Requirement For Patient Consent Research Articles

Social Media in Stroke Career Development.

Social Media in Stroke Career Development.

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review.

The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure that it meets their needs. Consent for research in the context of digital health is limited. This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings. A structured literature search was developed and deployed in 4 electronic databases-MEDLINE, IEEE Xplore, Scopus, and Web of Science-for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they discussed electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis. In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants' willingness to share PHI (25/75, 33%) and participants' perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured. There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.

Referral patterns, disease progression and impact of the kidney failure risk equation (KFRE) in a Queensland Chronic Kidney Disease Registry (CKD.QLD) cohort: a study protocol

IntroductionChronic kidney disease (CKD) is a rapidly increasing and global phenomenon which carries high morbidity and mortality. Although timely referral from primary care to secondary care confers favourable outcomes, it...

Timing of Colonoscopy and Factors Indicating Early Colonoscopy in Acute Lower Gastrointestinal Bleeding: A Large-Scale Multicenter Cohort Study

Background: Optimal timing of colonoscopy for acute lower gastrointestinal bleeding is controversial, and it is unclear which patients benefit from early colonoscopy. The reported proportion of hemodynamically unstable patients is lower in randomized controlled trials than in observational studies. Methods: We studied 6,311 patients admitted for acute hematochezia in 49 Japanese hospitals, named the CODE-BLUE J Study. One propensity score-matched cohort comprised patients who underwent early (<24 hours) vs. non-early (24–96 hours) colonoscopy; the other comprised elective (24–48 hours) vs. late (48–96 hours) colonoscopy. Interaction term models were used to identify characteristics of patients who benefited from early colonoscopy. Findings: We compared 1,960 pairs of early vs. non-early patients. The early group showed higher rates of identification of stigmata of recent hemorrhage (SRH), endoscopic hemostasis (31% vs. 18%, P<0·001), and 30-day rebleeding, and a shorter length of hospital stay. The interventional radiology (IVR)/surgery rate was marginally lower in the early cohort (1·1% vs. 1·8%, P=0·083). Thirty-day mortality and blood transfusion rates were not significantly different between the groups. Of 810 pairs of elective vs. late patients, the elective group had a higher rate of SRH identification and shorter length of hospital stay. Systolic blood pressure (SBP) ≤100 mmHg at admission modified the qualitative effect of timing (early vs non-early) on requirement for IVR/surgery (odds ratio: 2·58 [95% confidence interval: 1·00–6·66] vs 0·98 [0·55–1·40]; P for interaction=0·047). Interpretation: Early colonoscopy increased the rates of SRH identification and endoscopic hemostasis and reduced the length of hospital stay but did not improve rebleeding and mortality. Early colonoscopy benefited patients with low SBP at presentation. Funding Information: This work was partially supported by grants from the Ministry of Health, Labour and Welfare, JSPS (KAKENHI), Smoking Research Foundation, Takeda Science Foundation, and National Center for Global Health and Medicine. Declaration of Interests: The authors have no relevant conflicts of interest to declare. Ethics Approval Statement: Approval from the ethical committees and institutional review boards of all 49 participating hospitals was obtained using the opt-out method. The requirement for patient consent was waived considering the retrospective nature of the study.

Deep Learning Algorithm for Chest Radiography: Multicenter Respiratory Outpatient Diagnostic Cohort Study

