Trial of Sodium Phenylbutyrate-Taurursodiol for Amyotrophic Lateral Sclerosis

Background:Sodium phenylbutyrate and taurursodiol have been found to reduce neuronal death in experimental models.The efficacy and safety of a combination of the two compounds in persons with amyotrophic lateral sclerosis(ALS)are not known.Methods:In this multicenter,randomized,double-blind trial,we enrolled participants with definite ALS who had had an onset of symptoms within the previous 18 months.     

iPad-Based Patient Briefing for Radiological Examinations—a Clinical Trial

To analyze if an iPad-based patient briefing can serve as a digital alternative to conventional documentations prior to radiological examinations. One hundred one patients referred for routine MRI were randomized into two groups, who underwent iPad-based and classic written briefing in opposite order. For each briefing completion time, completeness and correctness were noted. Patient’s knowledge about the content of either briefing modality was subsequently tested. The influence of patient-related factors on the performance of the electronic briefing (EB) was analyzed. Finally, the patient’s subjective impression of the EB was assessed. The mean durations were 4.4 ± 2.2 min for EB and 1.7 ± 1.3 min for the classic briefing (p < 0.01). All iPad briefings were returned entirely filled out, whereas 11 % of the classic forms were returned with missing data. No significant differences in memorization of the briefing’s information were objectified. There was a positive correlation between the duration of EB and age (r = 0.53; p < 0.01), whereas a negative correlation was found between computer skills and patient’s age (r = −0.55; p < 0.01) or duration of EB (r = −0.62; p < 0.01). More than half of the study patients would prefer EB in the future; another 29 % had no preference at all. Patient briefing on iPads transfers the information for the patients equally well compared to the classic written approach. Although iPad briefing took patients longer to perform, the majority would prefer it to written consent briefings in the future. Nevertheless, measures have to be undertaken to improve the overall acceptance and performance.     

A Text Message–Based Intervention for Weight Loss: Randomized Controlled Trial

Background

To our knowledge, no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS (Short Message Service: text) and MMS (Multimedia Message Service: small picture) messages transmitted via mobile phones.

Objective

This paper describes the development and evaluation of a text message–based intervention designed to help individuals lose or maintain weight over 4 months.

Methods

The study was a randomized controlled trial, with participants being exposed to one of the following two conditions, lasting 16 weeks: (1) receipt of monthly printed materials about weight control; (2) an intervention that included personalized SMS and MMS messages sent two to five times daily, printed materials, and brief monthly phone calls from a health counselor. The primary outcome was weight at the end of the intervention. A mixed-model repeated-measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period. Analysis of covariance (ANCOVA) models examined weight change between baseline and 4 months after adjusting for baseline weight, sex, and age.

Results

A total of 75 overweight men and women were randomized into one of the two groups, and 65 signed the consent form, completed the baseline questionnaire, and were included in the analysis. At the end of 4 months, the intervention group (n = 33) lost more weight than the comparison group (−1.97 kg difference, 95% CI −0.34 to −3.60 kg, P = .02) after adjusting for sex and age. Intervention participants’ adjusted average weight loss was 2.88 kg (3.16%). At the end of the study, 22 of 24 (92%) intervention participants stated that they would recommend the intervention for weight control to friends and family.

Conclusions

Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00415870","term_id":"NCT00415870"}}NCT00415870; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00415870","term_id":"NCT00415870"}}NCT00415870 (Archived by WebCite at http://www.webcitation.org/5dnolbkFt)     

Are You "Tilting at Windmills" or Undertaking a Valid Clinical Trial?

