Open access Protocol Patient experience, satisfaction and shared decision-­making in colorectal cancer screening: protocol of the mixed-­ methods study CyDESA Anna Selva ‍ ‍,1,2 Pilar López,1 Teresa Puig,2,3 Francesc Macià,4,5 Clara Selva,6 Yolanda Álvarez-­Pérez,7 Rebeca Terraza,8 Andrea Burón,4,5 Salvador Tarek Machlab,9 Carles Pericay,10 Ivan Solà ‍ ‍,3,11 Núria Torà,12 Vanesa Rodríguez,13 Cristina Barrufet,4 Anna Aymar,3 Marisa Baré ‍ ‍14 To cite: Selva A, López P, ABSTRACT Puig T, et al. Patient Introduction Colorectal cancer (CRC) screening programmes STRENGTHS AND LIMITATIONS OF THIS STUDY experience, satisfaction and can reduce incidence and mortality from this condition ⇒ The combination of qualitative and quantitative shared decision-­making in methodologies enable obtaining a global and ho- if adherence to them is high. As patient experience and colorectal cancer screening: listic vision of the studied phenomenon to be more satisfaction are key factors in determining adherence protocol of the mixed-­methods to screening programmes, they need to be measured. representative of reality. study CyDESA. BMJ Open Furthermore, to promote highly patient-­centred healthcare, ⇒ Selection bias due to non-­responses might limit the 2022;12:e057687. doi:10.1136/ bmjopen-2021-057687 the perception of patients regarding shared decision-­making validity of results. during CRC screening needs to be known. This study aims ⇒ Selection bias would be minimised by conducting ► Prepublication history and reminder phone-­calls to non-­responders. to assess the experience, satisfaction and participation in additional supplemental material ⇒ Findings may not be applicable in areas that use decision-­making of participants in a CRC screening programme for this paper are available and of patients diagnosed with CRC through this programme in different colorectal cancer screening strategies than online. To view these files, please visit the journal online relation to the diagnostic and therapeutic processes of cancer. faecal immunochemical test every 2 years and suc- (http://dx.doi.org/10.1136/​ Methods and analysis The CyDESA study is a mixed-­ cessive colonoscopy. bmjopen-2021-057687). methods study with a four phase sequential design. In phase 1, we will conduct a systematic review of patient-­reported Received 27 September 2021 experience measures (PREMs) for patient experience or Accepted 25 April 2022 satisfaction with CRC screening. In case no located PREM is the second most common cancer among can be applied, in phase 2, we will develop a new PREM. women and the third among men.1 Its survival We will use the Delphi methodology to reach consensus depends on tumour stage at diagnosis, which among experts and patients and will conduct a pilot test is around 56%–57% at 5 years.2 That is why of the developed PREM. Phase 3 is a multicentric cross-­ early detection of CRC using screening strat- sectional study based on self-­reported questionnaires that egies can reduce the burden of this disease.3 4 will be conducted at three Spanish hospitals (n=843). The CRC screening programmes reduce the objective is to find out about the experience, satisfaction and incidence and mortality from CRC as they participation in decision-­making of participants in the CRC detect the disease in its early stages,5–9 leading screening programme who have had a positive screening to a more effective treatment than if the test result according to their final screening diagnosis: false positives, colorectal polyps or CRC. Phase 4 is a qualitative disease is diagnosed when it is already symp- phenomenological study based on individual interviews. It will tomatic.5 There is a range of tests for CRC explore the experiences of participants in the CRC screening screening, including stool tests, particularly programme and of those diagnosed with CRC. faecal immunochemical tests (FIT), the most Ethics and dissemination Ethics approval by the Ethics commonly used in Europe,5 10 11 while colo- Committees of Corporació Sanitària Parc Taulí, Hospital de noscopy is the most common procedure in © Author(s) (or their Sant Pau and Parc de Salut Mar. Findings will be published North America.10 employer(s)) 2022. Re-­use in peer-­reviewed journals and presented at conferences. permitted under CC BY-­NC. No In Catalonia (Spain), the CRC screening Trial registration number NCT04610086. programme is aimed at woman and men commercial re-­use. See rights and permissions. Published by between 50 and 69 years of age and it is based BMJ. INTRODUCTION on conducting a FIT every 2 years.12 13 People For numbered affiliations see Colorectal cancer and colorectal cancer with a negative FIT result receive the result by end of article. screening postal letter. Only when the FIT is positive are Correspondence to Colorectal cancer (CRC) is one of the most people contacted by the hospital: it contacts Anna Selva; ​aselva@​tauli.​cat frequently occurring cancers worldwide: it them by telephone and asks them to attend Selva A, et al. BMJ Open 2022;12:e057687. doi:10.1136/bmjopen-2021-057687 1 Open access a consultation with the screening programme nurse who Shared decision-­making is especially relevant in fields explains the meaning of having a positive FIT test and such as oncology, where it is common to find interven- offers a colonoscopy with sedation. tions in which the equilibrium between benefits and risks is very balanced and the best option depends on Patient experience and satisfaction the patient’s context and his/her values and prefer- Only when screening programmes have high participa- ences.27 For example, some patients would prefer to live tion do they achieve their expected efficacy and impact.5 for a shorter period of time as carriers of a stoma while Participation in screening programmes is related to patient others prefer to suffer major adverse effects in exchange experience and satisfaction with those programmes: satis- for small increases in survival.28 Shared decision-­making faction with