TY - JOUR
AU1 - Malecki-Ketchell, Alison
AU2 - Marshall, Paul
AU3 - Maclean, Joan
AB - Abstract Background Complex cardiac rhythm management device (CRMD) therapy provides an important treatment option for people at risk of sudden cardiac death. Despite the survival benefit, device implantation is associated with significant physical and psychosocial concerns presenting considerable challenges for the decision-making process surrounding CRMD implantation for patients and physicians. Aims The purpose of this scoping review was to explore what is known about how adult (>16 years) patients make decisions regarding implantation of CRMD therapy. Methods Published, peer reviewed, English language studies from 2000 to 2016 were identified in a search across eight healthcare databases. Eligible studies were concerned with patient decision-making for first time device implantation. Quality assessment was completed using the mixed methods appraisal tool for all studies meeting the inclusion criteria. Results The findings of eight qualitative and seven quantitative studies, including patients who accepted or declined primary or secondary sudden cardiac death prevention devices, were clustered into two themes: knowledge acquisition and the process of decision-making, exposing similarities and distinctions with the treatment decision-making literature. Conclusion The review revealed some insight in to the way patients approach decision-making but also exposed a lack of clarity and research activity specific to CRMD patients. Further research is recommended to support the development and application of targeted decision support mechanisms. Scoping review, implantable cardioverter defibrillator (ICD), cardiac resynchronisation therapy (CRT), cardiac device implantation, patient decision-making Introduction Sudden cardiac death (SCD) is a global problem. The exact incidence of SCD in Europe and the USA remains unclear although it is responsible for an estimated 15–20% of all deaths.1 It is usually the result of ventricular arrhythmia, most often associated with underlying heart disease or inherited conditions.2 Meta-analysis of large randomised controlled trials has firmly established the survival benefit of complex cardiac rhythm management devices (CRMDs) such as implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT) over conventional drug therapy, in a targeted but growing population of people who have survived (secondary device), or are at substantial risk (primary prevention) of sudden cardiac arrest (SCA).3–6 Despite the evident survival benefit, CRMD implantation is associated with significant potential complications and substantial patient and partner physical and psychosocial concerns.7 The enormity and uncertainty of both benefits and harms present challenges for the decision-making process surrounding CRMD implantation for patients and healthcare professionals. The degree of satisfaction with the decision to accept or decline CRMD implantation is complex, may affect the quality of the immediate treatment phase and influence the individuals’ overall acceptance, psychosocial adjustment and long-term outcomes with or without the device.7 A wealth of existing knowledge related to patient treatment decision-making, in the context of life-threatening conditions and the presence of uncertainty, complexity and limited rationality, refers predominantly to cancer with less emphasis on cardiovascular disease. The literature describes the distinction and interplay between individual and collective, participatory aspects of treatment decision-making.8 Individual decision-making refers to systematic and non-systematic (heuristic) methods of gathering information.9–12 Participatory decision-making has been conceptualised according to several models revolving around the level of control an individual has over decision-making, ranging from ‘passive’ paternalistic physician control, to ‘active’ informed patient control or shared involvement in information exchange, deliberation and final choice between physician, patient and significant others.13–15 Shared decision-making is widely advocated as the gold standard in the literature,15–18 yet while most patients appear to prefer a joint approach,19 a significant minority favour a passive style and others a more active approach.20–24 Factors such as patient demographics, condition, severity and healthcare experience appear to influence preference for involvement.20–30 A connection between achieving the desired level of involvement, being informed and decisional satisfaction has been reported,22,31–34 yet discordance between desired and actual decisional control appears to be prevalent.21,24,32,35–38 Regardless of the level of participation, widespread misunderstanding and dissatisfaction with the amount of information received appears to be common.22,23,26,39,40 Given the context of serious, sudden life-threatening cardiac arrhythmia and the uniqueness of device therapy it is not known whether findings from the broader literature can be applied to patients making decisions regarding CRMD implantation. In view of this, a scoping review was undertaken to discover ‘what is known about how adult (>16 years) patients make decisions regarding implantation of complex cardiac rhythm management device (CRMD) therapy’. Methods A five-stage scoping framework41 was used to explore the extent, range and nature of available knowledge, identify gaps in the existing literature, establish key areas for further study and consider implications for practice. The scoping framework involved developing the research question, identifying relevant studies, study selection, charting the data and reporting the results. The framework was further refined to include an analysis of quality42–45. The eligibility criteria (Table 1) were deliberately broad and not restricted by study design. Exclusion parameters were developed iteratively in response to exposure to the literature, to ensure that patient decision-making related to CRMDs remained the focal point of the review. The search strategy was designed to locate good quality, relevant studies published in English from the year 2000, reflecting the fact that complex CRMDs were not in mainstream practice until the 1990s. Search terms such as: adult patient and cardiac arrest or disease or failure or myopathy, and implantable defibrillator or device therapy and decision-making; were applied across eight databases (Table 2) particular to medicine, psychology, nursing, allied health publications and four grey literature databases. Hand searching of cardiology and decision-making journals and citation tracking ensured inclusivity. Titles and abstracts were searched (AM-K) for relevance against eligibility criteria retaining 244 (Table 1). Following the removal of duplications, 173 citations were organised into: include (n=35), unsure (n=8) and exclude (n=130) groups and full text scrutinised. Alternative publications of the same dataset were pooled and papers that did not meet the inclusion criteria or provide sufficient detail for analysis were excluded, resulting in 15 studies. Independent review (PM) of a random sample of 30 citations confirmed eligibility (Figure 1). The mixed methods appraisal tool (MMAT)46 was used to appraise methodological quality. This tool allows assessment of quantitative, qualitative and mixed methods designs, has good reported validity and reliability46–48 and has been used in previous reviews.49,50 Research design, methods and key findings extracted from the primary studies were collated into a detailed data chart to enable identification, interpretation and synthesis of commonalities, themes and gaps in the literature.41,45 Table 1. Inclusion criteria applied to scoping review on cardiac patient decision-making Included decision-making related to: i. Patients with serious life-threatening cardiac illness who meet selection criteria for ICD for secondary or primary prophylactic prevention of life-threatening ventricular arrhythmia or CRT for heart failure and at risk of life-threatening arrhythmia ii. Age >16 years to include adolescents iii. First time implant iv. Decision theory development or validation related to cardiac device therapy v. Individual and/or collective decision-making related to cardiac device therapy vi. Influential factors affecting acceptance or refusal of cardiac device therapy vii. Interventions e.g. decision aids to support decision-making related to cardiac device therapy viii. Development and validation of decision-making outcome measures related to cardiac device therapy ix. Any study design and applicable non-research material e.g. policy and guidance patient decision-making Included decision-making related to: i. Patients with serious life-threatening cardiac illness who meet selection criteria for ICD for secondary or primary prophylactic prevention of life-threatening ventricular arrhythmia or CRT for heart failure and at risk of life-threatening arrhythmia ii. Age >16 years to include adolescents iii. First time implant iv. Decision theory development or validation related to cardiac device therapy v. Individual and/or collective decision-making related to cardiac device therapy vi. Influential factors affecting acceptance or refusal of cardiac device therapy vii. Interventions e.g. decision aids to support decision-making related to cardiac device therapy viii. Development and validation of decision-making outcome measures related to cardiac device therapy ix. Any study design and applicable non-research material e.g. policy and guidance patient decision-making Open in new tab Table 1. Inclusion criteria applied to scoping review on cardiac patient decision-making Included decision-making related to: i. Patients with serious life-threatening cardiac illness who meet selection criteria for ICD for secondary or primary prophylactic prevention of life-threatening ventricular arrhythmia or CRT for heart failure and at risk of life-threatening arrhythmia ii. Age >16 years to include adolescents iii. First time implant iv. Decision theory development or validation related to cardiac device therapy v. Individual and/or collective decision-making related to cardiac device therapy vi. Influential factors affecting acceptance or refusal of cardiac device therapy vii. Interventions e.g. decision aids to support decision-making related to cardiac device therapy viii. Development and validation of decision-making outcome measures related to cardiac device therapy ix. Any study design and applicable non-research material e.g. policy and guidance patient decision-making Included decision-making related to: i. Patients with serious life-threatening cardiac illness who meet selection criteria for ICD for secondary or primary prophylactic prevention of life-threatening ventricular arrhythmia or CRT for heart failure and at risk of life-threatening arrhythmia ii. Age >16 years to include adolescents iii. First time implant iv. Decision theory development or validation related to cardiac device therapy v. Individual and/or collective decision-making related to cardiac device therapy vi. Influential factors affecting acceptance or refusal of cardiac device therapy vii. Interventions e.g. decision aids to support decision-making related to cardiac device therapy viii. Development and validation of decision-making outcome measures related to cardiac device therapy ix. Any study design and applicable non-research material e.g. policy and guidance patient decision-making Open in new tab Table 2. Data sources searched, number of hits and papers retrieved from November 2014 to 2016 Databases . Papers retrieved (of number of hits) . Cinahl (EBSCO Host) 41 (of 768 hits) Embase (Embase 1996 to 2014 week 47) 31 (1401) Medline (MEDLINE(R) 1996 to November week 2 2014) 45 (305) Medline (MEDLINE(R) Limited 2014 to 2016) 1 (76) PsycInfo (PsycINFO 1806 to November week 4 2014) 13 (13) Scopus (Health Sciences; Life Sciences; Social Sciences and Humanities) 13 (190) Web of Science (all databases) 44 (568) Cochrane Library 2 (76) Cochrane Database of Systematic Reviews 0 results Other Journals 30 Reference lists of citations and full text articles 13 Author search 3 Grey literature 0 Cardiac networks and organisations, policies and guidelines 8 Totals 244 (of 3451) Databases . Papers retrieved (of number of hits) . Cinahl (EBSCO Host) 41 (of 768 hits) Embase (Embase 1996 to 2014 week 47) 31 (1401) Medline (MEDLINE(R) 1996 to November week 2 2014) 45 (305) Medline (MEDLINE(R) Limited 2014 to 2016) 1 (76) PsycInfo (PsycINFO 1806 to November week 4 2014) 13 (13) Scopus (Health Sciences; Life Sciences; Social Sciences and Humanities) 13 (190) Web of Science (all databases) 44 (568) Cochrane Library 2 (76) Cochrane Database of Systematic Reviews 0 results Other Journals 30 Reference lists of citations and full text articles 13 Author search 3 Grey literature 0 Cardiac networks and organisations, policies and guidelines 8 Totals 244 (of 3451) Open in new tab Table 2. Data sources searched, number of hits and papers retrieved from November 2014 to 2016 Databases . Papers retrieved (of number of hits) . Cinahl (EBSCO Host) 41 (of 768 hits) Embase (Embase 1996 to 2014 week 47) 31 (1401) Medline (MEDLINE(R) 1996 to November week 2 2014) 45 (305) Medline (MEDLINE(R) Limited 2014 to 2016) 1 (76) PsycInfo (PsycINFO 1806 to November week 4 2014) 13 (13) Scopus (Health Sciences; Life Sciences; Social Sciences and Humanities) 13 (190) Web of Science (all databases) 44 (568) Cochrane Library 2 (76) Cochrane Database of Systematic Reviews 0 results Other Journals 30 Reference lists of citations and full text articles 13 Author search 3 Grey literature 0 Cardiac networks and organisations, policies and guidelines 8 Totals 244 (of 3451) Databases . Papers retrieved (of number of hits) . Cinahl (EBSCO Host) 41 (of 768 hits) Embase (Embase 1996 to 2014 week 47) 31 (1401) Medline (MEDLINE(R) 1996 to November week 2 2014) 45 (305) Medline (MEDLINE(R) Limited 2014 to 2016) 1 (76) PsycInfo (PsycINFO 1806 to November week 4 2014) 13 (13) Scopus (Health Sciences; Life Sciences; Social Sciences and Humanities) 13 (190) Web of Science (all databases) 44 (568) Cochrane Library 2 (76) Cochrane Database of Systematic Reviews 0 results Other Journals 30 Reference lists of citations and full text articles 13 Author search 3 Grey literature 0 Cardiac networks and organisations, policies and guidelines 8 Totals 244 (of 3451) Open in new tab Figure 1. Open in new tabDownload slide Flow diagram of study selection process Adapted from Moher et al.116 Results Overview of methodological approaches Of the 3451 citations retrieved, 15 studies fulfilled the inclusion