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General practitioner involvement in colorectal cancer survivorship care
Wieldraaijer, T.
Publication date
2019
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Final published version
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Citation for published version (APA):
Wieldraaijer, T. (2019). General practitioner involvement in colorectal cancer survivorship
care.
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General practitioner
involvement in
colorectal cancer
survivorship care
cancer survivorship care
General practitioner involvement in colorectal cancer survivorship care
Thesis, University of Amsterdam, the Netherlands Copyright 2019 © Thijs Wieldraaijer
ISBN: 978-94-6361-300-2
Paranymphs: Laura A.M. Duineveld & Partana Visser Lay-out & cover: Don Rhino Design & RWDesignStudio
Printing: Optima Grafische Communicatie, Rotterdam, the Netherlands
All rights reserved. No part of this thesis may be reproduced, stored or transmitted in any form or by any means without prior permission of the author or publishers of the included scientific papers.
This thesis was written at the department of General Practice of the Amsterdam UMC, location AMC.
Part of the research described in this thesis was funded by Alpe d’HuZes, part of the Dutch Cancer Society (KWF), grant number UVA 2013-5954.
Financial support for printing of this thesis was kindly provided by the SBOH, employer of GP trainees.
colorectal cancer survivorship care
ACADEMISCH PROEFSCHRIFT
ter verkrijging van de graad van doctor aan de Universiteit van Amsterdam
op gezag van de Rector Magnificus prof. dr. ir. K.I.J. Maex
ten overstaan van een door het College voor Promoties ingestelde commissie, in het openbaar te verdedigen in de Agnietenkapel
op woensdag 13 november 2019, te 12.00 uur
door Thijs Wieldraaijer geboren te Arnhem
Promotores Prof. dr. H.C.P.M. van Weert AMC-UvA Prof. dr. W.A. Bemelman AMC-UvA
Copromotor Dr. J. Wind AMC-UvA
Overige leden Dr. K.M. van Asselt AMC-UvA Prof. dr. N. van Dijk AMC-UvA
Prof. dr. J.W.M. Muris Universiteit Maastricht Prof. dr. P.J. Tanis AMC-UvA
Prof. dr. D.L. Willems AMC-UvA
Prof. dr. N.J. de Wit Universiteit Utrecht
Chapter 1 General introduction and thesis outline 7 Chapter 2 Improving care after colon cancer treatment in the
Netherlands, personalised care to enhance quality of life (ICARE study): study protocol for a randomised controlled trial
17
Chapter 3 Primary care-led survivorship care for patients with colon cancer and the use of eHealth: a qualitative study on perspectives of general practitioners
39
Chapter 4 Need for general practitioner involvement and eHealth in
colon cancer survivorship care: patients’ perspectives 63 Chapter 5 Follow-up of colon cancer patients; causes of distress and
need for supportive care: results from the ICARE cohort study
81
Chapter 6 Information needs and information seeking behaviour of
colorectal cancer survivors in the Netherlands 103 Chapter 7 Colorectal cancer patients’ preferences for type of caregiver
during survivorship care 125
Chapter 8 Introducing a time out consultation with the general practitioner between diagnosis and start of colorectal cancer treatment: patient-reported outcomes
141
Chapter 9 Clinical pattern of recurrent disease during the follow-up of
rectal carcinoma 159
Chapter 10 General discussion 177
Chapter 11 English summary
Nederlandse samenvatting List of contributing authors
Contribution of the authors per article Curriculum vitae Portfolio List of publications Dankwoord 200 204 208 210 214 215 217 219
General introduction and thesis outline
Background
Colorectal cancer is one of the most common types of cancer. In the Netherlands, thirty-seven people every day are diagnosed with this type of cancer, and fourteen people every day die because of it [1]. In recent years, these numbers have largely been stable. The Dutch population is growing in number, as well as growing older [2]. Increasing age is a risk factor for colorectal cancer, as the disease is more prevalent in elderly patients [3]. Moreover, the occurrence of colorectal cancer is associated with an inactive lifestyle, being overweight, and too much consumption of (red) meat and alcohol [4,5]. Combined, these factors mean that an ever
increasing number of people in the Netherlands are at risk of developing colorectal cancer.
Fortunately, in recent years the detection and treatment of colorectal cancer have also improved. In 2014, a national population screening program to detect colorectal cancer started. This enabled detection of (a precursor to) colorectal cancer at an earlier stage where it does not yet cause symptoms and curative treatment is more often possible [6]. Simultaneously, surgical procedures and treatment with radiotherapy and chemotherapy are constantly being improved to optimise chances of survival.
The growing and ageing population combined with the improved detection and treatment of colorectal cancer have resulted in a growing number of patients who have completed treatment intended to cure. The conventional term for these patients is ‘cancer survivors’. Colorectal cancer survivors in the Netherlands are included in a survivorship care program for five years following treatment [3]. The purpose of this survivorship care program is (1) detection of any recurrent cancer (also called ‘follow-up’), and (2) rehabilitation by attending to any remaining symptoms of the cancer and its treatment, and addressing issues or questions that patients have concerning their quality of life and well-being.
The traditional setting for cancer survivorship care in the Netherlands is secondary care. However, the growing number of colorectal cancer survivors has caused health care providers to consider other settings for survivorship care, especially because it often concerns older patients with a complex medical history of comorbid conditions and fragile living situations, who might not be best served
1
in a hospital setting [7].
Primary care
Primary care was proposed as a possible setting for colorectal cancer survivorship care as early as 2007 by the Dutch Health Council, and was followed by similar propositions by the Dutch Cancer Society and the Dutch College of General Practitioners [8-10].
Every patient in the Netherlands is enlisted with a general practitioner (GP), who acts as first contact and gatekeeper to secondary care. GPs are trained in providing continuous and comprehensive care, and know the patient and his/her family for a long time. Furthermore, the GP is familiar with the local network of health care providers, such as home care organisations, psychologists, physical therapists, nutritionists and pharmacists. The consideration of the GP as provider of colorectal cancer survivorship care therefore seems logical and sensible.
