A pregnancy wellness guide to enhance care through self-assessment, personal reflection, and self-referral.

OBJECTIVE: To develop a tool and evaluate its content validity and utility. The tool was designed to be used by women to assess lifestyle and psychosocial factors that could impact their pregnancies and unborn babies. It also provided resources for self-help. DESIGN: Methodological study in 4 phases. SETTING: Alberta Health Services, Calgary area and community. PARTICIPANTS: Thirty-five experts and 375 pregnant women. METHODS: Pregnant women and new mothers participated in focus groups to establish content validity; prenatal class attendees completed the self-assessment and a questionnaire, and women from the community completed a questionnaire on the instrument's utility. RESULTS: Responses from experts and participants in all 4 phases led to changes in the content, wording, and format of the tool. Survey responses indicated that it contained useful information that prompted a number of women to make positive changes during their pregnancies. CONCLUSION: The Pregnancy Wellness Guide is a simple tool that can help pregnant women assess their knowledge and health behaviors and self-refer to helpful resources. It will be widely distributed throughout the health region in the urban and rural Calgary area, and its use is anticipated to result in better health outcomes in pregnancy.

Development and psychometric testing of the nurses' attitudes toward obesity and obese patients (NATOOPS) scale.

This study was designed to develop and test an instrument to measure nurses' attitudes towards obesity and obese adult patients. Items were based on an earlier version of the instrument, obesity discrimination research, and clinical experience. After content validation of items, the instrument was sent to 1,400 randomly selected Registered Nurses. Factor analysis yielded a 5-factor solution, with 36 items reaching loadings of .4 or greater. Cronbach's alpha was .81 for the reduced scale, with a range of .45 to .79 on the five factors. Construct validity was supported by significant differences between contrast groups on three factors and consistency with underlying theory. Overall the instrument demonstrated acceptable psychometric properties and could be used in future research.

Ethical issues related to BRCA gene testing in orthodox Jewish women.

Persons exhibiting mutations in two tumor suppressor genes, BRCA1 and BRCA2, have a greatly increased risk of developing breast and/or ovarian cancer. The incidence of BRCA gene mutation is very high in Ashkenazi Jewish women of European descent, and many issues can arise, particularly for observant Orthodox women, because of their genetic status. Their obligations under the Jewish code of ethics, referred to as Jewish law, with respect to the acceptability of various risk-reducing strategies, may be poorly understood. In this article the moral direction that Jewish law gives to women regarding testing, confidentiality, and other issues is explored. The intent is to broaden nurses' knowledge of how a particular religious tradition could impact on decision making around genetics testing, with the aim of enhancing their understanding of culturally sensitive ethical care.

A randomized clinical trial of elk velvet antler in rheumatoid arthritis.

This article examines the effects of elk velvet antler on joint pain and swelling, patient/physician global assessment of disease activity, functional ability, quality of life, blood levels of C-reactive protein, and adverse events in persons with stage 2 to 3 rheumatoid arthritis experiencing residual symptoms after standard treatment. Patients (N=168) were enrolled in a 6-month randomized, triple-blind, placebo-controlled clinical trial. Instruments included the Arthritis Impact Measurement Scale, the Health Assessment Questionnaire, tender and swollen joint counts, and 100 mm-length visual analogue scales, along with blood tests. There were no significant differences between groups on any measures. The pattern of change of the measures across time points was essentially the same for both groups. Although some patients reported clinical improvements in their symptoms, there were no statistically significant differences between groups. Overall, elk velvet antler does not effectively manage residual symptoms in patients with rheumatoid arthritis.

Nursing support for family members of critically ill adults.

