Performance of methods for analyzing continuous data from stratified cluster randomized trials - A simulation study.

Background: The adoption of cluster randomized trials (CRTs) with the stratified design is currently gaining widespread interest. In the stratified design, clusters are first grouped into two or more strata and then randomized into treatment groups within each stratum. In this study, we evaluated the performance of several commonly used methods for analyzing continuous data from stratified CRTs. Methods: This is a simulation study where we compared four methods: mixed-effects, generalized estimating equation (GEE), cluster-level (CL) linear regression and meta-regression methods to analyze the continuous data from stratified CRTs using a simulation study with varying numbers of clusters, cluster sizes, intra-cluster correlation coefficients (ICCs) and effect sizes. This study was based on a stratified CRT with one stratification variable with two strata. The performance of the methods was evaluated in terms of the type I error rate, empirical power, root mean square error (RMSE), and width and coverage of the 95% confidence interval (CI). Results: GEE and meta-regression methods had high type I error rates, higher than 10%, for the small number of clusters. All methods had similar accuracy, measured through RMSE, except meta-regression. Similarly, all methods but meta-regression had similar widths of 95% CIs for the small number of clusters. For the same sample size, the empirical power for all methods decreased as the value of the ICC increased. Conclusion: In this study, we evaluated the performance of several methods for analyzing continuous data from stratified CRTs. Meta-regression was the least efficient method compared to other methods.

Team approach to polypharmacy evaluation and reduction: feasibility randomized trial of a structured clinical pathway to reduce polypharmacy.

BACKGROUND: Polypharmacy is associated with poorer health outcomes in older adults. Other than the associated multimorbidity, factors contributing to this association could include medication adverse effects and interactions, difficulties in managing complicated medication regimes, and reduced medication adherence. It is unknown how reversible these negative associations may be if polypharmacy is reduced. The purpose of this study was to determine the feasibility of implementing an operationalized clinical pathway aimed to reduce polypharmacy in primary care and to pilot measurement tools suitable for assessing change in health outcomes in a larger randomized controlled trial (RCT). METHODS: We randomized consenting patients ≥ 70 years old on ≥ 5 long-term medications into intervention or control groups. We collected baseline demographic information and research outcome measures at baseline and 6 months. We assessed four categories of feasibility outcomes: process, resource, management, and scientific. The intervention group received TAPER (team approach to polypharmacy evaluation and reduction), a clinical pathway for reducing polypharmacy using "pause and monitor" drug holiday approach. TAPER integrates patients' goals, priorities, and preferences with an evidence-based "machine screen" to identify potentially problematic medications and support a tapering and monitoring process, all supported by a web-based system, TaperMD. Patients met with a clinical pharmacist and then with their family physician to finalize a plan for optimization of medications using TaperMD. The control group received usual care and were offered TAPER after follow-up at 6 months. RESULTS: All 9 criteria for feasibility were met across the 4 feasibility outcome domains. Of 85 patients screened for eligibility, 39 eligible patients were recruited and randomized; two were excluded post hoc for not meeting the age requirement. Withdrawals (2) and losses to follow-up (3) were small and evenly distributed between arms. Areas for intervention and research process improvement were identified. In general, outcome measures performed well and appeared suitable for assessing change in a larger RCT. CONCLUSIONS: Results from this feasibility study indicate that TAPER as a clinical pathway is feasible to implement in a primary care team setting and in an RCT research framework. Outcome trends suggest effectiveness. A large-scale RCT will be conducted to investigate the effectiveness of TAPER on reducing polypharmacy and improving health outcomes. TRIAL REGISTRATION: clinicaltrials.gov NCT02562352 , Registered September 29, 2015.

Linking Patients' Goals and Priorities to Recommendations for Medication Changes in a Polypharmacy-Focused Structured Clinical Pathway.

