Privacy laws have recently created restrictions on how researchers can approach study participants.
In a randomised trial of 152 patients, 50–74 years old, in a family practice, 60 were randomly selected to opt‐out and 92 to opt‐in methods. Patients were sent an introductory letter by their doctor in two phases, opt‐out before and opt‐in after introduction of the new Privacy Legislation in December 2001. Opt‐out patients were contacted by researchers. Opt‐in patients were contacted if patients responded by email, free telephone number or a reply‐paid card.
Opt‐in recruited fewer patients (47%; 43/92) after invitation compared with opt‐out (67%; 40/60); (−20%; [−4% to −36%]). No proportional difference in recruitment was found between opt‐in and opt‐out groups varied by age, sex or socioeconomic status. The opt‐in group had significantly more people in active decision‐making roles (+30%; [10% to 50%]; p = 0.003). Non‐significant trends were observed towards opt‐in being less likely to include people with lower education (−11.8%; [−30% to 6.4%]; p = 0.13) and people who were not screened (−19.1%; [−40.1% to 1.9%]; p = 0.08). Opt‐in was more likely to recruit people with a family history of colorectal cancer (+12.7%; [−2.8%, 28.2%]; p = 0.12).
The number of participants required to be approached was markedly increased in opt‐in recruitment. Existing participants (eg, screening attendees) with a vested interest such as increased risk, and those preferring an active role in health decision making and with less education were likely to be recruited in opt‐in. Research costs and generalisability are affected by implementing privacy legislation.
Study objective. To compare patient satisfaction with emergency department (ED) opt-in and opt-out HIV screening.
Methods. We conducted a survey in an urban ED that provided rapid HIV screening using opt-in (February 1, 2007–July 31, 2007) and opt-out (August 1, 2007–January 31, 2008) approaches. We surveyed a convenience sample of patients that completed screening in each phase. The primary outcome was patient satisfaction with HIV screening. Results. There were 207 and 188 completed surveys during the opt-in and opt-out phases, respectively. The majority of patients were satisfied with both opt-in screening (95%, 95% confidence interval [CI] = 92–98) and opt-out screening (94%, 95% CI = 89–97). Satisfaction ratings were similar between opt-in and opt-out phases even after adjusting for age, gender, race/ethnicity, and test result (adjusted odds ratio 1.3, 95% CI = 0.5–3.1).
Conclusions. Emergency department patient satisfaction with opt-in and opt-out HIV screening is similarly high.
Genomic biorepositories will be important tools to help unravel the effect of common genetic variants on risk for common pediatric diseases. Our objective was to explore how parents would respond to the inclusion of children in an opt-out model biobank.
We conducted semi-structured interviews with parents in hospital-based pediatric clinics. Participants responded to a description of a biorepository already collecting samples from adults. Two coders independently analyzed and coded interviews using framework analysis. Opt-out forms were later piloted in a clinic area. Parental opt-out choices were recorded electronically, with opt-out rates reported here.
Parents strongly supported medical research in general and expressed a high level of trust that Vanderbilt University would keep their child’s medical information private. Parents were more likely to allow their child’s sample to be included in the biorepository than to allow their child to participate in a hypothetical study that would not help or harm their child, but might help other children. Only a minority were able to volunteer a concern raised by the description of the biobank. The opt-out rate was initially high compared with the opt-out rate in the adult biorepository, but after the first week decreased to near the baseline in adult clinics.
Parents in our study generally support an opt-out model biobank in children. Most would allow their own child’s sample to be included. Institutions seeking to build pediatric biobanks may consider the human non-subjects model as a viable alternative to traditional human-subjects biobanks.
pediatric research ethics; biorepository research; genomic research
Objective To evaluate the effect of opt-in compared with opt-out recruitment strategies on response rate and selection bias.
Design Double blind randomised controlled trial.
Setting Two general practices in England.
Participants 510 patients with angina.