Background: Commercially available deep learning algorithms (DLAs) for chest radiography (CXR) have been evaluated with variable clinical settings. This study evaluated a DLA for detecting and localizing referable thoracic abnormalities on CXRs in a multicenter respiratory outpatient diagnostic cohort and compared the performance of physicians with and without DLA assistance. Methods: A total of 6,006 consecutive participants who visited respiratory outpatient clinics from 3 institutions and underwent both CXR and CT in 2018 were retrospectively evaluated with DLA. Observer performance tests were conducted with a subset of 230 randomly sampled participants to assess whether the algorithm enhanced physician performance. The area under the receiver operating characteristic (ROC) curve (AUC) and the area under the alternative free-response ROC (AUAFROC) were measured to evaluate the performance of the DLA and physicians in image classification and lesion localization, respectively. Findings: In the assessments performed in 6,006 participants, 4,264 referable thoracic abnormal lesions were found in 3,337 (55·6%) participants, including 1,173 pulmonary nodules/masses (20%), 919 consolidations (15%), 15 pneumothoraces (0·2%), and 2,157 other lesions (51%). DLA showed an AUC of 0·86 to 0·87, sensitivity of 0·87 to 0·90, specificity of 0·70 to 0·76, false-positive findings per image of 0·31 to 0·42, and AUAFROC of 0·86 to 0·87. For the randomly sampled dataset (n=230), the average AUC increased from 0·86 (95% CI: 0·82, 0·90) to 0·89 (95% CI: 0·85, 0·92) (P=0·003) and the average AUFROC increased from 0·80 (95% CI: 0·76, 0·84) to 0·82 (95% CI: 0·78, 0·86) (P=0·003) with the aid of DLA. The AUROC of standalone DLA was 0·91, which was significantly higher than the standalone AUROCs of pulmonologists (0·84,P=0·01) and radiology residents (0·85, P=0·03). Interpretation: The DLA showed acceptable performance and could enhance physician performance for diagnosing referable thoracic abnormalities in daily clinical practice. Funding Statement: This work was supported by grant (HI19C0847) from Korea Health Industry Development Institute. Declaration of Interests: Activities not related to the present article: KNJ and HK received a research grant from Lunit. Other authors have neither financial interests nor conflicts of interest. Ethics Approval Statement: This study was approved by the institutional review boards of all participating institutions, which waived the requirement for patient consent.

H-repair in supravalvular aortic stenosis.

H-repair in supravalvular aortic stenosis.

Dynamic Changes in Viral Load and Intrapulmonary Inflammation on Imaging During COVID-19 Infection: A Single-Institution Cohort Study

Background: Our study aims to determine the dynamic changes in viral load and intrapulmonary inflammation on imaging and to discern their relative relationship through a large sample cohort study of patients with severe and non-severe COVID-19. Methods: Intrapulmonary inflammation was quantified by a 72-point, semi-quantitative CT score, and viral load was measured using the cycle threshold (Ct) of nucleic acid specimens derived from the nasal and pharyngeal swabs of all the patients. The viral load and intrapulmonary inflammation were each staged according to fitted curves of the scatterplots. Findings: A total of 403 patients with 1716 CT scans and 729 nasal and 209 pharyngeal swab specimens were evaluated. For the viral load, the peak stage, descending stage, and plateau stage occurred at approximately 15 days, respectively. For intrapulmonary inflammation, the peak stage in severe and non-severe cases occurred at 14–37 days and 12–13 days, respectively. For nasal swabs, the median peak stage Ct values in severe and non-severe COVID-19 cases were 28.8 (25.9–32) and 28.5 (24.6–32.5), respectively, and the median plateau stage Ct values were 34.6 (31.6–37) and 35.0 (31.9–37), respectively. For pharyngeal swabs, the median peak stage Ct values in severe and non-severe cases were 28.5 (24.2–31.4) and 29.1 (25.1–31.3), respectively, and the median plateau stage Ct values were 34.2 (31.7–36.2) and 34.4 (32.9–37), respectively. The semi-quantitative CT scores during the median peak stage in patients with severe and non-severe COVID-19 were 22 (15–33) and 12 (6–19), respectively. The semi-quantitative CT scores were significantly higher (p < 0.001) in all of the stages in severe cases than in non-severe cases. The semi-quantitative CT scores were not significantly associated with the Ct values of nasal swabs (Pearson correlation = 0.089, p = 0.240) or pharyngeal swabs (Pearson correlation= 0.089, p = 0.551). Interpretation: The intrapulmonary inflammation observed in patients with non-severe COVID-19 reached the peak time faster, had a shorter peak stage compared to severe patients. The viral load peaked rapidly within one week after the symptom onset and then declined rapidly but underwent a long plateau stage in which viral load levels were close to normal. There was no significant correlation between viral load and grade of infection, but patients with severe COVID-19 had severe intrapulmonary inflammation. Funding Statement: This work was supported by Sanming Project of Medicine in Shenzhen (fund No:SZSM201612053). Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: This study was approved by the Ethics Committee of the Third People’s Hospital of Shenzhen, which waived the requirement for patient consent for this retrospective analysis.