past stool test screening strongly predicts processes must be individualised, since patients’ prefer- participation in future screening rounds.14–16 Similarly, ences are not homogeneous and depend on personal in breast cancer screening, women’s satisfaction with factors such as age or gender.29 the screening process is related to good adherence to Published studies on patient satisfaction with CRC the programme.17–20 In addition, it should be borne in screening have focused mainly on some specific aspects of mind that the health system offers screening programmes the whole screening process: the screening test used,30 the to asymptomatic populations that have not requested conducting of a colonoscopy31 32 or the most initial part of healthcare for this condition. For the foregoing reasons, the screening process (invitation to and conducting of a it is important to measure and understand patient experi- screening test).33 However, to the best of our knowledge, ence and satisfaction with CRC screening. there is no study that has assessed patient experience, Although they are usually used interchangeably, patient satisfaction and participation in shared decision-­making experience and satisfaction have a slightly different during the whole CRC screening process, focusing partic- meaning.21 22 Patient experience refers to how patients ularly on the processes that follow a positive screening perceive the medical care received. However, patient test result and that take place in hospitals. satisfaction implies a subjective evaluation or rating of The primary objectives of this study are: (1) to find that experience,21 comparing it to with previous patient out about the experience, satisfaction and participation expectations.22 23 Patient experience and satisfaction are in decision-­making of participants in a CRC screening patient-­reported measures frequently used as quality indi- programme who had a positive screening result and (2) cators of healthcare services, to establish hospital rank- to find out about the experience, satisfaction and partic- ings, benchmark healthcare centre performance and to ipation in decision-­ making of patients diagnosed with measure the effectiveness of interventions.21 24 CRC through the screening programme in relation to the cancer diagnostic and therapeutic processes. Shared decision-making As secondary objectives, we aim to: (1) identify and Healthcare is becoming increasingly more patient-­ assess all available patient-­reported experience measures centred, considering the patient’s views and prefer- (PREMs) for patient experience and satisfaction with CRC ences and sharing with them the decisions related to screening; (2) identify which factors are associated with their healthcare process. Shared decision-­making is the and influence patient experience, satisfaction and partic- process through which patients and healthcare profes- ipation in decision-­making in relation to CRC screening sionals work together to make optimal decisions, along and cancer diagnostic and therapeutic processes and with the best scientific evidence available.25 26 (3) gain an in-­depth knowledge of patients’ experience, satisfaction and perceptions of shared decision-­making in relation to CRC screening and the cancer diagnostic and therapeutic process. METHODS Overall study design and setting This is a four phase, multicentric, mixed-­methods study34 where the results of each study phase will inform the data collection and analysis in proceeding phases (figure 1). The study is scheduled to be conducted between July 2020 and July 2023. Phase 1 consists of a systematic review of PREMs for patient experience or satisfaction with CRC screening. In case no identified PREM can be feasibly applied to our context, in phase 2, we will develop a new PREM to measure patient experience or satisfaction with Figure 1 Study phases and design. PREM, patient-­reported CRC screening. Phase 3 is a multicentric cross-­sectional experience measure. study that will be conducted in three hospitals. Finally, 2 Selva A, et al. BMJ Open 2022;12:e057687. doi:10.1136/bmjopen-2021-057687 Open access phase 4 will comprise a qualitative study based on indi- authors will assess the methodological quality of studies vidual interviews. using the COSMIN Risk of Bias checklist38 and will rate the result of each measurement property against the Phase 1: a systematic review of patient-reported experience updated criteria for good measurement properties based measures (PREMs) for patient experience and satisfaction on Terwee et al39 and Prinsen et al.40 Disagreements will be with colorectal cancer screening solved by consensus. Design We will conduct a systematic review of existing PREMs Data synthesis and analysis to measure patient experience and satisfaction with We will use descriptive statistics to synthesise findings colorectal cancer screening in order to: (1) identify and try to quantitatively pool the results of measure- and critically appraise the quality of the measurement ment properties of questionnaires reported by different properties of validated PREMs that are suitable for use studies. We will use SPSS V.25.0 (SPSS, Chicago, IL, USA) in phase 3 of the study and (2) identify the domains to perform the statistical analysis. We will report findings and items explored by the PREMs identified. The as a narrative synthesis of the characteristics and measure- protocol for this systematic review has been registered ment properties from each instrument. in PROSPERO (https://www.crd.york.ac.uk/prospero/; CRD42019118527). We will conduct this systematic review Phase 2: development of a patient-reported experience following the COnsensus-­based Standards for the selec- measure (PREM) questionnaire tion of health Measurement INstruments (COSMIN) We will develop a PREM based on the findings obtained methodology35 36 and will report the results following the in phase 1, following a multistep process if we cannot preferred reporting items for systematic review and