Quality of Life Research (2023) 32:1405–1425 https://doi.org/10.1007/s11136-022-03260-6 REVIEW Patient‑centered care in Coronary Heart Disease: what do you want to measure? A systematic review of reviews on patient‑reported outcome measures Yolanda Pardo1,2,3 · Olatz Garin1,2,4 · Cristina Oriol5 · Víctor Zamora1,2,4 · Aida Ribera1,6 · Montserrat Ferrer1,2,4 Accepted: 15 September 2022 / Published online: 9 November 2022 © The Author(s) 2022 Abstract Background The number of published articles on Patient-Reported Outcomes Measures (PROMs) in Coronary Heart Disease (CHD), a leading cause of disability-adjusted life years lost worldwide, has been growing in the last decades. The aim of this study was to identify all the disease-specific PROMs developed for or used in CHD and summarize their characteristics (regardless of the construct), to facilitate the selection of the most adequate one for each purpose. Methods A systematic review of reviews was conducted in MEDLINE, Scopus, and the Cochrane Database of Systematic Reviews. PROQOLID and BiblioPRO libraries were also checked. PROMs were classified by construct and information was extracted from different sources regarding their main characteristics such as aim, number of items, specific dimensions, original language, and metric properties that have been assessed. Results After title and abstract screening of 1224 articles, 114 publications were included for full text review. Finally, we identified 56 PROMs: 12 symptoms scales, 3 measuring functional status, 21 measuring Health-Related Quality of Life (HRQL), and 20 focused on other constructs. Three of the symptoms scales were specifically designed for a study (no met- ric properties evaluated), and only five have been included in a published study in the last decade. Regarding functional status, reliability and validity have been assessed for Duke Activity Index and Seattle Angina Questionnaire, which present multiple language versions. For HRQL, most of the PROMs included physical, emotional, and social domains. Responsive- ness has only been evaluated for 10 out the 21 HRQL PROMs identified. Other constructs included psychological aspects, self-efficacy, attitudes, perceptions, threats and expectations about the treatment, knowledge, adjustment, or limitation for work, social support, or self-care. Conclusions There is a wide variety of instruments to assess the patients’ perspective in CHD, covering several constructs. This is the first systematic review of specific PROMs for CHD including all constructs. It has practical significance, as it summarizes relevant information that may help clinicians, researchers, and other healthcare stakeholders to choose the most adequate instrument for promoting shared decision making in a trend towards value-based healthcare. Keywords Patient-reported outcomes · Coronary Heart Disease · Symptoms scale · Health-related quality of life · Functional status 4 * Olatz Garin Universitat Pompeu Fabra (UPF), Barcelona, Spain ogarin@imim.es 5 Unitat de Suport a la Recerca Metropolitana Nord, Institut 1 Universitari d’Investigació en Atenció Primària Jordi Gol CIBER Epidemiología y Salud Pública (CIBERESP), Dr. (IDIAP Jordi Gol), Mataró, Spain Aiguader 88, 08003 Barcelona, Spain 6 2 Cardiovascular Epidemiology and Research Unit, University Health Services Research Group, IMIM (Hospital del Mar Hospital and Research Institute Vall d’Hebron (VHIR), Medical Research Institute), Barcelona, Spain Barcelona, Spain 3 Universitat Autònoma de Barcelona (UAB), Barcelona, Spain 13 Vol.:(0123456789) 1406 Quality of Life Research (2023) 32:1405–1425 Background Broadly, PROMs fall into two main categories: condition- specific and generic. The latter measures health concepts Different initiatives have converged on the importance of that are relevant to a wide range of patient groups, enabling the patients’ perspective in the improvement of healthcare. aggregation and comparisons across varied conditions and The Institute of Medicine (2001) [1] identified patient- settings. Condition-specific PROMs capture elements of centered care as one of the six domains of high-quality health relevant to a particular group of patients [13], which healthcare, wherein patient-centered care supports clini- in the case of the present review will be CHD patients. Given cians in “attending to their patients’ physical and emo- the growing interest in these instruments, there are several tional needs and maintaining or improving their quality of reviews of the main characteristics of some of the most life.” The Patient-Centered Outcomes Research Institute widely used PROMs for CHD, but none have examined all [2] emphasizes the goal of “focusing on outcomes that the available instruments [12, 14–20]. people notice and care about such as survival, function, These reviews have focused on heart disease in general, symptoms, and health-related quality of life.” The Ameri- on specific heart conditions or on particular constructs (such can Heart Association (AHA, 2013) [3] states that Patient- as symptoms or HRQL) [16]. A review of instruments for Reported Outcome Measures (PROMs) implementation in patients undergoing elective coronary revascularization clinical settings has “the potential to support clinical care, identified 26 cardiovascular-specific PROMs [18]. Reviews evaluate healthcare quality, quantify an important compo- for