Free AI Software for Automatic CT Quantification of Coronavirus Disease 2019: An International Collaborative Development, Validation, and Distribution

Background: We aimed to develop and distribute free artificial intelligence (AI) software for the automatic quantification of coronavirus disease 2019 (COVID-19) pneumonia on computed tomography (CT) images. Methods: We included 150 chest CT scans (17 CT scanners; five vendors) of 105 COVID-19 patients from 13 Korean and Chinese institutions. Two experienced radiologists semi-automatically drew lung opacities in every CT image, preparing 28,580 positive and negative CT slices to develop the 2D U-Net for segmenting pneumonia. The 2D U-Net was distributed as downloadable free software for local use on computers without data privacy concerns. External validation was performed using a Japanese single-institutional dataset and a public Italian dataset. Primary measures for the performance of the network were correlation coefficients for extent (%) and weight (g) of pneumonia. We surveyed user experiences. Findings: In the internal validation dataset, the intraclass correlation coefficients between the 2D U-Net and reference values for the extent and weight were 0·987 and 0·992, respectively. In the Japanese dataset, the Pearson correlation coefficients between the visual CT severity score and 2D U-Net outcomes were 0·906 and 0·916, respectively. In the Italian dataset, the intraclass correlation coefficients between the 2D U-Net and reference values for extent and weight were 0·921 and 0·970, respectively. The median satisfaction score was 9/10 and most respondents replied to use the software willingly. Interpretation: AI software for the automatic quantification of COVID-19 pneumonia on CT images was successfully developed and distributed freely worldwide. Funding Statement: There was no funding source for this study. Declaration of Interests: Sang Joon Park is the CEO of Medical IP. Gin Mo Goo has grants from Infinitt Healthcare, grants from Dongkook Lifescience, outside the submitted work. All the other authors have no potential conflicts of interest to disclose. Ethics Approval Statement: The institutional review board of the participating hospitals approved this retrospective study, and the requirement for patient consent was waived.

P1571 Echocardiograms on Twitter: the good, the bad and the ugly

Abstract Background - Case reports are a well-established part of the medical literature presenting interesting cases which require patient consent and peer review as a prerequisite. The advent of social media platforms has changed the way knowledge is shared. Twitter is a micro-blogging site utilised by the medical profession including cardiologists and allied health care professionals (HCP), allowing sharing of interesting cases. Echocardiography is particularly complementary to the medium as images and short films can be included in Tweets. However, its immediacy means traditional safeguards are absent, meaning patients might be identifiable. The study aim was to sample the prevalence of echocardiography cases being shared on Twitter and analyse the degree of identifiable information present. Methods - A retrospective observational study of videos of echocardiograms uploaded to Twitter under the hashtag #echofirst over 4 months (Nov 18-Feb 19) was performed in May 2019. Only English language Tweets were included. All Tweeter Demographics and Followers were manually collected by reviewing biographies. Tweets were screened for ‘direct’ (name, address, date-of-birth) and ‘indirect’ (age, gender, ethnicity, diagnosis, clinical diagnosis, date study performed) patient identifiers. Numbers of interactions (replies, likes, retweets, views) were recorded at the time of viewing tweets. Results - 324 of screened tweets (120 unique users; 114 individuals, 6 organisations) met study criteria. 81 (67%) stated their city. 35 (29%) stated their hospital. One Tweet contained directly identifiable information. Patient consent was not mentioned in any Tweet. Table 1 demonstrates Tweets with the number of identifiers cross-referenced with Tweeters" location. Discussion - Social media is a highly accessible method for cardiologists and allied HCP to instantly share and discuss echocardiography cases. However, our analysis potentially demonstrates that specific patients could be identified based location and identifiers. Caution must be applied when posting cases as Tweets. Specific guidelines on this practice should be considered. Table 1 Identifiers (n) Worldwide (n = 324) Country (n = 284) City (n = 221) Hospital (n = 112) 0 98 (30%) 88 (31%) 64 (29%) 27 (24%) 1 114 (35%) 97 (34%) 77 (35%) 39 (35%) 2 50 (15%) 45 (16%) 33 (15%) 19 (17%) 3 24 (7%) 20 (7%) 15 (7%) 5 (4%) 4 36 (11%) 32 (11%) 31 (14%) 21 (19%) 5 2 (1%) 2 (1%) 1 (&amp;lt;1%) 1 (1%)

Prognostic significance of preoperative CT findings in patients with advanced gastric cancer who underwent curative gastrectomy.

