Needs Assessment and Decision-making Tool (NEAT-decision) Integrated in a Clinical Practice to Enhance Patient Involvement in Head and Neck Cancer Rehabilitation - a Randomized Controlled Trial
Phase: NA
Conditions: Head and Neck Neoplasms
Sponsor: Rigshospitalet, Denmark

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Needs assessment and decision-making tool (NEAT-decision) integrated in 
clinical practice to enhance patient involvement in Head and Neck Cancer 
Rehabilitation  - a randomised controlled trial 
 
 
Date: January 31, 2018 
 
 
 
 

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Background 
The global incidence of Head and Neck Cancer (HNC) is approximately 650,000 per year [1]. Prevalence in 
the Nordic Countries is 32,500 with an incidence of 4100 annually [2][3][4] and in Denmark there is a 
prevalence of 8800 with an incidence of 1300 annually  [5][6][7]. The five year survival rate is 68% [8].  
Head and neck cancer is a heterogenous disease, which involves tumors in the oral cavity, naso-, oro-, and 
hypopharynx and larynx [9]. More than 90% of malignancies affecting head and neck are squamous cell 
carcinomas [10]. Risk factors for HNC are primarily linked to lifestyle factors, such as excessive use of 
tobacco and alcohol [9][10] and HPV-positive oral cancer is linked to sexual behavior [11].Treatment for 
HNC is typically surgery, radiotherapy and chemotherapy. One modality or a combination may be used [10]. 
Treatment at an early stage is most effective, however many patients with head and neck cancers, 
especially oral cancer, are diagnosed at a late stage [12].  Due to the anatomical sites of the tumors and its 
treatment, functional abilities can be compromised affecting the patients’ psychological and physical 
wellbeing and social functioning [13][14][15].  
The most common complications and sequelae include pain and difficulties with nutrition, voice, 
swallowing, disfigurement, social life and psychological distress [16][17][18][19][20][21][22]. Artificial 
nutrition support  and an artificial voice [18] may be indicated and the patient may suffer from facial 
disfigurement due to reconstructive surgery [23].  
Patients will experience multiple symptoms occurring concurrently. One symptom may compound another 
or symptoms may be interrelated affecting quality of life (QoL) more negatively due to the synergistic effect 
of multiple symptoms [24].  Furthermore interrelatedness exists between the symptom burden, poorer 
physical functioning, social dysfunction and psychological distress [25]. Patients tend to withdraw from 
social life, due to disfigurement, problems with speech and eating in public or just interacting with partners, 
family and friends. Increased social isolation may be a risk factor for poorer physical recovery from the 
effects of the illness and treatment [26]. Some patients with HNC have a limited social network and/or no 
partner [27] and lower affiliation to the work force [28] than patients with other cancers, which may 
intensify the challenges of managing burdensome symptoms. Other factors of influence include  lower 
educational level or low income [29]. Two years after diagnosis, Danish HNC patients are among those with 
the highest symptom burden, compared to other cancer diagnoses [30]. Finally, HNC is found to be more 
emotionally traumatic than any other type of cancer [31] and there is a high prevalence of emotional or 
psychological distress in patients with head and neck cancer, again leading to poorer QOL [32]. 
Life as it was prior to the disease and treatment cannot be the same afterwards, yet prevention of sequela 
could give patients better QOL long term. Therefore, there is a need to prevent or alleviate symptoms and 
the early and late negative effects of the disease and its treatment. Symptoms that could lead to sequela 
need to be assessed and managed early by referral to specialist follow-up i.e. speech-language pathologist, 
physio-and occupational therapists, dietician, clinical nurse specialist and psychologist [33][34][35]. To a 
greater extent, patients with HNC come from backgrounds of short education and manual labour, which 
place them at risk for health disparity [36][37][38]. The type and quality of decision-making tools  used to 
assess health and rehabilitation needs are important to consider in patients with low health literacy [39].  
Acknowledgment of the importance of patient-involvement in needs assessments using Patient Reported 
Outcomes (PRO) is growing. However present PRO questionnaires have certain limitations. Firstly, they 
have been developed for research purposes, therefore little is known about how these can be applied  in 
the clinical setting to obtain the patient’s information on the symptoms experienced[40]. Secondly, PRO 
questionnaires do not incorporate needs assessments [40]. Finally, there is currently, a lack of knowledge 

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regarding   which type of decision making assessment tool would be optimal in patients with short 
education and low health literacy. 
 
Study hypothesis and objective 
The study’s hypothesis is that a disease-specific patient-reported needs assessment tool integrated in the 
clinical management of HNC will increase patient involvement in decision making, control the short and 
long term symptom burden and improve short and long term health related quality of life (HRQoL) in HNC 
patients, primarily surgically treated. The purpose of the study is to investigate whether a systematic 
patient reported needs and concerns assessment integrated prior to and during consultations with health 
care professionals (HCP), is feasible and safe, and will improve patient involvement in decision making 
during the consultation. Further, whether patient involvement will result in increased referral to the multi-
disciplinary team and ultimately reduce the symptom burden, improve physical, mental and social 
wellbeing and global HRQoL.  
 
Study designs and methods 
Study one is a literature review exploring early and late physical and psychosocial effects of surgery. Study 
two is designed as a qualitative study exploring nurse-patient interactions during formal and systematic 
rehabilitation consultations. Study three is a randomized, controlled trial (RCT) on the effect of applying a 
disease-specific needs and concerns assessment instrument in the context of clinical nurse consultations 
assessing and managing the patient’s rehabilitation needs.  Prior to the RCT, a cross-cultural validation of 
the instrument Patient Concerns Inventory (PCI) will be carried out. The PCI was developed at Aintree 
University Hospital, Liverpool, Great Britain, specifically for HNC patients[41] and since the PCI functions 
with a touch screen solution, an IT solution will be developed. The randomized controlled study will include 
a control group (CG) and intervention group (IG) and take place at the Department of Otolaryngology, Head 
and Neck Surgery and Audiology, (Dept. ORL, H&N),Copenhagen University Hospital, Rigshospitalet.  
 