Polypharmacy is associated with poorer health outcomes in older adults. It is challenging to minimize the harmful effects of medications while maximizing benefits of single-disease-focused recommendations. Integrating patient input can balance these factors. The objectives are to describe the goals, priorities, and preferences of participants asked about these in a structured process to polypharmacy, and to describe the extent that decision-making within the process mapped onto these, signaling a patient-centered approach. This is a single-group quasi-experimental study, nested within a feasibility randomized controlled trial. Patient goals and priorities were mapped to medication recommendations made during the intervention. Overall, there were 33 participants who reported 55 functional goals and 66 symptom priorities, and 16 participants reported unwanted medications. Overall, 154 recommendations for medication alterations occurred. Of those, 68 (44%) recommendations mapped to the individual's goals and priorities, whereas the rest were based on clinical judgment where no priorities were expressed. Our results signal this process supports a patient-centered approach: allowing conversations around goals and priorities in a structured process to polypharmacy should be integrated into subsequent medication decisions.

Persistent COVID-19 symptoms in community-living older adults from the Canadian Longitudinal Study on Aging (CLSA).

BACKGROUND: Symptom persistence in non-hospitalized COVID-19 patients, also known as Long COVID or Post-acute Sequelae of COVID-19, is not well characterized or understood, and few studies have included non-COVID-19 control groups. METHODS: We used data from a cross-sectional COVID-19 questionnaire (September-December 2020) linked to baseline (2011-2015) and follow-up (2015-2018) data from a population-based cohort including 23,757 adults 50+ years to examine how age, sex, and pre-pandemic physical, psychological, social, and functional health were related to the severity and persistence of 23 COVID-19-related symptoms experienced between March 2020 and questionnaire completion. RESULTS: The most common symptoms are fatigue, dry cough, muscle/joint pain, sore throat, headache, and runny nose; reported by over 25% of participant who had (n = 121) or did not have (n = 23,636) COVID-19 during the study period. The cumulative incidence of moderate/severe symptoms in people with COVID-19 is more than double that reported by people without COVID-19, with the absolute difference ranging from 16.8% (runny nose) to 37.8% (fatigue). Approximately 60% of male and 73% of female participants with COVID-19 report at least one symptom persisting >1 month. Persistence >1 month is higher in females (aIRR = 1.68; 95% CI: 1.03, 2.73) and those with multimorbidity (aIRR = 1.90; 95% CI: 1.02, 3.49); persistence >3 months decreases by 15% with each unit increase in subjective social status after adjusting for age, sex and multimorbidity. CONCLUSIONS: Many people living in the community who were not hospitalized for COVID-19 still experience symptoms 1- and 3-months post infection. These data suggest that additional supports, for example access to rehabilitative care, are needed to help some individuals fully recover.

Some people who develop COVID-19 experience persistence of symptoms. Here, we aimed to understand the factors associated with the severity and persistence of these symptoms in adults 50 years and older living in the community who had COVID-19. Using information provided by 23,757 participants from across Canada we compared the symptoms between those who had COVID-19 and those who did not. The number and severity of symptoms in participants who had COVID-19 was beyond what would be expected due to other causes. Over two-thirds of participants who had COVID-19 reported symptoms persisting for more than one month, and over half of the participants more than three months. Symptom persistence was higher in females, those with multiple chronic conditions, and lower perceived social status. This suggests that a substantial proportion of people who were not hospitalized for COVID-19 may require further healthcare assistance.

Health TAPESTRY Ontario: A Multi-Site Randomized Controlled Trial Testing Implementation and Reproducibility.

PURPOSE: Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a complex primary care program aimed at assisting older adults to stay healthier for longer. This study evaluated the feasibility of implementation across multiple sites, and the reproducibility of the effects found in the previous randomized controlled trial. METHODS: This was a pragmatic, unblinded, 6-month parallel group randomized controlled trial. Participants were randomized (intervention or control) using a computer-generated system. Eligible patients, aged 70 years and older, were rostered to 1 of 6 participating interprofessional primary care practices (urban and rural). In total, 599 (301 intervention, 298 control) patients were recruited from March 2018 through August 2019. Intervention participants received a home visit from volunteers to collect information on physical and mental health, and social context. An interprofessional care team created and implemented a plan of care. The primary outcomes were physical activity and number of hospitalizations. RESULTS: Based on the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, Health TAPESTRY had widespread reach and adoption. In the intention-to-treat analysis (257 intervention, 255 control), there were no statistically significant between-group differences for hospitalizations (incidence rate ratio = 0.79; 95% CI, 0.48-1.30; P = .35) or total physical activity (mean difference = -0.26; 95% CI, -1.18 to 0.67; P = .58). There were 37 non-study related serious adverse events (19 intervention, 18 control). CONCLUSIONS: We found Health TAPESTRY was successfully implemented for patients in diverse primary care practices; however, implementation did not reproduce the effect on hospitalizations and physical activity found in the initial randomized controlled trial.

Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers : A Randomized Trial.

BACKGROUND: It is uncertain if medical masks offer similar protection against COVID-19 compared with N95 respirators. OBJECTIVE: To determine whether medical masks are noninferior to N95 respirators to prevent COVID-19 in health care workers providing routine care. DESIGN: Multicenter, randomized, noninferiority trial. (ClinicalTrials.gov: NCT04296643). SETTING: 29 health care facilities in Canada, Israel, Pakistan, and Egypt from 4 May 2020 to 29 March 2022. PARTICIPANTS: 1009 health care workers who provided direct care to patients with suspected or confirmed COVID-19. INTERVENTION: Use of medical masks versus fit-tested N95 respirators for 10 weeks, plus universal masking, which was the policy implemented at each site. MEASUREMENTS: The primary outcome was confirmed COVID-19 on reverse transcriptase polymerase chain reaction (RT-PCR) test. RESULTS: In the intention-to-treat analysis, RT-PCR-confirmed COVID-19 occurred in 52 of 497 (10.46%) participants in the medical mask group versus 47 of 507 (9.27%) in the N95 respirator group (hazard ratio [HR], 1.14 [95% CI, 0.77 to 1.69]). An unplanned subgroup analysis by country found that in the medical mask group versus the N95 respirator group RT-PCR-confirmed COVID-19 occurred in 8 of 131 (6.11%) versus 3 of 135 (2.22%) in Canada (HR, 2.83 [CI, 0.75 to 10.72]), 6 of 17 (35.29%) versus 4 of 17 (23.53%) in Israel (HR, 1.54 [CI, 0.43 to 5.49]), 3 of 92 (3.26%) versus 2 of 94 (2.13%) in Pakistan (HR, 1.50 [CI, 0.25 to 8.98]), and 35 of 257 (13.62%) versus 38 of 261 (14.56%) in Egypt (HR, 0.95 [CI, 0.60 to 1.50]). There were 47 (10.8%) adverse events related to the intervention reported in the medical mask group and 59 (13.6%) in the N95 respirator group. LIMITATION: Potential acquisition of SARS-CoV-2 through household and community exposure, heterogeneity between countries, uncertainty in the estimates of effect, differences in self-reported adherence, differences in baseline antibodies, and between-country differences in circulating variants and vaccination. CONCLUSION: Among health care workers who provided routine care to patients with COVID-19, the overall estimates rule out a doubling in hazard of RT-PCR-confirmed COVID-19 for medical masks when compared with HRs of RT-PCR-confirmed COVID-19 for N95 respirators. The subgroup results varied by country, and the overall estimates may not be applicable to individual countries because of treatment effect heterogeneity. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research, World Health Organization, and Juravinski Research Institute.

Randomised trial of a serious illness decision aid (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning.

