Ethical review: Standardizing procedures and local shaping of ethical review practices

Since ethical review practice has developed in relation to specific regulatory regimes and local contexts, it cannot be understood without paying attention to the institutional context of ethical review practices. We believe the tendency towards strong central governance and standardization in ethical review implies a lack of understanding of how specific local institutional contexts actually affect ethical review practices. Our question is: “How do local institutional contexts relate to the way REC's shape their formal mandate, and what are the implications for research governance?” To get in-depth insights in how REC's shape their formal mandates in every-day practice, we did a qualitative ethnographic-sociological study of three Dutch REC's in different contexts: an academic context, a care context and a commercial context. In analyzing these three REC's we paid attention to the procedures operative in REC practices, the cultures and everyday experiences of REC members, the scientific, social and financial resources that are available to REC's, and the evaluative perspective REC's employ. We conclude that specific local, institutional contexts offer valuable resources for ethical review. To track this, insight into the institutional configuration as a whole is necessary. Variations in the ways REC's shape their formal mandate should not be regarded problematic, but rather as fruitful opportunities for public learning.     

Preliminary evaluation of the efficacy and implementation of the new NHS complaints procedure

The increase (28.8 per cent) in the number of complaints from pre-New NHS Complaints Procedure to the implementation of the new procedures in 1996 is a matter of concern because it is estimated that the current figure represents only 40 per cent of the number of people with some dissatisfaction. The Wilson Report prompted Government initiatives in producing a new NHS Complaints Procedure. The new procedure allows for complaints to be dealt with at a local level, or in a minority of cases through Independent Review. The new procedures, which were introduced in April 1996, oblige Trusts, GP practices and Health Boards to establish a Written Local Resolution process for handling complaints, responsibility for implementation lying with individual trusts. A preliminary assessment of the New Procedures was carried out in Lothian. A qualitative approach was utilised and semi-structured taped interviews lasting on average one hour ten minutes were administered to the six complaints officers. This study concentrates on how the six Lothian NHS Trusts are implementing the new procedure, the openness in complaints handling, and the awareness of how complaints can be used to improve standards. The conclusion is that Local Resolution 1 has been successful, and that complaints do receive a speedy response. The process is much simpler and easier for the lay population to access. Reservations remain, however, towards the Independent Review procedure.     

Senior GRADE methodologists encounter challenges as part of WHO guideline development panels: an inductive content analysis

BackgroundThe World Health Organization (WHO) classifies a substantial proportion of their recommendations as strong despite low or very low confidence (certainty) in estimates of effect. Such discordant recommendations are often inconsistent with Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance.ObjectiveTo gain the perspective of senior WHO methodology chairs regarding panels' use of GRADE, particularly regarding discordant recommendations.Data sourcesSenior active GRADE methodologists who had served on at least two WHO panels and were an author on at least one peer-reviewed published article on GRADE methodology.MethodsFive eligible methodologists participated in detailed semistructured interviews. Respondents answered questions regarding how they were viewed by other panelists and WHO leadership, and how they handled situations when panelists made discordant recommendations they felt were inappropriate. They also provided information on how the process can be improved. Interviews were recorded and transcribed, and inductive content analysis was used to derive codes, categories, and emergent themes.ResultsThree themes emerged from the interviews of five methodologists: (1) The perceived role of methodologists in the process, (2) Contributors to discordant recommendations, and (3) Strategies for improvement. Salient findings included (1) a perceived tension between methodologists and WHO panels as a result of panel members' resistance to adhering to GRADE guidance; (2) both financial and nonfinancial conflicts of interest among panel members as an explanation for discordant recommendations; and (3) the need for greater clarity of, and support for, the role of methodologists as co-chairs of panels.ConclusionsThese findings suggest that the role of the GRADE methodologist as a co-chair needs to be clarified by the WHO leadership. They further suggest the need for additional training for panelists, quality monitoring, and feedback to ensure optimal use of GRADE in guideline development at WHO.     

