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Introduction: Despite the importance of clinical trial participation among cancer patients, few participate—and even fewer patients from ethnic and racial minoritized groups. It is unclear whether suggested approaches to increase accrual are successful. We conducted a scoping review to identify evidence‐based approaches to increase participation in cancer treatment clinical trials that demonstrated clear increases in accrual. Notably, more stringent than other published reviews, only those studies with comparison data to measure a difference in accrual rates were included. Methods: We searched PubMed/MEDLINE, Embase, CINAHL, and Web of Science for English‐language articles published from January 1, 2012, to August 8, 2022. Studies were included if they were conducted in the United States, described single or multicomponent interventions, and provided data to measure accrual relative to baseline levels or that compared accrual rates with other interventions. Results: Sixteen articles were included: six with interventions addressing patient barriers, two addressing provider barriers, seven describing institutional change, and one describing policy change. Key themes emerged, such as a focus on patient education, cultural competency, and building the capacity of clinics. Few studies provide comparative accrual data, making it difficult to identify with certainty any effective, evidence‐based approaches for increasing accrual. Some patient‐ and system‐level interventions studies showed modest increases in accrual primarily through pre‐post measurement. Conclusion: Despite an extensive body of literature about the barriers that impede cancer treatment trial accrual, along with numerous recommendations for how to overcome these barriers, results reveal surprisingly little evidence published in the last 10 years on interventions that increase accrual relative to baseline levels or compared with other interventions. As clinical trials are a primary vehicle through which we improve cancer care, it is critical that evidence‐based approaches are used to inform all efforts to increase accrual. Strategies for increasing participation in cancer clinical trials must be developed and rigorously evaluated so that these strategies can be disseminated, participation in trials can increase and become more equitable, and trial results can become more generalizable. [ABSTRACT FROM AUTHOR]

This study aims to investigate the impact of implementing Islamic accrual accounting on the financial performance of Islamic banking in the digital era. Along with rapid economic and technological paradigm shifts, Islamic banking is faced with demands to adopt accounting practices that are in accordance with sharia principles while utilizing technological advances in financial management. The research method uses qualitative and quantitative approaches, with data analysis conducted through secondary data collection from the financial statements of Islamic banks that apply Islamic accrual accounting. The results showed that the application of Islamic accrual accounting has a significant impact on the financial performance of Islamic banking in the digital era. [ABSTRACT FROM AUTHOR]

Background: Disruptions to clinical trials conducted in the intensive care unit (ICU) due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2; coronavirus disease 2019 [COVID-19]) pandemic included fewer new trials activated and more trials stopped. While a number of ongoing, non-COVID-19 clinical trials remained open to enrollment, the direct impact of the pandemic on ICUs instilled chaos in this already challenging environment. The numerous challenges need to be reported so investigators can proactively plan and manage these myriad challenges. Thus, the purpose of this study was to describe the impact of the COVID-19 pandemic on screening and accrual for a non-COVID-19 parent clinical trial enrolling critically ill ICU patients receiving mechanical ventilatory support. Methods: A descriptive, retrospective design using quantitative data from detailed screening logs and qualitative observations with field notes from a parent clinical trial were used to address the objectives. The primary aims of the two-site parent clinical trial (n = 190) are to test the efficacy of self-administration of sedative therapy by mechanically ventilated ICU patients on anxiety and delirium occurrence. ICUs from two academic medical centers [names removed for blinding] plus a community hospital in Minnesota were screened daily for alert patients (Richmond Agitation Sedation Scale [RASS] − 2 to + 1), following commands, hemodynamically stable with sufficient hand grip strength to depress a push-button device. Screening data were summarized based on the primary reason patients were not enrolled (screen failures, declinations of consent). Descriptive statistics (frequencies, percentages), chi-square, and Fisher's Exact test were used to describe the data and to determine any differences among distributions of screening failures and recruitment declinations during the defined pre-pandemic (August 27, 2018–March 15, 2020, 2976 screened patients) and pandemic timeframes (March 16, 2020–February 28, 2022, 3912 screened patients). Qualitative data from varied sources such as screening logs, institutional email communications, staff field notes, and research team meeting minutes were summarized into themes. Results: Despite significantly fewer screen failures due to hypotension, cognitive impairment/dementia, coma, or chemical paralysis with 938 additional patients on the screening log, more were accrued pre-pandemic (n = 55) than during the pandemic period (n = 45); declination reasons were non-significant. Pandemic burdens experienced by study personnel, ICU care providers, and patients/families were revealed that attributed to decreased accrual. Conclusions: While the parent clinical trial remained opened, cumulative factors adversely impacted the trial during the pandemic period with fewer patients accrued. The human toll of the pandemic on research staff, clinicians, and patients/family members demands that investigators be proactive in managing these challenges to conduct ICU clinical trials successfully, including careful oversight of human and financial resources. Trial registration: ClinicalTrials.gov NCT#02,819,141 Registered 29 June 2016. [ABSTRACT FROM AUTHOR]