meta-­ identify any validated PREM that can be feasibly applied analysis statement.37 in our context. First, we will identify the different domains assessed Search methods in the questionnaires included in the systematic review We will conduct an exhaustive search in MEDLINE and will collect all the items and questions used in each (PubMed), EMBASE (Ovid), PsycINFO (Ovid) and domain. We will discuss each of these domains within all CINAHL (EBSCOHost) without language or date restric- the research team and will decide which would be the key tions. We will also search in BiblioPRO and check the domains for our PREM. Two authors will independently references listed in included studies. We will keep the read all the questions identified for each domain and search updated while we conduct the review. The detailed classify them into three categories: adequate, adequate search strategies are available in online supplemental with changes or not adequate for measuring experience annex I. We will use the software Procite® to manage or satisfaction with colorectal cancer screening. Disagree- search results and delete duplicates. ments will be solved by consensus. We will also identify Eligibility criteria and study selection if there are any uncovered domains for which new ques- We will include studies on the development or valida- tions need to be developed. tion of questionnaires measuring patient experience or Then, two authors will develop an initial version of the satisfaction with: colorectal cancer screening (irrespec- PREM that will be written in Catalan and Spanish. This tive of the screening test used), colonoscopy (irrespec- version will be discussed with experts in cancer screening tive of it being performed in the context of a screening and patients using a Delphi consensus survey on Google programme) and the screening result notification Forms.41–43 A convenience sample of two to three patients process. We will also consider studies (irrespective of will be invited to participate in the Delphi survey. Patients their design) that assessed patient experience or satisfac- will be offered to participate during the nurse visit in tion with colorectal screening as an outcome in order to which the final diagnosis of the screening programme is obtain information on the questionnaire used and try to communicated. The objective of this Delphi consensus locate its validation study. Two authors will independently survey will be to identify the most and least relevant items, assess the results of the search for eligibility and will then assess their content validity by asking about their rele- make a final decision based on the full text of references vance, comprehensiveness and comprehensibility and deemed eligible. to establish the best order of items. We will conduct the necessary Delphi rounds until a consensus is reached. Data extraction and methodological assessment Finally, we will pilot-­ test the final version of the We will develop and pilot-­test a case report form on Google questionnaire with a sample of 20 participants in the Forms to extract data from included studies. Two authors colorectal cancer screening programme with a positive will independently extract data on the general charac- screening result using the Survey Monkey® software. teristics of the study (country, year and language), popu- After its completion, we will conduct a phone interview lation, characteristics of the questionnaire (including with respondents to assess the acceptability of the PREM, domains and items assessed), evidence for its validity, the time needed to complete it, its relevance, comprehen- information on instrument’s psychometric properties sibility and comprehensiveness (content validity). We will and information on interpretability and feasibility. Two modify the PREM according to the input received and Selva A, et al. BMJ Open 2022;12:e057687. doi:10.1136/bmjopen-2021-057687 3 Open access Selection and recruitment Patients will be selected for their inclusion once the colo- noscopy findings and the pathology examination are available and communicated to them. According to these findings, patients will be classified into one of the three study groups: false positives; polyps or colorectal cancer. Patients will be recruited during the nurse visit in which the final screening programme diagnosis and the recom- Figure 2 Study scheme. FIT, faecal immunochemical mended surveillance is communicated to patients. The test; OUTPATSAT-­7, satisfaction with outpatient cancer screening programme nurse will explain the study objec- care; PATSAT-­C33, satisfaction with cancer care—core tives and obtain the informed consent. Patients with no questionnaire; PREM, patient-­reported experience measure; lesions that do not require a face-­to-­face nurse visit will be SDM-­Q-­9, 9-­item Shared Decision-­Making Questionnaire. recruited by phone and the informed consent will be sent along with the questionnaires. Patients will be recruited consecutively until sample size is reached. will circulate the final version of the PREM among whole the research team for its approval. We plan to assess Sample size other measurement properties of the developed PREM The sample size calculation is based on the proportion (construct validity, internal consistency and test–retest of patients in whom shared decision-­making is achieved, reliability) in specific validation study. according to the CollaboRATE top score (proportion of patients with the maximum score). We conducted a sepa- Phase 3: multicentre cross-sectional study rate sample size calculation for each diagnostic group Design (false positives, polyps and colorectal cancer) to ensure Multicentre cross-­sectional study based on surveys, with a representative estimation of the proportion of patients three study groups according to the final diagnosis of in each group that finally are diagnosed as a consequence screening: (1) false positive group: patients with a positive of their participation in the screening programme. FIT