Simple Tools to Facilitate Project Management of a Nursing Research Project.

Highly organized project management facilitates rigorous study implementation. Research involves gathering large amounts of information that can be overwhelming when organizational strategies are not used. We describe a variety of project management and organizational tools used in different studies that may be particularly useful for novice researchers. The studies were a multisite study of caregivers of stroke survivors, an Internet-based diary study of women with migraines, and a pilot study testing a sleep intervention in mothers of low-birth-weight infants. Project management tools were used to facilitate enrollment, data collection, and access to results. The tools included protocol and eligibility checklists, event calendars, screening and enrollment logs, instrument scoring tables, and data summary sheets. These tools created efficiency, promoted a positive image, minimized errors, and provided researchers with a sense of control. For the studies described, there were no protocol violations, there were minimal missing data, and the integrity of data collection was maintained.

Bright light therapy to promote sleep in mothers of low-birth-weight infants: a pilot study.

Having a low-birth-weight (LBW) infant in a neonatal intensive care unit (NICU) can intensify a mother's sleep disturbances due to both stress and the dim lighting in the ICU setting, which desynchronizes circadian rhythms. The purpose of this pilot study was to examine the effectiveness of a 3-week bright light therapy intervention on sleep and health outcomes of mothers with LBW infants in the NICU. Controlled stratified randomization was used to assign 30 mothers to a treatment or control group. Data were collected at pretreatment (second week postpartum) and after the 3-week intervention. Sleep data were assessed by wrist actigraph (total sleep time [TST], circadian activity rhythms [CARs]) and the General Sleep Disturbance scale. Other outcome variables were measured by the Lee's Fatigue scale, Edinburgh Postpartum Depression scale, and the Medical Outcomes Short Form 36, version 2. Mothers averaged 26.6 (SD = 6.3) years of age, and the majority were Black (73%). The mean gestational age for the infants was 27.7 (SD = 2.0) weeks. Small to large effect sizes were found when comparing the pre- to posttreatment differences between groups. Although none of the differences were statistically significant in this small sample, for mothers in the treatment group nocturnal TST (d = .33), CAR (d = 1.06), morning fatigue (d = .22), depressive symptoms (d = .40), physical health-related quality of life (d = .33), and mental health-related quality of life (d = .60) all improved compared to the control group. Bright light therapy is feasible for mothers with infants in an NICU. Clinically significant improvements have been evidenced; a larger-scale trial of effectiveness is needed.

Migraine headaches: diagnosis and management.

In spite of the fact that migraines are one of the major problems seen by primary care providers, almost half of people with migraines do not obtain appropriate diagnosis and/or treatment. Migraine occurs in about 18% of women, and is often aggravated by hormonal shifts occurring around women's menses, during pregnancy, and during perimenopause. Quality of life with migraines is often greatly diminished, and many women miss work days and/or are less productive with migraines. Women's health care providers are very likely to see women with poorly managed migraines, but are often not comfortable diagnosing and treating their patients with headaches. A variety of self-care treatments, acute care prescription and non-prescription headache medications, and preventive medications are available and if used by a knowledgeable provider can provide relief for many women who might not otherwise receive appropriate care.

Evaluation of superoxide dismutase from Helicobacter pylori as a protective vaccine antigen.

Helicobacter pylori, the major cause of gastric cancer, have mechanisms that allow colonization of the inhospitable gastric mucosa, including enzymes such as superoxide dismutase (SOD) which protect against reactive oxygen species. As SOD is essential for in vivo colonization, we theorized it might constitute a viable vaccine target. H. pylori SOD was expressed in E. coli and a purified recombinant protein used to vaccinate mice, prior to live H. pylori challenge. Partial protective immunity was induced, similar to that commonly observed with other antigens tested previously. This suggests SOD may have utility in a combination vaccine comprising several protective antigens.

Combined mucosal and systemic immunity following pulmonary delivery of ISCOMATRIX adjuvanted recombinant antigens.

Deep pulmonary delivery of an influenza ISCOMATRIX vaccine has previously been shown to induce a combined mucosal and systemic antibody response. To explore whether this combined response is influenced by intrinsic properties of the component antigen, we examined the efficacy of deep pulmonary delivery of ISCOMATRIX vaccines containing different recombinant antigens, specifically gB glycoprotein from cytomegalovirus and a fragment of catalase from Helicobacter pylori. Both these vaccines induced antigen-specific mucosal and systemic immunity, as well as antigen-specific proliferative cellular responses. Pulmonary immunisation with ISCOMATRIX vaccines may therefore be a generic way of inducing combined systemic and mucosal immunity.

An Internet-based migraine headache diary: issues in Internet-based research.