criteria. Table 3 presents a condensed numerical analysis of the extent, nature and distribution of the research. Eight qualitative studies, six non-randomised cohort trials and one integrative review were published between 2007 and 2016. All studies were conducted in North America (USA or Canada) with the exception of Agard et al.51 (Sweden), Groarke et al.52 (Ireland) and Chan et al.53 (Singapore). Sample sizes ranged from eight54 to 24053 patients post-CRMD recommendation. Several studies recruited from local or national registers or more than one implant centre.52,55–59 A ratio of two to four men to one woman was represented with the exception of 1:1 in Hauptman et al.56 The mean age ranged from 54.86 to 69 years with the exception of Lucas54 who targeted older adults (mean 84 years). Six studies53,55,57,60–62 included mixed race participants although the majority were Caucasian, and other demographic information such as marital status, educational level was scarcely reported. One study focused upon secondary ICD,51 six on primary ICD53,57–59,61,62 and five52,54,56,60,63 included both ICD indications. Five studies included ICD and CRT52,54,56,63,64 and it was not clear which indication or device type Gal et al.55 referred to. Four studies58,59,61,62 compared patients who accepted and declined devices, six51,52,54,55,60,63 studied acceptors only and two53,64 focused on those who refused CRMDs. With the exception of Hickman and colleagues60,65 non-standard, researcher designed instruments with unconfirmed validity and reliability were employed to explore decision styles, influencing factors, patient knowledge, decisional control preference, satisfaction and regret. Data collection occurred between one and 16 years post-implant. Where there is delayed follow-up, the validity of the findings could be questioned as recall of the detail surrounding the decision-making experience may have been affected. The integrative review49 was concerned with the trajectory of decision-making from implant to the end of life. The review of initial implant decision featured eight51,52,56,58,59,61,63,66 of the studies included in this analysis. Despite the distinction in focus, similarities in findings with this review emphasise commonalities in thematic interpretation. Overall, the level of reporting was variable but sufficient to enable quality assessment for all except one conference abstract62 providing limited methods information and the integrative review,49 which included an independent, comparative MMAT assessment. Of 13 appraised studies, six scored 100%, four scored 75% and three scored 50% (Table 3). Table 3. Descriptive analysis of the included studies Author & design . Sample size . Male n (%) . Female n (%) . Age – mean or median: (SD): range . Primary ICD . Secondary ICD . CRT . Accept device . Decline device . Ethnicity . Interval from implant to study . MMAT . Qualitative studies Agard et al. 200751 Grounded theory 31 25 (81%) 6 (19%) Mean 65 44–79 – 31 – 31 (100%) – ? Mean 40 months (61% no shock) 75% Carroll et al. 201158 Grounded theory 44 33 (75%) 11 (25%) Mean 65 (12.5) 26–87 34 – – 34 (27M : 7F) 10 (6 M:4 F) ? Accept – 1 month Decline up to 1 month 100% Gal et al. 201155 (GT) (Kantor et al. 201266) 191 140 (73%) 51 (27%) Median 60s 19–92 ? ? ? 191 (100%) – White 71%, AA and Hispanic Mean 5.39 years (61% no shock) 50% Lucas 201254 Phenomenology 8 6 (75%) 2 (25%) Mean 84 71–93 3 (+ 3 Unknown) 2 8 (100%) – Caucasian 100% (Jewish 75%) 1 to 16 years (50% >6 years) 50% Matlock et al. 201063 Descriptive 22 HF 16 (73%) 6 (27%) Mean 69 12 (55%) 7 (32%) 19 had a device – ? 3 patients did not have CRMD 100% Matlock et al. 201161 Descriptive 20 Patient 11 Dr 12 (60%) 8 (40%) Mean 59 34–72 14 – – 14 (70%) 6 (30%) White (65%) Black (25%) Native American (5%) Hispanic/Latino (5%) ? 100% Ottenburg et al. 201464 Descriptive 13 11 (85%) 2 (15%) Med 65 44–88 12 Offered – 1 Offered – 13 (100%) White 100% (10 77% married) Not applicable 100% Yuhas et al. 201259 Grounded theory 25 18 (72%) 7 (28%) Mean 69+3 years 35–94 12 (48%) – – 12 (48%) 4 F:8 M 13 (52%) 3 F:10 M White 100% Pre-implant 100% Quantitative studies Chan et al. 201653 Retrospective cohort 240 202 (84%) 38 (16%) Mean 61.2 (9.7) 240 Offered – – – 240 (100%) Chinese (71%) Malay (16%) Indian (11%) Other (2%) Not applicable 75% Groarke et al. 201252 Retrospective cohort 75 62 (83%) 13 (17%) Median 64 (9.4) 29–82 69 (92%) 6 (8%) 75 (100%) – ? Med 36 months (SD 1.9) 1–9 years 100% Hauptman et al. 201356 Retrospective cohort 41 Patient 11 Dr 20 (49%) 21 (51%) Mean 61.4 (14.7) 12 (29%) 29 (71%) 20 (49%) had >1 device procedure e.g. upgrade, recall, generator change ? 1 to 11 years 50% Hazleton et al. 201457 Prospective cohort 103 67 (65%) 36 (35%) Mean 54.86 (9.4) 19–90 ? All Primary – – – – Mixed race (53.3% Married) Pre-implant 75% Hickman et al. 201060 (& 201265) Retrospective 109 83 (76%) 26 (24%) Mean 65.64 (13.58) 92 (88%) 13 (12%) (4 Unknown) – 109 (100%) – Caucasian 79 (72%) Non-Caucasian 30 (28%) Mean 18 months (SD 0.75) 75% Singh et al. 201262 Retrospective cohort 50 ? ? Mean 62 +11 years 29 – – 29 (58%) 21 (42%) Caucasian 27 (54%) African American 18 (36%) Asian 5 (10%) ? – Lewis et al. 201449 Integrative review – – – – – – – – – – – – Author & design . Sample size . Male n (%) . Female n (%) . Age – mean or median: (SD): range . Primary ICD . Secondary ICD . CRT . Accept device . Decline device . Ethnicity . Interval from implant to study . MMAT . Qualitative studies Agard et al. 200751 Grounded theory 31 25 (81%) 6 (19%) Mean 65 44–79 – 31 – 31 (100%) – ? Mean 40 months (61% no shock) 75% Carroll et al. 201158 Grounded theory 44 33 (75%) 11 (25%) Mean 65 (12.5) 26–87 34 – – 34 (27M : 7F) 10 (6 M:4 F) ? Accept – 1 month Decline up to 1 month 100% Gal et al. 201155 (GT) (Kantor et al. 201266) 191 140 (73%) 51 (27%) Median 60s 19–92 ? ? ? 191 (100%) – White 71%, AA and Hispanic Mean 5.39 years (61% no shock) 50% Lucas 201254 Phenomenology 8 6 (75%) 2 (25%) Mean 84 71–93 3 (+ 3 Unknown) 2 8 (100%) – Caucasian 100% (Jewish 75%) 1 to 16 years (50% >6 years) 50% Matlock et al. 201063 Descriptive 22 HF 16 (73%) 6 (27%) Mean 69 12 (55%) 7 (32%) 19 had a device – ? 3 patients did not have CRMD 100% Matlock et al. 201161 Descriptive 20 Patient 11 Dr 12 (60%) 8 (40%) Mean 59 34–72 14 – – 14 (70%) 6 (30%) White (65%) Black (25%) Native American (5%) Hispanic/Latino (5%) ? 100% Ottenburg et al. 201464 Descriptive 13 11 (85%) 2 (15%) Med 65 44–88 12 Offered – 1 Offered – 13 (100%) White 100% (10 77% married) Not applicable 100% Yuhas et al. 201259 Grounded theory 25 18 (72%) 7 (28%) Mean 69+3 years 35–94 12 (48%) – – 12 (48%) 4 F:8 M 13 (52%) 3 F:10 M White 100% Pre-implant 100% Quantitative studies Chan et al. 201653 Retrospective cohort 240 202 (84%) 38 (16%) Mean 61.2 (9.7) 240 Offered – – – 240 (100%) Chinese (71%) Malay (16%) Indian (11%) Other (2%) Not applicable 75% Groarke et al. 201252 Retrospective cohort 75 62 (83%) 13 (17%) Median 64 (9.4) 29–82 69 (92%) 6 (8%) 75 (100%) – ? Med 36 months (SD 1.9) 1–9 years 100% Hauptman et al. 201356 Retrospective cohort 41 Patient 11 Dr 20 (49%) 21 (51%) Mean 61.4 (14.7) 12 (29%) 29 (71%) 20 (49%) had >1 device procedure e.g. upgrade, recall, generator change ? 1 to 11 years 50% Hazleton et al. 201457 Prospective cohort 103 67 (65%) 36 (35%) Mean 54.86 (9.4) 19–90 ? All Primary – – – – Mixed race (53.3% Married) Pre-implant 75% Hickman et al. 201060 (& 201265) Retrospective 109 83 (76%) 26 (24%) Mean 65.64 (13.58) 92 (88%) 13 (12%) (4 Unknown) – 109 (100%) – Caucasian 79 (72%) Non-Caucasian 30 (28%) Mean 18 months (SD 0.75) 75% Singh et al. 201262 Retrospective cohort 50 ? ? Mean 62 +11 years 29 – – 29 (58%) 21 (42%) Caucasian 27 (54%) African American 18 (36%) Asian 5 (10%) ? – Lewis et al. 201449 Integrative review – – – – – – – – – – – – Open in new tab Table 3. Descriptive analysis of the included studies Author & design . Sample size . Male n (%) . Female n (%) . Age – mean or median: (SD): range . Primary ICD . Secondary ICD . CRT . Accept device . Decline device . Ethnicity . Interval from implant to study . MMAT . Qualitative studies Agard et al. 200751 Grounded theory 31 25 (81%) 6 (19%) Mean 65 44–79 – 31 – 31 (100%) – ? Mean 40 months (61% no shock) 75% Carroll et al. 201158 Grounded theory 44 33 (75%) 11 (25%) Mean 65 (12.5) 26–87 34 – – 34 (27M : 7F) 10 (6 M:4 F) ? Accept – 1 month Decline up to 1 month 100% Gal et al. 201155 (GT) (Kantor et al. 201266) 191 140 (73%) 51 (27%) Median 60s 19–92 ? ? ? 191 (100%) – White 71%, AA and Hispanic Mean 5.39 years (61% no shock) 50% Lucas 201254 Phenomenology 8 6 (75%) 2 (25%) Mean 84 71–93 3 (+ 3 Unknown) 2 8 (100%) – Caucasian 100% (Jewish 75%) 1 to 16 years (50% >6 years) 50% Matlock et al. 201063 Descriptive 22 HF 16 (73%) 6 (27%) Mean 69 12 (55%) 7 (32%) 19 had a device – ? 3 patients did not have CRMD 100% Matlock et al. 201161 Descriptive 20 Patient 11 Dr 12 (60%) 8 (40%) Mean 59 34–72 14 – – 14 (70%) 6 (30%) White (65%) Black (25%) Native American (5%) Hispanic/Latino (5%) ? 100% Ottenburg et al. 201464 Descriptive 13 11 (85%) 2 (15%) Med 65 44–88 12 Offered – 1 Offered – 13 (100%) White 100% (10 77% married) Not applicable 100% Yuhas et al. 201259 Grounded theory 25 18 (72%) 7 (28%) Mean 69+3 years 35–94 12 (48%) – – 12 (48%) 4 F:8 M 13 (52%) 3 F:10 M White 100% Pre-implant 100% Quantitative studies Chan et al. 201653 Retrospective cohort 240 202 (84%) 38 (16%) Mean 61.2 (9.7) 240 Offered – – – 240 (100%) Chinese (71%) Malay (16%) Indian (11%) Other (2%) Not applicable 75% Groarke et al. 201252 Retrospective cohort 75 62 (83%) 13 (17%) Median 64 (9.4) 29–82 69 (92%) 6 (8%) 75 (100%) – ? Med 36 months (SD 1.9) 1–9 years 100% Hauptman et al. 201356 Retrospective cohort 41 Patient 11 Dr 20 (49%) 21 (51%) Mean 61.4 (14.7) 12 (29%) 29 (71%) 20 (49%) had >1 device procedure e.g. upgrade, recall, generator change ? 1 to 11 years 50% Hazleton et al. 201457 Prospective cohort 103 67 (65%) 36 (35%) Mean 54.86 (9.4) 19–90 ? All Primary – – – – Mixed race (53.3% Married) Pre-implant 75% Hickman et al. 201060 (& 201265) Retrospective 109 83 (76%) 26 (24%) Mean 65.64 (13.58) 92 (88%) 13 (12%) (4 Unknown) – 109 (100%) – Caucasian 79 (72%) Non-Caucasian 30 (28%) Mean 18 months (SD 0.75) 75% Singh et al. 201262 Retrospective cohort 50 ? ? Mean 62 +11 years 29 – – 29 (58%) 21 (42%) Caucasian 27 (54%) African American 18 (36%) Asian 5 (10%) ? – Lewis et al. 201449 Integrative review – – – – – – – – – – – – Author & design . Sample size . Male n (%) . Female n (%) . Age – mean or median: (SD): range . Primary ICD . Secondary ICD . CRT . Accept device . Decline device . Ethnicity . Interval from implant to study . MMAT . Qualitative studies Agard et al. 200751 Grounded theory 31 25 (81%) 6 (19%) Mean 65 44–79 – 31 – 31 (100%) – ? Mean 40 months (61% no shock) 75% Carroll et al. 201158 Grounded theory 44 33 (75%) 11 (25%) Mean 65 (12.5) 26–87 34 – – 34 (27M : 7F) 10 (6 M:4 F) ? Accept – 1 month Decline up to 1 month 100% Gal et al. 201155 (GT) (Kantor et al. 201266) 191 140 (73%) 51 (27%) Median 60s 19–92 ? ? ? 191 (100%) – White 71%, AA and Hispanic Mean 5.39 years (61% no shock) 50% Lucas 201254 Phenomenology 8 6 (75%) 2 (25%) Mean 84 71–93 3 (+ 3 Unknown) 2 8 (100%) – Caucasian 100% (Jewish 75%) 1 to 16 years (50% >6 years) 50% Matlock et al. 201063 Descriptive 22 HF 16 (73%) 6 (27%) Mean 69 12 (55%) 7 (32%) 19 had a device – ? 3 patients did not have CRMD 100% Matlock et al. 201161 Descriptive 20 Patient 11 Dr 12 (60%) 8 (40%) Mean 59 34–72 14 – – 14 (70%) 6 (30%) White (65%) Black (25%) Native American (5%) Hispanic/Latino (5%) ? 100% Ottenburg et al. 201464 Descriptive 13 11 (85%) 2 (15%) Med 65 44–88 12 Offered – 1 Offered – 13 (100%) White 100% (10 77% married) Not applicable 100% Yuhas et al. 201259 Grounded theory 25 18 (72%) 7 (28%) Mean 69+3 years 35–94 12 (48%) – – 12 (48%) 4 F:8 M 13 (52%) 3 F:10 M White 100% Pre-implant 100% Quantitative studies Chan et al. 201653 Retrospective cohort 240 202 (84%) 38 (16%) Mean 61.2 (9.7) 240 Offered – – – 240 (100%) Chinese (71%) Malay (16%) Indian (11%) Other (2%) Not applicable 75% Groarke et al. 201252 Retrospective cohort 75 62 (83%) 13 (17%) Median 64 (9.4) 29–82 69 (92%) 6 (8%) 75 (100%) – ? Med 36 months (SD 1.9) 1–9 years 100% Hauptman et al. 201356 Retrospective cohort 41 Patient 11 Dr 20 (49%) 21 (51%) Mean 61.4 (14.7) 12 (29%) 29 (71%) 20 (49%) had >1 device procedure e.g. upgrade, recall, generator change ? 1 to 11 years 50% Hazleton et al. 201457 Prospective cohort 103 67 (65%) 36 (35%) Mean 54.86 (9.4) 19–90 ? All Primary – – – – Mixed race (53.3% Married) Pre-implant 75% Hickman et al. 201060 (& 201265) Retrospective 109 83 (76%) 26 (24%) Mean 65.64 (13.58) 92 (88%) 13 (12%) (4 Unknown) – 109 (100%) – Caucasian 79 (72%) Non-Caucasian 30 (28%) Mean 18 months (SD 0.75) 75% Singh et al. 201262 Retrospective cohort 50 ? ? Mean 62 +11 years 29 – – 29 (58%) 21 (42%) Caucasian 27 (54%) African American 18 (36%) Asian 5 (10%) ? – Lewis et al. 201449 Integrative review – – – – – – – – – – – – Open in new tab Qualitative thematic analysis The selected papers were organised into ‘clusters’ based on study aims and within each cluster ‘subthemes’ emerged from the study findings (Table 4). Table 4. Emergent Clusters And Sub Themes . Cluster And Sub Themes . Researcher . Study Aims And Findings . 1 Patient Knowledge And Understanding Of The Indication For, Function And Benefits And Risks Of CRMD 1.1 Insight Into Condition, Device Role And Function 1.2 Physician Communication And Information Received Chan et al., 201610 Non Randomised Descriptive Perceived consequence of heart failure said to be stroke (42%), SCD (28%), MI (17%), don’t know (14%). 68% believed medication could prevent SCD, 16% believed exercise and diet could prevent SCD. Only 8% understood SCD preventative role. When asked about ICD function 52% correctly answered SCD prevention, 48% were not aware of SCD preventative role. Most feared consequence of heart failure was being bed bound (37%), breathlessness (30%), SCD (17%), chest pain (8%), don’t know (8%) All believed ICD would restrict life style including inability to do heavy lifting (30%), problems with electrical devices (17%), flying (10%), swimming (12%), sexual activity (5%) Chan conclude that limited consultation time, language barriers, deep seated beliefs that contradict physician advise could explain lack of understanding Groarke et al., 201211 Non Randomised Descriptive Retrospective cohort study to explore the knowledge, understanding and view of patients with (primary/secondary) ICD or CRT device. 