Selva et al. BMC Med Res Methodol (2021) 21:230 https://doi.org/10.1186/s12874-021-01430-7 RESEARCH Open Access Satisfaction and experience with colorectal cancer screening: a systematic review of validated patient reported outcome measures A. Selva1,2,3*, C. Selva4, Y. Álvarez‑Pérez5, N. Torà6, P. López1, R. Terraza‑Núñez7, V. Rodríguez8 and I. Solà9,10,11on behalf of The CyDESA group Abstract Background: Patient satisfaction or experience with colorectal cancer screening can determine adherence to screening programs. An evaluation of validated patient reported outcome measures (PROMs) for measuring expe‑ rience or satisfaction with colorectal cancer screening does not exist. Our objective was to identify and critically appraise validated questionnaires for measuring patient satisfaction or experience with colorectal cancer screening. Methods: We conducted a systematic review following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. We conducted searches on MEDLINE, EMBASE, PsychINFO, CINAHL and BiblioPRO and assessed the methodological quality of studies and measurement properties of ques‑ tionnaires according to the COSMIN guidelines for systematic reviews of PROMs. PROSPERO registration number: CRD42019118527. Results: We included 80 studies that used 75 questionnaires, of which only 5 were validated. Four questionnaires measured satisfaction with endoscopy: two in the context of colorectal cancer screening (for colonoscopy and sigmoidoscopy) and two for non-screening endoscopy. One questionnaire measured satisfaction with bowel prepa‑ ration. The methodological quality of studies was variable. The questionnaires with evidence for sufficient content validity and internal consistency were: the CSSQP questionnaire, which measures safety and satisfaction with screen‑ ing colonoscopy, and the Post-Procedure questionnaire which measures satisfaction with non-screening endoscopic procedures. Conclusions: This systematic review shows that a minority of existing PROMs for measuring patient satisfaction with colorectal cancer screening are validated. We identified two questionnaires with high potential for further use (CSSQP and the Post-Procedure questionnaire). Keywords: Patient satisfaction, Patient experience, Colorectal cancer screening, systematic review, Patient reported outcome measures, PROM, Instruments, Questionnaires Background *Correspondence: aselva@tauli.cat; annaolid@gmail.com Colorectal cancer is the third most common cancer 1 Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital among men and the second among women and is the Universitari, Corporació Sanitària Parc Taulí, Edifici Santa Fè. Parc Taulí 1, second cause of cancer death worldwide [1]. Its 5-year Sabadell, 08208 Barcelona, Catalonia, Spain Full list of author information is available at the end of the article survival rate is 57% for colon cancer and 56% for rectal © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://​creat​iveco​mmons.​org/​licen​ses/​by/4.​0/. The Creative Commons Public Domain Dedication waiver (http://​creat​iveco​ mmons.​org/​publi​cdoma​in/​zero/1.​0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Selva et al. BMC Med Res Methodol (2021) 21:230 Page 2 of 15 cancer [2]. Survival is related to tumor stage at diagno- satisfaction) and reliable (the measure is consistent) [19, sis, so screening strategies have the potential to reduce 20]. the burden of the disease through early detection [3, 4]. To our knowledge, an evaluation of validated PROMs Colorectal cancer screening aims to detect latent dis- to measure patient experience and/or satisfaction with ease in early stages, so it can be treated more effectively colorectal cancer screening does not exist. Our objective than if diagnosed when symptoms appear [5]. Organ- was to identify all the questionnaires used for measuring ized screening programs have proven to reduce inci- patient experience or satisfaction with colorectal cancer dence and mortality from colorectal cancer [5–9]. There screening and critically appraise the measurement prop- are different tests that can be used for colorectal cancer erties of those validated. screening: 1. stool tests (guaiac or immunochemical); 2. endoscopic tests (sigmoidoscopy and colonoscopy); 3. Methods image test (CT colonography and capsule endoscopy); We conducted a systematic review following the COn- and 4. biomarkers in peripheral blood. In Europe, stool sensus-based Standards for the selection of health Meas- tests, particularly fecal immunochemical tests, are the urement INstruments (COSMIN) methodology for most used in organized screening programs [5, 10, 11]. systematic reviews of patient-reported outcome meas- However, in North America, colonoscopy remains the ures (PROMs) [23–25]. We registered the review proto- most commonly used procedure [10]. col in PROSPERO (http://​www.​crd.​york.​ac.​uk/​PROSP​ For organized screening programs to have the ERO) [registration number CRD42019118527] and expected population impact, it is essential that the report its findings according to the PRISMA statement participation and adherence rates are high [5]. Patient [26]. This systematic review is part of a broader project, experience and satisfaction with screening programs the CyDESA study that aims to evaluate satisfaction and are among the factors that determine adherence to patient participation in decision making in colorectal them. Studies conducted on colorectal cancer screen- cancer screening. ing showed that satisfaction with past stool test screen- ing is a strong behavioral predictor of adherence to Search strategy future screening rounds [12–14]. In addition, for breast We conducted an exhaustive search in MEDLINE (Pub- cancer screening, several studies have shown that per- Med), EMBASE (Ovid), PsycINFO (Ovid) and CINAHL ceived