specific constructs in CHD have been mainly centered nent of procedural appropriateness, identify patients for on HRQL [10–14], showing that mostly generic instruments, prognostic discussions and serve as a foundation for shared such as the SF-36 or the EQ-5D, have been used in this medical decision making.” pathology. A review centered on symptom scales [20] found A patient-reported outcome has been defined [4] as “a 36 different instruments (both generic and specific meas- measurement based on a report that comes directly from ures) for all types of cardiovascular populations, including the patient (i.e., study subject) about the status of a patient’s 15 for CHD and angina pectoris. A recent scoping review of health condition without amendment or interpretation of the validated PROMs including more than one domain, either patient’s response by a clinician or anyone else.” PROMS developed or specifically modified for patients with heart are standardized questionnaires that collect information on disease, found 9 specific instruments for ischemic heart dis- health outcomes directly from patients and cover a wide ease and 5 more applied to all types of heart disease [18]. variety of constructs, including symptoms, functional status, These numerous reviews result in a kind of puzzle, with and Health-Related Quality of Life (HRQL) among others partial information and overlaps which make it difficult to [5]. HRQL is one of the constructs most commonly associ- obtain the global picture. Therefore, the aim of this study ated with PROMs, and it is a term referring to the health was to identify all the disease-specific PROMs (regardless of aspects of quality of life, generally considered to reflect the the construct) developed for or used in CHD and to describe impact of disease and treatment on disability and daily func- their main characteristics by conducting a systematic review tioning; it has also been considered to reflect the impact of of reviews. The review protocol is registered in the Interna- perceived health on an individual's ability to live a fulfilling tional Prospective Register of Systematic Reviews database life [6]. PROMs should ideally undergo psychometric valida- (PROSPERO CRD42021248504). tion to ensure that they accurately reflect the outcomes they purport to cover, and that they are reliable and can assess changes over time. Methods Coronary Heart Disease (CHD) has been the leading cause of disability-adjusted life years lost worldwide since A systematic review of reviews was conducted following the 1990 in people over 50 years old [7]. For patients with same process as systematic reviews of primary research, but CHD, the principal treatment goals are to reduce cardiac where the units of analysis were reviews rather than individ- events, eradicate angina, and optimize quality of life [8]. In ual studies. Following Cochrane recommendations of select- recent decades, the number of published articles reporting ing a minimum of two databases, searches were performed the use of PROMs in CHD has been growing, following in three electronic databases: MEDLINE, Scopus, and the the global tendency in most chronic pathologies [9]. The Cochrane Database of Systematic Reviews. We selected proportion of cardiovascular trials evaluating quality of MEDLINE because most of the publications on PROMs life has increased over time: from 0.34% in 1980 to 3.6% in are in the field of medical journals and Scopus because 1997 [10], to 14% in 2009 [11]; whereas patient-centered it is multidisciplinary and covers other areas. Addition- outcomes were reported in 29% of cardiac surgery trials ally, we searched in two specialized libraries: PROQOLID performed between 2010 and 2014 [12]. (Patient-Reported Outcomes and Quality of Life Instruments Database), and BiblioPRO (a virtual library of PROMs in 13 Quality of Life Research (2023) 32:1405–1425 1407 Spanish). As recommended by the Cochrane Database of of items and dimensions; and the original language and Systematic Reviews, the reference lists of relevant studies existence of other versions. To identify the linguistic adap- were also checked to find other potential eligible studies tations available, we searched in the PROQOLID and Bib- [21]. lioPRO libraries or the instrument's website. If alternative We applied a comprehensive search strategy developed versions of a PROM were available (for example short forms by experts in Patient-Reported Outcomes and experts in or pre- and post-treatment forms), they were considered as Systematic Reviews in cardiology, seeking to identify pub- part of the original. Additionally, we performed a search in lished reviews mentioning disease-specific PROMs for CHD PubMed and Scopus databases using the name of the instru- populations. For the electronic databases, we used Boolean ment as a search term to find publications of their use within search methods to identify relevant papers. The search strat- the last 10 years (from March 2011 to March 2021). egy was limited to “reviews” or “systematic reviews” (see For each instrument, we reviewed if there was available supplementary material). information on the main metric properties in patients with All the identified review articles were included, since the CHD: reliability (including reproducibility or test–retest reli- date of each database's inception until March 2021, regard- ability and