Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review.

Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI, Wanfang, VIP, SinoMed, PubMed, Web of Science, Embase, Cochrane library, JBI, CINAHL, PsycINFO, Clinical Trials Registry Platform portal, Clinical Trials Registry, Australian New Zealand Clinical Trials Registry, Center Watch Registry from inception to May 15, 2022 to find randomized controlled trials, non-randomized controlled trials, case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage, with search terms of mastitis, acute mastitis, lactation mastitis, puerperal mastitis, breast problem, breast engorgement, milk stasis, blocked ducked, breast pain, breast massage, and acupoint massage. Outcomes and the measurement schemes (measurement methods, timing of assessing outcome, frequency of assessing outcome, measurers) were extracted from the included studies. We used the Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) to assess the quality of each study, then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials (OMERACT) Filter 2.1 framework.Results We identified 85 clinical trials, in which 54 different outcomes were reported. A total of 81.2% (69/85) of studies were assessed as medium quality with a mean score of 2.6, and 18.8% (16/85) as low quality with a mean score of 0.9. These outcomes were organized in three core areas. Lump size (89.4%, 76/85) was the most frequently reported outcome, followed by breast pain (69.4%, 59/85) and milk excretion (68.2%, 58/85). Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous. Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.

Local anesthesia combined with intra-articular ropivacaine can provide satisfactory pain control in ankle arthroscopic surgery: A retrospective cohort study.

BACKGROUND: Local anesthesia (LA) is widely used in knee arthroscopic surgery but not in ankle arthroscopy. OBJECTIVE: To understand the effectiveness and safety of LA combined with ropivacaine in pain control for ankle arthroscopy. STUDY DESIGN: Retrospective cohort. METHODS: We retrospectively collected data for patients who underwent ankle arthroscopy from April 2012 to April 2017. Patients were grouped by anesthesia method: LA, LA with ropivacaine (LA+R), spinal anesthesia (SA), and SA with ropivacaine (SA+R). Intra- and postoperative visual analog scale (VAS) scores, complications, doses of supplemental pain medication, hospitalization cost and duration, and satisfaction with pain control during hospitalization were analyzed. RESULTS: The study included 276 patients (LA: 93; LA+R: 124; SA: 31; SA+R: 28). The LA and LA+R groups had significantly higher intraoperative VAS scores (LA vs. SA, p = 0.001; LA vs. SA+R, p = 0.002; LA+R vs. SA, p = 0.00; LA+R vs. SA+R, p = 0.00), but fewer complications, than the SA and SA+R groups. The LA+R and SA+R groups had significantly better outcomes for postoperative pain control (LA vs. LA+R, p = 0.01; LA vs. SA+R, p = 0.01; SA vs. SA+R, p = 0.01; SA vs. LA+R, p = 0.03) and required less supplemental pain medication. Hospitalization cost was lower and duration shorter in the LA and LA+R groups than in the SA and SA+R groups. There was no significant difference in satisfaction among the four groups. LIMITATIONS: This was a single-center retrospective and relatively short-term study. CONCLUSIONS: LA+R which could be safely applied in ankle arthroscopy provided satisfactory pain control, reduced postoperative pain intensity, fewer complications, shorter hospital stay, and good cost-effectiveness. It can be safely applied in ankle arthroscopy for the specific patients with ankle osteoarthritis.