Study one – Literature Review 
Aim 
To conduct a literature review to explore the early and late physical and psychosocial effects of patients 
primarily surgically treated for oral cancers and to investigate the factors that influence these effects. 
 
Material and methods  
Perform a systematic literature search in PubMed, Cinahl and PsycInfo, using the Boolean search operators 
and the search words: mouth neoplasms, rehabilitation, oral surgery, anxiety, body image, depression, 
distress, dysphagia, eating, pain, psychosocial, speech and swallowing. Include English language 
quantitative and qualitative articles published between January 2004 and January 2014 that investigates 
physical and psychosocial wellbeing in patients primarily surgically treated for oral cancer (non HPV-
induced squamous cell carcinomas) at one or more time points along the treatment trajectory, including 
time of diagnosis. Exclude articles that includes samples of patients with diagnoses other than non-HPV 
induced squamous cell cancer of the oral cavity and/or only treated oncologically, as well as articles 
describing surgical procedures. 
Methodological and statistical quality of the included  studies will be assessed independently by two 
persons using a 7-item criteria checklist [42]. The number of articles accessed, screened and read, will be 
noted, as well as time of measurements; types of articles (quantitative or qualitative articles) and study 

4 
 
designs. Finally the key areas of the physical and psychosocial early and late effects of the surgical 
treatment for oral cancers and the factors that influence these effects will be summarised. 
The literature review has been published (Mortensen, A; Jarden, M. “Early and late physical and 
psychosocial effects of primary surgery in patients with oral and oropharyngeal cancers: a systematic 
review,” Oral Surg. Oral Med. Oral Pathol. Oral Radiol., vol. 121, no. 6, pp. 583–594, 2016).   
Study two – Qualitative study 
Aim 
To explore the nurse-patient interaction, patient involvement and communication practices during nurse 
consultations in post-surgical patients with head and neck cancer. 
 
Methods and procedures 
An exploratory and descriptive qualitative study informed by ethnographic fieldwork. The study will include 
nonparticipant observations during nurse  consultations, individual patient interviews and focus group 
interviews with nurses performing  nurse consultations, employing Interpretive Description [43][44]. 
 
Population and recruitment 
Included are patients, who have been diagnosed and treated surgically for head and neck cancer, at stage 
T3 or T4, and able to speak and understand Danish. Excluded are patients treated surgically for thyroid or 
parotic cancers, patients referred to adjuvant radio – or chemotherapy and patients with unstable 
psychiatric illness.  
Patients  (n=15) will be informed about observational studies through posters in Dept. ORL, H&N on the 
observation days during June – July 2017 and January 2018. Using purposive sampling, patients (n=15) will 
be recruited for individual interviews after surgery for Head and Neck Cancer, from Dept. ORL, H&N,   at the 
following three time points: before discharge, seven – ten days post-op and two months post-op in the 
period from December 2017 – February 2018. Nurses (n=4) who deliver  nurse consultations will be 
recruited for a focus group interview at the Dept. ORL, H&N, through individual contact during February 
2018. 
 
Data analysis 
The focus group interview and the individual interviews will be recorded digitally, transcribed verbatim and 
coded in the software program NVivo. Thematic analysis will follow a model where the transcriptions will 
be read and re-read, coded according to emerging themes, a clustering of themes and finally reaching a 
number of themes, which describes the patient’s and nurses experiences with nurse-patient interactions 
[45].  Observations will be recorded as short field notes during observations and following this expanded as 
notes in a text-file. The field notes will follow the same analytic process as the interviews. Researcher 
triangulation will be applied.  
A detailed project description for this part of the study is attached (Appendix I) 
 
Study three – Randomized controlled trial  
Aim  
To evaluate the safety and effect of the PCI integrated in clinical practice. Specifically, to investigate 
whether patients and Health Care Professionals (HCP) find the PCI applicable and useful in assessing and 
managing care and rehabilitation needs. Furthermore, whether patients are referred more often to multi-
disciplinary follow-up, which types of follow-up and whether the new needs assessment and decision-

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making tool improves the interaction between HCPs and patients. Lastly, to explore whether patients 
experience a reduced symptom burden and improved HRQoL. 
Linguistic and cross cultural validation of the PCI and Development of an IT-solution  
Prior to the RCT, a linguistic and cross cultural validation of the PCI and development of an IT-solution within the 
context of a head and neck department in Denmark will be carried out. The PCI is a 57 item solution, where patients 
can select a range of items related to functional, emotional, social and existential areas [46] using touch screen 
buttons, which allows the patients to choose the items, they wish to discuss with the HCP. This enables the patient to 
express their concerns and symptoms and choose those items, they find important and meaningful to discuss. The PCI 
includes a brief electronic version of the University of Washington Quality of Life Questionnaire (UW-QoL), which aids 
the HCP in addressing needs that the patient may not be attentive to [41].  
The IT-solution functions with ‘buttons’ on a touch-screen. Each ‘button’ corresponds to one item. Thus the solution 
makes it easy to attain an overview of the items [41].The solution has been approved by Center for It, Medico and 
Telephone (CIMT) of the Capital Region, who requires that the actual programming is done by a private company (l-r 
software a/s). A four step validation process will follow the EORTC-guidelines for cross-cultural adaptation of QoL 
questionnaires [47] and include linguistic and cultural validation, but not psychometric, as the PCI is not a QoL 
questionnaire: (1) forward and (2) backward translation, (3) pilot testing  a paper version by HNC patients (n=10) and 
patients from patient networks (Dansk Landsforening for Hals- og Mundhuleopererede and Netværk for hals og 
mundhulekræft) . The testing will include interviews based on a brief structured questionnaire on the understand 
ability of the PCI [47].  (4) Finally, to ensure IT-solution suitability in clinical practice, it will be pilot tested by HNC 
patients (n=10), who will be interviewed on the basis of a brief questionnaire on the applicability and usefulness of the 
touch-screen solution. An in-depth validation protocol is attached (Appendix II). Two native Danish and English 
speaking persons will be asked to carry out the forward and backward translation. Patient recruitment for step 4 
(n=10) and 5 (n=10) of the validation process will be identical. The inclusion and exclusion criteria are the same as in 
study two. The PCI and IT-solution will be tested and re-tested on new patients until problems with 
comprehensiveness is resolved. A final translation report will be sent to consultants at Aintree Hospital, Liverpool for 
approval. 
 
