Active Surveillance as First-Line Management of Papillary Microcarcinoma.

Papillary thyroid microcarcinoma (PMC) is defined as papillary thyroid carcinoma ≤10 mm. Active surveillance of PMC without high-risk features, such as clinical node metastasis, distant metastasis, and clinical evidence of significant extrathyroid extension, was initiated in two Japanese hospitals in the mid-1990s. This strategy was incorporated into guidelines in Japan in 2010 and in the United States in 2015. In studies conducted by the two hospitals, most PMCs grew very slowly or did not grow, and none of the patients during active surveillance showed distant metastasis or died of thyroid carcinoma. Furthermore, none of the patients who underwent surgery after progression signs were detected showed significant recurrence. Therefore, we conclude that active surveillance should be the first line in management of low-risk PMC, because it is safer and less costly than immediate surgery. Active surveillance helps in avoiding adverse events of surgery and is an economical strategy.

Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process.

BACKGROUND: Proximal humerus fracture (PHF) complications, whether following surgery or nonoperative management, require standardization of definitions and documentation for consistent reporting. We aimed to define an international consensus core event set (CES) of clinically-relevant unfavorable events of PHF to be documented in clinical routine practice and research. METHODS: A Delphi exercise was implemented with an international panel of experienced shoulder trauma surgeons selected by survey invitation of AO Trauma members. An organized list of PHF events after nonoperative or operative management was developed and reviewed by panel members using on-line surveys. The proposed core set was revised regarding event groups along with definitions, specifications and timing of occurrence. Consensus was reached with at least a two-third agreement. RESULTS: The PHF consensus panel was composed of 231 clinicians worldwide who responded to at least one of two completed surveys. There was 93% final agreement about three intraoperative local event groups (device, osteochondral, soft tissue). Postoperative or nonoperative event terms and definitions organized into eight groups (device, osteochondral, shoulder instability, fracture-related infection, peripheral neurological, vascular, superficial soft tissue, deep soft tissue) were approved with 96 to 98% agreement. The time period for documentation ranged from 30 days to 24 months after PHF treatment depending on the event group and specification. The resulting consensus was presented on a paper-based PHF CES documentation form. CONCLUSIONS: International consensus was achieved on a core set of local unfavorable events of PHF to foster standardization of complication reporting in clinical research and register documentation. TRIAL REGISTRATION: Not applicable.

Complications after surgical management of proximal humeral fractures: a systematic review of event terms and definitions.

BACKGROUND: The most frequently used surgical procedures for treating a proximal humeral fracture (PHF) are plate osteosynthesis, nail osteosynthesis and arthroplasty. Evidence-based recommendations for an appropriate surgical procedure after PHF requires transparent and valid safety data. We performed a systematic review to examine reported terms and definitions of complications after surgically-treated PHFs. METHODS: A literature search was conducted on PubMed, Cochrane Library, EMBASE, Scopus and WorldCat to identify clinical articles and book chapters on complications of PHF published from 2010 to 2017. Complication terms and definitions were extracted from each selected article independently by two reviewers and grouped according to a predefined scheme. RESULTS: From 1376 initial references, we selected 470 articles, of which 103 were reviewed in reverse chronological order until no further information was gained. Twelve book chapters were reviewed. We found 667 local event terms associated with complications after surgical treatment of PHFs. The most frequently used event terms were infection (52 references), nonunion (n = 42), malunion (n = 35), avascular necrosis (n = 27) and pain (n = 25). Overall, 345, 177, 257 and 102 local event terms were related to plating, nailing, arthroplasty and other surgical techniques, respectively. Radiological assessment was the basis for the majority of event terms and complication definitions. Thirty-six event definitions were extracted, mostly defining the terms "secondary fracture displacement", "screw perforation/cutout", "malunion", "delayed healing" and "notching". CONCLUSION: Scientific literature on surgically-managed PHF uses different terms to describe complications and without approved definitions, which highlights a lack of agreement on adverse event terminology for PHFs. Defined event terms are mostly based on radiological observations. Consensus among shoulder surgeons on a core event set is indispensable to support the standardization of safety reporting for surgically-treated PHFs.

Core set of unfavorable events of shoulder arthroplasty: an international Delphi consensus process.

BACKGROUND: Shoulder arthroplasty (SA) complications require standardization of definitions and are not limited to events leading to revision operations. We aimed to define an international consensus core set of clinically relevant unfavorable events of SA to be documented in clinical routine practice and studies. METHODS: A Delphi exercise was implemented with an international panel of experienced shoulder surgeons selected by nomination through professional societies. On the basis of a systematic review of terms and definitions and previous experience in establishing an arthroscopic rotator cuff repair core set, an organized list of SA events was developed and reviewed by panel members. After each survey, all comments and suggestions were considered to revise the proposed core set including local event groups, along with definitions, specifications, and timing of occurrence. Consensus was reached with at least two-thirds agreement. RESULTS: Two online surveys were required to reach consensus within a panel involving 96 surgeons. Between 88% and 100% agreement was achieved separately for local event groups including 3 intraoperative (device, osteochondral, and soft tissue) and 9 postoperative event groups. Experts agreed on a documentation period that ranged from 3 to 24 months after SA for 4 event groups (peripheral neurologic, vascular, surgical-site infection, and superficial soft tissue) and that was lifelong until implant revision for other groups (device, osteochondral, shoulder instability, pain, late hematogenous infection, and deep soft tissue). CONCLUSION: A structured core set of local unfavorable events of SA was developed by international consensus to support the standardization of SA safety reporting. Clinical application and scientific evaluation are needed.

