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In this issue of JAMA, Zapata and colleagues discuss framing the provision of unnecessary medical care as a patient safety problem and managing this problem using the hospital patient safety committee.1 The case presented highlights the lack of clarity about who is accountable for addressing overuse issues. All hospitals are concerned with the safety of their patients, and the authors provide a thoughtful discussion of the merits and challenges of using patient safety infrastructure to target overuse. To retain focus on safety issues while facilitating greater attention to overuse requires defining the relationship between overuse and patient safety.

If you are working in mental health, you get used to being inspected and commented upon – the Mental Health Act Commission, Audit Commission, Social Services Inspectorate, Health Advisory Service (HAS, as was) and public inquiries into patient homicides. Working in multidisciplinary teams has made us used to operating with a variety of perspectives and for most of us this is a necessary and welcome part of the job. Few psychiatrists, however, are so sanguine about the former HAS or about homicide inquiries. The repeated complaint has been their inconsistency. Their quality and tone (potentially as damaging as their findings) have varied to quite an indefensible degree.

As efforts to address unmet need for family planning and contraception (FP/C) accelerate, voluntary use, informed choice and quality must remain at the fore. Active involvement of affected populations has been recognized as one of the key principles in ensuring human rights in the provision of FP/C and in improving quality of care. However, community participation continues to be inadequately addressed in large-scale FP/C programmes. Community and healthcare providers’ unequal relationship can be a barrier to successful participation. This scoping review identifies participatory approaches involving both community and healthcare providers for FP/C services and analyzes relevant evidence. The detailed analysis of 25 articles provided information on 28 specific programmes and identified three types of approaches for community and healthcare provider participation in FP/C programmes. The three approaches were: (i) establishment of new groups either health committees to link the health service providers and users or implementation teams to conduct specific activities to improve or extend available health services, (ii) identification of and collaboration with existing community structures to optimise use of health services and (iii) operationalization of tools to facilitate community and healthcare provider collaboration for quality improvement. Integration of community and healthcare provider participation in FP/C provision were conducted through FP/C-only programmes, FP/C-focused programmes and/or as part of a health service package. The rationales behind the interventions varied and may be multiple. Examples include researcher-, NGO- or health service-initiated programmes with clear objectives of improving FP/C service provision or increasing demand for services; facilitating the involvement of community members or service users and, in some cases, may combine socio-economic development and increasing self-reliance or control over sexual and reproductive health. Although a number of studies reported increase in FP/C knowledge and uptake, the lack of robust monitoring and evaluation mechanisms and quantitative and comparable data resulted in difficulties in generating clear recommendations. It is imperative that programmes are systematically designed, evaluated and reported.

The lack of systematic oversight of physician performance has led to some serious cases related to physician competence and behaviour. We are currently implementing a hospital-wide approach to improve physician oversight by incorporating it into the hospital credentialing process. Our proposed credentialing method involves four systems: (1) a system for monitoring and reporting clinical performance; (2) a system for evaluating physician behaviour; (3) a complaints management system; and (4) an administrative system for maintaining documentation. In our method, physicians are responsible for implementing an annual performance assessment program. The hospital will be responsible for the complaints management system and the system for collecting and reporting relevant health outcomes. Physicians and the hospital will share responsibility for monitoring professional behaviour. Medical leadership, effective governance, appropriate supporting information systems and adequate human resources are required for the program to be successful. Our program is proactive and will allow our hospital to enhance safety through a quality assurance framework and by complementing existing safety activities. Our program could be extended to non-hospital physicians through regional health or provider networks. Central licensing authorities could help to coordinate these programs on a province- or state-wide basis to ensure uniformity of standards and to avoid duplication of efforts.