satisfaction with screening can lead to good (EBSCOHost) without language or date restrictions. program adherence [15–18]. Furthermore, it should We kept the search updated while we conducted the be borne in mind that screening programs are aimed review and performed the last search in October 2020. at asymptomatic populations that have not required or The detailed search strategies and dates are available in requested health care for this condition, and it is the Annex A. We also searched in BiblioPRO and checked health system itself that invites them to participate. For the references listed in included studies. We designed a these reasons, it is necessary to measure and monitor search strategy combining controlled vocabulary from the experience and satisfaction of participants in rela- each database and text words related to the topics review tion to colorectal cancer screening. (e.g., satisfaction and colorectal screening). Although a Patient experience and patient satisfaction are patient- proposal to find studies on PROMs measurement prop- reported outcome measures (PROMs) often used inter- erties exists [27], we defined and used a more specific list changeably despite having a small difference in meaning of terms to filter the search results. [19, 20]. While patient experience provides a report of the health care from the receiver’s perspective, patient Eligibility criteria satisfaction involves some sort of rating or evaluation We included validation studies which reported the devel- [19]. Although patient satisfaction lacks a formal defini- opment and/or the evaluation of one or more measure- tion, it can be understood as a subjective evaluation of ment properties of questionnaires measuring patient health care based on the extent to which patients’ expec- experience or satisfaction with colorectal cancer screen- tations are met [20, 21]. Both patient experience and sat- ing, irrespective of the screening test used. To avoid isfaction have been used to monitor the quality of health being too restrictive, we also included studies on the care services, benchmark hospital performance and development or validation of questionnaires that meas- establish hospital rankings, and monitor the effective- ure patient experience or satisfaction with colonoscopy ness of interventions [19, 22]. The most used method to (irrespective of it was performed in the context of a obtain these patient-reported measures is self-reported screening program) and with the notification process of questionnaires. However, these questionnaires need to be a screening result. We also considered studies (irrespec- valid (they accurately represent the patient experience or tive of their design) that assessed patient experience or Selva et al. BMC Med Res Methodol (2021) 21:230 Page 3 of 15 satisfaction with colorectal screening as an outcome. Assessment of methodological quality of included studies From these studies, we tried to obtain information on the We assessed the methodological quality of each meas- questionnaire used to measure the outcome and tried to urement property study using the COSMIN Risk of Bias locate the validation study to consider its inclusion. checklist [24]. According to this checklist, methodologi- We limited the inclusion to studies published in Eng- cal quality of studies was rated as either “very good”, “ade- lish, Spanish, French and Italian. We excluded studies quate”, “doubtful” or “inadequate” for each measurement that assessed satisfaction with the decision to uptake property assessed. We used the COSMIN taxonomy to screening and studies that used alternative methods to determine which measurement property were assessed in questionnaires to measure experience or satisfaction, each study. such as interviews or diaries. Two authors independently assessed the results of Assessment of measurement properties results the search for eligibility, and then made a final decision The result of each measurement property study was rated based on the full text of the references deemed eligible. against the updated criteria for good measurement prop- Disagreements were resolved with the help of a third erties based on Terwee et al. [29] and Prinsen et al. [30] reviewer. (Annex B). Each result was rated as either sufficient (+), insufficient (−), or indeterminate (?). Following the COSMIN manual, we graded the qual- Data extraction ity of the evidence for the rating of each measure- We developed and pilot-tested a case report form (CRF) ment property of each questionnaire using the GRADE using Google Forms. The CRF is available from the approach [31], which specifies four levels of quality of authors on request. Two authors independently extracted evidence (high, moderate, low or very low) depending data from included studies and disagreements were on the presence of four factors (risk of bias, indirectness, resolved with the help of a third reviewer. When full inconsistency and imprecision). If the overall rating for a questionnaires were not reported in the paper, we tried measurement property is indeterminate (?), the quality of to contact the corresponding authors in order to obtain the PROM cannot be judged and there will be no grading them. of the quality of the evidence [23]. We extracted the following data from eligible docu- The process of assessing methodological quality of ments following the recommendations from the COS- studies, rating measurement properties and grading MIN user manual [23, 28]: 1. General characteristics the evidence was done by two authors independently of the study (country, year of publication, study design, and differences were resolved by consensus. Attempts objective, main outcomes); 2. Characteristics from the were made to contact the authors of included PROMs questionnaire targeted population or those that par- for information on all measurement properties of ticipated in the validation; 3. Main characteristics of questionnaires. the questionnaire (name, original language and avail- According to ratings on methodological quality and able translations, administration characteristics, domains the results of measurement properties, included PROMs measured, number of items, evidence for validity); 4. were classified providing a recommendation on the most Information on questionnaires psychometric properties; suitable questionnaire to be used [23] (Table 1). 