Institute of Health Policy Management and Evaluation
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The Institute of Health Policy, Management and Evaluation (IHPME) is the leading source for innovative thinking in health policy, management and evaluation. HPME brings together experts from wide variety of disciplines - health policy, organizational management, economics, law, clinical epidemiology, sociology, political science and information technology - to address the challenges facing the health care system. A recognized leader in research, HPME is committed to translating innovative ideas into practices that improve health care.
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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 Applying activity based costing in long term care(Canadian College of Health Service Executives, 1998-11) Wodchis, Walter PAs greater numbers of elderly use health services and health care costs climb, effective financial tracking is an essential activity. Cost management in health care can benefit if costs are linked to the care activities where they are incurred. Activity based costing (ABC) provides a useful approach. The framework aligns costs (inputs) through activities (process) to outputs and outcomes. It allocates costs based on client care needs rather than management structure. The ABC framework was tested in a residential care facility and in supportive housing apartments. The results demonstrate the feasibility and advantages of ABC for long term care agencies, including community based care.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 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 Atypical antipschotic drugs and risk of ischemic storke: population based retrospective cohort study(BMJ Publishing Group Limited, 2005-01) Gill, S.S. ; Rochon, P.A. ; Herrmann, N. ; Lee, P.E. ; Sykora, K. ; Gunraj, N. ; Normand, S-L. T. ; Gurwitz, J.H. ; Marras, C. ; Wodchis, W.P ; Mamdani, M.Objective To compare the incidence of admissions to hospital for stroke among older adults with dementia receiving atypical or typical antipsychotics. Design Population based retrospective cohort study. Setting Ontario, Canada. Patients 32 710 older adults ( ≥ 65 years) with dementia (17 845 dispensed an atypical antipsychotic and 14 865 dispensed a typical antipsychotic). Main outcome measures Admission to hospital with the most responsible diagnosis (single most important condition responsible for the patient’s admission) of ischaemic stroke. Observation of patients until they were either admitted to hospital with ischaemic stroke, stopped taking antipsychotics, died, or the study ended. Results After adjustment for potential confounders, participants receiving atypical antipsychotics showed no significant increase in risk of ischaemic stroke compared with those receiving typical antipsychotics (adjusted hazard ratio 1.01, 95% confidence interval 0.81 to 1.26). This finding was consistent in a series of subgroup analyses, including ones of individual atypical antipsychotic drugs (risperidone, olanzapine, and quetiapine) and selected subpopulations of the main cohorts. Conclusion Older adults with dementia who take atypical antipsychotics have a similar risk of ischaemic stroke to those taking typical antipsychotics.Item Atypical antipsychotic drugs and risk of ischaemic stroke: population based retrospective cohort study(BMJ publish group, 2005-02) Gill, Sudeep S ; Rochon, P.A ; Herrmann, N ; Lee, P E ; Sykora, K ; Gunraj, N ; Normand, S L ; Gurwitz, J H ; Marras, C ; Wodchis, Walter P ; Mamdani, MObjective To compare the incidence of admissions to hospital for stroke among older adults with dementia receiving atypical or typical antipsychotics. Design Population based retrospective cohort study. Setting Ontario, Canada. Patients 32 710 older adults ( ≥ 65 years) with dementia (17 845 dispensed an atypical antipsychotic and 14 865 dispensed a typical antipsychotic). Main outcome measures Admission to hospital with the most responsible diagnosis (single most important condition responsible for the patient’s admission) of ischaemic stroke. Observation of patients until they were either admitted to hospital with ischaemic stroke, stopped taking antipsychotics, died, or the study ended. Results After adjustment for potential confounders, participants receiving atypical antipsychotics showed no significant increase in risk of ischaemic stroke compared with those receiving typical antipsychotics (adjusted hazard ratio 1.01, 95% confidence interval 0.81 to 1.26). This finding was consistent in a series of subgroup analyses, including ones of individual atypical antipsychotic drugs (risperidone, olanzapine, and quetiapine) and selected subpopulations of the main cohorts. Conclusion Older adults with dementia who take atypical antipsychotics have a similar risk of ischaemic stroke to those taking typical antipsychotics.