Ethical review of health service research in the UK: implications for nursing

BACKGROUND: This paper examines the current systems and structures for ethical review of health services research in the United Kingdom (UK). Past criticisms and the adequacy of recent governance arrangements for Ethics Committees in addressing these are discussed. The implications for nurses are then considered. RATIONALE: This examination of the situation is prompted by the demand for more innovative research designs in health care evaluation, new regulations and guidance, and a climate of public anxiety regarding research conduct in the UK. FINDINGS: The evolution of Research Ethics Committees (RECs) has been slow and resulted in a lack in consistency. Criticisms made of RECs can be categorized into four main areas. New governance arrangements for RECs have emerged as potential solutions to these criticisms. This review identifies the limitations of the new governance arrangements in addressing past criticisms because of two factors. The first is insufficient funding. The second is confusion about the confidentiality and consent requirements of clinicians working in areas where research is conducted and on whom recruitment processes often rely. The current situation regarding health research ethical review has implications for nurses, whether they are working as researchers, members of Ethics Committees or clinicians where research is conducted. CONCLUSION: The new governance arrangements may go some way to addressing past problems. However, investment in RECs is required. It is also important to realize that maintaining ethical probity in health service research is a tripartite concern. It is reliant as it is on the actions of Ethics Committees and clinical research partners as well as those of the researchers themselves.     

Nursing implications of the 2006 NIH State of the Science Conference Statement: Cesarean Delivery on Maternal Request

Will the nation's higher rate of cesarean deliveries (CDs) (over 29%) lead to increased health risks for mothers and their babies? In March 2006, a National Institutes of Health State of the Science Conference was convened to assess available research on the topic. The focus was to identify outcomes from research studies addressing "cesarean delivery on maternal request" (CDMR), defined as CD without a medical indication for either the mother or the fetus. This conference concluded that it is currently unknown whether CDMR is really a trend in the United States, or whether the emergence of this phenomenon is associated with any specific benefits and harms to mothers and babies. More research is needed to determine if a trend exists. On the basis of systematic review of studies, no "strong quality-evidence" was found comparing CD and normal vaginal delivery outcomes. Future research was recommended to develop studies for this purpose in areas such as placental abnormalities (placenta previa and accreta) and various neonatal outcomes. Research on "modifiable" factors during labor and delivery which might decrease maternal and neonatal complications, including the risk for future pelvic floor disorders, was also recommended in the 2006 Conference Statement.     

Cutoff assignment strategies for enhancing randomized clinical trials.

The randomized clinical trial (RCT) is the preferred method for assessing the efficacy of treatments. Recent ethical and logistical criticisms suggest that new variations of the traditional RCT are needed. Some of these criticisms may be addressed with new hybrid designs that combine random assignment with assignment by one or more cutoff values on a baseline variable (e.g., severity of illness). In a simple version of such a "cutoff-based" RTC, persons scoring below a cutoff score on a baseline measure (i.e., the least severely ill) are automatically assigned to the control-treated group, those scoring above a second, higher cutoff (i.e., the most ill) are automatically assigned to the test-treated group, and those scoring in the interval between the cutoff scores (i.e., the moderately ill) are randomly assigned to either group. Depending on the baseline score, the patient is assigned to treatment either randomly or by the need-based, clinically related baseline score. Six cutoff-based design variations are studied via simulations and compared with the traditional RCT and the single-cutoff (i.e., regression-discontinuity) design. All variations yield unbiased estimates of the treatment effect but estimates differ in efficiency, with the RCT being most efficient and the single-cutoff design being least efficient. Secondary analyses of data from the Cross-National Collaborative Study of the Effects of Alprazolam (Xanax) on panic are conducted for each variation by selectivity discarding cases from the original dataset to stimulate cutoff-based assignment. The results confirm the simulations and illustrate how cutoff-based designs might look with real data.     

Is there a place for ontological hermeneutics in mental-health nursing research? A review of a hermeneutic study

A lot of research carried out within the context of mental-health nursing using qualitative data collection tools claims that it is hermeneutical, with usually just a short section describing the hermeneutical methodology as though it is a very broad philosophical approach. Criticisms of the latter approach more often than not concentrate on the level of the data collection tools without getting to grips with the underlying hermeneutical philosophy. This paper examines the difference between methodological and ontological hermeneutics and then gives an example of a piece of research using the latter approach. It is then argued that criticisms of the hermeneutical approach usually only concentrate on methodological hermeneutics with the consequence that they seriously misapply their criticisms if the research is using ontological hermeneutics.     

Research utilizaton: an evaluation and critique of research related to oral temperature measurement

The problem addressed was whether a research-based protocol on oral temperature measurement could be developed and used in the practice setting. The first phase of the study proposed to (a) identify research articles related to the subject; (b) evaluate the quality of the research; (c) assess the adequacy of the research base; and (d) select areas for future study. The results indicated that further clinically-based studies are needed before a protocol can be designed and tested in clinical practice.     

