RESUMO
OBJECTIVE: The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD). METHODS: AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres. The primary endpoint was the incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY). Analysis was conducted from a societal perspective, excluding indirect costs, and considering a one month time horizon. RESULTS: From 16 February 2016 to 29 May 2017, 160 patients were randomised (80 per group). A modified intention to treat analysis was performed with 153 patients (outpatient hospitalisation: n = 76; inpatient hospitalisation: n = 77). The patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92%). Rates of peri-operative complications were 20% (15 events) and 18% (14 events) for the outpatient and inpatient arms respectively (p = .81). Overall costs (difference: 187.83; 95% confidence interval [CI] -275.68-651.34) and QALYs (difference: 0.00277; 95% CI -0.00237 - 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm. The mean ICER was 67 741 per QALY gained for the base case analysis with missing data imputed using multiple imputation by predictive mean matching. The outpatient procedure was not cost effective for a willingness to pay of 50 000 per QALY and the probability of being cost effective was only 59% for a 100 000/QALY threshold. CONCLUSION: Outpatient hospitalisation is not cost effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a 50 000/QALY threshold.
Assuntos
Assistência Ambulatorial/economia , Procedimentos Endovasculares/economia , Custos Hospitalares , Hospitalização/economia , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/economia , Doença Arterial Periférica/terapia , Idoso , Redução de Custos , Análise Custo-Benefício , Procedimentos Endovasculares/efeitos adversos , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Estudos Prospectivos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Fatores de Tempo , Resultado do TratamentoRESUMO
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.