Institute of Health Policy Management and Evaluation - publications
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Item Regulatory regimes and procedural values for health-related motion data in the United States and Canada(Elsevier, 2022-06) Boyer, Philip; Donia, Joseph; Whyne, Cari; Burns, David; Shaw, JamesObjectives: Digital health technologies often have minimal regulatory oversight if the perceived risk to users is low. This is especially relevant to motion data captured from wearable devices, which are increasingly used across sectors and in clinical settings. The aim of this research is to identify gaps in procedural values embedded in two policy regimes for the governance of health-related motion data. Methods: This paper examines the policy regimes of the state of California in the United States and the province of Ontario in Canada with respect to digital health applications and the use of motion data, and demonstrates how three example technologies would be regulated under these regimes. This is followed by a gap analysis of procedural values within the two policy regimes. Results: Applications that are categorized as health and wellness or are not classified as medical devices under these regimes are not typically required to adhere to the strict guidelines of data usage, application standards and accountability reserved for health care, despite collecting and distributing data that may be used to infer information about a user’s health. The values-based gaps in these policy regimes illustrate three crucial issues for research and policy on this topic: Inconsistent regulatory implications for different entities, a lack of trustworthy practices, and challenges over the definition of “reasonableness”. Conclusion: Greater consideration of procedural values embedded in policies could better advance the goal of ameliorating the risks of motion data collected by wearable devices and applications.Item Metformin in women with type 2 diabetes in pregnancy (MiTy): a multicentre, international, randomised, placebo-controlled trial(Elsevier, 2020-10) Feig, Denice S; Donovan, Lois E; Zinman, Bernard; Sanchez, J Johanna; Asztalos, Elizabeth; Ryan, Edmond A; Fantus, I George; Hutton, Eileen; Armson, Anthony B; Lipscombe, Lorraine L; Simmons, David; Barrett, Jon F R; Karanicolas, Paul J; Tobin, Siobhan; McIntyre, H David; Tian, Simon Yu; Tomlinson, George; Murphy, Kellie E; Feig, Denice; Donat, Diane; Gandhi, Shital; Cleave, Barbara; Zhou, Vivian; Viguiliouk, Effie; Fong, Debbie; Strom, Michele; Deans, Melissa; Kamath, Aarthi; Godbout, Ariane; Weber, Florence; Mahone, Michele; Wo, Bi Lan; Bedard, Marie-Josee; Robinson, Melanie; Daigle, Sylvie; Leblanc, Sophie; Ludwig, Sora; Pockett, Sherri; Slater, Laurie; Donovan, Lois; Oldford, Carolyn; Young, Catherine; Virtanen, Heidi; Lodha, Abhay; Cooper, Stephanie; Yamamoto, Jennifer; Gougeon, Claire; Verhesen, Cheryl; Zahedi, Afshan; Taha, Nashwah; Turner, Marci; Neculau, Madalena; Robb, Cathy; Szwiega, Krystyna; Lee, Grace; Rey, Evelyne; Perreault, Sophie; Coolen, Jillian; Armson, Anthony B; Ransom, Thomas; Dias, Raquel; Slaunwhite, Janet; Baxendale, Darlene; Fanning, Cora; Halperin, Ilana; Gale, Veronica; Kader, Tina; Hirsimaki, Heidi; Long, Hélène; Lambert, Julie; Castonguay, Annie; Chalifoux, Steve; McManus, Ruth; Watson, Margaret; Powell, Anne-Marie; Sultana, Munira; ArthurHayward, Vinolia; Marin, Mauricio; Cauchi, Lorraine; MacBean, Leila; Keely, Erin; Malcolm, Janine; Clark, Heather; Karovitch, Allan; Belanger, Heather; Champagne, Josee; Schutt, Kayla; Sloan, Jennifer; Mitchell, Joyce; Favreau, Colette; O'Shea, Elaine; McGuire, Debbie; Peng, Melin; St Omer, Dynika; Lee, Julie; Klinke, Jennifer; Young, Sharon; Lee, Julie; Barts, Agnieszka; Carr, Francina; Subrt, Peter; Miller, David; Coles, Karen; Capes, Sarah; Smushkin, Galina; Phillips, Richard; Fergusson, Carol; Lacerte, Stacey; Houlden, Robyn; Breen, Adriana; Stone-Hope, Bonnie; Ryan, Edmond A; Kwong, Sarah; Rylance, Heather; Khurana, Rshmi; McNab, Tammy; Beauchamp, Shirley; Weisnagel, S John; D'Amours, Martin; Allen, Christyne; Dubé, Marie-Christine; Julien, Valérie-Ève; Lambert, Camille; Bourbonniere, Marie-Claude; Rheaume, Louise; Bouchard, Myriam; Carson, George; Williams, Suzanne; Wolfs, Maria; Berger, Howard; Cheng, Alice; Ray, Joel; Hanna, Amir; De Souza, Leanne; Berndl, Leslie; Meltzer, Sara; Garfield, Natasha; El-Messidi, Amira; Bastien, Louise; Segal, Shari; Thompson, David; Lim, Ken; Kong, Jason; Thompson, Sharon; Orr, Christine; Galway, Brenda; Parsons, Minnie; Rideout, Krista; Rowe, Bernadette; Crane, Joan; Andrews, Wayne; Joyce, Carol; Newstead-Angel, Jill; Brandt, Judy; Meier, Simona; Laurie, Josephine; McIntyre, David; Liley, Helen; Fox, , Jane; Barrett, Helen; Maguire, Frances; Nerdal-Bussell, Marnie; Nie, Wenjun; Bergan, Carolyn; Cavallaro, Bekki; Tremellen, Anne; Cook, Anne; Simmons, David; Rajagopal, Rohit; Vizza, Lisa; Mattick, Maureen; Bishop, Claudia; Nema, Jodie; Kludas, Renee; McLean, Mark; Hendon, Susan; Sigmund, Allison; Wong, Vincent; Lata, Prem; Russell, Hamish; Singh, Razita; Zinman, Bernard; Asztalos, Elizabeth; Fantus, George I; Lipscombe, Lorraine