Intervention Patients were randomly allocated to an opt-in (asked to actively signal willingness to participate in research) or opt-out (contacted repeatedly unless they signalled unwillingness to participate) approach for recruitment to an observational prognostic study of patients with angina.
Main outcome measures Recruitment rate and clinical characteristics of patients.
Results The recruitment rate, defined by clinic attendance, was 38% (96/252) in the opt-in arm and 50% (128/258) in the opt-out arm (P = 0.014). Once an appointment had been made, non-attendance at the clinic was similar (20% opt-in arm v 17% opt-out arm; P = 0.86). Patients in the opt-in arm had fewer risk factors (44% v 60%; P = 0.053), less treatment for angina (69% v 82%; P = 0.010), and less functional impairment (9% v 20%; P = 0.023) than patients in the opt-out arm.
Conclusions The opt-in approach to participant recruitment, increasingly required by ethics committees, resulted in lower response rates and a biased sample. We propose that the opt-out approach should be the default recruitment strategy for studies with low risk to participants.
The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment.
Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR.
The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are stored in a CDA document to be transferred to the first service. Three workflows have to be considered to integrate the suite into the PEHR: recording the consent, publishing documents and viewing documents.
Our approach solves the consent issue when using IHE profiles for regional health information networks. It is highly interoperable due to the use of international standards and can hence be used in any other region to leverage consent issues and substantially promote the use of IHE for regional health information networks in general.
Our objective was to develop a DNA biobank linked to phenotypic data derived from an electronic medical record (EMR) system. An “opt-out” model was implemented after significant review and revision. The plan included (i) development and maintenance of a de-identified mirror image of the EMR, namely, the “synthetic derivative” (SD) and (ii) DNA extracted from discarded blood samples and linked to the SD. Surveys of patients indicated general acceptance of the concept, with only a minority (~5%) opposing it. As a result, mechanisms to facilitate opt-out included publicity and revision of a standard “consent to treatment” form. Algorithms for sample handling and procedures for de-identification were developed and validated in order to ensure acceptable error rates (<0.3 and <0.1%, respectively). The rate of sample accrual is 700–900 samples/week. The advantages of this approach are the rate of sample acquisition and the diversity of phenotypes based on EMRs.
In Malaysia, many patients opted out of cancer-specific treatment for various reasons. This study was undertaken to investigate the survival rate of patients with stages I to III non-small cell lung cancer (NSCLC) who opted out of treatment, compared with those who accepted treatment. Case records of 119 patients diagnosed with NSCLC between 1996 and 2003 in two urban-based hospitals were retrospectively examined. Survival status was ascertained from follow-up medical clinic records or telephone contact with patients or their next-of-kin. Median (25–75% IQR) survival rate for 79 patients who accepted and 22 patients who opted out of treatment, were 8.6 (16.0-3.7) and 2.2 (3.5-0.8) months respectively [log rank p< 0.001, Kaplan-Meier survival analysis]. Except for proportionately more patients with large cell carcinoma who declined treatment, there was no significant difference between the two groups in relation with age, gender, ethnicity, tumour stage, and time delays between symptom onset and treatment or decision-to-treat. We concluded that there was a small but significant survival benefit in accepting cancer-specific treatment. The findings imply that there is no effective alternative therapy to cancer-specific treatment in improving survival. However, overall prognosis for patients with NSCLC remains dismal.
non-small cell lung cancer; survival; cancer-specific treatment; Malaysia
Human immunodeficiency virus (HIV) infected individuals are at high risk for malignancies. However, it is not currently standard of care to test routinely all cancer patients for HIV. In 2006, the Centers for Disease Control (CDC) recommended HIV testing in all healthcare settings, calling for standard non-targeted “opt-out” HIV screening. For a variety of reasons, routine opt-out HIV testing is still not widely utilized in the United States. Although many barriers to routine opt-out HIV testing have been addressed, such opt-out HIV testing continues to be conducted primarily in venues which target specific patient populations such as pregnant women. Although opt-out testing has been piloted in emergency departments, less emphasis has been placed on opt-out HIV testing in other clinical settings. We describe the background, rationale, and evidence for supporting opt-out HIV testing as routine care for cancer patients, and discuss evidence for its potential to improve clinical outcomes by facilitating appropriate HIV management during cancer treatment for those individuals who are found to be HIV positive.
