Sham radiation in clinical trials assessing radiotherapy for exudative age-related macular degeneration

Dennis M. Marcus, Matthew W. Camp, W. Chris Sheils, Sandra B. McIntosh, Diane B. Leibach, Maribeth H Johnson, Chander N. Samy

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background: To evaluate the effectiveness of sham radiation treatments in masking patients to their randomization group in the Radiation of Age- Related Macular Degeneration (ROARMD) Study. Methods: Patients with choroidal neovascularization complicating age-related macular degeneration were randomized to a treatment (RAD) group that received external beam irradiation (seven treatment sessions) or to a control (SHAM) group that received sham radiation (one sham treatment session). During a telephone survey, 62 of 73 randomized patients responded to the following questions: Do you think you received radiation? Why do you feel that way? Did the vision in your study eye women after enrollment? Results: Eighty-one percent of the RAD group and 59% of the SHAM group thought that they had received radiation. In patients who thought that their vision had stabilized or improved, 82% thought that they had received radiation. In patients who thought that their vision was worse, only 39% thought that they had received radiation. In 54% of patients, subjective perception of vision influenced their guess as to whether they received radiation. Conclusions: Subjective patient perception of visual outcome was the most influential variable for masking. Variation between radiation treatment and sham session techniques, such as equipment used and duration of treatments, played a lesser role in the masking of patients. Seven treatment days correlated with a higher number of patients who thought that they had received radiation. Although our procedures do not strictly mask the two groups, one sham radiation session was effective in keeping patients guessing their randomization group.

Original languageEnglish (US)
Pages (from-to)525-530
Number of pages6
JournalRetina
Volume19
Issue number6
DOIs
StatePublished - Jan 1 1999

Fingerprint

Macular Degeneration
Radiotherapy
Clinical Trials
Radiation
Placebos
Random Allocation
Choroidal Neovascularization
Visual Perception
Therapeutics
Masks
Telephone
Equipment and Supplies
Control Groups

Keywords

  • Age-related macular degeneration
  • Choroidal neovascularization
  • External beam irradiation
  • Masking
  • Placebo
  • Radiotherapy
  • Randomized clinical trial
  • Sham radiation

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Marcus, D. M., Camp, M. W., Sheils, W. C., McIntosh, S. B., Leibach, D. B., Johnson, M. H., & Samy, C. N. (1999). Sham radiation in clinical trials assessing radiotherapy for exudative age-related macular degeneration. Retina, 19(6), 525-530. https://doi.org/10.1097/00006982-199919060-00008

Sham radiation in clinical trials assessing radiotherapy for exudative age-related macular degeneration. / Marcus, Dennis M.; Camp, Matthew W.; Sheils, W. Chris; McIntosh, Sandra B.; Leibach, Diane B.; Johnson, Maribeth H; Samy, Chander N.

In: Retina, Vol. 19, No. 6, 01.01.1999, p. 525-530.

Research output: Contribution to journalArticle

Marcus, Dennis M. ; Camp, Matthew W. ; Sheils, W. Chris ; McIntosh, Sandra B. ; Leibach, Diane B. ; Johnson, Maribeth H ; Samy, Chander N. / Sham radiation in clinical trials assessing radiotherapy for exudative age-related macular degeneration. In: Retina. 1999 ; Vol. 19, No. 6. pp. 525-530.
@article{71801801fdee4afaaf7dd6ad2849d63d,
title = "Sham radiation in clinical trials assessing radiotherapy for exudative age-related macular degeneration",
abstract = "Background: To evaluate the effectiveness of sham radiation treatments in masking patients to their randomization group in the Radiation of Age- Related Macular Degeneration (ROARMD) Study. Methods: Patients with choroidal neovascularization complicating age-related macular degeneration were randomized to a treatment (RAD) group that received external beam irradiation (seven treatment sessions) or to a control (SHAM) group that received sham radiation (one sham treatment session). During a telephone survey, 62 of 73 randomized patients responded to the following questions: Do you think you received radiation? Why do you feel that way? Did the vision in your study eye women after enrollment? Results: Eighty-one percent of the RAD group and 59{\%} of the SHAM group thought that they had received radiation. In patients who thought that their vision had stabilized or improved, 82{\%} thought that they had received radiation. In patients who thought that their vision was worse, only 39{\%} thought that they had received radiation. In 54{\%} of patients, subjective perception of vision influenced their guess as to whether they received radiation. Conclusions: Subjective patient perception of visual outcome was the most influential variable for masking. Variation between radiation treatment and sham session techniques, such as equipment used and duration of treatments, played a lesser role in the masking of patients. Seven treatment days correlated with a higher number of patients who thought that they had received radiation. Although our procedures do not strictly mask the two groups, one sham radiation session was effective in keeping patients guessing their randomization group.",
keywords = "Age-related macular degeneration, Choroidal neovascularization, External beam irradiation, Masking, Placebo, Radiotherapy, Randomized clinical trial, Sham radiation",
author = "Marcus, {Dennis M.} and Camp, {Matthew W.} and Sheils, {W. Chris} and McIntosh, {Sandra B.} and Leibach, {Diane B.} and Johnson, {Maribeth H} and Samy, {Chander N.}",
year = "1999",
month = "1",
day = "1",
doi = "10.1097/00006982-199919060-00008",
language = "English (US)",
volume = "19",
pages = "525--530",
journal = "Retina",
issn = "0275-004X",
publisher = "Lippincott Williams and Wilkins",
number = "6",