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 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 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 Health-related quality of life measure based on the minimum data set(Cambridge University Press, 2003-08) Wodchis, Walter P ; Hirdes, John P ; Feeny, David HObjectives: To introduce a health-related quality of life measure for home care and institutional longterm care settings based on the Minimum Data Set (MDS) and the Health Utilities Index Mark 2 (HUI2). Methods: Health attributes of Health Related Quality of Life (HRQOL) were identified, and suitable constructs were determined. Items from the MDS were mapped to the HUI2. Scores for the Minimum Data Set Health Status Index (MDS-HSI) were calculated using the HUI2 scoring function. Measurement properties are examined and reported. HRQOL scores were compared across study populations and to an external reference population. Random samples were drawn from long-term care clients in private households (n=377), supportive housing apartments (n=80), two residential care facilities (n=166), and a chronic care hospital (n=274) in Ontario, Canada. All sampled residents were assessed for health-related items using the MDS. Results: The MDS-HSI results provide preliminary evidence of good validity. Institutional populations had lower overall HRQOL scores than community populations. Comparisons to existing Canadian national data support construct validity. Conclusions: The MDS-HSI provides a summary outcome measure and an indicator of health status in the six supporting attributes. Longitudinal research is required to assess the sensitivity of the measure to changes over time. Further research is also required to establish the consistency between the preference weights used in this application of the HUI2 and those thatwould be derived from a frail elderly populationItem Longitudinal effects of botox injections on voice-related quality of life (V-RQOL) for patients with adductory spasmodic dysphonia (part II)(American Medical Association, 2001-12) Rubin, A ; Wodchis, Walter P ; Spak, C ; Kileny, P R ; Hogikyan, N DObjective: To investigate the longitudinal effects of botulinum toxin type A (Botox) injections on voice-related quality of life (V-RQOL) for patients with adductory spasmodic dysphonia. Design: Prospective study. Setting: Academic tertiary care referral center. Participants: Forty-two patients who presented to our institution with dysphonia and were diagnosed as having adductory spasmodic dysphonia during a 38-month period. Intervention: Patients received Botox injections into both thyroarytenoid muscles via the cricothyroid membrane. The typical starting dose was 1.0 U per vocal fold. If necessary, the dosage was adjusted in subsequent injections to reduce adverse effects or to enhance duration of benefit. Main Outcome Measures: Patients filled out questionnaires, including the V-RQOL Measure and a selfassessed overall voice rating, before each injection. Postinjection questionnaires were completed 6 to 8 weeks after each treatment. Mean pretreatment and posttreatment scores were calculated for each treatment. Results: The number of treatments per patient ranged from 1 to 7. Statistically significant improvements in mean total and domain V-RQOL scores were calculated for every injection (P.01) (no postinjection questionnaires were available for the seventh injections). The magnitude of the effect remained constant for later injections. Eighty-two percent of the population recorded at least 1 category of improvement in overall self-assessed voice rating with each injection. Conclusions: Botox has a significant beneficial effect on V-RQOL for at least 6 injection cycles. This study demonstrates the efficacy of Botox for treating patients with adductory spasmodic dysphonia and further illustrates the usefulness and validity of the V-RQOL Measure in evaluating patients with dysphonia.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 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 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 A national study showed that diagnoses varied by age group in nursing home residents under age 65(Elsevier, 2005-02) Fries, Brant E ; Wodchis, Walter P ; Blaum, Caroline ; Buttar, Amna ; Drabek, John ; Morris, John NObjective: It is commonly held that those aged <65 in nursing homes (NHs) are substantially different from elderly residents. This study uses data gathered using the Resident Assessment Instrument’s Minimum Data Set (MDS) to describe these relatively rare residents. STUDY DESIGN AND SETTING, RESULTS, CONCLUSION Data: The study uses MDS assessments of close to three-quarter million residents in nine states from 1994-6. An algorithm resolved potentially incorrect ages caused by confusion between residents age < 15 from those 100-115. Methods: Residents are described within chronological age group (0-4, 5-14, etc.). Functional status, prevalence of chronic conditions and treatments are described for each group. Co-morbidity is examined using factor analyses and cross-tabulations. Results: Overall, pediatric residents appear substantially more physically and cognitively impaired than young adult residents. The youngest population primarily has diagnoses related to mental retardation and developmental disabilities, young adults have the highest prevalence of hemi- and quadriplegia, while older residents are typified by increasing prevalence of neurological diagnoses and more co-morbid conditions. Thirteen diagnostic factors describe nearly 85% of all NH residents and highlights differences between age groups. Conclusions: This study offers a first description of nearly all NH residents <65. The classification demonstrates significant differences within this population and between these residents and those 65+.Item Nursing home profit status and quality of care: is there any evidence of an association?