Researchers have identified the needs of family members of critically ill adults, explored their experiences, and investigated interventions. To address a gap in the theoretical knowledge about how nurses help these individuals, the authors developed a grounded theory of nursing support from the perspective of family members. Results indicated that family members were initiated into a cycle of Work to meet perceived responsibilities to Get Through the experience. Supportive nurses engaged in the process of Lightening Our Load to mitigate the negative effects of the critical care experience on family members by Engaging With Us, Sustaining Us, and Disengaging From Us. No previous research has yet identified the Work of these family members, the steps they take to gain nurses' respect, and the significance to them of nurses' Welcoming us and Saying goodbye. This theory extends the understanding of nursing support beyond current knowledge of family needs, caring, comfort, supportive care, and social support.

Partnerships in specialty care: exploring rural haemophilia provider resource needs.

OBJECTIVE: The purpose of this study was to determine whether rural providers have adequate preparation for safe and effective haemophilia care. DESIGN: This qualitative study proceeded in two phases: focus group (phase I) and telephone (phase II) interviews. SETTING: Five Canadian rural hospitals served by one urban haemophilia treatment centre and providing service to at least one haemophilia family. PARTICIPANTS: Phase I: focus groups of rural health professionals (site 1: n = 5; site 2: n = 6), including nursing, medicine and lab technology. Phase II: telephone interviews with nine participants from nursing, medicine, lab technology, social work and physiotherapy across three sites. MAIN OUTCOME MEASURES: Qualitative content analysis yielded categorical themes for specialty care resource requirements in a rural context. RESULTS: Resource needs reflected five main categories: communication network, subjective knowledge, team roles, objective knowledge and partnerships (C-STOP). CONCLUSIONS: The five C-STOP categories require resources and alignment of urban specialist, rural provider and family expertise. Specialty clinic efforts promoting self-care are incomplete without matched resources for rural providers.

Ethical considerations for nurses in clinical trials.

Ethical issues arise for nurses involved in all phases of clinical trials regardless of whether they are caregivers, research nurses, trial co-ordinators or principal investigators. Potential problem areas centre on nurses' moral obligation related to methodological issues as well as the notions of beneficence/non-maleficence and autonomy. These ethical concerns can be highly upsetting to nurses if they are not addressed, so it is imperative that they are discussed fully prior to the initiation of a trial. Failure to resolve these issues can place both the conduct and the results of research in jeopardy.

Enhancing rigor in qualitative description: a case study.

Qualitative description has generally been viewed as the "poor cousin" to more developed qualitative methods, such as grounded theory. As such, little has been written about rigor in qualitative description, and researchers lack a navigational map to guide them and facilitate decision making. The novice, in particular, can be faced with numerous challenges and uncertainties. Using an incontinence project as a case study, the authors describe the issues that arose within a qualitative descriptive study and approaches used to maintain rigor. The overall credibility of the study depended on the researcher's ability to capture an insider (emic) perspective and to represent that perspective accurately. Strategies to enhance rigor included flexible yet systematic sampling, ensuring participants had the freedom to speak, ensuring accurate transcription and data-driven coding, and on-going attention to context.

Clinical trials with complementary therapies.

As interest in complementary and alternative therapies grows, nurses can expect to be asked for advice regarding their use, but there are few clinical studies on which nurses can base their responses. Conducting research with complementary therapies is therefore important for nursing, but there are some pitfalls in doing research with these products, particularly if one is using standard clinical-trials methods. In this article, the authors outline some of those pitfalls based on their experience conducting a clinical trial to examine the effects of elk velvet antler on symptoms of rheumatoid arthritis. They discuss design issues related to justification, method, and ethics and explore some important regulatory issues of which nurses should be aware. Some recommendations are presented to help nurses engaging in such research to avoid problems that could interfere with the smooth conduct of their studies.

Promoting health in type 2 diabetes: nurse-physician collaboration in primary care.