OBJECTIVE: The primary purpose of this study was to explore the feasibility and acceptability of using an Internet-based headache diary to obtain acceptable completion rates of daily diaries. BACKGROUND: Migraine sufferers often perceive that headaches are unpredictable, but 70% have prodromal warning symptoms that may be identified via daily headache diaries. Although diaries are widely used for tracking headaches, Internet-based diaries have not been used previously. METHODS: A conventional headache diary was formatted for the Internet to collect daily headache data over 4 months using a time-series design.Women between 18 and 55 years who were not pregnant or postmenopausal, and whose headaches met migraine criteria, were recruited primarily via the Internet, completed online consent forms, and were screened via telephone. They completed health history questionnaires and daily diary pages containing scales and open-ended questions,which were saved to a database. Diaries were reviewed and participants were contacted weekly. Completion dates were tracked electronically. Follow-up interviews addressed perceptions about study experiences, and participants received feedback about headache patterns. RESULTS: The majority of participants were recruited from discussion boards and free classified web sites. Of the 101 participants enrolled, 24 withdrew prior to completing 4 months of diary entries. Participants (n = 77) had a mean age of 37.5(7.5) years and were primarily white (82%) and well-educated (93%). They lived in 21 US states, and one in the UK. The majority (68%) completed at least 50% of their diary pages within 24 hours; 75% of all pages were completed within 2 days. At least 64 (83%) kept notes or printed pages when they lacked Internet access. In a follow-up survey (n = 67), 87% would have been willing to continue the diary for another 2 months; 69% had not previously participated in any research. Participants also reported that the study helped them better understand their headache patterns, that the study was a major commitment but worthwhile, and that they felt they had helped others by participating. CONCLUSION: The Internet-based headache diary is a feasible, acceptable data collection tool that can access geographically diverse populations who have not previously participated in research studies. Use of an Internet-based approach was found to be feasible for recruitment and retention of such diverse populations.

The experiences of midlife women with migraines.

PURPOSE: To describe the experiences of midlife women with migraines. DESIGN AND METHODS: Qualitative data were collected in two consecutive studies, using open-ended interviews, focus groups, and online discussion boards. Interpretive methods were used for analysis. FINDINGS: Three patterns were identified: Changing Headache Patterns; Predicting, Preventing, and Controlling Headaches; and Keeping on the Move. These patterns indicated how women's headaches changed over time, how headaches were envisioned within the context of their lives, what strategies were used to meet work and home responsibilities, and how women controlled their headaches while maintaining a sense of perspective. CONCLUSIONS: Many midlife women with migraines receive inadequate or inappropriate treatment, and better dissemination of current diagnostic and treatment guidelines is necessary. Ongoing research is needed to increase understanding of how this problem affects midlife women's lives and of what interventions might prevent or alleviate migraine discomfort.

Seroepidemiology of Klebsiella pneumoniae in an Australian Tertiary Hospital and its implications for vaccine development.

The aim of this study was to determine the diversity of Klebsiella pneumoniae capsular serotypes in an Australian setting. Consecutive (n = 293) nonrepetitive isolates of K. pneumoniae from a large teaching hospital laboratory were analyzed. The majority of isolates were from urinary specimens (60.8%); the next most common source was sputum (14.3%), followed by blood (14%). Serotyping revealed a wide range of capsule types. K54 (17.1%), K28 (4.1%), and K17 (3.1%) were the most common, and K54 isolates displayed a high degree of clonality, suggesting a common, nosocomial source. In vitro, one K54 isolate was more adherent to urinary catheters and HEp-2 cells than four other tested isolates; it was slightly more resistant to chlorhexidine but was more susceptible to drying than heavily encapsulated strains. This is the first seroprevalence survey of K. pneumoniae to be performed on Australian isolates, and the high level of diversity of serotypes suggests that capsule-based immunoprophylaxis might not be useful for Australia. In addition there are significant differences in the predominance of specific serotypes compared to the results of surveys performed overseas, which has important implications for capsule-based immunoprophylaxis aimed at a global market.

Online Data Collection in Women's Health Research: A Study of Perimenopausal Women with Migraines.

An estimated 17 to 18 percent of all women, and six percent of men, experience migraines. Hormonal shifts may cause migraines to recur, worsen, or even begin during the perimenopause and are a significant cause of discomfort and disability. However, very little research has explored the experience of migraines in this population. The purpose of this study was to describe the experiences of perimenopausal women with migraines, via online questionnaires and discussion boards, and to evaluate the feasibility of collecting women's health data via the Internet. In an earlier study, we found that midlife women had difficulty attending focus groups due to other time commitments. This study was designed to increase accessibility to the research via the Internet. Of the 43 women recruited into the study, 21 were also interviewed in "real-time" qualitative interviews; all received passwords to complete online questionnaires and participate in three- to four-week discussion boards on the study Web site. Quantitative data were imported into SPSS; narrative qualitative data from discussion boards were transferred to a software package for analysis. Online questionnaires and discussion boards were found to be feasible methods for data collection for this population. Qualitative data analysis revealed themes related to women's efforts to predict and control their headaches, the relationship of headaches to women's menses and menopausal symptoms, and the effects of migraines on their lives. In this paper we describe the process of using the Internet, feminist issues related to this innovative methodology, and also discuss the results of a major study theme, the experience of headaches in relationship to the menstrual cycle.

Measurement issues related to data collection on the World Wide Web.

