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Sahota O, Narayanasamy M, Bastounis A, et al. Bisphosphonate alternative regimens for the prevention of osteoporotic fragility fractures: BLAST-OFF, a mixed-methods study. Southampton (UK): National Institute for Health and Care Research; 2024 Apr. (Health Technology Assessment, No. 28.21.)

Cover of Bisphosphonate alternative regimens for the prevention of osteoporotic fragility fractures: BLAST-OFF, a mixed-methods study

Bisphosphonate alternative regimens for the prevention of osteoporotic fragility fractures: BLAST-OFF, a mixed-methods study.

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Appendix 8Assessment of inconsistency

TABLE 18

Amendments to the study protocol

Amendment no.Protocol version no.Date issuedDetails of changes made
SA01 (V 1.1)30 April 2020Change PIC sites to research sites as interviews are done on site. Remove University Hospitals Birmingham and add Haywood Community Hospital. Add 2 community osteoporosis sites
Categorised as non-substantial
NSA01
(COVID-19 Amendment) 		v 1.215 May 2020COVID-19 contingency – additional recruitment from ROS members
Protocol v 1.2 30 April 2020
Poster for ROS recruitment v1.0 30 April 2020
Verbal consent form v1.0 30 April 2020
PIS patient open recruitment call ROS v1.0 30 April 2020
Patient reply form v1.0 30 April 2020
SA02 v 1.329 July 2020To add separate G.P and clinician interview schedules.
Add new interview schedules to protocol appendix 10.1
Update SOE to v2.0 to change postage cost from SSC to Research cost.
Interview schedule clinicians v1.0 26 February 2020
Interview schedule G.Ps v 1.0 26 February 2020
Schedule of events v2.0 18 March 2020
NSA 02
(COVID-19 Amendment) 		v 1.4To facilitate telephone or web-based patient and clinician interviews rather than face-to face contact under the current COVID-19 restrictions. To justify over recruitment of primary and secondary care patients via open invitation to reach data saturation as an end point.
Protocol v 1.4
Verbal consent Script and Confirmation Form patient v1.0 2 October 2020
Verbal Consent Script and Confirmation Form clinician v1.0 2 October 2020
Patient Information Sheet v1.2 2 October 2020
Clinician Information sheet v1.2 2 October 2020
G.P and Health Professional Invitation letter 1.0 10 September 20
Clinic patient invitation letter v1.2 9 September 2020

PIC, Participant Identification Centre;

PIS, patient information sheet.

Copyright © 2024 Sahota et al.

This work was produced by Sahota et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

Bookshelf ID: NBK602858
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