Although the Centers for Disease Control and Prevention recommends HIV testing in all settings unless patients refuse (opt-out consent), many state laws require written opt-in consent.
To quantify potential survival gains from passing state laws streamlining HIV testing consent.
We retrieved surveillance data to estimate the current annual HIV diagnosis rate in states with laws requiring written opt-in consent (19.3%). Published data informed the effect of removing that requirement on diagnosis rate (48.5% increase). These parameters then served as input for a model-driven projection of survival based on consent method. Other inputs included undiagnosed HIV prevalence (0.101%); and annual HIV incidence (0.023%).
Hypothetical cohort of adults (>13 years) living in written opt-in states.
Life years gained (LYG).
In the base-case, of the 53,036,383 adult persons living in written opt-in states, 0.66% (350,040) will be infected with HIV. Due to earlier diagnosis, revised consent laws yield 1.5 LYG per HIV-infected person, corresponding to 537,399 LYG among this population. Sensitivity analyses demonstrate that diagnosis rate increases of 24.8-72.3% result in 304,765–724,195 LYG. Net survival gains vanish if the proportion of HIV-infected persons refusing all testing in response to revised laws exceeds 18.2%.
The potential survival gains of increased testing are substantial, suggesting that state laws requiring opt-in HIV testing should be revised.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-011-1637-5) contains supplementary material, which is available to authorized users.
HIV; AIDS; screening; modeling; survival analysis
Electronic health records (EHRs) facilitate several innovations capable of reforming health care. Despite their promise, many currently unanswered legal, ethical, and financial questions threaten the widespread adoption and use of EHRs. Key legal dilemmas that must be addressed in the near-term pertain to the extent of clinicians' responsibilities for reviewing the entire computer-accessible clinical synopsis from multiple clinicians and institutions, the liabilities posed by overriding clinical decision support warnings and alerts, and mechanisms for clinicians to publically report potential EHR safety issues. Ethical dilemmas that need additional discussion relate to opt-out provisions that exclude patients from electronic record storage, sale of deidentified patient data by EHR vendors, adolescent control of access to their data, and use of electronic data repositories to redesign the nation's health care delivery and payment mechanisms on the basis of statistical analyses. Finally, one overwhelming financial question is who should pay for EHR implementation because most users and current owners of these systems will not receive the majority of benefits. The authors recommend that key stakeholders begin discussing these issues in a national forum. These actions can help identify and prioritize solutions to the key legal, ethical, and financial dilemmas discussed, so that widespread, safe, effective, interoperable EHRs can help transform health care.
electronic health records; ethics; medical; confidentiality
In this article, two different scientific approaches to personalized medicine are compared. Biorepository at Vanderbilt University (BioVU) is a genomic biorepository at Vanderbilt University Medical Center in Nashville, TN, USA. Genetic biosamples are collected from leftover clinical blood samples; medical information is derived from an electronic medical records. Greifswald Approach to Individualized Medicine is a research resource at the University of Greifswald, Germany, comprised of clinical records combined with biosamples collected for research. We demonstrate that although both approaches are based on the collection of clinical data and biosamples, different legal milieus present in the USA and Germany as well as slight differences in scientific goals have led to different ‘ethical designs’. While BioVU can successfully operate with an ‘opt-out’ mechanism, an informed consent-based ‘opt-in’ model is indispensable to allow GANI_MED to reach its scientific goals.
biorepositories; personalized medicine; research ethics; research regulation
A prospective cohort study was set up to investigate a possible association between antibiotic prescribing and antibiotic resistance of E. coli urinary tract infection in the community. Participation of patients with urinary tract infection was obtained through an opt-out methodology. This short paper reports on the acceptability of the opt-out recruitment approach.
