Search

Background/aim:Cost-efficient methods are essential for successful participant recruitment in clinical trials. Patient portal messages are an emerging means of recruiting potentially eligible patients into trials. We assessed the response rate and complaint rate from direct-to-patient, targeted recruitment through patient portals of an electronic medical record for a clinical trial, and compared response rates by differences in message content.Methods:The Study to Understand Fall Reduction and Vitamin D in You (STURDY) trial is a National Institutes of Health–sponsored, community-based study of vitamin D supplementation for fall prevention in older adults conducted at Johns Hopkins. Potential participants were identified using the Epic electronic medical record at the Johns Hopkins Health System based on age (≥70 years), ZIP code (30-mile radius of study site), and prior activation of a patient portal account. We prepared a shorter message and a longer message. Both had basic information about study participation, but the longer message also contained information about the significance of the study and a personal invitation from the STURDY principal investigator. The Hopkins Institutional Review Board did not require prior consent from the patient or their providers. We calculated the response rate and tracked the number of complaints and requests for removal from future messages. We also determined response rate according to message content.Results:Of the 5.5 million individuals receiving care at the Johns Hopkins Health System, a sample of 6896 met our inclusion criteria and were sent one patient portal recruitment message between 6 April 2017 and 3 August 2017. Assessment of enrollment by this method ended on 1 December 2017. There were 116 patients who expressed interest in the study (response rate: 1.7%). Twelve (0.2%) recipients were randomized. There were two complaints (0.03%) and one request to unsubscribe from future recruitment messages (0.01%). Response rate was higher with the longer message than the shorter message (2.1% vs 1.2%; p = 0.005).Conclusion:Patient portal messages inviting seniors to participate in a randomized controlled trial resulted in a response rate similar to commercial email marketing and resulted in very few complaints or opt-out requests. Furthermore, a longer message with more content enhanced response rate. Recruitment through patient portals might be an effective strategy to enroll trial participants.

A survey of nursing homes in the Brisbane area (n=102) showed that 11.8% (12) had a regular Pet Therapy Program (PTP) and 35.3% (36) were interested in having a PTP. Pet Therapy Programs were defined as having a pet walk freely around the institution and available to everyone. This type of program was preferred to a structured program. The most commonly kept pets were dogs, cats, birds and fish, however nursing home residents also fed wild birds and animals. Eighteen nursing home administrators thought the institution had legal liability for the residents, but most were unsure whether the liability covered the animals'. Administrative and professional staff members were responsible for implementing most PTP's (77.8%), however half of the PTP's operating in the institutions were not supervised or evaluated at any time. The main factor determining implementation of a PTP is whether the administrators want one or not. A study of elderly people who still lived in their own homes (n=50) showed that 52% still kept pets. There were no significant differences between those with or without pets and their perceived happiness, life satisfaction, depression or hobbies and interests nor medical problems. There were no significant differences between the no pet and pet owning groups who lived by themselves or with other people. A desexed whippet dog (8 months) was trained for placement as a resident and visiting dog for two nursing homes in the long term study. Three nursing homes in the Brisbane area took part in the long-term study; one (20 females, 11 males) had the visiting dog (each week), the second (24 females, 8 males) had the resident dog while the third (25 females, 7 males) the visiting researcher only (Control). Tension and Confusion were reduced in the nursing home with a resident dog (X2=21.18, df=10, P=0.02; x2=35.42, df=10, P=0.0001 respectively). This group also showed significant decreases in Depression (x2=31.19, df=10, P=0.0005) as did the Control group (x2=29.8, df=10, P=0.0009; x2=23.4, df=10, P=0.0009). Significant increases in Vigour were found in all three nursing homes (Visiting Dog (x2=43.91, df=10, P=0.0005, Resident Dog x2=42.92, df=10, P=0.0005, Control x2=38.52, df=10, P=0.0005). Fatigue decreased significantly in the Visiting and Resident dog groups (X2=21.58, df=10, P=0.02, x2=19.45, df=10, P=0.03) respectively. This longterm study indicates that there are many benefits from having a resident dog in a nursing home. However, if this is not an option, visiting dogs and/or visiting people improve the lives of nursing home residents.

