Introduction - University of Manchester



‘Thrust out of normality’ - How adults living with cystic fibrosis experience pulmonary exacerbations: a qualitative studyGabriela SCHMID-MOHLER PHD RN 1, Ann-Louise CARESS PHD RN 2, Rebecca SPIRIG PHD RN 3, Christian BENDEN MD FCCP 4, Janelle YORKE PHD RN 21 Centre of Clinical Nursing Science, University Hospital Zurich, Zurich, Switzerland2 Division of Nursing, Midwifery and Social Work, School of Health Sciences, University of Manchester, Manchester, England3 Directorate of Nursing and Allied Health Professionals, University Hospital Zurich, Zurich, Switzerland4 Division of Pulmonology, University Hospital Zurich, Zurich, SwitzerlandRunning title: cystic fibrosis exacerbation experienceCorresponding authorGabriela Schmid-Mohler (PhD, RN), Centre of Clinical Nursing Science, University Hospital Zurich, Ramistrasse 100, CH 8091 Zurich, Switzerlandphone: +41 (0)44 255 20 03, e-mail: gabriela.schmid@usz.chAbstractAim: To explore the experience of pulmonary exacerbation from the perspective of adults with cystic fibrosis.Background: While management of pulmonary exacerbations is a pillar of cystic fibrosis care, little is known of patients’ perspectives. Understanding the patient’s experience is essential for developing and evaluating interventions in support of patient self-management.Design: Qualitative study with longitudinal study in a subsample.Methods: The study took place from 2015 to 2016 in a university hospital. Eighteen patients with cystic fibrosis were included who were ≥ 18 years of age and had no solid organ transplant. Patients’ experiences were explored through semi-structured interviews and analysed using framework analysis. They each participated in one interview, with a subsample (N=7) being interviewed twice during and once after antibiotic therapy.Results: Patients (11 men and 7 female; median age 29.5 years, range 19-55 years; median FEV1 45%, range FEV1 23%-105%) experienced pulmonary exacerbations as disruptions of their normality, which led to a substantial increase in their emotional distress. Exacerbations represented a period of threat and domination by CF; that is, symptoms and treatment consumed energy, restricted physical activity and daily life roles. ‘Noting change’, ‘waiting until antibiotics help’, ‘returning to normality’ and ‘establishing a new normality’ characterised their descriptions of the pulmonary exacerbation trajectory. Emotional distress was the major driver for patients’ self-management, and personal goals and illness beliefs influenced also patients’ self-management decisions. Conclusion: The experienced degree and source of emotional distress are drivers for self-management decisions in patients with cystic fibrosis who experience a pulmonary exacerbation.Relevance to clinical practice: Our data provide new understanding that will be essential to informing clinical practice, future patient-reported outcomes measures and intervention development.KeywordsAdult Nursing, Respiratory Nursing, Symptom Perception, Symptom Control, Self-Management, Qualitative Study, Childhood Illness, Chronic Illness, Emotional Distress, Acute CareStudy Registration Number NCT02464267Impact statementWhat does this paper contribute to the wider global clinical community?These findings provide an understanding that patients have goals, conscious or subconscious, that guide their self-management decisions in acute phases such as pulmonary exacerbations. Elaborating on and balancing these goals in a shared-decision making process between health care professionals and patients may lower patient distress and improve self-care.This study provides the basis for the development of future patient reported outcome measures and interventions.IntroductionCystic Fibrosis (CF) is a genetic disease in which mutated proteins lead to thick, viscous secretions affecting the lungs, pancreas, liver and intestine and which life expectancy increased to a mean survival age of 50 in the recent decades PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdGVwaGVuc29uPC9BdXRob3I+PFllYXI+MjAxNTwvWWVh

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ADDIN EN.CITE.DATA (Sawicki, Sellers, & Robinson, 2009). This includes chest physiotherapy and inhalation of medications. With advancing disease severity, additional management regimens are required such as blood sugar monitoring, insulin injections, tube feeding and oxygen, adding to an already complex and time consuming regimen ADDIN EN.CITE <EndNote><Cite><Author>Bush</Author><Year>2015</Year><RecNum>3941</RecNum><DisplayText>(Bush, Bilton, &amp; Hodson, 2015)</DisplayText><record><rec-number>3941</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1493956161">3941</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Bush, A.</author><author>Bilton, D.</author><author>Hodson, M.E.</author></authors></contributors><titles><title>Hodson and Geddes&apos; cystic fibrosis</title></titles><edition>4th</edition><dates><year>2015</year></dates><pub-location>Boca Raton</pub-location><publisher>CRC Press</publisher><urls></urls></record></Cite></EndNote>(Bush, Bilton, & Hodson, 2015). Patients living with cystic fibrosis (CF) often experience two to three pulmonary exacerbations annually PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5kZSBCb2VyPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48