Introduction: Providing higher quality medical care to workers with occupationally associated carpal tunnel syndrome (CTS) may reduce disability, facilitate return to work, and lower the associated costs. Although many workers’ compensation systems have adopted treatment guidelines to reduce the overuse of unnecessary care, limited attention has been paid to ensuring that the care workers do receive is high quality. Further, guidelines are not designed to enable objective assessments of quality of care. This study sought to develop quality measures for the diagnostic evaluation and non-operative management of CTS, including managing occupational activities and functional limitations. Methods: Using a variation of the well-established RAND/UCLA Appropriateness Method, we developed draft quality measures using guidelines and literature reviews. Next, in a two-round modified-Delphi process, a multidisciplinary panel of 11 U.S. experts in CTS rated the measures on validity and feasibility. Results: Of 40 draft measures, experts rated 31 (78%) valid and feasible. Nine measures pertained to diagnostic evaluation, such as assessing symptoms, signs, and risk factors. Eleven pertain to non-operative treatments, such as the use of splints, steroid injections, and medications. Eleven others address assessing the association between symptoms and work, managing occupational activities, and accommodating functional limitations. Conclusions: These measures will complement existing treatment guidelines by enabling providers, payers, policymakers, and researchers to assess quality of care for CTS in an objective, structured manner. Given the characteristics of previous measures developed with these methods, greater adherence to these measures will probably lead to improved patient outcomes at a population level.

Este artigo tem por objetivo relatar a experiência de implantação e funcionamento dos Comitês de Prevenção da Mortalidade Infantil no Estado do Paraná, Brasil, apresentando as estratégias de operacionalização, composição e fluxo dos três níveis: estadual, regional e municipal. Para a efetiva implantação dessa proposta, foi necessário preparar profissionais para investigar o óbito infantil e, portanto, foram realizados treinamentos de Multiplicadores para Investigação dos Óbitos Infantis. Em dois anos, os comitês analisaram 50% dos óbitos do Estado. Pretende-se ampliar gradativamente o número de óbitos analisados, bem como dar continuidade ao acompanhamento e à reestruturação dos comitês, visando a obter melhor desempenho, mais agilidade e melhor qualidade dos dados.

L'article retrace l'histoire du traitement et de la regulation de la demence au sein du systeme de sante et de la legislation anglais entre 1845 et 1867. Le role des Lunacy Commissioners, les membres de la commission responsable des malades mentaux est decrit ici.

According to the Bylaws of the AACP, the Professional Affairs Committee is to study: issues associated with professional practice as they relate to pharmaceutical education, and to establish and improve working relationships with all other organizations in the field of health affairs. The Committee is also encouraged to address related agenda items relevant to its Bylaws charge and to identify issues for consideration by subsequent committees, task forces, commissions, or other groups. COMMITTEE CHARGE President Jeffrey Baldwin charged the 2009-10 American Association of Colleges of Pharmacy (AACP) Standing Committees to consider the role of the pharmacist in primary healthcare and identify the public policy, workforce, education and advocacy issues associated with advancing pharmacists' contributions to systems of primary care. The Argus Commission, Advocacy and Professional Affairs standing committees focused on the pharmacist's role in primary care. How will/do pharmacists integrate their unique expertise as medication use specialists into primary care delivery to improve patients' lives? Their work is grounded in the Institute of Medicine definition for primary care and the Joint Commission of Pharmacy Practitioners (JCPP) Vision Statement for Pharmacy Practice 2015: * "Primary care is the provision of integrated, accessible healthcare services by clinicians who are accountable for addressing a large majority of personal healthcare needs, developing a sustained partnership with patients, and practicing in the context of family and community;" (1) * "Pharmacists will be the healthcare professionals responsible for providing patient care that ensures optimal medication therapy outcomes," (2) Specifically, the 2009-10 Professional Affairs Committee is charged to: * Examine the evidence for pharmacists' integration in primary care practice in the community in the context of partnership with patients and healthcare service providers. * Provide analysis of current and potential care delivery models. BACKGROUND Healthcare reform is a topic at the forefront of concern for Congress, the public and healthcare professionals. The primary care workforce is comprised of a diverse complement of health professionals with direct patient care provided by allopathic and osteopathic physicians, nurse practitioners, physician assistants, and registered nurses. Pharmacists are among the health professionals with growing responsibilities in the provision of patient care services within the primary care environment. (3) Others include social workers, medical assistants, and nutritionists. An adequate supply of all healthcare professionals will be required to meet the future demand for services and many recent publications reflect a growing concern for the workforce supply fulfilling this demand. (4) It is important that pharmacists are considered in legislation related to the future of the health professions workforce and future healthcare policy. To determine how pharmacists may influence healthcare reform, a critical review of the evidence of pharmacists' involvement in primary care service delivery is necessary. In the early 1990s, the concept of pharmaceutical care emerged and took hold. (5) Healthcare reform, as pressing then as it is now, embraced pharmacists offering pharmaceutical care as the most vital contribution pharmacists could make in primary care to produce positive patient outcomes. Providing pharmaceutical care meant that pharmacists should enter into a partnership with patients, be accountable for drug therapy outcomes along with other healthcare providers, manage drug therapy, and coordinate the "continuum of drug therapy." (6) Several barriers to providing pharmaceutical care were identified, including lack of continuity between institutional and community pharmacy practice settings, lack of technology allowing pharmacists to take a greater responsibility for drug therapy outcomes and the lack of reimbursement for provision of pharmaceutical care. …