OBJECTIVE: To evaluate the feasibility and efficacy of a serious illness decision aid (Plan Well Guide) in increasing the engagement of substitute decision-makers (SDM) in advance care planning (ACP). METHODS: This trial was conducted (2017-2019) in outpatient settings in Ontario, Canada, aiming to recruit 90 dyads of patients aged 65 years and older at high risk of needing future medical decisions and their SDM. Participants were randomised to receive the intervention immediately or to a 3-month wait period. The Plan Well Guide was administered to the patient and SDM by a facilitator. Outcomes were change on the validated 17-item SDM ACP Engagement Survey (primary) and 15-item patient ACP Engagement Survey (secondary). RESULTS: Of 136 dyads approached, 58 consented and were randomised and 45 completed the study (28 immediate intervention, 17 delayed intervention). The trial was stopped early because of difficulties with enrolling and following up participants. The mean changes on the SDM ACP Engagement Survey and the patient ACP Engagement Survey favoured the first group but were not statistically significant (mean difference (MD)=+0.2 (95% CI: -0.3 to 0.6) and MD=+0.4 (95% CI: -0.1 to 0.8), respectively). In a post-hoc subgroup analysis, significant treatment effects were seen in SDMs with a lower-than-median baseline score compared with those at or above the median. CONCLUSIONS: In this statistically underpowered randomised trial, differences in SDM ACP engagement between groups were small. Further information is needed to overcome recruitment challenges and to identify people most likely to benefit from the Plan Well Guide.Trial registration number NCT03239639.

Evaluation of a Modified SBAR Report to Physician Tool to Standardize Communication on Neonatal Transport.

OBJECTIVE: SBAR (situation, background, assessment and recommendation) is a structured format for the effective communication of critically relevant information. This tool was developed as a generic template to provide structure to the communication of clinical information between health care providers. Neonatal transport often presents clinically stressful circumstances where concise and accurate information is required to be shared clearly between multidisciplinary health care providers. A modified SBAR communication tool was designed to facilitate structured communication between nonphysician bedside care providers operating from remote sites and physicians providing decision-making support at receiving care facilities. Prospective interventional study was designed to evaluate the reliability of a "SBAR report to physician tool" in sharing clinically relevant information between multidisciplinary care providers on neonatal transport. STUDY DESIGN: The study was conducted between 2011 and 2014 by a dedicated neonatal transport service based at McMaster Children's Hospital which provides care for approximately 500 infants in Southern Ontario annually. In the preintervention phase, 50 calls were randomly selected for the evaluation and 115 consecutively recorded transport calls following adoption of the reporting tool. The quality of calls prior to and after the intervention was assessed by reviewers independently. Inter-rater agreement was also assessed for both periods. RESULTS: Inter-rater agreement between raters was moderate to perfect in most components of the SBAR "report to the physician tool" except for the assessment component, which showed fair agreement during both preintervention and postintervention periods. There was an improvement in global score (primary outcome) with a mean difference of 0.95 (95% confidence interval [CI]: 0.77-1.14; p < 0.001) and in cumulative score with a mean difference of 8.55 (95% CI: 7.26-9.84; p < 0.001) in postintervention period. CONCLUSION: The use of the SBAR report to physician tool improved the quality of clinical information shared between nonphysician members of the neonatal transport team and neonatal transport physicians. KEY POINTS: · Long-Accurate and concise information sharing is crucial for decision-making in neonatal transport.. · Information sharing between multidisciplinary teams can be enhanced by using a commonly understood information sharing template.. · The SBAR report to physician tool improves the quality of information shared between multidisciplinary team members in neonatal transport..

Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial.

BACKGROUND: Polypharmacy in older adults can be associated with negative outcomes including falls, impaired cognition, reduced quality of life, and general and functional decline. It is not clear to what extent these are reversible if the number of medications is reduced. Primary care does not have a systematic approach for reducing inappropriate polypharmacy, and there are few, if any, approaches that account for the patient's priorities and preferences. The primary objective of this study is to test the effect of TAPER (Team Approach to Polypharmacy Evaluation and Reduction), a structured operationalized clinical pathway focused on reducing inappropriate polypharmacy. TAPER integrates evidence tools for identifying potentially inappropriate medications, tapering, and monitoring guidance and explicit elicitation of patient priorities and preferences. We aim to determine the effect of TAPER on the number of medications (primary outcome) and health-related outcomes associated with polypharmacy in older adults. METHODS: We designed a multi-center randomized controlled trial, with the lead implementation site in Hamilton, Ontario. Older adults aged 70 years or older who are on five or more medications will be eligible to participate. A total of 360 participants will be recruited. Participants will be assigned to either the control or intervention arm. The intervention involves a comprehensive multidisciplinary medication review by pharmacists and physicians in partnership with patients. This review will be focused on reducing medication burden, with the assumption that this will reduce the risks and harms of polypharmacy. The control group is a wait list, and control patients will be given appointments for the TAPER intervention at a date after the final outcome assessment. All patients will be followed up and outcomes measured in both groups at baseline and 6 months. DISCUSSION: Our trial is unique in its design in that it aims to introduce an operationalized structured clinical pathway aimed to reduce polypharmacy in a primary care setting while at the same time recording patient's goals and priorities for treatment. TRIAL REGISTRATION: Clinical Trials.gov NCT02942927. First registered on October 24, 2016.

