Economic analysis of surgical outcome monitoring using control charts: the SHEWHART cluster randomised trial.

IMPORTANCE: Surgical complications represent a considerable proportion of hospital expenses. Therefore, interventions that improve surgical outcomes could reduce healthcare costs. OBJECTIVE: Evaluate the effects of implementing surgical outcome monitoring using control charts to reduce hospital bed-days within 30 days following surgery, and hospital costs reimbursed for this care by the insurer. DESIGN: National, parallel, cluster-randomised SHEWHART trial using a difference-in-difference approach. SETTING: 40 surgical departments from distinct hospitals across France. PARTICIPANTS: 155 362 patients over the age of 18 years, who underwent hernia repair, cholecystectomy, appendectomy, bariatric, colorectal, hepatopancreatic or oesophageal and gastric surgery were included in analyses. INTERVENTION: After the baseline assessment period (2014-2015), hospitals were randomly allocated to the intervention or control groups. In 2017-2018, the 20 hospitals assigned to the intervention were provided quarterly with control charts for monitoring their surgical outcomes (inpatient death, intensive care stay, reoperation and severe complications). At each site, pairs, consisting of one surgeon and a collaborator (surgeon, anaesthesiologist or nurse), were trained to conduct control chart team meetings, display posters in operating rooms, maintain logbooks and design improvement plans. MAIN OUTCOMES: Number of hospital bed-days per patient within 30 days following surgery, including the index stay and any acute care readmissions related to the occurrence of major adverse events, and hospital costs reimbursed for this care per patient by the insurer. RESULTS: Postintervention, hospital bed-days per patient within 30 days following surgery decreased at an adjusted ratio of rate ratio (RRR) of 0.97 (95% CI 0.95 to 0.98; p<0.001), corresponding to a 3.3% reduction (95% CI 2.1% to 4.6%) for intervention hospitals versus control hospitals. Hospital costs reimbursed for this care per patient by the insurer significantly decreased at an adjusted ratio of cost ratio (RCR) of 0.99 (95% CI 0.98 to 1.00; p=0.01), corresponding to a 1.3% decrease (95% CI 0.0% to 2.6%). The consumption of a total of 8910 hospital bed-days (95% CI 5611 to 12 634 bed-days) and €2 615 524 (95% CI €32 366 to €5 405 528) was avoided in the intervention hospitals postintervention. CONCLUSIONS: Using control charts paired with indicator feedback to surgical teams was associated with significant reductions in hospital bed-days within 30 days following surgery, and hospital costs reimbursed for this care by the insurer. TRIAL REGISTRATION NUMBER: NCT02569450.

Hypoparathyroidism: Consequences, economic impact, and perspectives. A case series and systematic review.

BACKGROUND: Postoperative hypoparathyroidism (PH) is the most common complication after total thyroidectomy. Incidence varies from 2% to 83%, depending on the definition. OBJECTIVE: We performed a systematic review of the literature to determine the medico-economic effects of PH and update understanding of long-term consequences, morbidity, and quality of life related to hypoparathyroidism. METHODS: We considered relevant articles published between 2000 and 2020 concerning long-term consequences of PH and quality of life. All studies concerning the medico-economic assessment of PH were included. We compared data from 2018 to results in the literature. RESULTS: A proportion of 64/403 (16.8%) patients presented with transient PH during 2018, and 7/403 (1.7%) had permanent PH. Seven patients needed supplementation with alfacalcidol at 6-month follow-up. Factors predicting the need for alfacalcidol were age <45, thyroidectomy for goiter, and lymph node dissection. Additional therapy costs related to PH were €9781.10, and additional hospital costs were €230,400. We qualitatively synthesized 41 studies. Most were retrospective studies and only a few reported costs. No series assessed direct or indirect costs of postoperative PH. CONCLUSION: To our knowledge, no previous studies reported the medico-economic impact of PH. Decreasing PH associated with fluorescence usage should be considered, particularly concerning cost-effectiveness.

Partial Versus Total Thyroidectomy: What Influences Most Surgeons' Decision? Analysis of a Nationwide Cohort of 375,810 Patients Over 10 Years.

National and international guidelines about thyroid surgery seem to be moving more and more towards less radical surgical procedures but everyday practice does not seem to always align with them. We describe for the first time the role of non-surgical parameters in the surgeon's choice for thyroid surgery. OBJECTIVE: The ain of this study was to describe thyroid surgery and to identify the factors leading to either a total or a partial thyroidectomy regardless of the severity of the thyroid disease. SUMMARY BACKGROUND DATA: National and international guidelines about thyroid surgery seem to be moving more and more toward less radical surgical procedures but everyday practice does not seem to always align with them. METHODS: We based this nationwide retrospective cohort study on a national database that compiles discharge abstracts for every admission for thyroidectomy to French acute healthcare facilities (PMSI database 2010 to 2019). RESULTS: In this study, 375,810 patients (male: 23%; age = 53 ±â€Š15 years) had a thyroidectomy (partial: 28%) for cancer (17%), hyperthyroidism (16%), nonfunctioning goiter (64%), or other (3%). We noticed a global trend toward more partial thyroidectomy (P < 0.001) with a significant increase in the proportion of lobectomy in the post-ATA recommendations' period (P < 0.001) as well as in the "French Levothyrox crisis" period, in which we saw an unexpected rise of adverse events notifications associated with the marketing of a new formula of Levothyrox (P < 0.001) amid widespread media coverage. In a multivariate analysis, we also identified that complete resection was more frequently performed in centers with a caseload >40/year [P < 0.001, odds ratio (OR) = 1.48], for obese patients (body mass index >30 kg/m2; P < 0.001, OR = 1.42), and according to the indication of surgery (OR benign = 1, OR cancer = 2.25, OR hyperthyroidism = 4.13). CONCLUSION: We describe for the first time the role of non-surgical parameters in the surgeon's choice for thyroid surgery.

