American Society of Hematology living guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19: January 2022 update on the use of therapeutic-intensity anticoagulation in acutely ill patients.

BACKGROUND: COVID-19-related acute illness is associated with an increased risk of venous thromboembolism (VTE). OBJECTIVE: These evidence-based guidelines from the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in making decisions about the use of anticoagulation in patients with COVID-19. METHODS: ASH formed a multidisciplinary guideline panel that included patient representatives and applied strategies to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process and performed systematic evidence reviews (through November 2021). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess evidence and make recommendations, which were subject to public comment. This is an update to guidelines published in February 2021 as part of the living phase of these guidelines. RESULTS: The panel made one additional recommendation. The panel issued a conditional recommendation in favor of therapeutic-intensity over prophylactic-intensity anticoagulation in patients with COVID-19-related acute illness who do not have suspected or confirmed VTE. The panel emphasized the need for an individualized assessment of risk of thrombosis and bleeding. The panel also noted that heparin (unfractionated or low molecular weight) may be preferred because of a preponderance of evidence with this class of anticoagulants. CONCLUSION: This conditional recommendation was based on very low certainty in the evidence, underscoring the need for additional, high-quality, randomized controlled trials comparing different intensities of anticoagulation in patients with COVID-19-related acute illness.

American Society of Hematology living guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19: July 2021 update on postdischarge thromboprophylaxis.

BACKGROUND: COVID-19-related acute illness is associated with an increased risk of venous thromboembolism (VTE). OBJECTIVE: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in decisions about the use of anticoagulation for thromboprophylaxis in patients with COVID-19 who do not have confirmed or suspected VTE. METHODS: ASH formed a multidisciplinary guideline panel, including 3 patient representatives, and applied strategies to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including performing systematic evidence reviews (up to March 2021). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the grading of recommendations assessment, development, and evaluation (GRADE) approach to assess evidence and make recommendations, which were subject to public comment. RESULTS: The panel agreed on 1 additional recommendation. The panel issued a conditional recommendation against the use of outpatient anticoagulant prophylaxis in patients with COVID-19 who are discharged from the hospital and who do not have suspected or confirmed VTE or another indication for anticoagulation. CONCLUSIONS: This recommendation was based on very low certainty in the evidence, underscoring the need for high-quality randomized controlled trials assessing the role of postdischarge thromboprophylaxis. Other key research priorities include better evidence on assessing risk of thrombosis and bleeding outcomes in patients with COVID-19 after hospital discharge.

Focus groups and interviews with the public led to the development of a template for a GRADE Plain Language Recommendation (PLR).

OBJECTIVE: Clear communication of health care recommendations to patients and the public is essential. Current work has focused on creating patient versions of guidelines without much attention to single recommendations. In this study, we built on previously conducted research to test a template and explore the public's perceptions of, and attitudes towards plain language guideline recommendations. STUDY DESIGN AND SETTING: We conducted four focus groups with people interested in healthy aging to obtain general attitudes, perceptions, and understanding of recommendations. We then conducted nine user-tests of Plain Language Recommendations developed from GRADE guidelines. We performed a directed content analysis, and finalized a template for a Plain Language Recommendation. RESULTS: We identified themes related to personalized information; strength of recommendations; support with health care and appointments; amount and credibility of information; and formatting. When recommendations were conditional, participants wanted more information about why and what to consider. The template for a Plain Language Recommendation is available in the GRADEpro software to facilitate automation. CONCLUSION: We created a Plain Language Recommendation template to communicate specific information from guidelines to patients and the public. Broad application of the template is warranted and future research could measure the impact on understanding and behavior change.

Pharmacologic thromboprophylaxis in adult patients undergoing neurosurgical interventions for preventing venous thromboembolism.