In this review, several aspects surrounding the choice of a therapeutic intervention and the conduct of clinical trials are discussed. Some of the background for why human studies have evolved to their current state is also included. Specifically, the following questions have been addressed: 1) What criteria should be used to determine whether a scientific discovery or invention is worthy of translation to human application? 2) What recent scientific advance warrants a deeper understanding of clinical trials by everyone? 3) What are the different types and phases of a clinical trial? 4) What characteristics of a human disorder should be noted, tracked, or stratified for a clinical trial and what inclusion /exclusion criteria are important to enrolling appropriate trial subjects? 5) What are the different study designs that can be used in a clinical trial program? 6) What confounding factors can alter the accurate interpretation of clinical trial outcomes? 7) What are the success rates of clinical trials and what can we learn from previous clinical trials? 8) What are the essential principles for the conduct of valid clinical trials?     

How Should Debriefing Be Undertaken in Web-Based Studies? Findings From a Randomized Controlled Trial

Background

Internet research may raise older ethical issues in new forms or pose new issues. It has been recommended that debriefing information online be kept very short, with further information including study results made available if requested by participants. There are no empirical studies that compare possible alternative methods of debriefing in online studies.

Objective

To undertake a randomized controlled trial evaluating how to implement the recommended approach by assessing the effects of two different approaches on accessing of additional information.

Methods

All 11,943 participants in the Effects of Study Design and Allocation (ESDA) study, which employed deception, were randomly assigned to one of two methods of debriefing: Group A received the debriefing information in the body of an email with links to protocol and results pages; Group B was presented with these links after clicking on an initial link in the body of the email to view the debriefing information on a website. Outcomes assessed were the proportions clicking on the links to the protocol and results summary and the time spent on these pages by those accessing them.

Results

The group who were presented with no debriefing information in the body of the email and went to a website for this information (Group B) were approximately twice as likely to subsequently access the protocol and the results summary. These differences between the two groups were highly statistically significant. Although these differences are clear, the overall proportions accessing such information were low, and there were no differences in mean time spent reading these pages. Only one quarter of Group B actually accessed debriefing information.

Conclusions

In circumstances where the uptake of fuller information on study design, methods, and findings is deemed important, debriefing information may be better provided via a link and not included in the body of an email. Doing so may, however, reduce the extent of receiving any debriefing information at all. There is a wider need for high quality empirical studies to inform ethical evaluations.

Trial Registration

Australian New Zealand Clinical Trials Registry, ACTRN12610000846022 (http://www.anzctr.org.au/)     

Effectiveness of Web-Based Tailored Advice on Parents’ Child Safety Behaviors: Randomized Controlled Trial

Background

Injuries at home are a major cause of death, disability, and loss of quality of life among young children. Despite current safety education, required safety behavior of parents is often lacking. To prevent various childhood disorders, the application of Web-based tools has increased the effectiveness of health promotion efforts. Therefore, an intervention with Web-based, tailored, safety advice combined with personal counseling (E-Health4Uth home safety) was developed and applied.

Objective

To evaluate the effect of E-Health4Uth home safety on parents’ safety behaviors with regard to the prevention of falls, poisoning, drowning, and burns.

Methods

A randomized controlled trial was conducted (2009-2011) among parents visiting well-baby clinics in the Netherlands. Parents were randomly assigned to the intervention group (E-Health4Uth home safety intervention) or to the control condition consisting of usual care. Parents in the intervention condition completed a Web-based safety behavior assessment questionnaire; the resulting tailored safety advice was discussed with their child health care professional at a well-baby visit (age approximately 11 months). Parents in the control condition received counseling using generic safety information leaflets at this well-baby visit. Parents’ child safety behaviors were derived from self-report questionnaires at baseline (age 7 months) and at follow-up (age 17 months). Each specific safety behavior was classified as safe/unsafe and a total risk score was calculated. Logistic and linear regression analyses were used to reveal differences in safety behavior between the intervention and the control condition at follow-up.

