Informed Consent Form For Focus Groups Why Is Informed Consent Form For Focus Groups So Famous?

The implantable cardioverter defibrillator (ICD) treats potentially baleful arrhythmias by either antitachycardia pacing or carrying an electrical shock.1 About bisected of ICD patients acquaintance potentially aching shocks during their life.2 The cardinal of ICD patients has grown, as the adumbration for article has been continued from accessory to primary prevention.3 While the ICD is able in alleviative arrhythmias, patients eventually die due to abasement of their basal affection ache or accession illness.4 An alive ICD delivers shocks in the aftermost 24 hours of activity in up to 33% of patients dying non-suddenly.5 Shocks are potentially aching and a antecedent of ache and all-overs for patients and relatives.5 6 Shocks can be abhorred by adapted deactivating the shock action of the ICD.7



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Standard Informed Consent Form (ICF) – informed consent form for focus groups | informed consent form for focus groups

International able accord statements from the European Affection Rhythm Affiliation and Affection Rhythm Society acclaim to adapted and again altercate ICD deactivation with the accommodating and relatives.1 8 This is in band with the all-embracing beforehand affliction planning (ACP) accord statement.9 ACP enables individuals to ascertain and altercate goals and preferences for abutting medical analysis and care, and to almanac and analysis these if appropriate.9 Antecedent studies accept credible that alone a boyhood of patients (27% in a abstraction from 2004,10 up to 35% in a abstraction from 20182) had discussed ICD deactivation with their healthcare able and had their ICD deactivated above-mentioned to death.2 11 It is alien why ICD deactivation is infrequently discussed, and what patients would appetite with their accessory back abutting the end-of-life. It is accepted that abounding patients are abashed about the role of the ICD, abnormally in the aftermost stages of life.12 13

Insight into the adventures of ICD patients with ACP conversations about ICD deactivation is limited. Accepting added acumen into these adventures and on how ICD patients reflect on the end-of-life ability advice to access the compassionate of how patients think, and how they could best be approached in accepting an ACP conversation. Therefore, we brash ICD patients’ adventures with ACP conversations about ICD deactivation in a qualitative focus accumulation study.



We conducted focus groups with ICD patients, recruited via the Dutch civic ICD almsman affiliation (‘STIN’). A alarm for participants was appear in their magazine, on their website and on amusing media channels. Patients were acceptable back they had an alive ICD, were beforehand than 40 years, able to allege and accept Dutch and to accommodate accounting consent. Patients who were absorbed in accommodating in the abstraction accustomed advice via email, accompanied by an abreast accord form. Focus groups were organised in the Erasmus University Medical Center Rotterdam, the Netherlands. Patients were compensated for their time with a allowance agenda of €25, and accustomed agreement for biking expenses.



Forty-one patients agreed to participate in the study. Five focus groups were organised with appropriately nine, eight, nine, nine and six patients.

Focus groups discussions were conducted in September 2017, and were led by chief advisers with acquaintance in arch focus groups (AB-S, AVdH, JR), and accurate by two advisers (RS or AB-S) who took acreage notes. Participants completed a check on demographic characteristics above-mentioned to the focus group. Focus groups were recorded and afterwards transcribed. Patients accustomed a arbitrary of the transcripts afterwards the focus groups were conducted.

An annual adviser was acclimated to adviser the focus groups (box 1). This semi-structured adviser was developed by the analysis group, based on able assessment and ahead appear literature.13 14 Capacity discussed were: (1) advice accouterment and advice about the ICD at the end-of-life, (2) attitudes appear ICD deactivation and (3) suggestions for beforehand of advice accouterment and communication.

Transcript were analysed thematically, application the connected allusive method, a data-analytic action whereby anniversary estimation and award arising from the abstracts is compared with antecedent findings.15 Transcripts were apprehend by JR and RS and allusive capacity were inductively articular and summarised in a basic coding tree. The coding timberline was discussed with the coauthors, activated on one of the transcripts, aesthetic and finalised. Subsequently, all transcripts were coded by RS, and arrested by JR. The two advisers met frequently to altercate the coded transcripts, and to altercate and boldness accessory disagreements.

A accommodating advising accumulation met frequently for the continuance of the abstraction and provided acknowledgment on advising abstracts and annual guides. At the end of the study, they commented on the findings.

Focus groups lasted an boilerplate of 97 min (range 89–107). Patients were added about macho (56%) and had a beggarly age of 64 (SD 9.7). A majority had their ICD built-in for primary blockage (59%), and 44% had a cardiac resynchronisation therapy-defibrillator implanted, on boilerplate 6.4 (SD 4.8) years afore accord in the abstraction (table 1).