L; Barrett, Jon; Tomlinson, George; Murphy, Kellie; McMurray, Keitha; Karanicolas, Paul; Murphy, Helen; Sanchez, Johanna; Klein, Gail; Tian, Simon; Tobin, Siobhan; Mangoff, KathrynBackground: Although metformin is increasingly being used in women with type 2 diabetes during pregnancy, little data exist on the benefits and harms of metformin use on pregnancy outcomes in these women. We aimed to investigate the effects of the addition of metformin to a standard regimen of insulin on neonatal morbidity and mortality in pregnant women with type 2 diabetes. Methods: In this prospective, multicentre, international, randomised, parallel, double-masked, placebo-controlled trial, women with type 2 diabetes during pregnancy were randomly assigned from 25 centres in Canada and four in Australia to receive either metformin 1000 mg twice daily or placebo, added to insulin. Randomisation was done via a web-based computerised randomisation service and stratified by centre and pre-pregnancy BMI (<30 kg/m2 or ≥30 kg/m2) in a ratio of 1:1 using random block sizes of 4 and 6. Women were eligible if they had type 2 diabetes, were on insulin, had a singleton viable pregnancy, and were between 6 and 22 weeks plus 6 days' gestation. Participants were asked to check their fasting blood glucose level before the first meal of the day, before the last meal of the day, and 2 h after each meal. Insulin doses were adjusted aiming for identical glucose targets (fasting glucose <5·3 mmol/L [95 mg/dL], 2-h postprandial glucose <6·7 mmol/L [120 mg/dL]). Study visits were done monthly and patients were seen every 1–4 weeks as was needed for standard clinical care. At study visits blood pressure and bodyweight were measured; patients were asked about tolerance to their pills, any hospitalisations, insulin doses, and severe hypoglycaemia events; and glucometer readings were downloaded to the central coordinating centre. Participants, caregivers, and outcome assessors were masked to the intervention. The primary outcome was a composite of fetal and neonatal outcomes, for which we calculated the relative risk and 95% CI between groups, stratifying by site and BMI using a log-binomial regression model with an intention-to-treat analysis. Secondary outcomes included several relevant maternal and neonatal outcomes. The trial was registered with ClinicalTrials.gov, NCT01353391. Findings: Between May 25, 2011, and Oct 11, 2018, we randomly assigned 502 women, 253 (50%) to metformin and 249 (50%) to placebo. Complete data were available for 233 (92%) participants in the metformin group and 240 (96%) in the placebo group for the primary outcome. We found no significant difference in the primary composite neonatal outcome between the two groups (40% vs 40%; p=0·86; relative risk [RR] 1·02 [0·83 to 1·26]). Compared with women in the placebo group, metformin-treated women achieved better glycaemic control (HbA1c at 34 weeks' gestation 41·0 mmol/mol [SD 8·5] vs 43·2 mmol/mol [–10]; 5·90% vs 6·10%; p=0·015; mean glucose 6·05 [0·93] vs 6·27 [0·90]; difference −0·2 [–0·4 to 0·0]), required less insulin (1·1 units per kg per day vs 1·5 units per kg per day; difference −0·4 [95% CI −0·5 to −0·2]; p<0·0001), gained less weight (7·2 kg vs 9·0 kg; difference −1·8 [–2·7 to −0·9]; p<0·0001) and had fewer caesarean births (125 [53%] of 234 in the metformin group vs 148 [63%] of 236 in the placebo group; relative risk [RR] 0·85 [95% CI 0·73 to 0·99]; p=0·031). We found no significant difference between the groups in hypertensive disorders (55 [23%] in the metformin group vs 56 [23%] in the placebo group; p=0·93; RR 0·99 [0·72 to 1·35]). Compared with those in the placebo group, metformin-exposed infants weighed less (mean birthweight 3156 g [SD 742] vs 3375 g [742]; difference −218 [–353 to −82]; p=0·002), fewer were above the 97th centile for birthweight (20 [9%] in the metformin group vs 34 [15%] in the placebo group; RR 0·58 [0·34 to 0·97]; p=0·041), fewer weighed 4000 g or more at birth (28 [12%] in the metformin group vs 44 [19%] in the placebo group; RR 0·65 [0·43 to 0·99]; p=0·046), and metformin-exposed infants had reduced adiposity measures (mean sum of skinfolds 16·0 mm [SD 5·0] vs 17·4 [6·2] mm; difference −1·41 [–2·6 to −0·2]; p=0·024; mean neonatal fat mass 13·2 [SD 6·2] vs 14·6 [5·0]; p=0·017). 30 (13%) infants in the metformin group and 15 (7%) in the placebo group were small for gestational age (RR 1·96 [1·10 to 3·64]; p=0·026). We found no significant difference in the cord c-peptide between groups (673 pmol/L [435] in the metformin group vs 758 pmol/L [595] in the placebo group; p=0·10; ratio of means 0·88 [0·72 to 1·02]). The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group). Interpretation: We found several maternal glycaemic and neonatal adiposity benefits in the metformin group. Along with reduced maternal weight gain and insulin dosage and improved glycaemic control, the lower adiposity and infant size measurements resulted in fewer large infants but a higher proportion of small-for-gestational-age infants. Understanding the implications of these effects on infants will be important to properly advise patients who are contemplating the use of metformin during pregnancy.Item The association between