Background: Many randomised controlled trials (RCTs) struggle to recruit, despite valiant efforts. The QRI (QuinteT Recruitment Intervention) uses innovative research methods to optimise recruitment by revealing previously hidden barriers related to the perceptions and experiences of recruiters and patients, and targeting remedial actions. It was designed to be integrated with RCTs anticipating difficulties at the outset. A new version of the intervention (QRI-Two) was developed for RCTs already underway with enrolment shortfalls.Methods: QRIs in 12 RCTs with enrolment shortfalls during 2007-2017 were reviewed to document which of the research methods used could be rapidly applied to successfully identify recruitment barriers. These methods were then included in the new streamlined QRI-Two intervention which was applied in 20 RCTs in the USA and Europe during 2018-2019. The feasibility of the QRI-Two was investigated, recruitment barriers and proposed remedial actions were documented, and the QRI-Two protocol was finalised.Results: The review of QRIs from 2007 to 2017 showed that previously unrecognised recruitment barriers could be identified but data collection for the full QRI required time and resources usually unavailable to ongoing RCTs. The streamlined QRI-Two focussed on analysis of screening/accrual data and RCT documents (protocol, patient-information), with discussion of newly diagnosed barriers and potential remedial actions in a workshop with the RCT team. Four RCTs confirmed the feasibility of the rapid application of the QRI-Two. When the QRI-Two was applied to 14 RCTs underway with enrolment shortfalls, an array of previously unknown/underestimated recruitment barriers related to issues such as equipoise, intervention preferences, or study presentation was identified, with new insights into losses of eligible patients along the recruitment pathway. The QRI-Two workshop enabled discussion of the newly diagnosed barriers and potential remedial actions to improve recruitment in collaboration with the RCT team. As expected, the QRI-Two performed less well in six RCTs at the start-up stage before commencing enrolment.Conclusions: The QRI-Two can be applied rapidly, diagnose previously unrecognised recruitment barriers, and suggest remedial actions in RCTs underway with enrolment shortfalls, providing opportunities for RCT teams to develop targeted actions to improve recruitment. The effectiveness of the QRI-Two in improving recruitment requires further evaluation. [ABSTRACT FROM AUTHOR]

This article discusses the law regulating living annuities when spouses in South Africa are divorcing. It demonstrates that South African courts have interpreted the law to prejudice non-member spouses financially. It argues that courts have failed to consider matrimonial principles when determining whether living annuities are susceptible to being shared on divorce. It argues further that adequate consideration of matrimonial principles will render it impossible for retirement fund members to prejudice their spouses financially by purchasing living annuities without the consent of such spouses, particularly when married in community of property. Disregarding matrimonial law principles may lead to deprivation of property. [ABSTRACT FROM AUTHOR]

Adolescence is a critical time for the acquisition of peak bone mass. There are modifiable factors that may influence bone health in an adolescent. For those at risk for bone fragility, initial management includes optimization of calcium and vitamin D, weight-bearing exercise, and maintenance of a normal body weight. In certain scenarios, bisphosphonate treatment is indicated, as is reviewed. How hormonal contraceptives affect bone mineral density is unclear, but in patients with risk factors or known bone fragility, prescribers should consider their skeletal effects. Some conditions, including restrictive eating disorders and primary ovarian insufficiency, warrant long-term monitoring of bone health. [ABSTRACT FROM AUTHOR]

The article is devoted to the study of international practice of accrual and accounting for depreciation of fixed assets in comparison with national standards. The importance of depreciation deductions in the reproduction of fixed assets is determined. Differences were found between depreciation and amortization between IAS and P (C) BO. The essence of methods of depreciation calculation in international practice is revealed and methods are used in different countries. It is revealed that the vast majority of methods are used in Ukraine, however, as in other countries, the most popular method is straightforward. Determined items for depreciation of fixed assets that should be disclosed in accounting policies. The principal differences in the calculation and accounting of depreciation of fixed assets are revealed. [ABSTRACT FROM AUTHOR]

This article demonstrates how the application of the ordinary rules of property law in the determination of the property rights of spouses in Nigeria has been unfair to a financially weaker spouse (usually the wife). It calls for reconsideration of the present matrimonial property rights arrangement between a husband and a wife in Nigeria. It argues in favour of the statutory introduction of the concept of "matrimonial property" in Nigeria to apply both during marriage and at divorce. To give some background, reference is made to the South African matrimonial property system of community of property and the accrual system. The article proposes that a special category of property, known as "matrimonial property" and which emphasizes the equal proprietary rights of spouses, is recognized. [ABSTRACT FROM AUTHOR]

This study investigates the firm's Corporate Social Responsibility (CSR) from the perspective of Earnings' Management (EM) and role of Corporate Governance (CG) in this relationship. Current study adopted a systematic review approach to investigate this overarching idea. Systematic review findings revealed that by and large negative relationship between CSR and EM is more dominant which highlighted the notion that CSR oriented firms are less intended to engage in EM practices. However, evidence of positive relationship between CSR and EM was also provided by some studies and concluded that CSR is used by mangers to mask their EM practice. In addition, studies found the significant moderating role of CG between CSR and EM relationship, though evidence was very limited. Moreover, although the research on CSR-EM is very limited, yet it produced mixed results due to the important neglecting factors like lack of sufficient theoretical support, use of different types of EM and varying approaches of measuring CSR. Findings revealed that mostly studies used Accrual type of earnings' management but use of real activities based EM type is very rare. Measuring approaches of CSR also varied across the sample of selected studies. Most of studies used social indices approach to measure CSR and very few followed the content analysis approach especially in developing context. [ABSTRACT FROM AUTHOR]

