Thesis advisor: Callista L. Roy / Purpose: The purpose of this research was to address the gap in the literature related to frail older adults' experience of participating in clinical trials. Background: Frail older adults are generally underrepresented in the population of research volunteers from which evidence-based guidelines are derived. To improve care for frail older adults, research must be expanded to specifically target this population. Most of the users of healthcare today are greater than 65 years old, use more health care services than any other age cohort and suffer from coexisting illnesses for which they take several prescribed medications. Since the number of elders is increasing within the general population, it is important to reach a more thorough understanding of frail older adults' experience. Acquiring a better understanding of their experience will give the investigator more insight into barriers of recruitment, retention, and factors affecting elders' decision to participate in research. Method: Using a qualitative descriptive approach involving semi-structured interviews, a cohort of participants age 65 and older was asked about their experience of participating in research studies. Data analysis used an interpretive paradigm involving the methods of Miles, Huberman, and Saldana (2014). Results: Participants identified the main factors influencing their decision to participate as the opinions and encouragement of family members with the strongest influence being a recommendation from their doctor. Participants were varied in the emotions evoked by their participation in the study procedures. The majority of participants stressed how important it was to them to receive feedback in the form of results of studies in which they had participated. The majority of participants stated that receiving feedback or research results was the exception. Conclusions: Data generated from this study related to the experience of frail elder participation in clinical trials will be useful in designing future clinical trials to be more inclusive of this patient population. Keywords: frail elders, research participation, clinical trials, chronic illness, qualitative, multmorbidity / Thesis (PhD) — Boston College, 2015. / Submitted to: Boston College. Connell School of Nursing. / Discipline: Nursing.

Thesis (Ph.D.)--University of the Witwatersrand, Faculty of Health Sciences, 2013 / TITLE: Perceptions of participants and community members about research on gender-based violence The goal of this thesis was to explore ethical issues in conducting gender-based violence (GBV) research with human participants in South Africa. We study this question from the perspectives of both the researchers and the research participants. This thesis has two specific aims. First, to critically review the applicability and usefulness of the WHO 2001 guidelines in regulating community based research from the perspective of the researchers who do GBV work globally. Second, to explore peoples’ motivations for research participation, their perceptions of risks and benefits in participating in studies, the perceived psychological impact of answering sensitive questions, and adverse experiences of research participation. Three studies were conducted to meet the study aims, and were carried out using the combination of qualitative and quantitative methods and techniques. In the first study, 12 in-depth Interviews were conducted with GBV researchers from various countries and a desk review was also conducted. Study two had two components. First, 26 in-depth interviews (adult 19 women and 07 men) were conducted, and data were also collected using participant observation over a period spanning three months. Additionally, a real life incident was analysed as a case study of ethical dilemmas faced by researchers when unsolicitated incriminating disclosures by participants occur during the course of data collection. Thereafter, 22 in-depth interviews were conducted with men and women (over 18) who had recently participated in a survey on gender-based violence. In study 3, data were collected from 1085 women and 985 men (between ages 15-26) using a structured questionnaire. The results revealed no empirical evidence from published literature and from the accounts provided by researchers to support the view that GBV research is exceptionally risky when ethical guidelines are adhered to or that is has greater risks than other community based studies. From the perspective of the research participants, findings show that breach of confidentiality was viewed as a major concern in participating in studies. This was reported by both men and women, with, gender-differences. Women were more likely to fear violent reaction from their male partners for participating in the studies without man’s approval, and some women were threatened by their partners, but this was not GBV specific. No man reported this fear or any adverse reaction by intimate partners or others. Men rather feared other negative ramifications like being shamed, stigmatized, humiliated, and embarrassed in the community if breach of confidentiality could occur. Findings of this thesis reveal a complexity of people’s reasons for participating in community based studies. Participants reported multiple and various, sometimes conflicting, reasons for participating in the studies. Most were motivated by self-interest to enroll while others reported reasons that were viewed as altruistic. For example, the chance to be tested for HIV, financial incentive for research participation (R20), hope for immediate financial assistance with municipal debts, assistance with their ill-health and intervention in abusive relationships, were some of the reasons given. Also, the desire to help advance knowledge, to contribute to society, to provide information that would help others suffering from same illness or disease, or those in abusive relationships like them were also given as reasons by participants and in most cases, same individual participants gave reasons that overlapped or oscillated between altruistic and self-interest motives. Emotional distress as a result of being asked questions about interpersonal violence histories and other traumatic experiences is viewed as major risk in GBV studies, and data from interviews with researchers in this thesis confirm this. Data from interviews with participants revealed that being asked in research interviews about such histories made the participants to feel sad and some reported that reflecting on these experiences was painful. Yet, none described the impact as harmful, rather most stated that such emotions occurred for a very limited time and that they did not need professional support to deal with the emotions. Many, including those who had emotional reaction to some research questions or had regretted participating in the research, also viewed the experience of participating in research as beneficial. The findings in this thesis have implications for ethical and safety guidelines on GBV research and on future community based sensitive research in South Africa. Findings presented here provide support to the WHO 2001 guidelines that studies that are community based and researching sensitive issues with women, including partner violence, should keep secret the violence focus and other sensitive questions at community level, and such focus be divulged only to participating women. This thesis has shown that this recommendation may provide protection to a particularly vulnerable subgroup of women i.e. those in abusive or potentially abusive relationships from potential physical harm.