Results

A total of 1292 parents (response rate 44.79%) were analyzed. At follow-up, parents in the intervention condition (n=643) showed significantly less unsafe behavior compared to parents in the control condition (n=649): top of staircase (23.91% vs 32.19%; OR 0.65, 95% CI 0.50-0.85); bottom of staircase (63.53% vs 71.94%; OR 0.69, 95% CI 0.53-0.88); top and bottom of staircase (68.94% vs 78.28%; OR 0.62, 95% CI 0.48-0.81); storage of cleaning products (30.33% vs 39.91%; OR 0.67, 95% CI 0.53-0.85); bathing of the child (23.46% vs 32.25%; OR 0.65, 95% CI 0.51-0.84); drinking hot fluids (34.84% vs 41.73%; OR 0.76, 95% CI 0.61-0.96); using rear hotplates (79.34% vs 85.27%; OR 0.67, 95% CI 0.50-0.90); and the total risk score in which a higher score indicates more unsafe behavior (mean 13.63, SD 6.12 vs mean 15.34, SD 6.07; beta –1.59, 95% CI –2.26 to –0.93). There were no significant differences for other specific behaviors between the two study conditions.

Conclusions

Compared to generic written materials, the E-Health4Uth home safety intervention seems more effective in promoting parents’ safety behavior for safe staircases, storage of cleaning products, bathing, drinking hot fluids, and cooking. This study supports the application of Web-based, tailored, safety advice for the prevention of unintentional injuries in the youth health care setting.

Trial Registration

Nederlands Trial Register: NTR1836; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1836 (Archived by WebCite at http://www.webcitation.org/6MPIGQxpx).     

Long-Term Effects of a Multimodal Behavioral Intervention on Myocardial Perfusion—a Randomized Controlled Trial

Background  

Recent advances in drug therapy question as to the additional impact behavioral interventions may have on the prognosis of patients with clinically stable coronary heart disease (CHD).     

Does Brief Telephone Support Improve Engagement With a Web-Based Weight Management Intervention? Randomized Controlled Trial

Background

Recent reviews suggest Web-based interventions are promising approaches for weight management but they identify difficulties with suboptimal usage. The literature suggests that offering some degree of human support to website users may boost usage and outcomes.

Objective

We disseminated the POWeR (“Positive Online Weight Reduction”) Web-based weight management intervention in a community setting. POWeR consisted of weekly online sessions that emphasized self-monitoring, goal-setting, and cognitive/behavioral strategies. Our primary outcome was intervention usage and we investigated whether this was enhanced by the addition of brief telephone coaching. We also explored group differences in short-term self-reported weight loss.

Methods

Participants were recruited using a range of methods including targeted mailouts, advertisements in the local press, notices on organizational websites, and social media. A total of 786 adults were randomized at an individual level through an online procedure to (1) POWeR only (n=264), (2) POWeR plus coaching (n=247), or (3) a waiting list control group (n=275). Those in the POWeR plus coaching arm were contacted at approximately 7 and 28 days after randomization for short coaching telephone calls aimed at promoting continued usage of the website. Website usage was tracked automatically. Weight was assessed by online self-report.

Results

Of the 511 participants allocated to the two intervention groups, the median number of POWeR sessions completed was just one (IQR 0-2 for POWeR only, IQR 0-3 for POWeR plus coach). Nonetheless, a substantial minority completed at least the core three sessions of POWeR: 47 participants (17.8%, 47/264) in the POWeR-only arm and 64 participants (25.9%, 64/247) in the POWeR plus coaching arm. Participants in the POWeR plus coaching group persisted with the intervention for longer and were 1.61 times more likely to complete the core three sessions than the POWeR-only group (χ² ₁=4.93; OR 1.61, 95% CI 1.06-2.47; n=511). An intention-to-treat analysis showed between-group differences in weight loss (F _2,782=12.421, P<.001). Both intervention groups reported more weight loss than the waiting list control group. Weight loss was slightly, but not significantly, greater in the POWeR plus coaching group. A large proportion of participants assigned to POWeR plus coaching refused phone calls or were not contactable (57.9%, 143/247). Exploratory analyses identified health and sociodemographic differences between those who did and did not engage in coaching when it was made available to them. Users who engaged with coaching used the intervention more and lost more weight than those who did not.