Internationally, there have been similar initiatives, with some countries leading the way. In Canada, where many communities are remote from hospitals, GPs have been involved in care for cancer patients for a long time, and there have been encouraging reports of GP-led cancer survivorship care [11,12]. In Norway, Augestad et al. started a randomised controlled trial in 2008 to compare GP-led survivorship care of colon cancer with traditional secondary care [13]. No differences between primary and secondary care were observed in cancer survivors’ quality of life, or time to detection of recurrent cancer, but GP-led survivorship care was considerably cheaper [14]. In Australia, Wattchow et al. reported on a randomised controlled trial comparing GP-led with surgeon-led survivorship care after treatment for colon cancer [15]. Again, the results showed no difference in quality of life, patient satisfaction, recurrence, time to detection, and mortality rates between the different settings of care, with only variations in patterns of investigation. A systematic review by Lewis et al. from 2009 comparing survivorship care in primary with secondary care for breast and colon cancer once more reported no difference in patient well-being, recurrence rate, survival, or patient satisfaction, but concluded that GP-led survivorship care was cheaper [16]. The studies included in this review, however, were too small to reliably assess any
difference in recurrence detection. Typically, the countries where trials with GP-led survivorship care have been performed concern sparsely populated areas remote from hospitals. In the Netherlands, most patients live around the corner from their GP, but do not live far from their nearest hospital as well.
All this led an international collective of physicians to publish an article in the Lancet Oncology in 2015, which reconsidered the optimal role of primary care in cancer survivorship care [17]. It concluded that “Primary care has a potentially important role in cancer survivorship care, but its role in such care needs to be clearly defined”, and “Evidence suggests that primary-care-based and shared-care models of follow-up can be just as effective as secondary-care-led follow-up for breast and colon cancers; good communication between all care providers and clear guidance for primary care professionals are key” [17].
Colorectal cancer care by general practitioners in the Netherlands
Survivors of colorectal cancer are typically older patients with chronic comorbid conditions. The GP is familiar with providing comprehensive care and knows the living situations and contexts of his/her patients. This puts the GP in a unique position to support these patients during the rehabilitation after treatment for colorectal cancer. The part of survivorship care that deals with the detection of recurrent disease is performed in a standardised way and could possibly be performed by GPs as well.
Because the treatment and care for rectal cancer is more complex, research in the Netherlands has primarily focussed on the possibility of transferring (parts of) colon cancer survivorship care. Many Dutch GPs, however, were not too keen to take on a central role as provider of survivorship care for these patients [18]. Reasons mentioned in this regard are an increase in work load, and a lack of knowledge and guidelines [19-21]. Likewise, many patients were reluctant to have their survivorship care completely transferred to their GP, mostly because they thought the GP lacked specific knowledge on cancer and did not have access to the necessary diagnostic facilities [18]. However, a survey by Wind et al. also indicated that identification of psychosocial problems in secondary-care-led colon cancer survivorship needed improvement and suggested ways of increasing support for
1
more GP involvement in survivorship care [18].
The potential benefit of more GP involvement in colorectal cancer survivorship care that both health care providers and patients acknowledge, is contrasted with the hesitancy to actually expand the role of the GP. This hesitancy is based in part on assumptions and opinions that have not been explored. Therefore, we set out to examine current and future involvement of GPs in colorectal cancer survivorship care. We designed a randomised controlled trial to test the idea that GPs would be better in delivering comprehensive cancer care to patients than the surgery departments of the hospitals, without losing quality regarding recurrence detection and the care for sequelae of stage 1-3 colon cancer and its treatment. Furthermore, we investigated the needs that patients have during survivorship care of colorectal cancer, and explored the ideas of both patients and GPs on all aspects of survivorship care including its possible future transfer. Only then could we meet the requirement by Rubin et al. to “clearly define the role of primary care in colorectal cancer survivorship” [17].
Thesis outline
The aim of the studies described in this thesis is to examine current GP involvement in colorectal cancer survivorship care and identify ways of
improvement, with a view to possibly transfer survivorship care in the near future. To that end, the studies that are presented in this thesis address the following questions:
∞ What will be the outcome of comparing primary-care-led colon cancer survivorship care with currently standard secondary-care-led care? (Chapter 2)
∞ What do GPs think of their involvement in colon cancer survivorship care, and what do they require to take on a central role in colon cancer survivorship care? (Chapter 3)
∞ What do patients think of GP involvement and eHealth during colon cancer survivorship care? (Chapter 4)
∞ What are causes of distress and need for supportive care in colon cancer survivors? (Chapter 5)
∞ What are the information needs and the information seeking behaviour of colorectal cancer survivors? (Chapter 6)
∞ What are colorectal cancer survivors preferences concerning health care providers? (Chapter 7)
∞ What is the result of introducing a time out consultation with the general practitioner before start of colorectal cancer treatment? (Chapter 8) ∞ How are recurrent rectal cancers currently detected? (Chapter 9)
1
References1. Integraal Kankercentrum Nederland 2019, Cijfers over kanker, Nederlandse Kankerregistratie, viewed 15 February 2019, <http://www.cijfersoverkanker. nl/>.
2. Centraal Bureau voor de Statistiek 2019, Statistische trends, viewed 15 February 2019, <https://www.cbs.nl/nl-nl/reeksen/statistische-trends>. 3. Integraal Kankercentrum
Nederland 2019, Oncoline, Richtlijnen oncologische zorg, viewed 15 February 2019, <https://www.oncoline.nl/
colorectaalcarcinoom>.
4. World Cancer Research Fund and American Institute for Cancer Research. Colorectal Cancer 2011 Report. Food, Nutrition, Physical Activity, and the Prevention of Colorectal Cancer, Washington D.C., 2011. Available at: <https://www.wcrf.org/sites/default/files/ Colorectal-Cancer-2011-Report.pdf>. 5. Lanting CI, de Vroome EM, Elias SG, van den Brandt PA, van Leeuwen FE, Kampman E, et al. Contribution of lifestyle factors to cancer: secondary analysis of Dutch data over 2010 and a projection for 2020. Nederlands tijdschrift voor geneeskunde. 2014;159:A8085.
6. Gezondheidsraad.
Bevolkingsonderzoek naar darmkanker. Den Haag: Gezondheidsraad, 2009; publicatienr. 2009/13. Available at: <https://www.gezondheidsraad.nl/ documenten/adviezen/2009/11/17/ bevolkingsonderzoek-naar-darmkanker>.
7. van Dipten C, Olde Hartman TC, Biermans MC, Assendelft WJ. Substitution scenario in follow-up of chronic cancer patients in primary care: prevalence, disease duration and estimated extra consultation time. Family practice. 2016;33(1):4-9. 8. Gezondheidsraad. Nacontrole in de oncologie. Doelen onderscheiden, inhoud onderbouwen. Den Haag: Gezondheidsraad, 2007; publicatienr. 2007/10. Available at: <https://www. gezondheidsraad.nl/documenten/ adviezen/2007/03/27/nacontrole-in- de-oncologie.-doelen-onderscheiden-inhoud-onderbouwen>. 9. Signaleringscommissie Kanker van KWF Kankerbestrijding. Nazorg bij kanker: de rol van de eerste lijn, Amsterdam, 2011. Available at: <https:// www.kwf.nl/SiteCollectionDocuments/ rapport-Nazorg-bij-kanker-de-rol-van-de-eerste-lijn.pdf>.