83% (62 of 75) claimed to understand reason for ICD implant. Sub group - no patient suggested arrhythmia termination; inferred arrhythmia related reason; heart failure; various reasons including reducing risk of ‘heart attack’; unable to state reason other then physician recommendation. Excluding CRT patients recipients incorrectly believed device would improve cardiac function, breathing, exercise capacity, reduce risk of heart attack or stopping breathing. Shock recipients poorly prepared for shock therapy. 79% claimed to have sufficient information to consent. Patients who experienced device-related complication felt inadequately forewarned of complications. Despite pre implantation education, patient comprehension of risks & benefits of ICD therapy is poor and expectations of ICD therapy may be inappropriate. Hauptman et al., 201312 Non Randomised Descriptive Retrospective study to explore patient knowledge and physician communication of information during decision-making for cardiac device therapy (precise indication and device type unclear). Mean (SD) estimated number of patients out of 100 who would be saved by the ICD was 87.9 (20.1). Mean (SD) rating of preparedness for 39 patients was 5.7 (3.2) out of 10 at the time of the implant procedure and during the patient focus group meeting. Did not recall discussion of peri procedural risk or post implant complications. Limited discussions on QOL issues which focused upon fact that ICD would have no lifestyle effect. QOL measures not used pre or post implant. Pre implant mention of anxiety or depression infrequent. Gained knowledge of benefits and risks post implant. SP interviews focused medical history & procedure-related processes in context of medical benefit of ICD. Patients largely uniformed and overly optimistic about future expectations with ICD. Patient group consistently note inadequacy of information received pre implant and inattention paid to psychosocial issues post implant Hazleton et al., 201417 Non Randomised Descriptive Prospective study to develop and test a measure (ICD-DAS) of patient evaluated ICD pros and cons and its impact upon patient decision-making for a primary ICD or CRT (precise indication and device type unclear). Two-factor measure for ICD decision-making established with two subscales: ICD Pros and ICD Cons. ICD – DAS provides empirically tested & clinically useful pros & cons scale to help patient decision-making. Singh et al., 201214 Non Randomised Descriptive Prospective study to explore knowledge and influencing factors in decision to accept or decline primary ICD (precise indication and device type unclear). ICD pts and no ICD pts understanding of HF was poor. No ICD pts had less understanding of ICD purpose, were less likely to have been given written ICD information, less likely to recall recent discussion on ICD’s. Underutilization of primary ICD’s may be related to limited communication & poor understanding of HF, sudden death & devices. Agard et al., 20071 Grounded Theory Minimal criticism of lack of information or passive role played in DM. Participants agreed all they needed to know was they were high risk of life threatening arrhythmia to give consent. Did not recall discussion of alternative options; estimate of risk of potential fatal arrhythmia or expected time of survival with HF. Patients appeared not to need more information when related to life & death decisions and where no alternative option appeared to exist. Patients believed they had sufficient information to consent. They credited the device with saving their life despite not receiving shock therapy, believed it prevented further cardiac events or relieved symptoms. Carroll et al., 20112 Grounded Theory General lack of understanding of ICD role & function related to condition & symptoms. Participants did not recall receiving information related to alternatives to ICD therapy. Lewis et al. (2014)13 Integrative Review Pt’s with ICD misunderstood functionality or over estimated benefit. Recommend clinicians better support patients by 1) verifying understanding; 2) eliciting preferences; 3) promoting shared decision-making Lucas 20125 Phenomenological Limited information about device role, function & what they may expect. Some felt information was beyond their comprehension and most failed to seek additional information. Matlock et al., 20117 Descriptive Recipients reported not knowing about side effects until after device implant or when they experienced side effects. Cardiologists communication with ICD patients – 3 themes 1.Considerable variation existed in approach to patient centeredness and communication; 2. Cardiologists influenced by benefits presented in published guidelines; 3. Discussion revealed clear hierarchy in which cardiologists emphasised benefits but emphasis of risks varied greatly. Cardiologists adherence to guidelines appeared to inhibit SDM. Ottenburg et al., 20148 Descriptive ‘Gaps in learning’ – identified gaps in knowledge, participants keen to have all information. Clinicians perspectives refers to agreement between patients view of refusal and what clinicians had documented in medical notes as reason for non implant. Clinicians unaware that patients lacked knowledge of purpose & function of ICD. Yuhas et al., 20129 Grounded Theory Inaccurate perceptions of ICD-related risks and lifestyle limitations. Acceptors and decliners had reasonably good understanding of purpose & function of ICD 2 The Process Of And Factors Which Influenced The Patients Decision To Accept Or Decline CRMD Agard et al., 20071 Grounded Theory Explored patients with heart failure and previous life threatening arrhythmia experience and perception of role in secondary ICD decision-making. 1 way Dr to Patient communication. Facing a matter of fact - patients heeded recommendation of need for ICD. ‘An offer you cannot refuse’. Patients accepted physician recommendation for ICD as having no real choice if they valued longevity. Patients view themselves as laymen unable to have opinion of complex medical decision. Many desire to live longer so willing to accept technology despite poor prognosis, risks or inconvenience. Trust Dr judgement so accept recommendation. Negative experiences with ICD but did not regret implant decision because device increased chance of staying alive. 2.1 Approaches To Decision-making 2.2 Factors Influencing The Decision Style 2.3 Accepting Or Refusing Device Therapy Carroll et al., 20112 Grounded Theory Explored the decision-making process for patients who accepted and declined primary ICD DM triggered when assimilated risk of SCD. Physician recommendation & new awareness of SCD risk motivated acceptance. Pts occupy position somewhere along continuum between ‘active & engaged’ -‘passive & indifferent’ decision-making. Approach adopted largely influenced by 1) trust; 2) social influences; 3) patient’s health state. Main goal was to prolong life. Degree of activity or passivity in DM did not influence likelihood to accept / refuse ICD Gal et al., 20113 Grounded Theory (& Kantor et al., 20124) Explored the decision-making process for patients who had cardiac device therapy (precise indication & device type unclear). Reasons for choosing to accept - 2 key themes 1) Contributing factors; 2) Relationship to Dr / Doctor’s role. Researchers grouped themes as ’active’ relationship to DM & passivity. Those who described benefits of having ICD more likely to accept because ’peace of mind’ ’safety net’ (both considered to be active) and ’afraid to die’ (passive). Lucas 20125 Phenomenological Explored lived experience of older adults decision to accept primary or secondary ICD or CRT DM of older adults with ICD influenced by 1) trust & faith in physicians decision; 2) accepting device was necessary; 3) decision easy to make; 4) hope & desire to live longer. Limited involvement in decision-making, perceived option to be life or death, some family members involved in decision but physicians advise outweighed all else. Described trigger then all adopt passive approach (not described as such by Lucas) Matlock et al., 20106 Descriptive Explored patients with heart failure perceptions of difficult decisions and factors that influenced treatment decision-making (most had ICD or CRT). Described two distinct approaches to DM - 1) ‘Active’ associated with difficult decisions; participants considered & weighed up concerns related to side effects, family and overall QOL; required time to reflect & wanted second opinion. 2) ‘Passive’ did not identify difficult decision, described influencing factors as trust in God, physician and power of physician. Some passive DM believed all medical therapies helpful; others disengaged from medical care altogether. Matlock et al., 20117 Descriptive Explored patient and physician perception of decision-making for patients who accepted and declined primary ICD (inc refusal of secondary ICD). Patients who chose ICD - 3 themes 1) Desire to avoid death; 2) Need to follow physicians advice; 3) Discovery of risks post implant. Many accepted ICD on physicians advice without questioning benefit and risks. Patients who refused ICD - 1) Considered ICD to be unnecessary or believed risk of SCD did not apply to them 2) Perception that burden outweighed benefit. Physicians describe 2 main approaches - beneficent paternalistic and patient centred, shared approach. Ottenburg et al., 20148 Descriptive Explored reasons why patients declined primary cardiac device therapy. Major themes 1) ‘Don’t mess with a good thing’; 2) ‘My health is good enough’; 3) ‘Making independent decisions’; 4) ‘It’s your job, but it’s my choice’. Decliners described as collecting information from Dr and others to make informed decision & needed time to analyse and reflect - thus active DM. Patients who declined considered clinicians recommendation of need for device to be less influential than the way they felt. Patients considered DM to be a process not one off episode therefore some would re deliberate in future. Yuhas et al., 20129 Grounded Theory Explored perception of primary ICD to understand barriers to acceptance for patients who accepted and declined primary ICD. Major themes: 1) Personal risk; 2) Strength of recommendation; 3) Concerns over recall, malfunction, and surgical risk; 4) Feelings regarding invasive life-prolonging interventions played important role in ICD referral refusal. No significant demographic or clinical difference between participants & non participants and between acceptors and decliners Chan et al., 201610 Non Randomised Descriptive Explored demographic and social factors that influenced patients decision to decline 98% relied upon physician information only. 2% sought additional information from internet and publications Most (61%) believed they were most important person influencing decision, 15% felt that Dr played most important role. All refused because: cost (27%), invasive nature of procedure (24%), fear of complications (11%) advancing age (9%). Traditional factors associated with acceptance of more aggressive treatment ie younger, disease duration, educational attainment, salary were not evident. Groarke et al., 2012 Non Randomised Descriptive11 Strength of physician recommendation did influence decision ie weak recommendation associated with refusal. Chan conclude this may have been associated with passivity in information gathering. 65% did not regret decision, remaining unwilling to accept, 35% might agree to ICD in the future. Those most likely to reconsider were employed (poss financial reasons), feared SCD the most and acknowledged ICD preventative role 26 (35%) reported feeling frightened when informed of requirement for ICD. 35 of 75 (47%) suggested Dr decision, 19 (25%) stated patient decision & 21 (28%) stated joint decision. 40 (53%) preferred Dr to make decision and 35 (47%) desired all relevant information to facilitate own decision. 5 of subgroup of 25 (20%) stated physician recommendation as reason for implant. 93% satisfied with decision to accept ICD therapy. Hauptman et al., 201312 Non Randomised Descriptive When ICD deemed urgent, pts particularly overwhelmed by pace of DM. Older participants frequently deferred decision to family members. Interactions brief & decisions made quickly with little time to understand the implications. Some discharged home to consider decision. Many struggled with competing view of ICD as security net and source of physical and psychosocial discomfort. Lewis et al. 201413 Integrative Review Trajectory of key decision points were whether or not to initiate ICD therapy, replace battery & deactivate at end of life. 3 common themes from patient perspective – 1) Influence of patient - practitioner consultation on knowledge; 2) patients DM preference; 3) desire to live. Participants expressed mixed preference for desire to be involved in decisions. Decisions particularly difficult due to life & death trade off. Singh et al., 201214 Non Randomised Descriptive Quality of life more important than quantity. Religious belief and cultural values did not play major role in DM. Good access to health care resources & physicians. Women less likely to be married. Only 2 (7%) ICD patients would not accept ICD again; 18 no ICD (86%) pts would later reconsider implant. Hickman et al., 201015 & 201216 Retrospective study to assess decision regret and evaluate psychometrics of the Decision Regret Scale (DRS) among ICD recipients. Amount of decision regret (no regret vs. regret) not associated with demographic or clinical variables, such as the ICD indication (primary vs. secondary prevention) or ICD shock status (no shock vs. shock); while adjusting for the recipient’s age, gender and number of post-decision complications. Informational coping styles, monitoring and blunting significant predictors of decision regret; while adjusting for clinical and psychological variables. DRS psychometrically sound instrument for assessing decisional outcomes of ICD recipients . Cluster And Sub Themes . Researcher . Study Aims And Findings . 1 Patient Knowledge And Understanding Of The Indication For, Function And Benefits And Risks Of CRMD 1.1 Insight Into Condition, Device Role And Function 1.2 Physician Communication And Information Received Chan et al., 201610 Non Randomised Descriptive Perceived consequence of heart failure said to be stroke (42%), SCD (28%), MI (17%), don’t know (14%). 