Handling complaints in hospitals

GOAL: To find out about complaints procedures in hospitals in North-Holland and to determine to what extent they function independently. METHOD: All 21 hospitals were visited between the spring of 1992 and the autumn of 1993. Before the visit took place the hospital management had to complete and return a questionnaire relating to the complaints procedure in that hospital. RESULTS: All except two hospitals had rules for dealing with complaints. In 18 hospitals there was a complaints committee; in 12 of these the management was not--or was no longer--involved. The element of independence was expressed in a great variety of ways. In a quarter of the hospitals complaints were often not dealt with within two months. DISCUSSION: The situation with regard to complaints procedures in hospitals in North-Holland is definitely improving. Some hospitals, however, are much more successful than others in meeting the criteria for an adequate complaints procedure. There is room for improvement in two particular areas; complaints should be handled more promptly and independently.     

Hospital complaints procedures and no fault liability

This article considers the extent to which it would be feasible to introduce 'no fault liability' for medical accidents, while the present system for dealing with complaints procedures remains in force. What is needed, it is argued, is a genuinely independent review process for dealing with complaints about clinical judgments.     

从门诊医患关系探索门诊工作改进

目的 通过对门诊患者投诉原因深度剖析,寻找管理存在的漏洞,并持续改进,提出门诊建设亮点.方法 回顾性总结2014年1月至2015年1月门诊发生的213例投诉案例,采取一般统计描述法分析.结果 门诊投诉暴露出管理漏洞有门诊病历书写不规范、门诊布局不合理等,医务部门诊办公室根据短板做出一系列调整,效果显著. 结论 门诊医患关系是管理部门重要抓手,重视医患关系管理,深度剖析原因,持续提出改进措施是医院门诊工作持续改进的重要方法.     

Protesting patients: a study of complaints submitted to a Family Health Service Authority

The issue of complaints is a topical one. It is of interest to the Government who espouses a consumerist philosophy and to health care consumer groups who are keen to ensure that effective mechanisms for the redress of grievances are in place. The complaints machinery is currently being reviewed and debated by interested parties and the main suggestions for change are set out in this paper. It is suggested that the factors which impede reform are professional self regulation, which limits lay involvement in the assessment of matters complained about, and the new managerialism which, through its emphasis on consumerism, has the paradoxical effect of reinforcing the control of managers. If complaints procedures are to be reformed it is paramount that we have an insight into what people complain about. To this end this paper presents an analysis of the letters of complaint submitted to one Family Health Service Authority in the early 1990s.     

Second-tier reviews of complaints in health and social care

There has been a flurry of recent government initiatives concerning how citizens should be able to take up grievances against the state. In the fields of health and social care, people have been expected to use internal complaints procedures to resolve grievances. Research in this area suggests that there have been problems with the existing complaints procedures and there has been particular criticism of the 'second-tier' review stage in both health and social care. This has led to the introduction of more independent means of review. Different models of review have been developed in England, Wales and Scotland. Based on a review of recent policy documents and legislative instruments, this article looks at recent changes and proposals and considers the relative merits of the different models in the three administrations.     

Challenging the ‘view from nowhere’: citizen reflections on specialist expertise in a deliberative process

This paper presents analysis of citizen encounters with specialists in a deliberative process, called Deliberative Mapping, which explored options for addressing the shortage of organs for transplantation in the UK. There is a rich theoretical literature about the extent to which citizens are competent to question the knowledge claims of specialists in complex decision-making processes, suggesting the trustworthiness of scientific expertise will depend on the qualities of social interaction in face-to-face dialogue, but little empirical analysis of specific encounters. This paper presents evidence of how citizens located specialist expertise in making judgements about the legitimacy and credibility of specialist knowledge claims, in ways that reflect differences in epistemic procedures valued by the panels of men and women in this process.     

