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Optimal Strategies for the Diagnosis of Acute Pulmonary Embolism: A Health Technology Assessment — Project Protocol [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Sep 29. (CADTH Optimal Use Report, No. 6.3a.)

Cover of Optimal Strategies for the Diagnosis of Acute Pulmonary Embolism: A Health Technology Assessment — Project Protocol

Optimal Strategies for the Diagnosis of Acute Pulmonary Embolism: A Health Technology Assessment — Project Protocol [Internet].

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ETHICS REVIEW

This protocol was written a priori and will be followed throughout the review process.

There are two broad normative questions to consider regarding diagnosis of acute pulmonary embolism (PE):

  1. Should we provide diagnosis of acute PE?
  2. If yes, which strategies should be provided, and how best should those strategies be provided to diagnose those with acute PE?

Both of these questions are matters of systems-level or population-level ethics, which examine questions that will affect a large number of people and in which outcomes and interests are considered in aggregate (organizational ethics, policy ethics, and public health ethics are all domains of systems-level ethics). For systems-level ethics, instead of asking, “Does this technology benefit the patient?” and “Does this technology disadvantage vulnerable individuals?”, we ask, “Does this technology create overall benefit for the population?” and “Does this technology disadvantage marginalized groups?” Questions of individual autonomy are of lesser concern when using this approach; however, if a technology were to present broad challenges to individual choice within a relevant population, this would be reason to consider seriously whether it would be ethically justifiable to endorse or implement the technology universally.

The determination that a technology should not be implemented may be made for several reasons:

  • The technology offers little to no evidence of benefit at the population level.
  • The technology does offer benefit at the population level, but the degree of benefit is disproportionate to the cost.
  • The technology presents significant issues regarding respect for populations affected by the technology, and these issues cannot be mitigated by careful implementation. Such issues include systematic affronts to dignity, autonomy, and personhood and the oppression of particular groups, especially those who are already vulnerable or who may become vulnerable as a result of the technology.

If the answer to the first question is “yes, the technology should be implemented,” or at least not “no,” the second question on how the technology should be implemented should be pursued.

The development of a response to this question requires consideration of the nature of the technology from the individual perspective, invoking an individualist or bedside ethics approach (sometimes referred to as clinical ethics). Closer attention must be paid to considerations of respect, benefit, autonomy, dignity, and fairness from the individual perspective to uncover how the technology could be implemented and delivered in a way that lives up to key values or principles. If the analysis determines that the technology cannot be implemented in a way that sufficiently lives up to core values, it may cause the first question to be reconsidered.

The ethics analysis of strategies for diagnosing acute PE also involves a descriptive question:

  • What are the key ethical considerations identified in the literature on strategies for diagnosing acute PE?

This question aims to uncover the arguments and values that others have proposed to be relevant to ethical deliberation about the provision of diagnostic strategies for PE. Those arguments and values can be used to inform the answers to the normative questions posed by this health technology assessment (HTA).

Perspectives

The relevant perspectives that need to be considered in identifying and addressing the ethical issues associated with the various strategies for diagnosing acute PE include those of patients, family members or informal care-givers, health care providers, and health care insurers.

Inquiry

The nature of bioethical analysis requires a two-step approach to the identification of potential issues. In the first step, a review of the bioethics literature will be conducted; in the second step, additional searches will be conducted based on the issues found in the literature and the bioethical analysis. The aim is to identify and address the relative importance and strength of the identified concerns.

Review of the Bioethics Literature

A review of the empirical and normative bioethics literature will be conducted to identify two types of literature relevant to the identification and analysis of the potential ethical issues with diagnosing acute PE. The first type of literature is composed of those articles that explicitly and specifically raise ethical issues. The second type is composed of articles that are not explicitly about ethical issues — for example, an empirical investigation of patient attitudes toward diagnostic testing for PE — but that, when read through an ethics lens, raise or point to potential ethical issues. The relevant literature includes issues with diagnostic strategies specifically, and also ethical issues with similar technologies in the same population. Possible analogies will be scrutinized for relevance before being included.

A systematic review of patient and caregiver perspectives is already being performed for this HTA. The results of the planned review of patient and caregiver perspectives will inform this analysis, so no separate or additional search for this perspective will be conducted for the ethics analysis.

Literature Search Strategy

The literature search will be performed by an information specialist, using a peer-reviewed search strategy.