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ADDIN EN.CITE.DATA (de Boer et al., 2011). For most patients, pulmonary exacerbations mean an increase in their pre-existing symptom burden due to increased sputum production, coughing, breathlessness, fever, loss of appetite and decreased exercise tolerance ADDIN EN.CITE <EndNote><Cite><Author>Cystic Fibrosis Trust</Author><Year>2009</Year><RecNum>647</RecNum><DisplayText>(Cystic Fibrosis Trust, 2009)</DisplayText><record><rec-number>647</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1490172103">647</key></foreign-keys><ref-type name="Standard">58</ref-type><contributors><authors><author>Cystic Fibrosis Trust,</author></authors></contributors><titles><title>Antibiotic Treatment for Cystic Fibrosis - Report of the UK Cystic Fibrosis Trust Antibiotic Working Group</title></titles><dates><year>2009</year></dates><urls></urls></record></Cite></EndNote>(Cystic Fibrosis Trust, 2009). Pulmonary exacerbations are generally treated with antibiotics, with a nebulised or oral antibiotic course initially being attempted. Intravenous antibiotics might alternatively be indicated, with home treatment being an additional treatment modality offered to patients ADDIN EN.CITE <EndNote><Cite><Author>Cystic Fibrosis Trust</Author><Year>2009</Year><RecNum>647</RecNum><DisplayText>(Cystic Fibrosis Trust, 2009)</DisplayText><record><rec-number>647</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1490172103">647</key></foreign-keys><ref-type name="Standard">58</ref-type><contributors><authors><author>Cystic Fibrosis Trust,</author></authors></contributors><titles><title>Antibiotic Treatment for Cystic Fibrosis - Report of the UK Cystic Fibrosis Trust Antibiotic Working Group</title></titles><dates><year>2009</year></dates><urls></urls></record></Cite></EndNote>(Cystic Fibrosis Trust, 2009). Thus, patients face an increase in both symptom burden and treatment-related burden, likely having a negative effect on fatigue and the person’s sense of mastery over the illness and symptoms PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYWxhZ3VlcjwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+

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ADDIN EN.CITE.DATA (Esmond, Butler, & McCormack, 2006). A recent synthesis of qualitative studies provided a first insight and indicated that patients experiencing a pulmonary exacerbation often described a sense of loss or fear of loss, including decreased physical functioning and associated distress ADDIN EN.CITE <EndNote><Cite><Author>Schmid-Mohler</Author><Year>2018</Year><RecNum>4632</RecNum><DisplayText>(Schmid-Mohler, Yorke, Spirig, Benden, &amp; Caress, 2018)</DisplayText><record><rec-number>4632</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1527834211">4632</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Schmid-Mohler, G.</author><author>Yorke, J.</author><author>Spirig, R.</author><author>Benden, C.</author><author>Caress, A. L.</author></authors></contributors><auth-address>1 Centre of Clinical Nursing Science, University Hospital Zurich, Zurich, Switzerland.&#xD;2 Division of Nursing, Midwifery and Social Work, School of Health Sciences, University of Manchester, Manchester, England.&#xD;3 Directorate of Nursing and Allied Health Professionals, University Hospital Zurich, Zurich, Switzerland.&#xD;4 Division of Pulmonology, University Hospital Zurich, Zurich, Switzerland.</auth-address><titles><title>Adult patients&apos; experiences of symptom management during pulmonary exacerbations in cystic fibrosis: A thematic synthesis of qualitative research</title><secondary-title>Chronic Illn</secondary-title></titles><periodical><full-title>Chronic Illn</full-title></periodical><pages>1742395318772647</pages><keywords><keyword>Qualitative method</keyword><keyword>cystic fibrosis</keyword><keyword>exacerbation</keyword><keyword>literature review</keyword><keyword>symptom management theory</keyword><keyword>thematic synthesis</keyword></keywords><dates><year>2018</year><pub-dates><date>Jan 1</date></pub-dates></dates><isbn>1745-9206 (Electronic)&#xD;1742-3953 (Linking)</isbn><accession-num>29742923</accession-num><urls><related-urls><url>;(Schmid-Mohler, Yorke, Spirig, Benden, & Caress, 2018). This review highlighted a current lack of insight regarding what exacerbations indicate for patients and how the experience impacts patients’ self-management. Understanding patients’ experience of a pulmonary exacerbation is essential in order to develop interventions that support self-management and for the development of patient-reported outcome measures to enable evaluation of the efficacy of the interventions.The aim of the current study was to explore the experience of adults with CF during a pulmonary exacerbation over time. Data collection and interpretation of findings were guided by Symptom Management Theory PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb2RkPC9BdXRob3I+PFllYXI+MjAwMTwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA (Dodd et al., 2001; Humphreys et al., 2014), which describes several phases of symptom experience and self-management.MethodsDesignThis qualitative study was undertaken within a convergent mixed-method research project ADDIN EN.CITE <EndNote><Cite><Author>Creswell</Author><Year>2011</Year><RecNum>4332</RecNum><DisplayText>(Creswell, 2015; Creswell &amp; Plano Clark, 2011)</DisplayText><record><rec-number>4332</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1498286863">4332</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Creswell, J. W.</author><author>Plano Clark, V. L.</author></authors></contributors><titles><title>Designing and conducting mixed methods research</title></titles><edition>2nd</edition><dates><year>2011</year></dates><pub-location>CA: Thousand Oaks</pub-location><publisher>SAGE Publications</publisher><urls></urls></record></Cite><Cite><Author>Creswell</Author><Year>2015</Year><RecNum>4350</RecNum><record><rec-number>4350</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1499260277">4350</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Creswell, J. W.</author></authors></contributors><titles><title>A Concise Introduction to Mixed Methods Research</title></titles><dates><year>2015</year></dates><pub-location>Thousand Oaks, CA</pub-location><publisher>SAGE Publications</publisher><urls></urls></record></Cite></EndNote>(Creswell, 2015; Creswell & Plano Clark, 2011), using a longitudinal design in a subsample. The study was approved by the relevant Ethics Committee and performed in line with the Declaration of Helsinki. All patients completed informed consent forms. Two patients were involved in designing the study (per INVOLVE guidance, 2012) and assessed the study’s relevance as high.Theoretical framework guiding this studyData collection and interpretation of findings were guided by Symptom Management Theory PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb2RkPC9BdXRob3I+PFllYXI+MjAwMTwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA (Dodd et al., 2001; Humphreys et al., 