5. Information on interpretability of questionnaires (the degree to which a quantitative score or a change in score Data analysis and synthesis of a questionnaire can have a qualitative meaning) and We used descriptive statistics to synthesize findings, cal- feasibility (the ease of application of the questionnaire in culating absolute frequencies and proportions as appro- a setting). Interpretability and feasibility are not consid- priate. We planned to quantitatively pool the results ered measurement properties, but are important aspects reported by different studies on measurement properties for selecting a questionnaire to use in practice [23]. of each questionnaire. However, we were not able to do Table 1 Categories for classification of PROMs Category Characteristics Implications A Evidence for sufficient content validity (any level) and at least Have potential to be recommended as the most suitable questionnaire low evidence for sufficient internal consistency for the construct and population of interest B Questionnaire not categorized in A or C May have the potential to be recommended, but further validation studies are needed C High quality evidence for an insufficient measurement property Should not be recommended Selva et al. BMC Med Res Methodol (2021) 21:230 Page 4 of 15 so as we only found one study for each questionnaire. A 158 records for full-text assessment and finally included statistical analysis was performed using SPSS, version 80 studies. Reasons for exclusions are detailed in Fig. 1. 25.0 (SPSS Inc., Chicago, IL, USA). We report the find- ings of the review as a narrative synthesis of the charac- Characteristics of included studies and questionnaires teristics and measurement properties from each included We identified 80 studies published from 1992 to 2020 questionnaire. that used questionnaires to measure patient experience or satisfaction with colorectal cancer screening or with the conduction of non-screening colonoscopy, sigmoi- Ethical approval doscopy or with bowel preparation. Most of them were No ethical approval was required as this study is a sys- published in North America (38, 47.5%) and Europe (26, tematic review. 32.5%) from 2010 on (Table 2). Most studies were experi- mental or observational studies in which patient expe- Results rience or satisfaction were measured as outcomes (75, Study selection 93.7%) and only five studies (6.2%) described the develop- We describe the eligibility process in a PRISMA flow- ment of a questionnaire or its validation. These 80 stud- chart [26] (Fig. 1). We screened the titles and abstracts ies used 75 different questionnaires, being most of them of 3749 references obtained from the searches, selected self-administered (70, 93.3%) and written in English (61, Fig. 1 PRISMA 2009 Flow Diagram. *Reasons for exclusion: Not measures satisfaction with colorectal cancer screening (n = 46); Not uses a questionnaire (n = 13); Narrative review (n = 6); Measures satisfaction with the decision to participate in a study (n = 3); Not about colorectal cancer screening (n = 2); Study protocol (n = 1); Language (n = 1), Duplicate (n = 4), Measures satisfaction in relation to a small part of the process (use of a reminder letter, sedation protocol used, n = 2). PROMs: patient reported outcome measures Selva et al. BMC Med Res Methodol (2021) 21:230 Page 5 of 15 Table 2 Characteristics of included studies and questionnaires Characteristic of validated questionnaires Included studies (n = 80) N % From the 75 questionnaires identified, only seven (9.3%) were reported as validated tools [32–38]. There were Continent two studies that reported using validated questionnaires, North America 38 47.5 but we were unable to locate the development or vali- Europe 26 32.5 dation studies or to obtain a copy of them (although an Asia 8 10.0 effort was made to contact authors) [37, 38]. For that rea- Oceania 6 7.5 son, we could only analyze five validated questionnaires Other 2 2.5 (6.6%) [32–36]. Year of publication All five validated questionnaires measured patient sat-   < 2005 24 30.0 isfaction. Four questionnaires assessed satisfaction with 2005–2010 14 17.5 endoscopic procedures (Table 3). Two were developed   > 2010 42 52.5 in the context of colorectal cancer screening (the Colo- Study design noscopy Satisfaction and Safety Questionnaire (CSSQP) Experimental or quasi-experimental 28 35.0 for colonoscopy conducted after a positive stool test [32] Other study designs, patient experience/satisfaction is an 47 58.7 and the Screening Flexible Sigmoidoscopy Assessment outcome Questionnaire for screening sigmoidoscopy [36]). The Study on the development or validation of a questionnaire 5 6.2 other two measured satisfaction in the context of elec- ­ uestionnairesa Administration of q 75 tive upper or lower endoscopy (the Spanish modified Self-reported 70 93.3 Group Health Association of America- 9 Questionnaire By telephone 3 4.0 (SmGHAA-9 m) [34] and the Post Procedure Question- Not reported 2 2.7 naire [35]). The remaining questionnaire assessed satis- Availability of the ­questionnairea faction with bowel preparation for colonoscopy [33]. Yes 32 42.7 Three questionnaires used the English language and No 43 57.3 were developed and validated in the USA [33, 35, 36], Original language of the ­questionnairea while two were developed and validated in Spain and English 61 81.3 used the Spanish language although an English trans- Spanish 4 5.3 lation is available [32, 34]. All questionnaires were self- Chinese 2 2.7 administrated with the exception of the SmGHAA-9 m Korean 2 2.7 [34] which was administered by telephone. Other 6 8.0 The questionnaires were validated in samples of women Origin of the questionnaire ­useda and men between 50 and 69 years old, with the excep- Development of a new questionnaire for the study 51 68.0 tion of the Patient Satisfaction Scale with Bowel Prepa- Derived from an existing questionnaire 12 16.0 ration and the Post-Procedure endoscopic questionnaire Use of an existing questionnaire 8 10.7 [33, 35], which were evaluated in adults up to 80 years Not reported 4 5.3 old. Table 4 describes the characteristics of included Aspects/interventions ­assesseda populations. Bowel preparation 11 14.7 Bowel relaxant 1 1.3 Colonoscopy 32 42.7 Methodological quality of studies Diet 1 1.3 Methodological quality of studies on each measurement Stool test 13 17.3 property was evaluated according to the COSMIN Risk Pre-colonoscopy consultation 2 2.7 of Bias checklist [24] (Table 5). Ratings are provided for Sigmoidoscopy 12 16.0 only those measurement properties assessed in each CT-colonography 2 2.7 study. Whole screening program 1 1.3 According to the COSMIN guidelines, content valid- a n = 75 questionnaires in 80 studies ity is the most important measurement property [23] and it arises from the assessment of the relevance, compre- hensiveness and comprehensibility of the PROM. Evi- 81.3%). Most were created de novo (51, 68.0%) or devel- dence on these parameters comes from development and oped from existing questionnaires (12, 16.0%), with very validation studies. A detailed evaluation of the quality of few studies using an existing questionnaire (8, 10.7%). questionnaires’ development studies is available in Annex C. Methodological quality of studies for content validity Selva et al. BMC Med Res Methodol (2021) 21:230 Page 6 of 15 Table 3 Characteristics of validated questionnaires Questionnaire Country Language/ Mode of Intervention Construct Dimensions/ Number of items (Reference) translation administration assessed (according to Domains authors) CSSQP Spain Spanish Self-reported Colonoscopy after 1. Satisfaction 1. Satisfaction -Satisfaction scale: Brotons ­201932 English transla‑ a positive fecal 2.Safety scale: 15 tion occult blood test -Information -Safety scale: 3 in colorectal can‑ -Care cer screening -Service and facilities 2. Safety scale -Information gaps -Safety incidents Patient Satisfac‑ USA English Self-reported Bowel preparation 1.Satisfaction with 1. Current satis‑ 6 tion Scale with No translation bowel prepara‑ faction: Bowel Preparation tion -Difficulty using Hatoum ­201633 2. Acceptance or bowel-cleansing refusal of future preparations use of the prepa‑ -Ability to con‑ ration sume prepara‑ tions -Acceptability of taste -Overall experi‑ ence 2. Acceptance or refusal of future use of the same bowel prepara‑ tion Post procedure USA English Self-reported Gastrointestinal Satisfaction 1. Anxiety 7 endoscopy ques‑ Translation not endoscopy (upper 2. Pain or discom‑ tionnaire reported and lower) fort Peña ­200535 3. Distress or suf‑ fering 4. Physical needs met 5. Emotional needs met 6. Overall satisfac‑ tion 7. Willingness to repeat if neces‑ sary SmGHAA-9 m Spain Spanish By telephone by Gastrointestinal Satisfaction 1.Waiting times 7 Sánchez del Río English transla‑ an interviewer endoscopy (upper 2. Personal man‑ ­200534 tion and lower) ners 3. Information received 4. Discomfort 5. Overall rating 6. Willingness to repeat if neces‑ sary Selva et al. BMC Med Res Methodol (2021) 21:230 Page 7 of 15 Table 3 (continued) Questionnaire Country Language/ Mode of Intervention Construct Dimensions/ Number of items (Reference) translation administration assessed (according to Domains authors) Screening Flexible USA English Self-reported Screening sigmoi‑ Satisfaction 1. Convenience 18 Sigmoidoscopy Translation not doscopy and accessibility Assessment Ques‑ reported 2. Staff interper‑ tionnaire. sonal skills Schoen ­200036 3. Physical sur‑ roundings 4. Technical com‑ petence 5. Pain and dis‑ comfort 6. Expectations and beliefs 7. General satis‑ faction was rated as doubtful for all questionnaires because it reported and construct validity. It has sufficient internal was not clear if patients and experts were asked about consistency with a Cronbach’s alfa ≥0.7 (moderate qual- relevance, comprehensiveness, and comprehensibility in ity of evidence) and reliability with a Pearson correlation the validation studies. coefficient ≥ 0.7 (low quality of evidence), but an indeter- Structural validity and internal consistency address the minate measurement error because minimal important internal structure of a questionnaire, and are the next change was not defined. Responsiveness was sufficient most important measurement properties [23]. Three (moderate quality of evidence). studies were of adequate quality for structural validity and of very good quality for internal consistency [32, 35, PROMs measuring satisfaction with non‑screening 36]. The remaining two were of doubtful quality for inter- endoscopy nal consistency [33, 34]. Methodological quality of stud- There were two questionnaires assessing non-screening ies on remaining measurement properties is summarized endoscopic procedures, both upper and lower. The post- in Table 5. procedure questionnaire [35] has sufficient content valid- In Annex D we provide an example on how the meth- ity (low quality of evidence), and internal consistency odological quality evaluation and the rating of measure- with a Cronbach’s alfa ≥0.7 (low