The impact of pharmacologic prophylaxis for venous thromboembolism in patients undergoing neurosurgical intervention remains uncertain. We reviewed the efficacy and safety of pharmacologic compared with nonpharmacologic thromboprophylaxis in neurosurgical patients. Three databases were searched through April 2018, including those for randomized controlled trials (RCTs) and for nonrandomized controlled studies (NRSs). Independent reviewers assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Seven RCTs and 3 NRSs proved eligible. No studies reported on symptomatic proximal and distal deep vein thrombosis (DVT). Two RCTs reported on screening-detected proximal and distal DVTs. We used the findings of these 2 RCTs as the closest surrogate outcomes to inform the proximal and distal DVT outcomes. These 2 RCTs suggest that pharmacologic thromboprophylaxis may decrease the risk of developing asymptomatic proximal DVT (relative risk [RR], 0.50; 95% confidence interval [CI], 0.30-0.84; low certainty). Findings were uncertain for mortality (RR, 1.27; 95% CI, 0.57-2.86; low certainty), symptomatic pulmonary embolism (PE) (RR, 0.84; 95% CI, 0.03-27.42; very low certainty), asymptomatic distal DVT (RR, 0.54; 95% CI, 0.27-1.08; very low certainty), and reoperation (RR, 0.43; 95% CI, 0.06-2.84; very low certainty) outcomes. NRSs also reported uncertain findings for whether pharmacologic prophylaxis affects mortality (RR, 0.72; 95% CI, 0.46-1.13; low certainty) and PE (RR, 0.18; 95% CI, 0.01-3.76). For risk of bleeding, findings were uncertain in both RCTs (RR, 1.57; 95% CI, 0.70-3.50; low certainty) and NRSs (RR, 1.45; 95% CI, 0.30-7.12; very low certainty). In patients undergoing neurosurgical procedures, low certainty of evidence suggests that pharmacologic thromboprophylaxis confers benefit for preventing asymptomatic (screening-detected) proximal DVT with very low certainty regarding its impact on patient-important outcomes.

Conclusions from surveys may not consider important biases: a systematic survey of surveys.

OBJECTIVES: Surveys can inform important health care questions. However, should decision-makers believe strong conclusions that authors of surveys report? Objectives of this systematic survey of surveys are to describe the characteristics and conduct of surveys and investigate the association of the conduct with the conclusions. STUDY DESIGN AND SETTING: We randomly selected 180 surveys published over 1 year in core clinical journals that included a self-report instrument to elicit knowledge, attitudes, behaviors, and experiences regarding health. Study selection and abstraction was independent and in duplicate. We calculated frequencies of descriptive data. We conducted multivariable logistic regression analyses to assess the association of strong or weak conclusions with survey methods. RESULTS: Our results suggest that authors who validate questions in their survey make strong conclusions. We found that strong conclusions may not be associated with response rates or number of respondents. However, it did not appear that journal impact factor was related to strong conclusions. CONCLUSION: Our results suggest that users of surveys should not rely on the conclusions of authors. A critical appraisal tool for users of surveys and guidance for authors about factors to consider when making conclusions would be helpful.

McMaster Optimal Aging Portal: an evidence-based database for geriatrics-focused health professionals.

OBJECTIVE: The objective of this work was to provide easy access to reliable health information based on good quality research that will help health care professionals to learn what works best for seniors to stay as healthy as possible, manage health conditions and build supportive health systems. This will help meet the demands of our aging population that clinicians provide high quality care for older adults, that public health professionals deliver disease prevention and health promotion strategies across the life span, and that policymakers address the economic and social need to create a robust health system and a healthy society for all ages. RESULTS: The McMaster Optimal Aging Portal's (Portal) professional bibliographic database contains high quality scientific evidence about optimal aging specifically targeted to clinicians, public health professionals and policymakers. The database content comes from three information services: McMaster Premium LiteratUre Service (MacPLUS™), Health Evidence™ and Health Systems Evidence. The Portal is continually updated, freely accessible online, easily searchable, and provides email-based alerts when new records are added. The database is being continually assessed for value, usability and use. A number of improvements are planned, including French language translation of content, increased linkages between related records within the Portal database, and inclusion of additional types of content. While this article focuses on the professional database, the Portal also houses resources for patients, caregivers and the general public, which may also be of interest to geriatric practitioners and researchers.

The McMaster Optimal Aging Portal: Usability Evaluation of a Unique Evidence-Based Health Information Website.

