Defining a Standard Set of Patient-Reported Outcomes for Patients With Advanced Ovarian Cancer.

Purpose: Advanced ovarian cancer (AOC) and its treatment cause several symptoms and impact on patients' health-related quality of life (HRQoL). We aim to reach a consensus on the most relevant patient-reported outcome (PROs), the corresponding measures (PROMs), and measurement frequency during AOC patients' follow-up from patients' and healthcare professionals' (HCP) perspective. Methods: The project comprised five steps: 1) a literature review, 2) a focus group with patients, 3) a nominal group with HCP, 4) two round-Delphi consultations with patients and HCP, and 5) a final meeting with HCP. Delphi questionnaire was elaborated based on literature review, focus group (n=5 patients), and nominal group (n=16 HCP). The relevance of each PRO and the appropriateness (A) and feasibility (F) of the proposed PROM were assessed (Likert scale 1=strongly agree; 9=strongly disagree). The consensus was reached when at least 75% of the panelists rated it as 'relevant', 'appropriate', or 'feasible' (score 7-9). Results: A total of 56 HCP [51.8% Hospital Pharmacy; 41.1% Oncology; 3.6% Nursing; and 3.6% Psycho-oncology; mean time in specialty 12.5 (8.0) years] and 10 AOC patients [mean time diagnosis 5.4 (3.0) years] participated in the 1st round. All PROs achieved consensus regarding their relevance, except dry skin (58.0%). Agreement was reached for PRO-CTCAE to be used to assess fatigue (A:84.9%; F:75.8%), neuropathy (A:92.4%; F:77.3%), diarrhea (A:87.9%; F:88.7%), constipation (A:86.4%; F:75.8%), nausea (A:89.4%; F:75.8%), insomnia (A:81.8%; F:88.7%), abdominal bloating (A:82.2%; F:82.2%) and sexuality (A:78.8%; F:88.6%); EQ-5D to determine patients' HRQoL (A:87.9%; F:80.3%), pain (A:87.9%; F:75.8%) and mood (A:77.7%; F:85.5%); to assess treatment adherence the Morisky-Green (A:90.9%; F:84.9%) and the dispensing register (A:80.3%; F:80.3%) were chosen. It was agreed to note in the medical record whether the patient's treatment preferences had been considered during decision-making (A:78.8%; F:78.8%) and to use a 5-point Likert scale to assess treatment satisfaction (A:86.4%; F:86.4%). Panelists agreed (A:92.4%; F: 77.3%) to collect these PROs (1) at the time of diagnosis/relapse; (2) one month after starting treatment/change therapeutic strategy; (3) every three months during the 1st-year of treatment; and later (4) every six months until treatment completion/change. Conclusions: The consensus reached represents the first step towards including the patient's perspective in AOC follow-up. The standardized collection of PROs in clinical practice may contribute to optimizing the follow-up of these patients and thus improving the quality of care.

Efficacy and safety of preoperative preparation with Lugol's iodine solution in euthyroid patients with Graves' disease (LIGRADIS Trial): Study protocol for a multicenter randomized trial.

BACKGROUND: Currently, both the American Thyroid Association and the European Thyroid Association recommend preoperative preparation with Lugol's Solution (LS) for patients undergoing thyroidectomy for Graves' Disease (GD), but their recommendations are based on low-quality evidence. The LIGRADIS trial aims to provide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidectomy for GD. METHODS: A multicenter randomized controlled trial will be performed. Patients ≥18 years of age, diagnosed with GD, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy will be eligible for inclusion. Exclusion criteria will be prior thyroid or parathyroid surgery, hyperparathyroidism that requires associated parathyroidectomy, thyroid cancer that requires adding a lymph node dissection, iodine allergy, consumption of lithium or amiodarone, medically unfit patients (ASA-IV), breastfeeding women, preoperative vocal cord palsy and planned endoscopic, video-assisted or remote access surgery.Between January 2020 and January 2022, 270 patients will be randomized for either receiving or not preoperative preparation with LS. Researchers will be blinded to treatment assignment. The primary outcome will be the rate of postoperative complications: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death. Secondary outcomes will be intraoperative events (Thyroidectomy Difficulty Scale score, blood loss, recurrent laryngeal nerve neuromonitoring signal loss), operative time, postoperative length of stay, hospital readmissions, permanent complications and adverse events associated to LS. CONCLUSIONS: There is no conclusive evidence supporting the benefits of preoperative treatment with LS in this setting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03980132.