Design and methods (Figure 1 attached) 
The study is designed as a two arm randomized controlled study with a control group (CG) and intervention 
group (IG). Patients will be randomized via Research Electronic Data Capture (REDCap), an electronically 
based system for keeping research data, containing a randomisation module. Patients will be randomly 
assigned 1:1 to either CG or IG, stratified according to newly diagnosed and recurrences. The assignments 
will not be blinded to either investigator or patients. 
 
Population and recruitment 
Total study population (n=128).CG (n=64) and IG (n=64) will be recruited consecutively during hospital 
admission post-surgery from April 2018 - March 2019.  The inclusion and exclusion criteria will be the same 
as in study two.  
 
 
 

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Statistics 
The sample size of this study (n=128) is based on a power calculation with an SD of 20; effect size 10 and 
power of 0,8. SD is based on similar studies on Head and Neck patients [48] and effect size on 
recommendations from EORTC [49], further the sample size is based on previous research in the 
Department of ORL H&N, Copenhagen University Hospital. To account for an expected dropout rate and 
non-recruitment rate of approximately 20% [50][51], the number of  patients included in the study will be 
160.  Furthermore, based on the ratio between newly diagnosed patients and recurrences, we will stratify 
each study arm as follows; newly diagnosed (n=43) and recurrences (n=21). 
Procedures 
CG will receive standard care  according to the Danish Health and Medicine Board’s follow-up programme 
for HNC patients [52], which  requires all patients have their physical, emotional, social and existential 
needs assessed by interview with a HCP, at three time-points post-treatment. At present this is done at the 
Dept. of ORL, H&N during the admission period post-surgery, two weeks and two months post-surgery, by a 
staff nurse who is a member of the rehabilitation team who perform nurse  consultations. These 
consultations take place after the appointment with the surgeon. The nurse refers the patient to physical 
rehabilitation if needed. 
 
IG  will receive the PCI intervention integrated in clinical practice in accordance with present requirements 
as stated by the Danish Health and Medicine Board follow-up program for HNC patients [52]. The main 
investigator (AM) or the research assistant (a nurse from the rehabilitation team), will carry out the nurse 
consultation in 6 steps: 1. Welcoming the patient; 2. Introducing the patient to the PCI and guide in the use 
of this; 3. Starting with the symptoms and concerns the patient has highlighted in the PCI, the consultation 
will be based on these; 4. Follow up on the patients symptoms, concerns and emotional reactions or 
problems from a professional point of view; 5. Accompany and support the patient during the appointment  
with the surgeon and in cooperation with the patient and the surgeon ensure that problems arising from 
the nurse consultation needing medical attention are focused on; 6. Continue the consultation after the 
appointment with the surgeon; refer the patient to multi-disciplinary team members when needed. The 
nurse consultations will take place during the admission period post-surgery, two weeks and two months 
post-surgery. The management of symptoms arising from the needs assessment using the PCI, will be based 
on an evidence-based manual prepared for this purpose. In preparation of the intervention, the HCP 
multidisciplinary staff will be introduced to the intervention, including the use of the PCI, through written 
and oral information. The research assistant will be formally trained in the use of the PCI and interviewing 
patients with physical and emotional needs.  
  
Outcome measures 
Quantitative outcomes: The primary outcome  will measure the effect of the intervention by PRO quality of 
life and symptom questionnaire EORTC QLQ-H&N35. H&N35 is a 35-item questionnaire to be used with a 
core questionnaire[53]. The H&N module particularly measures oral pain, nutritional and voice problems. 
Patients will be asked to complete the EORTC QLQ-H&N35 at four time-points, 1) baseline (before 
randomisation) 2) between discharge and first follow-up in OPD 3) 7 days after first and 4) second post-
surgical appointments – by telephone. Presence and severity of symptoms will be evaluated by MDASI-HN 
(MD Anderson Symptom Inventory) which is a multi-symptom patient-reported outcome measure for clinical and 
research use ([54]). MDASI-HN is a 28-item questionnaire which measures symptoms of HNC patients. Finally the 
patients physical activity level will be measured according to the Saltin-Grimby Physical Activity Level Scale, which 

7 
 
is a four-item questionnaire measuring the patients activity level [55]. MDASI-HN and Saltins will be used at four  
time-points – baseline (before randomization); before discharge; at first and second post-surgical 
appointment.  Demographic and medical data (age, sex, diagnosis) will be registered at baseline and the 
types and number of multi-disciplinary referrals will be registered at each follow-up. The outcomes and 
items patients choose on the PCI will be registered. Finally the acceptance and adherence to the study will 
be assessed by registering the number of patients recruited and participating in the study and the attrition 
rate. 
 
Qualitative outcomes: Qualitative interviews and focus group interviews will be carried out at the second 
post-surgical appointment to explore patient and HCP perspectives regarding the use of PCI. The interviews 
will be based on semi-structured interview guides. For the qualitative individual interviews, patients from 
IG (n= 15) will be recruited at the OPD, at the two-week appointment, from August to September 2018  and 
carried out  October to November 2018 For the focus group interview, doctors and nurses (n=6-8) will be 
recruited at the Department from January  - February 2019 and carried out March 2019.  
 
Data and analysis  
The baseline demographic, medical data and number and types of referrals to multi-disciplinary team will 
be compared between the two trial arms using the chi-square test for categorical variables, the Student’s  
t-test for normally distributed continuous variables, and the Mann-Whitney test for non-parametric 
variables. Descriptive data will be presented as means with standard deviations, medians with inter-
quartile ranges or frequencies with percentage depending on the distribution of the variable. For the 
intervention group; feasibility, acceptance, adherence, attrition (and reasons) and safety will be calculated 
in mean and percentage. Data from the PRO questionnaires will be keyed in a database, compared across 
groups using SAS program to evaluate for statistical difference and effect size, by two-sample t-test.   
Analysis of covariance (ANCOVA) will be applied for comparisons of groups adjusted for, e.g. smoking and 
alcohol consumption status or sex. 
 