Participating practices (22) were requested to send a urine sample from all patients presenting with symptoms of urinary tract infection. Upon receipt of the sample in the laboratory, a letter explaining the study, an opt-out form and a freepost envelope were sent to all adult patients. A website with additional information and including an 'opt-out' button was set up for the study.
A total of 1362 urine samples were submitted by the 22 participating practices representing 1178 adult patients of whom 193 actively responded to the letter: 142 opted out by letter, 15 through the website, 2 by phone and 12 sent the letter back without indication, making a total of 171 patients or 14.5% opt-out; the remaining 22 patients (1.9%) explicitly opted in. The total group consisted of 80% women and the mean age was 50.9 years (sd 20.8). No significant differences were found between patients who participated and those who opted out in terms of age, gender or whether the urine sample was positive or not.
Overall the opt-out method was well received and participation in the study reached 85.5%. The low number of complaints (2) indicates that this is a generally acceptable method of patient recruitment. The 14.5% opt-out shows that it effectively empowers patients to decline participation. The similarity between patients opting out and the rest of the patients is reassuring for extrapolation of the results of the study.
The aims of this study were to determine which consent procedure patients prefer for use of stored tissue for research purposes and what the effects of consent procedures on actual consenting behaviour are.
We offered 264 cancer patients three different consent procedures: ‘one-time general consent' (asked written informed consent), ‘opt-out plus' (had the opportunity to opt out by a form), or the standard hospital procedure (control group). The two intervention groups received a specific leaflet about research with residual tissue and verbal information. The control group only received a general hospital leaflet including opt-out information, which is the procedure currently in use. Subsequently, all patients received a questionnaire to examine their preferences for consent procedures.
In all, 99% of patients consented to research with their residual tissue. In the ‘one-time consent' group 85% sent back their consent form. Patients preferred ‘opt-out plus' (43%) above ‘one-time consent' (34%) or ‘opt-out' (16%), whereas 8% indicated that they did not need to receive information about research with residual tissues or be given the opportunity to make a choice.
The ‘opt-out plus' procedure, which places fewer demands on administrative resources than ‘one-time consent', can also address the information needs of patients.
residual tissue; scientific research; consent procedure; ownership
OBJECTIVE: To assess the safety and appropriateness of antibiotic use in adult patients with pharyngitis who opted for a nurse-only triage and treatment algorithm vs patients who underwent a physician-directed clinical evaluation.
PATIENTS AND METHODS: Using International Classification of Diseases, Ninth Revision codes to query the electronic medical record database at our institution, a large multispecialty health care system in LaCrosse, WI, we identified adult patients diagnosed as having pharyngitis from September 1, 2005, through August 31, 2007. Diagnosis, treatment, and outcome data were collected retrospectively.
RESULTS: Of 4996 patients who sought treatment for pharyngitis, 3570 (71.5%) saw a physician and 1426 (28.5%) opted for the nurse-only triage and treatment algorithm. Physicians adhered to antibiotic-prescribing guidelines in 3310 (92.7%) of 3570 first visits, whereas nurses using the algorithm adhered to guidelines in 1422 (99.7%) of 1426 first visits (P<.001). Physicians were significantly less likely to follow guidelines at patients' subsequent visits for a single pharyngitis illness than at their initial one (92.7% [3310/3570] vs 83.7% [406/485]; P<.001).
CONCLUSION: Instituting a simple nurse-only triage and treatment algorithm for patients presenting with pharyngitis appears to reduce unnecessary antibiotic use.
Instituting a simple nurse-only triage and treatment algorithm for patients presenting with pharyngitis appears to reduce unnecessary antibiotic use.