Challenging the 'view from nowhere': citizen reflections on specialist expertise in a deliberative process

This paper presents analysis of citizen encounters with specialists in a deliberative process, called Deliberative Mapping, which explored options for addressing the shortage of organs for transplantation in the UK. There is a rich theoretical literature about the extent to which citizens are competent to question the knowledge claims of specialists in complex decision-making processes, suggesting the trustworthiness of scientific expertise will depend on the qualities of social interaction in face-to-face dialogue, but little empirical analysis of specific encounters. This paper presents evidence of how citizens located specialist expertise in making judgements about the legitimacy and credibility of specialist knowledge claims, in ways that reflect differences in epistemic procedures valued by the panels of men and women in this process.     

Work improvement and occupational safety and health management systems: common features and research needs

There is a growing trend in re-orientating occupational health research towards risk management. Such a trend is accelerated by the increasing attention to occupational safety and health management systems. The trend, also seen in many Asian countries, is offering new opportunities for strengthening primary prevention. Useful examples are provided from recent work improvement projects dealing with technology transfer, small workplaces and rural areas. Common features of both these work improvement projects and accepted occupational risk management principles are reviewed based on recent experiences in Asian countries. Such features seem highly relevant in examining the occupational health research strategies. These experiences clearly show that locally adjusted procedures for risk assessment and control must be developed. There are new research needs concerning (a) the effective ways to encourage voluntary control at the workplace; (b) practical methods for local risk assessment; and (c) the types of participatory steps leading to continual improvements in the varying local context. Criteria of action-oriented research that can contribute to more effective risk control in different settings are discussed. Six relevant criteria may be mentioned: (a) adaptive risk management; (b) work/risk relationships; (c) action-oriented risk assessment; (d) use of collective expertise; (e) participation of local people; and (f) mutual learning. It appears crucial to stimulate research into the practical risk control procedures adjusted to the local situation.     

Centers for Disease Control and Prevention Expert Panel Meetings on Prevention and Treatment of Anthrax in Adults

The Centers for Disease Control and Prevention convened panels of anthrax experts to review and update guidelines for anthrax postexposure prophylaxis and treatment. The panels included civilian and military anthrax experts and clinicians with experience treating anthrax patients. Specialties represented included internal medicine, pediatrics, obstetrics, infectious disease, emergency medicine, critical care, pulmonology, hematology, and nephrology. Panelists discussed recent patients with systemic anthrax; reviews of published, unpublished, and proprietary data regarding antimicrobial drugs and anthrax antitoxins; and critical care measures of potential benefit to patients with anthrax. This article updates antimicrobial postexposure prophylaxis and antimicrobial and antitoxin treatment options and describes potentially beneficial critical care measures for persons with anthrax, including clinical procedures for infected nonpregnant adults. Changes from previous guidelines include an expanded discussion of critical care and clinical procedures and additional antimicrobial choices, including preferred antimicrobial drug treatment for possible anthrax meningitis.     

The role of the FDA in the effort against AIDS.

The Food and Drug Administration has instituted several pro-active measures to expedite the review of treatments, diagnostics, and vaccines for AIDS and related conditions. In particular, the agency has established a special designation--1-AA--for a potential AIDS product which gives top priority to its review. This special expedited review process for AIDS products has provided for greater cooperation between their sponsors and FDA''s reviewers. AIDS products also receive prompt consideration for orphan product status--a status providing financial incentives to the developers of treatments for certain rare and complex diseases. FDA''s special procedures for AIDS drugs have resulted in several major advances in available AIDS treatments. Foremost among these was the FDA''s review and approval of zidovudine (commonly known as AZT) as the first effective palliative for AIDS within 107 days--an agency record. Similarly, the agency quickly evaluated and approved ELISA and Western blot diagnostic kits for detecting the presence of HIV antibody. These test kits have made an important contribution to safeguarding the nation''s blood supply. The agency has also instituted new "treatment" investigational new drug regulations to allow earlier pre-approval distribution of promising experimental treatments to patients with immediately life-threatening conditions, including persons with AIDS. Under this system and its earlier prototype, eligible AIDS patients were able to receive pre-approval treatment with zidovudine and trimetrexate (an experimental drug for the treatment of AIDS patients with Pneumocystis carinii pneumonia who have experienced severe adverse reactions using standard approved therapies). The agency has made institutional reforms to effectively streamline the review of candidate AIDS treatments and vaccines.(ABSTRACT TRUNCATED AT 250 WORDS)     

