3 Seminar Two

In this session, we will build on your recent learning about experimental trial protocols. Developing a trial protocol is a crucial process that requires meticulous planning, adherence to guidelines, and consideration of ethical and scientific standards. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines serve as a valuable framework for designing and reporting clinical trial protocols.

3.1 Task 1

Download the SPIRIT guidelines (Table 1):

• Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-207.

Choose one of the following study protocols and determine whether they meet the SPIRIT guidelines:

• Riemenschneider, M., Hvid, L. G., Ringgaard, S., Nygaard, M. K., Eskildsen, S. F., Petersen, T., … & Dalgas, U. (2021). Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES). BMJ open, 11(1), e043699.
• Gschwind, Y. J., Kressig, R. W., Lacroix, A., Muehlbauer, T., Pfenninger, B., & Granacher, U. (2013). A best practice fall prevention exercise program to improve balance, strength/power, and psychosocial health in older adults: study protocol for a randomized controlled trial. BMC geriatrics, 13, 1-13.
• Amano, S., Ludin, A. F. M., Clift, R., Nakazawa, M., Law, T. D., Rush, L. J., … & Clark, B. C. (2016). Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial. Trials, 17(1), 1-11.

3.2 Task 3

Download and ‘save as’ the following Staffordshire University Experimental Trial Protocol Template

3.3 Task 4

To gain the ethical approval needed to conduct your pilot study, you will need to submit (via blackboard) a detailed trial protocol for the project you are proposing.

Spend the rest of the session identifying what information you will need to gather in order to compile this document. Then start to populate it. This is a working document and as such it should develop over time, as your idea becomes more refined and as you read more literature.

3.4 Task 5

Start by detailing the following components of your study:

• Title and Description: Clearly state the title of the study and provide a brief description of the research question or objective.
• Study Type: Specify the type of study design being used, such as randomized controlled trial (RCT), observational study, crossover trial, etc.
• Study Setting: Describe where the study will take place, including any specific institutions, clinics, or geographic locations involved.
• Population:
  • Inclusion Criteria: Clearly define the characteristics that prospective participants must possess to be eligible for the trial. This includes age range, gender, medical history, disease severity, etc. Exclusion Criteria: Specify any factors that would disqualify individuals from participating in the trial, such as certain medical conditions, concomitant medications, or other criteria that might confound the results. Sample Size Justification: Explain how the sample size was determined based on statistical considerations and anticipated effect sizes. Intervention:
  • Description of Intervention: Provide a detailed description of the experimental treatment, including its formulation, dosage, route of administration, frequency, duration, and any relevant procedures or instructions. Rationale: Justify the choice of the intervention, explaining its theoretical basis, previous evidence supporting its efficacy, and potential benefits over existing treatments. Administration Protocol: Specify how the intervention will be administered, monitored, and adjusted (if applicable) throughout the trial.
• Outcome:
  • Primary Outcome(s): Clearly define the primary endpoint(s) of the trial, which represent the most important outcomes that will be used to evaluate the effectiveness of the intervention.
  • Secondary Outcome(s): Specify any additional outcomes that will be assessed to provide a more comprehensive understanding of the intervention’s effects.
  • Measurement Tools: Describe the methods and instruments that will be used to measure and assess each outcome, including any validated scales, questionnaires, laboratory tests, imaging modalities, etc. Timing of Outcome Assessments: Outline the schedule and frequency of outcome assessments, including baseline measurements, follow-up visits, and endpoints.