Conclusions

In common with most Web-based intervention studies, usage of POWeR was suboptimal overall. However, our findings suggest that supplementing Web-based weight management with brief human support could improve usage and outcomes in those who take it up.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 98176068; http://www.controlled-trials.com/ISRCTN98176068 (Archived by WebCite at http://www.webcitation.org/6OKRjM2oy).     

Effects of a Financial Incentive on Health Researchers’ Response to an Online Survey: a Randomized Controlled Trial

Background

Nonresponse to questionnaires can affect the validity of surveys and introduce bias. Offering financial incentives can increase response rates to postal questionnaires, but the effect of financial incentives on response rates to online surveys is less clear.

Objective

As part of a survey, we aimed to test whether knowledge of a financial incentive would increase the response rate to an online questionnaire.

Methods

A randomized controlled trial of 485 UK-based principal investigators of publicly funded health services and population health research. Participants were contacted by email and invited to complete an online questionnaire via an embedded URL. Participants were randomly allocated to groups with either “knowledge of” or “no knowledge of” a financial incentive (£10 Amazon gift voucher) to be provided on completion of the survey. At the end of the study, gift vouchers were given to all participants who completed the questionnaire regardless of initial randomization status. Four reminder emails (sent from the same email address as the initial invitation) were sent out to nonrespondents at one, two, three, and four weeks; a fifth postal reminder was also undertaken. The primary outcome measure for the trial was the response rate one week after the second reminder. Response rate was also measured at the end of weeks one, two, three, four, and five, and after a postal reminder was sent.

Results

In total, 243 (50%) questionnaires were returned (232 completed, 11 in which participation was declined). One week after the second reminder, the response rate in the “knowledge” group was 27% (66/244) versus 20% (49/241) in the “no knowledge” group (χ²₁ = 3.0, P = .08). The odds ratio for responding among those with knowledge of an incentive was 1.45 (95% confidence interval [CI] 0.95 - 2.21). At the third reminder, participants in the “no knowledge” group were informed about the incentive, ending the randomized element of the study. However we continued to follow up all participants, and from reminder three onwards, no significant differences were observed in the response rates of the two groups.

Conclusions

Knowledge of a financial incentive did not significantly increase the response rate to an online questionnaire. Future surveys should consider including a randomized element to further test the utility of offering incentives of other types and amounts to participate in online questionnaires.

Trial Registration

ISRCTN59912797; http://www.controlled-trials.com/ISRCTN59912797 (Archived by WebCite at http://www.webcitation.org/5iPPLbT7s)     

Can Facebook Be Used for Research? Experiences Using Facebook to Recruit Pregnant Women for a Randomized Controlled Trial

BackgroundRecruitment is often a difficult and costly part of any human research study. Social media and other emerging means of mass communication hold promise as means to complement traditional strategies used for recruiting participants because they can reach a large number of people in a short amount of time. With the ability to target a specified audience, paid Facebook advertisements have potential to reach future research participants of a specific demographic. This paper describes the experiences of a randomized controlled trial in Edmonton, Alberta, attempting to recruit healthy pregnant women between 8 and 20 weeks’ gestation for participation in a prenatal study. Various traditional recruitment approaches, in addition to paid Facebook advertisements were trialed.ObjectiveTo evaluate the effectiveness of paid advertisements on Facebook as a platform for recruiting pregnant women to a randomized controlled trial in comparison with traditional recruitment approaches.MethodsRecruitment using traditional approaches occurred for 7 months, whereas Facebook advertisements ran for a total of 26 days. Interested women were prompted to contact the study staff for a screening call to determine study eligibility. Costs associated with each recruitment approach were recorded and used to calculate the cost to recruit eligible participants. Performance of Facebook advertisements was monitored using Facebook Ads Manager.ResultsOf the 115 women included, 39.1% (n=45) of the women who contacted study staff heard about the study through Facebook, whereas 60.9% (n=70) of them heard about it through traditional recruitment approaches. During the 215 days (~7 months) that the traditional approaches were used, the average rate of interest was 0.3 (0.2) women/day, whereas the 26 days of Facebook advertisements resulted in an average rate of interest of 2.8 (1.7) women/day. Facebook advertisements cost Can $506.91 with a cost per eligible participant of Cad $20.28. In comparison, the traditional approaches cost Cad $1087, with approximately Cad $24.15 per eligible participant. Demographic characteristics of women were similar between the 2 recruitment methods except that women recruited using Facebook were significantly earlier in their pregnancy than those recruited using traditional approaches (P<.03).ConclusionsPaid Facebook advertisements hold promise as a platform for reaching pregnant women. The relative ease of placing an advertisement, the comparable cost per participant recruited, and the dramatically improved recruitment rates in comparison with traditional approaches highlight the importance of combining novel and traditional recruitment approaches to recruit women for pregnancy-related studies.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02711644","term_id":"NCT02711644"}}NCT02711644; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02711644","term_id":"NCT02711644"}}NCT02711644 (Archived by WebCite at http://www.webcitation.org/6kKpagpMk)     

