Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 3. Imatinib for Chronic Myeloid Leukemia (CML) (continued)

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Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy

Part 3. Imatinib for Chronic Myeloid Leukemia (CML) (continued)

Appendixes

Appendix A: MEDLINE® Search Strategy

Database: Ovid MEDLINE® <1966 to September Week 3 2004>

Search Strategy:

4    randomized controlled trial.pt. (194192)
5    controlled clinical trial.pt. (67292)
6    Randomized Controlled Trials/ (34359)
7    Random Allocation/ (51911)
8    Double-Blind Method/ (79820)
9    Single-Blind Method/ (8433)
10   or/4-9 (329367)
11   Animal/ not Human/ (2838957)
12   10 not 11 (311915)
13   clinical trial.pt. (392148)
14   exp Clinical Trials/ (159166)
15   (clinic$ adj25 trial$).tw. (103424)
16   ((singl$ or doubl$ or trebl$ or tripl$) adj (mask$ or blind$)).tw. (76365)
17   Placebos/ (23320)
18   placebo$.tw. (86217)
19   random$.tw. (294378)
20   Research Design/ (38965)
21   (latin adj square).tw. (2126)
22   or/13-21 (693867)
23   22 not 11 (643785)
24   23 not 12 (342333)
25   Comparative Study/ (1152523)
26   exp Evaluation Studies/ (499768)
27   Follow-Up Studies/ (288858)
28   Prospective Studies/ (178265)
29   (control$ or prospectiv$ or volunteer$).tw. (1483791)
30   Cross-Over Studies/ (15073)
31   or/25-30 (2964552)
32   31 not 11 (2271429)
33   32 not (12 or 24) (1817997)
34   12 or 24 or 33 (2472245)
38   (imatinib or gleevec or glivec or STI571).mp. (1613)
39   exp leukemia, myeloid, chronic/ (9737)
40   38 and 39 (718)
41   40 and 34 (286)
42   limit 41 to english language (250)

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Appendix B: Quality Criteria

Quality Criteria for Assessment of Experimental Studies

1. Was the assignment to the treatment groups random?

Adequate approaches to sequence generation:

Computer-generated random numbers.
Random numbers tables.

Inadequate approaches to sequence generation:

Use of alternation, case record numbers, birth dates or weekdays.

2. Was the treatment allocation concealed?

Adequate approaches to concealment of randomization:

Centralized or pharmacy-controlled randomization.
Serially-numbered identical containers.
On-site computer based system with a randomization sequence that is not readable until allocation.
Other approaches with robust methods to prevent foreknowledge of the allocation sequence to clinicians and patients.

Inadequate approaches to concealment of randomization:

Use of alternation, case record numbers, birth dates or weekdays.
Open random numbers lists.
Serially numbered envelopes (even sealed opaque envelopes can be subject to manipulation).

3. Were the groups similar at baseline in terms of important prognostic factors?

4. Were the eligibility criteria specified?

5. Were outcome assessors blinded to the treatment allocation?

6. Was the care provider blinded?

7. Was the patient blinded?

8. Were the point estimates and measure of variability presented for the primary outcome measure?

9. Did the analyses include an intention to treat analysis?

Quality Criteria for Assessment of Observational Studies

From the York CRD handbook (http://www.york.ac.uk/inst/crd/crd4_ph5.pdf):

Cohort studies

Is there a sufficient description of the groups and the distribution of prognostic factor?
Are the groups assembled at a similar point in their disease progression?
Is the intervention/treatment reliably ascertained?
Were the groups comparable on all-important confounding factors?
Was there adequate adjustment for the effects of these confounding variables?
Was a dose-response relationship between intervention and outcome demonstrated?
Was outcome assessment blind to exposure status?
Was followup long enough for the outcomes to occur?
What proportion of the cohort was followed up?
Were dropout rates and reasons for dropout similar across intervention and unexposed groups?

Case-control studies

Is the case definition explicit?
Had the disease state of the cases been reliably assessed and validated?
Were the controls randomly selected from the source of population of the cases?
How comparable are the cases and controls with respect to potential confounding factors?
Were interventions and other exposures assessed in the same way for cases and controls?
How was the response rate defined?
Were the non-response rates and reasons for non-response the same in both groups?
Is it possible that over-matching has occurred in that cases and controls were matched on factors related to exposure?
Was an appropriate statistical analysis used (matched or unmatched)?

Case series

Is the study based on a representative sample selected from a relevant population?
Are the criteria for inclusion explicit?
Did all individuals enter the survey at a similar point in their disease progression?
Was followup long enough for important events to occur?
Were outcomes assessed using objective criteria or was blinding used?
If comparisons of sub-series are being made, was there a sufficient description of the series and the distribution of prognostic factors?

Select for Appendix B Table: Quality of Included Studies.

Prepared for AHRQ under Contract No. 290-02-0025. By Amy P. Abernethy, M.D.; Douglas C. McCrory, M.D., M.H.S.; Duke Evidence-based Practice Center, Center for Clinical Health Policy Research.

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Current as of November 2005

Internet Citation:

Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy. Part 3. Imatinib for Chronic Myeloid Leukemia (CML). Technology Assessment. November 2005. Rockville, MD: Agency for Healthcare Research and Quality. http://www.ahrq.gov/clinic/ta/cml/