Published literature will be identified by searching the following databases: MEDLINE (1946–), Embase (1974–), and PsycINFO (1967–) via Ovid; Cumulative Index to Nursing and Allied Health Literature (CINAHL) via EBSCO; and PubMed. The search strategy will consist of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts will be PE or venous thromboembolism and Wells or Geneva clinical prediction rules, Pulmonary Embolism Rule-Out Criteria (PERC), d-dimer testing, computed tomography (CT) technologies, MRI technologies, ventilation-perfusion (V/Q)-based technologies, positron emission tomography–CT (PET-CT), and thoracic ultrasound (plus echocardiography).

Methodological filters will be applied to limit retrieval to studies of ethics, legal, or social implications. Retrieval will be limited to documents published since January 1, 2006. The search will also be limited to English- or French-language publications. Conference abstracts will be excluded from the search results. See Appendix 1 for the detailed search strategy.

The search will be completed in October 2016. Regular alerts will be established to update the searches until the publication of the final report. Regular search updates will be performed on databases that do not provide alert services. Studies identified in the alerts and that meet the selection criteria of the review will be incorporated into the analysis, if they are identified prior to the completion of the stakeholder feedback period of the final report. Any studies that are identified after the stakeholder feedback period will be described in the discussion, with a focus on comparing the results of these new studies to the results of the analysis conducted for this report.

Grey literature (literature that is not commercially published) will be identified by searching the Grey Matters checklist (https://www.cadth.ca/grey-matters), which includes the websites of HTA agencies, clinical guideline repositories, systematic review repositories, economics-related resources, patient-related groups, and professional associations. Google and other Internet search engines will be used to search for additional Web-based materials. These searches will be supplemented by reviewing the bibliographies of key papers and through contacts with appropriate experts and industry.

Selection Methods and Criteria

The selection of relevant literature will proceed in two stages. In the first stage, the title and abstracts of citations will be screened for relevance independently by an single reviewer (AP). Articles will be categorized as “retrieve” or “do not retrieve” according to whether they meet the following criterion:

  • Provides information (explicit) on or is relevant to identification (implicit) of an ethical issue related to diagnosing PE.

In the second stage of screening, two reviewers will independently assess the relevance of the full-text reports for all citations classified as “retrieve” in the first stage of screening. The relevance of the full-text reports will be assessed according to the following criteria:

  • On a relevant diagnostic strategy for PE
  • Explicitly mentions ethical issues (either individual or societal).

Reports meeting all criteria will be included in the analysis. Reports that do not meet these criteria will be excluded from analysis. Disagreements between reviewers will be resolved by discussion and consensus. In the event of persistent disagreement, a third assessor will adjudicate.

Data Extraction

The bibliographic details for each report (author, publication date, journal), the potential ethical issues raised, and the report’s conclusions will be captured in a table in Word format.

Analysis

Ethical issues will be analyzed using the methods and tools of analytic philosophy and bioethics.

Summarizing and Presenting Results

The ethical considerations identified in the literature review will be summarized according to key themes, principles, and values. The research findings and ethical analysis will determine the structure of this summary. For example, the results may be summarized according to a principlist framework (issues concerned with autonomy, beneficence, non-maleficence, and justice) or by categorizing moral concerns as micro-, meso-, and macro-level issues.

In addition, consideration will be given to the ways in which contextual features may alleviate or exacerbate the ethical themes, principles, and values summarized in this report. The ethical implications of a health technology are often determined by the nature of the local context. For example, the implications of values related to fair access and consistency of service within the population are determined by facts about how health care services are arranged and provided. To help decision-makers better understand localized impact, a number of contextualizing questions will be developed based on the identified issues.

Appendix 1. Literature Search Strategy For Ethics Review Of Diagnostic Strategies For Acute Pulmonary Embolism

(Note: Combined with search strings used for condition and technology for clinical search)