Background Effective maternal and perinatal audits are associated with improved quality of care and reduction of severe adverse outcome. Although audits at the level of care were formally introduced in Tanzania around 25 years ago, little information is available about their existence, performance, and practical barriers to their implementation. This study assessed the structure, process and impacts of maternal and perinatal death audit systems in clinical practice and presents a detailed account on how they could be improved. Methods A cross sectional descriptive study was conducted in eight major hospitals in Dar es Salaam in January 2009. An in-depth interview guide was used for 29 health managers and members of the audit committees to investigate the existence, structure, process and outcome of such audits in clinical practice. A semi-structured questionnaire was used to interview 30 health care providers in the maternity wards to assess their awareness, attitude and practice towards audit systems. The 2007 institutional pregnancy outcome records were reviewed. Results Overall hospital based maternal mortality ratio was 218/100,000 live births (range: 0 - 385) and perinatal mortality rate was 44/1000 births (range: 17 - 147). Maternal and perinatal audit systems existed only in 4 and 3 hospitals respectively, and key decision makers did not take part in audit committees. Sixty percent of care providers were not aware of even a single action which had ever been implemented in their hospitals because of audit recommendations. There were neither records of the key decision points, action plan, nor regular analysis of the audit reports in any of the facilities where such audit systems existed. Conclusions Maternal and perinatal audit systems in these institutions are poorly established in structure and process; and are less effective to improve the quality of care. Fundamental changes are urgently needed for successful audit systems in these institutions.

A lack of consistent policy direction, revealed by a review of nursing and midwifery documentation, presented researchers with an opportunity to engage clinicians in the process of evidence based policy development. By utilising the framework informed by both practice development and the principles of evidence based practice, clinicians were taken through an education program and a series of activities to develop their skills in discerning how research evidence and other literature can inform policy development. The clinicians' involvement maximised their investment in the final policy. Clinicians synthesised all the evidence associated with nursing and midwifery documentation and produced a set of seven guiding principles that formed the basis of an area wide policy for nursing and midwifery documentation. The strength of this approach to policy development was that the clinician's experience ensured that the concerns of the clinicians were included in the policy. Difficulties in completing tasks outside meeting times were highlighted.

Inherent in the dual role of physician-researcher is a conflict of interest arising out of the competing objectives of research and medical practice. Most commentary and policy recommendations on this conflict of interest have focused on the problems that arise in negotiations for informed consent. These are not, however, the only problems presented by this conflict; they are not necessarily even the most important. In order to deal with these problems, several commentators have suggested various procedural safeguards to protect the interests of the patient-subject--for example, separating the roles of physician and researcher, or introducing third parties into the relationship in order to assist in the initial or continuing negotiations for informed consent. In my view, the necessity for special procedural protections of patient-subject interests should be a discretionary judgment of the Institutional Review Board (IRB). In determining the need for special procedural protections for any research protocol, the IRB should consider three factors. To the extent that any one of these or a combination of two or more seems to present a problem, the IRB should consider it increasingly important to recommend special procedural protections: 1. There are serious impairments of the prospective subjects' capacities to consent. 2. The risk of physical or psychological injury presented by procedures done in the interests of research exceeds the threshold of "a minor increment above minimal risk." 3. The protocol is designed to introduce, test, evaluate, or compare therapeutic, diagnostic, or prophylactic maneuvers.