(SAGE publications, 2005-04) Hillmer, Michael P; Wodchis, Walter P; Gill, Sudeep S; Anderson, Geoffrey M; Rochon, Paula AObjective: To perform a systematic review examining the association between the profit status of North American nursing homes and the quality of care. Data Sources: Studies were identified by searching MEDLINE (January 1990 – October 2002), reference lists, letters, commentaries, and editorials. Data Extraction: The quality indicator(s) used to measure quality of care, and its relationship to profit status was extracted from each publication. The study design and risk-adjustment methodologies utilized were also extracted. The inter-rater reliability for these three items was determined to be 1.0, 0.6, and 0.8, respectively. Data Synthesis: A qualitative systematic review was performed using Donabedian’s framework of structure, process and outcome for analyzing medical quality of care. Conclusions: Empirical research in the past 12 years has found that systematic differences exist between for-profit and not-for-profit nursing homes. For-profit nursing homes appear to provide lower quality of care in many important areas of process and outcome.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 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 Payer incentives and physical rehabilitation therapy for non-elderly institutional long-term care residents: evidence from Michigan and Ontario.(Elsevier, 2004-02) Wodchis, Walter P. ; Fries, Brant E. ; Pollack, HaroldObjective: The purpose of this study is to examine the effect of payment incentives on the provision rehabilitation therapy to non-elderly nursing home residents. Design: Retrospective cross-sectional study. Participants and Setting: All non-elderly nursing home residents admitted to nursing homes in Michigan, U.S.A. or Complex Continuing Care facilities in Ontario, Canada in 1998 or 1999 (n=5,189) Main Outcome: The focus for the present study is the effect of payment on access to physical therapy (PT) and occupational therapy (OT) and total weekly therapy time for each therapy type. Results: A Medicare policy change from cost-based to a patient-specific case-mix payment method was associated with greater likelihood of receiving OT but reduced weekly minutes of PT and OT provided to residents. Medicare cost-based and private-insurance was associated with greater likelihood of receiving OT and PT and more therapy time for both types of therapy compared to private-pay residents. Global budget payment was associated with greater access to PT but less weekly minutes of OT and PT . Conclusions: Little information exists to describe the characteristics and treatment of non-elderly nursing home residents. This study finds that many of these residents receive rehabilitation and that residents whose care is paid for by more generous payers such as Medicare receive more therapy than those paid for by less generous payers.Item Physical rehabilitation following Medicare prospective payment for skilled nursing(Blackwell Publishing, 2004-10) Wodchis, Walter PObjective: To examine the effect of the Medicare prospective payment system (PPS) for Skilled Nursing Facilities (SNF) on the delivery of rehabilitation therapy to residents. Data Sources: Resident-level data are based on the Resident Assessment Instrument Minimum Data Set for nursing facilities. All elderly residents admitted to SNFs in Michigan and Ohio in 1998 and 1999 form the study population (n= 99,952). Study Design: A differences-in-differences identification strategy is used to compare rehabilitation therapy for SNF residents before and after a change in Medicare SNF payment. Logistic and linear regression analyses are used to examine the effect of PPS on receipt of physical, occupational, or speech therapy and total therapy time. Data Extraction: Data for the present study were extracted from the University of Michigan Assessment Archive Project (UMAAP). One assessment was obtained for each resident admitted to nursing facilities during the study period. Principal Findings: The introduction of PPS for all U.S. Medicare residents in July of 1998 was associated with specific targeting of rehabilitation treatment time to the most profitable levels of therapy. PPS was also associated with increased likelihood of therapy but less rehabilitation therapy time for Medicare residents. Conclusions: The present results indicate that rehabilitation therapy is sensitive to the specific payment incentives associated with PPS.