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Table 2 Secondary objectives and outcome measures

From: Effectiveness and cost-effectiveness of Improving clinicians’ diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): study protocol for a cluster randomised controlled trial

Objectives

Outcome measures

Time point(s) of evaluation of this outcome measure

Number of re-consultations to primary and secondary care and number of complications regarding the ALRTI

Re-consultation for new or worsening symptoms, new signs, or hospital admission, assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data), and number of complications regarding the ALRTI

First 6 weeks post-randomisation

Duration of moderate to severe symptoms

Number of days until the last day any of the symptoms is rated 3 or more. Symptoms will be rated daily as 0 (no problem) to 6 (as bad as it could be) until they resolve, and the information will be reported by patients in self-completed diaries.

First 6 weeks post-randomisation

Antibiotic prescription at the baseline visit, differentiating immediate and delayed antibiotic prescribing, and antibiotic dispensing at the pharmacies

Reported in the CRF. The number of patients treated with immediate and delayed antibiotic prescribing will be evaluated. Dispensing of the antibiotics at the pharmacies.

Baseline visit. The dispensing of antibiotics will be tracked in the first 6 weeks post-randomisation.

Drugs other than antibiotics

Reported by patients in self-completed diaries

First 6 weeks post-randomisation

Tests ordered by clinicians

Reported in the CRF

Baseline visit

Patient satisfaction with care

Reported in the symptom diaries

First 6 weeks post-randomisation

Patient perception of the usefulness of the information received

Collected in the symptom diaries

First 6 weeks post-randomisation

Patient future consulting intentions

Collected in the symptom diaries

First 6 weeks post-randomisation

Serious adverse events

Assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data)

First 6 weeks post-randomisation

Number of days of sick leave (absenteeism)

Collected in the CRFs

First 6 weeks post-randomisation

  1. ALRTI acute lower respiratory tract infection, CRF case report form