Purpose To evaluate the prognostic role of soluble CD163 (sCD163) in serum and macrophage infiltration in primary melanomas from patients with American Joint Committee on Cancer (AJCC) stage I/II melanoma. The scavenger receptor CD163 is associated with anti-inflammatory macrophages, and it is shed from their surface. Patients and Methods Serum samples from 227 patients with stage I/II melanoma obtained before definitive surgery (baseline) and during 5 years of follow-up were analyzed for sCD163 by enzyme-linked immunosorbent assay. Excised formalin-fixed, paraffin-embedded primary melanomas from 190 patients were available for immunohistochemical analyzes of CD163+ and CD68+ macrophage infiltration. They were estimated semiquantitatively in three different tumor compartments: tumor nests, tumor stroma, and at the invasive front of the tumor. Results Serum sCD163 treated as an updated continuous covariate as well as the baseline value were analyzed together with the covariate's ulceration and thickness in a Cox proportional hazards model. sCD163 was an independent prognostic factor for overall survival (baseline, hazard ratio [HR] = 1.4; 95% CI, 1.1 to 1.7; P = .01; and updated, HR = 1.4; 95% CI, 1.1 to 1.8; P = .003). Melanomas with dense CD163+ macrophage infiltration in tumor stroma and CD68+ macrophage infiltration at the invasive front were associated with poor overall survival (CD163, HR = 2.7; 95% CI, 0.8 to 9.3; P = .11; and CD68, HR = 2.8; 95% CI, 1.2 to 6.8; P = .02) independent (borderline for CD163) of thickness and ulceration. Conclusion Both serum levels of sCD163 and the presence of CD68+ macrophage infiltration at the tumor invasive front are independent predictors of survival in AJCC stage I/II melanoma. CD163+ cell infiltration in tumor stroma may be predictive of survival.

Purpose: Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design: sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results: Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P < 0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P < 0.05). Some key clinical information was discrepant between the two sources. Conclusions: The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients.

INTRODUCTION: The purpose of this analysis was to determine the potential efficacy of recombinant human tissue factor pathway inhibitor (tifacogin) in a subpopulation of patients with community-acquired pneumonia (CAP) from a phase III study of severe sepsis. METHODS : A retrospective review of patients with suspected pneumonia was conducted by an independent clinical evaluation committee (CEC) blinded to treatment assignment. The CEC reanalyzed data from patients enrolled in an international multicenter clinical trial of sepsis who had a diagnosis of pneumonia as the probable source of sepsis. The primary efficacy measure was all-cause 28-day mortality. RESULTS: Of 847 patients identified on case report forms with a clinical diagnosis of pneumonia, 780 (92%) were confirmed by the CEC to have pneumonia. Of confirmed pneumonia cases, 496 (63.6%) met the definition for CAP. In the CEC CAP population, the mortality rates of the tifacogin and placebo groups were 70/251 (27.9%) and 80/245 (32.7%), respectively. The strongest signals were seen in patients with CAP not receiving concomitant heparin, having microbiologically confirmed infection, or having the combination of documented infection and no heparin. The reduction in mortality in this narrowly defined subgroup when treated with tifacogin compared with placebo was statistically significant (17/58 [29.3%] with tifacogin and 28/54 [51.9%] with placebo; unadjusted P value of less than 0.02). CONCLUSIONS: Tifacogin administration did not significantly reduce mortality in any severe CAP patient. Exploratory analyses showed an improved survival in patients who did not receive concomitant heparin with microbiologically confirmed infections. These data support the rationale of an ongoing phase III study exploring the potential benefit of tifacogin in severe CAP. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00084071.

