancer. Trial 1 compared four platinum-based combination regimens. Trial 2 compared two sequences of carboplatin plus paclitaxel and gefitinib therapies. Nineteen of 119 (16%) and 153 (37%) patients declined to participate in Trials 1 and 2, respectively. Among the background patient characteristics, the only variable associated with trial participation or declining was the patients' attending physicians (P<0.001). Important differences were not observed in the clinical outcomes between participants and non-participants, for whom the response rates were 30.6 vs 34.2% and the median survival times were 489 vs 461 days, respectively. The hazard ratio for overall survival, adjusted for other confounding variables, was 0.965 (95% confidence interval: 0.73-1.28). In conclusion, there was no evidence to suggest any difference in the characteristics and clinical outcomes between participants and non-participants. Trial designs and the doctor-patient relationship may have an impact on the patient accrual to randomised trials. [ABSTRACT FROM AUTHOR]

Background: Although non-adherence to an immunosuppressive regimen (NAH) is a major risk factor for poor outcome after renal transplantation (RTx), very few studies have examined non-adherence intervention in this context. This pilot randomized controlled trial (RCT) tested the efficacy of an educational–behavioural intervention to increase adherence in non-adherent RTx patients. We also assessed how NAH evolves over time. Methods: Eighteen RTx non-adherent patients (age: 45.6±1.2 yr; 78.6% male) were randomly assigned to either an intervention group (IG) (n=6) or an enhanced usual care group (EUCG) (n=12), the latter receiving the usual clinical care. The IG received one home visit and three telephone interviews. We assessed NAH through electronic monitoring (EM) of medication intake during a nine-month period (three months intervention, six months follow-up). Results: Five of 18 patients withdrew. Inclusion in the study resulted in a remarkable decrease in NAH in both groups over the first three months (IG χ2=3.97, df=1, p=0.04; EUCG χ2=3.40, df=1, p=0.06). The IG showed the greatest decrease in NAH after three months, although this did not reach statistical significance (at 90 d, χ2=1.05, df=1, p=0.31). Thereafter, NAH increased gradually in both groups, reaching comparable levels at the end of the six-month follow-up (i.e. at nine months). Conclusion: Our findings suggest an inclusion effect. Although the intervention in this pilot RCT appeared to add further benefit in medication compliance, a lack of statistical power prevented us from making a strong statistical statement. [ABSTRACT FROM AUTHOR]

Discusses a randomized controlled trial of a structured teaching and self-management program for patients receiving oral anticoagulation. Suggestion that the control of oral anticoagulation therapy is inadequate; Objective; Main outcome measures; Results; Conclusions.

Objective: This study aimed to develop a questionnaire for measuring patient perceptions of participating in clinical trials. Development was based on earlier research on patient views of involvement in medical care and a literature review. Patients were recruited from an ongoing clinical trial focused on cardiovascular illness and from an outpatient psychiatry department. Factor analysis was conducted on a pilot version of the questionnaire in 2016 and on a revised version in 2017. Results: A total of 53 patients were recruited for the pilot study and 55 were recruited for the main study, substantially below the goal of 100 participants. Factor analysis revealed six factors measuring aspects of patients' perceptions of participating in clinical trials, including motivation, risks and benefits, the nature of the trial itself, and practical considerations, such as cost and convenience. Inter-scale correlations ranged between 0.06 and 0.64, indicating acceptable scale independence. Reliability scores (Cronbach's alphas) ranged from 0.62 to 0.85. Factor analysis results were somewhat unstable, with shared variance for several items across scales. This is likely due to the small sample sizes. In larger, more diverse patient samples, this questionnaire can be useful for measuring and incorporating patients' views into the design and execution of clinical trials. [ABSTRACT FROM AUTHOR]

Background: Few community urologists offer cancer patients the opportunity to participate in cancer clinical trials, despite national guidelines that recommend it, depriving an estimated 260,000 urological cancer patients of guideline-concordant care each year. Existing strategies to increase urologists' offer of clinical trials are designed for resource-rich environments and are not feasible for many community urologists. We sought to design an implementation intervention for dissemination in under-resourced community urology practices and to compare its acceptability, appropriateness and adoption appeal among trial-naïve and trial-experienced urologists.Methods: We used a design-for-dissemination approach, informed by the Theoretical Domains Framework and Behavior Change Wheel, to match determinants of the clinical trial offer to theoretically informed implementation strategies. We described the implementation intervention in evaluation workshops offered at urology professional society meetings. We surveyed participants to assess the implementation intervention's acceptability and appropriateness using validated instruments. We also measured adoption appeal, intention to adopt and previous trial offer.Results: Our design process resulted in a multi-modal implementation intervention, comprised of multiple implementation strategies designed to address six domains from the Theoretical Domains Framework. Evaluation workshops delivered at four meetings, convened five separate professional societies. Sixty-one percent of those offered an opportunity to participate in the implementation intervention indicated intention to adopt. Average implementation intervention acceptability and appropriateness ratings were 4.4 and 4.4 (out of 5), respectively. Acceptability scores were statistically significantly higher among those offering trials compared to those not (p = 0.03). Appropriateness scores did not differ between those offering trials and those not (p = 0.24). After urologists ranked their top three innovation attributes, 43% of urologists included practice reputation in their top three reasons for offering clinical trials; 30% listed practice differentiation among their top three reasons. No statistically significant differences were found between those who offered trials and those who did not among any of the innovation attributes.Conclusions: LEARN|INFORM|RECRUIT is a promising implementation intervention to address low accrual to clinical trials, poised for implementation and effectiveness testing. The implementation intervention is appealing to its target audience and may have equal uptake among trial-naïve and trial-experienced practices. [ABSTRACT FROM AUTHOR]

Intestinal dysbiosis in inflammatory bowel disease (IBD) patients depend on disease activity. We aimed to characterize the microbiota after 7 years of follow-up in an unselected cohort of IBD patients according to disease activity and disease severity. Fifty eight Crohn's disease (CD) and 82 ulcerative colitis (UC) patients were included. Disease activity was assessed by the Harvey-Bradshaw Index for CD and Simple Clinical Colitis Activity Index for UC. Microbiota diversity was assessed by 16S rDNA MiSeq sequencing. In UC patients with active disease and in CD patients with aggressive disease the richness (number of OTUs, p = 0.018 and p = 0.013, respectively) and diversity (Shannons index, p = 0.017 and p = 0.023, respectively) were significantly decreased. In the active UC group there was a significant decrease in abundance of the phylum Firmicutes (p = 0.018). The same was found in CD patients with aggressive disease (p = 0.05) while the abundance of Proteobacteria phylum showed a significant increase (p = 0.03) in CD patients. We found a change in the microbial abundance in UC patients with active disease and in CD patients with aggressive disease. These results suggest that dysbiosis of the gut in IBD patients is not only related to current activity but also to the course of the disease. [ABSTRACT FROM AUTHOR]