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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.

BackgroundCOVID-19–related acute illness is associated with an increased risk of venous thromboembolism (VTE).ObjectiveThese 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.MethodsASH 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.ResultsThe 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.ConclusionsThis 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.

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.

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.

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.

WOS: 000397406000012, PubMed ID: 28205285, Background: Development of inhibitors is the most serious complication in haemophilia A treatment. The assessment of risk for inhibitor formation in new or modified factor concentrates is traditionally performed in previously treated patients (PTPs). However, evidence on risk factors for and natural history of inhibitors has been generated mostly in previously untreated patients (PUPs). The purpose of this study was to examine cases of de novo inhibitors in PTPs reported in the scientific literature and to the EUropean HAemophilia Safety Surveillance (EUHASS) programme, and explore determinants and course of inhibitor development. Methods: We used a case series study design and developed a case report form to collect patient level data; including detection, inhibitor course, treatment, factor VIII products used and events that may trigger inhibitor development (surgery, vaccination, immune disorders, malignancy, product switch). Results: We identified 19 publications that reported 38 inhibitor cases and 45 cases from 31 EUHASS centres. Individual patient data were collected for 55/83 (66%) inhibitor cases out of 12 330 patients. The median (range) peak inhibitor titre was 4.4 (0.5-135.0), the proportion of transient inhibitors was 33% and only two cases of 12 undergoing immune tolerance induction failed this treatment. In the two months before inhibitor development, surgery was reported in nine (22%) cases, and high intensity treatment periods reported in seven (17%) cases. Conclusions: By studying the largest cohort of inhibitor development in PTPs assembled to date, we showed that inhibitor development in PTPs, is on average, a milder event than in PUPs., Canadian Hemophilia Society (CHS); PfizerPfizer, This study was supported by two independent unrestricted research grants: a 'Care until Cure' peer reviewed research grant, awarded in 2013 to AMB by the Canadian Hemophilia Society (CHS) supported the collection of inhibitor data reported in the literature; a Pfizer Investigator-Initiated Research grant awarded in 2014 to AI supported the collection of data reported to EUHASS.

Background: Evidence summaries and blogs can support evidence-informed healthy aging, by presenting high-quality health research evidence in plain language for a nonprofessional (citizen) audience. Objective: Our objective was to explore citizens’ perceptions about the usability of evidence summaries and blog posts on the Web-based McMaster Optimal Aging Portal. Methods: Twenty-two citizens (aged 50 years and older) and informal caregivers participated in a qualitative study using a think-aloud method and semistructured interviews. Eleven interviews were conducted in person, 7 over the telephone, and 4 by Skype. Results: We identified themes that fell under 4 user-experience categories: (1) desirability: personal relevance, (2) understandability: language comprehension, grasping the message, dealing with uncertainty, (3) usability: volume of information, use of numbers, and (4) usefulness: intention to use, facility for sharing. Conclusions: Participants recognized that high-quality evidence on aging was valuable. Their intended use of the information was influenced by how much it applied to their own health circumstances or those of a loved one. Some specific formatting features that were preferred included consistent layout, content organized by subheadings, catchy titles, numerical information summarized in a table, and inclusion of a glossary. [JMIR Hum Factors 2016;3(2):e22]

Aim The scope of this recommendation is to provide guidance for reporting of inhibitor cases in previously treated patients (PTPs) with hemophilia A. This guidance is intended to improve transparency and completeness of reporting of observed events; it does not cover planning, executing or analyzing original studies aimed at the assessment of inhibitor rates. Recommendation We recommend that for each case of inhibitor development reported in a published paper, a paragraph or a table is included in the main publication reporting as a minimum the underlined data fields in Table . We recommend transparent reporting when any of the suggested information is not available. We recommend that particular care is used in reporting the timeline of events by clearly identifying a reference time-point. We suggest that journals in the field adopt this guidance as instructions for the authors and as a guide for reviewers. Conclusion Development of inhibitors in PTPs is a very rare event. Standardized reporting of inhibitor characteristics will contribute to generating a body of evidence otherwise not available. Case by case reporting of the recommended data elements may shed light on the natural history and risk factors of inhibitor development in PTPs and be useful for tailoring care in similar future cases.