Efficacy of DiaLife,an Education Program for Relatives of Adults with Diabetes – A Cluster Randomized Controlled Trial

ObjectiveDiabetes affects the lives of patients and their close relatives. Considering the proven benefit of patient education programs, DiaLife was elaborated as the first German education program addressing the needs of relatives. The objective of this study was to investigate its efficacy.MethodsThe evaluation was implemented in the form of a cRCT with longitudinal design and waiting list condition. In total, 179 relatives were recruited. Participants’ diabetes-related knowledge was defined as the primary outcome. Diabetes-related strains, family interaction and other psychosocial factors were determined as secondary outcomes.ResultsA generalized estimating equation model showed a persistent increase of diabetes-related knowledge in the intervention group compared to the control group regardless of the type of diabetes. Concerning secondary outcomes, mixed linear models showed an improvement for relatives of people with type 2 diabetes who participated in the DiaLife program.ConclusionThis study provides evidence of DiaLife’s efficacy regarding a persistent increase of diabetes-related knowledge and a positive effect on psychosocial outcomes in relatives of people with type 2 but not in type 1 diabetes. Adding (an)other psychosocial module(s) might improve their well-being and psychosocial outcomes.Practice ImplicationsDiabetes centers should consider implementing an education program for relatives, such as DiaLife, in their curriculum.Trial registrationThe study was registered at the German Clinical Trials Register (DRKS00015157; date of registration: 24.08.2018).     

A Web-Based Psychoeducational Program for Informal Caregivers of Patients With Alzheimer’s Disease: A Pilot Randomized Controlled Trial

Background

Although several face-to-face programs are dedicated to informal caregivers of persons with dementia, they are not always accessible to overburdened or isolated caregivers. Based on a face-to-face intervention program, we adapted and designed a Web-based fully automated psychoeducational program (called Diapason) inspired by a cognitive approach.

Objective

This study aimed to evaluate through a pilot unblinded randomized controlled trial the efficacy and acceptability of a Web-based psychoeducational program for informal caregivers of persons with Alzheimer’s disease (PWAD) based on a mixed methods research design.

Methods

We recruited and randomized offline 49 informal caregivers of a PWAD in a day care center in Paris, France. They either received the Web-based intervention and usual care for 3 months (experimental group, n=25) or only usual care (control group, n=24). Caregivers’ perceived stress (PSS-14, primary outcome), self-efficacy, burden, perceived health status, and depression (secondary outcomes) were measured during 3 face-to-face on-site visits: at baseline, at the end of the program (month 3), and after follow-up (month 6). Additionally, semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis.