Comprehensive Care Management in Conjunction with Sputum Cytometry-Guided Pharmacotherapy in a Post-Discharge Clinic for Patients with COPD.

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are amongst the most common reasons for hospital admission, and recurrent episodes occur frequently. Comprehensive care management (CCM) strategies have modest effect in preventing re-admissions. The objectives of this study were to examine the utility of optimizing anti-inflammatory therapy guided by sputum cytometry in the post-hospitalization setting, and to assess the feasibility and effectiveness of a clinic combining CCM and sputum-guided therapy. This is an observational study examining patients who received open-label CCM and sputum cytometry-guided pharmacotherapy in a COPD post-discharge clinic. Referral was based on high risk for readmission after hospitalization for AECOPD. The primary outcome was the change in COPD-related healthcare utilization before and after Visit 1, and this was analyzed with a mixed-effects negative binomial model controlling for age, number of follow-up clinic visits, pack years, current smoking and FEV1. Of 138 patients referred to the clinic, 73% attended at least one visit. Mean FEV1 was 42.8 (19.3) % predicted. Of the patients attending clinic, 42.6% produced an adequate sputum sample, and 32.7% had an abnormal sputum. By individual, infectious bronchitis was the most common (25.7%), followed by eosinophilic bronchitis (13.9%). Comparing the 6-months prior to and after the first clinic visit, there was a lower incidence rate ratio after visit 1 for COPD-related healthcare utilization (0.26 (95%CI 0.22,0.33; p < 0.001)). A COPD post-discharge clinic combining sputum-guided treatment and CCM was feasible and associated with a nearly 75% reduction in the incidence of COPD-related healthcare utilization.

Effects of dance on cognitive function in older adults: a systematic review and meta-analysis.

BACKGROUND: dance is a mind-body activity that stimulates neuroplasticity. We explored the effect of dance on cognitive function in older adults. METHODS: we searched MEDLINE, EMBASE, CENTRAL and PsycInfo databases from inception to August 2020 (PROSPERO:CRD42017057138). Inclusion criteria were (i) randomised controlled trials (ii) older adults (aged ≥ 55 years), (iii) intervention-dance and (iv) outcome-cognitive function. Cognitive domains were classified with the Diagnostic and Statistical Manual of Mental Disorders-5 Neurocognitive Framework. Meta-analyses were performed in RevMan5.3 and certainty of evidence with GradePro. RESULTS: we reviewed 3,997 records and included 11 studies (N = 1,412 participants). Seven studies included only healthy older adults and four included those with mild cognitive impairment (MCI). Dance interventions varied in frequency (1-3×/week), time (35-60 minutes), duration (3-12 months) and type. We found a mean difference (MD) = 1.58 (95% confidence interval [CI) = 0.21-2.95) on the Mini Mental State Examination for global cognitive function (moderate-certainty evidence), and the Wechsler Memory Test for learning and memory had an MD = 3.02 (95% CI = 1.38-4.65; low-certainty evidence). On the Trail Making Test-A for complex attention, MD = 3.07 (95% CI = -0.81 to 6.95; high-certainty evidence) and on the Trail Making Test-B for executive function, MD = -4.12 (95% CI = -21.28 to 13.03; moderate-certainty evidence). Subgroup analyses did not suggest consistently greater effects in older adults with MCI. Evidence is uncertain for language, and no studies evaluated social cognition or perceptual-motor function. CONCLUSIONS: dance probably improves global cognitive function and executive function. However, there is little difference in complex attention, and evidence also suggests little effect on learning and memory. Future research is needed to determine the optimal dose and if dance results in greater cognitive benefits than other types of physical activity and exercise.

