Reassessing the approach to informed consent: the case of unrelated hematopoietic stem cell transplantation in adult thalassemia patients.

INTRODUCTION: The informed consent process is the legal embodiment of the fundamental right of the individual to make decisions affecting his or her health., and the patient's permission is a crucial form of respect of freedom and dignity, it becomes extremely important to enhance the patient's understanding and recall of the information given by the physician. This statement acquires additional weight when the medical treatment proposed can potentially be detrimental or even fatal. This is the case of thalassemia patients pertaining to class 3 of the Pesaro classification where Allogenic hematopoietic stem cell transplantation (HSCT) remains the only potentially curative treatment. Unfortunately, this kind of intervention is burdened by an elevated transplantation-related mortality risk (TRM: all deaths considered related to transplantation), equal to 30% according to published reports. In thalassemia, the role of the patient in the informed consent process leading up to HSCT has not been fully investigated. This study investigated the hypothesis that information provided by physicians in the medical scenario of HSCT is not fully understood by patients and that misunderstanding and communication biases may affect the clinical decision-making process. METHODS: A questionnaire was either mailed or given personally to 25 patients. A second questionnaire was administered to the 12 physicians attending the patients enrolled in this study. Descriptive statistics were used to evaluate the communication factors. RESULTS: The results pointed out the difference between the risks communicated by physicians and the risks perceived by patients. Besides the study highlighted the mortality risk considered to be acceptable by patients and that considered to be acceptable by physicians. CONCLUSIONS: Several solutions have been suggested to reduce the gap between communicated and perceived data. A multi-disciplinary approach may possibly help to attenuate some aspects of communication bias. Several tools have also been proposed to fill or to attenuate the gap between communicated and perceived data. But the most important tool is the ability of the physician to comprehend the right place of conscious consent in the relationship with the patient.

Identification alone versus intraoperative neuromonitoring of the recurrent laryngeal nerve during thyroid surgery: experience of 2034 consecutive patients.

BACKGROUND: The aim of this study was to evaluate the ability of intraoperative neuromonitoring in reducing the postoperative recurrent laryngeal nerve palsy rate by a comparison between patients submitted to thyroidectomy with intraoperative neuromonitoring and with routine identification alone. METHODS: Between June 2007 and December 2012, 2034 consecutive patients underwent thyroidectomy by a single surgical team. We compared patients who have had neuromonitoring and patients who have undergone surgery with nerve visualization alone. Patients in which neuromonitoring was not utilized (Group A) were 993, patients in which was utilized (group B) were 1041. RESULTS: In group A 28 recurrent laryngeal nerve injuries were observed (2.82%), 21 (2.11%) transient and 7 (0.7%) permanent. In group B 23 recurrent laryngeal nerve injuries were observed (2.21%), in 17 cases (1.63%) transient and in 6 (0.58%) permanent. Differences were not statistically significative. CONCLUSIONS: Visual nerve identification remains the gold standard of recurrent laryngeal nerve management in thyroid surgery. Neuromonitoring helps to identify the nerve, in particular in difficult cases, but it did not decrease nerve injuries compared with visualization alone. Future studies are warranted to evaluate the benefit of intraoperative neuromonitoring in thyroidectomy, especially in conditions in which the recurrent nerve is at high risk of injury.

Role of intraoperative neuromonitoring of recurrent laryngeal nerves in the outcomes of surgery for thyroid cancer.

INTRODUCTION: The aim of this retrospective study was to evaluate the ability of intraoperative neuromonitoring to predict the postoperative functional outcome and its role in reducing the postoperative recurrent laryngeal nerve palsy rate during thyroidectomy for thyroid malignancy. METHODS: Between June 2007 and March 2013, 656 consecutive patients with thyroid cancer underwent thyroidectomy by a single surgical team. We compared 357 patients who have had neuromonitoring (Group A) to 299 patients who have undergone surgery with nerve visualization alone (group B). RESULTS: In group A 7 recurrent laryngeal nerve paralysis were observed (1.96%), 6 (1.68%) transient and 1 (0.28%) permanent; a bilateral recurrent laryngeal palsy was observed in 1 of the 7 cases (0.28%). In group B 6 recurrent laryngeal nerve paralysis were observed (2.01%), 5 (2.01%) transient and 1 permanent (0.33%); bilateral palsy was observed in 1 of the 6 cases (0.33%). Differences were not statistically significative. CONCLUSIONS: Routine visual nerve identification remains the gold standard of recurrent laryngeal nerve management in surgery for thyroid cancer. Intraoperative neuromonitoring is safe, effective, reliable, and easy to perform in excluding postoperative recurrent laryngeal palsy. It helps to identify the nerve in thyroid cancer, but it did not decrease the injuries compared with visualization alone in this study; however, its use can change the operative strategy in order to prevent the risk of bilateral damage in case of signal loss. Future studies are needed to evaluate the benefit of intraoperative neuromonitoring in thyroidectomy for thyroid cancer.

Chronic pain following inguinal hernia repair: assessment of quality of life and medico-legal aspects.

The aim of our study was to evaluate the quality of life (QoL) of a group of patients who underwent tension-free inguinal hernia repair in light of the possible medicolegal implications. We conducted a retrospective study on the QoL of patients who underwent inguinal hernioplasty. One hundred and fifty patients who answered the SF-36 questionnaire were included in the study. Twenty-six (17.3%) had chronic pain, 18 (12%), sensory deficits, and 106 (70.6%) did not complain of any symptoms. There was no a significant deterioration in QoL compared to the reference population. In the group with chronic pain, 10 patients (38.4%) reported being very limited in performing "physically demanding activities"; 18 (69.2%) reported a deficit of performance in activities of daily living; 8 (30.7%) complained of a reduction of time spent at work because of emotional disorders. In one case the pain was particularly severe and required surgical treatment. The answers obtained through the questionnaire show that tension-free hernioplasty does not degrade patients'QoL. However in the group of patients with chronic pain examined one year after surgery, QoL had deteriorated so much that it affected the employment sphere and the social and relational sphere. Although there is a relatively low incidence and frequency of problems relating to chronic pain following inguinal hernioplasty, chronic pain can sometimes have serious effects on QoL and socio-economic and legal implications.