68% believed medication could prevent SCD, 16% believed exercise and diet could prevent SCD. Only 8% understood SCD preventative role. When asked about ICD function 52% correctly answered SCD prevention, 48% were not aware of SCD preventative role. Most feared consequence of heart failure was being bed bound (37%), breathlessness (30%), SCD (17%), chest pain (8%), don’t know (8%) All believed ICD would restrict life style including inability to do heavy lifting (30%), problems with electrical devices (17%), flying (10%), swimming (12%), sexual activity (5%) Chan conclude that limited consultation time, language barriers, deep seated beliefs that contradict physician advise could explain lack of understanding Groarke et al., 201211 Non Randomised Descriptive Retrospective cohort study to explore the knowledge, understanding and view of patients with (primary/secondary) ICD or CRT device. 83% (62 of 75) claimed to understand reason for ICD implant. Sub group - no patient suggested arrhythmia termination; inferred arrhythmia related reason; heart failure; various reasons including reducing risk of ‘heart attack’; unable to state reason other then physician recommendation. Excluding CRT patients recipients incorrectly believed device would improve cardiac function, breathing, exercise capacity, reduce risk of heart attack or stopping breathing. Shock recipients poorly prepared for shock therapy. 79% claimed to have sufficient information to consent. Patients who experienced device-related complication felt inadequately forewarned of complications. Despite pre implantation education, patient comprehension of risks & benefits of ICD therapy is poor and expectations of ICD therapy may be inappropriate. Hauptman et al., 201312 Non Randomised Descriptive Retrospective study to explore patient knowledge and physician communication of information during decision-making for cardiac device therapy (precise indication and device type unclear). Mean (SD) estimated number of patients out of 100 who would be saved by the ICD was 87.9 (20.1). Mean (SD) rating of preparedness for 39 patients was 5.7 (3.2) out of 10 at the time of the implant procedure and during the patient focus group meeting. Did not recall discussion of peri procedural risk or post implant complications. Limited discussions on QOL issues which focused upon fact that ICD would have no lifestyle effect. QOL measures not used pre or post implant. Pre implant mention of anxiety or depression infrequent. Gained knowledge of benefits and risks post implant. SP interviews focused medical history & procedure-related processes in context of medical benefit of ICD. Patients largely uniformed and overly optimistic about future expectations with ICD. Patient group consistently note inadequacy of information received pre implant and inattention paid to psychosocial issues post implant Hazleton et al., 201417 Non Randomised Descriptive Prospective study to develop and test a measure (ICD-DAS) of patient evaluated ICD pros and cons and its impact upon patient decision-making for a primary ICD or CRT (precise indication and device type unclear). Two-factor measure for ICD decision-making established with two subscales: ICD Pros and ICD Cons. ICD – DAS provides empirically tested & clinically useful pros & cons scale to help patient decision-making. Singh et al., 201214 Non Randomised Descriptive Prospective study to explore knowledge and influencing factors in decision to accept or decline primary ICD (precise indication and device type unclear). ICD pts and no ICD pts understanding of HF was poor. No ICD pts had less understanding of ICD purpose, were less likely to have been given written ICD information, less likely to recall recent discussion on ICD’s. Underutilization of primary ICD’s may be related to limited communication & poor understanding of HF, sudden death & devices. Agard et al., 20071 Grounded Theory Minimal criticism of lack of information or passive role played in DM. Participants agreed all they needed to know was they were high risk of life threatening arrhythmia to give consent. Did not recall discussion of alternative options; estimate of risk of potential fatal arrhythmia or expected time of survival with HF. Patients appeared not to need more information when related to life & death decisions and where no alternative option appeared to exist. Patients believed they had sufficient information to consent. They credited the device with saving their life despite not receiving shock therapy, believed it prevented further cardiac events or relieved symptoms. Carroll et al., 20112 Grounded Theory General lack of understanding of ICD role & function related to condition & symptoms. Participants did not recall receiving information related to alternatives to ICD therapy. Lewis et al. (2014)13 Integrative Review Pt’s with ICD misunderstood functionality or over estimated benefit. Recommend clinicians better support patients by 1) verifying understanding; 2) eliciting preferences; 3) promoting shared decision-making Lucas 20125 Phenomenological Limited information about device role, function & what they may expect. Some felt information was beyond their comprehension and most failed to seek additional information. Matlock et al., 20117 Descriptive Recipients reported not knowing about side effects until after device implant or when they experienced side effects. Cardiologists communication with ICD patients – 3 themes 1.Considerable variation existed in approach to patient centeredness and communication; 2. Cardiologists influenced by benefits presented in published guidelines; 3. Discussion revealed clear hierarchy in which cardiologists emphasised benefits but emphasis of risks varied greatly. Cardiologists adherence to guidelines appeared to inhibit SDM. Ottenburg et al., 20148 Descriptive ‘Gaps in learning’ – identified gaps in knowledge, participants keen to have all information. Clinicians perspectives refers to agreement between patients view of refusal and what clinicians had documented in medical notes as reason for non implant. Clinicians unaware that patients lacked knowledge of purpose & function of ICD. Yuhas et al., 20129 Grounded Theory Inaccurate perceptions of ICD-related risks and lifestyle limitations. Acceptors and decliners had reasonably good understanding of purpose & function of ICD 2 The Process Of And Factors Which Influenced The Patients Decision To Accept Or Decline CRMD Agard et al., 20071 Grounded Theory Explored patients with heart failure and previous life threatening arrhythmia experience and perception of role in secondary ICD decision-making. 1 way Dr to Patient communication. Facing a matter of fact - patients heeded recommendation of need for ICD. ‘An offer you cannot refuse’. Patients accepted physician recommendation for ICD as having no real choice if they valued longevity. Patients view themselves as laymen unable to have opinion of complex medical decision. Many desire to live longer so willing to accept technology despite poor prognosis, risks or inconvenience. Trust Dr judgement so accept recommendation. Negative experiences with ICD but did not regret implant decision because device increased chance of staying alive. 2.1 Approaches To Decision-making 2.2 Factors Influencing The Decision Style 2.3 Accepting Or Refusing Device Therapy Carroll et al., 20112 Grounded Theory Explored the decision-making process for patients who accepted and declined primary ICD DM triggered when assimilated risk of SCD. Physician recommendation & new awareness of SCD risk motivated acceptance. Pts occupy position somewhere along continuum between ‘active & engaged’ -‘passive & indifferent’ decision-making. Approach adopted largely influenced by 1) trust; 2) social influences; 3) patient’s health state. Main goal was to prolong life. Degree of activity or passivity in DM did not influence likelihood to accept / refuse ICD Gal et al., 20113 Grounded Theory (& Kantor et al., 20124) Explored the decision-making process for patients who had cardiac device therapy (precise indication & device type unclear). Reasons for choosing to accept - 2 key themes 1) Contributing factors; 2) Relationship to Dr / Doctor’s role. Researchers grouped themes as ’active’ relationship to DM & passivity. Those who described benefits of having ICD more likely to accept because ’peace of mind’ ’safety net’ (both considered to be active) and ’afraid to die’ (passive). Lucas 20125 Phenomenological Explored lived experience of older adults decision to accept primary or secondary ICD or CRT DM of older adults with ICD influenced by 1) trust & faith in physicians decision; 2) accepting device was necessary; 3) decision easy to make; 4) hope & desire to live longer. Limited involvement in decision-making, perceived option to be life or death, some family members involved in decision but physicians advise outweighed all else. Described trigger then all adopt passive approach (not described as such by Lucas) Matlock et al., 20106 Descriptive Explored patients with heart failure perceptions of difficult decisions and factors that influenced treatment decision-making (most had ICD or CRT). Described two distinct approaches to DM - 1) ‘Active’ associated with difficult decisions; participants considered & weighed up concerns related to side effects, family and overall QOL; required time to reflect & wanted second opinion. 2) ‘Passive’ did not identify difficult decision, described influencing factors as trust in God, physician and power of physician. Some passive DM believed all medical therapies helpful; others disengaged from medical care altogether. Matlock et al., 20117 Descriptive Explored patient and physician perception of decision-making for patients who accepted and declined primary ICD (inc refusal of secondary ICD). Patients who chose ICD - 3 themes 1) Desire to avoid death; 2) Need to follow physicians advice; 3) Discovery of risks post implant. Many accepted ICD on physicians advice without questioning benefit and risks. Patients who refused ICD - 1) Considered ICD to be unnecessary or believed risk of SCD did not apply to them 2) Perception that burden outweighed benefit. Physicians describe 2 main approaches - beneficent paternalistic and patient centred, shared approach. Ottenburg et al., 20148 Descriptive Explored reasons why patients declined primary cardiac device therapy. Major themes 1) ‘Don’t mess with a good thing’; 2) ‘My health is good enough’; 3) ‘Making independent decisions’; 4) ‘It’s your job, but it’s my choice’. Decliners described as collecting information from Dr and others to make informed decision & needed time to analyse and reflect - thus active DM. Patients who declined considered clinicians recommendation of need for device to be less influential than the way they felt. Patients considered DM to be a process not one off episode therefore some would re deliberate in future. Yuhas et al., 20129 Grounded Theory Explored perception of primary ICD to understand barriers to acceptance for patients who accepted and declined primary ICD. Major themes: 1) Personal risk; 2) Strength of recommendation; 3) Concerns over recall, malfunction, and surgical risk; 4) Feelings regarding invasive life-prolonging interventions played important role in ICD referral refusal. No significant demographic or clinical difference between participants & non participants and between acceptors and decliners Chan et al., 201610 Non Randomised Descriptive Explored demographic and social factors that influenced patients decision to decline 98% relied upon physician information only. 2% sought additional information from internet and publications Most (61%) believed they were most important person influencing decision, 15% felt that Dr played most important role. All refused because: cost (27%), invasive nature of procedure (24%), fear of complications (11%) advancing age (9%). Traditional factors associated with acceptance of more aggressive treatment ie younger, disease duration, educational attainment, salary were not evident. Groarke et al., 2012 Non Randomised Descriptive11 Strength of physician recommendation did influence decision ie weak recommendation associated with refusal. Chan conclude this may have been associated with passivity in information gathering. 65% did not regret decision, remaining unwilling to accept, 35% might agree to ICD in the future. Those most likely to reconsider were employed (poss financial reasons), feared SCD the most and acknowledged ICD preventative role 26 (35%) reported feeling frightened when informed of requirement for ICD. 35 of 75 (47%) suggested Dr decision, 19 (25%) stated patient decision & 21 (28%) stated joint decision. 40 (53%) preferred Dr to make decision and 35 (47%) desired all relevant information to facilitate own decision. 5 of subgroup of 25 (20%) stated physician recommendation as reason for implant. 93% satisfied with decision to accept ICD therapy. Hauptman et al., 201312 Non Randomised Descriptive When ICD deemed urgent, pts particularly overwhelmed by pace of DM. Older participants frequently deferred decision to family members. Interactions brief & decisions made quickly with little time to understand the implications. Some discharged home to consider decision. Many struggled with competing view of ICD as security net and source of physical and psychosocial discomfort. Lewis et al. 201413 Integrative Review Trajectory of key decision points were whether or not to initiate ICD therapy, replace battery & deactivate at end of life. 3 common themes from patient perspective – 1) Influence of patient - practitioner consultation on knowledge; 2) patients DM preference; 3) desire to live. Participants expressed mixed preference for desire to be involved in decisions. Decisions particularly difficult due to life & death trade off. Singh et al., 201214 Non Randomised Descriptive Quality of life more important than quantity. Religious belief and cultural values did not play major role in DM. Good access to health care resources & physicians. Women less likely to be married. Only 2 (7%) ICD patients would not accept ICD again; 18 no ICD (86%) pts would later reconsider implant. Hickman et al., 201015 & 201216 Retrospective study to assess decision regret and evaluate psychometrics of the Decision Regret Scale (DRS) among ICD recipients. Amount of decision regret (no regret vs. regret) not associated with demographic or clinical variables, such as the ICD indication (primary vs. secondary prevention) or ICD shock status (no shock vs. shock); while adjusting for the recipient’s age, gender and number of post-decision complications. Informational coping styles, monitoring and blunting significant predictors of decision regret; while adjusting for clinical and psychological variables. DRS psychometrically sound instrument for assessing decisional outcomes of ICD recipients 1. Agard A, Lofmark R, Edvardsson N and Ekman I. Views of patients with heart failure about their role in the decision to start implantable cardioverter defibrillator treatment: prescription rather than participation. Journal of Medical Ethics. 