Replacing standard consent materials with simplified materials is a promising intervention to improve patient comprehension, but there is little evidence on its real-world implementation. We employed a sequential two-arm design to compare the effect of standard versus simplified consent materials on potential donors’ understanding of biobank processes and their accrual to an active biobanking program. Participants were female patients of a California breast health clinic. Subjects from the simplified arm answered more items correctly (p = .064), reported “don’t know” for fewer items (p = .077), and consented to donate to the biobank at higher rates (p = .025) than those from the standard arm. Replacing an extant consent form with a simplified version is feasible and may benefit patient comprehension and study accrual. [ABSTRACT FROM AUTHOR]

Background Data about factors driving accrual to radiation oncology trials are limited. In oncology, 30%-40% of trials are considered unsuccessful, many because of poor accrual. The goal of the present study was to inform the design of future trials by evaluating the effects of institutional, clinician, and patient factors on accrual rates to a randomized radiation oncology trial. Methods Investigators participating in sabr-comet (NCT01446744), a randomized phase ii trial open in Canada, Europe, and Australia that is evaluating the role of stereotactic ablative radiotherapy (sabr) in oligometastatic disease, were invited to complete a survey about factors affecting accrual. Institutional ethics approval was obtained. The primary endpoint was the annual accrual rate per institution. Univariable and multivariable linear regression analyses were used to identify factors predictive of annual accrual rates. Results On univariable linear regression analysis, off-trial availability of sabr (p = 0.014) and equipoise of the referring physician (p = 0.014) were found to be predictive of annual accrual rates. The annual accrual rates were lower when centres offered sabr for oligometastases off-trial (median: 3.7 patients vs. 8.4 patients enrolled) and when referring physicians felt that, compared with having equipoise, sabr was beneficial (median: 4.8 patients vs. 8.4 patients enrolled). Multivariable analysis identified perceived level of equipoise of the referring physician to be predictive of the annual accrual rate (p = 0.023). Conclusions The level of equipoise of referring physicians might play a key role in accrual to radiation oncology randomized controlled trials. Efforts to communicate with and educate referring physicians might therefore be beneficial for improving trial accrual rates. [ABSTRACT FROM AUTHOR]

Background Data about factors driving accrual to radiation oncology trials are limited. In oncology, 30%-40% of trials are considered unsuccessful, many because of poor accrual. The goal of the present study was to inform the design of future trials by evaluating the effects of institutional, clinician, and patient factors on accrual rates to a randomized radiation oncology trial. Methods Investigators participating in SABR-COMET (NCT01446744), a randomized phase ii trial open in Canada, Europe, and Australia that is evaluating the role of stereotactic ablative radiotherapy (sabr) in oligometastatic disease, were invited to complete a survey about factors affecting accrual. Institutional ethics approval was obtained. The primary endpoint was the annual accrual rate per institution. Univariable and multivariable linear regression analyses were used to identify factors predictive of annual accrual rates. Results On univariable linear regression analysis, off-trial availability of SABR (p = 0.014) and equipoise of the referring physician (p = 0.014) were found to be predictive of annual accrual rates. The annual accrual rates were lower when centres offered sabr for oligometastases off-trial (median: 3.7 patients vs. 8.4 patients enrolled) and when referring physicians felt that, compared with having equipoise, sabr was beneficial (median: 4.8 patients vs. 8.4 patients enrolled). Multivariable analysis identified perceived level of equipoise of the referring physician to be predictive of the annual accrual rate (p = 0.023). Conclusions The level of equipoise of referring physicians might play a key role in accrual to radiation oncology randomized controlled trials. Efforts to communicate with and educate referring physicians might therefore be beneficial for improving trial accrual rates. [ABSTRACT FROM AUTHOR]

Balanced two-arm designs are more powerful than unbalanced designs and, consequently, Bayesian adaptive designs (BADs) are less powerful. However, when considering other subject- or community-focused design characteristics, fixed two-arm designs can be suboptimal. We use a novel approach to identify the best two-arm study design, taking into consideration both the statistical perspective and the community’s perception. Data envelopment analysis (DEA) was used to estimate the relative performance of competing designs in the presence of multiple optimality criteria. The two-arm fixed design has enough deficiencies in subject- and community-specific benefit to make it the least favorable study design. [ABSTRACT FROM AUTHOR]

Objectives Poor enrollment into prevention trials is a major obstacle to the conduct of clinical investigations. This study focuses on cognitive and affective influences on the decision to participate in a clinical trial aimed at reducing biomarkers of breast cancer risk. Methods Following a decision to participate or not in a clinical trial focused on reduction of breast cancer risk, women were recruited into the present study. Data were gathered via telephone survey. Results One hundred healthy women took part in the current study, 72 of whom had participated in the clinical trial, and 28 of whom had declined participation. Women who decided to enroll perceived more benefits and fewer costs, and they experienced more positive emotions and fewer negative emotions. They also made the decision more quickly, more easily, were more satisfied with it, and had fewer regrets than women who declined participation in the clinical trial. Conclusions Participants to this clinical trial differed from nonparticipants in terms of antecedents, process, and outcomes of the decision to enroll. Practice implications Although obstacles exist, accrual might be improved by greater emphasis on the practical and psychosocial benefits to participants. [ABSTRACT FROM AUTHOR]