10. Nederlands Huisartsen Genootschap (NHG). Standpunt oncologische zorg in de huisartsenpraktijk, Utrecht, 2014. Available at: <https://www.nhg.org/sites/ default/files/content/nhg_org/uploads/ nhg-standpunt_oncologische_zorg.pdf>. 11. Sisler JJ, Taylor-Brown J, Nugent Z, Bell D, Khawaja M, Czaykowski P, et al. Continuity of care of colorectal cancer survivors at the end of treatment: the oncology-primary care interface. J Cancer Surviv. 2012;6(4):468-75. 12. Sisler JJ, DeCarolis M, Robinson D, Sivananthan G. Family physicians who have focused practices in oncology: results of a national survey. Canadian family physician Medecin de famille canadien. 2013;59(6):e290-7.
13. Augestad KM, Vonen B, Aspevik R, Nestvold T, Ringberg U, Johnsen R, et al. Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events. BMC health services research. 2008;8:137.
14. Augestad KM, Norum J, Dehof S, Aspevik R, Ringberg U, Nestvold T, et al. Cost-effectiveness and quality of life in surgeon versus general
practitioner-organised colon cancer surveillance: a randomised controlled trial. BMJ Open. 2013;3(4).
15. Wattchow DA, Weller DP, Esterman A, Pilotto LS, McGorm K, Hammett Z, et al. General practice vs surgical-based follow-up for patients with colon cancer: randomised controlled trial. Br J Cancer. 2006;94(8):1116-21.
16. Lewis RA, Neal RD, Williams NH, France B, Hendry M, Russell D, et al. Follow-up of cancer in primary care versus secondary care: systematic review. The British journal of general practice : the journal of the Royal College of General Practitioners. 2009;59(564):e234-47.
17. Rubin G, Berendsen A, Crawford SM, Dommett R, Earle C, Emery J, et al. The expanding role of primary care in cancer control. Lancet Oncol. 2015;16(12):1231-72.
18. Wind J, Duineveld LA, van der Heijden RP, van Asselt KM, Bemelman WA, van Weert HC. Follow-up
after colon cancer treatment in the Netherlands; a survey of patients, GPs, and colorectal surgeons. Eur J Surg Oncol. 2013;39(8):837-43.
19. Potosky AL, Han PK, Rowland J, Klabunde CN, Smith T, Aziz N,
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et al. Differences between primary care physicians’ and oncologists’ knowledge, attitudes and practices regarding the care of cancer survivors. Journal of general internal medicine. 2011;26(12):1403-10.
20. Del Giudice ME, Grunfeld E, Harvey BJ, Piliotis E, Verma S. Primary care physicians’ views of routine follow-up care of cancer survivors. J Clin Oncol. 2009;27(20):3338-45.
21. Papagrigoriadis S, Koreli A. The needs of general practitioners in the follow-up of patients with colorectal cancer. Eur J Surg Oncol. 2001;27(6):541-4.
Improving care after colon cancer treatment in
the Netherlands, personalised care to enhance
quality of life (ICARE study): study protocol for a
randomised controlled trial
Laura A.M. Duineveld
Thijs Wieldraaijer
Kristel M. van Asselt
Ineke C. Nugteren
Sandra C. Donkervoort
Anthony W.H. van de Ven
Anke B. Smits
Anna A.W. van Geloven
Willem A. Bemelman
Frederique H. Beverdam
Willem F. van Tets
Marc J.P.M. Govaert
Judith E. Bosmans
Irma M. Verdonck-de Leeuw
Cornelia F. van Uden-Kraan
Henk C.P.M. van Weert
Jan Wind
Trials. 2015 16:284. doi: 10.1186/s13063-015-0798-7
Abstract
Background
It is expected that in 2020 more than 17,000 cases of colorectal cancer will be diagnosed in the Netherlands. To date, patients are included in a surgeon-led follow-up programme whose main focus is recurrence detection. However, patients often experience multiple physical and psychosocial problems. Currently, these problems are not always encountered. More care by a generalist is suggested as a solution. Furthermore, patients prefer to undergo rehabilitation in their own environment and to be more involved in their own health care. eHealth applications might enhance this. Oncokompas2.0 is an online self-management
application which facilitates access to supportive care. This study aims to evaluate primary care follow up and aftercare in comparison with secondary care follow-up and aftercare for patients with colon cancer. Second, the added value of Oncokompas2.0 to care will be assessed.
Methods
This is a multi-centre 2 × 2 factorial randomised controlled trial with a calculated sample size of 300 patients. Patients with stage I, II, or III colon carcinoma are eligible. Patients will be randomly assigned in four groups: (1) usual follow-up visits and aftercare provided in secondary care, (2) usual follow-up visits and aftercare provided in secondary care with additional use of Oncokompas2.0, (3)
follow-up and aftercare in primary care, and (4) follow-up and aftercare in primary care with additional use of Oncokompas2.0. The primary outcome is quality of life.
Secondary outcomes include physical outcomes, psychosocial outcomes, number of investigations, referrals and related communication between secondary and primary care, (time of) recurrence detection and protocol adherence, attention to preventive care, self-management of patients, patient satisfaction, and preference of care at the end of the trial. Data collection will be done by questionnaires and extractions from electronic medical records.
Discussion
The results of this study will provide evidence, which has been scarce to date, on prominent general practitioner involvement in care for colon cancer patients after initial treatment. Also, it evaluates the efficacy of an eHealth application to enhance patient empowerment.
2
IntroductionIt is expected that in 2020 more than 17,000 cases of colorectal cancer will be diagnosed in the Netherlands [1,2]. Currently, in the Netherlands after initial treatment, patients are typically included in a surgeon-led programme whose main focus is detection of recurrence and metachronous tumours; in general, this is called follow-up. There is evidence that intensive follow-up programmes improve (overall) survival of patients with colorectal cancer [3,4]. The Dutch guideline includes periodic visits combined with a carcinoembryonic antigen (CEA) blood test, imaging of the liver, and colonoscopy during the first five years after curative treatment [2]. Given that this follow-up programme is convenient to carry out, it is only a small step to hand over management of follow-up to general practitioners (GPs), especially since most patients have chronic co-morbid conditions and are familiar with their GP. Furthermore, primary health-care use is increased the first five years after colorectal cancer diagnosis [5].