Results

Intention-to-treat analysis did not show significant differences in self-perceived stress between the experimental and control groups (P=.98). The experimental group significantly improved their knowledge of the illness (d=.79, P=.008) from baseline to month 3. Of the 25 participants allocated to the experimental group, 17 (71%) finished the protocol and entirely viewed at least 10 of 12 online sessions. On average, participants used the website 19.72 times (SD 12.88) and were connected for 262.20 minutes (SD 270.74). The results of the satisfaction questionnaire showed that most participants considered the program to be useful (95%, 19/20), clear (100%, 20/20), and comprehensive (85%, 17/20). Significant correlations were found between relationship and caregivers’ program opinion (P=.01). Thus, positive opinions were provided by husbands and sons (3/3), whereas qualified opinions were primarily reported by daughters (8/11). Female spouses expressed negative (2/3) or neutral opinions (1/3). Caregivers expected more dynamic content and further interaction with staff and peers.

Conclusions

In this study, quantitative results were inconclusive owing to small sample size. Qualitative results indicated/showed little acceptance of the program and high expectations from caregivers. Caregivers did not rule out their interest in this kind of intervention provided that it met their needs. More dynamic, personalized, and social interventions are desirable. Our recruitment issues pointed out the necessity of in-depth studies about caregivers’ help-seeking behaviors and readiness factors.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01430286","term_id":"NCT01430286"}}NCT01430286; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01430286","term_id":"NCT01430286"}}NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).     

The Efficacy of Three Modalities of Internet-Based Psychotherapy for Non–Treatment-Seeking Online Problem Gamblers: A Randomized Controlled Trial

Background

Internet-based interventions targeted at the most at-risk gamblers could reduce the treatment gap for addictive disorders. Currently, no clinical trial has included non–treatment-seeking patients who have been recruited directly in their gambling environment. This study was the first exclusively Internet-based randomized controlled trial among non–help-seeking problem gamblers with naturalistic recruitment in their gambling environment.

Objective

The aim of this study was to assess the efficacy of three modalities of Internet-based psychotherapies with or without guidance, compared to a control condition, among problem gamblers who play online poker.

Methods

All active poker gamblers on the Winamax website were systematically offered screening. All problem poker gamblers identified with a Problem Gambling Severity Index (PGSI) score of ≥5 were eligible to be included in the trial. Problem gamblers were randomized into four groups: (1) waiting list (control group), (2) personalized normalized feedback on their gambling status by email, (3) an email containing a self-help book to be downloaded with a Cognitive Behavioral Therapy (CBT) program without guidance, and (4) the same CBT program emailed weekly by a trained psychologist with personalized guidance. Efficacy was assessed based on the change in PGSI between baseline and 6 weeks (end of treatment) or 12 weeks (maintenance) and supported by player account-based gambling data automatically collected at the three time points.

Results

All groups met high attrition rates (83%), but the group with guidance had a significantly higher dropout rate than the other three groups, including the control group. Although all groups showed some improvement, with a mean decrease of 1.35 on the PGSI, no significant difference in efficacy between the groups was observed. One-third of the problem gamblers fell below the problem gambling threshold at 6 weeks.

Conclusions

Guidance could have aversively affected problem gamblers who had not sought help. Despite the lack of significant difference in efficacy between groups, this naturalistic trial provides a basis for the development of future Internet-based trials in individuals with gambling disorders. Comorbidities, natural course of illness, and intrinsic motivation seem to be critical issues to consider in future designs.

Trial Registration

ANSM 2013-A00794-41     

Designing and Evaluating an Interactive Multimedia Web-Based Simulation for Developing Nurses’ Competencies in Acute Nursing Care: Randomized Controlled Trial