BACKGROUND: Increasingly, older adults and their informal caregivers are using the Internet to search for health-related information. There is a proliferation of health information online, but the quality of this information varies, often based on exaggerated or dramatic findings, and not easily comprehended by consumers. The McMaster Optimal Aging Portal (Portal) was developed to provide Internet users with high-quality evidence about aging and address some of these current limitations of health information posted online. The Portal includes content for health professionals coming from three best-in-class resources (MacPLUS, Health Evidence, and Health Systems Evidence) and four types of content specifically prepared for the general public (Evidence Summaries, Web Resource Ratings, Blog Posts, and Twitter messages). OBJECTIVE: Our objectives were to share the findings of the usability evaluation of the Portal with particular focus on the content features for the general public and to inform designers of health information websites and online resources for older adults about key usability themes. METHODS: Data analysis included task performance during usability testing and qualitative content analyses of both the usability sessions and interviews to identify core themes. RESULTS: A total of 37 participants took part in 33 usability testing sessions and 21 focused interviews. Qualitative analysis revealed common themes regarding the Portal's strengths and challenges to usability. The strengths of the website were related to credibility, applicability, browsing function, design, and accessibility. The usability challenges included reluctance to register, process of registering, searching, terminology, and technical features. CONCLUSIONS: The study reinforced the importance of including end users during the development of this unique, dynamic, evidence-based health information website. The feedback was applied to iteratively improve website usability. Our findings can be applied by designers of health-related websites.

A comparison of self-report and health care provider data to assess surveillance definitions of influenza-like illness in outpatients.

OBJECTIVE: Several surveillance definitions of influenza-like illness (ILI) have been proposed, based on the presence of symptoms. Symptom data can be obtained from patients, medical records, or both. Past research has found that agreements between health record data and self-report are variable depending on the specific symptom. Therefore, we aimed to explore the implications of using data on influenza symptoms extracted from medical records, similar data collected prospectively from outpatients, and the combined data from both sources as predictors of laboratory-confirmed influenza. METHODS: Using data from the Hutterite Influenza Prevention Study, we calculated: 1) the sensitivity, specificity and predictive values of individual symptoms within surveillance definitions; 2) how frequently surveillance definitions correlated to laboratory-confirmed influenza; and 3) the predictive value of surveillance definitions. RESULTS: Of the 176 participants with reports from participants and medical records, 142 (81%) were tested for influenza and 37 (26%) were PCR positive for influenza. Fever (alone) and fever combined with cough and/or sore throat were highly correlated with being PCR positive for influenza for all data sources. ILI surveillance definitions, based on symptom data from medical records only or from both medical records and self-report, were better predictors of laboratory-confirmed influenza with higher odds ratios and positive predictive values. DISCUSSION: The choice of data source to determine ILI will depend on the patient population, outcome of interest, availability of data source, and use for clinical decision making, research, or surveillance.

Agreement between self-report and medical records on signs and symptoms of respiratory illness.

BACKGROUND: Information on patient symptoms can be obtained by patient self-report or medical records review. Both methods have limitations. AIMS: To assess the agreement between self-report and documentation in the medical records of signs/symptoms of respiratory illness (fever, cough, runny nose, sore throat, headache, sinus problems, muscle aches, fatigue, earache, and chills). METHODS: Respondents were 176 research participants in the Hutterite Influenza Prevention Study during the 2008-2009 influenza season with information about the presence or absence of signs/symptoms from both self-report and primary care medical records. RESULTS: Compared with medical records, lower proportions of self-reported fever, sore throat, earache, cough, and sinus problems were found. Total agreements between self-report and medical report of symptoms ranged from 61% (for sore throat) to 88% (for muscle aches and earache), with kappa estimates varying from 0.05 (for chills) to 0.41 (for cough) and 0.51 (for earache). Negative agreement was considerably higher (from 68% for sore throat to 93% for muscle aches and earache) than positive agreement (from 13% for chills to 58% for earache) for each symptom except cough where positive agreement (77%) was higher than negative agreement (64%). Agreements varied by age group. We found better agreement for earache (kappa = 0.62) and lower agreements for headache, sinus problems, muscle aches, fatigue, and chills in older children (aged >5 years) and adults. CONCLUSIONS: Agreements were variable depending on the specific symptom. Contrary to research in other patient populations which suggests that clinicians report fewer symptoms than patients, we found that the medical record captured more symptoms than selfreport. Symptom agreement and disagreement may be affected by the perspectives of the person experiencing them, the observer, the symptoms themselves, measurement error, the setting in which the symptoms were observed and recorded, and the broader community and cultural context of patients.