Qualitative: The focus group interview and the individual interviews will be recorded digitally, transcribed 
verbatim and coded in the software program NVivo. Thematic analysis will follow a model where the 
transcriptions will be read and re-read, coded according to emerging themes, a clustering of themes and 
finally reaching a number of themes, which describes the patient’s or HCP’s experiences with the PCI in the 
new model of care [45].  Researcher triangulation will be applied.   
A detailed project description for this part of the study will be developed. 
 
Ethical considerations  
Patients will receive oral and written information that participation is voluntary and that they may 
withdraw at any time without affecting treatment and care. Written informed consent will be obtained 
from patients participating at time of recruitment.  The Regional Ethics Committee of the Capitol Region of 
Denmark has been approached regarding approval of the study. They have assessed this and deemed an 
approval unnecessary (Jr. no: 16036032) 
The study has been approved by the Danish Data Protection Agency (RH-2017-264 ,I-Suite no: 05781) and 
will be sought registered at ClinicalTrials.com. The study will be carried out in accordance to the Helsinki 
Declaration and published according to Vancouver guidelines. 
 

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Clinical Perspectives 
This study has the potential to be a new model of care incorporated in the head and neck surgery 
department, by allowing the patient to set the agenda at nurse consultations and strengthening the needs 
assessments of the head and neck cancer patient. In collaboration with the health care professionals it may 
strengthen the referral to multi-disciplinary follow-up, thus having the potential to prevent the late effects 
of treatment for head and neck cancer, physically, emotionally, socially and existentially. It is designed 
pragmatically to fit into the existing clinical practice setting, enabling implementation.  The new model of 
care with head and neck patients could be implemented with other patient groups  and within an 
international framework.  
 
Network: 
This study is part of Models of Cancer Care Research Program, at Finsen Centre, Copenhagen University 
Hospital, Rigshospitalet 
 
Funding: 
Novo Nordisk Foundation 
Danish Nurses Organization 
Supervisors and institutional affiliation 
Main supervisor: Mary Jarden  
Associate Professor, Head of Research, PhD, MScN, 
Finsen Centre. 
Copenhagen University Hospital, Rigshospitalet 
University of Copenhagen, Department of Public Health 
 
Co-supervisor: Irene Wessel 
Consultant, Ph.D., associate professor 
Department of Otolaryngology, Head and Neck Surgery and Audiology  
Copenhagen University Hospital, Rigshospitalet 
 
Co-supervisor: Simon Rogers 
FRCS FRCS (Max) MD   
Professor Faculty of Health and Social Care, Edge Hill University, Liverpool  
Consultant Regional Maxillofacial Unit, University Hospital Aintree, Liverpool 
 
Co-supervisor: Tine Bloch Jensen 
Chief Nurse, Dpl. Public Administration (Health Management) 
Department of Otolaryngology, Head and Neck Surgery and Audiology  
Copenhagen University Hospital, Rigshospitalet 
 
Time Plan (Appendix III) 
GANTT-chart  
 
 
 

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Dissemination 
Publications:  Four publications are planned: 1) Literature review: ‘Early and late physical and psychosocial 
effects of primary surgery in patients with oral and oropharyngeal cancers: a systematic review’ (published) 
2) Qualitative study: An exploration of nurse-patient communication and interactions during rehabilitation 
consultations with Head and Neck cancer patients 3) Randomised controlled study: ‘Needs assessment and 
decision-making tool integrated in clinical practice to enhance patient involvement in Head and Neck 
Cancer Rehabilitation’  and 4. Qualitative findings: Feasibility and patient experiences of new needs 
assessment and decision-making tool integrated in clinical practice to enhance patient involvement in Head 
and Neck Cancer Rehabilitation. The articles will be published according to Vancouver guidelines in peer 
reviewed scientific journals as Head & Neck; Oral Oncology; Support Care Cancer; Cancer Nursing; 
European Journal of Cancer Care. 
 
Conferences: The results will be presented at international conferences: Society of Otolaryngology, Head-
Neck nurses (SOHN) annual congress; International Head and Neck Cancer Quality of Life Conference; 
Annual meeting on supportive care in cancer (MAASC), and national conferences: Nationalt Symposium for 
Fagligt Selskab for ØNH-kirurgiske sygeplejersker and Landskursus for Fagligt Selskab for 
Kræftsygeplejersker.  
 
 
 

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Rehabilitation for Advanced-Stage Radiated Head and Neck Cancer Patients,” Otolaryngol. -- Head 
Neck Surg., vol. 148, no. 4, pp. 625–632, 2013. 
[34] 
K. A. Hutcheson and J. S. Lewin, “Functional assessment and rehabilitation: how to maximize 
outcomes.,” Otolaryngol. Clin. North Am., vol. 46, no. 4, pp. 657–70, Aug. 2013. 
[35] 
M. A. Morgan, “Cancer survivorship: history, quality-of-life issues, and the evolving multidisciplinary 
approach to implementation of cancer survivorship care plans.,” Oncol. Nurs. Forum, vol. 36, no. 4, 
pp. 429–36, 2009. 
[36] 
J. G. Vartanian, A. L. Carvalho, J. Toyota, I. S. G. Kowalski, and L. P. Kowalski, “Socioeconomic effects 
of and risk factors for disability in long-term survivors of head and neck cancer.,” Arch. Otolaryngol. 
Head. Neck Surg., vol. 132, no. 1, pp. 32–5, 2006. 
[37] 
C. E. Moore, “Head and Neck Cancer Disparity in Underserved Communities: Probable Causes and 
Ethics Involved,” J. Health Care Poor Underserved, vol. 23, no. 4, 2012. 
[38] 
Sundhedsstyrelsen, “Ulighed i sundhed,” 2011. 
[39] 
K. Koay et al., “Suboptimal health literacy in patients with lung cancer or head and neck cancer,” 
Support. Care Cancer, vol. 21, pp. 2237–2245, 2013. 
[40] 
M. S. Donaldson, “Taking PROs and patient-centered care seriously: Incremental and disruptive 
ideas for incorporating PROs in oncology practice,” Qual. Life Res., vol. 17, pp. 1323–1330, 2008. 
[41] 
S. N. Rogers, J. El-Sheikha, and D. Lowe, “The development of a Patients Concerns Inventory (PCI) to 
help reveal patients concerns in the head and neck clinic,” Oral Oncol., vol. 45, no. 7, pp. 555–561, 
2009. 
[42] 
M. L. Longacre, J. A. Ridge, B. A. Burtness, T. J. Galloway, and C. Y. Fang, “Psychological functioning 
of caregivers for head and neck cancer patients.,” Oral Oncol., vol. 48, no. 1, pp. 18–25, Jan. 2012. 
[43] 
S. Thorne, Interpretive Description Qualitative Research for Applied Practice, Second. New York: 
Routledge, 2016. 
[44] 
S. Thorne, S. R. Kirkham, and K. O’Flynn-Magee, “The Analytic Challenge in Interpretive Description,” 
Int. J. Qual. Methods, vol. 3, no. 1, pp. 1–11, 2004. 