Analysis and reporting of stratified cluster randomized trials-a systematic survey.

BACKGROUND: In order to correctly assess the effect of intervention from stratified cluster randomized trials (CRTs), it is necessary to adjust for both clustering and stratification, as failure to do so leads to misleading conclusions about the intervention effect. We have conducted a systematic survey to examine the current practices about analysis and reporting of stratified CRTs. METHOD: We used the search terms to identify the stratified CRTs from MEDLINE since the inception to July 2019. In phase 1, we screened the title and abstract for English-only studies and selected, including the main results paper of the identified protocols, for the next phase. In phase 2, we screened the full text and selected studies for data abstraction. The data abstraction form was piloted and developed using the REDCap. We abstracted data on multiple design and methodological aspects of the study including whether the primary method adjusted for both clustering and stratification, reporting of sample size, randomization, and results. RESULTS: We screened 2686 studies in the phase 1 and selected 286 studies for phase 2-among them 185 studies were selected for data abstraction. Most of the selected studies were two-arm 140/185 (76%) and parallel-group 165/185 (89%) trials. Among these 185 studies, 27 (15%) of them did not provide any sample size or power calculation, while 105 (57%) studies did not mention any method used for randomization within each stratum. Further, 43 (23%) and 150 (81%) of 185 studies did not provide the definition of all the strata, while more than 60% of the studies did not include all the stratification variable(s) in the flow chart or baseline characteristics table. More than half 114/185 (62%) of the studies did not adjust the primary method for both clustering and stratification. CONCLUSION: Stratification helps to achieve the balance among intervention groups. However, to correctly assess the intervention effect from stratified CRTs, it is important to adjust the primary analysis for both stratification and clustering. There are significant deficiencies in the reporting of methodological aspects of stratified CRTs, which require substantial improvements in several areas including definition of strata, inclusion of stratification variable(s) in the flow chart or baseline characteristics table, and reporting the stratum-specific number of clusters and individuals in the intervention groups.

Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation.

BACKGROUND: Health TAPESTRY (Health Teams Advancing Patient Experience: STRengthening qualitY) aims to help people stay healthier for longer where they live by providing person-focused care through the integration of four key program components: (1) trained volunteers who visit clients in their homes, (2) an interprofessional primary health care team, (3) use of technology to collect and share information, and (4) improved connections to community health and social services. The initial randomized controlled trial of Health TAPESTRY found promising results in terms of health care use and patient outcomes, indicating a shift from reactive to preventive care. The trial was based on one clinical academic center, thus limiting generalizability. The study objectives are (1) to test reproducibility of the established effectiveness of Health TAPESTRY on physical activity and hospitalizations, (2) to test the feasibility of, and understand the contributing factors to, the implementation of Health TAPESTRY in six diverse communities across Ontario, Canada, and (3) to determine the value for money of implementing Health TAPESTRY. METHODS: This planned study is a pragmatic parallel randomized controlled trial with a delayed intervention for control participants at 6 months. This trial will simultaneously assess effectiveness and implementation in a real-world setting (type II hybrid) in six diverse communities across Ontario. Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care). Intervention clients will receive an individualized plan of care from an interprofessional care team. The plan will be based on a client's goals and current health risks identified through volunteer visits. The study's outcomes are mapped onto the RE-AIM framework, with levels of physical activity and number of hospitalizations as the co-primary outcomes. The main analysis will be a comparison at 6 months. DISCUSSION: It is important to evaluate the effectiveness and implementation of Health TAPESTRY in multiple communities prior to scaling or widespread adoption. TRIAL REGISTRATION: ClinicalTrials.gov NCT03397836 . Registered on 12 January 2018.

The Impact of Prior Advance Care Planning Documentation on End-of-Life Care Provision in Long-Term Care.

