When Patient Engagement and Research Ethics Collide: Lessons from a Dementia Forum

Robillard, Julie M.; Feng, Tanya L.

doi:10.3233/jad-161285

Cited by 31 publications

(30 citation statements)

References 51 publications

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“…While patients with advanced or metastatic MCC do have the opportunity to participate in clinical trials, individuals with dementia or cognitive impairment are usually excluded from such trials; in this context, various countries have different regulations . In Germany, patients with cognitive impairment that precludes them from giving informed consent were – until recently – allowed to participate in clinical trials only if they stood to personally benefit from it.…”

Section: Psycho‐oncological Aspectsmentioning

confidence: 99%

S2k guidelines for Merkel cell carcinoma (MCC, neuroendocrine carcinoma of the skin) – update 2018

Becker

Eigentler

Frerich

et al. 2019

J Deutsche Derma Gesell

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Summary Merkel cell carcinoma (MCC, ICD‐O M8247 / 3) is a rare malignant primary skin tumor with epithelial and neuroendocrine differentiation. The neoplastic cells share many morphological, immunohistochemical and ultrastructural characteristics with Merkel cells of the skin. The diagnosis of MCC is rarely made on clinical grounds. Histological and immunohistochemical studies are usually required to confirm the clinical suspicion. Given the frequent occurrence of occult lymph node metastasis, sentinel lymph node biopsy should be performed once distant metastasis has been ruled out by cross‐sectional imaging. Primary tumors without evidence of organ metastases are treated with complete surgical excision with appropriate surgical margins. Radiation therapy should be considered at all stages of the disease. For advanced MCC that is no longer amenable to curative treatment by surgery or radiation therapy, there is currently no established systemic therapy for which an improvement in recurrence‐free survival or overall survival has been demonstrated in a prospective randomized trial. However, immunotherapy using PD‐1/PD‐L1 blockade seems to be superior to chemotherapy. Various factors warrant that further diagnostic and therapeutic interventions be determined by an interdisciplinary tumor board. These factors include the tumor's aggressiveness, the frequent indication for sentinel lymph node biopsy along with the frequent occurrence in the head and neck region, the potential indication for adjuvant radiation therapy as well as the complexity of the required diagnostic workup.

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Section: Psycho‐oncological Aspectsmentioning

confidence: 99%

S2k guidelines for Merkel cell carcinoma (MCC, neuroendocrine carcinoma of the skin) – update 2018

Becker

Eigentler

Frerich

et al. 2019

J Deutsche Derma Gesell

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“…The majority of participants in this study indicated a preference for online consent. Some studies argue that participants’ preferences and satisfaction should determine the method of providing informed consent information, suggesting that the most acceptable method for participants constitutes the best approach ( Agre et al , 1997 ; Kraft et al , 2016 ; Robillard et al , 2017 ). However, this survey raises questions about the acceptability of online consent and the extent to which this might be an example of the naturalistic fallacy (i.e.…”

Section: Discussionmentioning

confidence: 99%

The Acceptability of Online Consent in a Self-Test Serosurvey of Responders to the 2014–2016 West African Ebola Outbreak

McGowan

Houlihan

Kingori

et al. 2017

Public Health Ethics

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Online participation in research is used increasingly to recruit geographically dispersed populations. Obtaining online consent is convenient, yet we know little about the acceptability of this practice. We carried out a serostudy among personnel returning to the UK/Ireland following deployment to West Africa during the 2014–2016 Ebola epidemic. We used an online procedure for consenting returnees and designed a small descriptive study to understand: how much of the consent material they read, how informed they felt and if they preferred online to traditional face-to-face consent. Of 261 returnees, 111 (43 per cent) completed the consent survey. Participants indicated a high level of engagement with the consent materials, with 67 per cent reporting having read all and 20 per cent having read ‘most’ of the materials. All participants indicated feeling completely (78 per cent) or mostly (22 per cent) informed about the purpose, methods and intended uses of the research, as well as what participation was required and what risks were involved. Only three participants indicated a preference for face-to-face consent. Free-text comments suggested that online consent may be an acceptable modality for uncomplicated and low-risk studies. The study sample was largely composed of health professionals, suggesting acceptability of online consent within this population.