BackgroundPreoperative therapy has gained wide interest in advanced gastric cancer patients due to its potential advantages of improved disease control. Selection of high risk patients based on preoperative staging is crucial to choose the candidates for neoadjuvant therapy.MethodsOur institutional review board approved this retrospective study and waived the requirement for patient consent. We searched 394 advanced gastric cancer patients (pT2-4) who underwent curative resection in 2010 without neoadjuvant therapies. Two abdominal radiologists independently reviewed the preoperative CT including tumor depth on CT (CT-tumor depth), which was categorized as follows: intramural, minimal extramural(<1mm), spiculated extramural(≥1mm) and nodular extramural infiltration. The impact of clinicoradiologic factors on disease recurrence and disease free survival (DFS) was evaluated. Recursive partitioning analysis was performed to suggest prediction models for recurrence.ResultsOf total 394 patients, 86 patients (21.8%) experienced recurrence. Spiculated (≥1mm) and nodular extramural tumor infiltration and CT size of 5-10cm were independent predictors of disease recurrence and significantly associated with worse DFS. Lymph node involvement on CT was not significantly associated with patient outcome. Among patients with same pT4a stage, the recurrence rate rises and DFS gets worse as the extramural tumor infiltration progresses (P < 0.001). The prediction model for recurrence revealed that size and CT-tumor depth were the two major discriminating factors.ConclusionCT-tumor depth and size could be used as independent predictors for prognosis. Preoperative CT can be used for prognostic stratification to select high risk patients for whom neoadjuvant therapies might be considered.

Data and tissue research without patient consent: A qualitative study of the views of research ethics committees in New Zealand

Purpose: Secondary use of clinical tissue and data is an increasingly important platform for health research. Many jurisdictions allow research ethics committees (RECs) or institutional review boards (IRBs) the flexibility to waive the requirement for patient consent for secondary research. But most RECs/IRBs conduct their meetings “behind closed doors” and their decision-making processes are opaque to researchers and academics. The purpose of this study was to assess how New Zealand RECs weigh the potentially competing goals of enabling research and protecting patients’ rights. Methods: We used a participatory observation approach involving observation sessions (3), focus groups (4), and individual interviews (2) with members of the national-level health and disability ethics committees (HDECs) in 2016. Results: Twenty-four HDEC members participated (75% participation rate). Participants described the core ethical issues as consent, public benefit, and potential harms (to both collectives and individuals). Participants felt the weight of responsibility in waiving patients’ right to consent. Time pressure and a lack of specificity in the guidelines resulted in increased anxiety and stress. Participants’ comments demonstrate multiple different methods for defining and assessing public benefit. Conclusion: IRB/REC members have rich experience of moral reasoning regarding research ethics, especially in areas where the official guidance is underdeveloped. Their insights can contribute to the academic literature and suggest improvements in the review process and in ethical regulation and guidelines.

Legal Barriers to the Growth of Health Information Exchange-Boulders or Pebbles?

