A SYSTEMATIC REVIEW OF ETHICAL ISSUES IN THE HEALTH

TECHNOLOGY ASSESSMENT OF OVARIAN STIMULATION AND

OVULATION INDUCTION: CONVERGENCE AND DISJUNCTURE

Shawn Winsor, PhDc

Vanier Canada Graduate Scholar

Centre for Health Economics and Policy Analysis

McMaster University

PILOT STUDY OBJECTIVES

• identify, via systematic review of the non-empirical bioethics scholarship, the ethical issues related to ovarian stimulation (OS) and ovulation induction (OI)

• identify ethical issues in the health technology assessment (HTA) of OS and OI

• compare the two groups of issues for instances of coherence and disjuncture.

STUDY METHODOLOGY

1) Define key terms (“assisted reproductive technology”, “health technology assessment”), and identify inclusion and exclusion criteria for ARTs and HTAs to be the subject of study

2) Acquire HTAs and conduct analysis

3) Acquire Ethics Scholarship and conduct analysis

4) Compare analyses

HTA ACQUISITION PROCESS

1) Identify HTA database (University of York’s Centre for Reviews and Dissemination [CRD])

2) Search CRD dbase using MeSH and free term equivalents of ARTs meeting incl. criteria and evaluate HTAs found against HTA incl. and excl. criteria

3) Search internet (Google, Google Scholar, and individual HTA agency websites) for copies of full reports for those HTAs meeting incl. criteria but not accessible via CRD dbase

4) Contact via email individual HTA agencies for which no full English language report was located online

5) Conduct search for full English language HTAs using inclusion search criteria on all INAHTA member agencies and on those of non-members from whom a relevant HTA report was located via earlier search of CRD database

6) Review HTA report a) for descriptive and normative ethics issues to be clustered into themes for later comparative analysis with themes identified in ethics scholarship SR; b) to identify clinical terms to be used as search parameters for ethics scholarship SR

CONCEPT MAP : HTA ACQUISITION PROCESS

HTA INCLUDED IN STUDY

Technology

Total reports used in pilot study (i.e., meet inclusion criteria and full copy in possession)

Request for English copy made but no reply received from authoring agency

Reports not meeting inclusion criteria

Total excluded reports (i.e., did not meet inclusion criteria or not accessible from HTA agency)

Ovarian Stimulation / Induction

2

6

2

8

Corabian P, Scott A. Ovulation induction drug therapy for anovulatory infertility associated with polycystic ovary syndrome. Edmonton: Alberta Heritage Foundation for Medical Research (AHFMR). HTA 33. 2004.

Centre for Clinical Effectiveness. In women labelled as poor responders to ovulation stimulation in an assisted reproduction program, is there evidence for the effectiveness of increasing the total dose of FSH above 3000 IU? Clayton, Victoria: Centre for Clinical Effectiveness (CCE) 2000: 25

ETHICS SCHOLARSHIP SYSTEMATIC REVIEW (SR) AND ANALYSIS

1) Identify focused research question to support search of ethics scholarship

2) Develop search algorithm to answer the focused research question 3) Employ standardized search strategy across four pre-selected

dbases/search engines accommodating variations in each dbase’s search capacity

4) Assess references for relevance using eligibility criteria (i.e., English, published w/i 5 years of HTA, not empirical study on clinical topic)

5) Code summaries of descriptive and normative ethics-related information from papers selected from ethics scholarship SR

6) Employ chart to map correlations between HTAs and ethical issues and questions arising from the bioethics scholarship

7) Employ Grunwald (2004) criteria to determine whether ethical issues identified in ethics scholarship SR warrant HTA providing normative as well as descriptive analysis

BIBL IOGRAPHIC SEARCH STRATEGY – OS AND OI

Variant of Strech/McCullough systematic review search strategy for bioethics topics Search interfaces: Ethxweb (Georgetown Bioethics Research Library), Ethicsweb (16 dbases including

Medline/PubMed-Bioethics subset), NIH-NLM Catalog (Includes LOCATORPlus)

Subject: Ovarian Stimulation/Induction (collective noun for a number of related ARTs) Restricted to 1974-2002 (most recent HTA), English (N=247)

MeSH terms re selected inclusion & exclusion criteria developed from focused research question; duplicates removed (N=26)

Title, abstracts, and excerpts reviewed for relevance to the above (N=221)

Articles and books meeting criteria (N = 33)

Titles located through bibliography search of these selected sources and their abstracts/excerpts reviewed for relevance (N=20); of these, articles and books meeting criteria (N=14)

Articles and books unable to be located or upon reading full text assessed as failing to meeting inclusion criteria (N=12); Total used in study (N=35)

Articles and books meeting criteria (N = 47)

FINDINGS

Ethical issues in OS

Ethical issues:

HTA on OS

Ethical issues: bioethics lit on OS

Ethical issues addressed by both bioethics lit and HTAs

ISSUES FROM BIOETHICS SCHOLARSHIP ON OS/OI ALSO IDENTIFIED IN HTAS

ISSUES FROM BIOETHICS SCHOLARSHIP … CONT.

ISSUES FROM BIOETHICS SCHOLARSHIP … CONT.

ETHICAL ISSUES IDENTIFIED IN HTA NOT FOUND IN BIOETHICS LIT

• Financial costs (and its use as framing tool) re:

• Harms and benefits of treatment: direct (patient borne) and indirect (societal borne)

• Informed consent process should include cost data

• Outcome measures chosen by clinics do not adequately address potential downstream cost issues; specifically, the ‘quality’ of the birth as it relates to multiples and premature infants who are resource intensive

=> Live birth rate must be outcome measure so that all costs adequately captured

• Poor quality, availability and/or use of evidence

• Treatment guidelines lacking in available evidence

• Determinations of safety and efficacy not possible

=> National registry needed

META THEMES EMERGING FROM ANALYSIS

1. Lack of definition for key concepts (risk, health damage, best interest/welfare, quality of life, normal/healthy)

2. Outcomes selected for evaluating technologies are ultimately effectiveness-based even if there is ethics review..

3. Substantial ethics evaluation OR little to none that is explicit. Ethics principles that appear in either case are commonly: Non-maleficence, Appropriate allocation of resources, Empowered autonomy (also applies to protecting interests of the child to be born)

4. Call for more research (to determine risks/harms), better research (to increase validity and reduce subjectivity and bias), more timely research dominates every HTA, particularly those in which there is no ethics evaluation

5. Consideration of the future implications of the technology’s use or the need to address anticipated ethical issues is minimal beyond requesting more research to address risk uncertainties

QUESTIONS

FINAL HTA LIST