Assessment of the quality of sample labelling for clinical research / Evaluación de la calidad del etiquetado de muestras para investigación clínica

Objective: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. Method: A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed. Outcome: The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049), blinding reduced their quality (p = 0.017), and identification by kit number or by patient increased it (p < 0.01). The promoter was the variable which introduced the highest variability into the analysis. Conclusions: The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors (AU)

Objetivo: Evaluar la calidad de las etiquetas de muestras para ensayos clínicos mediante la normativa vigente y analizar su posible correlación con las características específicas de cada muestra. Método: Estudio transversal multicéntrico en el que se analizaron las muestras de ensayos clínicos de dos hospitales de tercer nivel. Se estudió la presencia de los once ítems de la Directiva 2003/94/CE, el nombre del ensayo y la dosis en la portada de la etiqueta como variables de calidad del etiquetado. Se analizó la influencia de las características propias de la muestra con la calidad del etiquetado. Resultado: Se analizaron un total de 503 muestras de 220 ensayos. La calidad media del etiquetado, entendido como el porcentaje de ítems del Anexo 13, fue del 91,9%. El 6,6% no contenía el nombre de la muestra en la cara externa de la etiqueta, mientras que a un 9,7% les faltaba la dosis. Las muestras con presentación de tipo ensayo clínico presentaron mayor calidad (p < 0,049), el enmascaramiento disminuía la calidad (p = 0,017) y la identificación por número de kit o por paciente la aumentaban (p < 0,01). La variable promotor fue la que más variabilidad introdujo en el análisis. Conclusiones: La calidad media del etiquetado es adecuada en la mayoría de las muestras del ensayo clínico. Resulta preocupante la ausencia de información esencial, como el código del ensayo clínico y el período de validez, en algunas muestras que pueden ser fuente potencial de errores de dispensación o de administración (AU)

Assessment of the quality of sample labelling for clinical research.

OBJECTIVE: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. METHOD: A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed. OUTCOME: The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049), blinding reduced their quality (p = 0.017), and identification by kit number or by patient increased it (p < 0.01). The promoter was the variable which introduced the highest variability into the analysis. CONCLUSIONS: The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors.

Objetivo: Evaluar la calidad de las etiquetas de muestras para ensayos clínicos mediante la normativa vigente y analizar su posible correlación con las características específicas de cada muestra. Método: Estudio transversal multicéntrico en el que se analizaron las muestras de ensayos clínicos de dos hospitales de tercer nivel. Se estudió la presencia de los once ítems de la Directiva 2003/94/CE, el nombre del ensayo y la dosis en la portada de la etiqueta como variables de calidad del etiquetado. Se analizó la influencia de las características propias de la muestra con la calidad del etiquetado. Resultado: Se analizaron un total de 503 muestras de 220 ensayos. La calidad media del etiquetado, entendido como el porcentaje de ítems del Anexo 13, fue del 91,9%. El 6,6% no contenía el nombre de la muestra en la cara externa de la etiqueta, mientras que a un 9,7% les faltaba la dosis. Las muestras con presentación de tipo ensayo clínico presentaron mayor calidad (p < 0,049), el enmascaramiento disminuía la calidad (p = 0,017) y la identificación por número de kit o por paciente la aumentaban (p < 0,01). La variable promotor fue la que más variabilidad introdujo en el análisis. Conclusiones: La calidad media del etiquetado es adecuada en la mayoría de las muestras del ensayo clínico. Resulta preocupante la ausencia de información esencial, como el código del ensayo clínico y el período de validez, en algunas muestras que pueden ser fuente potencial de errores de dispensación o de administración.

Erythropoiesis-stimulating agents in anaemia due to chronic kidney disease: a cost-minimization analysis.

