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PubMed2006

An industry perspective on the NIMH consensus statement on negative symptoms.

Negative symptoms of schizophrenia remain an area of substantial unmet clinical need. By convening a consensus conference in January 2005, the NIMH has taken a leading role in stimulating a resurgence of interest in methodological considerations related to development of new medications for treating negative symptoms. One audience for this work is clinical researchers in industry. They must take ideas, like those emerging from this consensus meeting, and determine whether they can be applied to their global trials in order to meet the needs of a broad group of customers, which include patients, clinicians, regulators, and payers. This article takes the ideas that surfaced from the NIMH consensus work and interprets them in terms of issues that industry faces for its clinical trials. Particular emphasis is given to addressing hurdles to study design and analysis that come when developing broad-spectrum or adjunctive agents that may be effective for negative symptoms.

Antipsychotic Agents↗
PubMed2001

Patient safety: a call to action: a consensus statement from the National Quality Forum.

OBJECTIVE: The Institute of Medicine (IOM) and the Presidential Advisory Commission on Consumer Protection and Quality in the Healthcare Industry have both recently highlighted healthcare errors as a serious public health problem. An in-depth review of the issue was conducted by the National Quality Forum (NQF) in preparation for work the federal government has asked the NQF to do. PARTICIPANTS: The membership of the NQF includes a wide array of public and private health agencies, healthcare provider organizations, consumer groups, healthcare purchasers, and research and quality improvement organizations. EVIDENCE: Published literature, including more than 350 journal articles and over 30 books and monographs, were reviewed, and input was solicited from individuals and organizations known to be knowledgeable on the topic, including the Harvard University Executive Session on Medical Error, the VA National Patient Safety Center, the Joint Commission on Accreditation of Healthcare Organizations, the National Patient Safety Foundation, and the IOM. The principal observations and findings were collated; 10 high-priority strategic areas needing action were identified; and specific recommendations for each area were crafted. CONSENSUS PROCESS: A draft statement was prepared and submitted to the NQF membership and Directors, as well as to external reviewers. The statement was revised following subsequent rounds of review and comment, after which it was approved by the NQF Board of Directors. CONCLUSIONS: There is an urgent need to reduce healthcare errors; however, numerous barriers impede progress in this regard, including widespread misunderstanding about why healthcare errors occur, the prevailing culture of "name and blame" surrounding these events, lack of user-friendly error-reporting mechanisms, and fear of litigation if errors are acknowledged and reported. To eliminate these barriers, and to begin to reduce healthcare errors, the NQF recommends that concerted action be taken in the 10 strategic areas identified here.

Medical Errors↗