Item 18: Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure)

Example

​

“With the assistance of a blinded investigator, participants will complete online outcome questionnaires preoperatively, the day following surgery, and at home at one, three, six and 12 postoperative months. Questionnaires will include: 1. VAS lower back pain; 2. VAS leg pain; 3. ODI; 4. Current situation/patient satisfaction questionnaire; 5. SF-12/EuroQol (EQ-5D) (quality of life questionnaire). Patients will receive standard post-operative trial blinded neurosurgical outpatient review at approximately 30–60 days following surgery at trial sites. Teleconsultation will occur at the three, six and 12 months. Patients will only receive further neurosurgical outpatient review if clinically indicated. ….. The participant timeline is illustrated below.”(Figure 2) [286]. 

​

Explanation

​

A concise timeline of the planned study visits, enrolment process, interventions, and assessments performed on participants can help to guide trial conduct and enable external review of participant burden and feasibility. These factors can also affect the decision of potential investigators and participants to join the trial (Item 20) [287].

A schematic diagram is highly recommended to efficiently present the overall schedule and time commitment for trial participants in each study group. Though various presentation formats exist, key information to convey includes the timing of each visit, starting from initial eligibility screening through to study close-out; time periods during which the trial intervention/comparator will be administered (including any run-ins and washout periods);(288) and the procedures and assessments performed at each visit (with reference to specific data collection forms, if relevant).

​​​​

Figure 2 Participant schedule of enrolment, interventions, and assessments for a randomised trial of lumbar microdiscectomy and post-operative activity restrictions a