BACKGROUND: The impact of prior advance care planning (ACP) documentation on substitute decision-makers' (SDMs) knowledge of values for end-of-life (EOL) care, and its correlation with SDM satisfaction with EOL care provision, have not been assessed in long-term care (LTC). METHODS: A cross-sectional survey of 2,595 SDMs from 27 LTC homes assessed: 1) knowledge of pre-existing ACP documentation and values for EOL care, and 2) the importance and satisfaction of EOL care provision in LTC. Knowledge of values for EOL care was compared to administrative documentation. Importance and satisfaction were plotted on a performance-importance grid. Multiple linear regression assessed whether knowledge of pre-existing ACP documentation correlated with satisfaction. RESULTS: The response rate was 25% (658/2,595); 69% of LTC residents had pre-existing ACP documentation. Discordance was noted between SDMs' knowledge of values for EOL care and administrative documentation. Pre-existing knowledge of ACP documentation was not correlated with EOL care provision satisfaction. Priority areas for increasing satisfaction include illness management, SDM communication, and relationships with LTC clinicians. CONCLUSIONS: The discordance between SDMs' knowledge of values for EOL care and formal documentation needs to be addressed. Although pre-existing ACP documentation does not impact satisfaction, EOL care provision could be improved by targeting illness management, SDM communication, and relationships with LTC clinicians.

An empirical comparison of methods for analyzing over-dispersed zero-inflated count data from stratified cluster randomized trials.

BACKGROUND: The assessment of methods for analyzing over-dispersed zero inflated count outcome has received very little or no attention in stratified cluster randomized trials. In this study, we performed sensitivity analyses to empirically compare eight methods for analyzing zero inflated over-dispersed count outcome from the Vitamin D and Osteoporosis Study (ViDOS) - originally designed to assess the feasibility of a knowledge translation intervention in long-term care home setting. METHOD: Forty long-term care (LTC) homes were stratified and then randomized into knowledge translation (KT) intervention (19 homes) and control (21 homes) groups. The homes/clusters were stratified by home size (<250/> = 250) and profit status (profit/non-profit). The outcome of this study was number of falls measured at 6-month post-intervention. The following methods were used to assess the effect of KT intervention on number of falls: i) standard Poisson and negative binomial regression; ii) mixed-effects method with Poisson and negative binomial distribution; iii) generalized estimating equation (GEE) with Poisson and negative binomial; iv) zero inflated Poisson and negative binomial - with the latter used as a primary approach. All these methods were compared with or without adjusting for stratification. RESULTS: A total of 5,478 older people from 40 LTC homes were included in this study. The mean (=1) of the number of falls was smaller than the variance (=6). Also 72% and 46% of the number of falls were zero in the control and intervention groups, respectively. The direction of the estimated incidence rate ratios (IRRs) was similar for all methods. The zero inflated negative binomial yielded the lowest IRRs and narrowest 95% confidence intervals when adjusted for stratification compared to GEE and mixed-effect methods. Further, the widths of the 95% confidence intervals were narrower when the methods adjusted for stratification compared to the same method not adjusted for stratification. CONCLUSION: The overall conclusion from the GEE, mixed-effect and zero inflated methods were similar. However, these methods differ in terms of effect estimate and widths of the confidence interval. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01398527. Registered: 19 July 2011.

Decision support intervention (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning: protocol for a randomised trial.

OBJECTIVE: The purpose of this randomised trial is to evaluate the efficacy of a decision support intervention for serious illness decisions (the Plan Well Guide decision aid; www.PlanWellguide.com) in increasing the engagement of substitute decision-makers (SDMs) in the patient's advance care planning process (ie, 'ACP engagement'), specifically the SDM's confidence and readiness for the role in the future. METHODS AND ANALYSIS: This study is a parallel group randomised controlled trial. We aim to enrol 90 participant dyads: patients aged 65 years and older attending outpatient healthcare settings and with indicators they would be at high risk of needing future medical decisions and their SDM. The intervention is the Plan Well Guide decision aid, administered to the patient by a facilitator, with the SDM present. The primary endpoint is change after 3 months in the SDM's ACP engagement using a validated measure of behavioural change (SDM's knowledge, contemplation, self-efficacy and readiness) to enact the role. The secondary endpoints are (1) ACP engagement of the patient measured by a validated survey; (2) change in SDM decisional conflict regarding involvement in future decision-making and (3) postintervention patient decisional conflict regarding preference for life-sustaining treatments. Primary and secondary continuous outcomes will be analysed using the linear regression. The mean difference and 95% CIs will be reported. ETHICS AND DISSEMINATION: Approval was received August 2017 (2017-3714-GRA) from the Hamilton Integrated Research Ethics Board. We plan to disseminate trial results in peer-reviewed journals, at national and international conferences, and via our web-based knowledge translation platforms. TRIAL REGISTRATION NUMBER: NCT03239639; Pre-results.

