Surgically treated adult acquired flatfoot deformity: Register-based study of patient characteristics, health-related quality of life and type of surgery according to severity.

BACKGROUND: Population-level data describing patient characteristics and interventions used in surgical treatment of adult acquired flatfoot deformity (AAFD) is lacking. METHODS: We analyzed baseline patient-reported data including PROMs and surgical interventions for patients with AAFD reported to the Swedish Quality Register for Foot and Ankle Surgery (Swefoot) 2014-2021. RESULTS: 625 feet with primary AAFD surgery were registered. Median age was 60 (range 16-83) years and 64% were women. Mean preoperative EQ-5D index and Self-Reported Foot and Ankle Score (SEFAS) were low. In stage IIa (n = 319) 78% had medial displacement calcaneal osteotomy and 59% had flexor digitorium longus transfer, with some regional variations. Spring ligament reconstruction was less common. In stage IIb (n = 225), 52% had lateral column lengthening, and in stage III (n = 66), 83% had hind-foot arthrodesis. CONCLUSIONS: Patients with AAFD have low health-related quality of life before surgery. Treatment in Sweden follows best-available evidence but regional variations exist. LEVEL OF EVIDENCE: III.

The challenge of equipoise in trials with a surgical and non-surgical comparison: a qualitative synthesis using meta-ethnography.

BACKGROUND: Randomised controlled trials in surgery can be a challenge to design and conduct, especially when including a non-surgical comparison. As few as half of initiated surgical trials reach their recruitment target, and failure to recruit is cited as the most frequent reason for premature closure of surgical RCTs. The aim of this qualitative evidence synthesis was to identify and synthesise findings from qualitative studies exploring the challenges in the design and conduct of trials directly comparing surgical and non-surgical interventions. METHODS: A qualitative evidence synthesis using meta-ethnography was conducted. Six electronic bibliographic databases (Medline, Central, Cinahl, Embase and PsycInfo) were searched up to the end of February 2018. Studies that explored patients' and health care professionals' experiences regarding participating in RCTs with a surgical and non-surgical comparison were included. The GRADE-CERQual framework was used to assess confidence in review findings. RESULTS: In total, 3697 abstracts and 49 full texts were screened and 26 published studies reporting experiences of patients and healthcare professionals were included. The focus of the studies (24/26) was primarily related to the challenge of recruitment. Two studies explored reasons for non-compliance to treatment allocation following randomisation. Five themes related to the challenges to these types of trials were identified: (1) radical choice between treatments; (2) patients' discomfort with randomisation: I want the best treatment for me as an individual; (3) challenge of equipoise: patients' a priori preferences for treatment; (4) challenge of equipoise: clinicians' a priori preferences for treatment and (5) imbalanced presentation of interventions. CONCLUSION: The marked dichotomy between the surgical and non-surgical interventions was highlighted in this review as making recruitment to these types of trials particularly challenging. This review identified factors that increase our understanding of why patients and clinicians may find equipoise more challenging in these types of trials compared to other trial comparisons. Trialists may wish to consider exploring the balance of potential factors influencing patient and clinician preferences towards treatments before they start recruitment, to enable issues specific to a particular trial to be identified and addressed. This may enable trial teams to make more efficient considered design choices and benefit the delivery of such trials.