and without risky lesions found through colonoscopy According to the number of patients expected to be (includes colonoscopy with no lesion or with no risky diagnosed in 1 year for each study group (760 false posi- lesions); (2) polyps group: patients with colorectal polyps tives, 1650 polyps and 120 CRC) in the three hospitals, (either adenomas or serrated polyps of any size, grade to detect at least a proportion of 50% of patients who of dysplasia and any number thereof, including carci- achieve shared decision-­making (maximum uncertainty noma in situ) and (3) colorectal cancer group: patients scenario), and accepting an alpha risk of 0.05, a preci- with colorectal cancer that at least infiltrates the submu- sion of 0.05% and 30% of follow-­up losses, it will be neces- cosa (pT1 according the TNM classification44). Figure 2 sary to include 831 patients (321 false positives, 411 with describes the study scheme. polyps and 99 with colorectal cancer). This study will be conducted in three hospitals in Catalonia (Spain) that take part in the region’s organ- Outcomes and data acquisition ised colorectal cancer screening programme: Parc The main outcomes will be satisfaction with the colorectal Taulí Hospital Universitari (Sabadell), Hospital del Mar cancer screening programme and with the cancer diag- (Barcelona) and Hospital de la Santa Creu i Sant Pau nostic and therapeutic process and participation in (Barcelona). These three hospitals are in urban areas and shared decision-­making. Data will be obtained using self-­ provide care to similar populations. reported questionnaires administered online or on paper depending on the participant’s preference. We will use the Population software Survey Monkey® (https://www.surveymonkey.​ We will include women and men between the ages of com/) for online surveys. Paper questionnaires will be 50 and 69 (target population of the colorectal cancer sent by post and will contain a postage paid envelope for screening programme) that have a positive FIT in the their return. If no response is received after 3 weeks, we colorectal cancer screening programme for whom a colo- will make a reminder phone call. We will use the following noscopy is indicated. Such population has the experience questionnaires: (1) the PREM for measuring patient expe- of participating in the whole screening process. We will rience and satisfaction with colorectal cancer screening exclude people for whom a colonoscopy is not indicated identified in phase 1 or developed in phase 2 (PREM-­ for medical reasons or because they refuse it; that do not satisfaction); (2) the CollaboRATE questionnaire45–47 and understand Spanish or Catalan; with an impaired cogni- the 9-­item Shared Decision-­Making Questionnaire (SDM-­ tive status that precludes them from understanding or Q-­9),48 49 two validated questionnaires for measuring answering the questionnaires on their own or with the participation in share-­decision making and (3) the Satis- help of a caregiver; or that have undertaken part of the faction with cancer care core questionnaire (EORTC diagnostic process in another hospital, for example, in a PATSAT-­C33) and the Satisfaction with outpatient cancer private centre. care (EORTC OUT-­PATSAT7)50 51 for measuring patient 4 Selva A, et al. BMJ Open 2022;12:e057687. doi:10.1136/bmjopen-2021-057687 Open access satisfaction with care delivery, two questionnaires based Phase 4: qualitative study on the validated questionnaire IN-­PATSAT3252 53 that are Design currently undergoing a large-­scale cross-­cultural psycho- Qualitative, exploratory-­ descriptive study following the metric assessment. Questionnaire rating is available in phenomenological approach based on individual inter- online supplemental annex II. views. Its objective is to find out about: (1) the experi- For false positive and polyps groups, we will administer ence of participants in the colorectal cancer screening the PREM-­satisfaction and CollaboRATE questionnaires programme who had a positive screening result, and after participants have received the screening result. For (2) the experience of people diagnosed with colorectal patients diagnosed with colorectal cancer, we will admin- cancer in the screening programme in relation to the ister questionnaires at two different stages: (1) after the cancer diagnostic and therapeutic processes. This study medical visit where the patient is informed of their cancer will be registered on Open Science Framework registries diagnosis: PREM-­ satisfaction, CollaboRATE and SDM-­ (osf.io) and will be conducted from the etic perspective Q-­9; (2) at 6 months of inclusion in the study: Collbaro- (from outside).54 RATE, SDM-­Q-­9 and PATSAT-­C33 and OUT-­PATSAT7. Figure 2 describes the time that the questionnaires are Population and setting administer to each study group. This study will take place in one of the participating We will collect information on sociodemographic centres, Hospital Parc Taulí, starting after the previous variables (eg, age, sex and occupation), clinical vari- study phases are concluded. As centres in which the CRC ables (eg, symptoms, other health conditions, familiar screening programme is conducted have similar charac- history of colorectal cancer, characteristics of the colo- teristics and the target population of the programme is noscopy, tumour stage and treatment in the colorectal the same in all them, by conducting a purposeful sampling cancer group) and variables related to the care process of participants in one centre, we can get a representative (eg, hospital centre and dates of FIT analysis, colonos- profile of the people who participate in the screening copy, pathology report and first treatment). A full list programme. We will recruit a theoretical purposive of study variables is available in online supplemental sample of participants in order to achieve the maximum annex III. Information on these variables will be obtained discursive variability.54–56 The sample will include repre- from hospital