According to research applying a social constructionist perspective, the sense of self is not lost in people with Alzheimer’s disease (AD). It is, however, greatly influenced by the symptoms and by how they are treated by other people. Without support, it is difficult to preserve a positive sense of self, when living with progressing cognitive impairments. The stigma associated with cognitive impairment also threatens their sense of self. Harré’s social constructionist theories of self and positioning have been used to study how people with AD express their sense of self. As there is a need to expand the previous research by involving additional participants and research contexts, the aim of the present thesis was to describe, in accordance with Harré’s theories of self and positioning, how people with AD expressed their sense of self in personal interviews and in support groups with other people with AD. The research consists of four substudies (I–IV), and has a qualitative, descriptive, and theory-testing approach. Thirteen people with mild and moderate AD were included, 11 of whom had the early onset form of the disease. Two support groups were formed, led by facilitators who supported the communication and the participants’ expressions of self. Each group met 10 times during an eight-month period. Topics were not predetermined, and introduced by both facilitators and participants. Semistructured interviews were conducted before the groups started and after they ended. The interviews and support group conversations were audio-recoded and analysed with qualitative content analysis, guided by Harré’s theories. In substudy I, the initial interviews were deductively analysed. The findings showed that Self 1 (the sense of being a singular, embodied person) was expressed by the participants without difficulties. Self 2 (the perception of one’s personal attributes and life history) was expressed as feeling mainly the same person. While some abilities had been lost, other had been developed. Self 3 (the socially constructed self) was described as mostly supported, but sometimes threatened in interactions with other people (I). In substudy II, support group conversations were analysed abductively with respect to expressions of Self 2. It was found that participants expressed Self 2 in terms of agency and communion, and a lack of agency and communion (II).In substudy III, a secondary analysis of the data from substudy II was performed inductively with the aim of describing how Self 3 was constructed in the interaction of the support group. Five first-order positions, generating lively interaction, were described: the project manager, the storyteller, the moral agent, the person burdened with AD, and the coping person (III). In substudy IV, all the collected data were reanalysed inductively, focusing on how participants expressed the experience of being research participants. Three themes were constructed: contributing to an important cause, gaining from participating, and experiencing risks and drawbacks (IV). In conclusion, it was found that participants constructed positive social selves through the support from each other, the facilitator, and researchers in the support group (III), and as research participants (IV). Agency and communion were central to Self 2, and decreased with the progression of AD (II). In spite of change, participants perceived themselves as basically the same people, with a potential to learn and develop as persons (I).

Clinical trials play an important role in advancing therapeutic and preventive care with many current modalities resulting from prior research. While prior research has described barriers to participation in therapeutic clinical trials, much less in known about barriers related to participation in trials aimed at prevention, prostate cancer prevention in particular. Physicians have been shown to play a critical role in access to trials; however, less is known about the individual and structural factors that influence their participation in prostate cancer prevention trials. This research provides rich ethnographic detail within the context of an ongoing trial. Research participants included physician/investigators who were either directly (serving as a co-investigator) or peripherally (referring patients for participation) involved in prostate cancer prevention intervention clinical trial (PCPICT), as well as those who were considered for participation but declined. Methods included open ended semi-structured interviews, participant-observation and a survey. Participants were recruited via direct inquiry, email and/or letter regarding participation. The results of this study show that individual and structural factors intersect, influencing both the willingness and ability of physician/investigators to participate or refer patients for participation in a prostate cancer prevention intervention clinical trial. Individual factors such as explanatory views on prevention, notions of risk and uncertainty, shared decision-making and duality of roles appear to have a greater influence on the willingness of physicians to participate while structural factors such as staffing, other resources and time are more influential in regards to the ability to participate. This research served as a critical first step towards providing an in-depth understanding of the individual and structural factors that influence a physician's participation in this type of trial. It builds from prior work where a better understanding of barriers and identification of successful strategies to overcome them was a noted void. The researcher identifies areas where additional research would be beneficial and provides applied recommendations for those considering the design of future cancer prevention intervention projects.

