¶ … McMillan, S.C., & Small, B.J. (2007). Using the COPE intervention for family caregivers to improve symptoms of hospice homecare patients. Oncology Nursing Forum, 34(2), 313-21. Are there any HIPAA concerns that are evident in this study?

Both caregivers and patients were required to sign informed consent documentation in order to participate in the study. Were any concerns related to HIPAA indicated in the protocol or procedures for conducting the study, those concerns would need to be delineated in the consent documents and explained to the participants. Since caregivers were an integral component to the hospice care and quality of life measures for patients, patient privacy could be maintained just as with any other medical or healthcare services.

What methods were put in place to ensure that the subjects were giving true informed consent?

The inclusion criteria and protocol for participating in the study required that patients and caregivers both be able to read English at least at a sixth-grade level so as to be able to understand the terms and conditions of the consent agreement and any implications for them with regard to adverse effects, privacy, and the like. In addition, during screening of potential participants, researchers administered the Short Portable Mental Status Questionnaire (SPMSQ) to ascertain the capability of participants to understand the research purpose and what they were permitting and agreeing to by giving consent: a minimum score of 7 on the SPMSQ was required to document consent.

3. What was the setting for the study?

The setting for the study was a large non-profit hospice in which patients were admitted, or received home care during which time they were attended to by family caregivers.

4. Was the sample adequate for the research design that was selected?

From a total of 354 patient-caregiver dyads, 25 patients or caregivers failed (scoring less than 7 on the assessment) the screening administered with the Short Portable Mental Status Questionnaire (SPMSQ), and the Palliative Performance Scale (PPS) (which required a score of 40 or better). The power calculations indicated that 160 patient-caregiver dyads would be optimal for each of the treatment groups. However, only 354 patient-caregiver dyads were available, and this included all of the consenting patient-caregiver dyads that did meet the inclusion criteria for the study.

5. Describe the data collection methodology. What instruments were used?

Data collection included patient interviews conducted privately by RA HHA at 24 to 48 hours after admission. The interviews included collection of demographic information, completion of the Hospice Quality-of-Life Index (HQLI), pain intensity scale (a numeric rating scale or NRS), dyspnea intensity scale, Constipation Assessment Scale (CAS), and the Memorial Symptom Assessment Scale (MSAS). At the same time that patients were being interviewed, an RA nurse interviewed the caregivers. The MSAS and the HQLI were repeated with patients at day 16 of their hospice stay and then again at 30 days, which would have been approximately two weeks after the first post-intervention assessment.

6. What did the authors say about the reliability and validity of their instruments?

The intervention visits were tape recorded to ensure consistency and compliance by the RA nurses with the protocols. Roughly 10% of the videotapes were reviewed by the researchers each month to determine intervention fidelity and to ensure the integrity of the implementation of the separate protocols for friendly visits and COPE intervention groups. Moreover, hospice staff member were instructed to not act as mediators of questions from patients or caregivers about the research study, instead referring them to a pager number of the RA intervention nurse. Further, behavioral drift of hospice staff during routine care was reviewed by asking caregivers to report on the amount of time hospice nurses spent talking about the three target symptoms. This served as an indicator for changes in hospice staff behavior due to knowledge of the research study: no behavioral change regarding hospice staff routine care was noted.

7. What limitations did the authors face in data collection? How could these have been lessened or minimized?

The researchers reported that funding issues prevented them from auditing the behaviors of the caregivers during the study. This meant that important data about whether the caregivers changed their behavior during symptom management -- or whether changes were made that were in fact both appropriate and effective -- was not available to the researchers. This limitation was addressed by recommendations for future research focused on this topic.

8. What demographic information was reported?

The baseline demographic data collected for the study included the following: Gender, age in years, and level of education reported in years. Although scores on these measures would not truly be considered demographic information, they were part of the baseline data collected...

What were the variables that were studied?
The variables studied included the following: The dependent variables included patient reports of symptom relief, including pain, dyspnea, constipation, symptoms distress, and quality of life. The independent variables included the problem solving intervention taught to caregivers referred to as the COPE intervention. Also of note were two control conditions, one of which served as an attempt to counter the attention received by caregivers by the RA nurses: this condition was referred to a "friendly visit."

10. Discuss the use of any figures, graphs and tables. Was the information conveyed in an understandable and meaningful way?

Figures, graphs, and tables were used to report the following: Progression of patients through the study; baseline demographic data; a summary of random-effects models over the follow-up period, as a function of intervention group status; and the scores on the Memorial Symptom Assessment Scale across the follow-up period by intervention group. The visual displays were all well designed and provided clear information that was highly relevant to an understanding of the research.

The following questions pertain to: Rosedale, M., & Fu, M.R. (2010). Confronting the unexpected: Temporal, situational, and attributive dimensions of distressing symptom experience for breast cancer survivors. Oncology Nursing Forum, 37(1), 28-33.

11. Are there any HIPAA concerns that are evident in this study?

Participants were required to sign informed consent documentation in order to participate in the study. Were any concerns related to HIPAA indicated in the protocol or procedures for conducting the study, those concerns would need to be delineated in the consent documents and explained to the participants.

12. What methods were put in place to ensure that the subjects were giving true informed consent?

All participants were required to sign informed consent forms that were constructed according to university level human subjects review standards. Moreover, the participants all spoke, and presumably read, English. The details of the human subjects and research description were provided in detail in the original article (Rosedale, 2009).

13. What was the setting for the study?

This research article describes a secondary qualitative analysis of the original data set by considering a different research question. As such, the research began with a text analysis of the original data, and used that as the basis for the interviews of the participants in the second iteration of the study.

14. Was the sample adequate for the research design that was selected?

The subjects in the study were recruited from a volunteer list of cancer survivors who participate in the Reach for Recovery network sponsored by the American Cancer Society (ACS). The number of subjects in the purposive sample consisted of 13 English-speaking women aged 33 -74 years who had completed treatment for breast cancer between 1 and 18 years prior to the study. For a qualitative study of this type, 13 participants is an adequate number of subjects in the sample.

15. Describe the data collection procedure.

Data collection consisted of transcripts from face-to-face interviews with subjects. A constant comparative method of data analysis was used to discover emerging themes in the text analysis, and to classify text according to a continually condensing body of relevant content. Atlas.ti.v.5.0 software was used to code the data and to create memos regarding the researchers' perceptions while coding and analyzing the data.

16. How did the authors address the reliability and validity of their methods?

When conducting qualitative data, the constructs of reliability and validity are not relevant to the degree that they are in quantitative research methods. Rather than focusing on reliability and validity, qualitative researchers look for indications that the data is credible and trustworthy.

17. What limitations could the authors face when using secondary data for analysis?

The secondary data set was from an earlier study conducted by the researchers, which meant that they were familiar with the data collection and data analysis methods, and so could design research that was entirely compatible with that secondary data. As with any qualitative research, certain procedures are needed to insure integrity of the data analysis, such as member checks, data audits, triangulation, and the like.

18. What demographic information was reported by the authors?

The only demographic data reported in this iteration of the research were ages, number of years past the treatment dates for their breast cancer, that the participants all spoke English, and that they had volunteered at the Reach for Recovery network.

19. What were the variables that were studied?

The dependent variables…