The purpose of this study is to examine effects of a nurse-physician collaborative approach to care of patients with type 2 diabetes and to determine possible effect sizes for use in computing sample sizes for a larger study. Forty patients from a family practice clinic with type 2 diabetes were randomly assigned to control or experimental groups. The control group received standard care, whereas the experimental group received standard care plus home visits from a nurse, as well as consultation with an exercise specialist and/or nutritionist. Follow-up continued for 3 months. Clinical end points included standard measures of diabetes activity as well as quality-of-life indicators. Focus group interviews were used to explore patients' responses to the program. Although findings were not statistically significant, a trend toward small to moderate positive effect sizes was found in glycosylated hemoglobin and blood pressure. Quality of life measures also showed a trend toward small to moderate, but nonsignificant, improvements in physical functioning, bodily pain, vitality, social and global functioning, energy, impact of diabetes, and health distress. Focus group interviews indicated a very positive response from patients, who expressed feelings of empowerment. In this study, patients treated with nurse-physician collaboration demonstrated small, but nonsignificant, improvements in blood chemistry after only 3 months. Physical and social functioning, energy, and bodily pain also showed a small improvement. Changes in awareness of effects of diabetes on health and an expressed sense of self-efficacy suggest that effects could be sustainable over the longer term.

Using the Canadian Code of Ethics for Registered Nurses to explore ethics in palliative care research.

Nursing research in palliative care raises specific and challenging ethical issues. Questions have arisen about whether such research is morally justified, given the low likelihood of direct benefit to dying patients as research participants. The Canadian Code of Ethics for Registered Nurses outlines eight primary values intended to guide nursing practice. We use these values to explore the moral dimensions of research with the palliative care population. Our conclusion is that palliative care research is needed to foster excellent care for these patients and their families, but that nurses must remain constantly vigilant to ensure that participants are protected from resultant harms. Through this exploration we highlight particular considerations that nurse researchers must contemplate when accessing a vulnerable population.

Exploring ethical perspectives of nurses and nurse managers.

With nursing shortages reaching crisis proportions, staff nurses need to believe that nurse managers are supportive. However, evidence exists that staff nurses view nurse managers as moving away from basic nursing values. Using an exploratory philosophical approach, the authors examine this issue as a function of differing ethical frameworks used by nurses and nurse managers. The main question is whether nurse managers are expected to subscribe to a corporate ethic versus a nursing ethic in making decisions, and whether these approaches are fundamentally different. The authors' supposition was that exposing differences might account for some dissatisfaction that nurses express with regard to nursing leadership. They conclude that there are differences of emphasis in ethical principles that may cause tension. Incongruencies between corporate and individual values emerge under fiscal constraints and with differing perceptions, expectations and decision-making criteria. This paper offers suggestions to help staff nurses and nurse managers reduce tensions experienced when difficult choices, particularly those of resource allocation, are required.

Attitudes of health-care providers towards research with newborn babies.

CONTEXT: By providing information and possibly shaping parents' preferences, health-care providers are thought to play a critical role in parental decisions to enroll their infants in research. Yet, little is known about health-care providers' beliefs about research with newborns. Previous studies suggest that parents and health-care providers are often at odds regarding attitudes towards research. OBJECTIVE: To examine the attitudes of health-care providers concerning the acceptability of research with newborn babies and the degree of research-related risk to which they would be willing to expose their own infant. These findings were compared with a previous study of parental attitudes. DESIGN, SETTING AND PARTICIPANTS: A survey (pretested questionnaire with 20 scaled items and five case scenarios) of 50 doctors and 64 nurses conducted in a large tertiary care center in western Canada. RESULTS: Study limitations were a response rate of 64.5% among nurses but only 22% among physicians. Both doctors and nurses were strongly supportive of research with newborns, but nurses were more averse to exposing infants to risk. Only 76.0% of nurses, compared to 92.2% of physicians, agreed that informed consent should be sought for all forms of research. When results were compared with parental perceptions, health-care providers were more likely to believe that research should be conducted for the good of all babies. Parents were generally less aware of the existence of an approval process for research in general. In responding to hypothetical scenarios with risk and direct benefit, parents were less willing to enroll their infants than were health-care providers. Approximately 30% of both groups would be willing to enroll their infants in a study involving moderate risk and no direct benefit. CONCLUSIONS: Views of nurses, physicians, and parents regarding research with newborns are different. Overall, there is support for research; however, nurses are more likely to never enroll their own baby and enroll babies into minor studies without consent.