loneliness and medication use in older adults(Oxford University Press, 2020-09-14) Vyas, Manav V; Watt, Jennifer A; Yu, Amy Y X; Straus, Sharon E; Kapral, Moira KBackground: Loneliness is common in older adults, and it is associated with unhealthy behaviours, including substance use. We evaluated the association between loneliness and self-reported use of opioids and benzodiazepines in older adults. Methods: We used data from the Canadian Community Health Survey’s ‘Healthy Aging’ sub-survey and included adults 65 years or older who administered their own medications. We classified individuals as lonely if they scored 6 or more on the three -item University of California, Los Angeles’s Loneliness Scale. We used multinomial logistic regression models, adjusting for demographics and self-reported comorbidities, to describe the association between loneliness and daily or occasional use of opioids, benzodiazepines and non-opioid analgesics. We also explored the association between loneliness and polypharmacy. Results: Our cohort included 15,302 older adults, of whom 2,096 (13.7%) were classified as lonely. Daily use of opioids (4.1%) and benzodiazepines (1.7%) were less common than daily use of non-opioid analgesics (33.9%). Lonely older adults had higher daily use of opioids (odds ratio [OR] 1.61, 1.31-1.98) and benzodiazepines (OR 1.66, 1.21-2.28), but not non-opioid analgesics (OR 1.05, 0.92-1.19). Loneliness was not associated with occasional use of opioids, benzodiazepines or non-opioid analgesics in older adults, but was associated with polypharmacy (OR 1.27, 1.06-1.52). Conclusions: Loneliness in older adults is associated with increased daily use of opioids and benzodiazepines. Further research should evaluate patient- and physician-level factors that mediate this association, and develop strategies to mitigate loneliness and its attendant adverse outcomes.Item Mental health among transgender women living with HIV in Canada: findings from a national community-based research study(Taylor & Francis, 2020-03-15) Lacombe-Duncan, Ashley; Warren, Laura; Kay, Emma Sophia; Persad, Yasmeen; Soor, Jaspreet; Kia, Hannah; Underhill, Angela; Logie, Carmen H; Kazemi, Mina; Kaida, Angela; de Pokomandy, Alexandra; Loutfy, MonaAntiretroviral therapy adherence among transgender (trans) women living with HIV (WLWH) is negatively impacted by depression and post-traumatic stress disorder (PTSD). Yet, little is known about factors associated with depression or PTSD among trans WLWH. Using cross-sectional data from a national community-based study of 1422 WLWH (n = 53 trans women), we characterized the prevalence of depressive and PTSD symptoms among trans WLWH and examined associations between factors (e.g., Trans stigma) and depressive and PTSD symptoms. Nearly half of participants reported clinically significant PTSD (45.3%) and depressive symptoms (45.3%) [mean Post-traumatic Stress Disorder Civilian Checklist Version-C score 13.8 (SD = 5.8); mean Center for Epidemiological Studies - Depression score 9.4 (SD = 8.0)]. Univariate linear regression analyses showed that <95% adherence, higher internalized HIV-related stigma, frequency of past-month hazardous alcohol use, and current injection drug use were significantly associated with both higher PTSD and depressive symptom scores, and higher resilience and social support with lower scores. A history of violence in adulthood was associated with higher depressive symptoms scores, whereas sexual relationship power and less difficulty meeting housing costs were associated with lower scores. Findings suggest a need for multi-level interventions to reduce barriers to mental wellbeing while fostering resilience and social support.Item Quality of life of older women living with HIV: comparative assessment of physical and mental health-related markers using a large Canadian Sexual and Reproductive Health Cohort Study(Taylor and Francis, 2019-07-08) Kteily-Hawa, Roula; Andany, Nisha; Wang, Ying; Logie, Carmen H; Tharao, Wangari; Conway, Tracey; Webster, Kath; de Pokomandy, Alexandra; Kaida, Angela; Hogg, Robert; Loutfy, MonaObjective: This study assessed and compared physical and mental health components of quality of life (QoL) for older and younger women living with HIV (WLWH). Method: Using survey data from the Canadian HIV Women's Sexual and Reproductive Health Cohort Study, demographic, well-being, and physical and mental health-related QoL (HR-QoL) variables were compared between older (≥50 years) and younger (<50 years) WLWH. As the only significantly different QoL component, bivariate analyses and linear regression were used to assess factors associated with physical HR-QoL of older women. Results: The sample frame comprised 1,422 women (28.0% older women). Younger WLWH's mean age was 37.8 years (SD = 7.4) compared to older WLWH (55.8 years, SD = 5.3). Compared to younger WLWH, older WLWH had poorer physical HR-QoL (40.0 vs. 50.7; p < 0.001) but similar mental HR-QoL (42.7 vs. 42.1; p > 0.001). Older WLWH had lower social support (p < 0.001) with no significant differences in depressive symptoms or resilience. Resilience was associated with improved physical HR-QOL. Food insecurity, poorer