For hypertensive women in CHIPS (Control of Hypertension in Pregnancy Study), we assessed whether the maternal benefits of tight control could be achieved, while minimizing any potentially negative effect on fetal growth, by delaying initiation of antihypertensive therapy until later in pregnancy. For the 981 women with nonsevere, chronic or gestational hypertension randomized to less-tight (target diastolic blood pressure, 100 mm Hg), or tight (target, 85 mm Hg) control, we used mixed-effects logistic regression to examine whether the effect of less-tight (versus tight) control on major outcomes was dependent on gestational age at randomization, adjusting for baseline factors as in the primary analysis and including an interaction term between gestational age at randomization and treatment allocation. Gestational age was considered categorically (quartiles) and continuously (linear or quadratic form), and the optimal functional form selected to provide the best fit to the data based on the Akaike information criterion. Randomization before (but not after) 24 weeks to less-tight (versus tight) control was associated with fewer babies with birth weight P interaction =0.005), but more preterm birth ( P interaction =0.043), and no effect on perinatal death or high-level neonatal care >48 hours ( P interaction =0.354). For the mother, less-tight (versus tight) control was associated with more severe hypertension at all gestational ages but particularly so before 28 weeks ( P interaction =0.076). In women with nonsevere, chronic, or gestational hypertension, there seems to be no gestational age at which less-tight (versus tight) control is the preferred management strategy to optimize maternal or perinatal outcomes. Clinical Trial Registration— URL: https://www.isrctn.com . Unique identifier: ISRCTN71416914.

Objective A single course of antenatal corticosteroids (ACS) is associated with a reduction in respiratory distress syndrome and neonatal death. Multiple Courses of Antenatal Corticosteroids Study (MACS), a study involving 1858 women, was a multicentre randomized placebo-controlled trial of multiple courses of ACS, given every 14 days until 33+6 weeks or birth, whichever came first. The primary outcome of the study, a composite of neonatal mortality and morbidity, was similar for the multiple ACS and placebo groups (12.9% vs. 12.5%), but infants exposed to multiple courses of ACS weighed less, were shorter, and had smaller head circumferences. Thus for women who remain at increased risk of preterm birth, multiple courses of ACS (every 14 days) are not recommended. Chronic use of corticosteroids is associated with numerous side effects including weight gain and depression The aim of this postpartum assessment was to ascertain if multiple courses of ACS were associated with maternal side effects. Methods Three months postpartum, women who participated in MACS were asked to complete a structured questionnaire that asked about maternal side effects of corticosteroid use during MACS and included the Edinburgh Postnatal Depression Scale Women were also asked to evaluate their study participation Results Of the 1858 women randomized, 1712 (92.1%) completed the postpartum questionnaire. There were no significant differences in the risk of maternal side effects between the two groups. Large numbers of women met the criteria for postpartum depression (14.1% in the ACS vs. 16.0% in the placebo group). Most women (94.1%) responded that they would participate in the trial again. Conclusion In pregnancy, corticosteroids are given to women for fetal lung maturation and for the treatment of various maternal diseases. In this international multicentre randomized controlled trial, multiple courses of ACS (every 14 days) were not associated with maternal side effects, and the majority of women responded that they would participate in such a study again.

Historically, cytogenetic studies of plasma cell neoplasms have been hampered by the fact that terminally differentiated plasma cells do not proliferate well in vitro. Although the use of interphase FISH (iFISH) has greatly improved the ability to detect cytogenetic abnormalities, cases with low numbers of neoplastic cells often do not demonstrate abnormalities. Using a four-assay, nine-probe iFISH panel, we compared the abnormality detection rate for overnight unstimulated bone marrow cultures (ONC) to that for plasma-cell enriched fractions obtained with use of CD138-coated immunomagnetic beads (PCE). In the ONC, an abnormality was detected in 11 of 29 cases (38%); in the PCE, an abnormality was detected in 30 of 33 cases (91%). For 28 cases in which iFISH results from ONC were compared directly with PCE samples, the overall abnormality rate was 36% for ONC and 89% for PCE (P < 0.01). The conventional GTG-banded chromosome analysis revealed only 2 of 34 cases with an abnormal karyotype (6%); both cases were hyperdiploid. We conclude that the plasma cell enrichment step for iFISH should be incorporated into the routine cytogenetic work-up for all patients with plasma cell neoplasms.

