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Modifications

Item 11b: Criteria for discontinuing or modifying allocated interventions for a given trial participant (e.g., drug dose change in response to harms, participant request, or improving/worsening disease).

Example

“Gastro-Intestinal Upset

The tablets may be taken in two equally divided doses, if necessary, to improve gastro-intestinal tolerance. Should it be necessary the daily dose may be reduced by one tablet at a time to improve gastro-intestinal tolerance.

Renal Function Impairment

Since sodium clodronate is excreted unchanged by the kidney its use is contra-indicated in patients with moderate to severe renal impairment (serum creatinine greater than 2 times upper limit of normal range of the centre). If renal function deteriorates to this extent the trial medication should be withdrawn from the patient. This should be reported as an adverse event. In patients with normal renal function or mild renal impairment (serum creatinine less than 2 times upper limit of normal range of the centre) serum creatinine should be monitored during therapy.

Allergic Reactions

Allergic skin reactions have been observed in rare cases. If this is suspected withdraw the trial medication from the patient. This should be reported as an adverse event.

Biochemical Disturbances

Asymptomatic hypocalcaemia has been noted rarely. Temporary suspension of the trial medication until the serum calcium returns into the normal range is recommended. The trial medication can be then restarted at half the previous dose. If the situation returns withdraw the trial medication from the patient. This should be reported as an adverse event . . .151

Explanation

For a given trial participant, the assigned study intervention may need to be modified or discontinued by trial investigators for various reasons, including harms, improved health status, lack of efficacy, and withdrawal of participant consent. Comparability across study groups can be improved, and subjectivity in care decisions reduced, by defining standard criteria for intervention modifications and discontinuations in the protocol. Regardless of any decision to modify or discontinue their assigned intervention, study participants should be retained in the trial whenever possible to enable follow-up data collection and prevent missing data (Item 18b).152

11a: Interventions 11c: Adherence
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