internal consistency), validity (content, criterion, less of whether they were systematic or not. The search was or construct validity), and sensitivity to change (responsive- not restricted to language or timeframe. ness). For information on the metric properties, we consid- The inclusion criteria were (1) systematic review or ered information on both the original instrument and the reviews; and (2) providing information about PROMs spe- linguistic adaptations. cifically designed for CHD or, in the case of being designed The review was conducted and has been reported in for heart diseases in general, having been applied and/or accordance with the Preferred Reporting Items for System- validated in patients with CHD; (3) including any type of atic Reviews and Meta-Analyses (PRISMA) guidelines [22]. construct measured: health-related quality of life, symptoms scales, functional status or activities of daily living, and psy- chological- or social-related construct; (4) instruments that Results are domain-specific (such as depression, anxiety, self-effi- cacy, or social support related to CHD) or treatment-specific The search strategy yielded 1131 review articles, and 93 (for example, coronary artery bypass grafting—CABS—or more were added from other sources such as manual refer- percutaneous coronary intervention—PCI). ence screening (Fig. 1). After the title and abstract screen- The following exclusion criteria were applied: (a) review ing, 114 publications were included in the full text review. or systematic review reporting on generic PROMs applied From these reviews, we identified 56 PROMs specifically to CHD (for example, SF-36 or EQ-5D); and (b) review or developed to be applied in patients with CHD: 21 measuring systematic review of PROMs specifically developed for chil- HRQL (1 of them measuring both symptoms and HRQL, the dren or adolescents (age under 18 years). “Speak from the Heart” instrument), 12 symptoms scales, 3 Two independent reviewers applied inclusion and exclu- instruments measuring functional status (1 of them measur- sion criteria to select titles and abstracts, and a single ing both functional status and symptoms, the Cardiovascular reviewer performed full text and data extraction. All the Limitations and Symptoms Profile), and 20 focused on other PROMs identified were categorized according to the con- constructs. struct measured. In case of discrepancy, consensus was Characteristics of PROMs assessing symptoms and func- reached with the help of a third expert. tional status are summarized in Table 1, ordered by the con- struct measured (symptoms or functional status) and year Data extraction and analysis of publication. Of the 12 symptoms scales identified, three were specifically designed ad hoc for a particular study A data extraction form was developed to collect the PROMs without any psychometric validation. Only the following 5 identified, stratified by construct: HRQL, symptoms, func- instruments have been included in a published study in the tional status, and others. last 10 years: Rose Angina Questionnaire (RAQ), Symp- For each identified PROM, we located the publication toms of Acute Coronary Syndromes Inventory (SACSI), reporting the instrument development and we collected McSweeney Acute and Prodromal Myocardial Infarction information about their general characteristics: author, year, Symptom Survey (MAPMISS), Cardiac Symptom Survey country of publication, and bibliographic reference of the (CSS), and Cardiovascular Limitations and Symptoms Pro- original development; aim (including the characteristics, file (CLASP). For these five instruments there is information conditions, or procedure of the population for which the at least on their reliability and construct validity. However, PROM was developed, e.g., coronary artery bypass grafting, no sensitivity to change data has been reported. All five congestive heart failure, or myocardial infarction); number instruments have two or more language versions. The RAQ 13 1408 Quality of Life Research (2023) 32:1405–1425 Fig. 1  Systematic Review Flow Chart. *One instrument (CLASP) could be included in the “Functional status” or “Symptoms scale” constructs deserves a special mention for being the most widely used designed for heart failure and there are many country-spe- in epidemiological surveys since its development in 1962, cific versions, we have only included the version that was and being adopted by the WHO [23]. The most common modified to evaluate HRQL in CHD [24]. symptom assessed among these symptoms scales is chest Among the questionnaires identified for measuring HRQL pain, followed by dyspnea or fatigue. in CHD patients, the most used worldwide are Angina Pec- Only two of the identified instruments focus on func- toris Quality of Life Questionnaire (APQLQ), QLI-car- tional status: Seattle Angina Questionnaire (SAQ) and diac version, the MacNew, Cardiac Health Profile (CHP), Duke Activity Status Index (DASI). Both were specifically Myocardial Infarction Dimensional Assessment Scale -35 developed for CHD patients, although DASI has nowadays (MIDAS-35), CROQ, and HeartQoL. They all have several been extended to other conditions. The SAQ, a 19-item ques- linguistic versions and have appeared in published studies tionnaire developed for assessing angina pectoris, has been in the last ten years (except for the APQLQ). In addition, translated