12 
 
[45] 
J. A. Smith and J. Osborn, “Interpretative Phenomenological Analysis,” in Qualitative psychology. A 
practical guide to research methods, 2008, pp. 53–80. 
[46] 
“Further analysis of the emotional consequences of head and neck cancer as reflected by the 
Patients’ Concerns Inventory - ClinicalKey.” [Online]. Available: https://www-clinicalkey-
com.ep.fjernadgang.kb.dk/#!/content/playContent/1-s2.0-
S0266435615001606?returnurl=null&referrer=null. [Accessed: 25-Feb-2016]. 
[47] 
D. Kulis, A. Bottomley, G. Velikova, E. Greimel, and M. Koller, “EORTC Quality of Life Group 
Translation Procedure,” 2017. 
[48] 
J. F. Carrillo, “The impact of treatment on quality of life of patients with head and neck cancer and 
its association with prognosis,” J. Cancer Surg., vol. 42, no. 2016, pp. 1614–1621, 2016. 
[49] 
K. Cocks et al., “Evidence-based guidelines for interpreting change scores for the European 
Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30,” Eur. 
J. Cancer, vol. 48, no. 11, pp. 1713–1721, 2012. 
[50] 
S. Al-Hayder, J. J. Elberg, and B. Charabi, “Clinical outcome and health-related quality-of-life 
following microsurgical reconstruction in patients with oral and oropharyngeal cancer,” Acta 
Otolaryngol., vol. 0, no. 0, pp. 1–5, 2016. 
[51] 
S. O. Rasmussen, M. B. Kristensen, I. Wessel, and J. R. Andersen, “Incidence and Risk Factors of 
Refeeding Syndrome in Head and Neck Cancer Patients—An Observational Study,” Nutr. Cancer, vol. 
68, no. 8, pp. 1320–1329, 2016. 
[52] 
Sundhedsstyrelsen, “Opfølgningsprogram for hoved- og hals- kræft,” 2015. 
[53] 
S. Singer et al., “Performance of the EORTC questionnaire for the assessment of quality of life in 
head and neck cancer patients EORTC QLQ-H&N35: A methodological review,” Qual. Life Res., vol. 
22, pp. 1927–1941, 2013. 
[54] 
C. S. Cleeland et al., “Assessing Symptom Distress in Cancer Patients,” Cancer, vol. 89, pp. 1634–
1646, 2000. 
[55] 
S. Bengt and G. Grimby, “Physiological Analysis of Middle-Aged and Old Former Athletes Comparison 
with Still Active Athletes of the Same Ages,” Circulation, vol. 38, no. December, pp. 1104–1115, 
1968. 
 
 
 

13 
 
Appendix I 
An exploration of nurse-patient interactions during nurse consultations with Head and Neck 
cancer patients - a qualitative study   
 
1. Background:  
Nurse-patient interaction is at the core of nursing care and may be planned with a therapeutic purpose 
or may occur spontaneously (in practice) (Evans 2016) involving physical, psychological, social and 
professional aspects as well as informative/instructional actions (Evans 2016).  The interaction is often 
based on verbal as well as non-verbal communication, as many nursing interactions and procedures can 
be performed without verbal interaction (Evans 2016).  Studies have shown that nurses tend to direct  
the goals of nurse-led consultations, but  allow for patient participation (Tobiano et al. 2016)(Mayor 
and Bietti 2017)(Brataas, Thorsnes, and Hargie 2010). Communication is an important and integral part 
of much nurse-patient interaction  (Evans 2016).There is a growing number of studies investigating 
communication between nurses and patients and the degree of patient involvement in head and neck 
cancer (HNC). These show  that nurses generally are skilful at informing about and responding to 
patient’s questions related to  medical issues (de Leeuw et al. 2014), but find it more difficult to 
respond to emotional cues (de Leeuw et al. 2014)(Sheldon, Hilaire, and Berry 2011). It has been found 
that nurses may acknowledge the cues, but choose to distance themselves from these in 
communication with the oncological or HNC  patient (de Leeuw et al. 2014)(Sheldon et al. 2011). 
Sheldon etc. al. found it to be important to be able to identify psychosocial needs in order to care for 
these needs or refer patients to professional support (Sheldon et al. 2011).  
However, studies have also shown that HNC patients  prioritize  medical information above  emotional 
support (Jabbour et al. 2017)(Salander et al. 2016). Furthermore the preferred modality of information 
differs depending on the patient’s educational level, and it has been shown that those of higher 
education have a preference for obtaining information from the Internet. However, all HNC patients 
prefer one-on-one communication/information from a healthcare professional(Jabbour et al. 
2017)(Papadakos et al. 2017). 
Finally studies have shown that patients coming from a background of short education, as some HNC 
patients do (Papadakos et al. 2017)(Olsen et al. 2015), are hesitant to express their own needs and 
need to be encouraged to do so (Protheroe et al. 2013). Nurse consultations take place in many 
settings in hospitals, however it is unclear what takes place in the interaction between the patient and 
nurse, during these consultations. Firstly it is not clear to which degree the patients find themselves 
involved in these consultations and secondly whether all patients, regardless of educational 
background, understand the information delivered during these consultations. 
 