Patients with cancer often experience multiple physical, functional, and psychosocial problems during and after the initial treatment phase [6]. These symptoms can cause considerable distress. Care with the purpose of alleviating these symptoms is called aftercare or supportive care [3]. Goals of aftercare are improvement of physical condition, finding emotional and social balance, coping with disabilities, and restoring autonomy by increasing self-efficacy and regaining confidence [7]. Currently, follow-up visits in secondary care do not always address these aspects, and studies suggest that only a small number of distressed patients are identified and supported [8–10]. Recently, our research group conducted a large cross-sectional survey in the Netherlands among patients, surgeons, and GPs in which current surgeon-led aftercare and possible future GP-led aftercare were evaluated. Only half of the patients were satisfied with the identification and treatment of psychosocial problems. Moreover, three out of four surgeons stated that, owing to their lack of time and experience, psychosocial problems in particular possibly received not enough attention [11]. Both the Dutch Health Council and the Dutch Cancer Foundation suggested more care by a generalist as a solution to these problems [3,12].
The number of cancer patients with co-morbidity is expected to increase as a result of ageing of the general population [12,13]. Besides giving attention to pre-existent morbidity, health-care professionals should be aware of newly developed co-morbidity after cancer treatment. Therefore, preventive care is important for all
survivors of colorectal cancer. Moreover, disease-free survival of patients with colorectal cancer is increased in those with higher levels of physical activity. Nevertheless, colorectal cancer survivors have the highest percentage of sedentary lifestyles among survivors of malignancies, and studies suggest that professionals miss opportunities to counsel cancer survivors—in particular, colorectal cancer survivors—about healthy behaviours [14].
The guidelines of the Dutch National Gastrointestinal Cancer group do not offer clear recommendations about which health-care professional should coordinate care after initial treatment [2]. The Dutch Cancer Society’s Signalling Committee on Cancer emphasizes the importance of primary care in cancer management [12]. GPs with their generalist and broad view, accessibility, continuity of care, experience with chronic disease management, and wide network of health-care providers might therefore be the most appropriate health-care professional to provide aftercare [15]. Few studies report on primary versus secondary care follow-up of breast and colonic cancer [16–18]. These studies show no significant difference for quality of life, recurrence rate, and anxiety. However, GP-led cancer follow-up was more cost-effective than hospital follow-up and this was due mainly to a difference in organisational and physician costs.
Furthermore, it would be preferable for as much of the rehabilitation as possible to be conducted in the patients’ own environment. Besides an expanded role for GPs, a more central role of the patient in management of his or her own health is emphasized by the Chronic Care Model [19]. Self-management or patient empowerment is defined as the individual’s ability to manage symptoms, treatment, physical and psychosocial consequences, and lifestyle changes inherent to living with a chronic condition [20]. Evidence shows that web-based interventions for patient empowerment can improve care for patients with cancer [21,22]. The aim of eHealth applications targeting patient empowerment is to enable patients with cancer to positively influence their treatment and
rehabilitation, in keeping with the professional execution of aftercare, by providing them with timely insight into, for instance, their individual state of health and their treatment stage or needs, and by offering personal lifestyle coaching based on their actual quality of life. An important example of these eHealth applications is Oncokompas2.0. In Oncokompas2.0, cancer survivors can monitor their quality
of life by means of participant-reported outcomes (PROs) (“Measure”) and this is followed by automatically generated tailored feedback (“Learn”) and personalised advice on supportive care services (“Act”) [10,23]. It is based on the
2
Dutch guideline Cancer rehabilitation and Screening for the need of psychosocial care [7,24]. The above-mentioned developments are subjects of the ICARE study because, to date, robust research on a more prominent role for primary care and the use of eHealth applications in the follow-up and aftercare for colon cancer patients after initial treatment is missing and possible benefits in terms of patients’ satisfaction and quality of life should be further assessed.
Therefore, the aims of this study are to determine the efficacy of GP-led follow-up and aftercare compared with secondary care-led follow-up and aftercare among patients with colon cancer and to determine the added value of the eHealth self-management application Oncokompas2.0. We hypothesize that GP involvement
improves aftercare and preventive care, resulting in improved quality of life and patients’ satisfaction. Furthermore, we hypothesize that a GP-led recurrence detection programme (follow-up) for patients after curative treatment of colon cancer leads to at least equal detection of recurrences and subsequently an equal number of curative recurrence resections. Finally, we hypothesize that usage of Oncokompas2.0 facilitates patients’ self-management and personalised access to
Methods
This is a multi-centre 2 × 2 factorial randomised controlled trial. Two
randomisation procedures (at the same moment) will be undertaken: one to create two groups for surgeon-led—usual care (i.e., control group)—versus GP-led follow-up and aftercare and a second randomisation for allocation of the eHealth application Oncokompas2.0. This factorial design results in four groups on a 1:1:1:1
ratio (Figure 1):
1. Usual follow-up visits and aftercare provided in secondary care (surgeon-led);
2. Usual follow-up visits and aftercare provided in secondary care (surgeon-led) with additional use of the eHealth application Oncokompas2.0;
3. Follow-up and aftercare in primary care (GP-led);
4. Follow-up and aftercare in primary care (GP-led) with additional use of the eHealth application Oncokompas2.0.
Randomisation will be performed centrally at the Academic Medical Centre in Amsterdam by using block randomisation to balance patient characteristics within each group on the basis of two variables: age and tumour stage. If a second patient of an already-participating GP is included, this patient (and all subsequent patients) will be allocated to the same follow-up/aftercare arm (i.e. primary or secondary care). The chance that two patients of the same GP will be diagnosed with colon cancer in the study period, will be eligible for inclusion in the study, and give informed consent is small. Nevertheless, we avoid having two patients of the same GP receive different care (primary care-led versus secondary care-led follow-up) as this will result in contamination. Owing to the nature of the intervention, it is not possible to conceal the allocation group from either participants or clinicians. However, the primary researchers are not involved in subsequent follow-up/ aftercare appointments in any way. Recruited patients will not be informed about other patients recruited in the same trial. Similarly, no information regarding trial progress will be revealed to the participating GPs or surgeons.
The study will be conducted in eight hospitals. The number of segmental colonic resections for cancer in the participating centres ranges between 60 and 160 patients per centre annually.
