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The completeness of intervention descriptions in published National Institute of Health Research HTA-funded trials: a cross-sectional study

The completeness of intervention descriptions in published National Institute of Health Research HTA-funded trials: a cross-sectional study
The completeness of intervention descriptions in published National Institute of Health Research HTA-funded trials: a cross-sectional study
Objectives

The objective of this study was to assess whether National Institute of Health Research (NIHR) Health Technology Assessment (HTA)-funded randomised controlled trials (RCTs) published in the HTA journal were described in sufficient detail to replicate in practice.

Setting

RCTs published in the HTA journal.

Participants

98 RCTs published in the HTA journal up to March 2011. Completeness of the intervention description was assessed independently by two researchers using a checklist, which included assessments of participants, intensity, schedule, materials and settings. Disagreements in scoring were discussed in the team; differences were then explored and resolved.

Primary and secondary outcome measures

Proportion of trials rated as having a complete description of the intervention (primary outcome measure). The proportion of drug trials versus psychological and non-drug trials rated as having a complete description of the intervention (secondary outcome measures).

Results

Components of the intervention description were missing in 68/98 (69.4%) reports. Baseline characteristics and descriptions of settings had the highest levels of completeness with over 90% of reports complete. Reports were less complete on patient information with 58.2% of the journals having an adequate description. When looking at individual intervention types, drug intervention descriptions were more complete than non-drug interventions with 33.3% and 30.6% levels of completeness, respectively, although this was not significant statistically. Only 27.3% of RCTs with psychological interventions were deemed to be complete, although again these differences were not significant statistically.

Conclusions

Ensuring the replicability of study interventions is an essential part of adding value in research. All those publishing clinical trial data need to ensure transparency and completeness in the reporting of interventions to ensure that study interventions can be replicated.
1-9
Douet, Lisa
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Milne, Ruairidh
bd90470b-bba2-49a1-aa12-f1319d78afc2
Anstee, Sydney
16f6038e-7583-4c80-9306-255713acfaee
Habens, Fay
3e4cce4b-4521-4702-9582-f817d25aad37
Young, Amanda
6bb7aa9c-776b-4bdd-be4e-cf67abd05652
Wright, David
a55be721-4b15-4555-bf61-73fcb75c1a39
Douet, Lisa
5b69d767-744c-4bda-9767-f231611e31e6
Milne, Ruairidh
bd90470b-bba2-49a1-aa12-f1319d78afc2
Anstee, Sydney
16f6038e-7583-4c80-9306-255713acfaee
Habens, Fay
3e4cce4b-4521-4702-9582-f817d25aad37
Young, Amanda
6bb7aa9c-776b-4bdd-be4e-cf67abd05652
Wright, David
a55be721-4b15-4555-bf61-73fcb75c1a39

Douet, Lisa, Milne, Ruairidh, Anstee, Sydney, Habens, Fay, Young, Amanda and Wright, David (2014) The completeness of intervention descriptions in published National Institute of Health Research HTA-funded trials: a cross-sectional study. BMJ Open, 4 (1), 1-9. (doi:10.1136/bmjopen-2013-003713).

Record type: Article

Abstract

Objectives

The objective of this study was to assess whether National Institute of Health Research (NIHR) Health Technology Assessment (HTA)-funded randomised controlled trials (RCTs) published in the HTA journal were described in sufficient detail to replicate in practice.

Setting

RCTs published in the HTA journal.

Participants

98 RCTs published in the HTA journal up to March 2011. Completeness of the intervention description was assessed independently by two researchers using a checklist, which included assessments of participants, intensity, schedule, materials and settings. Disagreements in scoring were discussed in the team; differences were then explored and resolved.

Primary and secondary outcome measures

Proportion of trials rated as having a complete description of the intervention (primary outcome measure). The proportion of drug trials versus psychological and non-drug trials rated as having a complete description of the intervention (secondary outcome measures).

Results

Components of the intervention description were missing in 68/98 (69.4%) reports. Baseline characteristics and descriptions of settings had the highest levels of completeness with over 90% of reports complete. Reports were less complete on patient information with 58.2% of the journals having an adequate description. When looking at individual intervention types, drug intervention descriptions were more complete than non-drug interventions with 33.3% and 30.6% levels of completeness, respectively, although this was not significant statistically. Only 27.3% of RCTs with psychological interventions were deemed to be complete, although again these differences were not significant statistically.

Conclusions

Ensuring the replicability of study interventions is an essential part of adding value in research. All those publishing clinical trial data need to ensure transparency and completeness in the reporting of interventions to ensure that study interventions can be replicated.

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More information

Accepted/In Press date: 29 November 2013
Published date: 2 January 2014
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 368196
URI: http://eprints.soton.ac.uk/id/eprint/368196
PURE UUID: f17116c4-3038-4215-a2f4-3376af9ff670
ORCID for Ruairidh Milne: ORCID iD orcid.org/0000-0002-5117-4380
ORCID for Sydney Anstee: ORCID iD orcid.org/0000-0002-1462-9446
ORCID for Amanda Young: ORCID iD orcid.org/0000-0002-1486-5561

Catalogue record

Date deposited: 20 Aug 2014 13:32
Last modified: 18 Feb 2021 17:12

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Contributors

Author: Lisa Douet
Author: Ruairidh Milne ORCID iD
Author: Sydney Anstee ORCID iD
Author: Fay Habens
Author: Amanda Young ORCID iD
Author: David Wright

University divisions

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