Ethical issues in adolescent consent for research.

Different opinions are expressed in the literature regarding when children and adolescents can start to make decisions to participate in research and give informed consent. Nurses are frequently involved in research, either as investigators or caregivers, and must therefore have a thorough understanding of consent and related issues. In this article the issues are explored from a Canadian perspective. The argument is put forward that adolescents may be capable of a greater involvement in the research consent process than is the norm. Increasing adolescents' involvement in research has the potential to enhance their growing autonomy and capabilities. Adolescents appreciate being treated with respect and dignity by adults. This can be achieved in an environment in which protection from harm does not also mean prevention from decision making. The use of empowering processes by nurses to enhance adolescent involvement will provide benefit to adolescents in their transition to adult levels of responsibility.

Elk velvet antler in rheumatoid arthritis: phase II trial.

The purpose of this phase II clinical trial was to examine safety of elk velvet antler taken concurrently with rheumatoid arthritis medications and to determine efficacy by dose to enable sample size estimation and dose standardization for a larger study. Forty patients with stage II rheumatoid arthritis were randomly assigned to 1 of 4 arms of 10 patients each. One group received placebo and the other 3 groups received 2, 4, or 6 capsules (215 mg) of elk velvet antler with appropriate placebos to total 6 capsules daily. All subjects continued to take their arthritis medications. Outcome variables were reported adverse events and health status. At 1 month, there were no significant differences between groups in number of adverse events or health status. The greatest improvement was in the 6 elk velvet antler group, the least was in the placebo group. Differences were not statistically significant. It was concluded that elk velvet antler can be taken safely in conjunction with a number of rheumatoid arthritis medications and should be studied further to assess efficacy.

Parents' perceptions of research with newborns.

OBJECTIVE: To examine beliefs and attitudes of parents about research with babies. STUDY DESIGN: Survey of 72 parents of newborn babies in the neonatal intensive care unit (NICU), and 159 parents of normal newborns using instrument designed for the study. The instrument included questions with graded responses and five research scenarios with varied risks and benefits. Statistical analysis included chi(2) analysis and Fisher's exact test. RESULTS: Parents showed generally favorable attitudes toward research with babies. There were few differences between the two groups of parents, but there was a trend toward more trust in doctors by "NICU parents." Couples with newborns in NICU were significantly more likely to enroll their newborn in a study involving moderate risk and possible major direct benefit. Almost a third of the sample in both groups was willing to enroll their newborn in a study with moderate risk and no direct benefit. CONCLUSION: Parents believe research is necessary and want to be asked for consent, but many feel they have limited knowledge and would depend on their physician's advice. The fact, that some might enroll their newborn in a study involving a risky procedure that would not benefit the newborn, supports the notion of vulnerability and emphasizes the fact that physicians must be alert to the possibility of coercion and undue influence.

Ethics in qualitative health research.

BACKGROUND: Since the release of the Tri-Council Policy Statement (TCPS), there has been a growing interest in research ethics concommitant with an increase in the use of qualitative design for health research. Qualitative studies present unique ethical problems that may be poorly understood by researchers and research ethics boards (REBs). OBJECTIVE: To describe the ethical problems in qualitative research, and to make recommendations that will help researchers develop ethical qualitative proposals, and help REBs review these proposals. METHOD: Review of literature and philosophical analysis. RESULTS AND CONCLUSION: Qualitative studies raise unique issues with respect to methods, protection from harm, informed consent, privacy, and confidentiality, all of which are central to the principles of the TCPS. The problems are partly inherent, as the design tends to emerge as the study proceeds, and the research question may change. Researchers and REBs must become more aware, through education and critical reflection, of the types of problems that might arise in these studies, and of the approaches that might be taken to minimize risk to participants.