quality of evidence) but ment properties were conducted for one questionnaire. indeterminate structural validity as results of the explora- tory factor analysis were not reported. It was classified as Measurement properties of PROMs A. PROMs measuring satisfaction with screening endoscopy The SmGHAA-9 m [34] has insufficient content validity There were two questionnaires assessing satisfaction (very low quality of evidence), sufficient internal consist- with screening endoscopic procedures. We gave a COS- ency with a Cronbach’s alfa ≥0.7 (very low quality of evi- MIN category A to the CSSQP questionnaire [32] which dence) and sufficient reliability with a weighted kappa of measures safety and satisfaction with a colonoscopy per- 0.78 (very low quality of evidence). It was classified as B. formed after a positive stool test for colorectal cancer screening. It has sufficient content validity (moderate PROMs measuring satisfaction with bowel preparation quality of evidence), sufficient internal consistency with The Patient Satisfaction Scale with Bowel Preparation a Cronbach’s alfa ≥0.7 (high quality of evidence), indeter- [33] was the only questionnaire identified that assessed minate structural validity because a confirmatory factor satisfaction with bowel preparation. It has insufficient analysis was not conducted, and indeterminate construct content validity (low quality of evidence), indeterminate validity (Table 6). construct validity and sufficient internal consistency with We gave a COSMIN category B to the Screening Flex- a Cronbach’s alfa ≥0.7 (low quality of evidence). This ible Sigmoidoscopy Assessment Questionnaire [36], questionnaire was classified as B. which measures satisfaction with screening sigmoidos- copy. It has inconsistent content validity (low quality Interpretability and feasibility of evidence), indeterminate structural validity because Detailed information on interpretability and feasibility of results of the confirmatory factor analysis were not questionnaires is summarized in Annex E and F. Overall, Selva et al. BMC Med Res Methodol Table 4 Characteristics of the included study populations Questionnaire (Reference) Population Disease characteristics Questionnaire administration N Age Gender Disease Setting Moment of administration Response rate Mean (SD) (2021) 21:230 Range (%) CSSQP32 505 60.7 (5.2) 38.6% female Women and men who had under‑ 2 hospitals The day after the colonoscopy 74.9% (378/505) gone a colonoscopy after a posi‑ and return to a mailbox tive fecal occult blood test within the colorectal cancer screening program Patient Satisfaction Scale with 1.211 56 61% female Women and men (18–80 years) University hospitals, academic Prior to the colonoscopy 98.7% (1195/1211) Bowel ­Preparation33 scheduled for an elective outpa‑ medical centers, private clinics tient colonoscopy Post- procedure ­questionnaire35 148 21–40 (18%) 63% female Women and men (≥18 years) who 1 hospital After the procedure 89,7% (148/165) 41–60 (64%) underwent routine procedures 61–80 (17%) (gastric endoscopy, colonoscopy, > 80 (1%) sigmoidoscopy) SmGHAA-9 ­m34 485 51 (16) 57% female Women and men scheduled for 2 hospitals: one private (the By telephone 3 weeks after the 93,8% an endoscopic procedure (colo‑ source of most patients) procedure (455/485) noscopy or gastroscopy) Screening Flexible Sig‑ 1.221 61.8 (6.1) 45.5% female Women and men who underwent 2 hospitals. 97% of participants After the sigmoidoscopy, prior to 100% moidoscopy Assessment screening flexible sigmoidoscopy were participants in an RCT​ discharge or returned by mail ­Questionnaire36 Page 8 of 15 Selva et al. BMC Med Res Methodol (2021) 21:230 Page 9 of 15 Table 5 Quality of studies on measurement properties Measurement property CSSQP32 Patient Post procedure SmGHAA-9 ­m34 Screening Flexible Satisfaction ­questionnaire35 Sigmoidoscopy ­Survey33 Assessment ­Questionnaire36 Content validity Asking patients Relevance D D D D – Comprehensiveness D D D D – Comprehensibility D D D D D Asking experts Relevance – D D – D Comprehensiveness – D D – D Internal structure Structural validity A – A – A Internal consistency V D V D V Cross-cultural validity – – – – – Other measure‑ Reliability – – – I A ment properties Measurement error – – – – A Criterion validity – – – – – Construct validity Convergent validity – D – – V Known groups V – – – – validity Responsiveness Comparison with – – – – – gold standard Comparison with – – – – V other instruments Comparison – – – – – between subgroups Comparison before – – – – – and after interven‑ tion V very good; A adequate; D doubtful; I: inadequate Cells not colored correspond to measurement properties not assessed in included studies studies provided scarce information about interpretabil- non-validated questionnaires, which is consistent with ity: most showed a low percentage of missing total scores findings of another systematic review of PROMs on (from 1.4 to 6.2%) [32–34, 36] but only two provided patient satisfaction in breast cancer screening [39]. This information on floor and ceiling effects [32, 33] and none shows clear room for improvement since the use of non- on the minimal important change or minimal impor- validated PROMs may result in a limited trustworthiness tant difference. Regarding feasibility aspects, none of the in measurements obtained through their use. studies provided information on the completion time, the Only five questionnaires have been validated for meas- cost of the questionnaire or the existence of copyright. uring patient satisfaction in relation to screening colo- The CSSQP [32] and the SmGHAA-9 m [34] are avail- noscopy and sigmoidoscopy [32, 36], non-screening able in Spanish and in English. However, none of these endoscopy (both upper and lower) [34, 35] and with questionnaires were culturally