2. Aim  
To explore nurse-patient interaction, patient involvement and communication practices during 
rehabilitation consultations in post-surgical patients with Head and Neck cancer (HNC).  
 
3. Methods 
An exploratory and descriptive qualitative study informed by ethnographic fieldwork. The study will 
include nonparticipant observations during nurse consultations (n=15), individual patient interviews 
(n=15) and focus group interviews with nurses performing nurse consultations (n=4), employing 
Interpretive Description (Thorne 2016) 

14 
 
Participants and setting: 
Study participants will be recruited from Dept. ORL, H&N. Included are patients, who have been 
diagnosed and treated surgically for head and neck cancer, at stage T3 or T4, and able to speak and 
understand Danish. Excluded are patients treated surgically for thyroid or parotic cancers, patients 
referred to adjuvant radio – or chemotherapy and patients with unstable psychiatric illness.  
 
Using purposive sampling, patients will be recruited in the post-treatment phase after surgery for Head 
and Neck Cancer in the bed ward before discharge, for interviews at three time points:  
1. before discharge in the bed ward 
2. 7 – 10 days post-operatively in the OPD 
3. 2 months post-operatively in the OPD 
Observations (n=5) and patient interviews (n=5) will be performed at each time point. 
 
Procedure 
Observations will be carried out by main investigator (AM), individual interviews by AM and research 
assistant (RM) and focus group interview by AM and research assistant (BN).Individual and focus group 
interviews will be based on separate semi-structured interview-guides. Interviews will be recorded 
digitally. 
Observations will be recorded by AM as short handwritten field notes during observations and 
following this expanded as field notes in a text-file. AM will situate herself in the field as a researcher 
and be conscious about her own previous role as a clinical nurse specialist. In order to perform an 
inductive analytic process, AM will also make field notes on her own experiences as a researcher in the 
field (Thorne 2016) 
 
Context - nurse rehabilitation consultations 
In the Department of Otolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet (Dept. ORL, 
H&N), formal nurse rehabilitation consultation takes place at three different time points post-surgically 
in Head and Neck cancer patients: 1. before discharge; 2. seven – ten days and  3. Two months 
postoperatively in the OPD. The purpose of the consultations are to evaluate the patient’s need for 
rehabilitation after surgical treatment for HNC in the areas of physical, emotional, social and existential 
needs and refer patients to multi-disciplinary follow-up if needed. 
 
Analysis 
Data will be analysed using Interpretive Description (ID) (Thorne, Kirkham, and O’Flynn-Magee 2004) 
(Thorne 2016) which is an inductive analytic approach designed to create ways of understanding clinical 
phenomena that yield application implications. When applying ID a concurrent data collection and 
analysis will take place, inspired by ethnographic analysis.  
The focus group interview and the individual interviews will be recorded digitally, transcribed verbatim, 
read and re-read in depth to get a preliminary understanding of the text, before coding in the software 
program NVivo (Bazeley and Jackson 2013). In order to conduct a  constant comparative analysis using 
ID, the further sorting of interview – and observational data will apply  systematic text condensation, 
using four steps: Total impression – from chaos to themes;  Identifying and sorting meaning units - from 
themes to codes; Condensation – from code to meaning; Synthesizing – from condensation to 
descriptions and concepts (Malterud 2012).  
Researcher triangulation will be applied. 

15 
 
4. Ethical issues 
Based on the ethical guidelines provided by the Northern Nurses’ Federation on nursing research in the 
Nordic countries (Federation 2003), the following ethical aspects of the project will be taken into 
consideration. The principles of autonomy; beneficence; non-maleficence and justice: this means that 
voluntary participation in the study will be ensured and any form of coercion avoided. Voluntariness 
will be based on oral and written information about the project. The information will be provided in 
such a manner that patients and nurses understand the purpose of the study and the consequences of 
their own participation, in this. Further is the self-determination of participants protected by ensuring 
that withdrawal from the project can take place without negative consequences. 
The information/data patients and nurses provide through observations and interviews will be treated 
in (such a manner) that their integrity will be respected and anonymity provided and finally it is 
ensured that the research will not be harmful to the participants in any way. 
Patients will be informed about observational studies through posters in Dept. ORL, H&N and individual 
patients will be asked to give oral consent to being observed prior to the observation. Nurses 
performing rehabilitation consultation will be informed through individual information and doctors and 
nurses through informational meetings and emails. 
Patients who participate in individual interviews will receive oral and written information that 
participation is voluntary and they may withdraw at any time without affecting treatment and care. 
Written informed consent will be obtained prior to the interview. Nurses participating in focus group 
interview will receive oral and written information. Written informed consent will be obtained prior to 
the interview. 
The study has been registered by The Regional Ethics Committee of the Capitol Region of Denmark (Jr. 
no: 16036032), the Danish Data Protection Agency (Jr. no: RH-2017-264, with I-Suite no: 05781) and 
will be registered with clinical trials.gov  
The study will be carried out in accordance to the Helsinki Declaration. 
 
5. Dissemination and outputs 
Publication:   
The study will be published according to Vancouver guidelines in peer reviewed scientific journals as 
Support Care Cancer; Cancer Nursing; European Journal of Cancer Care. 
 
Conferences: The results will be presented at international conferences as Society of Otolaryngology, 
Head-Neck nurses (SOHN) annual congress; International Head and Neck Cancer Quality of Life 
Conference; Annual meeting on supportive care in cancer (MAASC), and national conferences: 
Nationalt Symposium for Fagligt Selskab for ØNH-kirurgiske sygeplejersker and Landskursus for Fagligt 
Selskab for Kræftsygeplejersker.  
 