Little research has studied experimentally whether an opt-out policy will increase testing rates or whether this strategy is especially effective in the case of stigmatized diseases such as HIV.
Design and Main Outcome Measures
In Study 1, a 2 × 2 factorial design asked participants to make moral judgments about a person’s decision to test for stigmatized diseases under an opt-in versus an opt-out policy. In Study 2, a 2 × 2 factorial design measuring testing rates explored whether opt-out methods reduce stigma and increase testing for stigmatized diseases.
Study 1 results suggest that getting tested draws suspicion regarding moral conduct in an opt-in system, whereas not getting tested draws suspicion in an opt-out system. Study 2 results suggest that an opt-out policy may increase testing rates for stigmatized diseases and lessen the effects of stigma in people’s reluctance to test.
A social psychological approach to health services can be used to show how testing policies can influence both the stigmatization associated with testing and participation rates. An understanding of how testing policies may affect patient decision making and behavior is imperative for creating effective testing policies.
stigma; opt-out testing; infectious disease; HIV testing; CDC policy
This paper reviews the key arguments of the two predominant methods for the inclusion of human residual tissue in biobanks: opt-in and opt-out.
Residual samples are an important source of tissue for biobanks. They refer to leftover tissue that is obtained in the course of clinical care. Residual samples can be included through an opt-in method—that is, a person explicitly expresses consent to include residual tissue—or an opt-out method—that is, the tissue is stored unless a person explicitly refuses. At the moment there is a renewed interest in the appropriate method for the inclusion of residual samples in biobanks. The expansion of biobanks and rapid developments in biomedical research underscore the need to evaluate the proper procedure. In this article we revisit the arguments in favor and against opt-in and opt-out methods for residual tissue research. We conclude firstly that an opt-out method is only justifiable when certain conditions are met: (1) awareness has to be raised, (2) sufficient information has to be provided, and (3) a genuine possibility to object has to be offered. An opt-out procedure that fulfills these conditions can be called a “thick” opt-out method. As a consequence, the dichotomy between opt-in and opt-out is less stark than usually suggested, as both methods require a certain amount of effort. Secondly, we conclude that because of the diversity of tissue and research, not every situation can be treated alike. There are at least four situations that require opt-in procedures: (1) research with higher risks or increased burdens, (2) the use of controversial or high-impact techniques, (3) research on sensitive tissue types, and (4) research involving vulnerable patients. We suggest that further interdisciplinary debate should answer the question when to opt-in or when to opt-out.
We questioned whether children with optic pathway tumors (OPTs) have an increased frequency of other CNS tumors on the basis of experience with a number of such children treated at our institution. The medical records of all patients with OPTs treated at Golisano Children's Hospital at Strong at the University of Rochester from 1957 to 2000 were reviewed to determine the incidence of additional CNS tumors in these children and whether the occurrence of these other CNS tumors is associated with any risk factors. Twenty-six children had OPTs. Twelve of the 26 children had biopsy-proved tumors; the remaining 14 were diagnosed on the basis of CT or MRI scans. Eight of the 26 patients (31%) had a total of 11 additional CNS tumors. (One child had 2 additional CNS neoplasms, and a second child had 3.) Nine were biopsy proved (3 glioblastoma, 3 anaplastic astrocytoma, 3 low-grade astrocytoma), and 2 were diagnosed by imaging studies alone (acoustic neuromas). Eight of the 11 tumors occurred at a median of 5 years (0.8-25 years) subsequent to the diagnosis of the OPTs; 3 were diagnosed simultaneously with the OPT. Of the 17 children with neurofibromatosis (NF) and OPTs, 8 (47%) had additional CNS tumors, while none of the 9 children (0%) without NF had other CNS tumors (P = 0.023). There was no association between radiation treatment of the primary OPT and subsequent development of other CNS tumors in the group as a whole, or when the analysis was confined to children with NF. Despite this lack of statistical association, all 7 CNS tumors that occurred following radiation arose in irradiated areas. The risk of simultaneous or subsequent CNS tumors in children with NF and OPTs is high. These children should be closely monitored for the simultaneous or subsequent occurrence of other CNS tumors.