2014) which describes three phases of symptom management: first, patients experience symptoms by perceiving, evaluating and responding to them. Second, they manage the symptoms. Third, their symptom management results in outcomes such as emotional or physical functioning. The three steps interact simultaneously and continue until symptoms resolve themselves or stabilize. The three concepts are influenced by contextual variables, i.e. personal, environmental, health, and / or illness-related factors. The theory guided the development of the interview guide and the indexing stage of analysis.Setting and SampleThe study was conducted between April 2015 and July 2016 at a large university hospital in country anonymized.Inclusion and exclusion criteria: Two different samples were recruited (Cohorts A and B). Inclusion criteria for both cohorts were: a confirmed diagnosis of CF, 18 years of age or older and no solid organ transplant. Additional inclusion criterion for Cohort A was having experienced at least one pulmonary exacerbation in the previous year and for Cohort B, currently experiencing an acute pulmonary exacerbation. Acute pulmonary exacerbation was defined according to recognised criteria PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GdWNoczwvQXV0aG9yPjxZZWFyPjE5OTQ8L1llYXI+PFJl

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ADDIN EN.CITE.DATA (Liou et al., 2001). Sampling criteria were age, gender, FEV1 (forced expiratory volume in one second) in stable phases, number of pulmonary exacerbations in the past year requiring antibiotic treatment and BMI.Data collectionPatients were informed about the study by their CF team. If interested, patients were contacted by the first author, who had not been in prior contact with any of the patients. Further information was provided to the patients and their consent was sought. Four patients declined to participate for reasons that included time shortage (n = 2), feeling uncomfortable with audio recording (n = 1) or unwillingness to speak about this topic (n = 1).Cohort A patients were interviewed once by the first author. Cohort B patients were interviewed by the first author in the first and second week after commencement of antibiotic treatment and in the first or second week after antibiotic treatment completion. The first and second interviews were mainly over the telephone and focused on current symptom experience and management. The third interview was always conducted in person – one week to two weeks after termination of the antibiotics. The location for the interview was chosen by patients (their home, workplace, or office of the researcher). The researcher took field notes directly after the interview (see Table 1 for the interview guideline). Clinical data were retrieved from medical files, with patient consent. Data collection was concluded after no new substantial information could be obtained.INSERT Table 1. Interview guidelineData analysisThe qualitative interviews were audio-recorded, transcribed verbatim and analysed according to Framework Analysis which is a method widely used in health service research to analyse and summarize data under a predefined index ADDIN EN.CITE <EndNote><Cite><Author>Ritchie</Author><Year>2003</Year><RecNum>633</RecNum><DisplayText>(Ritchie, Spencer, &amp; O&apos;Connor, 2003)</DisplayText><record><rec-number>633</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1490172050">633</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Ritchie, J.</author><author>Spencer, L.</author><author>O&apos;Connor, W.</author></authors><secondary-authors><author>Ritchie, J.</author><author>Lewis, J.</author></secondary-authors></contributors><titles><title>Carrying out Qualitative Analysis</title><secondary-title>Qualitative Research Practice</secondary-title></titles><dates><year>2003</year></dates><pub-location>London</pub-location><publisher>Sage</publisher><urls></urls></record></Cite></EndNote>(Ritchie, Spencer, & O'Connor, 2003). We used a combination of deductive and inductive analysis, guided by Symptom Management Theory and the research question ADDIN EN.CITE <EndNote><Cite><Author>Gale</Author><Year>2013</Year><RecNum>622</RecNum><DisplayText>(Gale, Heath, Cameron, Rashid, &amp; Redwood, 2013)</DisplayText><record><rec-number>622</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1490172050">622</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Gale, N. K.</author><author>Heath, G.</author><author>Cameron, E.</author><author>Rashid, S.</author><author>Redwood, S.</author></authors></contributors><auth-address>Health Services Management Centre, University of Birmingham, Park House, 40 Edgbaston Park Road, Birmingham B15 2RT, UK. n.gale@bham.ac.uk.</auth-address><titles><title>Using the framework method for the analysis of qualitative data in multi-disciplinary health research</title><secondary-title>BMC Med Res Methodol</secondary-title><alt-title>BMC medical research methodology</alt-title></titles><periodical><full-title>BMC Med Res Methodol</full-title><abbr-1>BMC medical research methodology</abbr-1></periodical><alt-periodical><full-title>BMC medical research methodology</full-title><abbr-1>BMC Med Res Methodol</abbr-1></alt-periodical><pages>117</pages><volume>13</volume><keywords><keyword>Health Services Research/*methods</keyword><keyword>Humans</keyword><keyword>*Qualitative Research</keyword><keyword>Research Design</keyword></keywords><dates><year>2013</year></dates><isbn>1471-2288 (Electronic)&#xD;1471-2288 (Linking)</isbn><accession-num>24047204</accession-num><urls><related-urls><url>;(Gale, Heath, Cameron, Rashid, & Redwood, 2013). Data were entered into the framework matrix, using QSR NVivo 10 and labelled using the predefined concepts according to the elements of the Symptom Management Theory (perception, evaluation, response, management strategies, outcomes and influencing factors) and the research questions (meaning, distress and evolvement over time). The data in the concepts were analysed inductively to identify subthemes, and the final index, with concepts and subthemes, was defined and presented in a final theoretical framework (Figure 1).Data from both cohorts were combined by indexing data