 
 

16 
 
6. References 
Bazeley, Pat and Kristi Jackson. 2013. Qualitative Data Analysis with Nvivo. Second. Sage. 
Brataas, H. V., S. L. Thorsnes, and O. Hargie. 2010. “Themes and Goals in Cancer Outpatient - Cancer Nurse 
Consultations.” European Journal of Cancer Care 19(2):184–91. 
Evans, Emily C. 2016. “Exploring the Nuances of Nurse-Patient Interaction through Concept Analysis: Impact 
on Patient Satisfaction.” Nursing Science Quarterly 29(1):62–70. Retrieved 
(https://moodle.chatham.edu/pluginfile.php/656741/mod_resource/content/2/Exploring the 
Nuances of Nurse-Patient Interaction through Concept Analysis.pdf). 
Federation, Northern Nurses’. 2003. Etiske Retningslinier for Sygeplejeforskning I Norden Etiske 
Retningslinjer for Sykepleieforskning I Norden Etiska Riktlinjer För Omvårdnadsforskning I Norden 
Hoitotyön Tutkimuksen Eettiset Ohjeet Pohjoismaissa Siðfræðilegar Leiðbeiningar Um Hjúkrunarrann. 
Jabbour, Joe et al. 2017. “Education and Support Needs in Patients with Head and Neck Cancer: A Multi-
Institutional Survey.” Cancer 123(11):1949–57. 
de Leeuw, Jacqueline et al. 2014. “Nurse-Patient Communication in Follow-up Consultations after Head and 
Neck Cancer Treatment.” Cancer Nursing 37(2):E1-9. 
Malterud, K. 2012. “Systematic Text Condensation: A Strategy for Qualitative Analysis.” Scand J Public 
Health 40(8):795–805. Retrieved (http://sjp.sagepub.com/content/40/8/795.full.pdf). 
Mayor, Eric and Lucas Bietti. 2017. “Ethnomethodological Studies of Nurse-Patient and Nurse-Relative 
Interactions: A Scoping Review.” International Journal of Nursing Studies 70:46–57. Retrieved 
(http://dx.doi.org/10.1016/j.ijnurstu.2017.01.015). 
Olsen, Maja Halgren et al. 2015. “Socioeconomic Position and Stage at Diagnosis of Head and Neck Cancer - 
a Nationwide Study from DAHANCA.” Acta Oncologica (Stockholm, Sweden) 54(5):759–66. Retrieved 
September 13, 2016 
(http://www.tandfonline.com.ep.fjernadgang.kb.dk/doi/abs/10.3109/0284186X.2014.998279). 
Papadakos, Janet et al. 2017. “Informational Needs of Head and Neck Cancer Patients.” Journal of Cancer 
Education 1–10. 
Protheroe, Joanne, Helen Brooks, Carolyn Chew-Graham, Caroline Gardner, and Anne Rogers. 2013. 
“‘Permission to Participate?’ A Qualitative Study of Participation in Patients from Differing Socio-
Economic Backgrounds.” Journal Of Health Psychology 18(8):1046–55. Retrieved 
(http://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,url,uid,shib&db=cmedm&AN=231
04997&site=ehost-live%5Cnhttp://hpq.sagepub.com/content/18/8/1046.full.pdf). 
Salander, Paer, Joakim Isaksson, Brith Granstrom, and Goran Laurell. 2016. “Motives That Head and Neck 
Cancer Patients Have for Contacting a Specialist Nurse - an Empirical Study.” Journal of Clinical 
Nursing 25(21–22):3160–66. 
Sheldon, Lisa Kennedy, Dany Hilaire, and Donna L. Berry. 2011. “Provider Verbal Responses to Patient 
Distress Cues During Ambulatory Oncology Visits.” Oncology Nursing Forum 38(3):369–75. Retrieved 
(http://onf.ons.org/onf/38/3/provider-verbal-responses-patient-distress-cues-during-ambulatory-
oncology-visits). 
Thorne, Sally. 2016. Interpretive Description Qualitative Research for Applied Practice. second. New York: 
Routledge. 
Thorne, Sally, Sheryl Reimer Kirkham, and Katherine O’Flynn-Magee. 2004. “The Analytic Challenge in 
Interpretive Description.” International Journal of Qualitative Methods 3(1):1–11. Retrieved 
(http://journals.sagepub.com/doi/10.1177/160940690400300101). 
Tobiano, Georgia, Andrea Marshall, Tracey Bucknall, and Wendy Chaboyer. 2016. “Activities Patients and 
Nurses Undertake to Promote Patient Participation.” Journal of Nursing Scholarship 48(4):362–70. 

17 
 
Appendix II 
Translation Protocol – Patient Concerns Inventory 
1. Background 
 
The Patient Concerns Inventory (PCI-H&N) is a 55-item checklist specifically designed for use in routine 
follow-up clinics for patients with head and neck cancer. The first version of the PCI, was developed in 
2007, in Liverpool, Great Britain [1] 
 
The PCI-H&N is not a traditional Patient Reported Outcome, measuring Health-Related Quality of Life (HR-
QoL) outcomes, as the concept of a PCI is broader than that of HR-QoL, since it allows patients to formulate 
an individualized record of their concerns, needs and priorities that can be used as a framework to help 
patient’s express their needs; guide out-patient consultations and promote multidisciplinary care [2] . The 
PCI-H&N has been validated in several other languages, including Norwegian. 
 
2. Aim 
The aim of this translation procedure is to perform a correct linguistic and cultural forward-and-backward 
translation of the Patient Concerns Inventory for Head and Neck Cancer patients into the Danish language. 
Pre-testing will be carried out in 10 surgically treated Head and Neck cancer patients in Denmark.  
 
The final Danish version should be comprehensible to Head and Neck cancer patients of all levels of 
education, culturally acceptable and inoffensive, reflect the wording and structure from the original source, 
as well as the standard layout and formatting for online survey including the paper-and-pen version. 
 
3. Methods 
The translation process will follow the guidelines of the EORTC [3] 
  
3.2. Forward translation 
For the forward translation process, two separate, independent persons will translate the PCI-H&N from 
English to Danish. The translation will be done by native speakers of Danish with a very good command of 
English (primary investigator AM and research assistant RM). They do not have to be professional 
translators.  
The forward translators will receive the English original PCI. In the translation process they will  make sure 
that the translations are correct regarding grammar, syntax, orthography and punctuation, that the 
language is of current use and comprehensible, and that the wording and structure of the translation 
follows the English original. 
 