Although the clinical benefits of exchanging patients' health information electronically across providers have long been recognized, participation in health information exchange (HIE) has lagged behind adoption of electronic health records. Barriers erected by federal and state health information privacy law have been cited as a leading reason for the slow progress. A comprehensive assessment of these issues has not been undertaken for nearly a decade, despite a number of salient legal developments. Analysis of federal and state health information privacy statutes and regulations and secondary materials. Although some legal barriers to HIE persist, many have been ameliorated-in some cases, simply through improved understanding of what the law actually requires. It is now clear that the Health Insurance Portability and Accountability Act presents no obstacles to electronically sharing protected health information for treatment purposes and does not hold providers who properly disclose information liable for privacy breaches by recipients. The failure of federal efforts to establish a unique patient identifier number does slow HIE by inhibiting optimal matching of patient records, but other action to facilitate matching will be taken under the 21st Century Cures Act. The Cures Act also creates the legal architecture to begin to combat "information blocking." Varying patient consent requirements under federal and state law are the most important remaining legal barrier to HIE progress. However, federal rules relating to disclosure of substance-abuse treatment information were recently liberalized, and development of a technical standard, Data Segmentation for Privacy, or DS4P, now permits sensitive data requiring special handling to be segmented within a patient's record. Even with these developments, state-law requirements for patient consent remain daunting to navigate. Although patient consent requirements make HIE challenging, providers' expressed worries about legal barriers to participating in HIE likely primarily reflect concerns that are economically motivated. Lowering the cost of HIE or increasing financial incentives may boost provider participation more than further reducing legal barriers.

Sonographic features that can be used to differentiate between small triple-negative breast cancer and fibroadenoma.

PurposeOur study investigated whether any sonographic findings could be useful for differentiating between small triple-negative breast cancer (TNBC) and fibroadenoma.MethodsThis retrospective study was approved by our Institutional Review Board, which waived the requirement for patient consent. From January 2009 to December 2010, the sonographic features of 181 pathologically proven TNBC tumors and 172 fibroadenomas measuring less than or equal to 2 cm in the longest dimension were reviewed and analyzed according to the fifth edition of the Breast Imaging Reporting and Data System (BI-RADS) lexicon. Mean tumor roundness was also measured using in-house software.ResultsThe median longest lesion dimension was 16 mm (range, 13 to 18 mm) in TNBCs and 13 mm (range, 10 to 16 mm) in fibroadenomas. In comparison to fibroadenomas, small TNBC tumors presented with a higher incidence of irregular shapes (66.9%), noncircumscribed margins (91.7%), hypoechoic echotexture (59.1%), posterior acoustic enhancement (65.2%), and associated features (24.4%). Most TNBCs were classified as BI-RADS category 4 (65.2%) or 5 (28.2%). The mean tumor roundness of small TNBCs was greater than that of fibroadenomas (60%±12% vs. 53%±13%). Multivariate analysis showed that older patient age, irregular shape, nonparallel orientation, posterior acoustic enhancement, associated features, a BI-RADS final assessment category of 4 or 5, and greater tumor roundness were significant independent factors indicative of TNBCs.ConclusionTNBC tumors tend to demonstrate more suspicious sonographic features and greater tumor roundness than fibroadenomas. These features may have the potential to help differentiate between small TNBCs and fibroadenomas.

Health information exchange policies of 11 diverse health systems and the associated impact on volume of exchange.

Background: Provider organizations increasingly have the ability to exchange patient health information electronically. Organizational health information exchange (HIE) policy decisions can impact the extent to which external information is readily available to providers, but this relationship has not been well studied. Objective: Our objective was to examine the relationship between electronic exchange of patient health information across organizations and organizational HIE policy decisions. We focused on 2 key decisions: whether to automatically search for information from other organizations and whether to require HIE-specific patient consent. Methods: We conducted a retrospective time series analysis of the effect of automatic querying and the patient consent requirement on the monthly volume of clinical summaries exchanged. We could not assess degree of use or usefulness of summaries, organizational decision-making processes, or generalizability to other vendors. Results: Between 2013 and 2015, clinical summary exchange volume increased by 1349% across 11 organizations. Nine of the 11 systems were set up to enable auto-querying, and auto-querying was associated with a significant increase in the monthly rate of exchange (P = .006 for change in trend). Seven of the 11 organizations did not require patient consent specifically for HIE, and these organizations experienced a greater increase in volume of exchange over time compared to organizations that required consent. Conclusions: Automatic querying and limited consent requirements are organizational HIE policy decisions that impact the volume of exchange, and ultimately the information available to providers to support optimal care. Future efforts to ensure effective HIE may need to explicitly address these factors.