mental HR-QoL and depressive symptoms were associated with poorer physical health. Discussion: Compared to younger WLWH, older WLWH had poorer physical HR-QoL, which was associated with resilience, food insecurity and mental health factors, highlighting the complex interactions of health-related social-ecological factors impacting aging WLWH.Item Understanding Universality within a Liberal Welfare Regime: The Case of Universal Social Programs in Canada(Cogitatio, 2020-03-18) Béland, Daniel; Marchildon, Gregory P.; Prince, Michael J.Although Canada is known as a liberal welfare regime, universality is a key issue in that country, as several major social pro- grams are universal in both their core principles and coverage rules. The objective of this article is to discuss the meaning of universality and related concepts before exploring the development of individual universal social programs in Canada, with a particular focus on health care and old-age pensions. More generally, the article shows how universality can exist and become resilient within a predominantly liberal welfare regime due to the complex and fragmented nature of mod- ern social policy systems, in which policy types vary from policy area to policy area, and even from program to program within the same policy area. The broader analysis of health care and old-age pensions as policy areas illustrates this general claim. This analysis looks at the historical development and the politics of provincial universal health coverage since the late 1950s and at the evolution of the federal Old Age Security program since its creation in the early 1950s. The main argument of this article is that universality as a set of principles remains stronger in health care than in pensions yet key challenges remain in each of these policy areas. Another contention is that there are multiple and contested universalisms in social policy.Item Agreement between a health claims algorithm and parent-reported asthma in young children(2019-07-22) Omand, Jessica A; Maguire, Jonathon L; O'Connor, Deborah L; Parkin, Patricia C; Birken, Catherine S; Thorpe, Kevin E; Zhu, Jingqin; To, TeresaIntroduction: Asthma prevalence is commonly measured in national surveys by questionnaire. The Ontario Asthma Surveillance Information System (OASIS) developed a validated health claims diagnosis algorithm to estimate asthma prevalence. The primary objective was to assess the agreement between two approaches of measuring asthma in young children. Secondary objectives were to identify concordant and discordant pairs, and to identify factors associated with disagreement. Study design and setting: A measurement study to evaluate the agreement between the OASIS algorithm and parent‐reported asthma (criterion standard). Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated. Multivariable logistic regression was used to determine factors associated with disagreement. Results: Healthy children aged 1 to 5 years (n =3642) participating in the TARGet Kids! practice based research network 2008‐2013 in Toronto, Canada were included. Prevalence of asthma was 14% and 6% by the OASIS algorithm and parent‐reported asthma, respectively. The Kappa statistic was 0.43, sensitivity 81%, specificity 90%, PPV 34%, and NPV 99%. There were 3249 concordant and 393 discordant pairs. Statistically significant factors associated with asthma identified by OASIS but not parent report included: male sex, higher zBMI, and parent history of asthma. Males were less likely to have asthma identified by parent report but not OASIS. Conclusion: The OASIS algorithm identified more asthma cases in young children than parent‐reported asthma. The OASIS algorithm had high sensitivity, specificity, and NPV but low PPV relative to parent‐reported asthma. These findings need replication in other populations.Item Assessment of a multimedia-based prospective method to support public deliberations on health technology design: participant survey findings and qualitative insights(BioMed Central, 2016-10-26) Lehoux, P; Jimenez-Pernett, J; Miller, F A; Williams-Jones, BBackground Using a combination of videos and online short stories, we conducted four face-to-face deliberative workshops in Montreal (Quebec, Canada) with members of the public who later joined additional participants in an online forum to discuss the social and ethical implications of prospective technologies. This paper presents the participants’ appraisal of our intervention and provides novel qualitative insights into the use of videos and online tools in public deliberations. Methods We applied a mixed-method study design. A self-administered survey contained open- and close-ended items using a 5-level Likert-like scale. Absolute frequencies and proportions for the close-ended items were compiled. Qualitative data included field notes, the transcripts of the workshops and the participants’ contributions to the online forum. The qualitative data were used to flesh out the survey data describing the participants’ appraisal of: 1) the multimedia components of our intervention; 2) its deliberative face-to-face and online processes; and 3) its perceived effects. Results Thirty-eight participants