The design of venous thromboembolism prophylaxis trials: fondaparinux is definitely more effective than enoxaparin in orthopaedic surgery

The fondaparinux trials in venous thromboembolism (VTE) prevention after orthopaedic surgery have been subject to methodological criticisms recently summarised in this journal. These criticisms merit comments and corrections. Fondaparinux reduced the risk of VTE and of proximal deep-vein thrombosis by more than 55% compared with enoxaparin, based on the efficacy endpoint that supported the registration and use of low-molecular-weight heparins (LMWH) in all their prophylactic indications, an endpoint endorsed by international consensus statements and health authorities. Fondaparinux is the only antithrombotic agent that significantly reduced the rate of symptomatic VTE in a single orthopaedic surgery trial that was powered to detect this effect. In contrast to the paucity of data available on LMWH, the relationship between the timing of first administration and efficacy and safety has been well documented for fondaparinux. Fondaparinux used according to its approved regimen provides a simple, easy-to-use, effective and safe post-operative regimen for all orthopaedic surgery patients.     

If not evidence,then what? Or does medicine really need a base?

This essay analyses the concept of ' base' in relation to its use in evidence-based medicine (EBM). It evaluates the extent to which evidence provides a sufficient base for health care to rest and discusses whether medicine needs a base, and, if so, what are the other possible candidates. This paper will argue that EBM is linked epistemologically to the theory of foundationalism and shows how important criticisms of EBM emerge from anti-foundationalist epistemologies and interpretive frameworks. Drawing from recent writings in the philosophy of science, it is argued that there is a need to see multiple perspectives relevant to the practice and understanding of medicine.     

Protective orders: questions and conundrums

Current media portrayal of protective orders is often negative, focusing on weaknesses in how protective orders are obtained and enforced. This review of research findings on protective orders examines issues and suggests areas in need of future research to clarify and improve public policy. More specifically, this review has five main objectives: (a) to provide background information about partner violence and the need for protective orders; (b) to describe what protective orders are, how many women obtain them, and the advantages and disadvantages of obtaining protective orders; (c) to examine characteristics of women who seek protective orders; (d) to explore research on whether protective orders actually increase women's safety; and (e) to highlight opportunities and gaps in the practice and research literature regarding the use of protective orders for women with violent partners or ex-partners.     

Testis unis, testis nullas: one witness is no witness. Criticisms of the use of oral history in nursing research

In research, there is no perfection: no perfect method, no perfect sample, and no perfect data analyses tool. Coming to this understanding helps the researcher identify the inadequacies of their preferred method. This paper discusses the criticisms of the oral history method, drawing reference to its challenges and difficulties in relation to its use in nursing research. Oral history has the advantage over more traditional historical approaches in that the narrators can interpret events, personalities and relationships within the interview that are not accessible from written sources. The oral history interview may also provide a forum for unveiling documents and photographs, which might not have been otherwise discovered. Nonetheless, oral history, like most methodologies, is not flawless. This paper discusses the limitations of oral history and suggests ways in which a nurse can use oral history to provide an account of aspects of nursing history.     

Access to health care for nonmetro and metro Latinos of Mexican origin in the United States

BACKGROUND: A growing number of Latinos are moving to nonmetro areas, but little research has examined how this trend might affect the Latino-disadvantage in access to healthcare. OBJECTIVE: We investigate health care access disparities between non-Latino whites and Latinos of Mexican origin, and whether the disparities differ between metro and nonmetro areas. METHODS: A series of logistic regression models provide insight on whether individuals have a usual source of care and whether they have had any physician visits in the past year. Our analyses focus on the interaction between Mexican origin descent and nonmetro residence. SUBJECTS: Nationally representative data from the 2002-2003 Medical Expenditure Panel Survey are analyzed. The sample consists of working-aged adults age 18-64, yielding a sample size of 29,875. RESULTS: The Mexican disadvantage in having a usual source of care is much greater among nonmetro residents than among those living in metro areas. The Mexican disadvantage in the likelihood of seeing a physician at least 1 time during the year does not differ across locations. Although general and ethnicity-specific predictors explain the disadvantage of Mexicans in having a usual source of care, they do not explain the added disadvantage of being Mexican and living in nonmetro areas. CONCLUSIONS: This study identifies a new challenge to the goal of eliminating health care disparities in the United States. The Latino population living in nonmetro areas is growing, and our findings suggest that Latinos in nonmetro areas face barriers to having a usual source of care that are greater than those faced by Latinos in other areas.     