medical records and from the screening sentation of three groups of informants according to programme software. the final diagnosis of the screening programme as previ- ously described. Each group will comprise a category of informants and will include different profiles based on Data analysis plan gender, age, recommended surveillance and treatment of We will conduct a descriptive analysis using natural colorectal cancer. Table 1 summarises the groups of infor- frequencies and proportions for categorical variables and mants, their profiles and the estimated number of partic- using mean or median and SD or IQRs for quantitative ipants. Inclusion and exclusion criteria and recruitment outcomes. Basal characteristics of participants in each of participants will be the same as described in phase 3. study group will be compared using the χ2 test or Fisher’s exact test for categorical variables and Student’s t-­test or Data acquisition Mann-­Whitney U test for continuous variables. Sample We will conduct individual interviews as this is the most size was calculated for the main outcome participants appropriate method of data acquisition when asking who reached shared decision-­making. We will compare about personal experiences and to guarantee that partic- the proportion of participants with the top score in the ipants are comfortable.54 57 Interviews will be conducted CollaboRATE questionnaire according to the different online (with the Zoom software) or face-­to-­face according study groups, sex, age (categorised) and hospital centre, to participants’ preference. using cross tabs and the χ 2 Test, the Fisher Exact Test We plan to conduct 44 individual interviews according or Monte Carlo Exact Test if appropriate. A two-­sided to a pragmatic decision around sampling. We estimated alpha level of 0.05 will be considered statistically signif- that such number of participants could provide a rich icant. We will conduct a multivariate analysis by logistic corpus of data catching the breadth of our research ques- regression in which the dependent variable will be the tion and the experiential diversity from the participants.58 proportion of participants with the maximum score in Individual interviews will be semistructured, based on an CollaboRATE and will consider as covariables those that interview guide (online supplemental annex V), audio-­ were statistically significant in the bivariate analysis at a p taped and transcribed verbatim.59 They will be conducted value of <0.10 and those that were not will be if deemed by three researchers with experience in qualitative clinically relevant. Analysis will be conducted with SPSS research who are not related to the colorectal cancer V.25.0 (SPSS, Chicago, IL, USA). The analysis for other screening programme and will last approximately 40 min. outcomes is described in online supplemental annex IV. Open-­ ended questions on questionnaires will be anal- Data analysis plan ysed thematically in order to obtain categories with the We will conduct a reflexive thematic analysis.60 This support of the programme ​Atlas.​ti. strategy entails starting with the data to arrive at concepts: Selva A, et al. BMJ Open 2022;12:e057687. doi:10.1136/bmjopen-2021-057687 5 Open access Table 1 Description of the theoretical sample Groups of Number of informants Description Surveillance/treatment Profiles participants False positive Colonoscopy without lesions or Return to screening programme after Women 50–59 years 2 with benign lesions 10 years Women 60–69 years 2 Men 50–59 years 2 Men 60–69 years 2 Polyps Polyps that do not require Return to screening programme after Women 50–59 years 2 surveillance 10 years Women 60–69 years 2 Men 50–59 years 2 Men 60–69 years 2 Polyps that require standard Colonoscopy after 3 years Women 50–59 years 2 surveillance Women 60–69 years 2 Men 50–59 years 2 Men 60–69 years 2 Polyps that require intensive Colonoscopy after 1 year Women 50–59 years 2 surveillance Women 60–69 years 2 Men 50–59 years 2 Men 60–69 years 2 Colorectal Diagnosis of colorectal cancer Endoscopic resection Women 2 cancer Men 2 Surgery (without radio/ Women 2 chemotherapy) Men 2 Radio/chemotherapy±surgery Women 2 Men 2 by reading and analysing the transcripts of interviews, research ethics committees of Corporació Sanitària Parc we will elaborate a tentative list of codes. Data will be Taulí, Hospital de la Santa Creu i Sant Pau and Parc de segmented by group of informants. We will use the soft- Salut Mar. All personal data will be anonymised, assigning ware ​Atlas.​ti for the analysis. a study code to each participant. Questionnaires used in To guarantee quality of data, it will be contrasted phase 3 will be identified by the study code and will not with informants. Information will be triangulated by include any identifiable data. Participants in phases 3 and comparing the different groups of informants. Three 4 will be required to read the participant information experienced analysts will participate in this part. sheet and sign the informed consent form. This study involves human participants and was approved by Ethics Patient and public involvement statement Committee for Research of the Parc Taulí Hospital, Patients will be involved in conducting the research, Sabadell; Ethics Committee for Research of Sant Pau specifically in the development of a PREM for measuring Hospital, Barcelona; Ethics Committee for Research patient satisfaction with CRC screening (study phase of Hospital del Mar, Barcelona (Reference number: 2). Patients will be invited to participate together with 2019/502). Participants gave informed consent to partic- experts in cancer screening in a Delphi survey to identify the most and least relevant items of the first version of the ipate in the study before taking part. PREM, assess their content validity and establish the best Interviews to persons with CRC cancer will be conducted order of items. by a psychologist with wide experience in conducting individual interviews (CS). Also, we will avoid