with timeframes (i.e. before, during or after antibiotic treatment, deterioration or improvement of symptoms, number of days or weeks) and summarising the data which referred to the same timeframe.To ensure rigour, German-language transcripts were read by the third author, who is a native German speaker. Each transcript was summarised in English and read by the second and last authors. The authors discussed the framework index at monthly sessions during the analysis process, and two patients reviewed the findings and reported that they each found ’their exacerbation story’ within the summary.ResultsCharacteristics of the SampleEighteen patients (7 female; aged 19-55, forced expiratory volume in 1 seconds (FEV1) 23-105%) participated (Table 2). Eleven patients (Cohort A) were interviewed once and seven patients (Cohort B) were interviewed three times. One patient in Cohort B was interviewed only twice due to receiving a lung transplant after the second interview. In Cohort A, interviews lasted 63-94 minutes. In Cohort B, the first and second interviews lasted 15-60 minutes, the third interview 48-96 minutes.INSERT Table 2. Sample characteristics (n=18)The pulmonary exacerbation trajectoryThemes and subthemes from the framework index are written in italics or in brackets and are presented in Figure 1. Patients experienced an exacerbation as a trajectory from noting a change, waiting until the antibiotics helped, returning to normality until establishing new normality. INSERT Figure 1. The pulmonary exacerbation experience of patients living with CFIn the first phase patients ‘noted a change’ in their usual condition and had difficulty accepting that keeping up normality was not possible and treatment was needed, which might last from some hours to several weeks. This second phase ‘waiting until the antibiotics help’ included the time when patients experienced the peak of symptom burden as well as the point of change, typically between days three and five, when the antibiotics take effect. Some patients with mild CF lung disease (FEV1 > 60%) reported that during some ‘mild’ exacerbations they did not experience this peak of symptoms and were able to continue working. Their experience was identical to that reported in the next (third) phase. The third phase ‘returning to normality’ was the time after the point of change. In this phase, the symptoms improved steadily and patients took up normal life again, but treatment burden remained high. It lasted until the end of treatment, normally after two weeks. The fourth phase ‘establishing (new) normality’ included the time after antibiotic treatment ended until the patient achieved the same or similar level of physical performance as before the exacerbation, typically one to three months after the exacerbation.Patients reported that the intrusion of symptoms and treatment on daily normal life, affecting body, emotions, social relationships and everyday activities made the pulmonary exacerbations a distressing experience. The exacerbation, the symptoms or the treatment were perceived as distressing if they were associated with increased perception of threat, perceived domination of CF and / or loss of control, increased consumption of energy, restriction in activity and freedom, separation from others, and hindrance in daily meaningful activities.An infection burdens me because it restricts me in my activity, and has a negative impact on my lungs. I ask myself ’What will my future look like?’ (ID 90)An infection burdens me because I feel under strong pressure to get up again soon, take up my work as soon as possible again and not miss any social activities. (ID 77)In the different phases, patients tried to maintain or reestablish normality. Based on their goals regarding outcomes and their overall perception of pulmonary exacerbation patients applied the self-management strategies most helpful to achieving their desired outcomes (Figure 1). This process was influenced by various factors: illness-related (infection severity, treatment modality, disease severity and comorbidities), personal (earlier pulmonary exacerbation experience, illness beliefs, personality traits, self-management skill, spirituality beliefs, purpose in life), social (work situation, family and friends, care responsibilities, CF community and trust towards CF care), and environmental (organization of CF care and climate / season).Noting a changePatients described their ‘normality’ as their daily life with the usual symptoms and treatment which they perceived as ‘belonging’ to them. Only one patient did not have any symptoms or therapy in stable phases. All others experienced at least one CF-specific symptom (e.g. coughing) in stable phases, requiring at least one treatment, such as inhalation. Nonetheless, they perceived themselves as ‘normal’ and some even ‘healthy’ in stable phases:At home I always think of myself as a normal person, that I’m a healthy person. And then in the hospital I realise that I’m actually, you know, a bit handicapped and afterwards I kind of start to change the way I think. (ID 50)It’s just a feeling of not being normal - and a little different than everybody else. … I don’t have this feeling otherwise. It changes then (with the onset of a pulmonary exacerbation). (ID 34)At the beginning of a pulmonary exacerbation, patients experienced a change in pre-existing symptoms such as coughing or fatigue and the onset of new symptoms like sore throat or fever. The onset of an exacerbation changed their view of themselves, going from ‘being normal’ to ‘not being normal’ and often hindered them in participating in social life which (separation from others), again, was experienced as burdensome. Consequently, all patients experienced a pulmonary exacerbation as ‘being thrust out of their normality’:An infection is a burden for me every time. If I think, now I’m doing a bit better, then here comes the next blow. You’re glad to be going through a good period and then, the next setback comes. I live with it but it’s also the case that problems with my lungs have increased in recent years… more and more reduced lung function. …It hasn’t been at all stable recently. (ID 32)Most patients reported that their