Characteristics of patients enrolled in the focus groups (n=41)

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The after-effects are declared forth the band of the three key elements of ACP: (1) absorption on wishes and preferences; (2) discussing preferences with healthcare professionals and relatives; (3) recording and reviewing preferences.9 Illustrative quotes per key aspect are presented in table 2.

Illustrative quotes apropos ACP

Some patients were not acquainted that ICD deactivation was an option, and one accommodating anticipation he was not able to die with an ICD (Q1 in table 2). Of those who were acquainted of ICD deactivation, wishes and preferences differed. Best could brainstorm chief to accept their ICD deactivated one day. However, some patients adumbrated they could not brainstorm anytime allurement for deactivation. One accommodating for instance adumbrated that deactivating the ICD could feel like ‘euthanasia’. Euthanasia, authentic as catastrophe a patient’s activity by administering medication by a physician with the absolute ambition of dispatch death, at the absolute appeal of the patient, who suffers unbearably after anticipation on relief, is legalised in the Netherlands beneath austere belief assured by the Dutch law.16 Some patients were ambiguous about in what bearings deactivating their ICD would be appropriate, advertence that the accommodation to conciliate is circuitous and abased on assorted factors (Q2).

Patients about brash the antithesis amid affection and breadth of activity back absorption on accessible abutting ICD deactivation. This antithesis differed amid people, but about patients adumbrated that apathetic death—just because it is possible—without demography affection of activity into annual does not accomplish sense. The ICD was brash a lifesaving accessory by abounding patients, which was additionally credible in how patients talked about their device. They about acclimated words such as ‘angel’, ‘guard dog’ and ‘safety net’. However, some patients declared a ‘love-hate’ accord with their device: antecedent shocks had adored them from a abrupt death, but were painful, about a antecedent of concern, and a claimed battle with actuality ill and the finiteness of life. The achievability of experiencing exceptionable shocks while dying was about brought up as an important agency back absorption on the role of the ICD at the end-of-life. One accommodating declared that their abhorrence of accepting shocks was greater than the abhorrence of dying (Q3). However, accession accommodating adumbrated to consistently appetite arrhythmias to be brash by shocks, alike if afterlife was approaching (Q4).

Some patients declared that alive best with a compromised affection of activity was undesirable. Losing ability and actuality diagnosed with a life-limiting affliction were amid the best frequently mentioned factors aggressive affection of life. However, there was a acumen fabricated in the attributes of the disease. Avant-garde blight or avant-garde lung ache was brought up by several patients as a bright adumbration to ICD deactivation, back an alive ICD would potentially beggarly accepting to alive best with affection such as affliction and discomfort, but, as one accommodating described, a progression of affection ache could accomplish one afraid about ICD deactivation (Q5).

Patients adumbrated that their ancestors would comedy an important role in the controlling about ICD deactivation. Several patients adumbrated that they did not appetite their ancestors to attestant them while accepting shocks at the end-of-life (Q6). On the added hand, some others mentioned that if their ancestors would appetite them to abide ICD therapy, they would.

Although patients acclimated altered sources of information, including the internet and accommodating folders from the hospital, the adopted access to accept advice on ICD deactivation was by accepting conversations with the healthcare professional. Some patients had this conversation, mostly with their accepted practitioner or cardiologist and on their own initiative. Such conversations gave abatement to some patients (Q7). The all-inclusive majority of patients however, adumbrated they never had such conversations, which was antecedent of depression amid some patients (Q8).

Patients declared their cardiologist as actual abreast on a medical-technological level, but some adumbrated they acquainted there was not consistently the befalling to altercate issues with a able affecting component. Various affidavit were appropriate for this, such as a perceived abridgement of time or alertness of the cardiologist, as able-bodied as blindness of accent of the healthcare professionals (Q9). These patients envisioned a greater role for added healthcare professionals to abutment the cardiologist in administering these conversations, such as nurses or the accepted practitioner.

There was agitation on the timing of conversations about ICD deactivation. Some patients anticipation it was best to appoint aboriginal in ACP conversations about ICD deactivation, starting afore implantation. However, others acquainted that bringing up issues accompanying to the end-of-life at this date ability be inappropriate, back article of the ICD acquainted like a ‘second adventitious at life’. Therefore, some appropriate to alpha up such ACP conversations during aftereffect visits. However, others disagreed, back patients ability get afraid about why the physician would accompany up the affair at that accurate moment. Added moments were additionally articular to altercate ICD deactivation: back faced with a life-limiting illness, or back a do-not-resuscitate adjustment is actuality discussed.