mentioning Ethics and dissemination the word ‘cancer’ or ‘tumour’ in the questionnaires and This study will be conducted in accordance with the interviews, and will refer to the health problem as ‘your Helsinki Declaration.61 It has been approved by the intestinal health problem’. We do not expect any adverse 6 Selva A, et al. BMJ Open 2022;12:e057687. doi:10.1136/bmjopen-2021-057687 Open access event for participating in this study, just the time required AB, CB are responsible for the organisation of the fieldwork in each centre. AS, TP to answer the questionnaires (phase 3) and attend the and FM were responsible for obtaining the Ethics Committee approval. AS wrote the manuscript and STM, TP, AB, CB, CS, RT, YA-­P, NT and IV critically reviewed it and interviews (phase 4). made significant contributions to its improvement. All authors approved the final The dissemination plan includes publication in peer-­ manuscript. reviewed journals, presentations at conferences, dissemi- Funding This work was supported by Instituto de Salud Carlos Tercero, grant nation of plain language summaries through institutional number (PI18/00460). webpages, an executive summary of study findings for Competing interests None declared. participants and social media posts. Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details. DISCUSSION Patient consent for publication Consent obtained directly from patient(s). This study will provide an insight into areas for improve- Provenance and peer review Not commissioned; externally peer reviewed. ment in the CRC screening programme and in cancer diag- Supplemental material This content has been supplied by the author(s). It has nostic and therapeutic processes, focusing on patients’ not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been views and experiences. By using a mixed approach, peer-­reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and combining quantitative and qualitative methods, we will responsibility arising from any reliance placed on the content. Where the content quantify the phenomenon of interest and identify the includes any translated material, BMJ does not warrant the accuracy and reliability associated factors and also delve into the phenomenon of the translations (including but not limited to local regulations, clinical guidelines, based on the experience of those affected, obtaining a terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. global understanding of the phenomenon. Open access This is an open access article distributed in accordance with the If results confirm that the study hypotheses, satisfaction Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which and perception of shared decision-­ making of patients permits others to distribute, remix, adapt, build upon this work non-­commercially, differ according to the final screening diagnostic, it and license their derivative works on different terms, provided the original work is will be possible to design different strategies (eg, in the properly cited, appropriate credit is given, any changes made indicated, and the use is non-­commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. communication of screening results or in the manage- ment of waiting times) adapted to the diagnostic group ORCID iDs of participants in order to minimise inconveniences. Anna Selva http://orcid.org/0000-0002-2754-3158 Ivan Solà http://orcid.org/0000-0003-0078-3706 Marisa Baré http://orcid.org/0000-0001-8085-2833 Author affiliations 1 Clinical Epidemiology and Cancer Screening, Consorci Corporació Sanitària Parc Taulí, Sabadell, Catalunya, Spain 2 Department of Paediatrics, Obstetrics, Gynaecology and Preventive Medicine, Autonomous University of Barcelona, Barcelona, Catalunya, Spain REFERENCES 3 Clinical Epidemiology and Healthcare Services, Institut d’Investigació Biomèdica 1 IARC. Globocan 2012: estimated cancer incidence, mortality and Sant Pau IIB Sant Pau, Barcelona, Catalunya, Spain prevalence worldwide in 2012. Available: http://globocan.iarc.fr/​ 4 Epidemiology and Evaluation Department, Hospital del Mar Institute for Medical Pages/fact_sheets_cancer.aspx [Accessed 1 Aug 2018]. 2 De Angelis R, Sant M, Coleman MP, et al. Cancer survival in Research, Barcelona, Catalunya, Spain Europe 1999–2007 by country and age: results of EUROCARE-­- 5 Health Services Research on Chronic Patients Network, REDISSEC, Madrid, Spain 5—a population-­based study. Lancet Oncol 2014;15:23–34 http://​ 6 Psychology and Educational Sciences Studies, UOC, Barcelona, Catalunya, Spain linkinghub.elsevier.com/retrieve/pii/S1470204513705461 7 3 edCubiella JF, Castillejo MM MJ. Diagnóstico Y prevención del Servicio de Evaluación del Servicio Canario de la Salud, Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Santa Cruz de Tenerife, cáncer colorectal. Guía de práctica clínica. Madrid: Asociación Española de Gastroenterología y Sociedad Española de Medicina de Santa Cruz de Tenerife, Spain 8 Familia y comunitaria, 2018. Departament de Salut, Barcelona, Catalunya, Spain 4 Issa IA, Noureddine M. Colorectal cancer screening: an 9 Gastroenterology Department, Consorci Corporació Sanitària Parc Taulí, Sabadell, updated review of the available options. World J Gastroenterol Catalunya, Spain 2017;23:5086–96 https://pubmed.ncbi.nlm.nih.gov/28811705/ 10 Medical Oncology Department, Consorci Corporació Sanitària Parc Taulí, Sabadell, 5 Comission ESegnan N, Patnick J von KL, eds. European guidelines Catalunya, Spain for quality assurance in colorectal cancer screening and diagnosis. 