When people 'go to the theatre' we know that they are audiences. When young people go to Contact, however, they might be audiences, performers and/or theatre makers - they might play all three or more roles. Contact's users blur existing concepts and terminology. When we want to know more about theatre audiences, audience research offers models based on the distinction between audiences and theatre makers. If we want to know more about Contact's users, however, a model reflecting the blending of audiences and theatre makers' roles has yet to be developed. This thesis engages with Contact's users. It maps some of their multiple roles and experiences by asking two main questions: What are the practices of the people attending Contact and how can these practices be researched? A range of qualitative methods is necessary in order to investigate the wide variety of Contact's users' roles and experiences. Individual and group interviews are drawn from audience research, creative workshops are drawn from communication studies, and participant observation and visual research from the social sciences. Finally, a new method, Walking Fieldwork, is adapted for the use in theatre. A number of case studies are employed to investigate Contact's users. These case studies involve the observation of young actors during rehearsals and performances, the observation of participants in an outreach project, the investigation of audiences' experiences of two productions, and several short post-show interviews with general Contact audiences. This study found evidence that the relationship between theatre makers and audiences is changing. The term 'theatre user' is introduced as it opens up an area of overlap between the two and fits contemporary practices at Contact more closely. Contact's users function as communities, participants and co-creators. The descriptions of these roles and experiences contained in this thesis are understood as an initial exploration into practices of contemporary theatre users. However, further research is needed to build a more detailed understanding of these practices. In terms of research methods, this study found that the academic field of audience research needs to develop methods which are sensitive to both the backgrounds of theatre users and the theatrical context. The argument is put forward that audience research should become more aware of methods for the investigation of human experience and should enter into a 'methods-dialogue' with other academic fields of study.

Indiana University-Purdue University Indianapolis (IUPUI) / Phase I clinical trials (P1Ts) are the first step in testing new medical therapies in humans, and are essential for developing new and innovative therapies for children with cancer. P1Ts are ethically controversial as they are not intended to directly benefit participants, but are particularly controversial for children with cancer who are only able to participate when there is no known curative therapy for their cancer. Benefits of pediatric oncology P1T participation may include improved quality of life (QOL) and hope. Risks may include fostering unrealistic hope, burdening children with additional medical procedures and toxicities, and limiting the opportunity for palliation. The goal of this dissertation was to investigate the P1T participation experience for children with cancer and their parents by: (1) assessing what is currently known about the participation experience, (2) exploring ways to understand and assess treatment burden and QOL during participation, and (3) interviewing parents about the experience of having a child participate in a P1T. Following a review of the literature, two studies were conducted: a longitudinal pilot study of 13 parent and child dyads who enrolled in a pediatric oncology early phase clinical trial at the recruiting institution, and a phenomenological study of 11 parents of children with cancer who participated in pediatric oncology P1Ts. Key findings included a dearth of research on the experiences of children and parents in pediatric oncology P1Ts. Instead, existing research has focused on consent processes. The longitudinal pilot study provided some insight into experiences of children and parents during trial participation, including that there may be time points when parents’ and children’s perceptions of the child’s quality of life substantively differ. Interviews with parents confirmed some of the anticipated benefits and risks of participation in P1Ts, and highlighted parents’ sense of running out of time to find an effective treatment and needing to use time they have with their child well. Specific challenges in conducting this research were participant attrition due to disease progression and the need for multi-site research to obtain an adequate sample.

Yes / This case outlines the rationale and methods used when carrying out ethnographic fieldwork in a care home environment with research participants who were living with a dementia diagnosis. Although concerns had been raised at ethics approval about the use of such methods – visual ethnography in particular – we found that there were ethical benefits for the participants whose capacity for research participation, and for social participation generally, was, in every case, higher than anticipated at the outset. By comparison we found that formal methods for assessing ability to give informed consent often appeared to create excess disability, and to exacerbate ill-being for people with dementia. The case draws on specific examples to show how issues related to methods and to ethical conduct of research are frequently intertwined, and should be considered together rather than in isolation.