In dosimetry-based treatment planning protocols, patients with rapid clearance of the radiopharmaceutical require a larger amount of initial activity than those with slow clearance to match the absorbed dose to the critical organ. As a result, the dose-rate to the critical organ is higher in patients with rapid clearance and may cause unexpected toxicity compared to patients with slow clearance. In order to account for the biological impact of different dose-rates, radiobiological modeling is beginning to be applied to the analysis of radionuclide therapy patient data. To date, the formalism used for these analyses is based on kinetics derived from activity in a single organ, the target. This does not include the influence of other source organs to the dose and dose-rate to the target organ. As a result, only self-dose irradiation in the target organ contributes to the dose-rate. In this work, the biological effective dose (BED) formalism has been extended to include the effect of multiple source organ contributions to the net dose-rate in a target organ. The generalized BED derivation has been based on the Medical Internal Radionuclide Dose Committee (MIRD) schema assuming multiple source organs following exponential effective clearance of the radionuclide. A BED-based approach to determine the largest safe dose to critical organs has also been developed. The extended BED formalism is applied to red marrow dosimetry, as well as kidney dosimetry considering the cortex and the medulla separately, since both those organs are commonly dose limiting in radionuclide therapy. The analysis shows that because the red marrow is an early responding tissue (high alpha/beta), it is less susceptible to unexpected toxicity arising from rapid clearance of high levels of administered activity in the marrow or in the remainder of the body. In kidney dosimetry, the study demonstrates a complex interplay between clearance of activity in the cortex and the medulla, as well as the initial activity ratio and the S value ratio between the two. In some scenarios, projected BED based on both the cortex and the medulla is a more appropriate constraint on the administered activity than the BED based on the cortex only. Furthermore, different fractionated regimens were considered to reduce renal toxicity. The MIRD-based BED formalism is expected to be useful for patient-specific adjustments of activity and to facilitate the investigation of dose-toxicity correlations with respect to dose-rate and tissue repair mechanism.

Research associates (RAs) play an important role in ensuring the quality of clinical trials. They are largely responsible for maintaining the accuracy and timeliness of data collected and for complying with applicable regulations. At the ACR Imaging Network (ACRIN), a cooperative group, RAs have formed a committee with the mission of helping ACRIN achieve its goal of conducting quality multi-institutional imaging clinical trials. Because of the varying backgrounds and levels of experience of ACRIN’s RAs, one of the first goals of the committee was to develop an educational program that would provide standard training to all RAs. The committee also felt that RAs should be involved in the protocol development process from the earliest stages, and they are now represented on each major ACRIN committee. Other committee activities include publishing a newsletter, conducting an RA questionnaire, maintaining a Web page, and developing an online training tool. With hard work from the committee members, support from ACRIN’s leadership, and demonstrated accomplishments, the committee has become an integral part of ACRIN’s organization.

While professions hold their members responsible for self-regulation, many physicians have insufficient information about outcome measures in their practices to judge performance and are inexperienced in performing audits to gather the information they need to judge performance.To develop a structure and process to support family doctors with little experience in doing quality improvement studies to conduct morbidity and mortality (MM) audits.A family medicine teaching group provides members on a rotating basis to an MM review committee. The committee meets eight times a year and has done four audits, the most comprehensive on the topic of preventable hospital admissions. Both implicit and explicit criteria were incorporated into decision making. Strengths and limitations of the audit process and practice changes that resulted from the audit are discussed.Morbidity and mortality audits can vary in rigour. To promote physicians' interest in and commitment to audits, factors considered should reflect the goals, needs, skills, and time available of the physicians involved. Practical learning often results from simple projects.