2
a patients’ preference group (Figure 1). In this arm, baseline data similar to those of the randomised study arms are gathered, but the allocation is based on the patients’ treating surgeon and patient preference.
Study population
Inclusion criteria
To be eligible to participate in this study, a subject must meet all of the following criteria:
- Carcinoma located in the colon and rectosigmoid defined as a tumour located 15 cm above the anal verge by colonoscopy or above the sacral promontory as seen preoperatively;
- Stage I, II, or III carcinoma;
- Surgical treatment with curative intent;
- Qualified for routine follow-up attendance by surgeon or oncologist according to the national guideline;
- Patients who have temporary stoma and who received adjuvant
GP, general practitioner.
chemotherapy are also eligible.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Stage IV colorectal tumours;
- Hereditary colorectal cancer (e.g. Lynch and familial adenomatous polyposis);
- Colorectal cancer in patients with inflammatory bowel disease; - Rectal cancer;
- (Sub)total colectomy or proctocolectomy;
- History of second primary cancer (except basal cell carcinoma of the skin) within the last 15 years;
- Participation in other (clinical) research, which will affect the outcome measurements of this trial;
- Permanent open wounds after surgery or other conditions in which specialised care is needed;
- Any other condition that warrants increased intensity of surveillance with respect to colon cancer follow-up;
- Not able to speak and read Dutch or English.
Inclusion procedure
Patients are asked for their informed consent postoperatively after the results of the pathological examination of the resection specimen with its consequences have been discussed with the patient. Patients will be recruited by treating physicians at the different hospitals. The treating physician will inform patients, and written informed consent is obtained by the research team. Participants will be given as much time as they desire to consider their decision.
Intervention
Intervention 1 (GP-led follow-up and aftercare)
Guidelines for follow-up will be according to the national guideline for colon carcinoma [2]. The follow-up guideline is similar in both arms. GPs allocated to the intervention arm are given written instructions on what to do if recurrence
2
is suspected and this mainly includes prompt re-referral. The follow-up guidelines have been summarized in a survival care plan especially to support the participating GPs. This survival care plan also contains information on possible physical and psychosocial problems patients might have and subsequent interventions. In case of questions regarding the information in the letter or in the survival care plan, relevant contact information will be supplied. The survival care plan will also be available at the study website (see http://www.icarestudie.nl/). Also, both surgeons and GPs are informed on evidence-based recommendations concerning aftercare as described in several guidelines [2,7].
Patients randomly assigned to GP-led follow-up and aftercare will be referred to their GP for postoperative follow-up and aftercare according to the national guideline (Tables 1 and 2). An information letter provided by the treating surgeon will be given to the GP. This letter contains information about surgery, any complications, disease stage, the use of chemotherapy, subsequent side effects, and risk of recurrence of the referred patient. If the treating surgeon or oncologist recommends an altered follow-up schedule, they will give clear advice.
Table 1 Follow-up after colon carcinoma resection with curative intent of
carcinoma limited to submucosal involvement (T1N0M0).
Year 1 Year 2-5
Office visits Every 6 months Yearly
Physical examination Only if indicated Colonoscopy of computed
tomography colonography Within 3 months postoperatively if
preoperatively the colon was not visualized completely. If whole colon is visualized preoperatively, colonoscopy after 1 year.
3 years after the last colonoscopy, followed by colonoscopies each 3–5 years depending on the number, size, and localization of polyps
Table 2 Follow-up after colon carcinoma resection with curative intent of
carcinoma extending beyond the submucosa but without distant metastasis (all stages with the exception of T1N0).
Year 1 Year 2 Year 3 Years 4-5
Office visits Every 6 months Every 6 months Every 6 months Yearly Physical
examination Only if indicated Carcinoembryonic
antigen monitoring Every 3 months Every 3 months Every 3 months Every 6 months Abdominal
ultrasonography (or CT abdomen†)
Every 6 months Every 6 months Yearly Yearly
Colonoscopy of CT
colonography Within 3 months postoperatively if preoperatively the colon was not visualized completely. If whole colon is visualized preoperatively, colonoscopy after 1 year 3 years after the last colonoscopy, followed by colonoscopies each 3–5 years depending on the number, size, and localization of polyps
†Computed tomography (CT) scan is indicated if an abdominal ultrasonography is not readily interpretable (e.g. in the presence of liver steatosis), or a CT scan can be considered in patients with a high risk of recurrence (T4N+) because of its higher sensitivity.
Intervention 2 (the use of the Oncokompas2.0)
Patients who are allocated to the eHealth application Oncokompas2.0 (http://
www.oncokompas.nl/) will receive an account to be able to make use of the online application. Patients who do not have the availability of internet at home or do not possess sufficient eHealth literacy skills will be supported in the use of Oncokompas2.0 by a trial nurse. Oncokompas2.0 is an online self-management
application which facilitates access to supportive care in cancer survivors. Oncokompas2.0 consists of three components: (1) Measure, (2) Learn, and (3) Act
2
In the “Measure” component, cancer survivors can independently complete PROs targeting the following quality-of-life domains: physical functioning, psychological functioning, social functioning, healthy lifestyle, and existential issues. Data from the “Measure” component are processed in real time and linked to tailored feedback to the cancer survivor in the “Learn” component. In the “Learn” component, feedback is provided to the participant on the level of the topics (e.g. depression and fatigue) by means of a three-color system: green (no elevated wellbeing risks), orange (elevated well-being risks), and red (seriously elevated well-being risks). Cancer survivors receive elaborated personalised information on the outcomes; for example, on the topic of depression, information is provided on the symptoms of depression and the proportion of cancer survivors who have depression. Special attention is paid to evidence-based associations between outcomes. For example, additional feedback on the association between depression and fatigue is provided if a participant has an orange or a red score on depression as well as on fatigue. The feedback in the “Learn” component concludes with comprehensive self-care advice (tips and tools). All this advice is tailored to the individual cancer survivor.
In the “Act” component, survivors are provided with personalised supportive care options on the basis of their PRO scores and expressed preferences (e.g. guided or unguided interventions and preference for individual therapy versus group therapy). If a participant has elevated well-being risks (orange score), the feedback includes suggestions for self-management options. If a participant has “seriously elevated well-being risks” (red score), the feedback includes advice to contact their own medical specialist or GP for further medical evaluation. Supportive care options are extracted from a national database with those options.