Background Underenrollment of clinical studies wastes resources and delays assessment of research discoveries. We describe the organization and impact of a centralized recruitment core delivering comprehensive recruitment support to investigators. Methods The Rockefeller University Center for Clinical and Translational Science supports a centralized recruitment core, call center, Research Volunteer Repository, data infrastructure, and staff who provide expert recruitment services to investigators. During protocol development, consultations aim to optimize enrollment feasibility, develop recruitment strategy, budget, and advertising. Services during study conduct include advertising placement, repository queries, call management, prescreening, referral, and visit scheduling. Utilization and recruitment outcomes are tracked using dedicated software. Results For protocols receiving recruitment services during 2009-2013: median time from initiation of recruitment to the first enrolled participant was 10 days; of 4,047 first-time callers to the call center, 92% ( n = 3,722) enrolled in the Research Volunteer Repository, with 99% retention; 23% of Repository enrollees subsequently enrolled in ≥1 research studies, with 89% retention. Of volunteers referred by repository queries, 49% (280/537) enrolled into the study, with 92% retained. Conclusions Provision of robust recruitment infrastructure including expertise, a volunteer repository, data capture and real-time analysis accelerates protocol accrual. Application of recruitment science improves the quality of clinical investigation. [ABSTRACT FROM AUTHOR]

The time is right for the use of Bayesian Adaptive Designs (BAD) in comparative effectiveness trials. For example, Patient Centered Outcomes Research Institute has joined the Food and Drug Administration and National Intitutes of Health in adopting policies/guidelines encouraging their use. There are multiple aspects to BAD that need to be considered when designing a comparative effectiveness design. First, the adaptation rules can determine the expected size of the trial. Second, a utility function can be used to combine extremely important co-endpoints (e.g., efficacy and tolerability) and is a valuable tool for incorporating clinical expertise and potentially patient preference. Third, accrual rate is also very, very important. Specifically, there is a juxtaposition related to accrual and BAD. If accrual rate is too fast we never gain efficient information for adapting. If accrual rate is too slow we never finish the clinical trial. We propose methodology for finding the 'sweet spot' for BAD that addresses these as design parameters. We demonstrate the methodology on a comparative effectiveness BAD of pharmaceutical agents in cryptogenic sensory polyneuropathy. The study has five arms with two endpoints that are combined with a utility function. The accrual rate is assumed to stem from multiple sites. We perform simulations from which the composite accrual rates across sites result in various piecewise Poisson distributions as parameter inputs. We balance both average number of patients needed and average length of time to finish the study. Copyright © 2015 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Poor accrual is a significant barrier to the successful completion of oncology clinical trials; half of all phase 3 oncology trials close due to insufficient accrual. Timely access to accrual data fosters an understanding of successful trial design and can be used to inform the design of new clinical trials prospectively. Accrual statistics are available within research networks, such as the cancer cooperative groups, but comprehensive data reflecting the overall portfolio of cancer clinical trials are lacking. As a demonstration case, the purpose of this study was to quantify the public availability of accrual data across all recent renal cell carcinoma (RCC) trials. Methods: The database for the Aggregate Analysis of ClinicalTrials.gov (AACT) summarizes all trials registered between October 2007 and September 2010. In total, 108 trials of pharmacologic therapy for RCC were included. Accrual data on these trials were gathered via ClinicalTrials.gov (CTG), a manual review of resulting publications, and online surveys sent to principle investigators or trial coordinators. Results: In total, 26% (20 of 76) of trials listing a government, academic, or cooperative group (GAC) sponsor responded to the survey vs 0% (0 of 32) of those listing only industry sponsors. Across all methods, accrual data were available for only 40% (43 of 108) of trials, including 37% (28 of 76) of GAC trials and 47% (15 of 32) of industry trials. Moreover, 87% (66 of 76) of GAC trials were ongoing (open, actively recruiting, or of unknown status) vs 75% (24 of 32) of industry trials, while 9% (10 of 108) of trials were terminated or suspended. Conclusions: Despite extensive efforts (surveys, phone calls, CTG abstraction, publication searches), accurate accrual data remained inaccessible for 60% of the RCC trial cohort. While CTG reports trial results, ongoing accrual data are also critically needed. Poor access to accrual data will continue to limit attempts to develop a national summary of clinical trials metrics and to optimize the cancer clinical research portfolio. [ABSTRACT FROM AUTHOR]