The difficulty involved in recruiting healthy older adults into clinical trials, especially those involving pharmacologic agents, is an important issue in research. The Ginkgo Evaluation of Memory (GEM) Study, a double-blind, placebo-controlled randomized clinical trial evaluating Ginkgo biloba to prevent dementia, successfully recruited 3072 participants age 75 years and older at four U.S. sites from September 2000 through June 2002. Using targeted mailing lists, an estimated 243,400 study brochures were mailed out to potential participants. Subsequent attempts were made to reach 14,603 households by telephone, from which 12,186 (83.4%) successful contacts were made. Overall, telephone or in-person evaluations identified 2149 (17.6%) ineligible persons for cognitive (20.6%), medical (49.4%), or other (30.0%) reasons. A total of 6944 (57.0%) refused participation resulting in 3072 enrolled into the study, a recruitment rate of 25.2% based on telephone contacts made or 1.3% of all mailed brochures. Recruitment rates were stable over the 21-month enrollment period but were higher for the two urban centers than the two rural ones. Recruitment was dependent most on mailing lists available, density of older adults in the catchment areas, and Institutional Review Board restrictions. Men and persons under age 85 were more likely to enroll. Primary reason for refusals involved lack of interest (48.4%) or self-perceived poor health (16.2%). Over 9% were unwilling to give up current Ginkgo supplementation or would not accept assignment to placebo. An additional 7% did not want another medication and almost 4% had care-giving responsibilities which prevented involvement. Mass mailings were the most successful approach for recruitment at all four sites and the method through which the vast majority of interviewees had learned about the study. Information on the experience of the GEM Study recruitment may be helpful to other clinical trials attempting to randomize older adults into prevention trials.

(1998). Pet Ownership and Health Status of Elderly in the Community. Anthrozoos: Vol. 11, No. 3, pp. 168-171.

The study was conducted at the Returned Soldiers League (RSL) War Veterans Home at Pinjarra Hills (Brisbane, Queensland, Australia) where a spayed female Whippet, Heidi, was placed as a therapy dog. Of the 80 staff members, 47 (58.75%) returned completed questionnaires on attitudes towards Animal-Assisted Therapy (AAT) programs and the disappearance of Heidi two days after placement. The Pet Attitude Scale (Templer et al. 1981) was used in conjunction with the staff attitude questionnaire.Respondents with high Pet Attitude scores were more upset (χ2(2)=8.41, p

Summary Your time spent browsing through reviews of interventions in normal labour has been fruitful. Tomorrow you can reply to your registrar's challenge. You have decided to seek a meeting with the director of midwifery to discuss provision of one-to-one support for all women in labour. An imaginative approach to staffing in the labour ward will be required to achieve this goal. You will introduce the concept of number needed to treat to the director of midwifery and together prepare a presentation for management, showing how a reduction in labour-intensive activities such as epidural anaesthesia and instrumental delivery may free up staff to fulfil the commitment to one-to-one support. If you fail to achieve a commitment to one-to-one support for all women, you may be prepared to compromise by asking for one-to-one support for all women labouring for the first time. You know from the systematic review of amniotomy that early amniotomy reduces the duration of labour without any other harmful or beneficial effects. A policy of early amniotomy might be a means of making more staff available to provide continuous professional support during labour without extra cost, but you doubt that women in your community will accept this as a valid reason for intervention. You are now in a position to share with your registrar what you have learned about using an overview to help with decisions about management of individual patients or groups of patients.

Three nursing homes in the Brisbane area took part in the study. The Moreton Bay Nursing Care Unit (20 females, 11 males) had a visiting dog (each week), the Returned Services League War Veterans Home (24 females, eight males) had a resident dog and the Wheeler Garden Settlement (25 females, seven males) the visiting researcher only (control). A desexed female whippet, 11 months old was used in this study. Tension and confusion were reduced in the nursing home with a resident dog ( x 2 = 21.18, d.f. = 10, P = 0.02; x 2 = 35.42, d.f. = 10, P = 0.0001, respectively). The resident dog group showed significant decreases in depression ( x 2 = 31.19, d.f. = 10, P = 0.0005) as did the control group ( x 2 = 29.8, d.f. = 10, P = 0.0009; x 2 = 23.4, d.f. = 10, P = 0.009). Significant increases in vigour were found in all three nursing homes (visiting dog, x 2 = 43.91, d.f. = 10, P = 0.0005; resident dog, x 2 = 42.92, d.f. = 10, P = 0.0005; control, x 2 = 38.52, d.f. = 10, P = 0.0005). Fatigue decreased significantly in the visiting and resident dog groups ( x 2 = 21.58, d.f. = 10, P = 0.02; x 2 = 19.45, d.f. = 10, P = 0.03, respectively). This long-term study indicates that there are many benefits from having a resident dog in a nursing home. However, if this is not an option, visiting dogs and/or visiting people improve the lives of nursing home residents.