2007; 33: 514-8. 2. Carroll SL, Strachan PH, de Laat S, Schwartz L and Arthur HM. Patients’ decision making to accept or decline an implantable cardioverter defibrillator for primary prevention of sudden cardiac death. Health Expectations. 2011; 16: 69-79. 3. Gal C, Bullinger J and Kantor P. Peace of Mind: The Decision to Accept an Implantable Cardiac Defibrillator (ICD): Qualitative Findings: 1-36 (2011, accessed 19th December 2014). 4. Kantor PB, Bullinger JM and Gal CS. Patient decision-making modes and causes: A preliminary investigation. Journal of the American Society for Information Science & Technology. 2012; 63: 1339-49. 5. Lucas LA. The lived experience of decision-making for older adults who had an implantable cardioverter defibrillator inserted. Dissertation Abstracts International: Section B: The Sciences and Engineering. 2012; 73: 2825. 6. Matlock D, Nowels C and Bekelman D. Patient perspectives on decision making in heart failure. Journal Of Cardiac Failure 2010; 16 1634-44. 7. Matlock D, Nowels C, Masoudi F, et al. Patient and cardiologist perceptions on decision making for implantable cardioverter defibrillators: A qualitative study. PACE. 2011; 34 1634-44. 8. Ottenberg AL, Mueller PS, Topazian RJ, Kaufman S and Swetz KM. “It’s not broke, so let’s not try to fix it”: Why patients decline a cardiovascular implantable electronic device. Pacing and Clinical Electrophysiology. 2014; 00: 1-9. 9. Yuhas J, Mattocks K, Gravelin L, et al. Patients’ attitudes and perceptions of implantable cardioverter-defibrillators: potential barriers to appropriate primary prophylaxis. Pacing & Clinical Electrophysiology. 2012; 35: 1179-87. 10. Chan L, Lim C, Aung S, et al. Patient barriers to implantable cardioverter defibrillator implantation for the primary prevention of sudden cardiac death in patients with heart failure and reduced ejection fraction. Singapore Medical Journal. 2016; 57: 182-7. 11. Groarke J, Beirne A, Buckley U, et al. Deficiencies in Patients’ Comprehension of Implantable Cardioverter Defibrillator Therapy. Pacing & Clinical Electrophysiology. 2012; 35: 1097-102. 12. Hauptman PJ, Chibnall JT, Guild C and Armbrecht ES. Patient Perceptions, Physician Communication, and the Implantable Cardioverter-Defibrillator. Jama Internal Medicine. 2013; 173: 571-7. 13. Lewis KB, Stacey D and Matlock DD. Making decisions about implantable cardioverter-defibrillators from implantation to end of life: An integrative review of patients’ perspectives. The Patient: Patient-Centered Outcomes Research. 2014; 7: 243-60. 14. Singh N, Hall E, Lucas E, et al. Potential primary prevention implantable cardioverter-defibrillator patients lack understanding, want more information and are willing to reconsider implant refusal. Circulation. 2012; 21: 126. 15. Hickman R. Decision regret in recipients of implantable cardioverter defibrillators. Clinical and Translational Science. 2010; 3 (2): S21-S2. 16. Hickman Jr RL, Pinto MD, Lee E and Daly BJ. Exploratory and confirmatory factor analysis of the decision regret scale in recipients of internal cardioverter defibrillators. Journal of Nursing Measurement. 2012; 20: 21-34. 17. Hazelton AG, Sears SF, Ford J, et al. Decisional balance among potential implantable cardioverter defibrillator recipients: Development of the ICD-Decision Analysis Scale (ICD-DAS). Pacing and Clinical Electrophysiology. 2014; 37: 63-72. Open in new tab Table 4. Emergent Clusters And Sub Themes . Cluster And Sub Themes . Researcher . Study Aims And Findings . 1 Patient Knowledge And Understanding Of The Indication For, Function And Benefits And Risks Of CRMD 1.1 Insight Into Condition, Device Role And Function 1.2 Physician Communication And Information Received Chan et al., 201610 Non Randomised Descriptive Perceived consequence of heart failure said to be stroke (42%), SCD (28%), MI (17%), don’t know (14%). 68% believed medication could prevent SCD, 16% believed exercise and diet could prevent SCD. Only 8% understood SCD preventative role. When asked about ICD function 52% correctly answered SCD prevention, 48% were not aware of SCD preventative role. Most feared consequence of heart failure was being bed bound (37%), breathlessness (30%), SCD (17%), chest pain (8%), don’t know (8%) All believed ICD would restrict life style including inability to do heavy lifting (30%), problems with electrical devices (17%), flying (10%), swimming (12%), sexual activity (5%) Chan conclude that limited consultation time, language barriers, deep seated beliefs that contradict physician advise could explain lack of understanding Groarke et al., 201211 Non Randomised Descriptive Retrospective cohort study to explore the knowledge, understanding and view of patients with (primary/secondary) ICD or CRT device. 83% (62 of 75) claimed to understand reason for ICD implant. Sub group - no patient suggested arrhythmia termination; inferred arrhythmia related reason; heart failure; various reasons including reducing risk of ‘heart attack’; unable to state reason other then physician recommendation. Excluding CRT patients recipients incorrectly believed device would improve cardiac function, breathing, exercise capacity, reduce risk of heart attack or stopping breathing. Shock recipients poorly prepared for shock therapy. 79% claimed to have sufficient information to consent. Patients who experienced device-related complication felt inadequately forewarned of complications. Despite pre implantation education, patient comprehension of risks & benefits of ICD therapy is poor and expectations of ICD therapy may be inappropriate. Hauptman et al., 201312 Non Randomised Descriptive Retrospective study to explore patient knowledge and physician communication of information during decision-making for cardiac device therapy (precise indication and device type unclear). Mean (SD) estimated number of patients out of 100 who would be saved by the ICD was 87.9 (20.1). Mean (SD) rating of preparedness for 39 patients was 5.7 (3.2) out of 10 at the time of the implant procedure and during the patient focus group meeting. Did not recall discussion of peri procedural risk or post implant complications. Limited discussions on QOL issues which focused upon fact that ICD would have no lifestyle effect. QOL measures not used pre or post implant. Pre implant mention of anxiety or depression infrequent. Gained knowledge of benefits and risks post implant. SP interviews focused medical history & procedure-related processes in context of medical benefit of ICD. Patients largely uniformed and overly optimistic about future expectations with ICD. Patient group consistently note inadequacy of information received pre implant and inattention paid to psychosocial issues post implant Hazleton et al., 201417 Non Randomised Descriptive Prospective study to develop and test a measure (ICD-DAS) of patient evaluated ICD pros and cons and its impact upon patient decision-making for a primary ICD or CRT (precise indication and device type unclear). Two-factor measure for ICD decision-making established with two subscales: ICD Pros and ICD Cons. ICD – DAS provides empirically tested & clinically useful pros & cons scale to help patient decision-making. Singh et al., 201214 Non Randomised Descriptive Prospective study to explore knowledge and influencing factors in decision to accept or decline primary ICD (precise indication and device type unclear). ICD pts and no ICD pts understanding of HF was poor. No ICD pts had less understanding of ICD purpose, were less likely to have been given written ICD information, less likely to recall recent discussion on ICD’s. Underutilization of primary ICD’s may be related to limited communication & poor understanding of HF, sudden death & devices. Agard et al., 20071 Grounded Theory Minimal criticism of lack of information or passive role played in DM. Participants agreed all they needed to know was they were high risk of life threatening arrhythmia to give consent. Did not recall discussion of alternative options; estimate of risk of potential fatal arrhythmia or expected time of survival with HF. Patients appeared not to need more information when related to life & death decisions and where no alternative option appeared to exist. Patients believed they had sufficient information to consent. They credited the device with saving their life despite not receiving shock therapy, believed it prevented further cardiac events or relieved symptoms. Carroll et al., 20112 Grounded Theory General lack of understanding of ICD role & function related to condition & symptoms. Participants did not recall receiving information related to alternatives to ICD therapy. Lewis et al. (2014)13 Integrative Review Pt’s with ICD misunderstood functionality or over estimated benefit. Recommend clinicians better support patients by 1) verifying understanding; 2) eliciting preferences; 3) promoting shared decision-making Lucas 20125 Phenomenological Limited information about device role, function & what they may expect. Some felt information was beyond their comprehension and most failed to seek additional information. Matlock et al., 20117 Descriptive Recipients reported not knowing about side effects until after device implant or when they experienced side effects. Cardiologists communication with ICD patients – 3 themes 1.Considerable variation existed in approach to patient centeredness and communication; 2. Cardiologists influenced by benefits presented in published guidelines; 3. Discussion revealed clear hierarchy in which cardiologists emphasised benefits but emphasis of risks varied greatly. Cardiologists adherence to guidelines appeared to inhibit SDM. Ottenburg et al., 20148 Descriptive ‘Gaps in learning’ – identified gaps in knowledge, participants keen to have all information. Clinicians perspectives refers to agreement between patients view of refusal and what clinicians had documented in medical notes as reason for non implant. Clinicians unaware that patients lacked knowledge of purpose & function of ICD. Yuhas et al., 20129 Grounded Theory Inaccurate perceptions of ICD-related risks and lifestyle limitations. Acceptors and decliners had reasonably good understanding of purpose & function of ICD 2 The Process Of And Factors Which Influenced The Patients Decision To Accept Or Decline CRMD Agard et al., 20071 Grounded Theory Explored patients with heart failure and previous life threatening arrhythmia experience and perception of role in secondary ICD decision-making. 1 way Dr to Patient communication. Facing a matter of fact - patients heeded recommendation of need for ICD. ‘An offer you cannot refuse’. Patients accepted physician recommendation for ICD as having no real choice if they valued longevity. Patients view themselves as laymen unable to have opinion of complex medical decision. Many desire to live longer so willing to accept technology despite poor prognosis, risks or inconvenience. Trust Dr judgement so accept recommendation. Negative experiences with ICD but did not regret implant decision because device increased chance of staying alive. 2.1 Approaches To Decision-making 2.2 Factors Influencing The Decision Style 2.3 Accepting Or Refusing Device Therapy Carroll et al., 20112 Grounded Theory Explored the decision-making process for patients who accepted and declined primary ICD DM triggered when assimilated risk of SCD. Physician recommendation & new awareness of SCD risk motivated acceptance. Pts occupy position somewhere along continuum between ‘active & engaged’ -‘passive & indifferent’ decision-making. Approach adopted largely influenced by 1) trust; 2) social influences; 3) patient’s health state. Main goal was to prolong life. Degree of activity or passivity in DM did not influence likelihood to accept / refuse ICD Gal et al., 20113 Grounded Theory (& Kantor et al., 20124) Explored the decision-making process for patients who had cardiac device therapy (precise indication & device type unclear). Reasons for choosing to accept - 2 key themes 1) Contributing factors; 2) Relationship to Dr / Doctor’s role. Researchers grouped themes as ’active’ relationship to DM & passivity. Those who described benefits of having ICD more likely to accept because ’peace of mind’ ’safety net’ (both considered to be active) and ’afraid to die’ (passive). Lucas 20125 Phenomenological Explored lived experience of older adults decision to accept primary or secondary ICD or CRT DM of older adults with ICD influenced by 1) trust & faith in physicians decision; 2) accepting device was necessary; 3) decision easy to make; 4) hope & desire to live longer. Limited involvement in decision-making, perceived option to be life or death, some family members involved in decision but physicians advise outweighed all else. Described trigger then all adopt passive approach (not described as such by Lucas) Matlock et al., 20106 Descriptive Explored patients with heart failure perceptions of difficult decisions and factors that influenced treatment decision-making (most had ICD or CRT). Described two distinct approaches to DM - 1) ‘Active’ associated with difficult decisions; participants considered & weighed up concerns related to side effects, family and overall QOL; required time to reflect & wanted second opinion. 