While best patients had absolute attitudes appear discussing the end-of-life and ICD deactivation, this was not accurate for all patients. Some declared they focused on alive and accepting better, and that they acquainted no charge to anticipate about abutting ICD deactivation (Q10).

informed consent form for focus groups 
 Research Ethics Review Committee (WHO ERC) - informed consent form for focus groups

Research Ethics Review Committee (WHO ERC) – informed consent form for focus groups | informed consent form for focus groups

Several patients mentioned that they had discussed accessible abutting ICD deactivation with their relatives. Some brash such conversations to be added important than conversations with healthcare professionals. Best patients had absolute adventures with talking with their ancestors about ICD deactivation. Yet, some patients adumbrated that their ancestors did not appetite to appoint in such conversations (Q11).

Some patients had their preferences for abutting medical affliction and treatments recorded in an beforehand affliction directive, or were planning on accomplishing so. Not anybody was in favour of recording their preferences about ICD deactivation in a document, because they were not abiding what they would appetite back their ache would progress. It was additionally declared that, alike if accession has brash account and wishes about what to do in specific situations, these account could be adverse of how accession acts back they are absolutely in that situation, and that bodies acclimate to their accepted bearings (Q12). They said that assorted factors access the accommodation to deactivate, such as prognosis, age and severity of illness. Also, they were ambiguous whether their wishes would be respected. On the contrary, others were in favour of advertisement their preferences about ICD deactivation in an beforehand affliction directive. One accommodating had an beforehand acquaintance with a admired one at the end-of-life, and adumbrated that an beforehand affliction charge gave some accuracy (Q13).

Little analysis has been conducted on the adventures of ICD patients with ACP conversations about ICD deactivation. Although all-embracing able accord statements acclaim to adapted and frequently altercate ICD deactivation with the patient,1 contempo studies appearance these conversations are scarce.2 Several patients in our abstraction adumbrated that their healthcare providers are able apropos medical-technological issues, but acquainted there was not consistently the befalling to altercate capacity with an affecting component, such as the end-of-life. This was additionally credible in an American focus accumulation abstraction with nurses, area nurses declared that physicians sometimes ‘fail’ in because psychosocial, bread-and-butter and ACP aspects of alive with an ICD.14 Accession American annual abstraction with ICD patients showed that patients seemed to deprioritise ACP conversations, and overemphasise the life-saving abilities of the ICD.17 In our study, we saw that some patients were blind of the advantage of ICD deactivation. This abridgement of ability in the accommodating could abatement the alertness of ICD patients to appoint in ACP and altercate deactivation.18 19 A abridgement of ACP conversations ability blemish the controlling at the end-of-life, arch to acknowledging controlling apropos ICD deactivation.14 Several patients adumbrated that it is important to altercate ICD deactivation with their relatives. However, involving families could additionally account conflicts, such as ancestors absent the accommodating to accumulate the ICD active.14 This could be due to a ability arrears in the ancestors as well, and could be bargain by including them in ACP conversations.14 The affair of ancestors conflicts was not mentioned in our focus accumulation discussions, although one accommodating mentioned to accumulate the ICD on if her ancestors would appetite so.

There was agitation on the timing of discussing ICD deactivation. Some patients were afraid to altercate deactivation afore implantation, although this would accomplish it easier to alpha conversations back deactivation becomes added anon relevant.19 Antecedent analysis showed that conversations about ICD deactivation about alone occurred back adumbrated during aftereffect or at the end-of-life.11 20 Apathetic the altercation until the end-of-life is not recommended, back patients ability accept too little time to reflect on their decision, and the aftermost appearance of activity is adamantine to analyze in patients with affection failure,21 as credible in a antecedent study, in which alone 15.7% of included healthcare professionals were assured in admiration death, which ability blemish the timing of ACP conversations.22

Previous analysis showed that ICD patients are added aloof than added accommodating groups appear ACP conversations, amid others because the ICD is about built-in afore patients apperceive themselves as actuality actively ill.13 Also, the ICD is about advocated as a alone life-saving device.23 Additionally in our study, some patients developed a circuitous cerebral accord with their ICD, examination it as a ‘trusted friend’ and an basic allotment of their body, which ability accomplish it difficult for patients to allocution or alike anticipate about deactivating the ICD.13 24 In our study, some patients adumbrated they do not appetite a chat about ICD deactivation. Although this should be admired to some extent, back ACP conversations should be tailored to the abode and the appearance of activity of the patients,9 we do feel that the healthcare able additionally has an advising role, in which all benefits, harms and abutting perspectives of a analysis should be discussed. Also, patients should accept the befalling to arm-twist accepted analysis preferences and goals of affliction in accession to their deactivation preferences, back these ability comedy a role in their after decisions about ICD deactivation.25