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“…Im Falle eines fortgeschrittenen oder metastasierten MCC besteht in begrenztem Umfang die Möglichkeit der Behandlung im Rahmen von klinischen Studien. In der Regel sind aber demente oder kognitiv eingeschränkte Patienten von der Teilnahme an klinischen Studien ausgeschlossen, wobei es in verschiedenen Ländern diesbezüglich auch differente Regelungen gibt . Bis vor kurzem war in Deutschland die Studienteilnahme von Patienten, die aufgrund kognitiver Einschränkungen nicht mehr selbst einwilligen können, nur dann erlaubt, wenn damit ein möglicher Nutzen für sie selbst verbunden ist.…”

Section: Psychoonkologische Aspekteunclassified

S2k‐Leitlinie Merkelzellkarzinom (MZK, MCC, neuroendokrines Karzinom der Haut) – Update 2018

Becker

Eigentler

Frerich

et al. 2019

J Deutsche Derma Gesell

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Zusammenfassung Das Merkelzellkarzinom (MCC, ICD‐O M8247/3) ist ein seltener, maligner, primärer Hauttumor mit epithelialer und neuroendokriner Differenzierung. Die Tumorzellen teilen viele morphologische, immunhistochemische und ultrastrukturelle Eigenschaften mit den Merkelzellen der Haut. Die Diagnose MCC wird selten klinisch gestellt. Erst histologisch und immunhistochemisch wird der Verdacht auf ein MCC bestätigt. Nachdem eine Fernmetastasierung durch Bildgebung mit Schnittbildverfahren ausgeschlossen worden ist, sollte aufgrund der hohen Zahl von okkulten Lymphknotenmetastasen eine Schildwächterlymphknotenbiopsie erfolgen. Bei Primärtumoren ohne Hinweise auf das Vorliegen von Organmetastasen soll eine vollständige chirurgische Exzision mit Sicherheitsabstand erfolgen. Die strahlentherapeutische Behandlung sollte in allen Stadien der Tumorerkrankung in Betracht gezogen werden. Für das fortgeschrittene, operative oder strahlentherapeutische nicht mehr kurativ behandelbare MCC gibt es bisher keine etablierte systemische Therapie, für die in einer prospektiv‐randomisierten Studie eine Verbesserung des rezidivfreien Überlebens oder des Gesamtüberlebens demonstriert werden konnte. Eine Immuntherapie mittels PD‐1/PD‐L1‐Blockade erscheint aber einer Chemotherapie überlegen zu sein. Aufgrund seiner Aggressivität, der in der Regel gegebenen Indikation zur Schildwächterlymphknotenbiopsie bei gleichzeitig häufiger Lokalisation im Kopf‐Hals‐Bereich, der zu evaluierenden Indikation einer adjuvanten Radiotherapie sowie der Komplexität der notwendigen Diagnostik zur korrekten Prognoseabschätzung soll das Vorgehen im Rahmen einer interdisziplinären Zusammenarbeit (interdisziplinäres Tumorboard) festgelegt werden.

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When Patient Engagement and Research Ethics Collide: Lessons from a Dementia Forum

Cited by 31 publications

References 51 publications

S2k guidelines for Merkel cell carcinoma (MCC, neuroendocrine carcinoma of the skin) – update 2018

S2k guidelines for Merkel cell carcinoma (MCC, neuroendocrine carcinoma of the skin) – update 2018

The Acceptability of Online Consent in a Self-Test Serosurvey of Responders to the 2014–2016 West African Ebola Outbreak

S2k‐Leitlinie Merkelzellkarzinom (MZK, MCC, neuroendokrines Karzinom der Haut) – Update 2018

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