contributed to the workshops and 57 to the online forum. A total of 46 participants filled-in the survey, for a response rate of 73 % (46/63). The videos helped 96 % of the participants to understand the fictional technologies and the online scenarios helped 98 % to reflect about the issues raised. Up to 81 % considered the arguments of the other participants to be well thought-out. Nearly all participants felt comfortable sharing their ideas in both the face-to-face (89 %) and online environments (93 %), but 88 % preferred the face-to-face workshop. As a result of the intervention, 85 % reflected more about the pros and cons of technology and 94 % learned more about the way technologies may transform society. Conclusions This study confirms the methodological feasibility of a deliberative intervention whose originality lies in its use of videos and online scenarios. To increase deliberative depth and foster a strong engagement by all participants, face-to-face and online components need to be well integrated. Our findings suggest that online tools should be designed by considering, one the one hand, the participants’ self-perceived ability to share written comments and, on the other hand, the ease with which other participants can respond to such contributions.Item Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies(Kerman University of Medical Sciences, 2017-01-25) Lehoux, Pascale; Miller, Fiona A; Daudelin, Geneviève; Denis, Jean-LouisAbstract Background: New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Methods: Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec’s (Canada) publicly funded healthcare system. Results: Entrepreneurs have a direct influence over a new technology’s value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the “double” value of a new technology —as a health intervention and as an economic commodity— and provide economic worth to the venture that is bringing the technology to market. Conclusion: Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy.Item Understanding relevance of health research: considerations in the context of research impact assessment(BioMed Central, 2017-04-17) Dobrow, Mark J; Miller, Fiona A; Frank, Cy; Brown, Adalsteinn DBackground: With massive investment in health-related research, above and beyond investments in the management and delivery of healthcare and public health services, there has been increasing focus on the impact of health research to explore and explain the consequences of these investments and inform strategic planning. Relevance is reflected by increased attention to the usability and impact of health research, with research funders increasingly engaging in relevance assessment as an input to decision processes. Yet, it is unclear whether relevance is a synonym for or predictor of impact, a necessary condition or stage in achieving it, or a distinct aim of the research enterprise. The main aim of this paper is to improve our understanding of research relevance, with specific objectives to (1) unpack research relevance from both theoretical and practical perspectives, and (2) outline key considerations for its assessment. Approach: Our approach involved the scholarly strategy of review and reflection. We prepared a draft paper based on an exploratory review of literature from various fields, and gained from detailed and insightful analysis and critique at a roundtable discussion with a group of key health research stakeholders. We also solicited review and feedback from a small sample of expert reviewers. Conclusions: Research relevance seems increasingly important in justifying research investments and guiding strategic research planning. However, consideration of relevance has been largely tacit in the health research community, often depending on unexplained interpretations of value, fit and potential for impact. While research relevance seems a necessary condition for impact – a process or component of efforts to make rigorous research usable – ultimately, relevance stands apart from research impact. Careful and explicit consideration of research relevance is vital to gauge the overall value and impact of a wide range of individual and collective research efforts and investments. To improve understanding, this paper outlines four key considerations, including how research relevance assessments (1) orientate to, capture and compare research versus non-research sources, (2) consider both instrumental versus non-instrumental uses of research, (3) accommodate dynamic temporal-shifting perspectives on research, and (4) align with an intersubjective understanding of relevanceItem Parent Experience With False-Positive Newborn Screening Results for Cystic Fibrosis(American Academy of Pediatrics, 2016-09) Hayeems, Robin Z; Miller, Fiona A; Barg, Carolyn J; Bombard, Yvonne; Kerr, Elizabeth; Tam, Karen; Carroll, June C; Potter, Beth K; Chakraborty, Pranesh; Davies, Christine; Milburn, Jennifer; Patton, Sarah; Bytautas, Jessica P; Taylor, Louise; Price, April; Gonska, Tanja; Keenan, Katherine; Ratjen, Felix; Guttmann, AstridBACKGROUND: The risk of psychosocial harm in families of infants with false-positive (FP) newborn bloodspot screening (NBS) results