Prenatal HIV testing: women's experiences of informed consent in Toronto, Ontario.

OBJECTIVE: All Canadian jurisdictions have human immunodeficiency virus (HIV) testing programs requiring that clinicians discuss HIV testing with all pregnant women and seek their consent to be tested. Our goal was to evaluate how the informed consent process was being carried out in Ontario. METHODS: Between November 2002 and February 2004, women in postpartum wards in three Toronto teaching hospitals were invited to participate in the study. A structured questionnaire was administered on the ward, medical records were reviewed, and data from the Central Public Health Laboratory were examined to verify whether or not the women had been tested. RESULTS: Of 446 women invited, 299 (67%) participated. All except one participant had at least one prenatal visit, and 92% had more than five visits. Seventy-four percent of participants recalled a clinician talking to them about testing, and 70% of these felt that they were given the option to refuse the test. Twenty-one women overall (7%) believed that they were not tested during pregnancy or were not certain whether they had been tested or not, but actually had been tested. Women who felt that their care provider did not have an opinion about whether they should undergo testing were more likely to decline. Eighty-six percent were completely satisfied with the testing experience. CONCLUSION: Informed consent for prenatal HIV testing is generally being obtained in a manner consistent with provincial guidelines. Our findings raise concern, however, that a significant number of women are not offered testing or in some cases are tested without their consent. Increases in testing rates could be achieved by offering the test to all women and emphasizing that carrying out testing is a recommended part of medical care.

Medical records and women's self-report are not reliable sources for determining whether prenatal HIV testing was done.

OBJECTIVE: To determine whether medical records and the self-report of a postpartum patient provide reliable information about whether or not prenatal HIV testing has been done. METHODS: Women on the postpartum wards at three Toronto teaching hospitals who gave informed consent were included in the study. The presence or absence of prenatal HIV testing was determined by interviews with postpartum women, review of hospital charts, and search of the Public Health Provincial Laboratory and Prenatal Testing databases. RESULTS: Two hundred ninety-nine women were enrolled. All had had at least one prenatal visit, and 92% had copies of prenatal records in their hospital charts. Health records and patient reports were both unreliable for determining who had and who had not had HIV testing. HIV status was documented on 55% of the charts; on 46% it was noted that testing was performed, and on 46% there was documentation of pre& or post&test counselling. In interviews, 73% of the women reported having an HIV test during this pregnancy. Using the laboratory databases as the gold standard of whether testing had truly been done, medical record sensitivity and specificity were 65% and 62% respectively, and self-report sensitivity and specificity were 87% and 52% respectively. Using medical records resulted in an underestimation and self-reports an overestimation of the number of women who had been tested. CONCLUSIONS: Both medical records and patient self-report are unreliable at the time of labour and delivery for determining whether or not a woman has been tested for HIV in pregnancy. Clinical and public health decisions may therefore be compromised by a lack of accurate testing information at the bedside.

The experiences of men receiving androgen deprivation treatment for prostate cancer: a qualitative study.

OBJECTIVE: This exploratory study was intended to investigate men's ways of integrating and understanding experiences with Androgen Deprivation Therapy (ADT), including how hormone treatment affected their sense of identity. PATIENTS AND METHODS: Twelve men, averaging 61 years of age and treated with ADT, participated in a single interview about their experiences with prostate cancer and hormone treatment. In keeping with a qualitative approach, questions were initially open-ended, with patients encouraged to describe experiences in their own words. RESULTS: Seven prominent themes appeared in the interviews: 1) starting on hormones, 2) matching expectations with reality, 3) tracking changes, 4) dealing with changes in sexuality, 5) navigating relationships, 6) putting things in context, and 7) interpreting gender-relevant changes. CONCLUSION: The effects of ADT on men with prostate cancer were varied and often substantial in their impact. Additionally, men often receive insufficient information to prepare them to deal with side effects. While the physiological situation of the men in our study could be described as "liminal" (i.e., straddled between two categories of gender), interview data showed that they refuse their liminality, claiming to be neither less masculine nor more feminine because of treatment. While men are grateful to receive potentially life-extending treatment, the challenge for the health care system is to provide them with the information and clinical support that will make their remaining years the best that they can be.