Ethics Database Search

OVERVIEW
Interface:Ovid
Databases:Embase
MEDLINE Daily and MEDLINE
MEDLINE In-Process & Other Non-Indexed Citations
PsycINFO
Note: Duplicates between databases were removed in Ovid.
Date of Search:October 12, 2016
Alerts:Monthly search updates until project completion
Study Types:Ethics/legal/social implication studies
Limits:Date limit: 2006-present
Language limit: English- and French-language, Conference abstract excluded
SYNTAX GUIDE
/At the end of a phrase, searches the phrase as a subject heading
expExplode a subject heading
*Before a word, indicates that the marked subject heading is a primary topic; or, after a word, a truncation symbol (wildcard) to retrieve plurals or varying endings
adjRequires words are adjacent to each other (in any order)
.tiTitle
.abAbstract
.hwHeading word; usually includes subject headings and controlled vocabulary
.kfAuthor keyword heading word
.fs
psyb
pmez
oemezd		Floating subheading
Ovid database code; PsycINFO 1967 to present
Ovid database code; MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE Daily and Ovid MEDLINE 1946 to Present
Ovid database code; Embase 1974 to present, updated daily
MULTI-STRATEGY SEARCH
#Searches
1exp pulmonary embolism/
2((pulmonary or lung) adj4 (embolism* or embolus or emboli* or emboly or thromboemboli* or thrombo-emboli* or microemboli* or microembolus or micro-emboli* or micro-embolus or blood clot*)).ti,ab,kf.
3Venous Thromboembolism/
4((venous or vein) adj4 (thromboemboli* or thrombo-emboli*)).ti,ab,kf.
5VTE.ti,ab,kf.
6or/1-5
7exp Tomography, X-Ray Computed/ or Tomography Scanners, X-Ray Computed/
8((computed or computer* or electron beam) adj4 (tomograph* or angiograph*)).ti,ab,kf.
9(CT scan* or X-ray CT or CT X Ray? or CAT scan* or multi-detector CT or tomodensitometry or cine CT or Helical CT or spiral CT or Four Dimensional CT).ti,ab,kf.
10(CTPA or CT pulmonary angiography or CT angiography).ti,ab,kf.
11or/7-10
12exp Magnetic Resonance Imaging/
13(magnetic resonance imag* or MR imag* or MRI* or fMRI* or magnetic resonance tomograph* or MR tomograph* or magnetization transfer contrast imag* or magnetisation transfer imag* or magnetization transfer imag* or magnetisation transfer imag* or chemical shift imag* or NMR imag* or zeugmatography or NMR tomography or proton spin tomography or magnetic resonance scan* or MR scan*).ti,ab,kf.
1412 or 13
15Perfusion Imaging/ or Tomography, Emission-Computed, Single-Photon/ or Radionuclide Imaging/
16(radionuclide imag* or gamma camera imag* or perfusion imaging or lung perfusion or scintigraph* or scintigram* or scintiphotograph* or laminoscintigraph* or scintillation or scintillograph* or scintiscan).ti,ab,kf.
17(ventilation-perfusion adj4 (imag* or scan* or SPECT)).ti,ab,kf.
18("ventilation/perfusion" adj4 (imag* or scan* or SPECT)).ti,ab,kf.
19((ventilation and perfusion) adj4 (imag* or scan* or SPECT)).ti,ab,kf.
20((VQ or V-Q or "v/q" or "V/P" or VP or V-P) adj4 (imag* or scan* or SPECT)).ti,ab,kf.
21or/15-20
22Positron-Emission Tomography/
23(PET adj4 (scan* or imag*)).ti,ab,kf.
24(FDGPET or FDG PET or PETCT or PET CT or positron).ti,ab,kf.
25or/22-24
26exp Lung/us
27exp Ultrasonography/
28(ultrasound or sonogra* or ultrasonic or ultrasonogra* or echotomogra* or echogra* or doppler).ti,ab,kf.
29or/27-28
30exp lung/
31(lung or lungs or thoracic or thorax or chest).ti,ab,kf.
32or/30-31
3329 and 32
34exp Echocardiography/
35(cardiac echo* or heart echo* or echocardiogra* or echo-cardiogra* or cardiac echogra* or cardiac scan* or cardial echography or cardioechography or heart echography or heart scan* or myocardi* scan* or ultrasound cardiography).ti,ab,kf.
36or/26,33-35
3711 or 14 or 21 or 25 or 36
386 and 37
3938 use pmez
40lung embolism/
41pulmonary embolism/
42((pulmonary or lung) adj4 (embolism* or embolus or emboli* or emboly or thromboemboli* or thrombo-emboli* or microemboli* or microembolus or micro-emboli* or micro-embolus or blood clot*)).ti,ab,kw.
43Venous Thromboembolism/