Background A number of clinical trials have encountered difficulties enrolling a sufficient number of patients upon initiating the trial. Recently, many screening systems that search clinical data warehouses for patients who are eligible for clinical trials have been developed. We aimed to estimate the number of eligible patients using routine electronic medical records (EMRs) and to predict the difficulty of enrolling sufficient patients prior to beginning a trial. Methods Investigator-initiated clinical trials that were conducted at Kyoto University Hospital between July 2004 and January 2011 were included in this study. We searched the EMRs for eligible patients and calculated the eligible EMR patient index by dividing the number of eligible patients in the EMRs by the target sample size. Additionally, we divided the trial eligibility criteria into corresponding data elements in the EMRs to evaluate the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. We evaluated the correlation between the index and the accrual achievement with Spearman's rank correlation coefficient. Results Thirteen of 19 trials did not achieve their original target sample size. Overall, 55% of the trial eligibility criteria were mapped into data elements in EMRs. The accrual achievement demonstrated a significant positive correlation with the eligible EMR patient index (r = 0.67, 95% confidence interval (CI), 0.42 to 0.92). The receiver operating characteristic analysis revealed an eligible EMR patient index cut-off value of 1.7, with a sensitivity of 69.2% and a specificity of 100.0%. Conclusions Our study suggests that the eligible EMR patient index remains exploratory but could be a useful component of the feasibility study when planning a clinical trial. Establishing a step to check whether there are likely to be a sufficient number of eligible patients enables sponsors and investigators to concentrate their resources and efforts on more achievable trials. [ABSTRACT FROM AUTHOR]

Background Accrual to Cancer Control and Supportive Care (CCL) studies can be challenging. Our objective was to identify facilitators and perceived barriers to successful Children's Oncology Group (COG) CCL accrual from the clinical research associate (CRA) perspective. Methods A survey was developed that focused on the following features from the institutional perspective: (1) Components of successful accrual; (2) Barriers to accrual; (3) Institutional changes that could enhance accrual; and (4) How COG could facilitate accrual. The survey was distributed to the lead CRA at each COG site with at least 2 CCL accruals within the previous year. The written responses were classified into themes and sub-themes. Results 57 sites in the United States (n = 52) and Canada (n = 5) were contacted; 34 (60%) responded. The four major themes were: (1) Staff presence and dynamics; (2) Logistics including adequate numbers of eligible patients; (3) Interests and priorities; and (4) Resources. Suggestions for improvement began at the study design/conception stage, and included ongoing training/support and increased reimbursement or credit for successful CCL enrollment. Conclusions The comments resulted in suggestions to facilitate CCL trials in the future. Soliciting input from key team members in the clinical trials process is important to maximizing accrual rates. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: Pancreatic cancer (PC) is associated with a dismal prognosis. Few studies have examined characteristics and outcome in an unselected population-based cohort of PC patients. Therefore, we investigated patient baseline characteristics, therapy choices and survival in a complete cohort of patients with PC. Methods: All cases diagnosed with PC between 2007 and 2009 in the Region of Southern Denmark (pop: 1,200,000) were prospectively registered. Patient characteristics including performance status, information about haematology, liver function and therapy were retrieved from patient charts, and used to compare differently treated and untreated groups. Results: Six-hundred-eighteen cases were registered as PC; 25 of which did not have adenocarcinomas. Patients were divided in 3 clinical groups based on initial therapy; group 1: resection (n =64), group 2: chemotherapy or chemo-radiotherapy (n =191), group 3: no tumour directed therapy (n =324). Median survival (mOS) (95% confidence interval (CI)) in the three groups was 25.7months (18–30), 8.1months (7.0–9.5) and 1.1months (1.0–1.3) respectively. Three percent of patients participated in clinical trials. An evaluation of baseline factors prognostic value suggested that treated patients differed significantly from non-treated patients. Conclusion: This study reports survival in treated groups comparable to results obtained from clinical trials with highly selected patients. However the majority of patients with PC do not receive cancer directed therapy. This group was significantly different in several baseline factors, which could suggest a different biology. Improving the outcome of PC patients calls for research into the large group of untreated patients, as only a minority of patients receive cancer directed therapy. [Copyright &y& Elsevier]

Purpose: Treatment protocols in pediatric oncology have historically known high accrual rates, up to 94 %. Accrual for supportive care studies on the other hand appears to be a challenge. The aim of this study was to search for reasons explaining this poor accrual and for possible interventions to improve patient enrolment. Methods: The failure screen log of our supportive care study (the Aristocaths study) was analyzed, and subsequently, a literature search was performed. Results: The literature search (1985-2011) revealed three factors that can influence accrual. Firstly, study implementation and patient enrolment can be facilitated by appointing a dedicated clinical investigator in all participating centers and by facilitating clinical research nurses. Furthermore, adequate and tailor-made information is required for families to make a well-informed decision regarding study participation. Lastly, sufficient time should be assured for the process of decision making, especially since the number of eligible studies is increasing rapidly. Concerning our study, all three elements were met, but the most striking finding was the presumed burden of study participation by the majority of parents (82 %) as the main argument against randomization. Conclusions: Accrual of pediatric oncology patients in supportive care studies is challenging. Nevertheless, well-designed randomized controlled trials in supportive care will be essential for the improvement of pediatric cancer care. Therefore, we will need to increase awareness through (inter)national supportive care working groups regarding the need for supportive care trials and stimulate accrual when such trials are open. [ABSTRACT FROM AUTHOR]