american psychiatric association: Effective Psychiatric Care Requires Blending of Home and Hospital Environment

In the fall of 1959, eight Catholic hospitals in the Philadelphia area announced that they would terminate their contractual relationship with the Associated Hospital Service of Philadelphia (Blue Cross) as of midnight December 31, 1959.

The decision came after 18 months of analysis of the new Blue Cross contract and its effect on them. These hospitals wanted a contract based on hospital charges or billings. The Philadelphia Blue Cross stated two principal reasons for opposing this sort of contract: (1) that charges in hospitals varied too widely to provide a constant base of reference, and (2) that the Pennsylvania insurance commissioner would not permit a Blue Cross plan in the state to pay charges.

The Catholic hospitals also objected to administrative and contractual methods adopted by the Philadelphia Blue Cross. Their complaints, described in an article in the August, 1960 issue of Hospital Topics,** dealt with the verification procedure, review procedures of the Physicians' Review Board, late payments, amount of payment for outpatient services, complicated nature of Blue Cross contracts, discounts to Blue Cross, coinsurance, and regulations for hospital extension of care to subscribers following a hospital's termination of its Blue Cross contract.

The dispute between these hospitals and Blue Cross ended on September 16, 1960, when the hospitals signed a new contract which incorporated many of the principles they called essential when they announced their withdrawal.

How is the contract working out? Dennis J. J. McGee, head of the negotiating committee appointed by the hospitals, answers that question in this sequel to the 1960 article.     

Patterns of decline among inpatient procedures.

This paper explores how the new financial incentives and organizational structures that prevail in the hospital industry have affected the mix of services provided by hospitals. Using data from the Agency for Health Care Policy and Research''s Healthcare Cost and Utilization Project, the authors studied the 150 procedures that were most frequently performed on inpatients in 1980. They found that (a) 37 of the 150 procedures declined in use more than 40 percent by 1987, (b) patients that continued to receive one of the 37 procedures in 1987 on an inpatient basis tended to be more severely ill than in 1980, and (c) rates of decline were disproportionately large for Medicaid recipients. Three main factors have contributed to the decline in inpatient use of these procedures. Most important has been the shift from inpatient to outpatient settings, a result of new technologies and pressures from reimbursement mechanisms and utilization review policies. Some procedures have been replaced by less invasive, more effective approaches. Other procedures are now considered ineffective by the medical community and have been largely abandoned as a result.     

Obtaining disability weights in rural Burkina Faso using a culturally adapted visual analogue scale

Burden of disease (BOD) estimates used to foster local health policy require disability weights which represent local preferences for different health states. The global burden of disease (GBD) study presumes that disability weights are universal and equal across countries and cultures, but this is questionable. This indicates the need to measure local disability weights across nations and/or cultures. We developed a culturally adapted version of the visual analogue scale (VAS) for a setting in rural Burkina Faso. Using an anthropologic approach, BOD-relevant health states were translated into culturally meaningful disability scenarios. The scaling procedure was adapted using a locally relevant scale. Nine hypothetical health states were evaluated by seven panels of in total 39 lay individuals and 17 health professionals. Results show that health professionals' rankings and valuations of health states matched those of lay people to a certain extent. In comparison to that of the lay people, health professionals rated seven out of nine health states as slightly to moderately less severe. The instrument scored well on inter-panel and test-retest reliability and construct validity. Our research shows the feasibility of eliciting disability weights in a rural African setting using a culturally adapted VAS. Moreover, the results of the present study suggest that it might be possible to use health professionals' preferences on disability weights as a proxy for lay people's preferences.     

