The study by Song et al. (2020) is chosen as it includes a considerable number of human subjects who receive certain training or obtain usual care, depending on the group they belonged to, control or experimental group.
- What are your research objectives?
- The goal of the research by Song et al. (2020) is to explore the impact of a telehealth educational program on patients’ medication adherence, as well as disease activity, after the discharge of these patients.
- Discuss the significance and scientific merit of the study.
- The significance of this study is associated with the expansion of the knowledge base related to the potential use of telehealth and its impact on patient outcomes. The effective use of telehealth educational programs can have a positive influence on patient outcomes due to improved medication adherence. The researchers also shed light on certain limitations and areas for further improvement as the intervention had no significant effect on patients’ disease activity.
- In what manner and to what extent will human subjects be involved?
- Adult patients with rheumatoid arthritis will be included and no vulnerable populations (such as children or people with mental health disorders) will participate. The samples will be provided with standard or additional care, so no potentially negative effects on their health and safety are expected.
- What procedures, instruments, etc. will be employed?
- The participants in the experimental group received four training sessions (via telephone) during twelve weeks. The samples in the control group got standard post-discharge instruction on the day of the discharge. The results of the intervention were collected with the help of the Chinese version of the Compliance Questionnaire Rheumatology (CQR) and the medical records of the participants. The data were collected during the twelfth and twenty-fourth weeks after the discharge, during routine visits.
- What existing data, if any, will be used?
- Song et al. (2020) implemented a brief literature review regarding the use of telehealth in post-discharge treatment of different populations, including rheumatoid patients.
- What will the subjects be told about their involvement in the study?
- The samples were informed about the aims, methodology, and procedures of the study, and they did not receive any remuneration. The participants were also assured that they could withdraw from the study at any point.
- Describe the procedures for obtaining and recording the informed consent of subjects. Attach a copy of the consent form if written consent is planned. If oral consent is planned, attach a copy of the text of the statement and a request for waiver of written consent.
- When the recruitment process is over, the recruited people receive written consent forms where major details concerning the study are provided. On signing this form, these people become the participants of the research. The consent form will be provided in English and Chinese.
- Describe any potential risks to the subjects, including psychological stress and physical hazards. How are these risks outweighed by the sum of the benefits to the subjects and the importance of the knowledge to be gained?
- The participants will not be exposed to any risk during this study. The samples in the control group will be provided with standard care, while those in the intervention group will have phone calls and communicate with a healthcare professional regarding their health status and health-related behaviors. These activities are not associated with any physical hazards or psychological distress.
- Describe any interventions or manipulations of subjects or their environments.
- The participants will be at their homes, so no manipulations will occur as the participants in the experimental group will receive phone calls and communicate with a healthcare practitioner.
- What measures will be taken to safeguard the welfare of subjects, their right to privacy and confidentiality of information?
- The measures taken to safeguard the participants’ confidentiality and privacy are not described in the articles. However, the authors note that the study conformed to the standards and principles described in the Declaration of Helsinki, so all the necessary steps were undertaken.
- Are school-age children or other minors to be involved? If so, please describe the subject population.
- People aged 18 years old or older took part in the study, and the mean age was 55.54.
- Are psychological tests to be used? If so, please name them.
- The participants completed the Chinese version of the Compliance Questionnaire Rheumatology and Disease Activity Score 28 (Song et al., 2020).
- Describe the debriefing of subjects. What steps will be taken to deal with the after-effects of emotional stress resulting from the research procedure?
- Your participation is voluntary, and the samples will be able to withdraw from the research at any time, so no emotional stress is expected.
- What procedures will be taken to ensure prompt reporting of (a) proposed changes in the activity, (b) any unanticipated problems involving risks to the subjects or others, (c) any injury to subjects, and (d) any noncompliance with policies and procedures?
- The participants were patients with rheumatoid arthritis who received care, so they were in contact with healthcare professionals, with regular check-ups held. Those in the intervention group received regular phone calls and also had check-ups. Hence, the participants had an opportunity to report any issues.
- What type of remuneration, if any, will be offered to subjects for their participation in the research?
- No remuneration was provided to the participants by Song et al. (2020).
Reference
Song, Y., Reifsnider, E., Zhao, S., Xie, X., & Chen, H. (2020). A randomized controlled trial of the Effects of a telehealth educational intervention on medication adherence and disease activity in rheumatoid arthritis patients. Journal of Advanced Nursing, 76(5),1172-1181. Web.