for cystic fibrosis (CF) is a longstanding concern. Whether well designed retrieval and confirmatory testing systems can mitigate risks remains unknown. METHODS: Using a mixed-methods cohort design, we obtained prospective self-report data from mothers of infants with FP CF NBS results 2 to 3 months after confirmatory testing at Ontario’s largest follow-up center, and from a randomly selected control sample of mothers of screen negative infants from the same region. Mothers completed a questionnaire assessing experience and psychosocial response. A sample of mothers of FP infants completed qualitative interviews. RESULTS: One hundred thirty-four mothers of FP infants (response rate, 55%) and 411 controls (response rate, 47%) completed questionnaires; 54 mothers of FP infants were interviewed. Selected psychosocial response measures did not detect psychosocial distress in newborns or 1 year later (P > .05). Mothers recalled distress during notification of the positive result and in the follow-up testing period related to fear of chronic illness, but valued the screening system of care in mitigating concerns. CONCLUSIONS: Although immediate distress was reported among mothers of FP infants, selected psychometric tools did not detect these concerns. The NBS center from which mothers were recruited minimizes delay between notification and confirmatory testing and ensures trained professionals are communicating results and facilitating follow-up. These factors may explain the presence of minimal psychosocial burden. The screening system reflected herein may be a model for NBS programs working to minimize FP-related psychosocial harm.Item Using Newborn Screening Bloodspots for Research: Public Preferences for Policy Options(American Academy of Pediatrics, 2016-06) Hayeems, Robin Z; Miller, Fiona A; Barg, Carolyn J; Bombard, Yvonne; Cressman, Celine; Painter-Main, Michael; Wilson, Brenda; Little, Julian; Allanson, Judith; Avard, Denise; Giguere, Yves; Chakraborty, Pranesh; Carroll, June COBJECTIVES: Retaining residual newborn screening (NBS) bloodspots for medical research remains contentious. To inform this debate, we sought to understand public preferences for, and reasons for preferring, alternative policy options. METHODS: We assessed preferences among 4 policy options for research use of residual bloodspots through a bilingual national Internet survey of a representative sample of Canadians. Fifty percent of respondents were randomly assigned to select reasons supporting these preferences. Understanding of and attitudes toward screening and research concepts, and demographics were assessed. RESULTS: Of 1102 respondents (94% participation rate; 47% completion rate), the overall preference among policy options was ask permission (67%); this option was also the most acceptable choice (80%). Assume permission was acceptable to 46%, no permission required was acceptable to 29%, and no research allowed was acceptable to 26%. The acceptability of the ask permission option was reduced among participants assigned to the reasoning exercise (84% vs 76%; P = .004). Compared with assume/no permission required, ordered logistic regression showed a significant reduction in preference for the ask permission option with greater understanding of concepts (odds ratio, 0.87; P < .001), greater confidence in science (odds ratio, 0.16; P < .001), and a perceived responsibility to contribute to research (odds ratio, 0.39; P < .001). CONCLUSIONS: Surveyed Canadians prefer that explicit permission is sought for storage and research use of NBS bloodspots. This preference was diminished when reasons supporting and opposing routine storage, and other policy options, were presented. Findings warrant consideration as NBS communities strategize to respond to shifting legislative contexts.Item Organizing the entrepreneurial hospital: Hybridizing the logics of healthcare and innovation(Elsevier, 2016) Miller, Fiona A.; French, MartinContemporary research hospitals occupy a vexed position in the policy landscape. On the one hand, as healthcare providers, they must abide by the logic of healthcare policy, which expects health research to support improved health outcomes and high quality healthcare systems. On the other hand, as research facilities, they are beholden to the logic of innovation policy, which seeks to advance research-driven, science and technology-derived innovations, where industry is the key customer and client. At the intersection of these policy logics, the research hospital must orchestrate a range of interests that may not always coexist harmoniously. Through a detailed case study of a Canadian research hospital, we illustrate organizational efforts to hybridize healthcare and innovation logics. The need to be more ‘business like’ and the expected financial and reputational rewards encourage acceptance of a mandate for technology transfer and commercialization. As well, there is hope that the entrepreneurial turn can serve the hospital's own mission, by prioritizing the needs of patients and the organization itself as a user of its own innovations. Further, insofar as successful technology transfer and commercialization is a transformative