While previous prospective multicenter studies have conducted cardiovascular disease surveillance, few have detailed the techniques relating to the ascertainment of and data collection for events. The Cardiovascular Health Study (CHS) is a population-based study of coronary heart disease and stroke in older adults. This article summarizes the CHS events protocol and describes the methods of surveillance and ascertainment of hospitalized and nonhospitalized events, the use of medical records and other support documents, organizational issues at the field center level, and the classification of events through an adjudication process. We present data on incidence and mortality, the classification of adjudicated events, and the agreement between classification by the Events Subcommittee and the medical records diagnostic codes. The CHS techniques are a successful model for complete ascertainment, investigation, and documentation of events in an older cohort.

Objective. —To develop a consensus on the use of antenatal corticosteroids for fetal maturation in preterm infants. Participants. —A nonfederal, nonadvocate, 16-member consensus panel including representatives from neonatology, obstetrics, family medicine, behavioral medicine, psychology, biostatistics, and the public; 19 experts in neonatology, obstetrics, and pharmacology presented data to the consensus panel and a conference audience of approximately 500. Evidence. —An extensive bibliography of references was produced for the consensus panel and the conference audience using a variety of on-line databases including MEDLINE. The consensus panel met several times prior to the conference to review the literature. It also commissioned an updated meta-analysis, a neonatal registry review, and an economic analysis that were presented at the conference. The experts prepared abstracts for distribution at the conference, presented data, and answered questions from the panel and audience. The panel evaluated the strength of the scientific evidence using the grading system developed by the Canadian Task Force on the Periodic Health Examination and adapted by the US Preventive Services Task Force. Consensus. —The consensus panel, answering predefined consensus questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. Consensus Statement. —The consensus panel composed a draft statement that was read in its entirety at the conference for comment. The panel released a revised statement at the end of the conference and finalized the revisions a few weeks after the conference. Conclusions. —Antenatal corticosteroid therapy is indicated for women at risk of premature delivery with few exceptions and will result in a substantial decrease in neonatal morbidity and mortality, as well as substantial savings in health care costs. The use of antenatal corticosteroids for fetal maturation is a rare example of a technology that yields substantial cost savings in addition to improving health. (JAMA. 1995;273:413-418)

SummaryOne hundred and twenty-four patients were transferred antenatally to the regional referral centre for neonatal intensive care at Hammersmith Hospital. A total of 142 babies were born to these patients. The transfers were indicated by preterm labour, severe pre-eclampsia or antepartum fetal distress. The main obstetric problems encountered were the inefficiency of β-sympathomimetic drugs in arresting preterm labour in some cases, and the difficulty of timing uterine preterm delivery in cases of severe pre-eclampsia and intra-uterine fetal growth retardation. The uncorrected perinatal mortality in this high risk group was 232/1000 total births.

SummaryIn a random prospective trial the prophylactic me of oral ritodrine or cephalexin was found to be of no advantage to the newborn with preterm premature rupture of the membranes in the absence of uterine contractions.

SummaryThe hazards of vaginal breech delivery occur against a background of delay in delivery, fetal hypoxia and fetal hypotonia. The ordinary manipulations of delivery may then cause damage to the aftercoming head with intra-cranial haemorrhage, well known to be associated with tears of the tentorium and falx, and also skull fractures and occipital diastasis. Significant intracranial damage is found at autopsy much more frequently in infants delivered by the breech than in vertex presentations (Wigglesworth and Husemeyer, 1977). Extracranial injuries involving the spinal cord, abdominal viscera and skeletal muscles can also occur.