Oncokompas2.0 comprises a generic module for all cancer survivors, targeting
psychological functioning (anxiety, depression, fear of recurrence, and cognitive functioning), physical functioning (pain, sexuality, sleep, fatigue, body image, diarrhoea, constipation, hearing, loss of appetite, nausea/vomiting, lymph oedema, dyspnoea, and functioning in daily living), social functioning (social life/loneliness, relationships, financial issues, return to work, and communication with care providers), healthy lifestyle (smoking, alcohol use, exercising, nutrition, weight, and stress), and life questions. Furthermore, a tumour-specific module for colon cancer, targeting bladder and urinary problems, heredity, stools, ostomy, pain, and abdominal bloating, is available for study participants of the ICARE study.
Outline of the study and data collection procedures
Approximately 3–4 weeks postoperatively, patients will be seen at the surgical outpatient clinic. At this visit, a clinical examination will be performed, and information about the histology and results of the surgery will be shared with each patient. Patients not receiving adjuvant chemotherapy and eligible for study inclusion will be asked for their informed consent. Also, patients who need adjuvant chemotherapy and are eligible for study inclusion will be asked for their informed consent. However, before final inclusion in the study, the patients will be referred to the oncologist for chemotherapeutic treatment. After completion of adjuvant chemotherapy, these patients will be included definitively.
After a patient has given informed consent, the GP is contacted if he or she wants to participate in the study. If the GP participates, the patient is finally randomised. If a patient declines randomisation (or the GP of the patient declines
randomisation), the patient is asked to participate in a patients’ preference group and will receive surgeon-led follow-up and aftercare. Patients allocated to GP-led follow-up may be referred back to the hospital at any time during the study. Similarly, patients in the surgeon-led groups are free to consult their GP any time during the study. Subjects can leave the study at any time for any reason without any consequence.
Outcomes
Data will be collected in all groups in identical ways and at identical time points. Changes in health status and valuation over time will be measured by using the following questionnaires:
1. Generic and disease-specific quality-of-life questionnaires (EORTC QLQ-C30, EORTC QLQ-CR29, and EQ-5D-5 L) [25–27].
2. Patients’ satisfaction (consumer quality index questionnaire) is measured [28].
3. A short list of questions concerning smoking habits, height, weight, physical exercise, and perceived autonomy (based partly on existing questionnaires) [29,30].
4. Patient activation (Patient Activation Measure questionnaire) and perceived efficacy in patient-physician interactions (5-item Perceived Efficacy in Patient-Physician Interaction Questionnaire (PEPPI-5) questionnaire) [31,32]. 5. Short questionnaire on process evaluation regarding Oncokompas2.0.
2
The majority of these questionnaires will be filled out directly after the first postoperative visit at the outpatient clinic department and after 3, 6, 12, 24, 36, 48, and 60 months. Extractions from the GPs’ electronic medical record (EMR) and PROs will be used to evaluate preventive care. We will use the EQ-5D-5 L to calculate quality-adjusted life years. For the economic evaluation, health-care utilisation will be measured by using the iMTA Medical Consumption Questionnaire (iMTA MCQ) [33]. The Short-Form Health and Labour Questionnaire (SFHLQ) will be used to measure absenteeism from paid and unpaid work.
GPs will be asked at the end of the study to fill out a short questionnaire to evaluate care. Focus group interviews are planned with patients and health-care professionals (GPs, surgeons, and nurses involved in aftercare) to evaluate their experiences, limitations, and recommendations.
Quality control
An independent data and safety monitoring board (DSMB) will evaluate the progress of the trial and will examine safety parameters at regular intervals (every 45 patients or every 6 months). In particular, all recurrences will be assessed to analyse whether there is a diagnostic delay caused by the study protocol. Also, all involved physicians will repetitively be asked by the primary researchers to report any potential adverse events caused by following the study protocol. These adverse events will be listed and discussed with the DSMB. The input of the study participants along with a progress report of the project leader (JW) will be supplied to the DSMB before they have a meeting. All deceased patients will be evaluated by the safety committee for cause of death and possible trial-related serious adverse effects. The DSMB committee can ask for a full report in order to discuss a specific adverse event. The DSMB will consist of an epidemiologist/statistician who is the chairman, an independent surgeon, and an independent GP. None of these members has a conflict of interest with the sponsor of the study. The advice of the DSMB will be sent to the sponsor of the study. Should the project leader decide not to fully implement the advice of the DSMB, the sponsor will send the advice to the reviewing ethics committee, including a note to substantiate why (part of) the advice of the DSMB will not be followed.
Analysis
Sample size
The sample size calculation is based on the primary endpoint: quality of life. In accordance with previous studies, we consider an effect of 10 units of improvement of the EORTC QLQ C30 to be clinically relevant [34]. To detect an intervention effect of 10 units of change (standard deviation of 20) in quality of life, we will need 64 participants in each group (alpha of 0.05 and power of 80 %). As we expect some drop-out, we aim for 75 patients in each group. The total sample size is therefore 300 patients. Given the sample size calculation and the factorial design of the study, the assumptions are made that the effects of the two interventions are independent and that there are no important interactions (synergy).
Analysis of main study parameters
All analysis will be performed according to the intention-to-treat principle. Crude data are presented with statistical comparison made between randomisation groups on the basis of chi-squared tests for binary or categorical data, the t test or analysis of variance as appropriate for comparing group means, and the Kruskal-Wallis test for comparing medians. For continuous normally distributed data, the analysis-of variance test will be used. The primary analysis will be the comparison between factors, and the comparison between study arms will be part of a secondary, exploratory analysis. For these purposes, univariate and multiple linear or logistic regression analyses will be performed. Quality of life will be assessed through multi-level modelling. A two-sided P value of less than 0.05 will be considered statistically significant. Nevertheless, in all appropriate cases, 95 % confidence intervals will be given. Changes in health status and valuation over time will be measured by using the questionnaires mentioned above. Next to validated questionnaires and prospective monitoring of the trial endpoints, extractions from the GPs’ EMR and patients’ hospital records will be used to complete the data.