Abstract: Screening and recruitment of qualified subjects for clinical trials is an essential component of translational research, and it can be quite challenging if the most efficient recruitment method is not utilized. In this report, we describe a successful web-based screening and accrual method used in a randomized prospective chemoprevention clinical trial with urinary biomarker endpoints. The targeted study population was a group of at-risk healthy current smokers with no evidence of lung disease. Craigslist was used as the sole recruitment modality for this study. All interested subjects were directed to a pre-screening website, in which subject questionnaire responses were linked to the study coordinator''s secure e-mail account. Of the 429 initial inquiries, 189 individuals were initially eligible based on the questionnaire response. One hundred twenty‐two people were telephone-screened, of whom 98 subjects were consented, 84 were randomized and 77 subjects completed the study successfully. Utilizing this single web-based advertising strategy, accrual for the trial was completed 7months prior to the projected date. Craigslist is a cost effective and efficient web-based resource that can be utilized in accruing subjects to some chemoprevention trials. [Copyright &y& Elsevier]

Objective: To review reasons for suboptimal recruitment for a randomized controlled trial (RCT) of varicocelectomy versus intrauterine insemination (IUI) for treatment of male infertility and to suggest means for improving future study recruitment.Design: Survey of Reproductive Medicine Network (RMN) participating sites.Setting: Reproductive Medicine Network.Patient(s): None.Intervention(s): None.Main Outcome Measure(s): Ascertain reasons for inadequate recruitment and suggest improvements for future varicocelectomy trails.Result(s): This study screened seven and enrolled three couples, with the first couple randomized on June 30, 2010. The study was subsequently stopped on March 30, 2011. The following themes were cited most frequently by sites and therefore determined to be most likely to have played a role in suboptimal recruitment: [1] men must be screened at the beginning of a couple's infertility evaluation, [2] inclusion of infertile women who had failed previous fertility interventions appeared to be associated with the couple's intolerance of a placebo arm, and [3] an apparent bias against the use of unstimulated IUI cycles indicated a prejudicial preference for surgical intervention in the male partner.Conclusion(s): Improved recruitment may be realized through screening infertile men as early as possible while minimizing study-related time commitments. Focused patient education may promote improved equipoise and acceptance of a placebo arm in male infertility studies. Creative approaches to implementing varicocelectomy trials must be considered in addition to having a network of motivated researchers who carry a high volume of possible study participants because very large numbers may need to be screened to complete the clinical trial enrollment. [ABSTRACT FROM AUTHOR]

The general policy in South African insolvency law is that assets must be recovered and included in the insolvent estate, and that this action must be to the advantage of the creditors of the insolvent estate. But there are several exceptions to this rule and an asset that is the subject of such an exception may be excluded from the insolvent estate. The Insolvency Act, however, does not expressly distinguish between excluded and exempt assets, thereby resulting in problem areas in the field of exemption law in insolvency in South Africa. It may be argued that the fundamental difference between excluded and exempt assets is that excluded assets should never form part of an insolvent estate and should be beyond the reach of the creditors of the insolvent estate, while exempt assets initially form part of the insolvent estate, but in certain circumstances may be exempted from the estate for the benefit of the insolvent debtor, thereby allowing the debtor to use such excluded or exempt assets to start afresh before or after rehabilitation. Modern society, sociopolitical developments and human rights requirements have necessitated a broadening of the classes of assets that should be excluded or exempted from insolvent estates. This article considers assets excluded from the insolvent estates of individual debtors by legislation other than the Insolvency Act. It must, however, be understood that these legislative provisions relate to insolvent estates and thus generally overlap in one way or another with some provisions of the Insolvency Act. [ABSTRACT FROM AUTHOR]

From 2004-2009 a total of 226 out of a target of 750 prostate cancer patients have been randomised into the Timing of Androgen Deprivation trial between immediate and delayed androgen deprivation. A screening log was kept by participating centres for the first 928 patients, which documented the reasons for non-entry into the trial; 42.7% of screened patients were ineligible and a further 33.0% were not entered for other reasons. Fewer than 10% of patients cited not wanting to be part of a clinical trial as a reason for non-entry. Strategies to improve recruitment included broadening the eligibility criteria, encouraging international collaboration, the use and support of research nurses in the private health care environment, and the use of phone follow-up. Recruitment will be completed at the number originally intended to inform the interim analysis designed to test the validity of the statistical assumptions, and a combined survival analysis with the Canadian study is planned. [ABSTRACT FROM AUTHOR]

The article focuses on the examination of clinical trial enrollment, patient characteristics, and survival differences in metastatic colorectal cancer patients receiving chemotherapy. It is stated that the examination was carried out to determine whether metastatic colorectal cancer (mCRC) patients represent general cancer population concerning patient characteristics and survival or not.

The article reports on a study examining how do investigators within cancer centers seek to recruit patients to trials in everyday life, and how are recruitment activities related to clinic-based barriers to recruitment. It has been suggested in the study that future research should examine whether providers in other settings also target their recruitment efforts and this research should also consider if differentially recruiting patients can impact the ethnic diversity of trial participants.

The article discusses a study which examines site preparedness for phase 2/IIb/III HIV prevention trials. The sites studied are Durban and Hlabisa in South Africa, Lusaka in Zambia and Moshi in Tanzania. Preparatory studies provide accurate local estimates of HIV incidence, recruitment and retention rates, and behavioral characteristics of targeted populations.