Rights and Duties of HIV Infected Health Care Professionals

In 1991, the CDC recommended that health care workers (HCWs) infectedwith HIV or HBV (HbeAg positive) should be reviewed by an expert paneland should inform patients of their serologic status before engaging inexposure-prone procedures. The CDC, in light of the existing scientificuncertainty about the risk of transmission, issued cautiousrecommendations. However, considerable evidence has emerged since 1991suggesting that we should reform national policy. The data demonstratesthat risks of transmission of infection in the health care setting areexceedingly low. Current policy, moreover, does not improve patientsafety. At the same time, implementation of current national policy atthe local level poses significant human rights burdens on HCWs.Consequently, national policy should be changed to ensure patient safetywhile protecting the human rights of HCWs. This article proposes a newnational policy, including: (1) a program to prevent bloodborne pathogentransmission; (2) a responsibility placed on infected HCWs to promotetheir own health and well-being and to assure patient safety; (3) adiscontinuation of expert review panels and special restrictions forexposure-prone procedures; (4) a discontinuation of mandatorydisclosure of a HCW's inflection status; and (5) the imposition ofpractice restrictions if a HCW is unable to practice safely because of aphysical or mental impairment or failure to follow careful infectioncontrol techniques. A new national policy, focused on management of theworkplace environment and injury prevention, would achieve high levelsof patient safety without discrimination and invasion of privacy.     

Clinical complaints and their handling: a time for change?

OBJECTIVES--To assess the performance of the hospital complaints procedure for complaints proceeding to peer review and the quality of responses to complainants. DESIGN--Retrospective study of data on clinical complaints proceeding to peer review during 1986-91 from clinical records, correspondence, reports of the complaints investigations, and expert review of written responses to complainants. SETTING--Northern Regional Health Authority, covering three million people. SUBJECTS--All 71 clinical complaints investigated to the third stage of the hospital complaints procedure and a sample of 65 written responses to complainants. MAIN MEASURES--Characteristics, duration, and outcome of complaints; findings of peer review; and quality of written responses at various stages in the procedure as evaluated by an expert panel against eight agreed criteria. RESULTS--The median duration of a complaint investigated through all stages of the procedure was 381 days. The longest median stages were those involving attempted resolution locally (131 days) and in which peer review was being arranged (113 days). More complaints alleging failure of communication were upheld by peer review (46/59, 78%) than those alleging misapplication of clinical skills (20/98, 20%) or failure to initiate appropriate investigations or treatment (8/32, 25%). Written responses commonly fell below the standards agreed by the expert panel. CONCLUSIONS--The hospital complaints procedure takes too long and its final peer review stage may not demonstrate sufficient impartiality. The written responses suggest that criticism is not welcomed as a way of improving service. IMPLICATION--The clinical complaints procedure needs to be reformed to ensure true accountability to patients.     

Patients' complaints as a management tool for continuous quality improvement

Continuous quality improvement focuses on the customer and, therefore, requires attention to customers' feedback as a vital input. Customers' feedback in general hospitals includes utilization statistics of various services, patient satisfaction surveys and patients' complaints. The role of complaint data as a management tool, and particularly as applied to quality improvement, has received little attention in the literature. As a quality control tool, complaints are investigated on the individual, unit and organizational levels. Repeated complaints about the same units, procedures or individuals, are especially important for quality review. The role of the hospital administration is to draw on the human, technological and procedural resources at its disposal, along a solution time interval (immediate, short and long term), in designing its policy for quality improvement. Presents three examples of policy changes. The aggregate of complaint data serves, in addition, for follow-up of the effect of changes introduced by policy decisions.