11 1st ed. Luxembourg, 2010. CIBERESP, CIBER, Madrid, Comunidad de Madrid, Spain 6 Hewitson P, Glasziou P, Irwig L, et al. Screening for colorectal cancer 12 Cancer Screening Programs, Althaia Foundation of Manresa, Manresa, Catalunya, using the faecal occult blood test, Hemoccult. Cochrane Database Spain Syst Rev 2007;2007:CD001216 https://pubmed.ncbi.nlm.nih.gov/​ 13 TecnoCampus Superior School of Health Science, Pompeu Fabra University, 17253456/ Mataro, Catalunya, Spain 7 Shaukat A, Mongin SJ, Geisser MS, et al. Long-­Term mortality after 14 screening for colorectal cancer. N Engl J Med 2013;369:1106–14 Epidemiology and Cancer Screening, Consorcio Corporacion Sanitaria Parc Tauli, https://pubmed.ncbi.nlm.nih.gov/24047060/ Sabadell, Spain 8 Fitzpatrick-­Lewis D, Ali MU, Warren R, et al. Screening for colorectal cancer: a systematic review and meta-­analysis. Clin Colorectal Twitter Anna Selva AnnaSelva @cribratgetauli Cancer 2016;15:298–313 https://pubmed.ncbi.nlm.nih.gov/​ 27133893/ Acknowledgements To Christina McGown for reviewing the English language 9 Ventura L, Mantellini P, Grazzini G, et al. The impact of edition. immunochemical faecal occult blood testing on colorectal cancer incidence. Dig Liver Dis 2014;46:82–6 https://pubmed.ncbi.nlm.nih.​ Contributors AS conceptualised and designed the study, in collaboration gov/24011791/ with NT, VR, RT, PL, CS, MB and IS. STM and CP provided clinical expertise. NT 10 Navarro M, Nicolas A, Ferrandez A, et al. Colorectal cancer provided statistical advice. RT, CS, AB and YA-­P provided expertise in qualitative population screening programs worldwide in 2016: an update. World methodology. IS provided expertise in systematic review methodology and is J Gastroenterol 2017;23:3632–42 https://pubmed.ncbi.nlm.nih.gov/​ responsible of the design and conduction of search strategies. AS, PLL, TP, AA, FM, 28611516/ Selva A, et al. BMJ Open 2022;12:e057687. doi:10.1136/bmjopen-2021-057687 7 Open access 11 Schreuders EH, Ruco A, Rabeneck L, et al. Colorectal cancer evaluation of the community pharmacy. Gastroenterol Hepatol screening: a global overview of existing programmes. Gut 2017;40:265–75 https://pubmed.ncbi.nlm.nih.gov/27292268/ 2015;64:1637–49 https://pubmed.ncbi.nlm.nih.gov/26041752/ 34 Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed 12 Ministerio de Sanidad y Política Social. Estrategia en cancer del. methods designs-­principles and practices. Health Serv Res Madrid: Sistema Nacional de Salud, 2010. 2013;48:2134–56 https://pubmed.ncbi.nlm.nih.gov/24279835/ 13 d’Oncologia PD. Pla Contra El C ncer a Catalunya 2015-­2020 2015. 35 Prinsen CAC, Mokkink LB, Bouter LM, et al. COSMIN guideline for 14 Osborne JM, Wilson C, Duncan A, et al. Patterns of participation systematic reviews of patient-­reported outcome measures. Qual over four rounds of annual fecal immunochemical test-­based Life Res 2018;27:1147–57 http://www.ncbi.nlm.nih.gov/pubmed/​ screening for colorectal cancer: what predicts rescreening? 29435801 BMC Public Health 2017;18:81 https://pubmed.ncbi.nlm.nih.gov/​ 36 Mokkink LB, Prinsen CAC, Patrick DL. COSMIN methodology for 28764667/ systematic reviews of Patient‐Reported outcome measures (PROMs). 15 Duncan A, Turnbull D, Wilson C, et al. Behavioural and demographic Qual Life Res 2018 https://www.cosmin.nl/wp-content/uploads/​ predictors of adherence to three consecutive faecal occult blood COSMIN-syst-review-for-PROMs-manual_version-1_feb-2018.pdf test screening opportunities: a population study. BMC Public Health 37 Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for 2014;14:238. systematic review and meta-­analysis protocols (PRISMA-­P) 2015 16 Duncan A, Turnbull D, Gregory T, et al. Using the Transtheoretical statement. Syst Rev 2015;4:1 http://www.ncbi.nlm.nih.gov/pubmed/​ model of behaviour change to describe readiness to rescreen for 25554246 colorectal cancer with faecal occult blood testing. Health Promot J 38 Mokkink LB, de Vet HCW, Prinsen CAC, et al. COSMIN risk of Austr 2012;23:122–8 https://pubmed.ncbi.nlm.nih.gov/23088473/ bias checklist for systematic reviews of patient-­reported outcome 17 Soler-­Michel P, Courtial I, Bremond A. [Reattendance of women measures. Qual Life Res 2018;27:1171–9 http://www.ncbi.nlm.nih.​ for breast cancer screening programs. A review]. Rev Epidemiol gov/pubmed/29260445 Sante Publique 2005;53:549–67 https://pubmed.ncbi.nlm.nih.gov/​ 39 Terwee CB, Bot SDM, de Boer MR, et al. Quality criteria 16434928/ were proposed for measurement properties of health status 18 Almog R, Hagoel L, Tamir A. Quality Control in a National Program questionnaires. J Clin Epidemiol 2007;60:34–42 https://pubmed.ncbi.​ for the Early Detection of Breast Cancer. Women’s Satisfaction With nlm.nih.gov/17161752/ the Mammography Process. Women’s Heal Issues 2008;18:110–7 40 Prinsen CAC, Vohra S, Rose MR, et al. How to select outcome https://pubmed.ncbi.nlm.nih.gov/18319148/ measurement instruments for outcomes included in a "Core 19 Tang TS, Patterson SK, Roubidoux MA, et al. Women's Outcome Set" - a practical guideline. Trials 2016;17:449 https://​ mammography experience and its impact on screening adherence. pubmed.ncbi.nlm.nih.gov/27618914/ Psychooncology 2009;18:727–34 https://pubmed.ncbi.nlm.nih.gov/​ 41 Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi 19035468/ survey technique. J Adv Nurs 2000;32:1008–15 https://pubmed.ncbi.​ 20 Peipins LA, Shapiro JA, Bobo JK, et al. Impact of women's nlm.nih.gov/11095242/ experiences during mammography on adherence to rescreening 42 Geist MR. Using the Delphi method to engage stakeholders: a (United States). Cancer Causes Control 2006;17:439–47 https://​ comparison of two studies. Eval Program Plann 2010;33:147–54 pubmed.ncbi.nlm.nih.gov/16596296/ https://pubmed.ncbi.nlm.nih.gov/19581002/ 21 Beattie M, Murphy DJ, Atherton I, et al. Instruments to measure 43 McPherson S, Reese C, Wendler MC. Methodology update: Delphi patient experience of healthcare quality in hospitals: a systematic studies. Nurs Res 2018;67:404–10 https://pubmed.ncbi.nlm.nih.gov/​ review. Syst Rev 2015;4:97 https://pubmed.ncbi.nlm.nih.gov/​ 30052591/ 26202326/ 44 Brierley JD, ed. Tnm classification of malignant tumours. 8th ed. 22 Klose K, Kreimeier S, Tangermann U, et al. Patient- and person-­ Wiley, 2021. https://www.wiley.com/en-ad/TNM+Classification+of+​ reports on healthcare: preferences, outcomes, experiences, and Malignant+Tumours%2C+8th+Edition-p-9781119263579 satisfaction – an essay. Health Econ Rev 2016;6:1–11. 