The experiences of adults living with an implantable cardioverter defibrillator for cardiovascular disease: a systematic review of qualitative evidence protocol

Centers conducting the review Memorial University of Newfoundland and Queens Joanna Briggs Collaboration for Patient Safety: a Collaborating Center of the Joanna Briggs Institute Review question/objective The objective of the review is to explore the everyday life experiences of adult individuals living with an implantable cardioverter defibrillator (ICD) for cardiovascular disease. Background Cardiovascular disease is the leading cause of death worldwide, with over 17 million deaths in 2008.1 The World Health Organization (WHO) estimates that by 2030, the number of deaths related to cardiovascular disease annually will reach beyond 23.6 million.2 Every year more than 40,000 Canadians die from cardiovascular disease.3 The province of Newfoundland (NL) has one of the highest prevalence rates of cardiovascular disease in Canada.4 Contributing to this high rate is the strong presence of genetically linked cardiovascular conditions such as Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), a lethal condition that causes a sudden cardiac death, primarily in young males.5 In order to reduce the prevalance of cardiovascular disease the WHO, the World Stroke Organizaton and the World Heart Federation agree that national strategies need to focus on survelliance and monitoring, early identification and reduction of cardiovascular risk factors, and timely access to resources.1,6 Technological advancements, such as the implantable cardioverter defibrillator (ICD), also play a key role in cardiovascular disease management.6 The treatment of many heart conditions, particularly those of a genetic origin, includes an ICD. The ICD is a small device inserted under the chest wall. In the event of an arrhythmia, it delivers an electrical shock or “fires” to restore the heart to a normal sinus rhythm. The first successful human implant of an ICD was performed in 1980.7 In the 1990s, the ICD was introduced in Canada. Almost 35 years later, the ICD is currently the treatment of choice for the prevention of life threatening arrhythmias.8 To date, several large studies have demonstrated the efficacy of the ICD as a successful treatment for cardiovascular disease.9–17 In NL, there are approximately 4000 individuals living with an ICD (personal communication D. Rideout, 2012). A preliminary review of the literature has shown that there is a dearth of synthesized qualitative research that captures the day-to-day experiences of this population. Given the prevalence of the ICD in NL and its recent success as an effective treatment modality for ARVC,18 it is critical that health care professionals understand the impact of this device on one's health. Evidence is not clear as to the psychosocial impact of living with this device. Although researchers note that a lengthy period of adjustment is required for many of these ICD patients,19,20,21 what remains ambiguous is the longevity of these psychosocial issues, when they arise, and the contributing factors that may either facilitate or impede the coping process through the patient's lens. Existing literature describes the ICD as something that instills a sense of security and trust in its capabilities to save one's life in the event of a cardiac episode.20–27 A recent study in NL examined the experiences of individuals with ARVC, and findings indicated that the majority of participants wanted an ICD as it provided them with a sense of solace and prolonged their lives.28 Despite the positive attributes of the ICD, living with an ICD has been found in the literature to cause varying levels of psychological distress; however, there is no consensus as to the onset and duration of this distress and influencing factors.29 A reoccurring theme in the literature is that the everyday management of the ICD negatively impacts quality of life and psychological health of this population.22,29,30,31 Feelings of anxiety prior to the ICD firing and post-shock have been documented in the ICD literature.20,26,29 One study reports that this post-shock anxiety is so severe that several participants have considered removing it.21 Accounts of the psychological stress that participants endured as they tried to predict when the ICD would fire have also been noted in the cardiovascular literature.21,24,32,33 Researchers suggest that a large part of the ICD related distress is related to participants' resistance to relinquish control over their lives to the ICD.24,34 Some have found that anxiety associated with ICD management is chronic in nature, lasting at times up to one year,35,36 while others report that the apprehension associated with the ICD firing subsides, as participants become accustomed to its firing and recognize that this is to be expected.20,23 Living with an ICD can be challenging in other ways. Several studies report that participants have difficulty with adjusting to the weight of the ICD, being nervous about having it in their body, having a sense of discomfort, feeling weak, and having problems sleeping.24 An alteration in one's body image, due to visibility of the ICD and incision scarring, is another factor that has been identified in the literature as causing ICD recipients to experience psychological distress.32,37 Given that the literature addressing the psychosocial impact of living with an ICD on one's everyday life is not straightforward, it is important that a systematic review of the literature is undertaken to gain a more comprehensive understanding of this phenomenon. A search of the Johanna Briggs Institute Database of Systematic Reviews and Implementation Reports, the Cochrane Database of Systematic Reviews and PROSPERO found no qualitative systematic reviews in this area. Although there have been two recent qualitative systematic reviews that have explored the experiences of individuals who have had an ICD, the literature included is limited to that published pre-January 