Aims. The aim of this paper is to report the rates and reasons for refusal given by 817 eligible participants from 10 completed and ongoing nursing and behavioural medicine studies in paediatric oncology from 1994 to 2004. Background. Eligible participants have the right to accept or decline participation in research studies. Information about rates of refusal and reasons for refusal could be useful in determining participant-perceived burden related to study participation, in accurately estimating the time needed to accrue an adequate number of participants to achieve the study aims, and in interpreting study findings from certain groups of participants. Methods. A 13-item survey form about study characteristics was completed prospectively for each study included in this report; categories of reasons for refusal were inductively identified and defined using a semantic content analytic technique. Results. The overall rate of refusal was 23·6% (range: 6·7–46·7%). The studies that involved blood sampling or end-of-life decision-making had the highest refusal rates and an instrumentation study had the lowest. Eligible male participants had consistently higher rates of refusal than did females across the 10 studies. Nine categories of refusal were inductively identified, with the most commonly reported reason being the burden of the research methods. Conclusion. A careful informed consent process will still result in some refusals. The refusal rates reported here can be used to help future researchers more accurately estimate accrual periods for studies involving blood sampling or investigating sensitive topics in paediatric oncology. [ABSTRACT FROM AUTHOR]

Abstract: Clinical trials are essential in developing new treatments, care, and prevention for people with cancer. Unfortunately U.S. accrual rates for adult cancers are approximately 2–3%, partly due to the way the clinical trial system operates. Breast cancer patient advocates know enrollment has to accelerate to translate the many new scientific discoveries into effective use. Most newly diagnosed women, however, know nothing about clinical trials or why to consider them. The way a woman is approached about clinical trials can create fear and misunderstanding during a time when her body puts her into a physiological state of shock. These misunderstandings exacerbate the situation, and can lead to mistrust that will taint future medical interactions if they are not assuaged immediately. Many women, family members, and friends want to investigate clinical trials, but have no guide to help them through this daunting process. They have to contact many sources, decipher medical jargon, find a “clinical trial doctor,” and fight for insurance coverage. It is time for new approaches that make sense to patients. Clear information that helps people understand the value of research studies must also be presented in caring ways that reinforce the support people seek during crisis. Working together, cancer patient advocates and cancer researchers can provide this kind of useful information. The Clinical Trials Information Project (CTIP), a nonprofit organization established by patients and family members, has introduced a new approach through the CTIP Breast Cancer Kit. [ABSTRACT FROM AUTHOR]

Background: Poor recruitment of patients is the predominant reason for early termination of randomized clinical trials (RCTs). Systematic empirical investigations and validation studies of existing recruitment models, however, are lacking. We aim to provide evidence-based guidance on how to predict and monitor recruitment of patients into RCTs. Our specific objectives are the following: (1) to establish a large sample of RCTs (target n = 300) with individual patient recruitment data from a large variety of RCTs, (2) to investigate participant recruitment patterns and study site recruitment patterns and their association with the overall recruitment process, (3) to investigate the validity of a freely available recruitment model, and (4) to develop a user-friendly tool to assist trial investigators in the planning and monitoring of the recruitment process.Methods: Eligible RCTs need to have completed the recruitment process, used a parallel group design, and investigated any healthcare intervention where participants had the free choice to participate. To establish the planned sample of RCTs, we will use our contacts to national and international RCT networks, clinical trial units, and individual trial investigators. From included RCTs, we will collect patient-level information (date of randomization), site-level information (date of trial site activation), and trial-level information (target sample size). We will examine recruitment patterns using recruitment trajectories and stratifications by RCT characteristics. We will investigate associations of early recruitment patterns with overall recruitment by correlation and multivariable regression. To examine the validity of a freely available Bayesian prediction model, we will compare model predictions to collected empirical data of included RCTs. Finally, we will user-test any promising tool using qualitative methods for further tool improvement.Discussion: This research will contribute to a better understanding of participant recruitment to RCTs, which could enhance efficiency and reduce the waste of resources in clinical research with a comprehensive, concerted, international effort. [ABSTRACT FROM AUTHOR]

Abstract: This note addresses the questions of whether one should safeguard against a potential loss of power due to random variations of the accrual time, how this “insurance” can be formulated, and how much the sample size needs to be increased to obtain it. [Copyright &y& Elsevier]