Sensitivity of methods for analyzing continuous outcome from stratified cluster randomized trials - an empirical comparison study.

The assessment of the sensitivity of statistical methods has received little attention in cluster randomized trials (CRTs), especially for stratified CRT when the outcome of interest is continuous. We empirically examined the sensitivity of five methods for analyzing the continuous outcome from a stratified CRT - aimed to investigate the efficacy of the Classroom Communication Resource (CCR) compared to usual care to improve the peer attitude towards children who stutter among grade 7 students. Schools - the clusters, were divided into quintile based on their socio-political resources, and then stratified by quintile. The schools were then randomized to CCR and usual care groups in each stratum. The primary outcome was Stuttering Resource Outcomes Measure. Five methods, including the primary method, were used in this study to examine the effect of CCR. The individual-level methods were: (i) linear regression; (ii) mixed-effects method; (iii) GEE with exchangeable correlation structure (primary method of analysis). And the cluster-level methods were: (iv) cluster-level linear regression; and (v) meta-regression. These methods were also compared with or without adjustment for stratification. Ten schools were stratified by quintile, and then randomized to CCR (223 students) and usual care (231 students) groups. The direction of the estimated differences was same for all the methods except meta-regression. The widths of the 95% confidence intervals were narrower when adjusted for stratification. The overall conclusion from all the methods was similar but slightly differed in terms of effect estimate and widths of confidence intervals. TRIALREGISTRATION: Clinicaltrials.gov, NCT03111524. Registered on 9 March 2017.

Incident Fragility Fractures Have a Long-Term Negative Impact on Health-Related Quality of Life of Older People: The Canadian Multicentre Osteoporosis Study.

Although the short-term impact of incident fragility fractures on health-related quality of life (HRQL) of older people has been confirmed, we lack long-term evidence. We explored the impact of incident fragility fractures on HRQL, among people aged 50 years and older, using 10-year prospective data from the Canadian Multicentre Osteoporosis Study (CaMos). This study was based on data from 7753 (2187 men and 5566 women) participants of CaMos. The HRQL, measured through the Health Utility Index (HUI), was captured at baseline and year 10. The incident fragility fractures were recorded over 10 years of follow-up at spine, hip, rib, shoulder, pelvis, or forearm. Multivariable regression analysis was conducted to measure the mean difference, termed as deficit, in the HUI scores for participants with and without fractures. We examined the effects of single or multiple fragility fractures, time (fractures that occurred between year 1 to 5 and 6 to 10) and recovery to the prefracture level. Incident spine and hip fractures were associated with significant deficits (varied from -0.19 to -0.07) on the HUI scores. Hip and spine fractures were associated with negative impact on mobility, self-care, and ambulation. Fractures that occurred closer to the follow-up assessment were associated with significant impact on HRQL compared to fractures occurring a long time before it, except for hip fracture (deficits lasted 5 years or longer). Similarly, multiple hip (-0.14), spine (-0.16), and rib (-0.21) fractures significantly impacted the HRQL of women. Women with a hip fracture never recovered to their prefracture level score (OR = 0.41; 95% confidence interval [CI], 0.19 to 0.98). Our analysis suggests that single and multiple hip fractures as well as multiple spine and rib fractures strongly impact the HRQL of older people over a prolonged period of time. © 2019 American Society for Bone and Mineral Research.