2009 and only one used a critical appraisal tool comprised of ten questions.38 In addition, both of these systematic reviews excluded grey literature and those unpublished. In order to capture what life is like for those living with an ICD, it is important that a comprehensive systematic literature review which includes an appraisal and synthesis of existing evidence is done using a formal approach such as the Joanna Briggs Institute (JBI) Model of Evidence-based Health Care.40 The knowledge from this review will inform the needs of this population, and identify gaps in research, practice and education. Furthermore, given that in NL there is no formal referral process in place for patients who have an ICD in the event they experience psychosocial difficulties, this review will offer recommendations could inform this process in practice. Inclusion criteria Types of participants This review will focus on adults who are 18 years or older and have had an ICD, including single and dual chamber ICDs, for any duration of time for the management of cardiovascular disease. Participants with other co-morbidities or receiving other interventions in addition to the ICD will be included, regardless of the severity of cardiovascular disease. Types of intervention(s)/phenomena of interest This review will consider the phenomenon of interest of the everyday life experience of adults living with an implantable cardioverter defibrillator. This may include how individuals living with an ICD conceptualize their sense of wellbeing, how they cope with having an ICD, and how they manage their daily lives within the context of family relationships, the workplace, everyday roles, personal obligations, medical appointments, interactions with health care providers, disease progression and their spirituality. Context The context of the review includes the experiences of participants from all cultures, socioeconomic backgrounds and countries. Types of studies This review will consider studies that focus on qualitative data including but not limited to designs such as phenomenology, grounded theory, ethnography, action research, feminist research and interpretive research. The textual component of the review will consider expert opinion, discussion papers, position papers, and other texts. Search strategy The search strategy aims to find both published and unpublished studies. A three-step search strategy will be used in this review. An initial limited search of PubMed and CINAHL will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Third, the reference list of all identified reports and articles will be searched for additional studies. Only studies published in English from all countries will be considered for inclusion in this review. Studies published between 1990 and 2015 will be considered for inclusion in this review. This date is chosen because it is around this time that the ICD was introduced as an effective treatment for cardiovascular disease thus, a flurry of research activity was being done in the field. The databases to be searched include: PubMed, PsycINFO, CINAHL, EMBASE, International Bibliography of the Social Sciences, Sociological Abstracts and Healthstar. The search for unpublished studies will include: OpenGrey, MEDNAR, Dissertation Abstracts International and Google. Authors of primary studies will be contacted for missing information or to clarify unclear data. Initial keywords to be used will be: implantable defibrillator, implantable cardioverter defibrillator, ICD, artificial pacemaker, experience, perception, perspective, qualitative research methods, psychological adaptation, quality of life, well-being, role attainment, safety and social adaptation. Assessment of methodological quality Qualitative papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer. Textual papers selected for retrieval will be assessed by two independent reviewers for authenticity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Narrative, Opinion and Text Assessment and Review Instrument (JBI-NOTARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer. Data extraction Qualitative data will be extracted from papers included in the review using the standardized data extraction tool from JBI-QARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Textual data will be extracted from papers included in the review using the standardized data extraction tool from JBI-NOTARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods, and outcomes of significance to the review question and specific objectives. Data synthesis Qualitative research findings will, where possible, be pooled using JBI-QARI. This will involve the aggregation or synthesis of findings to generate a set of statements that represent that aggregation, through assembling the findings (Level 1 findings) rated according to their quality, and categorizing these findings on the basis of similarity in meaning (Level 2 findings). These categories are then subjected to a meta-synthesis in order to produce a single comprehensive set of synthesized findings (Level 3 findings) that can be used as a basis for evidence-based practice. Where textual pooling is not possible the findings will be presented in a narrative form. Textual papers will, where possible, be pooled using JBI-NOTARI. This will involve the aggregation or synthesis of conclusions to generate a set of statements that represent that aggregation, through assembling and categorizing these conclusions on the basis of similarity in meaning. These categories are then subjected to a meta-synthesis in order to produce a single comprehensive set of synthesized findings that can be used as a basis for evidence-based practice. Where textual pooling is not possible the conclusions will be presented in narrative form. Conflicts of interest The researchers declare no conflict of interest. Acknowledgements The researchers would like to express their gratitude for the support provided by Memorial University School of Nursing.

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