Addressing Risks to Advance Mental Health Research

Iltis, Ana S.; Misra, Sahana; Dunn, Laura B.; Brown, Gregory K.; Campbell, Amy T.; Earll, Sarah A.; Glowinski, Anne L.; Hadley, Whitney B.; Pies, Ronald W.; DuBois, James M.

doi:10.1001/jamapsychiatry.2013.2105

Cited by 27 publications

(50 citation statements)

References 86 publications

(62 reference statements)

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“…These safety features are standard practice for the conduct of clinical trials. [93] Outside of these settings, the safety monitoring of ketamine, still an investigational drug for depression, must instead rely on passive surveillance through the voluntary reporting of adverse events by patients and clinicians. Even in countries with established pharmacovigilance programs, adverse outcomes, including serious adverse events, are notoriously underreported.…”

Section: Discussionmentioning

confidence: 99%

Ketamine for Treatment-Resistant Unipolar and Bipolar Major Depression: Critical Review and Implications for Clinical Practice

et al. 2016

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There is an urgent need for more rapidly effective pharmacotherapies for major depressive disorder and bipolar disorder (BP) that are efficacious and tolerable for depressed patients who respond poorly to conventional treatments. Multiple controlled trials have now demonstrated a rapid, nonsustained antidepressive response to a single intravenous infusion of ketamine. Early controlled studies of intranasal or serial infusion therapy appear promising. The effective dose for depression is lower than the typical anesthetic doses, and side-effects are generally mild and transient. The data investigating the adjunctive use of concurrent ketamine in the course of electroconvulsive therapy (ECT) for depression do not suggest efficacy or tolerability. The therapeutic potential of ketamine has stimulated considerable excitement among clinicians, patients, and industry, and has led to the increasing use of ketamine as an off-label substitute for ECT and other antidepressive treatments. This clinical review of ketamine will assess the evidence-based use of ketamine and initial clinical implications of further development of a potentially novel treatment for rapid reduction of symptoms in depressed patients.

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Section: Discussionmentioning

confidence: 99%

Ketamine for Treatment-Resistant Unipolar and Bipolar Major Depression: Critical Review and Implications for Clinical Practice

et al. 2016

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“…Information provided Consent as “informed” [ 15 , 21 , 37 ] Information provided [ 15 , 58 , 61 ] ii. Comprehension of information Strength of information exchange process [ 14 , 21 , 27 , 32 , 33 , 38 , 57 , 58 ] Barriers to comprehension [ 18 , 37 , 39 , 40 , 52 , 62 ] Strategies to verify comprehension [ 14 , 32 , 37 , 62 ] iii. Voluntariness Factors influencing [ 15 , 18 , 19 , 21 , 22 , 31 , 35 , 45 ] Potential coercion due to emergency context [ 1 , 15 , 18 , 19 , 21 , 31 , 37 , 44 , 51 ] Autonomy and capacity Normative connections [ 19 , 21 , 33 , 46 , 51 ...…”

Section: Resultsmentioning

confidence: 99%

“…Authors stressed the ethical imperative to maximise benefit and minimise harm through a favourable risk/benefit ratio and appropriate strategies to mitigate the inherent risks present in all research [ 19 , 35 – 37 ]. This does not require research to be risk free [ 25 ], but recognises that emergencies automatically expose participants to higher risks [ 38 , 39 ].…”

Section: Resultsmentioning

confidence: 99%

Ethical standards for mental health and psychosocial support research in emergencies: review of literature and current debates