Background: The Venous Thromboembolism Prophylaxis (VTE-PRO) randomized trial is a pilot study evaluating the impact of extended-duration prophylaxis on venous thromboembolic events in patients undergoing lung cancer resection. Enrolled VTE-PRO participants self-inject either low-molecular weight heparin or a saline placebo for 30 days postoperatively. Study outcomes include feasibility, incidence of venous thromboembolism, and venous thromboembolism-related morbidity and mortality. Initial analyses demonstrated low rates of accrual and retention for the VTE-PRO pilot. Therefore, the purpose of the current study was to develop a knowledge translation intervention to improve VTE-PRO pilot trial accrual and retention.Methods: Eligible participants were surveyed to identify the barriers to VTE-PRO participation. The Theoretical Domains Framework was used to categorize these barriers. Barriers were mapped to the capabilities, opportunities, and behavior (COM-B) behavioral change wheel to identify potential interventions to support trial accrual and retention. The resulting knowledge translation intervention was titled Inform, Remind, Involve and Support to improve Accrual and Retention (IRIS-AR). Key informant interviews with patients were held to refine and confirm the validity of identified barriers and perceived acceptability of the proposed IRIS-AR intervention. Institutional Review Board approval was granted for this study.Results: The resulting intervention included: information booklets and counseling sessions to identify unique participant challenges to trial participation (Inform); daily reminders to administer injections (Remind); involvement of family/caregivers in study processes (Involve); and leverage of an existing home-care nursing program to provide injection support when needed (Support). Twenty-six key informant participants were interviewed. The most common barriers to trial participation included lack of social support and fear of needle injection. Participants generally supported use of information booklets, involvement of family/caregivers, and support by a home-care nursing program; however, not all supported the use of daily reminders.Conclusion: Developed using theory and integrated knowledge translation, the IRIS-AR presents a patient-centered intervention that leverages existing programs to promote trial engagement. The proposed strategy can likely be adapted to improve compliance with other patient-directed interventions.Trial Registration: ClinicalTrials.gov, NCT02334007 . Registered on 8 January 2015. [ABSTRACT FROM AUTHOR]

Background: Across sub-Saharan Africa (SSA), HIV disproportionately affects men-who-have-sex-with-men (MSM) compared with other men of the same age group in the general population. Access to HIV services remains low among this group although several effective interventions have been documented. It is therefore important to identify what has worked well to increase the reach of HIV services among MSM.Methods: We searched MEDLINE, POPLINE and the Web of Science databases to collect published articles reporting HIV interventions among MSM across sub-Saharan Africa. Covidence was used to review the articles. The review protocol was registered in International Prospective Register of Systematic Reviews (PROSPERO) - CRD42017060808.Results: The search identified 2627 citations, and following removal of duplicates and inclusion and exclusion criteria, only 15 papers were eligible for inclusion in the review. The articles reported various accrual strategies, namely: respondent driven sampling, known peers identified through hotspot or baseline surveys, engagement with existing community-based organizations, and through peer educators contacting MSM in virtual sites. Some programs, however, combined some of these accrual strategies. Peer-led outreach services were indicated to reach and deliver services to more MSM. A combination of peer outreach and mobile clinics increased uptake of health information and services. Health facilities, especially MSM-friendly facilities attract access and use of services by MSM and retention into care.Conclusions: There are various strategies for accrual and delivering services to MSM across SSA. However, each of these strategies have specific strengths and weaknesses necessitating combinations of interventions and integration of the specific context to inform implementation. If the best of intervention content and implementation are used to inform these services, sufficient coverage and impact of HIV prevention and treatment programs for MSM across SSA can be optimized. [ABSTRACT FROM AUTHOR]

Abstract: This session focused on issues related to implementation of randomized clinical trials in palliative care studies. Topics discussed included what kinds of clinical sites and patient populations were suitable, what types of clinical investigators (clinical specialty) should be involved in or lead the studies, what multisite mechanisms could be used to conduct the trials, and what funding issues were related to these studies. A trial of operative versus nonoperative management for small bowel obstruction caused by recurrent intra-abdominal cancer was considered. The feasibility of such a trial was examined in terms of whether there was “equipoise” for a majority of likely investigators in the field around the trial question, what other issues might impact accrual to the trial, and how many patients would be required to answer which of these two treatment arms was better. This last question is related to selection of a primary endpoint for the trial and was a modestly contentious issue for the trial design group. Both sensible compromises in endpoint selection and the education of the community of investigators for a particular randomized trial in palliative care are crucial steps for successful implementation. A major conclusion of this session is that implementation considerations are intimately related to the architecture of a specific trial and should be addressed practically and early in the design phase of any randomized trial addressing a palliative care question. In this respect, randomized trials in palliative care are no different than in other fields. [Copyright &y& Elsevier]

In headwater coastal streams of southwestern British Columbia, previous research suggested that light limited periphyton growth and abundance of grazing invertebrates. Logging along a reach of stream allowed us to further examine the importance of light, as well as other abiotic factors, in regulating stream periphyton and grazers. We placed unglazed ceramic tiles in three watershed, two of which served as controls. In the third watershed, we placed tiles in one reach that was newly harvested, as well as in an upstream, forested reach. Tiles were placed in streams in late June and removed weekly over a six-week period for determination of periphyton chlorophyll a and ash-free dry mass. We also measured discharge, dissolved nitrate and phosphate, and counted the number of invertebrate grazers on each removed tile weekly. Peak biomass, as chlorophyll a, was reached on day 29 with alga biomass at the logged site, seven to fourteen times higher than at the control sites. Stepwise, multiple linear regression suggested that light was the single best predictor explaining 64% of the variation in peak biomass of chlorophyll a. Although periphyton biomass on tileswas much higher in the clear-cut reach, so was fine sediment. Inorganic mass entrapped in the periphyton mat was two to four times higherin the clear-cut stream than at other sites. Grazer abundance was not related to periphyton biomass, but was negatively related to sediment levels. Our results are consistent with the hypothesis that grazerabundance was determined by sediment levels rather than alga biomass. [ABSTRACT FROM AUTHOR]