As the World Wide Web has become more prominent as a mode of communication, it has opened up new possibilities for research data collection. This article identifies measurement issues that occur with Internet data collection that are relevant to qualitative and quantitative research approaches as they occurred in a triangulated Internet study of perimenopausal women with migraine headaches. Issues associated with quantitative data collection over the Internet include (a) selecting and designing Internet data collection protocols that adequately address study aims while also taking advantage of the Internet, (b) ensuring the reliability and validity of Internet data collected, (c) adapting quantitative paper-and-pencil data collection protocols for the Internet, (d) making Internet data collection practical for respondents and researchers, and (e) ensuring the quality of quantitative data collected. Qualitative data collection over the Internet needs to remain true to the philosophical stance of the qualitative approach selected. Researcher expertise in qualitative data collection must be combined with expertise in computer technology and information services if data are to be of ultimate quality The advantages and limitations of collecting qualitative data in real time or at a later time are explored, as well as approaches to enhance qualitative data collection over the Internet. It was concluded that like any research approach or method, Internet data collection requires considerable creativity, expertise, and planning to take advantage of the technology for the collection of reliable and valid research data.

Using Internet discussion boards as virtual focus groups.

While the potential of Internet-based qualitative research methods is substantial, such methods are not without their problems. Some of these methodological challenges are unique to the medium, while others are similar to those of more traditional qualitative methods. This article presents some of these methodological challenges, and explores some of the issues involved in using on-line discussion boards as virtual focus groups in a study of perimenopausal women with migraines. Design of the study and its advantages and disadvantages are discussed, including the role of the moderator. Some of the problems encountered included potential for misunderstandings due to limits of written communications, and difficulty encouraging participation.

Patient experiences with atrial fibrillation and treatment with implantable atrial defibrillation therapy.

BACKGROUND: Patient perspectives about their illness experiences, symptoms, and treatment are essential aspects of quality of life and provide direction for patient and provider decision making regarding innovative therapies such as implantable devices for arrhythmia. PURPOSE: The purpose of this qualitative study was to describe: 1) the experience of patients living with symptomatic, drug-refractory atrial fibrillation (AF) and 2) patient experiences and acceptance of treatment with the implantable cardioverter defibrillator (ICD) with atrial therapies (ICD-AT) including ventricular and atrial defibrillation therapy. PARTICIPANTS: Subjects were 3 women and 8 men, 35 to 80 years of age, who received the Medtronic Jewel AF 7250 ICD-AT as therapy for recurrent, drug-refractory AF, had a history of AF for 3 to 20 years and had experienced multiple treatment modalities including frequent external cardioversion in an effort to control their AF. METHODS: A semi-structured interview addressed experiences of symptoms and prior treatment for AF and experiences, concerns, and perceived benefits of the ICD-AT. Interviews were recorded and transcribed verbatim. Narratives were coded and categorized using Atlas Ti(R) software. Qualitative interpretive analysis methods were used to identify key themes. RESULTS: Before ICD-AT, patient themes focused on AF that was: 1) misdiagnosed, minimized, and poorly treated; 2) distressful because of frequent and intense AF symptoms (fatigue, dizziness, shortness of breath, and anxiety) before ICD-AT; 3) limiting of activities of daily living; 4) associated with distress from enduring previous treatment; and 5) associated with the continuous pursuit of successful treatment and maintenance of normalcy. Decision making regarding ICD-AT therapy included weighing symptom or treatment distress versus anticipated risks or benefits, hope for better outcomes, and lack of options. After ICD-AT, themes included positive perceptions of the device because of AF symptom relief, ability to resume normalcy, and medication tolerance; incorporation of shock experiences into life routines; and patient suggestions regarding preparation and social support. IMPLICATIONS: Symptoms of AF have a major negative impact on overall quality of life. Treatment with the ICD-AT confers a sense of security and reduced symptom distress. Greater provider attention to patient preparation and facilitating social support are important for future ICD-AT patient care.

A new foundation for methodological triangulation.

PURPOSE: To show how triangulation with qualitative and quantitative methods can help confirm a theory to a greater degree than can either method alone. CONSTRUCT: Coherence view of theory structure and confirmation. Evidence helps confirm a theory if the theory is the most coherent way of accounting for the evidence, and one theory is more coherent than another insofar as it leaves fewer unanswered questions (and fewer unquestioned answers). METHODS: The method of this theoretical essay is analytic. Analysis of the debate over methodological triangulation reveals presuppositions about theory structure and confirmation. Well-known arguments in the philosophy of science are presented to show that the presuppositions are false. The arguments provide evidence for the construction of an alternative, coherence model of theory structure and confirmation. FINDINGS: Three consequences of the analysis are: (a) qualitative and quantitative methods do not produce theories with different structures; (b) qualitative and quantitative methods help to confirm theory in the same ways; and (c) used together, qualitative and quantitative methods can confirm a theory to a greater degree than the use of either method alone. CONCLUSIONS AND IMPLICATIONS: A coherence of model of theory structure and confirmation supports a version of the blending view of methodological triangulation. Triangulation can provide completeness, abductive inspiration, and confirmation. This version of blending provides principles for resolving issues of methodological dominance and order, and it indicates how different methods can disconfirm theory.