lowest point was on the day of starting treatment or immediately before: first, the symptom burden was high and second, the moment of accepting the necessity of antibiotic treatment was emotionally the most burdensome moment. And when I come out of the pharmacy with all of these bags full of material for the intravenous treatment. That’s the moment where you know: ?OK, I can pretty much write off the next two or three weeks?. ….Because it’s kind of a different life during this period. (ID 10)Coughing up blood, severe breathlessness due to coughing attacks or an overwhelming lack of energy were experienced as threatening symptoms, sometimes even life threating (existential threat) and memories of earlier pulmonary exacerbation experiences may be brought on:Because of all of the experiences I’ve been through, there’s a certain recognition. Maybe a bit of fear, that it could get worse, that I have to cough up a ton [massive amount] of blood. You’ve got all of the scenes from what happened before on your mind... and they replay over and over again. (ID 61)Patients who suffered from such comorbidities as depression and rheumatic disease reported that those impacted symptom perception, e.g. depression increasing the lack of energy or rheumatic disease causing joint pain.Maintaining normality, getting better and not harming the lungs (regaining distance from threat) were the important outcome goals during the phase ‘noting a change’. To achieve these goals, patients applied different self-management strategies: they observed and evaluated their symptoms continuously and compared them with earlier pulmonary exacerbation experiences. Encountering a symptom pattern that patients did not typically connect with pulmonary exacerbation prolonged this phase.One time I have blood in my sputum. One time I have HIGH fever, one time not so high. One time I have no appetite, another time I have. There are always different symptoms, all somehow mixed up together. …I can’t tell in advance if it’s something serious or not. Next time I’ll go sooner to see what’s going on, because I know I could be totally mistaken again. (ID 50)Patients tried to make good decisions regarding treatment and subsequent self-management strategies whereby ‘good’ meant that they could be incorporated into their daily lives. Illness beliefs had a great impact on decision-making. Patients who believed that they had an infection or pneumonia rather than just having a cold or a cough and who believed that untreated exacerbations could destroy their lungs and may restrict their life in the long-term were motivated to seek early treatment, but also felt very threatened by the infection:In the back of my mind I know that my lungs can only get worse, and the doctor has told me that the lungs decline after every lung infection. And I thought of this when I had the infection, and had a huge panic attack. (ID 36)Most patients knew other peers with CF or were in constant contact over social media with the larger CF community. Those exchanges influenced beliefs about treatment and the subsequent decision-taking. Patients who delayed help-seeking believed that not every exacerbation must be treated with oral or intravenous antibiotics, feared that antibiotics help less with ongoing disease, or believed that antibiotics burden the body. Patients favoured home intravenous therapies if they had a mild infection, had experience and the requisite self-management skills with self-administration of intravenous therapy. Home administration was also preferred if the patient’s living situation (purpose in life) conflicted with a hospital stay because they had care responsibilities towards children or pets or felt some obligation to be present at work (working situation). Some patients believed hospital treatment to be more effective than home intravenous treatment.Waiting until the antibiotics helpPatients generally experienced a peak of symptom burden at the start of treatment and in the first days of antibiotic treatment, often accompanied by a lack of control over bodily symptoms, particularly coughing, and an overwhelming lack of energy. These were so strong for some patients that they felt that CF took control of the body and that the body dominated life (domination of CF): You’re kind of at the mercy of your body and you just have to wait until your body responds to the treatment. In that moment I have to admit that my body is stronger than my own will. I can’t fight against it, just have to accept it. (ID 67)Symptoms and treatment consumed a substantial part of the patients’ energy which had already been depleted. Coughing in particular was reported to take a lot of energy. Often symptoms like night time coughing affected sleep. Additionally, decreased muscle strength and weight loss added to the lack of energy, leading to loss of appetite. The treatment consumed energy as well: airway clearance therapy triggered energy-depleting coughing and some patients reported fatigue as a side-effect of the intravenous antibiotics (consumption of energy). Just after the infusion, I’ve felt so weak that I had to immediately get into bed and rest for at least an hour. In the morning I’ve inhaled, coughed up, inhaled. I need at least an entire hour for everything. Then I am totally exhausted. Also after a coughing attack, I completely collapse, so that I’m not able to do anything for a while. I have to recover first. Then, I just need quiet, otherwise I just can’t recover from this exhaustion. (ID 32)During this phase, patients might reach a new peak of their symptoms such as they had never experienced before and by which they felt greatly threatened. Some perceived this as a foretelling of the future or even death (existential threat). Patients listed for transplant reported thinking often at this point about the lung transplant and hoping that the wait would not be too long.It (the pulmonary exacerbation) gives you a taste of what it’s going to be like when it is eventually over. … And then you know: ok, this might be what’s normal for the next few years or a couple of months. That can make you anxious. (ID 62)To the point that you think you won’t make it another two three months … sometimes it feels