The Emergency Care Summary (ECS) was introduced in 2006 to allow aspects of the general practitioner (GP; family doctor, equivalent to primary care physician) medical record to be viewed in hospitals and out-of-hours centers in Scotland. Records were automatically uploaded unless patients actively opted out. This study investigated patient awareness and acceptance of this process.
This was a questionnaire survey of patients in a GP surgery (office) in Paisley, Scotland.
Survey results indicated that 42 percent of patients were aware of the ECS, and 16 percent said that they recognized the leaflet posted to households. Of those who recognized the leaflet, 92 percent said they were happy for their record to be part of the system, while the others did not realize their record was to be included. Having read the leaflet, 97 percent said that they were happy for their record to be included in the ECS.
This study shows that most patients were not aware of the Emergency Care Summary or did not remember seeing the leaflet posted to households. Having read the leaflet, the vast majority of patients were happy for their records to be included in the system. The low awareness of the ECS calls into question the validity of an implied consent model using an information leaflet distributed by post.
Emergency Care Summary; consent; Summary Care Record; confidentiality; electronic care summary; implied consent; informed consent
The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods.
Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed.
The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed.
Australian New Zealand Clinical Trials Registry ACTRN12610000332022
Background Identifying patients with learning disabilities within primary care is central to initiatives for improving the health of this population. UK general practitioners (GPs) receive additional income for maintaining registers of patients with learning disabilities as part of the Quality and Outcomes Framework (QOF), and may opt to provide Directed Enhanced Services (DES), which requires practices to maintain registers of patients with moderate or severe learning disabilities and offer them annual health checks.
Objectives This paper describes the development of a register of patients with moderate or severe learning disabilities at one UK general practice.
Methods A Read code search of one UK general practice's electronic medical records was conducted in order to identify patients with learning disabilities. Confirmation of diagnoses was sought by scrutinising records and GP verification. Cross-referencing with the practice QOF register of patients with learning disabilities of any severity, and the local authority's list of clients with learning disabilities, was performed.
Results Of 15 001 patients, 229 (1.5%) were identified by the Read code search as possibly having learning disabilities. Scrutiny of records and GP verification confirmed 64 had learning disabilities and 24 did not, but the presence or absence of learning disability remained unclear in 141 cases. Cross-referencing with the QOF register (n=81) and local authority list (n=49) revealed little overlap.
Conclusion Identifying learning disability and assessing its severity are tasks GPs may be unfamiliar with, and relying on Read code searches may result in under-detection. Further research is needed to define optimum strategies for identifying, cross-referencing and validating practice-based registers of patients with learning disabilities.
identification; learning disabilities; primary care
Residual clinical samples represent a very appealing source of biomaterial for translational and clinical research. We describe the implementation of an opt-in biobank, with consent being obtained at the time of registration and the decision stored in our electronic health record, Epic. Information on that decision, along with laboratory data, is transferred to an application that signals to biobank staff whether a given sample can be kept for research. Investigators can search for samples using our i2b2 data warehouse. Patient participation has been overwhelmingly positive and much higher than anticipated. Over 86% of patients provided consent and almost 83% requested to be notified of any incidental research findings. In 6 months, we obtained decisions from over 18 000 patients and processed 8000 blood samples for storage in our research biobank. However, commercial electronic health records like Epic lack key functionality required by a registrar-based consent process, although workarounds exist.
Biological specimen banks; biorepository; informed consent; electronic health records; medical informatics
Approximately 10 million Americans enter jails annually. The Centers for Disease Control and Prevention now recommends routine opt-out HIV testing in these settings. The logistics for performing routine opt-out HIV testing within jails, however, remain controversial. The objective of this study was to evaluate the optimal time to routinely HIV test newly incarcerated jail detainees using an opt-out strategy.