44((venous or vein) adj4 (thromboemboli* or thrombo-emboli*)).ti,ab,kw.
45VTE.ti,ab,kw.
46or/40-45
47exp computer assisted tomography/
48((computed or computer* or electron beam) adj4 (tomograph* or angiograph*)).ti,ab,kw.
49(CT scan* or X-ray CT or CT X Ray? or CAT scan* or multi-detector CT or tomodensitometry or cine CT or Helical CT or spiral CT or Four Dimensional CT).ti,ab,kw.
50(CTPA or CT pulmonary angiograph* or CT angiograph*).ti,ab,kw.
51or/47-50
52exp nuclear magnetic resonance imaging/
53(magnetic resonance imag* or MR imag* or MRI* or fMRI* or magnetic resonance tomograph* or MR tomograph* or magnetization transfer contrast imag* or magnetisation transfer imag* or magnetization transfer imag* or magnetisation transfer imag* or chemical shift imag* or NMR imag* or zeugmatography or NMR tomography or proton spin tomography or magnetic resonance scan* or MR scan*).ti,ab,kw.
5452 or 53
55exp scintigraphy/ or single photon emission computer tomography/ or exp scintiscanning/ or lung scintiscanning/
56(radionuclide imag* or gamma camera imag* or perfusion imaging or lung perfusion or scintigraph* or scintigram* or scintiphotograph* or laminoscintigraph* or scintillation or scintillograph* or scintiscan).ti,ab,kw.
57(ventilation-perfusion adj4 (imag* or scan* or SPECT)).ti,ab,kw.
58("ventilation/perfusion" adj4 (imag* or scan* or SPECT)).ti,ab,kw.
59((ventilation and perfusion) adj4 (imag* or scan* or SPECT)).ti,ab,kw.
60((VQ or V-Q or "v/q" or "V/P" or VP or V-P) adj4 (imag* or scan* or SPECT)).ti,ab,kw.
61or/55-60
62positron emission tomography/
63(PET adj4 (scan* or imag*)).ti,ab,kw.
64(FDGPET or FDG PET or PETCT or PET CT or positron).ti,ab,kw.
65or/62-64
66exp echography/
67(ultrasound or sonogra* or ultrasonic or ultrasonogra* or echotomogra* or echogra* or doppler).ti,ab,kw.
68or/66-67
69exp lung/
70(lung or lungs or thoracic or thorax or chest).ti,ab,kw.
71or/69-70
7268 and 71
73(cardiac echo* or heart echo* or echocardiogra* or echo-cardiogra* or cardiac echogra* or cardiac scan* or cardial echography or cardioechography or heart echography or heart scan* or myocardi* scan* or ultrasound cardiography).ti,ab,kw.
74exp echocardiography/
75or/72-74
7651 or 54 or 61 or 65 or 75
7746 and 76
7877 use oemezd
7978 not conference abstract.pt.
80exp pulmonary embolism/
81((pulmonary or lung) adj4 (embolism* or embolus or emboli* or emboly or thromboemboli* or thrombo-emboli* or microemboli* or microembolus or micro-emboli* or micro-embolus or blood clot*)).ti,ab,kf.
82Venous Thromboembolism/
83((venous or vein) adj4 (thromboemboli* or thrombo-emboli*)).ti,ab,kf.
84VTE.ti,ab,kf.
85or/80-84
86Fibrin Fibrinogen Degradation Products/
87(d-dimer or fibrin or fibrinogen or fibrinolytic).ti,ab,kf.
88Decision Support Techniques/
89(wells or geneva or PERC or rule out criteria or gestalt or risk stratification).ti,ab,kf.
90(decision adj4 (rule* or model* or analys?s or support or aid*)).ti,ab,kf.
91(prediction adj4 (rule* or model* or analys?s or support or aid*)).ti,ab,kf.
92(rule out or decision or prediction).ti.
93or/86-92
9485 and 93
9594 use pmez
96lung embolism/
97pulmonary embolism/
98((pulmonary or lung) adj4 (embolism* or embolus or emboli* or emboly or thromboemboli* or thrombo-emboli* or microemboli* or microembolus or micro-emboli* or micro embolus or blood clot*)).ti,ab,kw.
99Venous Thromboembolism/
100((venous or vein) adj4 (thromboemboli* or thrombo-emboli*)).ti,ab,kw.
101VTE.ti,ab,kw.
102or/96-101
103fibrin degradation product/ or D dimer/
104(d-dimer or fibrin or fibrinogen or fibrinolytic).ti,ab,kw.
105decision support system/
106(wells or geneva or PERC or rule out criteria or gestalt or risk stratification).ti,ab,kw.
107(decision adj4 (rule* or model* or analys?s or support or aid*)).ti,ab,kw.
108(prediction adj4 (rule* or model* or analys?s or support or aid*)).ti,ab,kw.
109(rule out or decision or prediction).ti.
110or/103-109
111102 and 110
112111 use oemezd
113112 not conference abstract.pt.
11439 or 79 or 95 or 113
115exp Ethics/
116exp Privacy/
117exp Sociology/