SAMMANFATTNING  Bakgrund: Sjuksköterskor och forskare som arbetar med forskning inom psykiatri har ett ansvar att ta del av patienters erfarenheter i samband med deltagande. Syftet med denna studie har därför varit att undersöka uppfattningar om att delta i forskning och skillnader i uppfattningar och rapporterad hälsa hos patienter med schizofreni, depression och frisk kontrollgrupp. Samt undersöka samband mellan uppfattningar om deltagande och rapporterad hälsa hos de tre grupperna.  Metod: En tvärsnittsstudie med data från 175 forskningsdeltagare med diagnoserna schizofreni, depression samt friska kontrollpersoner. Forskningspersonerna har deltagit i fem olika psykiatriska studier som genomförts mellan åren 2014 och 2022. Deltagarna har i slutet av studierna de deltagit i svarat på frågor om hur de uppfattat att delta, samt sin rapporterade hälsa i slutet av forskningsdeltagandet.  Resultat: Friska kontrollpersoner skattade signifikant högre i tillfredställelse med att delta i forskning och rapporterad hälsa än patienter med schizofreni och depression. Ingen signifikant skillnad mellan patienter med schizofreni och depression i forskningsdeltagande påvisades generellt. Dock skattade patienter med schizofreni signifikant lägre i förtroende jämfört med övriga två grupper. Patienter med depression skattade signifikant lägre i jämförelse med övriga två grupperna i positiva aspekter och rapporterad hälsa. En signifikant överensstämmelse mellan positiva uppfattningar och rapporterad hälsa påvisades hos patienter med depression.  Slutsats: Sjukdomsgraden och stigmatisering kan påverka förtroende och glädje att delta i psykiatrisk forskning hos patienter med schizofreni och depression och. Detta är något som behöver tas i beaktande vid utformningen av nya studier, i bemötande och informationsöverföring till patienterna. För att på djupet fånga upplevelse av deltagande efterfrågas fler studier med kvalitativa inslag. / ABSTRACT Background: Nurses and researchers conducting psychiatric research have a responsibility to avoid objectifying the participant and to consider patients' experiences in connection with participation. Therefore, the aim of this study was to investigate perceptions and differences in perceptions and reported health among patients with schizophrenia, depression, and a healthy control group. It also aimed to examine the correlation between perceptions of participation and reported health in the three groups.  Method: A cross-sectional study with data from 175 research participants with diagnoses of schizophrenia, depression, and healthy control individuals. The research participants participated in five different psychiatric studies conducted between the years 2014 and 2022. At the end of the studies, the participants answered questions about their perceptions of participation, and their reported health at the end of their research participation.  Results: Healthy control individuals rated significantly higher satisfaction with participation in research and reported health than patients with schizophrenia and depression. No significant difference in research participation was shown generally between patients with schizophrenia and depression. However, patients with schizophrenia rated significantly lower in confidence compared to the other two groups. Patients with depression rated significantly lower compared to the other two groups in positive aspects and reported health. A significant correlation between positive perceptions and reported health was shown in patients with depression.  Conclusion: Disease severity and stigma can affect confidence and enjoyment in participating in psychiatric research among patients with schizophrenia and depression. This is something that needs to be considered when designing new studies, in the approach and information transfer to patients. To deeply capture the experience of participation, more studies with qualitative aspects are requested.

Yes / Public and patient involvement (PPI) has been shown to have a positive impact on health and social care research. However, adequate examples describing how to operationalise effective PPI, especially in doctoral studies, are lacking. Hence, doctoral researchers new to research, or those with limited experience, can be discouraged from facilitating PPI in their research. This paper aims to describe and discuss in detail the approaches used by four doctoral researchers to incorporate PPI at different stages of their research studies from study design to disseminating findings. We aim to inform other doctoral researchers about the challenges and limitations relating to PPI that we faced. Through these, we share pragmatic recommendations for facilitating PPI during doctoral studies. The description of four case studies demonstrated that PPI could be incorporated at various stages during doctoral research. This has had a beneficial impact on our research study progression, researcher self-esteem and lastly, helped alleviate researcher isolation during doctoral studies. / Supported by Research Design Service Yorkshire and the Humber (RDSYH), the National Institute for Health Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre (NIHR Yorkshire and Humber PSTRC). This paper presents independent research funded by NIHR under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0317-20010). / Research Development Fund Publication Prize Award winner, July 2019.

Efforts to improve inclusion in research have included mandating the recruitment of ethnic minorities and women into NIH funded studies. However, little research has been completed on who attends such interventions. This is particularly worrisome in populations for which attendance to interventions can have dire consequences. HIV is a public health concern for pregnant women in substance using communities, as pregnant women are much less likely to use condoms during intercourse to prevent HIV. Group modular HIV prevention interventions have long been the standard for HIV prevention. However, little attention in research on HIV prevention interventions RCTs has been focused on attendance to these interventions. This study examined predictors of intervention and control group attendance in a randomized controlled trial comparing a 5-session Safer Sex Skill Building (SSB) intervention to a 1-session HIV education control group in a sample of pregnant women at risk for prenatal substance use. This study identified psychosocial and mental health variables associated with both 1 session control group and 5-session SSB intervention attendance as well as endeavored to identify the number of sessions necessary to attend to achieve an adequate dose in treatment. Findings include younger age and marital status as being predictive of participation in the one session HE control group and having a trade, skill, or profession as being predictive of participation in the five session SSB intervention group. Further research is needed to understand what factors may impact five-session SSB group attendance.