adapted nor validated bowel preparation [33]. Although two additional stud- in a setting different to that in which they were created ies reported the use of validated questionnaires [37, 38], (cross-cultural validation). we were unable to obtain the required information to appraise them. We did not identify any validated ques- Discussion tionnaire for assessing satisfaction or experience with the Main findings use of stool tests for colorectal cancer screening, which This systematic review identified many studies that is the most used screening test in European screening measured patient satisfaction or experience with colo- programs [5, 10], or with other aspects of the screening rectal cancer screening or procedures and tests included process such as the communication of screening results. in these preventive programs. These findings mean that The decision to use one PROM over another will patient reported measurements are increasingly being depend on different factors, but it is important to considered in this setting and other research fields as ascertain both the methodological quality of studies in well [20]. However, the majority of these studies used which the PROMs were validated and the questionnaire Table 6 Summary of measurement properties of questionnaires Questionnaire Context of use Measurement property Methodolo- Ratingb Quality of Evidence Recommen- gical dationc ­qualitya CSSQP32 Screening colonoscopy Content validity Doubtful (+) Based on review ratings. Devel‑ Moderate A opment and validation study not Serious RoB (content validity and provide enough information to judge development study of doubtful relevance, comprehensiveness or quality) Selva et al. BMC Med Res Methodol comprehensibility Structural validity Adequate (?) A confirmatory factor analysis was * not conducted Internal consistency Very good (+) Cronbach’s alpha 0.86 (≥0.7) High Spearman-Brown coefficient 0.85 No RoB Construct validity Very good (?) No hypothesis defined High (2021) 21:230 No RoB Patient Satisfaction Scale with Bowel preparation Content validity Doubtful (−) Relevance doubtful, comprehen‑ Low B Bowel ­Preparation33 siveness (−) and comprehensibility Very serious RoB (no content validity (−) as patients and professionals were study, development study of doubtful not asked quality) Internal consistency Doubtful (+) Cronbach’s alpha 0.79 (≥0.70) Low Very serious RoB (one study of doubt‑ ful quality) Construct validity Doubtful (?) Results in accordance with hypoth‑ * esis, associated with narra-tives, but no correlations calculated Post-procedure ­questionnaire35 Upper and lower endoscopy Content validity Doubtful (+) Relevance, comprehensiveness Low A and comprehensibility were (+) Serious RoB (content validity and development study of doubtful qual‑ ity) and indirectness Structural validity Adequate (?) No results of exploratory factor * analysis Internal consistency Very good (+) Low Cronbach’s alpha ≥0.7 for 4 of 8 items Serious RoB (one study of adequate analyzed quality) and indirectness SmGHAA-9 ­m34 Upper and lower endoscopy Content validity Inadequate (−) Relevance, comprehensiveness, Very low B and comprehensibility rated (−) Serious RoB (no content validity study and development study of inadequate quality). Indirectness Internal consistency Doubtful (+) Cronbach’s alpha ≥0.7 Very low Very serious RoB (one study of doubt‑ ful quality) and indirectness Reliability Inadequate (+) Weighted kappa of 0.78 Very low Extremely serious RoB (one study of inadequate quality) and indirectness Page 10 of 15 Table 6 (continued) Questionnaire Context of use Measurement property Methodolo- Ratingb Quality of Evidence Recommen- gical dationc ­qualitya Selva et al. BMC Med Res Methodol Screening Flexible Sig‑ Screening sigmoidoscopy Content validity Doubtful (+/−) Relevance (+) by reviewers, Low B moidoscopy Assessment comprehensiveness (−) and compre‑ Serious RoB (content validity and ­Questionnaire36 hensibility (+/−) development studies of doubtful quality) and indirectness Structural validity Adequate (?) Comparative fit index, Tucker-Lewis * (2021) 21:230 index, Root Mean Square Error of approximation or Standardized root mean residuals not reported Internal consistency Very good (+) Cronbach’s alpha 0.87 for overall Moderate satisfaction and 0.84 for pain and No serious RoB but indirectness discomfort scale Reliability Adequate (+) Pearson correlation coefficient Low 0.82 (≥0.7) Serious RoB (only one study of adequate quality) and indirectness Measurement error Adequate (?) Minimal important change not * defined Construct validity Very good (?) Results in accordance with hypoth‑ * esis and associated with narratives, but no correlations calculated Responsiveness Very good (+) responses in accordance to nar‑ Moderate ratives No RoB but indirectness RoB Risk of bias a Assessed according to the COSMIN Risk of Bias checklist [23–25]: each measurement property was assigned a rating of “very good”, “adequate”, “doubtful”, “inadequate” or “not applicable” b Psychometric properties were rated according to the updated criteria for good measurement properties based on Terwee et al. [14] and Prinsen et al. [30]. (Annex B) Ratings can be:“+” = sufficient,” – “= insufficient, “?” = indeterminate, or “+/” inconsistent c Recommendations: A: Have the potential to be recommended as the most suitable questionnaire fo the construct and population of interest;B: May have the potential to be recommended, but further validation studies are needed; C:Should not be recommended *In case the overall rating is indeterminate (?), it is not possible to judge the quality of the instrument, and there is no grading of the quality of the evidence [23] Page 11 of 15 Selva et al. BMC Med Res Methodol (2021) 21:230 Page 12 of 15 measurement properties themselves. We used the