Background: Functional anorectal pain (FAP) is a common functional gastrointestinal disorder. FAP is characterized by chronic or recurrent pain in the anorectal region. The condition has no identifiable organic cause. Clinical trials of FAP interventions report different outcomes. This heterogeneity limits the comparison and synthesis of study results. A core outcome set (COS) for FAP has not been developed.
Methods: The development of the FAP-COS will include three phases. First, a systematic literature review will be conducted. The review will identify outcomes previously reported in effectiveness studies of FAP. A focus group discussion will be conducted with the study ‘s Patient and Public Involvement (PPI) group. Second, a Delphi survey will be conducted. The survey will prioritize outcomes for inclusion in the FAP-COS. Stakeholders will include colorectal surgeons, gastroenterologists, pain specialists, rehabilitation physicians, acupuncturists, traditional Chinese medicine practitioners, and patients. Finally, a consensus meeting will be held. The meeting will ratify the FAP-COS.
Discussion: The FAP-COS is expected to be collected in all clinical trials, audits of practice, and other research concerning FAP. This will facilitate the comparison and synthesis of studies. The goal is to improve outcomes for patients with FAP.
Wenhui Huang, Hong Lu, Yin Qu
Department of Anorectal Surgery
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Disease Category: Anaesthesia & pain control
Disease Name: Functional Anorectal Pain
Age Range: 18 - 65
Sex: Either
Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Drug, Physical, Procedure, Psychological & behavioural, Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Ethicists
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
The development of the FAP-COS will include three phases. First, a systematic literature review will be conducted. The review will identify outcomes previously reported in effectiveness studies of FAP. A focus group discussion will be conducted with the study ‘s Patient and Public Involvement (PPI) group. Second, a Delphi survey will be conducted. The survey will prioritize outcomes for inclusion in the FAP-COS. Stakeholders will include colorectal surgeons, gastroenterologists, pain specialists, rehabilitation physicians, acupuncturists, traditional Chinese medicine practitioners, and patients. Finally, a consensus meeting will be held. The meeting will ratify the FAP-COS.