}

TY - JOUR

T1 - Sham radiation in clinical trials assessing radiotherapy for exudative age-related macular degeneration

AU - Marcus, Dennis M.

AU - Camp, Matthew W.

AU - Sheils, W. Chris

AU - McIntosh, Sandra B.

AU - Leibach, Diane B.

AU - Johnson, Maribeth H

AU - Samy, Chander N.

PY - 1999/1/1

Y1 - 1999/1/1

N2 - Background: To evaluate the effectiveness of sham radiation treatments in masking patients to their randomization group in the Radiation of Age- Related Macular Degeneration (ROARMD) Study. Methods: Patients with choroidal neovascularization complicating age-related macular degeneration were randomized to a treatment (RAD) group that received external beam irradiation (seven treatment sessions) or to a control (SHAM) group that received sham radiation (one sham treatment session). During a telephone survey, 62 of 73 randomized patients responded to the following questions: Do you think you received radiation? Why do you feel that way? Did the vision in your study eye women after enrollment? Results: Eighty-one percent of the RAD group and 59% of the SHAM group thought that they had received radiation. In patients who thought that their vision had stabilized or improved, 82% thought that they had received radiation. In patients who thought that their vision was worse, only 39% thought that they had received radiation. In 54% of patients, subjective perception of vision influenced their guess as to whether they received radiation. Conclusions: Subjective patient perception of visual outcome was the most influential variable for masking. Variation between radiation treatment and sham session techniques, such as equipment used and duration of treatments, played a lesser role in the masking of patients. Seven treatment days correlated with a higher number of patients who thought that they had received radiation. Although our procedures do not strictly mask the two groups, one sham radiation session was effective in keeping patients guessing their randomization group.

AB - Background: To evaluate the effectiveness of sham radiation treatments in masking patients to their randomization group in the Radiation of Age- Related Macular Degeneration (ROARMD) Study. Methods: Patients with choroidal neovascularization complicating age-related macular degeneration were randomized to a treatment (RAD) group that received external beam irradiation (seven treatment sessions) or to a control (SHAM) group that received sham radiation (one sham treatment session). During a telephone survey, 62 of 73 randomized patients responded to the following questions: Do you think you received radiation? Why do you feel that way? Did the vision in your study eye women after enrollment? Results: Eighty-one percent of the RAD group and 59% of the SHAM group thought that they had received radiation. In patients who thought that their vision had stabilized or improved, 82% thought that they had received radiation. In patients who thought that their vision was worse, only 39% thought that they had received radiation. In 54% of patients, subjective perception of vision influenced their guess as to whether they received radiation. Conclusions: Subjective patient perception of visual outcome was the most influential variable for masking. Variation between radiation treatment and sham session techniques, such as equipment used and duration of treatments, played a lesser role in the masking of patients. Seven treatment days correlated with a higher number of patients who thought that they had received radiation. Although our procedures do not strictly mask the two groups, one sham radiation session was effective in keeping patients guessing their randomization group.

KW - Age-related macular degeneration

KW - Choroidal neovascularization

KW - External beam irradiation

KW - Masking

KW - Placebo

KW - Radiotherapy

KW - Randomized clinical trial

KW - Sham radiation

UR - http://www.scopus.com/inward/record.url?scp=0033512396&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033512396&partnerID=8YFLogxK

U2 - 10.1097/00006982-199919060-00008

DO - 10.1097/00006982-199919060-00008

M3 - Article

C2 - 10606453

AN - SCOPUS:0033512396

VL - 19

SP - 525

EP - 530

JO - Retina

JF - Retina

SN - 0275-004X

IS - 6

ER -