This prospective, controlled trial of routine opt-out HIV testing was conducted among 298 newly incarcerated male inmates in an urban men's jail in New Haven, Connecticut. 298 sequential entrants to the men's jail over a three week period in March and April 2008 were assigned to be offered routine opt-out HIV testing at one of three points after incarceration: immediate (same day, n = 103), early (next day, n = 98), or delayed (7 days, n = 97). The primary outcome was the proportion of men in each group consenting to testing.
Routine opt-out HIV testing was significantly higher for the early (53%: AOR = 2.6; 95% CI = 1.5 to 4.7) and immediate (45%: AOR = 2.3; 95% CI = 1.3 to 4.0) testing groups compared to the delayed (33%) testing group. The immediate and early testing groups, however, did not significantly differ (p = 0.67). In multivariate analyses, factors significantly associated with routine opt-out HIV testing were assignment to the ‘early’ testing group (p = 0.0003) and low (bond ≥$5,000, immigration or federal charges or pre-sentencing >30 days) likelihood of early release (p = 0.04). Two subjects received preliminary positive results and one of them was subsequently confirmed HIV seropositive.
In this men's jail where attrition was high, routine opt-out HIV testing was not only feasible, but resulted in the highest rates of HIV testing when performed within 24 hours of incarceration.
This prescription-monitoring study was conducted to establish the drug-prescribing trend of anti-asthmatic drugs in various hospitals of Gorakhpur.
The study covered three famous hospitals of Gorakhpur.
Patients and Methods:
Hundred patients were studied using a prescription auditing performa. Data was recorded from the patient's attending the out patient department using a chance random sample method for two months. Patients who co- operated were interviewed and information was filled in the performa.
The results suggested that b-agonist (40%) were the most frequently prescribed anti-asthmatic drugs followed by Methylxanthine (27%), corticosteroids (25%), leukotriene antagonist (4.4%) and anti-histaminics (3.6%) was the least prescribed. Analysis of prescription revealed that multiple drug therapy (81%) was opted for a significant number of patients as compared to single drug therapy (19%). Contrary to popular belief, oral dosage form tablets (56.3%) were preferred over inhalation (33.8%).
It is concluded that the present prescribing pattern of anti-asthmatics in Gorakhpur does not completely meet standard guidelines of asthma treatment. Hence there is a need to encourage physicians of Gorakhpur to follow the guidelines while treating asthma.
Prescription-monitoring; out patient department; asthma
Although some aspects of the NHS care record service have a broad consensus agreement, issues of consent and security are dividing health professionals, the public, and the national programme for information technology. Nigel Watson believes his experience of opting out shows it to be the most workable option, but John Halamka uses a US model to argue that opting in is the only way to ensure confidentiality
Many breast cancer patients currently turn to Internet-based education and support to help them cope with their illness. This study explores the role of training in influencing how patients use a particular Interactive Cancer Communication System (ICCS) over time and also examines what pre-test characteristics predict which people are most likely to opt in or out of training in the first place. With use of pre-test survey and unobtrusive individual records of ICCS system use data (N = 216), nonparametric tests revealed that only having a later stage of cancer predicted whether or not patients participated in training. Results indicated that participating in training was a significant predictor of higher levels of using the CHESS system. In particular, the repeated measures analysis of covariance found the significant interaction as well as main effect of group (i.e., training vs. no training) and time (i.e., individual’s CHESS usages at different times) in interactive and information CHESS services, suggesting that 1) the training group has a higher level of usage than the no training group, 2) both of the groups’ usage decreased over time, and 3) these joint patterns hold over time. Practical guidelines for future ICCS campaign implementation are discussed.
Breast cancer; the Interactive Cancer Communication System; training; usage; patient education