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Introduction: Patient-reported outcome measures (PROM) are questionnaires that can be used to elicit care outcome information from patients. We sought to develop and validate the first PROM for adult patients without a primary mental health or addictions presentation receiving emergency department (ED) care and who were not hospitalized. Methods: PROM development used a multi-phase process based on national and international guidance (FDA, NQF, ISPOR). Phase 1: ED outcome conceptual framework qualitative interviews with ED patients post-discharge informed four core domains (previously published). Phase 2: Item generation scoping review of the literature and existing instruments identified candidate questions relevant for each domain for inclusion in tool. Phase 3: Cognitive debriefing existing and newly written questions were tested with ED patients post-discharge for comprehension and wording preference. Phase 4: Field and validity testing revised tool pilot tested on a national online survey panel and then again at 2 weeks (test-retest). Phase 5: Final item reduction using a Delphi process involving ED clinicians, researchers, patients and system administrators. Phase 6: Validation - psychometric testing of PROM-ED 1.0. Results: Four core outcome domains were defined in Phase 1: (1) understanding; (2) symptom relief; (3) reassurance and (4) having a plan. The domains informed a review of existing relevant questionnaires and instruments and the writing of additional questions creating an initial long-form questionnaire. Eight patients participated in cognitive debriefing of the long-form questionnaire. Expert clinicians, researchers and patient partners provided input on item refinement and reduction. Four hundred forty-four patients completed a second version of the long-form questionnaire (add in retest numbers) which informed the final item reduction process by a modified Delphi method involving 21 diverse contributors. The questionnaire was validated and underwent final revisions to create the 21 questions that constitute PROM-ED 1.0. Conclusion: Using accepted PROM instrument development methodology, we developed the first outcome questionnaire for use with adult ED patients who are not hospitalized. This questionnaire can be used to systematically gather patient-reported outcome information that could support and inform improvement work in ED care.
Objectives: Many innovative health technologies do not have a sufficient evidence-base to allow for adequate assessment of their benefits. Funders in several countries have been exploring arrangements that allow for temporary or partial coverage of these technologies, but only as part of a further evaluation. The public's support of arrangements that restrict access to innovative technology until sufficient evidence is available is crucial if these arrangements are going to remain viable. The project's other objective is to examine the lay public's views on a case in which patients’ publicly funded access to an innovative health technology is being delayed until there is sufficient evidence to justify a coverage decision. The case considered is the Ontario (Canada) government's decision to restrict access to positron emission tomography (PET) scans until further evidence becomes available.
Methods: The case was deliberated on by twenty-six members of the Toronto Health Policy Citizens' Council, with a follow-up survey administered to individual council members.
Results: The majority of council members agreed that the approach taken by the government was reasonable and in the best interests of its citizens. The council did express concerns regarding certain aspects of the case, including about the length of time it is taking to obtain further evidence.
Conclusions: Public support for arrangements that limit access to new technologies will likely vary depending on the details of the specific arrangement being proposed. Deliberative public dialogue can be effectively used to identify cases the general public is most likely to support.
Objectives: To elucidate important differences between a health technology assessment (HTA) and a systematic review, using an HTA of positron emission tomography (PET) as an example.
Methods: Interviews with seventeen individuals who were authors or users of the PET HTA.
Results: Those interviewed identified seven areas in which HTAs often differ from traditional systematic reviews: (i) methodological standards (HTAs may include literature of relatively poor methodological quality if a topic is of importance to decision-makers), (ii) replication of previous studies (relatively common for HTAs but not systematic reviews), (iii) choice of topics (more policy oriented for HTAs, while systematic reviews tend to be driven by researcher interest), (iv) inclusion of content experts and policy-makers as authors (policy-makers more likely to be included in HTAs, although there are potential conflicts of interest), (v) inclusion of economic evaluations (more often with HTAs, although economic evaluations based upon poor clinical data may not be useful), (vi) making policy recommendations (more likely with HTAs, although this must be done with caution), and (vii) dissemination of the report (more often actively done for HTAs).
Conclusions: This case study of an HTA of PET scanning confirms that HTAs are a bridge between science and policy and require a balance between the ideals of scientific rigor and the realities of policy making.
Clinical prediction rules are decision-making tools that incorporate three or more variables from the history, physical examination or simple tests. They help clinicians make diagnostic or therapeutic decisions by standardizing the collection and interpretation of clinical data. There is growing interest in the methodological standards for their development and validation. This article describes the methods used to derive the Canadian C-Spine Rule and provides a valuable reference for investigators planning to develop future clinical prediction rules.
This paper is Part I of a 2-part series to describe the background and methodology for the Canadian C-Spine Rule study to develop a clinical decision rule for rational imaging in alert and stable trauma patients. Current use of radiography is inefficient and variable, in part because there has been a lack of evidence-based guidelines to assist emergency physicians. Clinical decision rules are research-based decision-making tools that incorporate 3 or more variables from the history, physical examination or simple tests. The Canadian CT Head and C-Spine (CCC) Study is a large collaborative effort to develop clinical decision rules for the use of CT head in minor head injury and for the use of cervical spine radiography in alert and stable trauma victims. Part I details the background and rationale for the development of the Canadian C-Spine Rule. Part II will describe in detail the objectives and methods of the Canadian C-Spine Rule study.