45 Forcino RC, Bustamante N, Thompson R, et al. Developing and pilot 23 Crow R, Gage H, Hampson S. The measurement of satisfaction with testing a Spanish translation of collaborate for use in the United healthcare: Implications for practice from a systematic review of the States. PLoS One 2016;11:e0168538 https://pubmed.ncbi.nlm.nih.​ literature [Internet]. Vol. 6, Health Technology Assessment. Health gov/28002422/ Technol Assess 2002 https://pubmed.ncbi.nlm.nih.gov/12925269/ 46 Elwyn G, Barr PJ, Grande SW, et al. Developing collaborate: a fast 24 Doyle C, Lennox L, Bell D. A systematic review of evidence and frugal patient-­reported measure of shared decision making on the links between patient experience and clinical in clinical encounters. Patient Educ Couns 2013;93:102–7 https://​ safety and effectiveness. BMJ Open 2013;3. doi:10.1136/ pubmed.ncbi.nlm.nih.gov/23768763/ bmjopen-2012-001570. [Epub ahead of print: 03 Jan 2013] https://​ 47 Barr PJ, Thompson R, Walsh T, et al. The psychometric properties of pubmed.ncbi.nlm.nih.gov/23293244/ collaborate: a fast and frugal patient-­reported measure of the shared 25 Elwyn G, Frosch D, Thomson R, et al. Shared decision making: a decision-­making process. J Med Internet Res 2014;16:e2 https://​ model for clinical practice. J Gen Intern Med 2012;27:1361–7 https://​ pubmed.ncbi.nlm.nih.gov/24389354/ pubmed.ncbi.nlm.nih.gov/22618581/ 48 De las Cuevas C, Perestelo-­Perez L, Rivero-­Santana A, et al. 26 Olthuis G, Leget C, Grypdonck M. Shared decision making needs a Validation of the Spanish version of the 9-­item shared decision-­ care perspective. BMJ 2012;345:e7419. making questionnaire. Health Expect 2015;18:2143–53 https://​ 27 Zafar SY, Malin JL, Grambow SC, et al. Chemotherapy use and pubmed.ncbi.nlm.nih.gov/24593044/ patient treatment preferences in advanced colorectal cancer: a 49 Kriston L, Scholl I, Hölzel L, et al. The 9-­item shared decision making prospective cohort study. Cancer 2013;119:854–62 http://www.ncbi.​ questionnaire (SDM-­Q-­9). development and psychometric properties nlm.nih.gov/pubmed/22972673 in a primary care sample. Patient Educ Couns 2010;80:94–9 https://​ 28 Currie A, Askari A, Nachiappan S, et al. A systematic review of pubmed.ncbi.nlm.nih.gov/19879711/ patient preference elicitation methods in the treatment of colorectal 50 Brédart A, Anota A, Young T, et al. Phase III study of the European cancer. Colorectal Dis 2015;17:17–25 http://doi.wiley.com/ organisation for research and treatment of cancer satisfaction with 29 Damm K, Vogel A, Prenzler A. Preferences of colorectal cancer cancer care core questionnaire (EORTC PATSAT-­C33) and specific patients for treatment and decision-­making: a systematic literature complementary outpatient module (EORTC OUT-­PATSAT7). Eur J review. Eur J Cancer Care 2014;23:762–72 http://www.ncbi.nlm.nih.​ Cancer Care 2018;27:e12786 https://pubmed.ncbi.nlm.nih.gov/​ gov/pubmed/24840999 29094784/ 30 Kirkøen B, Berstad P, Botteri E, et al. Acceptability of two colorectal 51 Brédart A, Beaudeau A, Young T, et al. The European organization cancer screening tests: pain as a key determinant in sigmoidoscopy. for research and treatment of cancer - satisfaction with cancer care Endoscopy 2017;49:1075–86 http://www.thieme-connect.de/DOI/​ questionnaire: revision and extended application development. DOI Psychooncology 2017;26:400–4 https://pubmed.ncbi.nlm.nih.gov/​ 31 Sipe BW, Fischer M, Baluyut AR, et al. A low-­residue diet improved 27546090/ patient satisfaction with split-­dose oral sulfate solution without 52 Brédart A, Bottomley A, Blazeby JM, et al. An international impairing colonic preparation. Gastrointest Endosc 2013;77:932–6 prospective study of the EORTC cancer in-­patient satisfaction with https://pubmed.ncbi.nlm.nih.gov/23531424/ care measure (EORTC IN-­PATSAT32). Eur J Cancer 2005;41:2120–31 32 Ghanouni A, Plumb A, Hewitson P, et al. Patients' experience of https://pubmed.ncbi.nlm.nih.gov/16182120/ colonoscopy in the English bowel cancer screening programme. 53 Neijenhuijs KI, Jansen F, Aaronson NK, et al. A systematic review Endoscopy 2016;48:232–40 https://pubmed.ncbi.nlm.nih.gov/​ of the measurement properties of the European organisation for 26841268/ research and treatment of cancer in-­patient satisfaction with care 33 Burón A, Posso M, Sivilla J, et al. Analysis of participant satisfaction questionnaire, the EORTC IN-­PATSAT32. Support Care Cancer in the Barcelona colorectal cancer screening programme: positive 2018;26:2551–60 https://pubmed.ncbi.nlm.nih.gov/29732482/ 8 Selva A, et al. BMJ Open 2022;12:e057687. doi:10.1136/bmjopen-2021-057687 Open access 54 Berenguera A, Fernández MJ, Pons M. Escuchar, observar Y 58 Braun V, Clarke V. To saturate or not to saturate? Questioning data comprender. Recuperando La narrativa en las Ciencias de la Salud. saturation as a useful concept for thematic analysis and sample-­size Aportaciones de la investigación cualitativa. 1st ed. Barcelona: rationales. Qual Res Sport Exerc Health 2021;13:201–16. Institut Universitari d’Investigació en Atenció Prim ria Jordi Gol, 59 Jefferson G. Glossary of tanscript symbols with an introduction. In: 2014. Conversation analysis studies from the first generation. Amsterdam: Publishing JB, 2004: 13–31. 55 Ruíz Olabuénaga Jde DU, ed. Metodología de la investigación 60 Braun V, Clarke V. Using thematic analysis in psychology. Qual Res cualitativa. Bilbao, 1995: 112–3. Psychol 2006;3:77–101 https://www.tandfonline.com/doi/abs/ 56 Teddlie C, Yu F. Mixed methods sampling. A typology with examples. 61 The Helsinki Declaration of the World Medical Association (WMA). Baton Rouge: Sage Publications, 2007: 1. 77–100. Ethical principles of medical research involving human subjects. 57 Green JTN. Interviews I-­deph. In: Qualitative methods for health Available: https://pubmed.ncbi.nlm.nih.gov/24964504/ [Accessed 6 research. 4th ed. London: SAGE Publications Ltd, 2018. Jul 2021]. Selva A, et al. BMJ Open 2022;12:e057687. doi:10.1136/bmjopen-2021-057687 9