BackgroundWeb-based learning is becoming an increasingly important instructional tool in nursing education. Multimedia advancements offer the potential for creating authentic nursing activities for developing nursing competency in clinical practice.ObjectiveThis study aims to describe the design, development, and evaluation of an interactive multimedia Web-based simulation for developing nurses’ competencies in acute nursing care.MethodsAuthentic nursing activities were developed in a Web-based simulation using a variety of instructional strategies including animation video, multimedia instructional material, virtual patients, and online quizzes. A randomized controlled study was conducted on 67 registered nurses who were recruited from the general ward units of an acute care tertiary hospital. Following a baseline evaluation of all participants’ clinical performance in a simulated clinical setting, the experimental group received 3 hours of Web-based simulation and completed a survey to evaluate their perceptions of the program. All participants were re-tested for their clinical performances using a validated tool.ResultsThe clinical performance posttest scores of the experimental group improved significantly (P<.001) from the pretest scores after the Web-based simulation. In addition, compared to the control group, the experimental group had significantly higher clinical performance posttest scores (P<.001) after controlling the pretest scores. The participants from the experimental group were satisfied with their learning experience and gave positive ratings for the quality of the Web-based simulation. Themes emerging from the comments about the most valuable aspects of the Web-based simulation include relevance to practice, instructional strategies, and fostering problem solving.ConclusionsEngaging in authentic nursing activities using interactive multimedia Web-based simulation can enhance nurses’ competencies in acute care. Web-based simulations provide a promising educational tool in institutions where large groups of nurses need to be trained in acute nursing care and accessibility to repetitive training is essential for achieving long-term retention of clinical competency.     

Components of family history associated with women's disease perceptions for cancer: A report from the Family Healthware™ Impact Trial

PurposeTo determine the specific components of family history and personal characteristics related to disease perceptions about breast, colon, and ovarian cancers.MethodsBaseline, cross-sectional data on 2,505 healthy women aged 35–65 years enrolled from 41 primary care practices in the cluster-randomized Family Healthware™ Impact Trial, assessed for detailed family history and perceived risk, perceived severity, worry, and perceived control over getting six common diseases including breast, colon, and ovarian cancers.ResultsParticipants provided family history information on 41,841 total relatives. We found evidence of underreporting of paternal family history and lower perceived breast cancer risk with cancer in the paternal versus maternal lineage. We observed cancer-specific perceived risks and worry for individual family history elements and also found novel “spillover” effects where a family history of one cancer was associated with altered disease perceptions of another. Having a mother with early-onset breast or ovarian cancer was strongly associated with perceived risk of breast cancer. Age, parenthood, and affected lineage were associated with disease perceptions and ran counter to empiric risks.ConclusionsUnderstanding patients' formulation of risk for multiple diseases is important for public health initiatives that seek to inform risk appraisal, influence disease perceptions, or match preventive interventions to existing risk perceptions.     

Who Enrolls in an Online Cancer Survivorship Program? Reach of the INSPIRE Randomized Controlled Trial for Hematopoietic Cell Transplantation Survivors

The internet can be a valuable tool in delivering survivorship care to hematopoietic cell transplantation (HCT) cancer survivors. We describe the reach of INSPIRE, an Internet and social media-based randomized controlled trial, to address healthcare and psychosocial needs of HCT survivors. All survivors 2-10 years after HCT for hematologic malignancy or myelodysplasia from 6 transplantation centers in the US were approached by mail and follow-up calls. Eligible participants had access to the Internet, an email address, and did not have active disease in the past 2 years. We used logistic regression to determine characteristics of eligible survivors who were more or less likely to enroll. Of 2578 eligible HCT survivors, 1065 (41%) enrolled in the study. The mean age of enrollees was 56.3 ± 12.6 years (range, 19 to 89 years), 52% were male, and 94% were white. Survivors less likely to enroll included those who were male, age <40 years, and who received an autologous transplant (all P < .001). Compared with white survivors, African Americans were less likely to enroll (P < .001), whereas Native Americans/Alaska Natives were more likely to join the study (P = .03). The reach of the INSPIRE program was broad, including to survivors who traditionally have less access to resources, such as Native Americans/Alaskan Natives and rural residents. Strategies are still needed to improve the enrollment of online studies of survivorship resources for males, young adults, African American, and autologous HCT survivors because their use may improve outcomes.