2) ‘Passive’ did not identify difficult decision, described influencing factors as trust in God, physician and power of physician. Some passive DM believed all medical therapies helpful; others disengaged from medical care altogether. Matlock et al., 20117 Descriptive Explored patient and physician perception of decision-making for patients who accepted and declined primary ICD (inc refusal of secondary ICD). Patients who chose ICD - 3 themes 1) Desire to avoid death; 2) Need to follow physicians advice; 3) Discovery of risks post implant. Many accepted ICD on physicians advice without questioning benefit and risks. Patients who refused ICD - 1) Considered ICD to be unnecessary or believed risk of SCD did not apply to them 2) Perception that burden outweighed benefit. Physicians describe 2 main approaches - beneficent paternalistic and patient centred, shared approach. Ottenburg et al., 20148 Descriptive Explored reasons why patients declined primary cardiac device therapy. Major themes 1) ‘Don’t mess with a good thing’; 2) ‘My health is good enough’; 3) ‘Making independent decisions’; 4) ‘It’s your job, but it’s my choice’. Decliners described as collecting information from Dr and others to make informed decision & needed time to analyse and reflect - thus active DM. Patients who declined considered clinicians recommendation of need for device to be less influential than the way they felt. Patients considered DM to be a process not one off episode therefore some would re deliberate in future. Yuhas et al., 20129 Grounded Theory Explored perception of primary ICD to understand barriers to acceptance for patients who accepted and declined primary ICD. Major themes: 1) Personal risk; 2) Strength of recommendation; 3) Concerns over recall, malfunction, and surgical risk; 4) Feelings regarding invasive life-prolonging interventions played important role in ICD referral refusal. No significant demographic or clinical difference between participants & non participants and between acceptors and decliners Chan et al., 201610 Non Randomised Descriptive Explored demographic and social factors that influenced patients decision to decline 98% relied upon physician information only. 2% sought additional information from internet and publications Most (61%) believed they were most important person influencing decision, 15% felt that Dr played most important role. All refused because: cost (27%), invasive nature of procedure (24%), fear of complications (11%) advancing age (9%). Traditional factors associated with acceptance of more aggressive treatment ie younger, disease duration, educational attainment, salary were not evident. Groarke et al., 2012 Non Randomised Descriptive11 Strength of physician recommendation did influence decision ie weak recommendation associated with refusal. Chan conclude this may have been associated with passivity in information gathering. 65% did not regret decision, remaining unwilling to accept, 35% might agree to ICD in the future. Those most likely to reconsider were employed (poss financial reasons), feared SCD the most and acknowledged ICD preventative role 26 (35%) reported feeling frightened when informed of requirement for ICD. 35 of 75 (47%) suggested Dr decision, 19 (25%) stated patient decision & 21 (28%) stated joint decision. 40 (53%) preferred Dr to make decision and 35 (47%) desired all relevant information to facilitate own decision. 5 of subgroup of 25 (20%) stated physician recommendation as reason for implant. 93% satisfied with decision to accept ICD therapy. Hauptman et al., 201312 Non Randomised Descriptive When ICD deemed urgent, pts particularly overwhelmed by pace of DM. Older participants frequently deferred decision to family members. Interactions brief & decisions made quickly with little time to understand the implications. Some discharged home to consider decision. Many struggled with competing view of ICD as security net and source of physical and psychosocial discomfort. Lewis et al. 201413 Integrative Review Trajectory of key decision points were whether or not to initiate ICD therapy, replace battery & deactivate at end of life. 3 common themes from patient perspective – 1) Influence of patient - practitioner consultation on knowledge; 2) patients DM preference; 3) desire to live. Participants expressed mixed preference for desire to be involved in decisions. Decisions particularly difficult due to life & death trade off. Singh et al., 201214 Non Randomised Descriptive Quality of life more important than quantity. Religious belief and cultural values did not play major role in DM. Good access to health care resources & physicians. Women less likely to be married. Only 2 (7%) ICD patients would not accept ICD again; 18 no ICD (86%) pts would later reconsider implant. Hickman et al., 201015 & 201216 Retrospective study to assess decision regret and evaluate psychometrics of the Decision Regret Scale (DRS) among ICD recipients. Amount of decision regret (no regret vs. regret) not associated with demographic or clinical variables, such as the ICD indication (primary vs. secondary prevention) or ICD shock status (no shock vs. shock); while adjusting for the recipient’s age, gender and number of post-decision complications. Informational coping styles, monitoring and blunting significant predictors of decision regret; while adjusting for clinical and psychological variables. DRS psychometrically sound instrument for assessing decisional outcomes of ICD recipients . Cluster And Sub Themes . Researcher . Study Aims And Findings . 1 Patient Knowledge And Understanding Of The Indication For, Function And Benefits And Risks Of CRMD 1.1 Insight Into Condition, Device Role And Function 1.2 Physician Communication And Information Received Chan et al., 201610 Non Randomised Descriptive Perceived consequence of heart failure said to be stroke (42%), SCD (28%), MI (17%), don’t know (14%). 68% believed medication could prevent SCD, 16% believed exercise and diet could prevent SCD. Only 8% understood SCD preventative role. When asked about ICD function 52% correctly answered SCD prevention, 48% were not aware of SCD preventative role. Most feared consequence of heart failure was being bed bound (37%), breathlessness (30%), SCD (17%), chest pain (8%), don’t know (8%) All believed ICD would restrict life style including inability to do heavy lifting (30%), problems with electrical devices (17%), flying (10%), swimming (12%), sexual activity (5%) Chan conclude that limited consultation time, language barriers, deep seated beliefs that contradict physician advise could explain lack of understanding Groarke et al., 201211 Non Randomised Descriptive Retrospective cohort study to explore the knowledge, understanding and view of patients with (primary/secondary) ICD or CRT device. 83% (62 of 75) claimed to understand reason for ICD implant. Sub group - no patient suggested arrhythmia termination; inferred arrhythmia related reason; heart failure; various reasons including reducing risk of ‘heart attack’; unable to state reason other then physician recommendation. Excluding CRT patients recipients incorrectly believed device would improve cardiac function, breathing, exercise capacity, reduce risk of heart attack or stopping breathing. Shock recipients poorly prepared for shock therapy. 79% claimed to have sufficient information to consent. Patients who experienced device-related complication felt inadequately forewarned of complications. Despite pre implantation education, patient comprehension of risks & benefits of ICD therapy is poor and expectations of ICD therapy may be inappropriate. Hauptman et al., 201312 Non Randomised Descriptive Retrospective study to explore patient knowledge and physician communication of information during decision-making for cardiac device therapy (precise indication and device type unclear). Mean (SD) estimated number of patients out of 100 who would be saved by the ICD was 87.9 (20.1). Mean (SD) rating of preparedness for 39 patients was 5.7 (3.2) out of 10 at the time of the implant procedure and during the patient focus group meeting. Did not recall discussion of peri procedural risk or post implant complications. Limited discussions on QOL issues which focused upon fact that ICD would have no lifestyle effect. QOL measures not used pre or post implant. Pre implant mention of anxiety or depression infrequent. Gained knowledge of benefits and risks post implant. SP interviews focused medical history & procedure-related processes in context of medical benefit of ICD. Patients largely uniformed and overly optimistic about future expectations with ICD. Patient group consistently note inadequacy of information received pre implant and inattention paid to psychosocial issues post implant Hazleton et al., 201417 Non Randomised Descriptive Prospective study to develop and test a measure (ICD-DAS) of patient evaluated ICD pros and cons and its impact upon patient decision-making for a primary ICD or CRT (precise indication and device type unclear). Two-factor measure for ICD decision-making established with two subscales: ICD Pros and ICD Cons. ICD – DAS provides empirically tested & clinically useful pros & cons scale to help patient decision-making. Singh et al., 201214 Non Randomised Descriptive Prospective study to explore knowledge and influencing factors in decision to accept or decline primary ICD (precise indication and device type unclear). ICD pts and no ICD pts understanding of HF was poor. No ICD pts had less understanding of ICD purpose, were less likely to have been given written ICD information, less likely to recall recent discussion on ICD’s. Underutilization of primary ICD’s may be related to limited communication & poor understanding of HF, sudden death & devices. Agard et al., 20071 Grounded Theory Minimal criticism of lack of information or passive role played in DM. Participants agreed all they needed to know was they were high risk of life threatening arrhythmia to give consent. Did not recall discussion of alternative options; estimate of risk of potential fatal arrhythmia or expected time of survival with HF. Patients appeared not to need more information when related to life & death decisions and where no alternative option appeared to exist. Patients believed they had sufficient information to consent. They credited the device with saving their life despite not receiving shock therapy, believed it prevented further cardiac events or relieved symptoms. Carroll et al., 20112 Grounded Theory General lack of understanding of ICD role & function related to condition & symptoms. Participants did not recall receiving information related to alternatives to ICD therapy. Lewis et al. (2014)13 Integrative Review Pt’s with ICD misunderstood functionality or over estimated benefit. Recommend clinicians better support patients by 1) verifying understanding; 2) eliciting preferences; 3) promoting shared decision-making Lucas 20125 Phenomenological Limited information about device role, function & what they may expect. Some felt information was beyond their comprehension and most failed to seek additional information. Matlock et al., 20117 Descriptive Recipients reported not knowing about side effects until after device implant or when they experienced side effects. Cardiologists communication with ICD patients – 3 themes 1.Considerable variation existed in approach to patient centeredness and communication; 2. Cardiologists influenced by benefits presented in published guidelines; 3. Discussion revealed clear hierarchy in which cardiologists emphasised benefits but emphasis of risks varied greatly. Cardiologists adherence to guidelines appeared to inhibit SDM. Ottenburg et al., 20148 Descriptive ‘Gaps in learning’ – identified gaps in knowledge, participants keen to have all information. Clinicians perspectives refers to agreement between patients view of refusal and what clinicians had documented in medical notes as reason for non implant. Clinicians unaware that patients lacked knowledge of purpose & function of ICD. Yuhas et al., 20129 Grounded Theory Inaccurate perceptions of ICD-related risks and lifestyle limitations. Acceptors and decliners had reasonably good understanding of purpose & function of ICD 2 The Process Of And Factors Which Influenced The Patients Decision To Accept Or Decline CRMD Agard et al., 20071 Grounded Theory Explored patients with heart failure and previous life threatening arrhythmia experience and perception of role in secondary ICD decision-making. 1 way Dr to Patient communication. Facing a matter of fact - patients heeded recommendation of need for ICD. ‘An offer you cannot refuse’. Patients accepted physician recommendation for ICD as having no real choice if they valued longevity. Patients view themselves as laymen unable to have opinion of complex medical decision. Many desire to live longer so willing to accept technology despite poor prognosis, risks or inconvenience. Trust Dr judgement so accept recommendation. Negative experiences with ICD but did not regret implant decision because device increased chance of staying alive. 2.1 Approaches To Decision-making 2.2 Factors Influencing The Decision Style 2.3 Accepting Or Refusing Device Therapy Carroll et al., 20112 Grounded Theory Explored the decision-making process for patients who accepted and declined primary ICD DM triggered when assimilated risk of SCD. Physician recommendation & new awareness of SCD risk motivated acceptance. Pts occupy position somewhere along continuum between ‘active & engaged’ -‘passive & indifferent’ decision-making. Approach adopted largely influenced by 1) trust; 2) social influences; 3) patient’s health state. Main goal was to prolong life. Degree of activity or passivity in DM did not influence likelihood to accept / refuse ICD Gal et al., 20113 Grounded Theory (& Kantor et al., 20124) Explored the decision-making process for patients who had cardiac device therapy (precise indication & device type unclear). Reasons for choosing to accept - 2 key themes 1) Contributing factors; 2) Relationship to Dr / Doctor’s role. Researchers grouped themes as ’active’ relationship to DM & passivity. Those who described benefits of having ICD more likely to accept because ’peace of mind’ ’safety net’ (both considered to be active) and ’afraid to die’ (passive). Lucas 20125 Phenomenological Explored lived experience of older adults decision to accept primary or secondary ICD or CRT DM of older adults with ICD influenced by 1) trust & faith in physicians decision; 2) accepting device was necessary; 3) decision easy to make; 4) hope & desire to live longer. Limited involvement in decision-making, perceived option to be life or death, some family members involved in decision but physicians advise outweighed all else. Described trigger then all adopt passive approach (not described as such by Lucas) Matlock et al., 20106 Descriptive Explored patients with heart failure perceptions of difficult decisions and factors that influenced treatment decision-making (most had ICD or CRT). Described two distinct approaches to DM - 1) ‘Active’ associated with difficult decisions; participants considered & weighed up concerns related to side effects, family and overall QOL; required time to reflect & wanted second opinion. 