force, it is expected to enable the research hospital to achieve its goal of translational and impactful health research. As we illustrate, there is much optimism that these hybridizing efforts will produce a successful cross. Yet the trajectory of change in the context of mixed logics is necessarily uncertain, and other hybrid futures cannot be foreclosed. More sterile or monstrous outcomes remain possible, with potentially significant implications for the intellectual, economic and health benefits that will arise as a result.Item Psychosocial Response to Uncertain Newborn Screening Results for Cystic Fibrosis(Elsevier, 2017-05) Hayeems, Robin Z; Miller, Fiona A; Barg, Carolyn J; Bombard, Yvonne; Carroll, June C; Tam, Karen; Kerr, Elizabeth; Chakraborty, Pranesh; Potter, Beth K; Patton, Sarah; Bytautas, Jessica P; Taylor, Louise; Davies, Christine; Milburn, Jennifer; Price, April; Gonska, Tanja; Keenan, Katherine; Ratjen, Felix; Guttmann, AstridTo explore the psychosocial implications of diagnostic uncertainty that result from inconclusive results generated by newborn bloodspot screening (NBS) for cystic fibrosis (CF).Item Credibility of Health Information and Digital Media: New Perspectives and Implications for Youth(2007-08-12T15:34:32Z) Eysenbach, GuntherIn this book chapter from the volume "Digital Media, Youth, and Credibility" (part of the MacArthur Foundation Series on Digital Media and Learning), Gunther Eysenbach considers the role of web technologies on the availability and consumption of health information. He notes that, contrary to some well-publicized surveys of individuals’ health information seeking behaviors, the actual incidence of health-related searches on the Internet is much lower than most estimates. Thus, although many people have sought health information online, virtually nobody does so frequently. The implication is that people, and especially young people, are largely unfamiliar with trusted health sources online, making credibility particularly germane when considering online health information. Eysenbach argues that as information consumers use these tools to participate more in their own health choices and decisions, humans and technologies act as new intermediaries—or “apomediaries”—that “stand by” and steer consumers to high quality information. He concludes by highlighting the credibility implications of this paradigm shift and demonstrating how it can empower health information seekers of all ages.Item The FA4CT Algorithm: A New Model and Tool for Consumers to Assess and Filter Health Information on the Internet(2007) Eysenbach, Gunther ; Thomson, MariaBackground: eHealth-literate consumers, consumers able to navigate and filter credible information on the Internet, are an important cornerstone of sustainable health systems in the 21st century. Various checklists and tools for consumers to assess the quality of health information on the Internet have been proposed, but most fail to take into account the unique prop-erties of a networked digital environment. Method: A new educational model and tool for assessing information on the Internet has been designed and pilot tested with consumers. The new proposed model replaces the “traditional” static questionnaire/checklist/rating approach with a dynamic, process-oriented approach, which emphasizes three steps con-sumers should follow when navigating the Internet. FA4CT (or FACCCCT) is an acronym for these three steps: 1) Find Answers and Compare [information from different sources], 2) Check Credibility [of sources, if conflicting information is provided], 3) Check Trustworthiness (Reputation) [of sources, if conflicting information is provided]. In contrast to existing tools, the unit of evaluation is a “fact” (i.e. a health claim), rather than a webpage or website. Results: Formative evalua-tions and user testing suggest that the FA4CT model is a reli-able, valid, and usable approach for consumers. Conclusion: The algorithm can be taught and used in educational interven-tions (“Internet schools” for consumers), but can also be a foundation for more sophisticated tools or portals, which automate the evaluation according to the FA4CT algorithm..Item Voice-related quality of life (V-RQOL) following type I thyroplasty for unilateral vocal fold paralysis(Elsevier, 2000-09) Hogikyan, N ; Wodchis, Walter P ; Terrell, J E ; Bradford, C R ; Esclamado, R MUnilateral vocal fold paralysis is a common clinical problem which frequently causes severe dysphonia. Various treatment options exist for this con- dition, with the type I thyroplasty being one of the more commonly performed surgical procedures for vocal rehabilitation. The Voice-Related Quality of Life (V- RQOL) Measure is a validated outcomes instrument for voice disorders. This study measured the V-RQOL of patients with unilateral vocal fold paralysis who had undergone a type I thyroplasty and compared these scores to those of patients with untreated and uncompensated unilateral vocal fold paralysis and to normals. Treated patients had significantly higher domain and overall V-RQOL scores than untreated patients, but also scored lower than normals. These differences were true across gender