Our results in the context of previous research COSMIN methodology to classify each PROM into To our knowledge, this is the first systematic review to three possible categories that have different implica- identify and assess PROMs for measuring patient satis- tions regarding the potential to recommend one PROM faction and experience with colorectal cancer screen- over another. From the five validated questionnaires ing. However, there are hundreds of systematic reviews included, only two (CSSQP [32] and Post-procedure using the COSMIN methodology. Some have focused on questionnaire [35]) showed sufficient content validity screening [45–48], and one specifically assessed PROMs and internal consistency to be recommended for their for measuring patient satisfaction or experience in rela- use in practice. tion to breast cancer screening [39]. These systematic There are additional important factors to consider reviews also found variability in the methodological qual- when choosing a PROM. For example, the population for ity of included studies [19, 39, 45, 46, 48]. In our work, which the PROM is intended, the availability of cross- methodological quality of studies ranged from inad- cultural validation of the questionnaire and aspects equate to very good, depending on the measurement related to its feasibility. The CSSQP [32] and the post- property assessed. procedure questionnaire [35] measure satisfaction with We were able to assess limited information about some different procedures and are targeted at different popula- (but not many) psychometric properties of question- tions. The CSSQP [32] assesses the safety and satisfaction naires, which is consistent with results of similar litera- with colonoscopy conducted after having a positive stool ture reviews [19, 39]. However, unlike other settings in test in the context of colorectal cancer screening. On which there are some studies assessing each PROM, we the other hand, the post-procedure questionnaire [35] only found one study for each questionnaire reporting measures satisfaction with both upper and lower non- data related to its development and validation. We did screening endoscopy. These differences in population are not find further validation studies, which limits the avail- important as screening program attendees have peculi- able evidence on the questionnaires’ validity, as each new arities with respect to those who attend colonoscopy for study provides further confirmation of the ability of a other factors (e.g., evaluation of symptoms, surveillance questionnaire to measure the construct of interest [19]. of polyps, etc.). They are healthy people with no symp- Another important aspect is that patient satisfaction toms that have not sought health care and may experi- and patient experience, despite being related, are not ence high levels of anxiety [40], so their expectations exactly the same [19, 20, 49]. Some authors advocate (and therefore their satisfaction) may differ from the rest that measuring patient experience is preferred because of patients [32]. Another important aspect is that the it is a more descriptive and objective measure (rather CSSQP [32] was developed and validated in the Spanish than evaluative) and is less affected by gratitude bias and population. Although this questionnaire was translated other factors [19, 20, 49]. As these concepts have been to English following a translation back-translation pro- used interchangeably many times in the literature [50], cess, it still has not been culturally adapted nor validated we included both so that important information was not in other populations. In the same way, the post-proce- left out. However, all validated questionnaires included dure questionnaire [35] was developed and validated in measured patient satisfaction. a population from the USA and is only available in Eng- lish. If questionnaires are used in countries other than Limitations and strengths those in which they have been developed and validated, We conducted an exhaustive search including sources it is necessary to translate them (with a translation-back that index questionnaires and measurement instru- translation process), conduct a culturally adaptation and ments for the identification of all available PROMs, but finally study their cross-cultural validity before their use the possibility of selection bias still exists as we limited [28, 41–44]. Cross-cultural validity is evaluated assessing the inclusion to studies published in English, Spanish, whether the scale is measurement invariant or whether French and Italian, and we did not look at grey literature differential item functioning occurs between at least two to check the use of questionnaires in technical reports culturally different groups of people [23]. None of the assessing the results from local or national screening included questionnaires were culturally adapted and nei- programs. Despite this drawback, we could expect that, ther conducted this sort of validation. at least for validated PROMs, the researchers made the The remaining three questionnaires [33, 34, 36] did not effort to report the process in a journal article. It is also report data in enough detail to ascertain their validity. It possible that we did not evaluate all measurement prop- does not mean that these questionnaires cannot be rec- erties of questionnaires because this information was not ommended, but further validation studies will be needed reported in published papers. In order to minimize this [23]. bias, we attempted to contact questionnaire developers Selva et al. BMC Med Res Methodol (2021) 21:230 Page 13 of 15 for further information and complete scoring. However, assessing patient experience or satisfaction with the use we did not always receive an answer. It is possible that of stool tests for