Objective: To explore the impact of methodologic issues on
the results of meta-analyses. The following issues were examined:
the type of literature search strategy used; inclusion or exclusion
of non–peer-reviewed studies; the inclusion or exclusion of
non-English language publications; the effect of trial quality; and the
inclusion or exclusion of non–placebo-controlled studies.
Methods: The International Study of Perioperative Transfusion (ISPOT)
meta-analyses were used to evaluate each of
the methodologic issues. The 10 meta-analyses consisted of
technologies to reduce the need for perioperative red blood cell
transfusion. The number of trials for each of the meta-analyses
varied from 2 to 45. Both EMBASE and MEDLINE searches were
conducted, including the use of systematic search strategies.
Results: MEDLINE identified the vast majority of trials. Alone,
MEDLINE would have missed 8 studies compared to 10 for EMBASE. Use of
the systematic search strategies greatly reduced the number of
articles to be reviewed compared to open searches. Type of
publication, country of study origin, inclusion of non-English
publications, and trial quality had very little impact on the
estimates of effect. The use of placebo versus open-label control
affected the magnitude of the odds ratio for two of the
meta-analyses. The results of the two meta-analyses were not statistically
significant if only placebo-controlled trials were included.
Conclusions: While methodologic issues had very little impact
on the ISPOT meta-analyses, further studies are needed in a variety
of other clinical settings. Because MEDLINE, coupled with a review
of the references in the identified trials, identified the vast
majority of trials, one needs to consider the costs and benefits of
searching EMBASE and the pursuance of unpublished and unindexed
Background: Despite the growing medical and public interest in
reducing exposure to allogeneic blood, little is known about the use of
alternatives to allogeneic transfusion. This study was conducted to determine
the availability of these technologies in Canadian hospitals and was
undertaken under the auspices of the International Study of Peri-Operative
Transfusion (ISPOT), a 10-country study of the effectiveness of, attitudes
toward, and practices related to the use of alternatives to allogeneic
Methods: A cross-sectional national mail survey of Canadian
hospitals with greater than 50 medical/surgical beds. Chiefs of
anesthesia, surgery, and the divisions of cardiac, orthopedic, vascular, and
urology were initially mailed a brief postcard asking which of seven
technologies were used in their center. This was then followed up with a
one-page questionnaire asking how frequently the technologies were used, their
thoughts on the appropriateness of the use of the technologies, barriers to
their greater use, and reasons for nonuse of the technologies.
Results: Response rates to the postcard survey ranged from
70%–98%, depending on the technology and type of surgery, and ranged
from 27%–53% for the follow-up questionnaire. All technologies were used
most frequently in cardiac surgery. Aprotinin, tranexamic acid, aminocaproic
acid, desmopressin, and cell salvage were reported used in over 70% of cardiac
surgery centers. Of these, tranexamic acid and cell salvage were the only ones
used routinely in some centers. Acute normovolemic hemodilution and
erythropoietin were used in 45% and 20% of cardiac centers, respectively. The
drugs were used in less than 15% of orthopedic, vascular, and urologic
divisions, with the exception of desmopressin in urologic and vascular surgery
and aminocaproic acid in urologic surgery. The techniques of cell salvage and
acute normovolemic hemodilution were used in 30%–45% of these divisions,
with the exception of cell salvage, which was used in less than 15% of urology
units. In more than 60% of cases, the technologies were considered to be used
“about right,” although an important minority felt that they were
Conclusions: In general, alternatives to perioperative allogeneic
transfusion were rarely used except in cardiac surgery.
Objectives: Due to the discovery in the 1980s that blood
transfusion can transmit HIV, there has been increased interest in
technologies that reduce the amount of allogeneic blood used during and after
surgery. These technologies include drugs (aprotinin, tranexamic acid,
epsilon-aminocaproic acid, erythropoietin), devices (cell salvage), and
techniques (acute hemodilution, predeposited autologous donation). The purpose
of this study was to ascertain the degree of practice variation, if any, that
exists for eight technologies in nine countries in orthopedic and cardiac
Methods: In each country, either all hospitals or a random sample
of hospitals with medical/surgical beds were surveyed between 1995 and
1997. Two instruments were used. The first instrument was a postcard that
asked recipients whether the technologies were currently being used in their
hospital for orthopedic and/or cardiac surgery to reduce perioperative
allogeneic transfusion. The second questionnaire elicited information
regarding the degree of use both in qualitative and quantitative terms. Data
were collected, entered, and analyzed in each country, with summary results
submitted to the Canadian coordinating center on a standardized data
Results: Pharmaceuticals were generally used in a much smaller
proportion of hospitals in orthopedic than in cardiac surgery. Aprotinin and
tranexamic acid were the drugs most frequently used in cardiac surgery.
Nonpharmacological technologies were used to a greater degree than drugs in
orthopedic surgery, although there was wide variation among technologies and
countries. Acute hemodilution and cell salvage were used in a greater
proportion of hospitals for cardiac surgery than orthopedic surgery.
Conclusions: The results of this survey indicate that there is
considerable practice variation in the use of technologies to minimize
exposure to perioperative allogeneic transfusion within and between countries.
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