Economic evaluation analysis
The aims of the economic evaluation are to describe the societal costs of patients who after an operation for colon cancer receive follow-up at the hospital or by the GP and to relate these costs to the clinical effects in these groups. The time horizon of the economic evaluation is up to 5 years after surgery. A societal perspective
2
is chosen, meaning that not only health-care costs but also patient and lost
productivity costs are taken into account. Health-care utilization will be measured by using the iMTA MCQ at baseline and after 3, 6, 12, 24, 36, 48, and 60 months of follow-up [33]. Health-care costs include costs of GP care, costs of psychiatric and psychological care, costs of ambulatory and inpatient hospital care, costs of visits to allied health care professionals such as physical therapists and social workers, costs of medication and examinations, and costs of home care. The SF-HLQ will be used to measure absenteeism from paid and unpaid work at all follow-up moments. For the valuation of health-care utilization, standard prices published in the Dutch costs guidelines will be used [35]. Medication use will be valued by using prices of the Royal Dutch Society for Pharmacy [36]. Quality of life will be measured by using the 5-level version of the EuroQol (EQ-5D-5 L) [27]. Health states will be converted to utility scores by using the Dutch tariff for the EQ-5D-5 L. Quality-adjusted life-years will be calculated by using linear interpolation between time points.
Costs will be discounted at 4 % and effects at 1.5 % as recommended by the Dutch guidelines for costing studies [29]. Missing cost and effect data will be imputed by using multiple imputation according to the MICE (Multiple Imputation by Chained Equations) algorithm developed by Van Buuren et al. [37]. Costs typically have a highly skewed distribution [38]. Therefore, bias-corrected and accelerated bootstrapping with 5000 replications will be used to estimate 95 % confidence intervals around the mean difference in total societal costs between the groups. Incremental cost-effectiveness ratios (ICERs) will be calculated by dividing the difference in mean total costs between the groups by the difference in mean effects between the groups. Bootstrapping will be used to estimate the uncertainty surrounding the ICERs which will be graphically presented on cost-effectiveness planes. Cost-effectiveness acceptability curves will also be estimated. Cost effectiveness acceptability curves show the probability that care by GPs is cost-effective in comparison with usual care for a range of different ceiling ratios, thereby showing decision uncertainty [39]. The iMTA MCQ and SF-HLQ questionnaires will be sent to the participant simultaneously with the quality-of-life questionnaires (EQ-5D-5 L) to facilitate patient’s response. Besides the information provided by the patients themselves by means of the methods mentioned above, the researchers will systematically gather data directly from hospital and GP files. This information will be used to compare health-care usage and be correlated to compare health-care costs. The following items will be
checked at the time intervals mentioned above: outpatient clinic visits, GP practice visits, telephone consultations, hospital admittances (number of days), laboratory tests, all medical imaging, endoscopies, referrals to (other) medical specialist care, referrals to paramedical care, and drug prescriptions. Note that health-care use in both primary and secondary care will be evaluated for patients allocated to any group of randomisation to create a complete survey of health care use.
Each single item will be stored in the case record file created for each participant. Via this information from health care use, the costs used by each participant will be determined by using standardised reference lists.
Ethics and safety
The medical ethics committee of the Academic Medical Centre (Amsterdam, the Netherlands) has approved the study protocol (MEC 2014_332). This study will be conducted according to the principles of Good Clinical Practice.
2
DiscussionThe aims of this study are to examine the quality of care for patients after colon cancer treatment in primary care and to determine the effect of the use of the eHealth application Oncokompas2.0 in these patients. To date, the evidence on
this subject has been scarce. Nevertheless, future care for the so-called “cancer tsunami” should be organised efficiently and in the best way for patients, in which currently unmet physical and psychosocial needs are better addressed. The ICARE study will provide evidence regarding the question of whether GPs should have a more prominent role in follow-up and aftercare for patients with colon cancer after their initial treatment. The randomised ICARE study not only evaluates quality of life and patients’ satisfaction but also assesses safety and costs during a 5-year follow-up time.
Trial status
At the time of submission, the study protocol was approved by our medical ethics committee and registered in the Dutch Trial Register. Recruitment of participants started in April 2015.
Abbreviations
ICARE, Improving Care After colon canceR treatment in the Netherlands. Personalised care to Enhance quality of life; DSMB, Data and safety monitoring board; EMR, Electronic medical record; EORTC, European Organisation for Research and Treatment of Cancer; EQ-5D-5 L, 5-level version of the EuroQol; GP, General practitioner; ICER, Incremental cost-effectiveness ratio; iMTA MCQ, iMTA Medical Consumption Questionnaire; PRO, Participant-reported outcome; SF-HLQ, Short-Form Health and Labour Questionnaire.
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Primary care-led survivorship care for patients
with colon cancer and the use of eHealth: a
qualitative study on perspectives of general
practitioners
Laura A.M. Duineveld
Thijs Wieldraaijer
Jan Wind
Irma M. Verdonck-de Leeuw
Henk C.P.M. van Weert
Cornelia F. van Uden-Kraan
BMJ Open. 2016;6:e010777. doi:10.1136/bmjopen-2015-010777
Abstract
Objectives
The aim of this study was to explore the perspectives of general practitioners (GPs) regarding their current and future role in survivorship care of patients with colon cancer, and to assess their perspectives on patients’ self-management capacities and the value of the eHealth application Oncokompas2.0 used by patients.
Setting
GPs from the central part of the Netherlands were interviewed at their location of preference.
Participants
20 GPs participated (10 men, 10 women, age range 34–65 years, median age 49.5 years). The median years of experience as a GP was 14.5 years (range 3–34 years).
Results
GPs indicated attempting to keep in contact with patients after colon cancer treatment and mentioned being aware of symptoms of recurrent disease. Most participants would have liked to be more involved and expected to be able to provide survivorship care of colon cancer. Requirements mentioned were agreements with secondary care and a protocol. GPs considered Oncokompas2.0,
which stimulates patients to structure their own survivorship care, as a useful additional tool for a specific group of patients (i.e., young and highly-educated patients).
Conclusions
Based on the perspectives of the GPs, survivorship care of colon cancer in primary care is deemed feasible and the use of an eHealth application such as Oncokompas2.0 is expected to benefit specific groups of patients after colon cancer
3
IntroductionIt is expected that, in 2020, more than 17 000 patients in the Netherlands will be diagnosed with colorectal cancer [1]. After initial treatment, patients are included in a surgeon-led programme that mainly focuses on detection of recurrent
disease and metachronous tumours. This so-called ‘follow-up’ includes periodical carcinoembryonic antigen blood testing, imaging of the abdomen and colonoscopy during the first five postoperative years [1]. Scheduled follow-up is part of
survivorship care, which also includes care to alleviate physical and psychosocial concerns, provision of information, evaluation of late and adverse effects due to treatment or disease, and lifestyle counselling after initial treatment [2].