Self-assessment of voice outcomes after total thyroidectomy using the Voice Handicap Index questionnaire: Results of a prospective multicenter study.

BACKGROUND: Voice disorders are frequent after thyroidectomy. We report the long-term voice quality outcomes after thyroidectomy using the voice handicap index self-questionnaire. METHODS: Eight hundred patients who underwent total thyroidectomy between 2014 and 2017 in 7 French hospitals were prospectively included. All patients filled in voice handicap index questionnaires, preoperatively and 2 and 6 months after surgery. RESULTS: Median (range) voice handicap index scores were significantly increased at month 2 (4 [0; 108]) compared to preoperative values (2 [0; 76]) and were unchanged at month 6 (2 [2; 92]). Clinically significant voice impairment (voice handicap index score difference ≥18 points) was reported in 19.7% at month 2 and 13% at month 6. Thirty-seven (4.6%) had postoperative vocal cord palsy. In patients with vocal cord palsy compared to those without, median voice handicap index scores were increased at month 2 (14 [0; 107] vs 4 [0; 108]; P = .0039), but not at month 6 (5 [0; 92] vs 2 [0; 87]; P = .0702). Clinically significant impairment was reported in 38% vs 19% at month 2 (P = .010), and in 19% vs 13% at month 6 (P = .310). Thyroid weight, postoperative hypocalcemia, vocal cord palsy, and absence of intraoperative neuromonitoring utilization were associated with an increased risk of clinically significant self-perceived voice impairment at month 2. CONCLUSION: Thyroidectomy impairs patients' voice quality perception in patients with and without vocal cord palsy.

Assessment of the Aldosteronona resolution score as a predictive resolution score of hypertension after adrenalectomy for aldosteronoma in French patients.

PURPOSE: Aldosteronoma Resolution Score (ARS) is a predictive score for cure of hypertension after adrenalectomy for hyperaldosteronism and has been validated in American patients. The aim of the study was to validate this score in a French population. METHOD: Data concerning patients operated from 2002 to 2015 in 7 French University Hospitals were retrospectively collected. Diagnosis of Aldosterone-producing adenoma (APA) was confirmed with clinical and biochemical hyperaldosteronism and adrenal nodule on CT scan. Adrenal venous sampling was performed when CT failed to identify laterality. ARS is based on four variables: female sex, BMI ≤25 kg/m2, duration of hypertension ≤6 years, number of antihypertensive medications ≤2. One point is attributed for the first three and 2 points for the last. Patients were considered as cured if they had no hypertension and no antihypertensive medications at least 6 months after surgery. Patients with bilateral adrenal hyperplasia were excluded. RESULTS: This multicenter study included 310 patients with APA. ARS and follow-up were obtained in 257 patients. 46.6% of patients were cured and potassium serum level was normalized in 97.7%. In multivariate analysis, odds ratio for female sex, BMI ≤25 kg/m2, duration of hypertension ≤6 years, and number of antihypertensive medications ≤2 were 1.60 (p = 0.09), 1.77 (p = 0.04), 1.28 (p = 0.4), 3.41 (p < 0.001), respectively. Cure rate were, respectively, 22.2, 41.4 and 74% for patients with a score ARS 0-1, 2-3, 4-5. The area under the curve (AUC) of ARS was 0.715. CONCLUSION: ARS is not a predictive score efficient enough in a French population maybe due to different metabolic data and genetic conditions.

Crude versus case-mix-adjusted control charts for safety monitoring in thyroid surgery.

INTRODUCTION: Patient-safety monitoring based on health-outcome indicators can lead to misinterpretation of changes in case mix. This study aimed to compare the detection of indicator variations between crude and case-mix-adjusted control charts using data from thyroid surgeries. METHODS: The study population included each patient who underwent thyroid surgery in a teaching hospital from January 2006 to May 2008. Patient safety was monitored according to two indicators, which are immediately recognisable postoperative complications: recurrent laryngeal nerve palsy and hypocalcaemia. Each indicator was plotted monthly on a p-control chart using exact limits. The weighted κ statistic was calculated to measure the agreement between crude and case-mix-adjusted control charts. RESULTS: We evaluated the outcomes of 1405 thyroidectomies. The overall proportions of immediate recurrent laryngeal nerve palsy and hypocalcaemia were 7.4% and 20.5%, respectively. The proportion of agreement in the detection of indicator variations between the crude and case-mix-adjusted p-charts was 95% (95% CI 85% to 99%). The strength of the agreement was κ = 0.76 (95% CI 0.54 to 0.98). The single special cause of variation that occurred was only detected by the case-mix-adjusted p-chart. CONCLUSIONS: There was good agreement in the detection of indicator variations between crude and case-mix-adjusted p-charts. The joint use of crude and adjusted charts seems to be a reasonable approach to increase the accuracy of interpretation of variations in outcome indicators.