Information on patient symptoms can be obtained by patient self-report or medical records review. Both methods have limitations. 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). 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. 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. 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 self-report. 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.

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. Key words: Influenza; influenza-like illness; surveillance definition; data source

Background Audit and feedback programs are considered to be one of the most effective antimicrobial stewardship (ASP) strategies to improve antibiotic prescribing; however, resource requirements are a limiting factor. Methods In a controlled, quasi-experimental study we evaluated the impact of once weekly ASP rounds conducted with one Medicine teaching team, while two Medicine teams served as controls, at a tertiary care center from November 2014 until November 2015. We assessed process measures and changes in antibiotic utilization (reported as monthly defined daily doses per 1000 patient days from November 2013 to November 2015 using statistical process control charts). Results In total, 249 patients (40% of 627 patients on the team) were on anti-infectives on the day of the rounds and had been discussed, of which 18% (48/249) were already followed by infectious diseases. A total of 79 interventions were made. Reduced duration of therapy comprised over half of the recommendations (39/76, 51%). Discontinuing antibiotics on the same day was the second most common intervention (20/76, 26%). All stewardship suggestions were accepted by the Medicine team. However, no significant changes in antibiotic utilization were observed with a similar reduction in both groups for piperacillin-tazobactam and meropenem while at the same time, an increased use of first and third-generation cephalosporins was observed. Conclusion While the process measures demonstrated a change in the treatment plan in 1 out of 3 patients reviewed, this did not translate into a significant change in antibiotic utilization as compared with the control groups. This may be related to the comparably small proportion of patients reviewed by ASP given that rounds occurred only once a week, and were cancelled 28 times within a one year period due to limited Medicine clinician availability. There also could have been cross-contamination between the two study arms with faculty and trainees who received the intervention while on the intervention team continuing their learned practice while on a control team. Process measures are an important means to measure the impact of ASPs, as antibiotic utilization is not a sensitive metric and may not reliably reflect improvement in antibiotic management at the individual patient level. Disclosures All authors: No reported disclosures.

Our goal was to determine whether introducing rapid point-of-care (POC) whole-blood HIV testing as alternative to standard laboratory-based testing is acceptable and changes the rate of receiving test results at an anonymous testing program. From December 2001 through April 2002 all patients requesting HIV testing at Hassle Free Clinic in Toronto were offered rapid POC or standard testing. Routine clinical data was collected. All patients were invited to complete a questionnaire evaluating testing procedure. Test counselors also completed evaluation questionnaires. HIV-positive patients were invited to an in-depth interview. There were 1610 patients, 91% chose the rapid POC test. Overall 98.9% of patients received final results, compared with 93% in the previous year. Among the rapid testers, 100% received an initial result, and 18 of 22 testing positive returned for confirmatory results. Among standard testers 90.8% returned for results (p < 0.001 compared to rapid testers) including all of the 4 with positive tests. There were 1257 (79%) patients who completed questionnaires, 4 with positive tests agreed to interviews, and test counselors evaluated every visit. Standard testers indicated significantly greater difficulty than rapid testers with the testing procedure. Test counselors also indicated that standard testers had greater difficulty. HIV-positive patients coped well with the testing procedure and indicated high quality counseling was important. Rapid HIV testing was acceptable to patients and test counselors, provided more patients with test results and reduced total time and number of visits. High-quality pretest and posttest counseling is particularly important for rapid testers with positive results. The impact of false-positive results requires further study.

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.