like you would drown in your own sputum. (ID 92)It was especially worrisome for patients if symptoms did not improve as expected. This fear was either reinforced or lessened by objectively measurable signs like lung spirometry or weight loss, confirming or contradicting their perceptions (existential threat). Bodily symptoms (e.g. a bit short of air or breathlessness, lack of energy or coughing) limited physical activity and led to the feeling of being restricted in essential tasks such as caring for oneself (restriction activity and freedom). I found that really harsh because I had never been affected by an infection to that extent before... it was a bit of a shock that you aren’t even able to brush your teeth or comb your hair. (ID 67)If hospitalized, some patients experienced the separation from loved ones and beloved pets as burdensome. If isolated due to multi-resistant bacteria, loneliness was considerable (separation from others), as one patients stated: In the hospital the loneliness is enormous. The absolute rock bottom when you have an infection is the loneliness. (ID 91)Most patients experienced a significant improvement in symptoms, usually in three to five days: the point of change. The point of noticeable symptom change was characterised by a decrease in symptom severity, an increase in energy and positive emotions like ‘joie de vivre’.When the antibiotic has taken effect, you feel hopeful again and then you see a bit of light at the end of the tunnel where before there’s just darkness. (ID 90)It’s rather hard at the beginning because you feel ill, you have to do the IV, you’re restricted and the intravenous treatment is rather aggressive, and you notice side effects. But you also notice it quickly when the antibiotics really take effect. I noticed that I felt better and there’s this feeling of happiness inside. (ID 10)For patients with severe CF lung disease (FEV1 <40% ), this phase often took longer and the improvement of symptoms grew less with each subsequent pulmonary exacerbations. Two patients with end-stage lung function awaiting lung transplant did not experience this point of change clearly, but rather experienced constant ups and downs.During the first phase of the pulmonary exacerbation, getting better and regaining control of symptoms were the predominant outcome goals for patients.Returning to normalityAfter patients experienced a significant improvement in symptoms, normally three to five days after start of the antibiotic treatment, they attempted to return to normality. They had more energy for doing chores or undertaking things. Patients reported that the first sense of normality came when they felt a desire to get things done or to do chores at home again:Normality returns … when I suddenly feel like doing things again. Then I know: yes, then it’s good. When I get restless and no longer want to stay home, or I do this or that, or do some more work at home. (ID 90)During this period, hospitalised patients often chose to continue with intravenous antibiotic therapy at home, which supported their sense of ‘normality’. Patients who started intravenous therapies in hospital reported great relief upon coming home, because they felt a sense of belonging (separation from others) and freedom (restriction in activity and freedom). I got back to normal from the day that I was allowed to go home (to continue with home intravenous therapies)…. I was really happy on that day, as if it had all never happened. As of that day I’ve also started to gain weight. It was as if a great weight had been lifted from my shoulders… you have animals around you again, your family is there again… then you can forget the rest. In the hospital you’re almost forced to think of it (CF). (ID 36)The best day was when I could go home. … I was within my four walls again. Yeah, it’s pretty simple... FREEDOM. (ID 91)In this period, symptoms improved further, but were not yet returned to normal. Often patients still suffered from reduced energy or from coughing during physical activity. Some patients were especially distressed if symptoms interrupted social interactions. Especially as regards coughing, since it was triggered by laughing, having sex or common physical activity which meant a moment of intimacy or a shared relationship was disrupted. Some patients also mentioned that inhalation therapy kept them from being with and meeting others because they did not want to cough up sputum in front of others (separation from others). In this period, treatment burden remained unchanged or the time needed even increased. Patients reported that intravenous antibiotic treatment dictated their daily schedule, as they were homebound and consequently restricted in their sphere of activity; consumed time and energy as patients needed an additional one to three hours per day for the intravenous-treatment; and in one patient interrupted sleep with his having to keep to a strict six or eight hour treatment plan; or in another patient when spending the night in the emergency unit, having to change the intravenous access (restriction in activity and freedom, consumption of energy).What bothers me is kind of that I’m not as free. I always have to invest the time before I go to bed or before getting up. I have to schedule in the time. …I really budget for the time. (ID 34)Additionally, resuming normality brought new challenges such as completing daily chores and meeting one’s own expectations. Generally, patients’ expectations regarding participation in daily activities rose in this period. If they were not able to meet them, patients experienced some distress. Patients were unable to fulfil their usual work load due to limited concentration, could not exercise as usual or go out because of limited energy, or a single mother could not live up to her own expectations regarding childcare due to fatigue (hindrance in daily activities).You feel restricted because you can’t do the things that you would like to do. Whether that’s to go out more, or more sports. (ID 62)Reestablishing normality in life was the important outcome goal for patients during the phase ‘returning to normality’. This was dependent on patients’ purpose in life and working situation ‘normality’ differed from person to person. For some, it was important to be with their loved ones again (belonging to social network), for others restarting activities such as going to work or childcare (fulfil own expectations).Administering antibiotics at home was one strategy often applied to combine non-illness-specific daily demands with illness-specific demands. For some, this resulted in excessive demands, especially if combining full-time work with an intravenous regimen requiring administration four times a day (treatment modality) and a not fully functioning intravenous access.Establishing (new) normalityPatients reported that with finishing the antibiotic treatment they had a feeling of ‘being normal again’:You take the venous catheter out and you’re OK and then normal life starts again …It’s a bit like when you run a computer at full speed and then have to turn off the power switch and you have to start it again and do the system check until the black screen comes up that shows strange stuff. The phase is kind of like that. (ID 10)Full normality was established after some weeks or even two to three months after having achieved the same or similar level of physical performance. For some patients, ‘new’ normality described living with a slightly reduced level of physical performance. Some patients reported that increased symptoms, e.g. breathlessness and lack of energy, made keeping up with others impossible and also led to separation.It’s also hard to find something that you can join in on. Like for example, hiking: I just can’t do that. I’m getting along with people well and then they do something that I just can’t take part in. (ID 88) On the other hand, feeling socially embedded helped some patients to overcome distress due to separation (family and friends). Patients reported as especially frustrating not having any influence on preventing a pulmonary exacerbation and experiencing new symptoms shortly after having finished the last IV. After an initial period of anger and frustration, they felt downhearted and powerless (domination of CF).I’m familiar with all of the feelings of disappointment ‘I just had antibiotics and already here’s another infection!’, or ‘it’s been pretty nice weather, how can there be another infection?’, or ‘I just put on a kilo, I should be doing well right now.’ It leads to frustration because you are completely powerless. (ID 63)As pulmonary exacerbations were one indicator for the progress of CF lung disease, health professionals often raised topics such as disability insurance or lung transplantation as the ultimate therapy option during or after such episodes. Some patients reported that after an infection they switched in their ‘normal’ modus where CF and illness was put in the background and that they felt less open to discuss illness-related issues:Then suddenly you’re confronted with things like disability benefits. The doctor asks me ‘What? You have NEVER thought about that?’ Then you feel so... yeah, I really should have earlier … Yeah, now I’m almost under a bit of pressure, now I have to change something. It was exactly like that with the issue of the ‘lung transplant’. For me it was also, um, it’ll happen at some point. (ID 67)Decreasing treatment burden to a minimum and gaining distance from threat were patients’ outcome goals in this period. DiscussionThis study is the first that explores in depth the pulmonary exacerbation trajectory in individuals with CF from the patient’s perspective and uses a longitudinal design in a subsample. The trajectory progressed from the patient noting a change, waiting until the antibiotics helped, returning to normality, and establishing new normality. Phases of the pulmonary exacerbation trajectory have also been reported in chronic obstructive pulmonary disease (COPD), with three phases - change, seeking care and recovery – being identified PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MZWlkeTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl

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ADDIN EN.CITE.DATA (Leidy et al., 2010). The differences between our study and Leidy et al’s regarding phases may be explained in two ways. First, the work of Leidy focused on the detection and severity of a pulmonary exacerbation, a different conceptual approach from ours, in which phases were differentiated on characteristics of symptom and treatment experience, self-management strategies, and outcome expectations. Second, experience of a pulmonary exacerbation may differ between COPD and CF patients. The younger CF population is confronted with multiple demands of work, family and treatment, and home intravenous therapies are a common treatment option ADDIN EN.CITE <EndNote><Cite><Author>Cystic Fibrosis Trust</Author><Year>2009</Year><RecNum>647</RecNum><DisplayText>(Cystic Fibrosis Trust, 2009)</DisplayText><record><rec-number>647</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1490172103">647</key></foreign-keys><ref-type name="Standard">58</ref-type><contributors><authors><author>Cystic Fibrosis Trust,</author></authors></contributors><titles><title>Antibiotic Treatment for Cystic Fibrosis - Report of the UK Cystic Fibrosis Trust Antibiotic Working Group</title></titles><dates><year>2009</year></dates><urls></urls></record></Cite></EndNote>(Cystic Fibrosis Trust, 2009). For this reason, resumption of normal life may be a much more prominent topic amongst this population, explaining the patients’ differentiation of these phases. This qualitative study was guided by Symptom Management Theory PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb2RkPC9BdXRob3I+PFllYXI+MjAwMTwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA (Korpershoek, Vervoort, Nijssen, Trappenburg, & Schuurmans, 2016; Laue, Melbye, & Risor, 2017). Consequently, illness-related emotional distress, the role of beliefs and patient outcome expectations has to be taken into consideration if the Symptom Management Theory is being used to guide interventions in acute episodes. This is a novel finding.It was clear from the data that pulmonary exacerbations are episodes during which patients experience peaks of illness-related feelings of threat and loss