Comparison of Postoperative Unfavorable Events in Patients with Low-Risk Papillary Thyroid Carcinoma: Immediate Surgery Versus Conversion Surgery Following Active Surveillance.

Background: Active surveillance (AS) for low-risk papillary thyroid microcarcinoma (PTMC) was initiated at Kuma Hospital in 1993 and has gradually spread worldwide. We previously demonstrated that AS is associated with a much lower incidence of unfavorable events than immediate surgery (IS). However, conversion surgery (CS) raises concerns about increased surgical complications due to advanced disease. In this study, we conducted a comparative analysis of unfavorable events after IS and CS. Methods: Between 2005 and 2019, 4635 patients clinically diagnosed with low-risk PTMC at Kuma Hospital were enrolled. Of these, 2896 underwent AS (AS group), and the remaining 1739 underwent IS (IS group). To date, 242 patients (0.8%) in the AS group have undergone CS for various reasons (CS group). Results: The incidence of unfavorable events, such as levothyroxine administration after surgery, postoperative hematoma, transient/persistent hypoparathyroidism, and transient/persistent vocal cord paralysis, did not differ between the CS and IS groups. None of the patients in the CS group had permanent vocal cord paralysis; however, this occurred in 15 patients (0.9%) in the IS group and was caused by accidental injury in 4 patients and carcinoma invasion in 11 patients. The incidence of surgery, levothyroxine administration, postoperative hematoma, transient/permanent hypoparathyroidism, and vocal cord paralysis was significantly higher (p < 0.001) in the IS group than in the AS group. There were no differences in the incidence of lymph node recurrence and overall mortality between the AS and IS groups. None of the patients in the AS and IS groups showed distant metastasis or died from thyroid carcinoma. Conclusions: There were no differences in the incidence of unfavorable events between the CS group and the IS group. Although none of the CS and AS groups had permanent vocal cord paralysis, accidental injury of the recurrent laryngeal nerve occurred in four patients (0.2%) in the IS group. The IS group had a significantly higher incidence of unfavorable events than the AS group. The prognoses of patients in both the AS and IS groups were excellent. Therefore, we recommend AS as the first-line management for low-risk PTMC.

Conservative Surveillance Management of Low-Risk Papillary Thyroid Microcarcinoma.

Most low-risk papillary thyroid microcarcinomas are indolent. Ten years of active surveillance at Kuma Hospital revealed that only 8.0% of patients showed enlargement of 3 mm or greater, whereas only 3.8% showed nodal metastasis. None, including those who underwent rescue surgery after the detection of progression, showed life-threatening recurrence or distant metastasis, and none died of thyroid carcinoma. Adverse events were significantly more frequent in patients who underwent immediate surgery than in those who had active surveillance. Medical costs were significantly higher. Therefore, active surveillance ought to be the primary method of low-risk papillary thyroid microcarcinoma management.

Insights into the Management of Papillary Microcarcinoma of the Thyroid.

BACKGROUND: Rapid increases in the incidence of thyroid carcinoma with stable mortality rates from thyroid carcinoma have been reported from many countries, and these increases are thought to be due mostly to the increased detection of small papillary thyroid carcinomas (PTCs), including papillary microcarcinomas (PMCs; i.e., PTCs ≤10 mm). Some researchers have suggested that small PTCs have been overdiagnosed and overtreated. In Japan, the active surveillance of patients with low-risk PMCs was initiated by Kuma Hospital (1993) and Tokyo's Cancer Institute Hospital (1995) based on the extremely higher incidences of both latent thyroid carcinomas in autopsy studies and small PTCs detected in mass screening studies using ultrasound examinations compared to the prevalence of clinical thyroid carcinomas. METHODS: The above two institutions' data are summarized regarding the active surveillance of low-risk PMCs, and future prospects for their management are discussed. RESULTS: At 10-year observations in the Kuma Hospital series of 1235 patients, only 8% and 3.8% of the PMC patients showed size enlargement by ≥3 mm and the novel appearance of node metastasis, respectively. In contrast to clinical PTC, PMCs are most unlikely to grow in older patients (≥60 years). In the Kuma Hospital series, the 974 patients who underwent immediate surgery had significantly higher incidences of unfavorable events than the 1179 patients who chose active surveillance. The total cost of immediate surgery, including the costs for salvage surgery and postoperative care for 10 years, was 4.1 times the total cost of 10-year management by active surveillance. Only 8% of the 51 PMC patients showed tumor enlargement during pregnancy, and the rescue surgeries after delivery were successful. In the Cancer Institute Hospital series of 230 patients with 300 lesions, only 7% and 1% of the patients showed size enlargement and novel node metastasis, respectively, and that institution's analysis also revealed that macroscopic or rim calcification and poor vascularity were correlated with non-progressing disease. In both series, none of the patients who underwent rescue surgery after progression signs were detected showed significant recurrence or died of PTC. CONCLUSION: Active surveillance of low-risk PMC can be the first-line management. Interestingly, older patients with low-risk PMCs are the best candidates for active surveillance.