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ObjectivesTo develop and validate a values clarification tool, the Short Graphic Values History Tool (GVHT), designed to support person-centred decision making during serious illness.MethodsThe development phase included input from experts and laypersons and assessed acceptability with patients/family members. In the validation phase, we recruited additional participants into a before-after study. Our primary validation hypothesis was that the tool would reduce scores on the Decisional Conflict Scale (DCS) at 1-2 weeks of follow-up. Our secondary validation hypotheses were that the tool would improve values clarity (reduce scores) more than other DCS subscales and increase engagement in advance care planning (ACP) processes related to identification and discussion of one's values.ResultsIn the development phase, the tool received positive overall ratings from 22 patients/family members in hospital (mean score 4.3; 1=very poor; 5=very good) and family practice (mean score 4.5) settings. In the validation phase, we enrolled 157 patients (mean age 71.8 years) from family practice, cancer clinic and hospital settings. After tool completion, decisional conflict decreased (-6.7 points, 95% CI -11.1 to -2.3, p=0.003; 0-100 scale; N=100), with the most improvement seen in the values clarity subscale (-10.0 points, 95% CI -17.3 to -2.7, p=0.008; N=100), and the ACP-Values process score increased (+0.4 points, 95% CI 0.2 to 0.6, p=0.001; 1-5 scale; N=61).ConclusionsThe Short GVHT is acceptable to end users and has some measure of validity. Further study to evaluate its impact on decision making during serious illness is warranted.

ContextThe validated 82-item Advance Care Planning (ACP) Engagement Survey measures a broad range of ACP behaviors but is long.ObjectivesDetermine whether shorter survey versions (55-item, 34-item, 15-item, 9-item, and 4-item versions) can detect similar change in response to two well-validated ACP interventions and provide practical effect size information.MethodsWe assessed ACP engagement for 986 English- and Spanish-speaking adults in a randomized trial of PREPARE vs. an advance directive-only study arms. The survey was administered at baseline, one week, three months, six months, and 12 months. We calculated mean change scores from baseline to follow-up time points by study arm, intraclass correlation coefficients of change scores between the 82-item survey with shorter versions, and within-group and between-group effect sizes of the mean change scores.ResultsShorter survey versions were able to detect within-group and between-group changes at all time points. Within-group intraclass correlations of the 82-item to shorter versions were high (0.78-0.97), and the amount of between-group differences was comparable using all survey versions. Twelve-month within-group effect sizes ranged narrowly from 0.76 to 1.05 for different survey versions in the PREPARE arm and from 0.44 to 0.64 for the advance directive-only version. Between-group effect sizes ranged narrowly from 0.24 to 0.30 for different survey versions. Results were similar when stratified by English and Spanish speakers.ConclusionShorter versions of the ACP Engagement Survey were able to detect within-group and between-group changes comparable with the 82-item version and can be useful for efficiently and effectively measuring ACP engagement in research and clinical settings.

ObjectiveWe studied decision making regarding inhaled nitric oxide (iNO) in preterm infants with Pulmonary Hypertension (PH).Study designWe asked members of the AAP-Society of Neonatal-Perinatal Medicine and Division-Chiefs to select from three management options- initiate iNO, engage parents in shared decision making or not consider iNO in an extremely preterm with PH followed by rating of factors influencing their decision.ResultsThree hundred and four respondents (9%) completed the survey; 36.5% chose to initiate iNO, 42% to engage parents, and 21.5% did not consider iNO. Provider's prior experience, safety, and patient-centered care were rated higher by those who initiated or offered iNO; lack of effectiveness and cost considerations by participants who did not chose iNO.ConclusionsMost neonatologists offer or initiate iNO therapy based on their individual experience. The minority who chose not to consider iNO placed higher value on lack of effectiveness and cost. These results demonstrate a tension between evidence and pathophysiology-based-therapy/personal experience.