BACKGROUND: Some publications have shown that equivalent doses of erythropoiesis-stimulating agents (ESA) defined on label differ from those effective in clinical practice. Therefore, real costs could vary from theoretical costs in the treatment of anaemia in chronic kidney disease (CKD). OBJECTIVES: To perform a cost-minimization analysis to establish the economic impact of the principal ESAs used in treating anaemia secondary to CKD in daily practice. SECONDARY OBJECTIVES: to determine patient-month cost based on the erythropoietin resistance index (ERI); to analyze the difference in cost between pre-dialysis and peritoneal dialysis (PD) patients; and to analyze the association between iron deposits and ESA cost. SETTING: This study was carried out at 2 tertiary hospitals in Spain. METHOD: A multicentre cost-minimization analysis was performed in adult outpatients treated with ESAs for anaemia due to CKD. MAIN OUTCOME MEASURE: The primary outcome was the patient-month cost for each ESA. RESULTS: 409 patients were included. Median patient-month cost was: epoetin (103.2 [63.7, 187.8] euros), darbepoetin α (134.4 [67.2, 216.0] euros) and CERA (147.5 [98.3, 196.7] euros). Median patient-month cost according to ERI was: epoetin (1.60 [0.90, 2.60] euros/kg), darbepoetin α (2.01 [0.95, 3.48] euros/kg) and CERA (1.87 [1.33, 3.00] euros/kg). Median patient-month cost in pre-dialysis was 126.0 (73.7, 201.6) euros and in PD 153.0 (100.2, 275.4) euros. Median patient-month cost for patients with TSI < 20% was 147.5 (98.3, 224.9) euros compared to 100.9 (67.2, 196.7) euros which was the cost for patients with IST ≥ 20%. The median patient-month cost for patients with ferritin < 100 mcg/l was 134.4 (85.0, 201.6) euros compared to 100.8 (68.8, 196.7) euros, which was the cost for patients with ferritin ≥ 100 mcg/l (p = 0.242). CONCLUSION: Doses of CERA used in clinical practice are lower than those recommended on label, which directly influences cost and treatment efficiency. Cost stratification based on iron deposits has shown that patients with low TSI or ferritin require higher doses and consequently an associated higher cost. Thus, to guarantee adequate iron levels is essential in the rational use of ESAs.

Clinical results in the management of Frey's syndrome with injections of Botulinum toxin.

INTRODUCTION: Frey's Syndrome is defined by facial hyperhidrosis in the preauricular region unleashed by gustatory stimulus and caused mainly by parotidectomy. Several treatment and prevention measures have been proposed, with no conclusive results. Recently, injections of Botulinum Toxin have been suggested, obtaining encouraging results. The objective is to describe our experience in treating Frey's Syndrome with this drug. MATERIALS AND METHOD: Between 2004 and 2007, our team treated 10 patients suffering from Frey's Syndrome. All cases were caused by parotid resection. In 60%of cases a complete elevation of the SMAS (superficial musculoaponeurotic system) was carried out. In the remaining cases, such elevation was either not made or the SMAS was severely damaged. All patients were treated with intradermic injections of Botulinum Toxin. Recorded data were: units administered, affected area, time lapse until improvement in the symptoms, and the evolution after one, six and twelve months after the injection. Possible side effects were also recorded. RESULTS: The average treated area per patient was 26 cm2. An average of 38 units of Botulinum Toxin per patient was injected. Average time lapse until improvement was 5.5 days. Five patients were injected with a second dose after an average of 18 months from the first injection. On this occasion, the area affected was considerably smaller than that presented before the first injection. The most frequently reported side effect was dry mouth. CONCLUSION: Our team considers that treating Frey's Syndrome with Botulinum Toxin is effective. The effects of the treatment are long-lasting and side effects are minimal and temporary. A second injection is needed after 15 to 18 months of the first, although the affected area is usually smaller.

Clinical results in the management of Frey’s Syndrome with injections of Botulinum Toxin

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Introduction: Frey’s Syndrome is defined by facial hyperhidrosis in the preauricular region unleashed by gustatory stimulus and caused mainly by parotidectomy. Several treatment and prevention measures have been proposed, with no conclusive results. Recently, injections of Botulinum Toxin have been suggested, obtaining encouraging results. The objective is to describe our experience in treating Frey’s Syndrome with this drug.Materials and method: Between 2004 and 2007, our team treated 10 patients suffering from Frey’s Syndrome. Allcases were caused by parotid resection. In 60% of cases a complete elevation of the SMAS (superficial musculoaponeurotic system) was carried out. In the remaining cases, such elevation was either not made or the SMAS was severely damaged. All patients were treated with intradermic injections of Botulinum Toxin. Recorded data were: units administered, affected area, time lapse until improvement in the symptoms, and the evolution after one, six and twelve months after the injection. Possible side effects were also recorded.Results: The average treated area per patient was 26 cm2. An average of 38 units of Botulinum Toxin per patient was injected. Average time lapse until improvement was 5.5 days. Five patients were injected with a second dose after an average of 18 months from the first injection. On this occasion, the area affected was considerably smaller than that presented before the first injection. The most frequently reported side effect was dry mouth.Conclusion: Our team considers that treating Frey’s Syndrome with Botulinum Toxin is effective. The effects of the treatment are long-lasting and side effects are minimal and temporary. A second injection is needed after 15 to 18 months of the first, although the affected area is usually smaller (AU)