colorectal cancer screening or with the included questionnaires have been harshly criticized in communication of screening results, so it would be nec- their methodological quality as the COSMIN methodol- essary to develop and validate PROMS to measure these ogy considers applying the lowest rating of any standard aspects. Any additional effort to develop new PROMs in in the box to the overall rating of each study (“the lowest this field should ensure the involvement of the public in score counts” principle) [24]. their development and validation [52]. This study has several strengths. To our knowledge, this is the first paper that reviews and appraises available PROMs to measure patient experience or satisfaction Conclusion with colorectal cancer screening. We conducted system- Only a minority of PROMs used for measuring patient atic searches in four different databases and the selection satisfaction with colorectal cancer screening or proce- and data abstraction processes were conducted in dupli- dures related to it are validated. Questionnaires vary in cate in order to minimize selection bias and errors. We their measurement properties and methodological qual- used an internationally agreed and explicit methodology ity and are designed for different settings and popula- (COSMIN [23]) for assessing the methodological quality tions. The CSSQP questionnaire may be the most suitable of studies and questionnaires’ measurement properties. questionnaire for measuring satisfaction with screening We must highlight, though, that the use of this guidance colonoscopy in Spanish population [32]. For the North is limited to trained and skilled researchers and that its American population, the Post-procedure questionnaire use is burdensome at some stages. There is clear room may be more suitable, despite being designed to measure for improvement for reporting in this field. Recently, satisfaction with non-screening endoscopy [35]. Satisfac- guidelines for reporting primary studies on measure- tion with other aspects of colorectal screening process ment properties have been published [51] and their use (use of stool tests, bowel preparation, screening flex- should improve transparency and facilitate the appraisal ible sigmoidoscopy, communication of screening results) of these studies. On the other hand, reporting guidelines need new validation studies of available questionnaires or for reviews of PROMs would be of great interest to ease even the development of new PROMs. the preparation of manuscripts in this field and improve the quality of such evidence syntheses. Supplementary Information The online version contains supplementary material available at https://​doi.​ org/​10.​1186/​s12874-​021-​01430-7. Implications for practice and research This systematic review will help clinicians, managers, Additional file 1. policy makers and researchers to select the most suitable PROM taking into consideration their context of use. Acknowledgements This will, in turn, facilitate the systematic use of these val- to Christina Mcgown for reviewing the English language edition. idated questionnaires to identify areas for enhancement from the patients’ perspective and drive improvements in Authors’ contributions AS: Conceptualization, Methodology, Validation, Formal analysis, Investiga‑ the quality of colorectal cancer screening programs. tion, Data curation, Writing- original draft, Visualization, Project administration, Some validated questionnaires with good measurement Funding acquisition. YAP: Investigation, Data curation, Writing-Review and properties for measuring patient satisfaction with screen- Editing. PL: Investigation. VR: Investigation. CS: Investigation, Validation, Data curation, Writing-Review and Editing. IS: Conceptualization, Software, Inves‑ ing and non-screening colonoscopy are already available, tigation, Resources, Writing-Review and Editing. NT: Investigation, Writing- so it is not necessary to develop new questionnaires on Review and Editing. RT: Investigation. The author(s) read and approved the this aspect [32, 35]. Efforts should be made in conduct- final manuscript. ing further validations of existing questionnaires (assess- Funding ing all psychometric properties), in translating them into This work was supported by the Instituto de Salud Carlos III, Spain (FIS different languages and validating them in different pop- PI18/00460); Fondo Europeo de Desarrollo Regional (FEDER), “Una manera de hacer Europa”. ulations, so they could be used in different settings. How- ever, for measuring satisfaction with bowel preparation Availability of data and materials or screening sigmoidoscopy, we could identify only one The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. validated questionnaire for each procedure, with not suf- ficient psychometric properties for it to be recommended for use. In these cases, it would be necessary to conduct Declarations further validation studies or even develop new PROMs. Ethics approval and consent to participate Likewise, we did not identify any validated PROM for Not applicable. Selva et al. BMC Med Res Methodol (2021) 21:230 Page 14 of 15 Consent for publication 24];46(1):82–6. Available from: https://​pubmed.​ncbi.​nlm.​nih.​gov/​24011​ Not applicable. 791/ 10. Navarro M, Nicolas A, Ferrandez A, Lanas A. Colorectal cancer popula‑ Competing interests tion screening programs worldwide in 2016: An update [Internet]. Vol. The authors declare that they have no competing interests 23, World Journal of Gastroenterology. Baishideng Publishing Group Co., Limited; 2017 [cited 2021 Feb 24]. p. 3632–42. Available from: https://​ Author details pubmed.​ncbi.​nlm.​nih.​gov/​28611​516/ 1 Clinical Epidemiology and Cancer Screening, Parc Taulí Hospital Univer‑ 11. 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