and age. Patients who were more distant from surgery had lower V- RQOL scores than those who had more recently been treated. It is concluded that type I thyroplasty leads to a significantly higher V-RQOL for patients with unilateral vocal fold paralysis. This study also demonstrates further the utility of patient- oriented measures of treatment outcome.Item Longitudinal effects of botulinum toxin injections on voice-related quality of life (V-RQOL) for patients with adductory spasmodic dysphonia(Elsevier, 2003-04) Hogikyan, N ; Wodchis, Walter P ; Spak, C ; Kileny, P RAdductory spasmodic dysphonia is a focal dystonia of laryngeal muscles. Patients with this disorder typically have severe vocal difficulties, with significant functional, social, and emotional consequences. There is no widely accepted cure for this condition, however, botulinum toxin injections of the thyroarytenoid muscles are considered by most voice clinicians to be the state of the art treatment. Based on extensive experience treating patients for adductory spasmodic dysphonia, we feel that traditional means of voice assessment do not adequately measure either the disease severity or the treatment outcomes. That is, listening to or acoustically analyzing limited phonatory samples does not capture the functional, social, and emotional consequences of this disorder. These consequences will be reflected in a patient's voice-related quality of life (V-RQOL). Using a validated voice outcomes instrument, the V-RQOL Measure, the purpose of this study was to quantify longitudinal changes in the V-RQOL of patients with adductory spasmodic dysphonia who are undergoing botulinum toxin injections. Twenty-seven consecutive new patients presenting with dysphonia to our institution during an 18-month period were diagnosed with adductory spasmodic dysphonia, and treated patients were evaluated prospectively using the V-RQOL Measure. Results indicated that (1) V-RQOL was initially very low for these patients, (2) botulinum toxin injections improved it significantly for each injection cycle studied, and (3) the magnitude of the treatment effect appears to change across injections.Item The effect of Medicare’s prospective payment system on discharge outcomes of skilled nursing facility residents(Excellus, 2004-12) Wodchis, Walter P ; Fries, B F ; Hirth, R AIn July 1998, the Centers for Medicare and Medicaid Services (CMS) changed the payment method for Medicare (Part A) skilled nursing facility (SNF) care from a cost-based system to a prospective payment system (PPS). Unlike the previous cost-based payment system, PPS restricts skilled nursing facility payment to pre-determined levels. CMS also reduced the total payments to SNFs coincident with PPS implementation. These changes might reduce quality of care at skilled nursing facilities and could be reflected in resident discharge patterns. The present study examines the effect of the 1998 policy change on resident discharge outcomes. The results indicate that PPS reduced the relative risk of discharge to home and to death for Medicare residents (compared to non-Medicare residents) and had no significant effect on hospitalizations or transfers.Item Variations in geographical distribution of foreign and domestically trained physicians in the United States: ‘safety nets’ or ‘surplus exacerbation’?(Elsevier, 1999-10) Mick, S S ; Lee, S-Y D ; Wodchis, Walter PIn the United States. a debate has existed for decades about whether foreign-trained physicians (known in the US as ‘international medical graduates’ or ‘IMGs’) and US medical graduates (USMGs) have been differentially distributed such that IMGs were more likely to be found in locales characterized as high in need or medical underservice. This ‘safety net’ hypothesis has been countered by the IMG ‘surplus exacerbation’ argument that IMGs have simply swelled an already abundant supply of physicians without any disproportionate service to areas in need. Through an analysis of the American Medical Association Physician Masterfile and the Area Resource File, we classified post-resident IMGs and USMGs into low and high need counties in each of the US states, compared the percentage distributions, and determined whether IMGs were found disproportionately in high need or underserved counties. Using four measures (infant mortality rate, socio-economic status, proportion non-white population, and rural county designation), we show that there were consistently more states having IMG disproportions than USMG disproportions. The magnitude of the differences was greater for IMGs than for USMGs, and there was a correlation between IMG disproportions and low doctor/100,000 population ratios. These findings are shown to exist simultaneously with two empirical facts: first, not all IMGs were located in high new or underserved counties; second, IMGs were more likely than USMGs to be located in states with a large number of physicians. The juxtaposition of an IMG presence in ‘safety net’ locales and of IMGs' contribution to a physician abundance is discussed within the context of the current debate about a US physician ‘surplus’ and initiatives to reduce the number of IMGs in residency training.