2) ‘Passive’ did not identify difficult decision, described influencing factors as trust in God, physician and power of physician. Some passive DM believed all medical therapies helpful; others disengaged from medical care altogether. Matlock et al., 20117 Descriptive Explored patient and physician perception of decision-making for patients who accepted and declined primary ICD (inc refusal of secondary ICD). Patients who chose ICD - 3 themes 1) Desire to avoid death; 2) Need to follow physicians advice; 3) Discovery of risks post implant. Many accepted ICD on physicians advice without questioning benefit and risks. Patients who refused ICD - 1) Considered ICD to be unnecessary or believed risk of SCD did not apply to them 2) Perception that burden outweighed benefit. Physicians describe 2 main approaches - beneficent paternalistic and patient centred, shared approach. Ottenburg et al., 20148 Descriptive Explored reasons why patients declined primary cardiac device therapy. Major themes 1) ‘Don’t mess with a good thing’; 2) ‘My health is good enough’; 3) ‘Making independent decisions’; 4) ‘It’s your job, but it’s my choice’. Decliners described as collecting information from Dr and others to make informed decision & needed time to analyse and reflect - thus active DM. Patients who declined considered clinicians recommendation of need for device to be less influential than the way they felt. Patients considered DM to be a process not one off episode therefore some would re deliberate in future. Yuhas et al., 20129 Grounded Theory Explored perception of primary ICD to understand barriers to acceptance for patients who accepted and declined primary ICD. Major themes: 1) Personal risk; 2) Strength of recommendation; 3) Concerns over recall, malfunction, and surgical risk; 4) Feelings regarding invasive life-prolonging interventions played important role in ICD referral refusal. No significant demographic or clinical difference between participants & non participants and between acceptors and decliners Chan et al., 201610 Non Randomised Descriptive Explored demographic and social factors that influenced patients decision to decline 98% relied upon physician information only. 2% sought additional information from internet and publications Most (61%) believed they were most important person influencing decision, 15% felt that Dr played most important role. All refused because: cost (27%), invasive nature of procedure (24%), fear of complications (11%) advancing age (9%). Traditional factors associated with acceptance of more aggressive treatment ie younger, disease duration, educational attainment, salary were not evident. Groarke et al., 2012 Non Randomised Descriptive11 Strength of physician recommendation did influence decision ie weak recommendation associated with refusal. Chan conclude this may have been associated with passivity in information gathering. 65% did not regret decision, remaining unwilling to accept, 35% might agree to ICD in the future. Those most likely to reconsider were employed (poss financial reasons), feared SCD the most and acknowledged ICD preventative role 26 (35%) reported feeling frightened when informed of requirement for ICD. 35 of 75 (47%) suggested Dr decision, 19 (25%) stated patient decision & 21 (28%) stated joint decision. 40 (53%) preferred Dr to make decision and 35 (47%) desired all relevant information to facilitate own decision. 5 of subgroup of 25 (20%) stated physician recommendation as reason for implant. 93% satisfied with decision to accept ICD therapy. Hauptman et al., 201312 Non Randomised Descriptive When ICD deemed urgent, pts particularly overwhelmed by pace of DM. Older participants frequently deferred decision to family members. Interactions brief & decisions made quickly with little time to understand the implications. Some discharged home to consider decision. Many struggled with competing view of ICD as security net and source of physical and psychosocial discomfort. Lewis et al. 201413 Integrative Review Trajectory of key decision points were whether or not to initiate ICD therapy, replace battery & deactivate at end of life. 3 common themes from patient perspective – 1) Influence of patient - practitioner consultation on knowledge; 2) patients DM preference; 3) desire to live. Participants expressed mixed preference for desire to be involved in decisions. Decisions particularly difficult due to life & death trade off. Singh et al., 201214 Non Randomised Descriptive Quality of life more important than quantity. Religious belief and cultural values did not play major role in DM. Good access to health care resources & physicians. Women less likely to be married. Only 2 (7%) ICD patients would not accept ICD again; 18 no ICD (86%) pts would later reconsider implant. Hickman et al., 201015 & 201216 Retrospective study to assess decision regret and evaluate psychometrics of the Decision Regret Scale (DRS) among ICD recipients. Amount of decision regret (no regret vs. regret) not associated with demographic or clinical variables, such as the ICD indication (primary vs. secondary prevention) or ICD shock status (no shock vs. shock); while adjusting for the recipient’s age, gender and number of post-decision complications. Informational coping styles, monitoring and blunting significant predictors of decision regret; while adjusting for clinical and psychological variables. DRS psychometrically sound instrument for assessing decisional outcomes of ICD recipients 1. Agard A, Lofmark R, Edvardsson N and Ekman I. Views of patients with heart failure about their role in the decision to start implantable cardioverter defibrillator treatment: prescription rather than participation. Journal of Medical Ethics. 2007; 33: 514-8. 2. Carroll SL, Strachan PH, de Laat S, Schwartz L and Arthur HM. Patients’ decision making to accept or decline an implantable cardioverter defibrillator for primary prevention of sudden cardiac death. Health Expectations. 2011; 16: 69-79. 3. Gal C, Bullinger J and Kantor P. Peace of Mind: The Decision to Accept an Implantable Cardiac Defibrillator (ICD): Qualitative Findings: 1-36 (2011, accessed 19th December 2014). 4. Kantor PB, Bullinger JM and Gal CS. Patient decision-making modes and causes: A preliminary investigation. Journal of the American Society for Information Science & Technology. 2012; 63: 1339-49. 5. Lucas LA. The lived experience of decision-making for older adults who had an implantable cardioverter defibrillator inserted. Dissertation Abstracts International: Section B: The Sciences and Engineering. 2012; 73: 2825. 6. Matlock D, Nowels C and Bekelman D. Patient perspectives on decision making in heart failure. Journal Of Cardiac Failure 2010; 16 1634-44. 7. Matlock D, Nowels C, Masoudi F, et al. Patient and cardiologist perceptions on decision making for implantable cardioverter defibrillators: A qualitative study. PACE. 2011; 34 1634-44. 8. Ottenberg AL, Mueller PS, Topazian RJ, Kaufman S and Swetz KM. “It’s not broke, so let’s not try to fix it”: Why patients decline a cardiovascular implantable electronic device. Pacing and Clinical Electrophysiology. 2014; 00: 1-9. 9. Yuhas J, Mattocks K, Gravelin L, et al. Patients’ attitudes and perceptions of implantable cardioverter-defibrillators: potential barriers to appropriate primary prophylaxis. Pacing & Clinical Electrophysiology. 2012; 35: 1179-87. 10. Chan L, Lim C, Aung S, et al. Patient barriers to implantable cardioverter defibrillator implantation for the primary prevention of sudden cardiac death in patients with heart failure and reduced ejection fraction. Singapore Medical Journal. 2016; 57: 182-7. 11. Groarke J, Beirne A, Buckley U, et al. Deficiencies in Patients’ Comprehension of Implantable Cardioverter Defibrillator Therapy. Pacing & Clinical Electrophysiology. 2012; 35: 1097-102. 12. Hauptman PJ, Chibnall JT, Guild C and Armbrecht ES. Patient Perceptions, Physician Communication, and the Implantable Cardioverter-Defibrillator. Jama Internal Medicine. 2013; 173: 571-7. 13. Lewis KB, Stacey D and Matlock DD. Making decisions about implantable cardioverter-defibrillators from implantation to end of life: An integrative review of patients’ perspectives. The Patient: Patient-Centered Outcomes Research. 2014; 7: 243-60. 14. Singh N, Hall E, Lucas E, et al. Potential primary prevention implantable cardioverter-defibrillator patients lack understanding, want more information and are willing to reconsider implant refusal. Circulation. 2012; 21: 126. 15. Hickman R. Decision regret in recipients of implantable cardioverter defibrillators. Clinical and Translational Science. 2010; 3 (2): S21-S2. 16. Hickman Jr RL, Pinto MD, Lee E and Daly BJ. Exploratory and confirmatory factor analysis of the decision regret scale in recipients of internal cardioverter defibrillators. Journal of Nursing Measurement. 2012; 20: 21-34. 17. Hazelton AG, Sears SF, Ford J, et al. Decisional balance among potential implantable cardioverter defibrillator recipients: Development of the ICD-Decision Analysis Scale (ICD-DAS). Pacing and Clinical Electrophysiology. 2014; 37: 63-72. Open in new tab Cluster 1: Device knowledge acquisition and recall Subtheme 1.1: Insight into condition, device role and function Some recipients conveyed a lack of insight about their condition,62 the reason for implant,52,56 and misunderstood device role and function often with inaccurate and overoptimistic expectations of device therapy regardless of decision approach.51–54,56,58,61,62,64 A poor understanding of role and function was associated with dissatisfaction with the lack of information.54 Subtheme 1.2: Physician communication and information received There appeared to be a focus on the ‘benefit bias’ presented in published guidelines. Some recipients reported a tendency for physicians to focus on the medical procedure, with knowledge of risk only becoming apparent when experienced post-implant.51,56,61 Unexplained medical jargon was often used and there was a primary emphasis on prevention of SCD whereas study data on the prevalence of actual life-saving shock therapy, the number who require shock therapy or the risk of death despite shock therapy was rarely included.51,56 Some recipients reported receiving advice about potential periprocedural risks, e.g. infection, bleeding, but denied discussion of post-implant complications such as lead displacement, ICD recall or inappropriate shock.51,52,54,56,61 Patients reported infrequent reference to possible psychosocial outcomes, e.g. anxiety, depression or quality of life issues other than social concerns such as security devices.56 An emphasis on ICD as the only option, with minimal recall of any discussion of alternatives, e.g. drug or ablation therapy existed.51,58 The use of decision aids did not feature in the ICD studies with the exception of Hazleton et al.57 who designed and tested the ICD decision analysis scale (DAS) and recommended its use in practice to facilitate information exchange and deeper discussion of patient knowledge, understanding and preferences for an ICD. Cluster 2: The process of decision-making Subtheme 2.1: Approaches to decision-making The literature identified a combination of approaches reflecting the interplay between individual and collective decision-making. Passive decision-makers accepted the decision quickly, sought little additional information or time to deliberate due to fear or disinterest akin to non-systematic, heuristic information processing. They described one-way physician–patient communication and devolved decision-making to expert medical opinion and or family and significant others.51–56,58,61,63 Chan et al.53 reported that 235 (98%) relied solely on expert opinion for information, whereas two studies52,63 revealed an almost 50:50 split between passive and active decision-makers. Participants who adopted an active approach appeared to invest time to systematically seek further information and second opinions from a range of sources, take time to comprehend fully the function of and develop trust in the device to reach a decision.52,55,58,63,64 Rather than distinct approaches, Carroll et al.58 described participants as occupying a position along a continuum between ‘passive, indifferent’ and ‘active, engaged’ decision-making. For some patients information transfer appeared to be the crucial element of, and synonymous with, involvement in decision-making rather than implementation of the final decision.58 Others made ‘independent decisions’ based on their preferences while acknowledging guidance by physician recommendation or the experience of others as a potential influence.58,61,64 Subtheme 2.2: Factors influencing the decision style Fluctuation in the level of engagement in decision-making appeared to be influenced by: Age: older adults contemplating device therapy were more inclined to passivity deferring the decision to physician or family members54,56 (small sample sizes limit generalisability). Gender: despite little mention of potential gender differences, one study found that women were 2.7 times more likely than men to actively confirm their ICD decision to others and consider the physician to be a detailed information giver rather than authority figure.55,66 Passivity was influenced by the degree of importance assigned to various situational factors: Perceived difficulty of the decision, fear and uncertainty;51,52,54–56,58,61,63 Symptom severity and current health state;51,54,55,58,59,61,63 Insufficient perception of severity, symptomatology and minimised belief in personal risk and device necessity among some patients contemplating primary devices,58,59 (appreciation of personal risk prompted active involvement for others);58 Confidence and trust in physician recommendation;51,52,54,55,58,63 Lack of trust in the physician prompted passive reliance upon well informed family to support or make the decision;55,58,59 Social and family influence;55,58,63 Insufficient time to deliberate;51,53,55,56,58,63 Pervading sense of ‘no choice’ and an ‘offer you can’t refuse’, among some secondary ICD recipients who described themselves as laymen unable to have an opinion on such complex medical decisions.51,54,55 Groarke et al.52 explored desired and actual participation and found that 40 (53%) patients desired passive involvement with 35 (47%) reporting that the decision had been made by the physician. Thirty-five (47%) preferred an active role but only 19 (25%) reported making independent choices.52 Despite an apparent mismatch between desired and actual involvement, 70 (93%) respondents were satisfied with their decision.52 Subtheme 2.3: Accepting or refusing device therapy Acceptance was influenced by:51,52,54,55,57–59,61,63 Strength of, trust in and desire to heed physician recommendation; Current health status and desire for life prolongation; Perceived severity of the condition or undesirable symptoms were a persuasive factor to accept the device in the mistaken belief that it would alleviate symptoms; Family concerns. In contrast, patients more likely to decline CRMDs:53,58,59,61,62,64 Perceived the strength of recommendation to be weak; Considered current health state to be satisfactory, (particularly evident among primary prevention candidates who denied the personal risk of SCD and deemed the ICD unnecessary); Reported inadequate knowledge; Valued quality of life over quantity; Believed the burden of the device outweighed the benefit; Belief that it would impose unwanted restrictions upon lifestyle; The cost; Invasive