ContextStandardized outcomes that define successful advance care planning (ACP) are lacking.ObjectiveThe objective of this study was to create an Organizing Framework of ACP outcome constructs and rate the importance of these outcomes.MethodsThis study convened a Delphi panel consisting of 52 multidisciplinary, international ACP experts including clinicians, researchers, and policy leaders from four countries. We conducted literature reviews and solicited attendee input from five international ACP conferences to identify initial ACP outcome constructs. In five Delphi rounds, we asked panelists to rate patient-centered outcomes on a seven-point "not-at-all" to "extremely important" scale. We calculated means and analyzed panelists' input to finalize an Organizing Framework and outcome rankings.ResultsOrganizing Framework outcome domains included process (e.g., attitudes), actions (e.g., discussions), quality of care (e.g., satisfaction), and health care (e.g., utilization). The top five outcomes included 1) care consistent with goals, mean 6.71 (±SD 0.04); 2) surrogate designation, 6.55 (0.45); 3) surrogate documentation, 6.50 (0.11); 4) discussions with surrogates, 6.40 (0.19); and 5) documents and recorded wishes are accessible when needed 6.27 (0.11). Advance directive documentation was ranked 10th, 6.01 (0.21). Panelists raised caution about whether "care consistent with goals" can be reliably measured.ConclusionA large, multidisciplinary Delphi panel developed an Organizing Framework and rated the importance of ACP outcome constructs. Top rated outcomes should be used to evaluate the success of ACP initiatives. More research is needed to create reliable and valid measurement tools for the highest rated outcomes, particularly "care consistent with goals."

ContextDespite increasing interest in advance care planning (ACP) and previous ACP descriptions, a consensus definition does not yet exist to guide clinical, research, and policy initiatives.ObjectiveThe aim of this study was to develop a consensus definition of ACP for adults.MethodsWe convened a Delphi panel of multidisciplinary, international ACP experts consisting of 52 clinicians, researchers, and policy leaders from four countries and a patient/surrogate advisory committee. We conducted 10 rounds using a modified Delphi method and qualitatively analyzed panelists' input. Panelists identified several themes lacking consensus and iteratively discussed and developed a final consensus definition.ResultsPanelists identified several tensions concerning ACP concepts such as whether the definition should focus on conversations vs. written advance directives; patients' values vs. treatment preferences; current shared decision making vs. future medical decisions; and who should be included in the process. The panel achieved a final consensus one-sentence definition and accompanying goals statement: "Advance care planning is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future medical care. The goal of advance care planning is to help ensure that people receive medical care that is consistent with their values, goals and preferences during serious and chronic illness." The panel also described strategies to best support adults in ACP.ConclusionsA multidisciplinary Delphi panel developed a consensus definition for ACP for adults that can be used to inform implementation and measurement of ACP clinical, research, and policy initiatives.

ContextA validated 82-item Advance Care Planning (ACP) Engagement Survey measures a broad range of behaviors. However, concise surveys are needed.ObjectivesThe objective of this study was to validate shorter versions of the survey.MethodsThe survey included 57 process (e.g., readiness) and 25 action items (e.g., discussions). For item reduction, we systematically eliminated questions based on face validity, item nonresponse, redundancy, ceiling effects, and factor analysis. We assessed internal consistency (Cronbach's alpha) and construct validity with cross-sectional correlations and the ability of the progressively shorter survey versions to detect change one week after exposure to an ACP intervention (Pearson correlation coefficients).ResultsFive hundred one participants (four Canadian and three US sites) were included in item reduction (mean age 69 years [±10], 41% nonwhite). Because of high correlations between readiness and action items, all action items were removed. Because of high correlations and ceiling effects, two process items were removed. Successive factor analysis then created 55-, 34-, 15-, nine-, and four-item versions; 664 participants (from three US ACP clinical trials) were included in validity analysis (age 65 years [±8], 72% nonwhite, 34% Spanish speaking). Cronbach's alphas were high for all versions (four items 0.84-55 items 0.97). Compared with the original survey, cross-sectional correlations were high (four items 0.85; 55 items 0.97) as were delta correlations (four items 0.68; 55 items 0.93).ConclusionShorter versions of the ACP Engagement Survey are valid, internally consistent, and able to detect change across a broad range of ACP behaviors for English and Spanish speakers. Shorter ACP surveys can efficiently measure broad ACP behaviors in research and clinical settings.