Background People with haemophilia face many treatment decisions, which are largely informed by evidence from observational studies. Without evidence-based 'best' treatment options, patient preferences play a large role in decisions regarding therapy. The shared decision-making (SDM) process allows patients and health care providers to make decisions collaboratively based on available evidence, and patient preferences. Decision tools can help the SDM process. The objective of this project was to develop two-sided decision tools, decision boxes for physicians and patient decision aids for patients, to facilitate SDM for treatment decisions in haemophilia. Methods Development of the decision tools comprised three phases: topic selection, prototype development and usability testing with targeted end-users. Topics were selected using a Delphi survey. Tool prototypes were based on a previously validated framework and were informed by systematic literature reviews. Patients, through focus groups, and physicians, through interviews, reviewed the prototypes iteratively for comprehensibility and usability. Results The chosen topics were: (i) prophylactic treatment: when to start and dosing, (ii) choosing factor source and (iii) immunotolerance induction: when to start and dosing. Intended end users (both health care providers and haemophilia patients and caregivers) were engaged in the development process. Overall perception of the decision tools was positive, and the purpose of using the tools was well received. Conclusions This study demonstrates the feasibility of developing decision tools for haemophilia treatment decisions. It also provides anecdotal evidence of positive perceptions of such tools. Future directions include assessment of the tools' practical value and impact on clinical practice.

Openness about one's sexual orientation in the health care context contributes to lesbians satisfaction with care and to continued use of health services. We undertook a qualitative study to examine lesbians experiences in the health care environment and explain why openness about sexual orientation may be resisted by lesbians. Data were derived from four focus groups conducted with lesbians who discussed their expectations and preferences for their health care, as well as their met and unmet health care needs. Transcripts of the focus groups were analyzed using NUD∗IST qualitative software to derive salient themes presented by the women. Five major themes were identified: anxiety and concern related to self-disclosure, non-disclosure of sexual orientation, seeking out gay-positive physicians, frustration with assumptions of heterosexuality, and treatment of lesbian partners. Examples for each of the major themes are provided. Data from this study suggest ways health care providers can alleviate ...

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. [JMIR Hum Factors 2016;3(1):e14]

Introduction Quality improvement in primary care can be facilitated by the ability to measure indicators in practice. This paper reports on the process and impacts of data collection on indicators of a quality assessment tool in seven interprofessional group family practices in Ontario, Canada. Methods The programme addressed indicators and collected data across multiple domains of practice including clinical quality, physical factors, and patient and staff perceptions. A system audit of the practice, a patient survey, a staff satisfaction survey and chart audits (on hypothyroidism and hyperlipidaemia) were designed to measure selected indicators across the domains. Practices were trained and collected their own data. Practices provided feedback on the process and impacts during a postprogramme workshop and on a survey 1 year later. Results Four-hundred charts audits were completed for each of hyperlipidaemia and hypothyroidism, 319 patient satisfaction surveys were administered in four practices, and the staff satisfaction survey was completed by 77 staff in six practices. Most practices demonstrated indicators of privacy, access and safety. There was more variability in indicators relating to staff professional development and team involvement in meetings. Patient satisfaction with providers was rated highly, whereas some aspects of practice access were rated lower. Practices approached the challenge of participation by engaging multidisciplinary team members and dividing tasks. Most practices reported continued participation in various quality improvement initiatives 1 year later. Conclusions Using a set of indicators, structured processes and training, family practices find the process of gathering and reviewing their data useful for quality improvement.

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.

Health issues unique to women and differences in healthcare experiences have recently gained attention as health plans and systems seek to extend and improve health promotion and disease prevention in the population. Successful efforts focused on enhancing quality of care will require information from the patient's perspective on how to improve such services to best support women's attempts to lead healthy and productive lives. The National Centers of Excellence in Women's Health program (CoE), sponsored by the Office on Women's Health within the Department of Health and Human Services, is based on an integrated model uniting research, training, healthcare, and community education and outreach. To examine women's concept and definitions of healthcare quality, 18 focus groups comprising 137 women were conducted nationwide on experiences and attributes of healthcare that women value in primary care. Following the focus groups, a woman-focused healthcare satisfaction instrument was developed for the purpose of assessing and improving healthcare delivery. We describe the qualitative results of the focus group study.