nature of the treatment; Fear of complications; Advancing age. Discussion The widespread lack of knowledge and understanding of condition, device role, risks and alternative options across the CRMD studies is a concern. Reported inaccuracies may have been a function of the time between implant and data collection (1–16 years) on retention and recall of information. However, interviews one month post-implant by Carroll et al.58 revealed similar findings, suggesting that the gravity of the situation may have affected what recipients hear, recall and a focus on survival information. Age, cognitive and emotional barriers, communication deficits, situation seriousness, individual experience and variation in the desired amount and type of device information may impact on patient perception of information or even reduce the relevance of some facts.56,67 The ICD studies reviewed referred predominantly to patient–physician information exchange, whereas many implant centres now adopt a multiprofessional approach. The focus on benefit bias and procedural issues, rather than psychosocial outcomes, resembles other studies which reveal differences in physician priority on survival and longevity over patients’ preference for preservation of quality of life.68 In a multicentre Danish survey, physicians reported greater emphasis on the clinical aspects and procedural risks of ICD implantation and focus on advantages at the expense of disadvantages of treatment, than non-physicians.69 This was reflected in a recent systematic review that concluded that most patients, regardless of intervention type, overestimated benefit and underestimated harm.70 Thus there is a need for comprehensible, predictive information regarding benefits and risks to augment realistic expectations and informed choices.70,71 However, physician recommendations are made on increasingly complex clinical evidence, which is indication and device specific and reliant on contemporary expert knowledge which may influence the degree of importance assigned to clinical matters. It may also challenge the ability of the physician to gauge accurately what, and how much, information a patient wants and how to present it in a clear, understandable way, relevant to the patient’s clinical need and capacity to assimilate and comprehend it. Furthermore, physicians spend significantly less time with ICD recipients prior to implantation than non-physicians, limiting the opportunity to consider the emotional impact.69 In contrast, non-physicians reported a greater emphasis on psychosocial and quality of life concerns.69 Thus, increased involvement of cardiac specialist nurses, clinical physiologists and psychologists, and the development of more reliable patient websites to reinforce and complement physician information may improve this.72 The decision approach may influence information exchange. While shared decision-making and collaborative styles are key topics in the decision-making literature,73–80 the level of shared decision-making in cardiology consultations is not well known,81 and only one CRMD study alluded to patient perception of joint decision-making.52 In contrast to the preference for shared decision-making in the general literature,24,38,76 reference to distinct passive and active approaches dominated the CRMD studies. The majority of ICD patients desired passive involvement, echoing findings among general cardiology patients.36 Rapid, intuitive referral to the ‘expert opinion heuristic’ and passive deferral of decision-making responsibility to the physician was evident among secondary device recipients. Although paternalistic and criticised for failing to embrace patient-centredness and informed choice,14,82,83 this approach could be appropriate in the context of post-SCA secondary prevention in which the benefit–risk ratio is well established.4 Recovery from the traumatic event, symptom severity and treatment complexity, limited time to deliberate, feeling ill-equipped to make a choice and high levels of trust in physician expertise, evident in the CRMD studies, are factors widely associated with passivity in the decision literature.20,84–88 However, passivity was also described among patients contemplating primary prophylactic devices53,58,61,63 when symptoms may be absent, suggesting that more deliberation time may not increase engagement in decision-making. The clarity of the perceived benefit and risk for primary devices may be a factor. The risk of life-threatening arrhythmia and survival benefit afforded by the device, in the presence of ischaemic aetiology or certain heart failure characteristics, is well known.3,5,6 Therefore, reference to clinical guidelines for CRMD implantation, particularly when framed as essential rather than optional,55,59 may present an air of confidence which promotes patient trust in physician recommendation and consequent passive acceptance of device therapy. It may not however guarantee ‘informed’ consent. Furthermore, predictive risk stratification of inherited cardiac conditions is less established and the balance between not treating and risking a preventable arrhythmic event and the inevitable cost and complications associated with implantation is uncertain.89 Therefore, a lack of standardised information may lead to poorer patient understanding and diminished confidence in the physician and perceived strength of recommendation, which may explain subsequent passive reliance on significant others to decide55,58,59 or refusal of therapy.58 Ultimately, an explicit link between passivity, poorer knowledge and understanding described by the CRMD studies is problematic.51,53,54,58 In contrast, independent information gathering and leaving the ultimate treatment decision exclusively to CRMD patients presupposes that they are truly autonomous, that their information needs, values and preferences are known, and they are certain of their wishes.14 The source of the information is also a concern as the reliability and confidence in information acquired from ‘non-expert’ sources, such as family, friends and media avenues has been described as ‘highly variable’,39,90,91 and may explain the lack of accurate knowledge also found among ‘active information seeking’ device recipients.64 Moreover, the expression and interpretation of patient preferences and values, based on subconscious intuitive judgement processes, may challenge decision-making. For instance, referral to past experiences or anecdotal experiences of others, known as the ‘availability heuristic’,9,11 thought to motivate some patients to accept or decline therapies,15,86 was acknowledged among CRMD patients.53,61,64 This may be relevant as the exact mechanism of heuristic-based treatment decision-making is not clear in the general literature; however, the potential bias effect on rational decision-making has been demonstrated.9,19,37,92–94 Individuals could be induced to make suboptimal decisions based on positive or negative events that contradict physician advice.53 For example, third-hand knowledge of shock experience or device-related complications may present sufficient anticipation of adverse events to deter some who would benefit from acceptance, presenting a negative availability heuristic. In contrast, risk aversion may exaggerate patient preference for more invasive treatments, whereby the presence of a small but above average risk of SCA may unnecessarily provoke patients to request the highest end technology available. The degree to which primary and secondary CRMD recipients refer to systematic information gathering and heuristic processes merits further investigation as the literature is not clear. Collaborative decision-making acknowledges an inferred imbalance in medical knowledge and social power between patient and physician, by allowing each to lead different aspects of the discussion, capturing the notion of negotiated responsibility, mutual participation and cooperation rather than emphasis on shared choice.13,95–98 The desire for information exchange and deliberation expressed by some CRMD patients, while relinquishing responsibility for the final decision to physician expertise58 was an indicator of active involvement in collaborative decision-making and may paradoxically represent a degree of autonomy.22,97,99,100 Greater emphasis on collaborative CRMD decision-making may facilitate improved knowledge acquisition and foster the inclusion of personal preference, which is valued and perceived as greater involvement in decision-making by patients.74,101–103 Decision aids designed to support preference-sensitive decision-making improve understanding, enhance concordance between values and choice and reduce decisional conflict have become increasingly popular in the literature.16,104–107 However, thus far they have not been fully implemented in general practice103,108 or in the context of CRMD uptake. The only CRMD study to develop and test a decision aid specific to ICD57 was based on a relatively small sample of clinic patients and may not be entirely representative. A pilot study to develop and test a decision aid designed to support patients contemplating primary prophylaxis ICD implantation is currently underway.109 Although decision approach did not appear to influence device acceptance,58 inadequate knowledge was associated with device refusal53,62 and dissatisfaction.54 Other factors influencing acceptance or refusal such as condition severity and perception of necessity, strength of, trust in and desire to heed the recommendation and the trade-off between longevity and quality of life, corresponds with cancer treatment decision-making.86 An association between increasing age, passivity and poor knowledge acquisition described in the general decision literature27,29 was apparent among older adults contemplating device therapy;54,56 however, generalisation is limited by the small cohort size. Further focused investigation into the impact of complex factors associated with older age and potentially exacerbated in heart failure and post-SCA, such as diminished cognitive function, low health literacy, numeracy and depression39,110–115 is warranted if support strategies to meet specific needs are to be developed. There was little mention of potential gender differences in the CRMD studies,55,66 although the tendency for women towards active engagement compares with other findings.20,23,27,97 Consistent with the treatment literature86 there is limited information regarding the influence of culture, ethnicity and other potential demographic differences in the CRMD studies. The impact of device indication, type and role as an indicator of health status on decision-making is uncertain due to the inclusion of primary and secondary devices in several studies, therefore a more focused investigative approach on specific device types is recommended. Limitations Although the small number of studies included in the review could be considered a limitation, the reviewers were confident that a thorough and comprehensive search was undertaken. Unlike systematic reviews or narrative analysis of qualitative studies with similar methodological approaches, scoping reviews by their very nature incorporate a range of published materials, study designs and mixed methods, and so the presenting challenge of attempting to summarise, interpret and synthesise the complex and often large volume of diverse data cannot be underestimated. Furthermore, qualitative content analysis in this context assumes a degree of interpretation of findings emerging from several studies, which have already been subject to researcher analysis and interpretation. The potential loss of some important findings is therefore real. Conclusion This scoping review generated some insight into the way patients approach decision-making related to CRMD recommendation, identified similarities and distinctions with the treatment decision-making literature, and exposed a lack of clarity and research activity specific to some patients. It has demonstrated scope for an examination of relationships among a range of factors, with a particular focus on device indication and use of valid outcome measures within a more judicious timeframe. Further insight into what inspires active engagement, the degree and influence of heuristic thinking, time to deliberate and appropriateness of shared decision-making for patients contemplating CRMDs is recommended. Emphasis on the development of strategies to enhance information assimilation and recall is essential. Although decisional satisfaction and avoidance of cognitive dissonance and regret are evidence of effective patient decision-making, measures of decision outcome such as decisional control preference and concordance, conflict, satisfaction and regret are scarce in the literature and warrant greater inclusion. An appreciation of the way in which the patient arrives at a decision to proceed or not with CRMD implantation among different groups may provide a better understanding of potential disparities and the evidence to facilitate development of a framework of tailored information or decision aid, to enable effective collaborative decision-making, to facilitate truly informed choices, to improve the patient experience and to help acceptance and adjustment to life with technology. Acknowledgement The authors are grateful for the invaluable content expertise and personal perspectives on preliminary findings contributed by a group of service users and carers. Conflict of interest The authors declare that there is no conflict of interest. Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Implications for practice Explore the potential influence of demographic and situational characteristics upon the individual and collective process of focused cardiac rhythm management device decision-making. Examine the potential relationships between decision style and knowledge uptake to inform the development, validation, application and evaluation of targeted information and support strategies. Develop methods of assessing adequacy of knowledge and understanding to facilitate informed consent. References 1 Hayashi M , Sihimizu W, Albert C . The spectrum of epidemiology underlying sudden cardiac death . Circ Res 2015 ; 116 : 1887 – 1906 . 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TI - Adult patient decision-making regarding implantation of complex cardiac devices: a scoping review
JF - European Journal of Cardiovascular Nursing
DO - 10.1177/1474515117715730
DA - 2017-10-01
UR - https://www.deepdyve.com/lp/oxford-university-press/adult-patient-decision-making-regarding-implantation-of-complex-Xy4n853HnC
SP - 567
EP - 584
VL - 16
IS - 7
DP - DeepDyve
ER -