118exp Jurisprudence/
119Morale/
120exp Morals/
121Paternalism/
122exp Prejudice/
123Social Values/
124Social Norms/
125"Legislation & Jurisprudence".fs.
126ethics.fs.
127exp Geography, Medical/
128Medically Underserved Area/
129((Healthcare or Health Care or nonclinical or Community Based) adj (Deliver* or Distribution* or System*)).ti,ab,kf.
130(geographic adj (region* or area*)).ti,ab,kf.
131(remote or urban or rural).ti,ab,kf.
132(ethic or ethics or ethical or moral* or bioethic*).ti,ab,hw,kf.
133(legal* or liabilit* or litigation* or constitutional or justice or law or laws or jurisprudence or complicit*).ti,ab,hw,kf.
134(lawsuit* or lawyer* or lawmaker*).ti,ab,kf.
135human right*.ti,ab,kf.
136civil right*.ti,ab,kf.
137(prejudice* or stigma or stigmas or stigmatization or stigmatize or stigmatise or stigmatisation or inequalit* or fairness).ti,ab,kf.
138((care or treatment) adj2 (duty or obligat*)).ti,ab,kf.
139(social* adj (responsibl* or obligat*)).ti,ab,kf.
140(communitarian* or beneficence or nonmaleficence or maleficence or accountability).ti,ab,kf.
141harm.ti,ab,kf.
142(privacy or private or confidential*).ti,ab,hw,kf.
143((informed or presumed) adj2 (consent or choice or decision making)).ti,ab,kf.
144autonomy.ti,ab,hw,kf.
145transparency.ti,ab,kf.
146or/115-145
147114 and 146
148limit 147 to yr="2006 -Current"
149embolisms/
150((pulmonary or lung) adj4 (embolism* or embolus or emboli* or emboly or thromboemboli* or thrombo-emboli* or microemboli* or microembolus or micro-emboli* or micro-embolus or blood clot*)).ti,ab.
151((venous or vein) adj4 (thromboemboli* or thrombo-emboli*)).ti,ab.
152VTE.ti,ab.
153or/149-152
154exp ethics/
155exp "law (government)"/
156privacy/
157exp social influences/
158morality/
159((Healthcare or Health Care or nonclinical or Community Based) adj (Deliver* or Distribution* or System*)).ti,ab,id.
160(geographic adj (region* or area*)).ti,ab,id.
161(remote or urban or rural).ti,ab,id.
162(ethic or ethics or ethical or moral* or bioethic*).ti,ab,id.
163(legal* or liabilit* or litigation* or constitutional or justice or law or laws or jurisprudence or complicit*).ti,ab,id.
164(lawsuit* or lawyer* or lawmaker*).ti,ab,id.
165human right*.ti,ab,id.
166civil right*.ti,ab,id.
167(prejudice* or stigma or stigmas or stigmatization or stigmatize or stigmatise or stigmatisation or inequalit* or fairness).ti,ab,id.
168((care or treatment) adj2 (duty or obligat*)).ti,ab,id.
169(social* adj (responsibl* or obligat*)).ti,ab,id.
170(communitarian* or beneficence or nonmaleficence or maleficence or accountability).ti,ab,id.
171harm.ti,ab,id.
172(privacy or private or confidential*).ti,ab,id.
173(distributive justice or precautionary principle or solidarity or equity).ti,ab,id.
174((informed or presumed or shared) adj2 (consent or choice or decision making)).ti,ab,id.
175autonomy.ti,ab,hw,id.
176transparency.ti,ab,id.
177or/154-176
178153 and 177
179limit 178 to yr="2006 -Current"
180179 use psyb
181148 or 180
182limit 181 to (english or french)
183remove duplicates from 182
OTHER DATABASES
PubMedSearched to capture records not indexed in MEDLINE. Same MeSH, keywords and limits used as per MEDLINE search, with appropriate syntax used.
CINAHLSearched to capture records not indexed in MEDLINE. Same MeSH, keywords and limits used as per MEDLINE search, with appropriate syntax used, including the addition of CINAHL headings.

Grey Literature

Dates for Search:Sept 2016
Keywords:Pulmonary embolism, venous thromboembolism
Limits:Publication years 2006 – present

Relevant websites from the following sections of the CADTH grey literature checklist, “Grey matters: a practical tool for searching health-related grey literature” (https://www.cadth.ca/grey-matters), will be searched:

  • HTA Agencies
  • Health Economics
  • Clinical Practice Guidelines
  • Databases (free)
  • Internet Search
  • Open Access Journals.
Copyright © 2016 CADTH.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK401823
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