Currently, several aspects of survivorship care are not well addressed in secondary care. Only a small number of distressed patients are identified and supported [3,4]. A cross-sectional survey among Dutch patients, surgeons and general practitioners (GPs), demonstrated that patients were satisfied with the current surgeon-led care concerning recurrent disease detection and identification of physical symptoms [5]. However, only half of the patients were satisfied with the identification and treatment of psychosocial concerns [5]. Care of a GP is suggested by the Health Council of the Netherlands, the Dutch Cancer Society and the Dutch College of General Practitioners, to improve survivorship care [6-8]. The current role of GPs in survivorship care is not well defined.
Besides a more prominent role for GPs in survivorship care, the Dutch Federation of Cancer Patients Organizations and the Dutch Cancer Society recommend a more central role of patients in managing their own health [7]. This is in line with the Chronic Care Model (CCM) [9]. Self-management is defined as the individual’s ability to manage symptoms, physical and psychosocial consequences and lifestyle changes inherent to living with a chronic condition [10]. Web-based interventions (eHealth) can have a positive effect on self-management in patients with a chronic disease such as cardiac failure, diabetes and chronic obstructive pulmonary disease (COPD) [11]. Also, after cancer treatment, eHealth is becoming more important to involve patients in structuring their own rehabilitation [11,12]. An example of a self-management eHealth application to enable patients with cancer to
positively influence their rehabilitation is Oncokompas2.0. In Oncokompas2.0, cancer
survivors can monitor their quality of life by means of patient-reported outcomes (‘Measure’), which is followed by automatically generated tailored feedback (‘Learn’) and personalised advice on supportive care services (‘Act’) [13-15].
According to various Dutch health care and patients’ organisations, both a more prominent role of GPs and patients’ self-management are important aspects to improve survivorship care of cancer [6-8]. Therefore, it is important to explore the feasibility of these recommendations together. To date, combined research on these aspects in the survivorship care of patients with colon cancer is scarce. Therefore, the aim of this study was to explore the perspectives of GPs regarding their current and future role in survivorship care of patients with colon cancer, and to assess their perspectives on patients’ self-management capacities and the value of the eHealth application, Oncokompas2.0.
3
MethodsStudy sample
In this qualitative study, GPs were interviewed. GPs were chosen to be the group of interest because their views can help in preparing GPs in case their role in survivorship care becomes more prominent. GPs were recruited through the network of the department of General Practice of the Academic Medical Centre (AMC) in Amsterdam. All selected GPs worked in cities and villages of three provinces around Amsterdam, in the Netherlands. First, GPs were invited by email with information about the study. Subsequently, the GPs were informed by one researcher (L.A.M.D.) by phone on details about the study and asked for agreement to participate. During recruitment, we used purposive sampling to achieve a wide sample of participants with respect to gender, age, years of experience as a GP, area of occupation (i.e. urban vs rural) and employment (self-employed or (self-employed).
In total, 10 men and 10 women participated in semi-structured individual
interviews. Table 1 shows their characteristics. No GPs declined participation. All participants provided verbal consent, which was digitally recorded. The Research Ethics Committee of the AMC reviewed the protocol and assessed that the Medical Research Involving Human Subjects Act does not apply to this study. An official approval by the committee was therefore not required and written informed consent not obtained.
Table 1 Participants’ characteristics (n=20).
Age in years, median (range) 49.5 (34–65 years)
Gender, n (%)
Male 10 (50%)
Female 10 (50%)
Experience as a GP in years, median (range) 14.5 (3-34 years) Area of occupation, n (%)
Urban 15 (75%)
Rural 5 (25%)
Health care practice, n (%)
Self-employed GP 14 (70%)
Employed GP 6 (30%)
Procedure
Interviews were performed by one researcher (L.A.M.D.), who received training in qualitative methods and had previously conducted another qualitative study. Interviews took place at a location preferred by the participants, for example, at the researcher’s workplace (n=9), at the participant’s clinic (n=7) or at the participant’s home (n=4). Topics and questions were based on the literature and clinical expertise of the research team. The four topics discussed during the interview were: current involvement of the GP in survivorship care of patients with colon cancer, the possibility of a more prominent role in the future, the capability of patients’ self-management and the expected potential of the eHealth application, Oncokompas2.0 (Table 2). Interviews were digitally recorded and
transcribed verbatim, and field notes were made during and after the interviews. The duration of the interviews lasted between 39 and 66 minutes (median 48 min). The interviews started with an explanation of two key words, i.e. follow-up and survivorship care, as defined in the introduction section. During the interview, questions concerning eHealth (Table 2) were preceded by an introduction of the application, Oncokompas2.0. As many participants had difficulties conceptualising
the idea of this web-based intervention, six screenshots of Oncokompas2.0 were
shown to the respondents [13-15].
When no new information was found from four consecutive transcripts during the data analysis, we assumed that data saturation was reached [16].
Table 2 Interview topics.
Topics Key questions
GPs’ current involvement in
survivorship care of patients with colon cancer
What is your current involvement in survivorship care of patients who have been treated for colon cancer?
Future role of GPs in survivorship care
for colon patients with cancer To what extent would you like to be involved after treatment of colon cancer with curative intent?
Are you willing to coordinate survivorship care of colon cancer?
Under what condition(s) are you willing to provide survivorship care, including follow-up, of colon cancer?
Patients’ self-management after colon
3
The use of Oncokompas2.0 insurvivorship care of colon cancer What is the value of Oncokompas
2.0 regarding the future role of patients in survivorship care of colon cancer?
To what extent do you want to be involved if your patient uses Oncokompas2.0?
GPs, general practitioners.
Data analysis
Data analysis was conducted by two coders (L.A.M.D. and T.W.), using thematic data analysis. The first 10 transcripts were independently analysed, in which citations regarding GPs’ views about the four topics were selected, and key issues and themes identified (Table 2). The two coders compared their key issues and themes, and discussed all discrepancies until consensus was reached. In case of disagreement, a third researcher (C.F.v.U.-K. or J.W.) was consulted. Related themes were combined and refined. The coders together created a framework, based on these 10 interviews. Subsequently, the remaining 10 transcripts were analysed by one coder (L.A.M.D.) according to the framework as previously defined. Transcripts containing quotes that did not reflect the framework were discussed with the second coder (T.W.) until consensus was reached. One coder (L.A.M.D.) re-examined all transcripts to ensure that the analysis was robust and to confirm that all data were reflected in the coding. Data analysis was conducted using MAXQDA V.11.0 software. Reporting of the data was carried out using the consolidated criteria for reporting qualitative research (COREQ) [17].