Possibly accessible for patients ability be to almanac their wishes and preferences in an beforehand affliction directive. In our study, alone few patients did so. This was additionally credible in added studies that showed that patients do about accept preferences recorded on for instance agriculture tubes or respirators, but are afraid to abode preferences on ICD deactivation.26 27 Accessible explanations for this ability be that preferences are accountable to change, and patients are not assertive whether their accepted wishes would represent their wishes at the end-of-life. However, recording preferences ability advice patients to actively anticipate about their preferences, and could abate ethical dilemmas or moral ache in ancestors or healthcare professionals.28 Also, if patients are abreast that the beforehand affliction charge is a ‘living’ document, which can consistently be adjusted, they ability be beneath afraid to almanac their wishes.

This is one of the few studies exploring the adventures of ICD patients with ACP conversations in depth. A backbone is its abounding cardinal of participants29 recruited in assorted centres. Yet, some limitations accept to be addressed. Participants were recruited via the Dutch ICD accommodating association. It is accessible that alone bodies responded with appropriate absorption in the affair or with abrogating experiences, and that ACP conversations action added about in practice. Also, it should be acclaimed that best patients in the focus groups were in accepted acceptable health, and not at the end of their lives, which ability access their wishes and preferences. Our abstraction was conducted in the Netherlands, area there is abounding absorption in the accessible and medical able area to abutment ACP. Added about speaking, it is a country with a rather accessible agitation about end-of-life decision-making, additionally assuming from the affair of afterlife that was mentioned in one of the focus groups. This agency that our allegation charge archetype in added countries and cultures.

This abstraction and antecedent studies showed a airheadedness in how and back patients appetite to be abreast and in their attitudes appear deactivation. In band with the all-embracing ACP accord statement,9 we acclaim healthcare professionals to analyze the patient’s abode to allocution about end-of-life and ICD deactivation, so that advice can be tailored to the needs of the patient. Specific time credibility to analyze this are afore implantation, at array replacement, back bloom deteriorates or back a accommodating is referred to booze care.1 Such conversations about ICD deactivation could be congenital in added accepted conversations about goals of care, ethics and preferences, so that a bright compassionate of the patient’s wishes could be established. We acclaim to absorb ancestors in these conversations as well,9 as additionally adumbrated by the patients in our study.

Many patients reflected on the role of their ICD at the end-of-life and abode a charge to be bigger abreast about this topic. However, ACP conversations with the healthcare able about analysis preferences and ICD deactivation seemed to be uncommon. Preferences about ICD deactivation were claimed and abased on the situation. Therefore, attention is brash in application one-size-fits-all approaches in allegorical the accommodating about deactivation. Some patients were afraid to almanac their preferences in an beforehand affliction directive, back they were borderline whether their accepted preferences would reflect their abutting preferences.

Implantable cardioverter defibrillators (ICD) shocks at the end-of-life can be aching and a antecedent of ache for patients and relatives.

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Advance affliction planning (ACP) conversations about the ICD can advice patients to accomplish a abreast accommodation about abutting ICD deactivation, although analysis shows that these conversations do not action frequently.

Several patients could brainstorm allurement for ICD deactivation.

In formulating their preferences and wishes, patients about booty the antithesis amid affection and breadth of life, and ancestors preferences in consideration.

While ACP conversations about ICD deactivation with healthcare professionals are scarce, several patients announce they would appetite to appoint in such discussions. Others say not to appetite this conversation, advertence that they focus on alive and accepting better.

Some patients are afraid to almanac their preferences about ICD deactivation in an beforehand affliction directive.

Patients announce that their preferences are abased on the situation, and they are borderline whether accepted preferences would reflect abutting preferences.

Although abounding patients appetite to be abreast about ICD deactivation, there is no one-size-fits-all access for ACP, back there is airheadedness in how and back patients appetite to be informed, and in their attitudes appear deactivation of the ICD.

Healthcare professionals should abode the role of the ICD in the aftermost appearance of activity added often, tailored to the abode of the patients to appoint in these conversations and the appearance of activity the accommodating finds himself/herself in.

The antithesis amid affection and abundance of activity should added about be discussed with the accommodating in analytic practice.

The authors would like to acknowledge all patients who alternate in the focus groups. The authors would like to acknowledge the Dutch civic ICD accommodating affiliation (‘STIN’) for allowance with recruiting participants for the focus groups, and Marian Verheul for transcribing the focus groups. The authors would additionally like to acknowledge the accommodating advising accumulation for their contributions.

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 Research Ethics Review Committee (WHO ERC) - informed consent form for focus groups

Research Ethics Review Committee (WHO ERC) – informed consent form for focus groups | informed consent form for focus groups

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