Death of a normal volunteer highlights problems with research review and protection of subjects ### Healthy volunteer dies in asthma study On July 19, after investigating the death of a previously healthy volunteer, the United States Office for Human Research Protections (OHRP) suspended nearly all federally funded medical research involving human subjects at Johns Hopkins University. The death has been described as “particularly disturbing” because 24 year old Ellen Roche was a healthy volunteer who had nothing to gain by taking part in the study.1 Her death has revived debate about the adequacy of oversight of medical research that followed the death of 18 year old Jesse Gelsinger who volunteered for a gene therapy experiment. Ellen Roche was a 24 year old technician from the Johns Hopkins Asthma and Allergy Centre who volunteered to take part in a study designed to provoke a mild asthma attack in order to help doctors discover the reflex that protects the lungs of healthy people against asthma attacks. After inhaling hexamethonium, a medication used for treating high blood pressure in the 1950s and 60s, Ms Roche became ill. She developed a cough and her condition worsened over the next week until she was put on a ventilator. With her lung tissue breaking down, blood pressure falling and her kidneys beginning to fail, nothing could be done to save her.2 She died on June 2, about a month after entering the study. The Office for Human Research Protections (OHRP) investigated the circumstances of Ms Roche's death and accused the Hopkins Institutional Review Board (IRB) of failing to take proper precautions. It also evaluated the human subject protection system at Hopkins. The OHRP found that prior to approving the study, Hopkins researcher …

To describe priority setting for new technologies in medicine.Qualitative study using case studies and grounded theory.Two committees advising on priorities for new technologies in cancer and cardiac care in Ontario, Canada.The two committees and their 26 members.Accounts of priority setting decision making gathered by reviewing documents, interviewing members, and observing meetings.Six interrelated domains were identified for priority setting for new technologies in medicine: the institutions in which the decision are made, the people who make the decisions, the factors they consider, the reasons for the decisions, the process of decision making, and the appeals mechanism for challenging the decisions.These domains constitute a model of priority setting for new technologies in medicine. The next step will be to harmonise this description of how priority setting decisions are made with ethical accounts of how they should be made.

To provide information and recommendations to facilitate decision-making when a mammographic abnormality is detected by screening.References identified by use of MEDLINE, AIDSLINE, CANCERLIT and reference lists of review articles to December 1996. Where experimental evidence is lacking, recommendations are based on expert opinion. The evidence is graded accordingly in "levels" (page S2).Exclusion or confirmation of the presence of cancer with minimum intervention and delay.When an abnormality is detected on screening mammography, clinical evaluation and thorough radiologic work-up are needed to determine its significance. Clinical evaluation should include a history and a thorough examination of the breast, axilla and supraclavicular areas. In the radiologic work-up, diagnostic mammograms should be obtained with additional views, spot compression and magnification views as appropriate. Current mammograms should be compared with previous mammograms whenever possible. The mammographic report should include a precise description of the abnormal features visualized and an estimate of the level of suspicion of cancer they imply. Whenever there is any doubt in the interpretation of mammograms, the interpretation of 2 experienced readers should be obtained. (The following radiologic classification into 4 categories is suggested: 1--benign, not due to cancer; 2--low risk, probability of cancer under 2%; 3--intermediate risk, probability of cancer 2% to 10%; 4--high risk, probability of cancer over 10%.) Ultrasonography can be used to clarify the nature of noncalcified nodular lesions. Management decisions require close communication between the woman and her physicians. Throughout, a clinician in charge should be identified who will coordinate and transmit all decisions. Management will depend on the estimated level of risk Category 1 abnormalities require no further investigation. Category 2 abnormalities may be followed up by periodic mammographic and clinical examinations. Follow-up examination of category 2 abnormalities should be carried out at approximately 6 and 12 months. If the abnormality is stable, examination should be repeated annually for 2 to 3 years thereafter. The rationale of follow-up should be explained, and women should be made aware that it is not possible to provide complete assurance that an abnormality is benign. Category 3 abnormalities usually require image-guided fine-needle or core biopsy. Every image-guided needle biopsy should be accompanied by a full report. Category 4 abnormalities should usually be excised. This may be preceded by image-guided needle biopsy. When surgical biopsy is carried out, the margins of the resected specimen must be free of tumour. The intact pathology specimen should be examined radiographically to confirm that all mammographic abnormalities have been removed. The patient should be kept fully informed as to the reason for each test and the meaning of its results. The process, from initial detection of the mammographic abnormality to the final management decision, should be completed as rapidly as possible.Guidelines were reviewed and revised by the Writing Committee, expert primary reviewers, secondary reviewers selected from all regions of Canada and by the Steering Committee. The final document reflects a consensus of all these contributors.