ObjectivesTo assess the feasibility, acceptability and clinical sensibility of a novel survey, the advance care planning (ACP) Engagement Survey, in various healthcare settings.SettingA target sample of 50 patients from each of primary care, hospital, cancer care and dialysis care settings.ParticipantsA convenience sample of patients without cognitive impairment who could speak and read English was recruited. Patients 50 and older were eligible in primary care; patients 80 and older or 55 and older with clinical markers of advanced chronic disease were recruited in hospital; patients aged 19 and older were recruited in cancer and renal dialysis centres.OutcomesWe assessed feasibility, acceptability and clinical sensibility of the ACP Engagement Survey using a 6-point scale. The ACP Engagement Survey measures ACP processes (knowledge, contemplation, self-efficacy and readiness) on 5-point Likert scales and actions (yes/no).Results196 patients (38-96 years old, 50.5% women) participated. Mean (±SD) time to administer was 48.8±19.6 min. Mean acceptability scores ranged from 3.2±1.3 in hospital to 4.7±0.9 in primary care, and mean relevance ranged from 3.5±1.0 in hospital to 4.9±0.9 in dialysis centres (p

Background: Routine imaging of patients with spine-related complaints referred for surgical assessment may represent an inefficient use of technological resources. Our objective was to explore Canadian spine surgeons' requirements with respect to imaging studies accompanying spine-related referrals. Methods: We administered an 8-item survey to all 100 actively practicing surgeon members of the Canadian Spine Society that inquired about demographic variables and imaging requirements for patients referred with spine-related complaints. Results: Fifty-five spine surgeons completed our survey, for a response rate of 55%. Most respondents (43; 78%) required imaging studies to accompany all spine-related referrals. The type of imaging required was highly variable, with respondents endorsing 7 different combinations. Half (47%) required magnetic resonance imaging and 38% required plain radiographs either alone or in combination with other forms of imaging. Half of the respondents refused to see 20% or more of all patients referred for spine-related complaints. Conclusion: Most Canadian spine surgeons require imaging studies to accompany spine-related referrals; however, the type and combination of studies is highly variable, and many patients who are referred are never seen (for a consultation). Standardization and optimization of imaging practices for patients with spine-related complaints referred for surgical assessment may be an important area for cost savings. Contexte : Le recours systematique aux epreuves d'imagerie chez les patients qui se plaignent de maux de dos et qui sont referes pour consultation en chirurgie pourrait constituer une utilisation inefficace des ressources technologiques. Notre objectif etait d'analyser les epreuves d'imagerie demandees par les chirurgiens canadiens specialistes de la colonne vertebrale, suite aux demandes de consultation qui leur sont adressees pour des patients qui ont des problemes de colonne vertebrale. Methodes : Nous avons administre un sondage en 8 questions aux 100 chirurgiens en pratique active qui forment la Canadian Spine Society; le questionnaire portait sur des variables demographiques et sur les demandes d'epreuves d'imagerie pour les patients qui leur sont referes pour des maux de dos. Resultats : Cinquante-cinq chirurgiens de la colonne ont repondu a notre sondage, pour un taux de reponse de 55%. La plupart des repondants (43; 78%) ont dit demander des epreuves d'imagerie pour toutes les references qui leur sont adressees pour des problemes de colonne vertebrale. Les types d'epreuves d'imagerie demandes variaient considerablement et les repondants ont mentionne 7 combinaisons d'epreuves differentes. La moitie d'entre eux (47%) demandaient une imagerie par resonnance magnetique et 38% demandaient des radiographies ordinaires, seules ou combinees a d'autres modalites d'imagerie. La moitie des repondants ont dit refuser de voir 20% ou plus de tous les patients qui leur etaient referes pour des maux de dos. Conclusion : La plupart des chirurgiens specialistes de la colonne vertebrale au Canada demandent des epreuves d'imagerie pour tous les patients qui leur sont referes pour des problemes de colonne vertebrale; toutefois, les types d'epreuves et leurs combinaisons sont tres variables et de nombreux patients qui sont referes en consultation ne reussissent jamais a voir les specialistes. La standardisation et l'optimisation des pratiques au chapitre de l'imagerie pour les patients qui souffrent de maux de dos et qui sont referes a un chirurgien representent un poste budgetaire important ou des economies pourraient etre realisees., Spine-related complaints are common among adults, (1) and patients whose symptoms fail to resolve in a timely manner or who present with neurologic involvement are often referred for surgical assessment. [...]