Correlation of the Strength of Recommendations for Additional Imaging to Adherence Rate and Diagnostic Yield

PurposeThe aim of this study was to evaluate the association between the wording of radiologist recommendations for chest CT with the likelihood of recommendation adherence and the diagnostic yield of the recommended follow-up CT imaging. MethodsThis HIPAA-compliant retrospective study had institutional review board approval, including waiver of the requirement for patient consent. All outpatient chest radiographic (CXR) studies performed at a tertiary care academic medical center in 2008 (n = 29,138) were searched to identify examinations with recommendations for chest CT. The wording of chest CT recommendations was classified as conditional or absolute, on the basis of whether the recommendation stood independent of the clinical judgment of the ordering clinician. Using the radiology information system, patients who underwent chest CT within 90 days of the index CXR study containing the recommendation were determined, and the CT studies were evaluated to determine if there were abnormalities corresponding to the CXR abnormalities that prompted the recommendations. Corresponding abnormalities were categorized as clinically relevant or not, on the basis of whether further workup or treatment was warranted. Groups were compared using t tests and Fisher exact tests. ResultsRecommendations for chest CT appeared in 4.5% of outpatient CXR studies (1,316 of 29,138; 95% confidence interval [CI], 4.3%–4.8%); 39.4% (519 of 1,316; 95% CI, 36.8%–42.0%) were conditional and 60.6% (797 of 1,316; 95% CI, 58.0%–63.2%) were absolute. Patients with absolute recommendations were significantly more likely to undergo follow-up chest CT within 90 days than patients with conditional recommendations (67.8% vs 45.8%, respectively, P < .001). Despite this difference in provider adherence, there was no significant difference between the conditional and absolute recommendation groups with regard to the incidence of clinically relevant corresponding findings (P = .16) or malignancy (P = .08) on follow-up CT. ConclusionsConditional radiologist recommendations are associated with decreased provider adherence, though the likelihood of a clinically relevant finding on follow-up CT is no different than with absolute recommendations.

Effect of MicroEEG on Clinical Management and Outcomes of Emergency Department Patients With Altered Mental Status: A Randomized Controlled Trial

Altered mental status (AMS) is a common presentation in the emergency department (ED). A previous study revealed 78% electroencephalogram (EEG) abnormalities, including nonconvulsive seizure (NCS; 5%), in ED patients with AMS. The objective of this study was to assess the impact of EEG on clinical management and outcomes of ED patients with AMS. This was a randomized controlled trial at two urban teaching hospitals. Adult patients (≥18 years old) with AMS were included. Excluded patients had immediately correctable AMS (e.g., hypoglycemia) or were admitted before enrollment. Patients were randomized to routine care (control) or routine care plus EEG (intervention). Research assistants used a scalp electrode set with a miniature, wireless EEG device (microEEG) to record standard 30-minute EEGs at presentation, and results were reported to the ED attending physician by an off-site epileptologist within 30 minutes. Primary outcomes included changes in ED management (differential diagnosis, diagnostic work-up, and treatment plan from enrollment to disposition) as determined by surveying the treating physicians. Secondary outcomes were length of ED and hospital stay, intensive care unit (ICU) requirement, and in-hospital mortality. A total of 149 patients were enrolled (76 control and 73 intervention). Patients in the two groups were comparable at baseline. EEG in the intervention group revealed abnormal findings in 93% (95% confidence interval [CI] = 85% to 97%), including NCS in 5% (95% CI = 2% to 13%). Using microEEG was associated with change in diagnostic work-up in 49% (95% CI = 38% to 60%) of cases and therapeutic plan in 42% (95% CI = 31% to 53%) of cases immediately after the release of EEG results. Changes in probabilities of differential diagnoses and the secondary outcomes were not statistically significant between the groups. An EEG can be obtained in the ED with minimal resources and can affect clinical management of AMS patients.

International comparisons of health system performance among OECD countries: Opportunities and data privacy protection challenges

ObjectiveHealth data constitute a significant resource in most OECD countries that could be used to improve health system performance. Well-intended policies to allay concerns about breaches of confidentiality and to reduce potential misuse of personal health information may be limiting data use. A survey of 20 OECD countries explored the extent to which countries have developed and use personal health data and the reasons why data use may be problematic in some. ResultsCountries are divided, with one-half engaged regularly in national data linkage studies to monitor health care quality. Country variation is linked to risk management in granting an exemption to patient consent requirements; in sharing identifiable data among government authorities; and in project approvals and granting access to data. The resources required to comply with data protection requirements is a secondary problem. The sharing of person-level data across borders for international comparisons is rarely reported and there were few examples of studies of health system performance. DiscussionLaws and policies enabling data sharing and data linkage are needed to strengthen national information infrastructure. To develop international studies comparing health care quality and health system performance, actions are needed to address heterogeneity in data protection practices.