Marie Curie nurses: enabling patients with cancer to die at home

Marie Curie Cancer Care established its nursing service in 1958; however, the service has had little formal evaluation. This study aimed to describe and evaluate the care provided by Marie Curie nurse, and in particular to determine whether patients in their care remained and died at home. Two existing data sets were used: data on all patients referred to the Marie Curie Nursing Services in 147 areas of England, Wales, Scotland and Northern Ireland for 26 months, and data on cancer death registrations in England. A request for a Marie Curie nurse was made for 26,632 patients, 97% of whom had cancer and 11% of whom lived alone. The amount of care provided varied enormously (<1 hour-2862 hours), although the vast majority of patients less than 300 hours of nursing care. Place of death was recorded for only half these patients; 94% died at home, 2.5% in a hospice, 2.3% in a hospital, 0.2% in a nursing home and 0.6% other. Home death was most often associated with patients receiving medication via a syringe driver, patients living with other people, patients with cancer, other than prostate cancer, shorter time between referral and death and younger age. The results lend support to the theory that the care given to patients in their homes by Marie Curie nurses facilitated home death for many patients. Services need to ensure that mechanisms are in place to achieve data collection. Rigorous prospective evaluation is needed in the future.     

The experiment: is it worthwhile?

Parallel developments in social and educational research as well as more explicit humanistic philosophies of nursing have influenced views on what types of investigation are acceptable or useful to this field. Shifts in opinion towards more participative and qualitative studies reflect the move away from the predominant traditions of medical research and the experiment. This paper attempts to explore the reasons for such a change and examine the related criticisms of the positivist school and in particular deductive experimental approaches in order to assess whether such approaches should continue to have a role in building nursing knowledge.     

RELATIONSHIP OF RECOLLECTIONS OF FIRST DEATH EXPERIENCE TO CURRENT DEATH ATTITUDES

Previous research (Dickinson, 1992) has investigated adults memories of their first childhood experience with death. The present study extended this work to examine the relationship of various qualitative aspects of the rst experience with death to current death attitudes. College students (196 females, 101 males) described their first childhood death experience and provided memories of: (a) who died; (b) whether parental discussion of death had occurred; (c) whether they had unanswered questions at the time; and (d) whether they had cried at the time. They then completed the Death Attitude Profile-Revised (DAP-R; Wong, Reker, & Gesser, 1994). Results indicated that although boys and girls did not respond differently to the first death experience, gender did appear to moderate the relationship between the qualities of this experience and current death attitudes.     

Patient perceptions of a remote monitoring intervention for chronic disease management

Use of telecommunications technology to provide remote monitoring for people with chronic disease is becoming increasingly accepted as a means to improve patient outcomes and reduce resource use. The purpose of this project was to evaluate patient perceptions of a nurse-managed remote monitoring intervention to improve outcomes in veterans with comorbid diabetes and hypertension. Postintervention evaluation data were collected using a 12-item questionnaire and an open-ended question. Participants rated the program as generally positive on the questionnaire, but responses to the open-ended question revealed criticisms and suggestions for improvement not captured on the questionnaire. Interviewing participants in these programs may offer richer data for identifying areas for program improvement.     

Current state of information technologies for the clinical research enterprise across academic medical centers

Information technology (IT) to support clinical research has steadily grown over the past 10 years. Many new applications at the enterprise level are available to assist with the numerous tasks necessary in performing clinical research. However, it is not clear how rapidly this technology is being adopted or whether it is making an impact upon how clinical research is being performed. The Clinical Research Forum's IT Roundtable performed a survey of 17 representative academic medical centers (AMCs) to understand the adoption rate and implementation strategies within this field. The results were compared with similar surveys from 4 and 6 years ago. We found the adoption rate for four prominent areas of IT-supported clinical research had increased remarkably, specifically regulatory compliance, electronic data capture for clinical trials, data repositories for secondary use of clinical data, and infrastructure for supporting collaboration. Adoption of other areas of clinical research IT was more irregular with wider differences between AMCs. These differences appeared to be partially due to a set of openly available applications that have emerged to occupy an important place in the landscape of clinical research enterprise-level support at AMC's.     

The search for meanings in nursing: could Facet Theory be a way forward?

This paper examines some of the underlying tenets of Benner & Wrubel's Primacy of Caring, and suggests the use of Facet Theory as a possible route to overcome criticisms of the lack of systematic data collection and analysis in this approach to nursing research Some of the steps undertaken in Facet Theory are described, and its use in wider nursing research discussed It is proposed that Facet Theory offers a method of studying the multidimensional nature of nursing, which has the potential for a scientific approach without losing the essential ontological data     

Sensory decision theory methods in pain research: A reply to Rollman

Positive reviews of the developing literature on Sensory Decision Theory (SDT) pain research have been provided by Lloyd and Appel [21] and Hall [17]. In contrast, Rollman [24] has criticized the application of SDT methodology to the study of pain, arguing that it is “an error in logic to utilize SDT parameters to reach definitive conclusions about mechanisms altered during pain modulation”, and he has attacked the procedures employed by decision theory researchers in data collection and analysis. This paper is a response to Rollman written from the perspective of a single group of SDT pain researchers. I will first bring to issue certain fundamental statements that appear recurrently throughout Rollman's paper, and I will argue that many of his criticisms lack substance because these assertions are inappropriate. In addition, I will deal briefly with some of Rollman's specific methodologic criticisms, limiting my comments to those points that are salient to the multidisciplinary audience of this journal, and I will briefly describe the pain model that has been implicit in the work of our laboratory group.