et al. 2017

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BackgroundResearch in emergencies is needed to understand the prevalence of mental health and psychosocial problems and strengthen the evidence base for interventions. All research - including operational needs assessments, programme monitoring and evaluation, and formal academic research - must be conducted ethically. While there is broad consensus on fundamental principles codified in research ethics guidelines, these do not address the ethical specificities of conducting mental health and psychosocial support (MHPSS) research with adults in emergencies. To address this gap, this paper presents a review of multidisciplinary literature to identify specific ethical principles applicable to MHPSS research in emergencies.DiscussionFifty-nine sources meeting the literature review inclusion criteria were analysed following a thematic synthesis approach. There was consensus on the relevance of universal ethical research principles to MHPSS research in emergencies, including norms of participant informed consent and protection; ensuring benefit arises from research participation; researcher neutrality, accountability, and safety; and the duty to ensure research is well designed and accounts for contextual factors in emergency settings.We go onto discuss unresolved issues by highlighting six current debates relating to the application of ethics in emergency settings: (1) what constitutes fair benefits?; (2) how should informed consent be operationalised?; (3) is there a role for decision making capacity assessments?; (4) how do risk management approaches impact upon the construction of ethical research?; (5) how can ethical reflection best be achieved?, and (6) are ethical review boards sufficiently representative and equipped to judge the ethical and scientific merit of emergency MHPSS research? Underlying these debates is a systemic tension between procedural ethics and ethics in practice.Summary and recommendationsIn summary, underpinning the literature is a desire to ensure the protection of participants exposed to emergencies and in need of evidence-based MHPSS. However, there is a lack of agreement on how to contextualise guidelines and procedures to effectively maximise the perspectives of researchers, participants and ethical review boards. This is a tension that the field must address to strengthen ethical MHPSS research in emergencies.

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“…Estas propuestas corresponden a la noción tradicional de riesgo (78), que conlleva la de daño y de magnitud del daño (92), usualmente abordadas por la epidemiología que considera múltiples causas. No obstante, el agotamiento profesional suscita interrogantes que van más allá del tradicional establecimiento de prioridades por magnitud, gravedad o relevancia -pensadas originalmente para lidiar con enfermedades infecciosas-, y obliga a superar problemas tales como la reducción (solo un tipo de conocimiento), la rigidez secuencial (de lo básico a lo aplicado) o la visión meramente utilitarista (solo sirve lo aplicable y a la vez rentable) (93).…”

Section: Posibles Líneas De Investigaciónunclassified

Agotamiento profesional (burnout): concepciones e implicaciones para la salud pública

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2014

biomedica

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El agotamiento profesional (burnout) se describió originalmente como una condición mental caracterizada por disminución del desempeño laboral, sensación de impotencia y frustración e incapacidad para alcanzar objetivos o metas laborales. Para algunos autores, el agotamiento profesional es un conjunto de signos y síntomas mal definido, en tanto que para otros es una enfermedad en sí misma y un problema potencial de salud pública. Se ha observado en todo el mundo que los profesionales y técnicos más afectados son aquellos que prestan servicios o asisten a otras personas, especialmente los dedicados a la atención en salud. Este ensayo se centra en la idea de que el agotamiento profesional debe ser asumido como una enfermedad más que como un síndrome; que sus referentes teóricos y metodológicos han variado a medida que han cambiado las definiciones de salud y enfermedad; que se detecta y se reporta cada vez más, y que sigue siendo una condición objeto de debate en diversos círculos científicos donde se esgrimen posturas radicalmente opuestas que son materia de análisis aquí. Tras exponer las diversas concepciones en torno a esta condición, el ensayo concluye con la exposición de las implicaciones y las opciones de estudio del agotamiento profesional como enfermedad en función de las condiciones y los entornos que favorecen su aparición entre los profesionales dedicados a la salud.Palabras clave: agotamiento profesional, salud pública, epidemiología, conocimiento, investigación en los servicios de salud, vigilancia de la salud del trabajador.

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Addressing Risks to Advance Mental Health Research

Cited by 27 publications

References 86 publications

Ketamine for Treatment-Resistant Unipolar and Bipolar Major Depression: Critical Review and Implications for Clinical Practice

Ketamine for Treatment-Resistant Unipolar and Bipolar Major Depression: Critical Review and Implications for Clinical Practice

Ethical standards for mental health and psychosocial support research in emergencies: review of literature and current debates

Agotamiento profesional (burnout): concepciones e implicaciones para la salud pública

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