Palliative care, double effect and the law in Australia

Care and decision-making at the end of life that promotes comfort and dignity is widely endorsed by public policy and the law. In ethical analysis of palliative care interventions that are argued potentially to hasten death, these may be deemed to be ethically permissible by the application of the doctrine of double effect, if the doctor's intention is to relieve pain and not cause death. In part because of the significance of ethics in the development of law in the medical sphere, this doctrine is also likely to be recognized as part of Australia's common law, although hitherto there have been no cases concerning palliative care brought before a court in Australia to test this. Three Australian States have, nonetheless, created legislative defences that are different from the common law with the intent of clarifying the law, promoting palliative care, and distinguishing it from euthanasia. However, these defences have the potential to provide less protection for doctors administering palliative care. In addition to requiring a doctor to have an appropriate intent, the defences insist on adherence to particular medical practice standards and perhaps require patient consent. Doctors providing end-of-life care in these States need to be aware of these legislative changes. Acting in accordance with the common law doctrine of double effect may not provide legal protection. Similar changes are likely to occur in other States and Territories as there is a trend towards enacting legislative defences that deal with the provision of palliative care.

State Generic Substitution Laws Can Lower Drug Outlays Under Medicaid

To stem the rising costs of medications provided to patients enrolled in Medicaid, states have implemented varying policies about generic substitution. These policies differ in the extent to which pharmacists or patients can influence which medications they choose. Using national Medicaid data, we evaluated the relationship between different generic substitution policies and the use of generic simvastatin, a cholesterol-lowering drug, after the patent for the brand-name equivalent, Zocor, expired. States that implemented policies requiring patients' consent prior to generic substitution experienced rates of substitution that were 25 percent lower than those of states that did not require patient consent. By eliminating patient consent requirements, state Medicaid programs could expect to save more than $100 million in coverage for three top-selling medications that are nearing patent expiration. Although these consent requirements are probably intended to increase patient autonomy, policy makers should consider the sizable opportunity costs.

Lung Cancer Detected at Cardiac CT: Prevalence, Clinicoradiologic Features, and Importance of Full–Field-of-View Images

To retrospectively evaluate the prevalence and clinicoradiologic features of lung cancer detected at cardiac computed tomography (CT) and compare the detection rates at different field-of-view (FOV) settings. The institutional review board approved this retrospective study and waived the requirement for patient consent. Patients with lung cancer initially detected at cardiac CT were identified by means of a retrospective search of a lung cancer registry patient database between January 2004 and December 2007. Patients known to have lung cancer at the time of cardiac CT were excluded. The prevalence and clinical and radiologic features of lung cancer were evaluated. The rates of lung cancer detection at three FOVs-limited and full FOV at cardiac scanning and full FOV at thoracic scanning-were compared by using McNemar testing. The prevalence of lung cancer detected at CT was 0.31% (36 of 11654 patients, 16 [44%] never smokers) and was higher in patients suspected or known to have coronary artery disease (0.43% [24 of 5615 patients]) than in asymptomatic screening-examined patients (0.20% [12 of 5924 patients]) (P = .0457). Adenocarcinoma was the most common (in 31 [86%] of 36 patients) histologic subtype. Of 34 non-small cell lung cancers, 23 (68%)-including 16 stage IA cancers-were resectable. Four (11%) and 19 (53%) of the 36 CT-depicted cancers were visible in limited and full FOV at cardiac scanning, respectively, and 17 (47%) were visible in full FOV at thoracic scanning only. The prevalence of lung cancer at cardiac CT was 0.31%; and 68% of these malignancies were at a resectable stage. Use of a limited FOV at cardiac scanning led to a large majority (89% [32 of 36 cancers]) of the lung cancers detected at full thoracic scanning being missed; thus, inclusion of the entire chest at cardiac CT is advisable.