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Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study

Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study
Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study
Problem: Recruitment to randomised trials is often difficult, and many important trials are not mounted because recruitment is thought to be "impossible."
Design: Controversial ProtecT (prostate testing for cancer and treatment) trial embedded within qualitative research.
Background and setting: Screening for prostate cancer is hotly debated, and evidence from trials about the effectiveness of treatments (surgery, radiotherapy, and monitoring) is lacking. Mounting a treatment trial is controversial because of past failures and concerns that differences in complications of treatment but not survival make randomisation unacceptable to patients and clinicians, particularly for a trial including monitoring.
Strategy for change: In-depth interviews explored interpretation of study information. Audiotape recordings of recruitment appointments enabled scrutiny of content and presentation of study information by recruiters. Initial qualitative findings showed that recruiters had difficulty discussing equipoise and presenting treatments equally; they unknowingly used terminology that was misinterpreted by participants. Findings were used to determine changes to content and presentation of information.
Effects of change: Changes to the order of presenting treatments encouraged emphasis on equivalence, misinterpreted terms were avoided, the non-radical arm was redefined, and randomisation and clinical equipoise were presented more convincingly. The randomisation rate increased from 40% to 70%, all treatments became acceptable, and the three arm trial became the preferred design.
Lessons learnt: Changes to information and presentation resulted in efficient recruitment acceptable to patients and clinicians. Embedding this controversial trial within qualitative research improved recruitment. Such methods probably have wider applicability and may enable even the most difficult evaluative questions to be tackled.
randomised trials, qualitative research, protect, design and conduct, prostate testing
0959-8138
766-770
Dovovan, J.
79fa531f-89a6-400b-a0e3-4b15c8ae7fa3
Mills, N.
3d19d20f-4290-4e30-b188-8f45316ce3e2
Smith, M.
558e1c6b-5c57-444a-9508-509c50128f91
Brindle, L.
17158264-2a99-4786-afc0-30990240436c
Jacoby, A.
aae507a3-ae25-4d64-af80-13090425ff90
Peters, T.
9aca9392-f159-4016-bf12-19a7b4b50c47
Frankel, S.
edd646ee-93c5-48aa-af30-dc82b01a4f6e
Neal, D.
37174619-cca5-4624-8851-646ab0e46fe0
Hamdy, F.
f283c676-ac2a-42a1-93f4-139b1f61ca41
Dovovan, J.
79fa531f-89a6-400b-a0e3-4b15c8ae7fa3
Mills, N.
3d19d20f-4290-4e30-b188-8f45316ce3e2
Smith, M.
558e1c6b-5c57-444a-9508-509c50128f91
Brindle, L.
17158264-2a99-4786-afc0-30990240436c
Jacoby, A.
aae507a3-ae25-4d64-af80-13090425ff90
Peters, T.
9aca9392-f159-4016-bf12-19a7b4b50c47
Frankel, S.
edd646ee-93c5-48aa-af30-dc82b01a4f6e
Neal, D.
37174619-cca5-4624-8851-646ab0e46fe0
Hamdy, F.
f283c676-ac2a-42a1-93f4-139b1f61ca41

Dovovan, J., Mills, N., Smith, M., Brindle, L., Jacoby, A., Peters, T., Frankel, S., Neal, D. and Hamdy, F. (2002) Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. British Medical Journal, 325 (7367), 766-770. (doi:10.1136/bmj.325.7367.766).

Record type: Article

Abstract

Problem: Recruitment to randomised trials is often difficult, and many important trials are not mounted because recruitment is thought to be "impossible."
Design: Controversial ProtecT (prostate testing for cancer and treatment) trial embedded within qualitative research.
Background and setting: Screening for prostate cancer is hotly debated, and evidence from trials about the effectiveness of treatments (surgery, radiotherapy, and monitoring) is lacking. Mounting a treatment trial is controversial because of past failures and concerns that differences in complications of treatment but not survival make randomisation unacceptable to patients and clinicians, particularly for a trial including monitoring.
Strategy for change: In-depth interviews explored interpretation of study information. Audiotape recordings of recruitment appointments enabled scrutiny of content and presentation of study information by recruiters. Initial qualitative findings showed that recruiters had difficulty discussing equipoise and presenting treatments equally; they unknowingly used terminology that was misinterpreted by participants. Findings were used to determine changes to content and presentation of information.
Effects of change: Changes to the order of presenting treatments encouraged emphasis on equivalence, misinterpreted terms were avoided, the non-radical arm was redefined, and randomisation and clinical equipoise were presented more convincingly. The randomisation rate increased from 40% to 70%, all treatments became acceptable, and the three arm trial became the preferred design.
Lessons learnt: Changes to information and presentation resulted in efficient recruitment acceptable to patients and clinicians. Embedding this controversial trial within qualitative research improved recruitment. Such methods probably have wider applicability and may enable even the most difficult evaluative questions to be tackled.

Full text not available from this repository.

More information

Published date: October 2002
Keywords: randomised trials, qualitative research, protect, design and conduct, prostate testing

Identifiers

Local EPrints ID: 19193
URI: http://eprints.soton.ac.uk/id/eprint/19193
ISSN: 0959-8138
PURE UUID: 97bb2214-a2a3-42c6-a938-6289fa3a5d8f
ORCID for L. Brindle: ORCID iD orcid.org/0000-0002-8933-3754

Catalogue record

Date deposited: 19 Jan 2006
Last modified: 17 Dec 2019 01:45

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