of control. The perception of threat during a pulmonary exacerbation was substantial in some of our participants; one patient reported living through this sort of threatening experience repeatedly. Experiencing loss of control and existential threat are characteristics of a traumatic experience and are also two main components of post-traumatic stress disorder ADDIN EN.CITE <EndNote><Cite><Author>American Psychiatric Association</Author><Year>2013</Year><RecNum>557</RecNum><DisplayText>(American Psychiatric Association, 2013)</DisplayText><record><rec-number>557</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1483544930">557</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>American Psychiatric Association,</author></authors><tertiary-authors><author>fifth edition</author></tertiary-authors></contributors><titles><title>Diagnostic and Statistical Manual of Mental Disorders (DSM–5)</title></titles><dates><year>2013</year></dates><urls></urls></record></Cite></EndNote>(American Psychiatric Association, 2013). Both were reported in the current study. In recent years, the body of research investigating the role of post-traumatic stress disorder after pulmonary exacerbation in COPD has grown, indicating that symptoms related to post-traumatic stress disorder increase as the patient’s exacerbation progresses PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UZWl4ZWlyYTwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+

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ADDIN EN.CITE.DATA (Trollvik, Nordbach, Silén, & Ringsberg, 2011). This novel finding is important and merits further attention from researchers, given that pulmonary exacerbations subjectively experienced as ‘severe’ have been found to have an impact on long-term depressive symptomatology in CF PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PbHZlaXJhPC9BdXRob3I+PFllYXI+MjAxNjwvWWVhcj48

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ADDIN EN.CITE.DATA (Olveira et al., 2016). This is particularly so in CF, as a decline in lung function predicts a decline in physical, social and emotional functioning ADDIN EN.CITE <EndNote><Cite><Author>Abbott</Author><Year>2013</Year><RecNum>3367</RecNum><DisplayText>(Abbott, Hurley, Morton, &amp; Conway, 2013)</DisplayText><record><rec-number>3367</rec-number><foreign-keys><key app="EN" db-id="9f99xavz1dt9a8e0999v2edkv0se2fzze2fe" timestamp="1491971771">3367</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Abbott, J.</author><author>Hurley, M. A.</author><author>Morton, A. M.</author><author>Conway, S. P.</author></authors></contributors><auth-address>School of Psychology, University of Central Lancashire, Preston, UK. jabbott@uclan.ac.uk</auth-address><titles><title>Longitudinal association between lung function and health-related quality of life in cystic fibrosis</title><secondary-title>Thorax</secondary-title></titles><periodical><full-title>Thorax</full-title></periodical><pages>149-54</pages><volume>68</volume><number>2</number><edition>2012/11/13</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Cystic Fibrosis/*physiopathology</keyword><keyword>Female</keyword><keyword>Forced Expiratory Volume</keyword><keyword>Health Status</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Prospective Studies</keyword><keyword>*Quality of Life</keyword><keyword>Young Adult</keyword></keywords><dates><year>2013</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1468-3296 (Electronic)&#xD;0040-6376 (Linking)</isbn><accession-num>23143792</accession-num><urls><related-urls><url>;(Abbott, Hurley, Morton, & Conway, 2013). Our findings further suggest that self-management interventions during pulmonary exacerbations should aim to increase the patient’s feeling of control and decrease feelings of threat.The strength of this study was the longitudinal exploration of the pulmonary exacerbation experience in a subsample which made a description of the phenomenon over time possible. A limitation of this study is that it included only nationality anonymized patients from a single centre. There was consequently little cultural diversity in this study’s sample. It is likely that exacerbation and symptom experience are influenced by cultural values and the health-care system (Bacon et al., 2009, Dodd et al., 2001), therefore, pulmonary exacerbation experience may be different in other cultures.ConclusionThese findings highlight that health professionals must acknowledge emotional distress as a key driver for self-management decisions and consider the different sources of emotional distress within a shared-decision making process.Relevance for practiceThese finding provide an understanding for the patients’ experience of pulmonary exacerbations. They highlight that an assessment of patients’ distress and goals is a prerequisite for the development of patient-centered and patient-accepted care plans during pulmonary exacerbations. Nurses play a key role here, as they are involved in the management of CF exacerbations and provide self-management education and psychosocial support during these episodes PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZXJlbTwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+PFJl

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ADDIN EN.CITE.DATA (Conway et al., 2014; Kerem, Conway, Elborn, Heijerman, & Consensus, 2005). The nurses’ awareness and acknowledgment of patients’ experience may therefore make a substantial contribution to a better communication and interaction between patients and the CF team during pulmonary exacerbations.Furthermore, these findings will inform and provide invaluable guidance for future research to develop interventions and patient-reported outcome measures to measure illness-related emotional distress.References ADDIN EN.REFLIST Abbott, J., Hurley, M. A., Morton, A. M., & Conway, S. P. (2013). Longitudinal association between lung function and health-related quality of life in cystic fibrosis. Thorax, 68(2), 149-154. doi:10.1136/thoraxjnl-2012-202552American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders (DSM–5) (f. edition Ed.).Balaguer, A., & Gonzalez de Dios, J. (2012). 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