EVALUATION OF PATIENT AND PUBLIC INVOLVEMENT INITIATIVES IN HEALTH TECHNOLOGY ASSESSMENT:A SURVEY OF INTERNATIONAL AGENCIES

Although there is increased awareness of patient and public involvement (PPI) among health technology assessment (HTA) organizations, evaluations of PPI initiatives are relatively scarce. Our objective as members of Health Technology Assessment International's (HTAi's) Patient and Citizen Involvement Group (PCIG) was to advance understanding of the range of evaluation strategies adopted by HTA organizations and their potential usefulness. In March 2016, a survey was sent to fifty-four HTA organizations through the International Network of Agencies for Health Technology Assessment (INAHTA) and contacts of members of HTAi's PCIG. Respondents were asked about their organizational structure; how patients and members of the public are involved; whether and how PPI initiatives have been evaluated, and, if so, which facilitators and challenges to evaluation were found and how results were used and disseminated. Fifteen (n = 15) programs from twelve countries responded (response rate 27.8 percent) that involved patients (14/15) and members of the public (10/15) in HTA activities. Seven programs evaluated their PPI activities, including participant satisfaction (5/7), process (5/7) and impact evaluations (4/7). Evaluation results were used to improve PPI activities, identify education and training needs, and direct strategic priorities. Facilitators and challenges revolved around the need for stakeholder buy-in, sufficient resources, senior leadership, and including patients in evaluations. A small but diverse set of HTA organizations evaluate their PPI activities using a range of strategies that reflect the range of rationales and approaches to PPI in HTA. It will be important for HTA organizations to draw on evaluation theories and methods

Health technology assessment methods guidelines for medical devices : how can we address the gaps? The International Federation of Medical and Biological Engineering perspective

Objectives Current health technology assessment (HTA) methods guidelines for medical devices may benefit from contributions by biomedical and clinical engineers. Our study aims to: (i) review and identify gaps in the current HTA guidelines on medical devices, (ii) propose recommendations to optimize the impact of HTA for medical devices, and (iii) reach a consensus among biomedical engineers on these recommendations. Methods A gray literature search of HTA agency Web sites for assessment methods guidelines on devices was conducted. The International Federation of Medical and Biological Engineers (IFMBE) then convened a structured focus group, with experts from different fields, to identify potential gaps in the current HTA guidelines, and to develop recommendations to fill these perceived gaps. The thirty recommendations generated from the focus group were circulated in a Delphi survey to eighty-five biomedical and clinical engineers. Results Thirty-two panelists, from seventeen countries, participated in the Delphi survey. The responses showed a strong agreement on twenty-seven of thirty recommendations. Some uncertainties remain about the methods to accurately assess the effectiveness and safety, and interoperability of a medical device with other devices or within the clinical setting. Conclusions As medical devices differ from drug therapies, current HTA methods may not accurately reflect the conclusions of their assessment. Recommendations informed by the focus group discussions and Delphi survey responses aimed to address the perceived gaps, and to provide a more integrated approach in medical device assessments in combining engineering with other perspectives, such as clinical, economic, patient, human factors, ethical, and environmental

Case studies on the use of sentiment analysis to assess the effectiveness and safety of health technologies : a scoping review

A health technology assessment (HTA) is commonly defined as a multidisciplinary approach used to evaluate medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. To help inform HTA recommendations, the surveillance of social media platforms can provide important insights to the clinical community and to decision makers on the effectiveness and safety of the use of health technologies on a patient. A scoping review of the published literature was performed to gain some insight on the accuracy and automation of sentiment analysis (SA) used to assess public opinion on the use of health technologies. A literature search of major databases was conducted. The main search concepts were SA, social media, and patient perspective. Among the 1,776 unique citations identified, 12 studies that described the use of SA methods to evaluate public opinion on or experiences with the use of health technologies as posted on social media platforms were included. The SA methods used were either lexicon-or machine learning-based. Two studies focused on medical devices, three examined HPV vaccination, and the remaining studies targeted drug therapies. Due to the limitations and inherent differences among SA tools, the outcomes of these applications should be considered exploratory. The results of our study can initiate discussions on how the automation of algorithms to interpret public opinion of health technologies should be further developed to optimize the use of data available on social media

Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group

AbstractBackgroundHealth technology assessments (HTAs) are increasingly used to inform coverage, access, and utilization of medical technologies including molecular diagnostics (MDx). Although MDx are used to screen patients and inform disease management and treatment decisions, there is no uniform approach to their evaluation by HTA organizations.ObjectivesThe International Society for Pharmacoeconomics and Outcomes Research Devices and Diagnostics Special Interest Group reviewed diagnostic-specific HTA programs and identified elements representing common and best practices.MethodsMDx-specific HTA programs in Europe, Australia, and North America were characterized by methodology, evaluation framework, and impact. Published MDx HTAs were reviewed, and five representative case studies of test evaluations were developed: United Kingdom (National Institute for Health and Care Excellence's Diagnostics Assessment Programme, epidermal growth factor receptor tyrosine kinase mutation), United States (Palmetto's Molecular Diagnostic Services Program, OncotypeDx prostate cancer test), Germany (Institute for Quality and Efficiency in Healthcare, human papillomavirus testing), Australia (Medical Services Advisory Committee, anaplastic lymphoma kinase testing for non–small cell lung cancer), and Canada (Canadian Agency for Drugs and Technologies in Health, Rapid Response: Non-invasive Prenatal Testing).ResultsOverall, the few HTA programs that have MDx-specific methods do not provide clear parameters of acceptability related to clinical and analytic performance, clinical utility, and economic impact. The case studies highlight similarities and differences in evaluation approaches across HTAs in the performance metrics used (analytic and clinical validity, clinical utility), evidence requirements, and how value is measured. Not all HTAs are directly linked to reimbursement outcomes.ConclusionsTo improve MDx HTAs, organizations should provide greater transparency, better communication and collaboration between industry and HTA stakeholders, clearer links between HTA and funding decisions, explicit recognition of and rationale for differential approaches to laboratory-developed versus regulatory-approved test, and clear evidence requirements

A third of systematic reviews changed or did not specify the primary outcome : A PROSPERO register study

OBJECTIVES: To examine outcome reporting bias of systematic reviews registered in PROSPERO. STUDY DESIGN AND SETTING: Retrospective cohort study. The primary outcomes from systematic review publications were compared with those reported in the corresponding PROSPERO records; discrepancies in the primary outcomes were assessed as upgrades, additions, omissions or downgrades. Relative risks (RR) and 95% confidence intervals (CI) were calculated to determine the likelihood of having a change in primary outcome when the meta-analysis result was favourable and statistically significant. RESULTS: 96 systematic reviews were published. A discrepancy in the primary outcome occurred in 32% of the included reviews and 39% of the reviews did not explicitly specify a primary outcome(s); 6% of the primary outcomes were omitted. There was no significant increased risk of adding/upgrading (RR 2.14, 95% CI 0.53 to 8.63) or decreased risk of downgrading (RR 0.76, 0.27-2.17) an outcome when the meta-analysis result was favourable and statistically significant. As well, there was no significant increased risk of adding/upgrading (RR 0.89, 0.31-2.53) or decreased risk of downgrading (RR 0.56, 0.29-1.08) an outcome when the conclusion was positive. CONCLUSIONS: We recommend review authors carefully consider primary outcome selection and journals are encouraged to focus acceptance on registered systematic reviews

Clinical effectiveness of rapid tests for methicillin resistant Staphylococcus aureus (MRSA) in hospitalized patients: a systematic review

<p>Abstract</p> <p>Background</p> <p>Methicillin resistant <it>Staphylococcus aureus </it>(MRSA) are often resistant to multiple classes of antibiotics. The research objectives of this systematic review were to evaluate the clinical effectiveness of polymerase chain reaction (PCR) versus chromogenic agar for MRSA screening, and PCR versus no screening for several clinical outcomes, including MRSA colonization and infection rates.</p> <p>Methods</p> <p>An electronic literature search was conducted on studies evaluating polymerase chain reaction techniques and methicillin (also spelled meticillin) resistant <it>Staphylococcus aureus </it>that were published from 1993 onwards using Medline, Medline In-Process & Other Non-Indexed Citations, BIOSIS Previews, and EMBASE. Due to the presence of heterogeneity in the selected studies, the clinical findings of individual studies were described.</p> <p>Results</p> <p>Nine studies that compared screening for MRSA using PCR versus screening using chromogenic agar in a hospital setting, and two studies that compared screening using PCR with no or targeted screening were identified. Some studies found lower MRSA colonization and acquisition, infection, and transmission rates in screening with PCR versus screening with chromogenic agar, and the turnaround time for screening test results was lower for PCR. One study reported a lower number of unnecessary isolation days with screening using PCR versus screening with chromogenic agar, but the proportion of patients isolated was similar between both groups. The turnaround time for test results and number of isolation days were lower for PCR versus chromogenic agar for MRSA screening.</p> <p>Conclusions</p> <p>The use of PCR for MRSA screening demonstrated a lower turnaround time and number of isolation days compared with chromogenic agar. Given the mixed quality and number of studies (11 studies), gaps remain in the published literature and the evidence remains insufficient. In addition to screening, factors such as the number of contacts between healthcare workers and patients, number of patients attended by one healthcare worker per day, probability of colonization among healthcare workers, and MRSA status of hospital shared equipment and hospital environment must be considered to control the transmission of MRSA in a hospital setting.</p

Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review

Abstract Background Medical devices have improved the treatment of many medical conditions. Despite their benefit, the use of devices can lead to unintended incidents, potentially resulting in unnecessary harm, injury or complications to the patient, a complaint, loss or damage. Devices are used in hospitals on a routine basis. Research to date, however, has been primarily limited to describing incidents rates, so the optimal design of a hospital-based surveillance system remains unclear. Our research objectives were twofold: i) to explore factors that influence device-related incident recognition, reporting and resolution and ii) to investigate interventions or strategies to improve the recognition, reporting and resolution of medical device-related incidents. Methods We searched the bibliographic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and PsycINFO database. Grey literature (literature that is not commercially available) was searched for studies on factors that influence incident recognition, reporting and resolution published and interventions or strategies for their improvement from 2003 to 2014. Although we focused on medical devices, other health technologies were eligible for inclusion. Results Thirty studies were included in our systematic review, but most studies were concentrated on other health technologies. The study findings indicate that fear of punishment, uncertainty of what should be reported and how incident reports will be used and time constraints to incident reporting are common barriers to incident recognition and reporting. Relevant studies on the resolution of medical errors were not found. Strategies to improve error reporting include the use of an electronic error reporting system, increased training and feedback to frontline clinicians about the reported error. Conclusions The available evidence on factors influencing medical device-related incident recognition, reporting and resolution by healthcare professionals can inform data collection and analysis in future studies. Since evidence gaps on medical device-related incidents exist, telephone interviews with frontline clinicians will be conducted to solicit information about their experiences with medical devices and suggested strategies for device surveillance improvement in a hospital context. Further research also should investigate the impact of human, system, organizational and education factors on the development and implementation of local medical device surveillance systems

Engaging the Canadian public on reimbursement decision-making for drugs for rare diseases: a national online survey

Background: Funding of drugs for rare diseases (DRDs) requires decisions that balance fairness for all individuals within the healthcare system with compassion for affected individuals. Our study objective was to conduct a national online survey to determine the Canadian public’s perspective, including regional variations, associated with DRD decision-making. Methods: The survey collected responses from 1631 Canadians. Respondents were asked to rank at least three and up to five DRD decision-making priorities, out of a total of eight priorities presented. They were also asked to compare and rate their agreement level on a 5-point Likert scale with four funding scenarios described. The frequency of each priority, independent of where it was ranked in relation to the other priorities, was calculated. Regression analyses were conducted to measure the association between respondents’ demographics and selected priorities with their agreement level for each funding scenario. Results: Among the survey respondents, Improved Quality of Life and Effective Health Care were most frequently selected as top priorities. Also, 79.2% of respondents agreed with equal access to DRDs across Canada, and 73.0% agreed with DRD funding if additional expenses are justified in the DRD’s cost-effectiveness. Approximately half agreed to pay for DRDs independent of their effectiveness. There were no geographic differences in priorities. Selecting Effective Health Care in the top priorities was positively associated with both prioritizing other programs over programs for rare diseases and DRD funding only if deemed as cost-effective. Respondents, who selected National Access as one of the top priorities, were less likely to agree to fund DRDs only if deemed as cost-effective and were more likely to agree with the scenario to provide national access to DRDs. Conclusions: The survey results suggest the level of public support for funding decisions and programs that incorporate assessment of the effectiveness of drugs for improving quality of life, and to promote similar access across Canada. The responses anticipate public responses to different policy scenarios and the priorities that underlie them. Decision-makers may find it useful to consider whether and how to incorporate these results into policy decisions and their justification to citizens and patients.Medicine, Faculty ofPharmaceutical Sciences, Faculty ofOther UBCNon UBCPopulation and Public Health (SPPH), School ofReviewedFacult

Patient safety revisited

Patient safety has always been an important responsibility for Clinical Engineering Departments (CEDs), but the breadth of safety issues changed dramatically over the years, from electrical-focused safety and electromagnetic interference in the latter half of the 20th century to a concern with adverse events (AEs) and medical errors in the 21st century (Frize, 2017). Although this is a well-known fact, especially since the publication of the article: To Err is Human (Institute of Medicine (1985), patient safety in healthcare institutions has not improved despite the significant attention that has been focused on this topic in the past 20 years, advancements in healthcare technology, and the increasing cost of health care