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2007.06.026 Byline: John J. You (a)(h), Anna Woo (b)(e), Dennis T. Ko (a)(d)(e), Douglas A. Cameron (b)(e), Alexandra Mihailovic (f), Murray Krahn (c)(e)(g) Abstract: Sudden cardiac death (SCD) is a devastating complication of hypertrophic cardiomyopathy (HCM). The optimal strategy for the primary prevention of SCD in HCM remains controversial. Author Affiliation: (a) Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada (b) Division of Cardiology, University Health Network, Toronto, Ontario, Canada (c) Division of General Internal Medicine, University Health Network, Toronto, Ontario, Canada (d) Division of Cardiology and Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (e) Department of Medicine, Toronto, Ontario, Canada (f) Department of Surgery, Toronto, Ontario, Canada (g) Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada (h) Departments of Medicine and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada Article History: Received 15 September 2006; Accepted 19 June 2007

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2007.01.027 Byline: John J. You (a)(b)(e), Peter C. Austin (a)(c)(d), David A. Alter (a)(b)(d)(f), Dennis T. Ko (a)(b)(f)(g), Jack V. Tu (a)(b)(d)(e)(g) Abstract: Troponin level elevations are common in patients with acute decompensated heart failure (ADHF), yet their prognostic value above and beyond traditional predictors of outcomes in heart failure is uncertain. Author Affiliation: (a) Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada (b) Department of Medicine, University of Toronto, Toronto, Ontario, Canada (c) Department of Public Health Sciences, University of Toronto, Toronto, Ontario, Canada (d) Department of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada (e) Division of General Internal Medicine, Sunnybrook Hospital, Toronto, Ontario, Canada (f) Division of Cardiology and The Li Ka Shing Knowledge Institute of St. Michael's Hospital, Sunnybrook Hospital, Toronto, Ontario, Canada (g) Division of Cardiology and Schulich Heart Centre, Sunnybrook Hospital, Toronto, Ontario, Canada Article History: Received 12 June 2006; Accepted 16 January 2007 Article Note: (footnote) [star] Dr You is supported by fellowships from the Canadian Institutes for Health Research, Ottawa, Ontario; the Canadian Cardiovascular Outcomes Research Team, Toronto, Ontario; and the Department of Medicine at the University of Toronto, Toronto, Ontario. Dr Austin is supported by a New Investigator Award from the Canadian Institutes for Health Research. Dr Alter is supported by a New Investigator Award from the Canadian Institutes for Health Research and by the Heart and Stroke Foundation of Canada, Ottawa, Ontario. Dr Ko is supported by a research grant from the Heart and Stroke Foundation of Canada. Dr Tu is supported by a Canada Research Chair in Health Services Research, Ottawa, Ontario, and by a Career Investigator award of the Heart and Stroke Foundation of Ontario, Toronto, Ontario. The EFFECT study was funded by a grant to the Canadian Cardiovascular Outcomes Research Team (www.ccort.ca) from the Canadian Institutes of Health Research and the Heart and Stroke Foundation of Canada. The Institute for Clinical Evaluative Sciences is supported by an operating grant from the Ontario Ministry of Health and Long-term Care, Toronto, Ontario.

Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol., Author(s): Benjamin Kasenda 1, Erik von Elm 2,*, John J. You 3,4, Anette Blümle 5, Yuki Tomonaga 6, Ramon Saccilotto 1, Alain Amstutz 1, Theresa Bengough 2,7, Joerg J. Meerpohl [...]