3.3 Reconciliation 
The two forward translations are reconciled into one by MJ and AM.  The aim of the reconciliation is to 
choose or build from the two forward translations an optimal translation of each item. 
 
3.4 Back translation 
The reconciled translation is translated back into English by two translators working independently of one 
another (VK and CS). Optimally they should be native speakers of English, but if there are difficulties finding 

18 
 
such people, the back translations can be done by people who are not native speakers but have a good 
command of English. They do not have to be professional translators.  
The two translators should receive only the reconciled translation and should work independently and 
without knowledge of the original Inventory in English. In their translations they should follow the structure 
and wording as closely as possible in order to reflect the translation in an accurate way that allows MJ and 
AM to review the back translations.   
 
3.5 Back translation report 
The back translation report will be prepared by AM and include all five translations: two forward 
translations from English into Danish, the reconciled translation, the two back translations into English and 
any comments regarding the translations. 
 
3.7 Pilot-testing 
The translated PCI-H&N will be pilot-tested on a group of surgically treated Head and Neck cancer patients 
in order to check its comprehensibility in Danish. The group will comprise 10 patients and will be recruited 
from the Dept. Of Otorhinolaryngology, Head and Neck Surgery and Audiology, at Rigshospitalet, 
Copenhagen University Hospital. Patients may also be recruited from two patient head and neck 
associations : ‘Netværk for hals – og mundhulekræft’ and ‘Dansk Landsforening for hals – og 
mundhuleopererede’.  
 
Furthermore five  health care staff will be asked to check the comprehensibility of the PCI-H&N in Danish. 
The staff will be recruited by AM from the Dept. Of Otorhinolaryngology, Head and Neck Surgery and 
Audiology, at Rigshospitalet, Copenhagen University Hospital. 
All patients and health care staff should be native speakers of Danish and constitute a representative group 
in terms of socio-demographic characteristics (gender, age and education). 
 
The pilot-testing step consists of two parts: 
1. Patients and health care staff receive and complete the translated PCI-H&N. 
2. AM discusses the translation with the patients and health care staff individually. 
 
3.7.1 Pilot-testing interview 
When discussing the translation, AM will go through each part of the PCI-H&N asking the patients or health 
care staff whether the translation was: 
1. Difficult to answer 
2. Confusing 
3. Difficult to understand 
4. Upsetting/offensive 
A probe for general comprehension is the statement: How would you state this statement in your own 
words? 
If there are any comments, the patients should be invited to reword the statement in a way that would be 
easier to understand, less confusing, upsetting or offensive. 
 
 
 

19 
 
3.7.2 Pilot-testing report 
On the basis of the results of the pilot-testing, AM will compile a summary in the translation report. All 
items that elicited comments should be filled in with information on what the problem was, with the 
patients’ or health care staff’s comments translated into English, and analysis of the comments. If changes 
to the wording are suggested, they should be explained and the new version should be back translated into 
English. 
An electronic copy of the PCI-H&N response sheets filled in by patients and  health care staff should be 
added as an appendix to the report. 
The pilot-testing report will then be sent to Simon Rogers.  
 
3.7.3. Re-testing 
If any items elicited comments because of problems with comprehensibility AM suggests a change in the 
wording that was approved and the item will be re-tested on a few patients, including the patients that 
reported the comprehension problems and some that did not report problems. The re-test serves to ensure 
that the problem has been solved and that the new version is understandable for everybody. 
In the re-test, the interviewer should only check the items in question with the patients and not the whole 
inventory. The comments will be communicated to Simon Rogers as a written report. 
When all issues have been solved and all changes approved, AM will prepare the final translation based on 
the wording agreed upon in the pilot-testing phase. 
 
3.8 Final translation 
The final translation will be sent to Simon Rogers for final approval. Once approved, AM will terminate the 
translation project, making the translation available for use, archiving the documentation from the 
translation process. 
 
4. Copyrights of PCI-H&N and publication policy 
The final Danish version of the PCI-H&N will be used for assessing needs of Head and Neck patients and 
facilitate patient involvement in out-patient clinics without cost. The methods of responding to the Danish 
PCI-H&N in the project will be by tablets. The Danish PCI-H&N will be handled as confidential material as 
part of the protocol. The project group does not own the Danish PCI-H&N and for use of the Danish PCI-
H&N in another project or by other researchers, Edge Hill University and Professor Simon Rogers, University 
Hospital Aintree, Liverpool, Great Britain, will be contacted for approval and will decide whether the Danish 
PCI-H&N can be used in relation to their copyright policy. 
References: 
[1] 
S. N. Rogers, J. El-Sheikha, and D. Lowe, “The development of a Patients Concerns Inventory (PCI) to 
help reveal patients concerns in the head and neck clinic,” Oral Oncol., vol. 45, no. 7, pp. 555–561, 
2009. 
[2] 
S. N. Rogers and D. Lowe, “An evaluation of the Head and Neck Cancer Patient Concerns Inventory 
across the Merseyside and Cheshire Network,” Br. J. Oral Maxillofac. Surg., vol. 52, no. 7, pp. 615–
623, 2014. 
[3] 
D. Kulis, A. Bottomley, G. Velikova, E. Greimel, and M. Koller, “EORTC Quality of Life Group 
Translation Procedure,” 2017. 

20 
 
Appendix III 
Project Timeplan 
 
 
 
2017 
April 1 – Dec 31 
 
 
2018 
Jan 1 – Dec. 31 
 
2019 
Jan 1 – Feb 28 
 
2020 
 
 
 
4 
5 
56 
7 
8 
9 
10 
11 
12 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
1 
2 
3 
Project 
preparation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Part 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Validate PCI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Test PCI  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop IT-
solution 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Test IT 
solution 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ph.D. courses 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Manuscript 
preparation 2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Part 2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Project 
preparation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Qualitative 
study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study visit 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RCT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Interviews 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Focus groups 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analyse data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Manuscript 
preparation 3 
and 4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Write thesis