into 54 languages, and a short form is available information on reliability, validity, and responsiveness has with seven items. The DASI has 12 items and is available in been reported for all of them. several languages. Both instruments have evidence on their The APQLQ was developed in 1988 in Sweden to assess metric properties: reliability, validity, and responsiveness the impact of angina pectoris on patients’ quality of life and (Table 1). has 9 other language versions. The QLI-cardiac version, also Table 2 shows the characteristics of PROMs assessing known as Ferrans and Powers questionnaire (1993) [24], was HRQL, ordered by year of publication between 1988 and developed to measure quality of life in terms of satisfaction 2019. The first ones were developed in Scandinavia for with life in patients with heart diseases and has more than patients with CHD, and most were originally developed 10 country versions. The MacNew was also developed in in English (11 out of 21 are from UK, USA, Canada, or the early 1990s, initially for myocardial infarction under the Australia). Four out of these 21 PROMs were specifically name of Quality of Life after Myocardial Infarction (QLMI) designed for measuring HRQL of patients receiving sur- and later expanded to evaluate the impact of treatment for gical, percutaneous revascularization or antiarrhythmic patients with myocardial infarction, angina pectoris, and medications: Questionnaire for coronary artery bypass heart failure, and has been adapted to more than 80 lan- grafting, Coronary Revascularization Outcomes Question- guages. The CHP was developed in 1996 with the main aim naire (CROQ), Monash University Cardiac Patient-reported to assess HRQL in patients with cardiovascular disease and Outcome Measure (MC-PROM), and Cardiac Arrhythmia has a specific version for CHD. It has been adapted into Suppression Trial (CAST). The number of items included 13 languages and is nowadays still applied. The MIDAS- in HRQL instruments varies widely, from 14 (HeartQoL), to 35 was developed approximately one decade later (2002), 70 (Ferrans and Powers QLI-cardiac version). Although the to be a short measure of health status for individuals with Chronic Heart Failure (CHF) questionnaire was originally acute myocardial infarction. It was originally created for UK 13 Table 1  Characteristics of PROMs that assess symptoms and functional status Publication: Instrument Acronym Aim Number Dimensions Original language Studies Reliability Validity Responsiveness Author, year of items and adaptations published last [reference] 10 years 1 Rose GA, 1962 Rose Angina RAQ to standardize 7 English Yes Internal con- Criterion valid- [28] ­Questionnaireb the identifica- (UK) + unspeci- sistency ity tion of angina fied No. of lan- Reproducibility Construct effort, pain guage versions validity of possible infarction, and intermit- tent claudica- tion Quality of Life Research (2023) 32:1405–1425 2 Herlitz J., 1988 Cardiac - to assess rehos- ? Swedish No [100] follow-up pitalization, ­questionnairea bypass sur- gery, smoking habits, work- ing situation, symptoms of chest pain and dyspnea, and medication 5 years after reporting chest pain 3 Keresztes P, Symptoms ­scalea SS “to assess level 4 Angina English (USA) No Internal con- Construct 1993 [30] of angina, Shortness of sistency validity shortness breath of breath, Fatigue fatigue, and the extent to which the symptoms interfere with overall functional ability” 4 Artinian NT, Symptoms - “to measure 20 English (UK) No Internal con- 1993 [31] ­Inventorya cardiac sur- sistency gery-specific recovery” 13 1409 Table 1  (continued) 1410 Publication: Instrument Acronym Aim Number Dimensions Original language Studies Reliability Validity Responsiveness Author, year of items and adaptations published last 13 [reference] 10 years 5 Plach SK, 2001 Cardiac Symp- CSS “to measure 8 English (UK) No Internal con- Content valid- [32] tom ­Scaleac the frequency sistency ity of physical Construct symptoms validity that may occur follow- ing a cardiac procedure such as angio- plasty or heart surgery” 6 Schroeder S, Schroeder - “to assess clini- ? German No 2001 [101] ­questionnairea cal long-term the outcome (in patients treated with percutaneous transluminal coronary angioplasty) and it focused on the patient’s medical his- tory as well as clinical status (self-rated health, angina pectoris)” 7 DeVon HA, Symptoms SACSI “to describe the 50 Type of symp- English (USA) Yes Internal con- Content valid- 2003 [34] of Acute type (includ- toms + 1 language sistency ity Coronary ing severity), Pain or discom- Reproducibility Construct Syndromes location and fort location validity Inventory quality of Quality of pain symptoms or discomfort for unstable angina” Quality of Life Research (2023) 32:1405–1425 Table 1  (continued) Publication: Instrument Acronym Aim Number Dimensions Original language Studies Reliability Validity Responsiveness Author, year of items and adaptations published last [reference] 10 years 8 McSweeney JC, McSweeney MAPMISS “to develop 67 Acute, prodro- English (USA) Yes Reproducibility Content valid- 2004 [35] Acute and an instru- mal symptom, + 1 language ity Prodromal ment validly, and demo- Criterion valid- Myocardial describing graphic and ity Infarction women's risk factor Symptom prodromal Survey and acute symptoms of myocardial Quality of Life Research (2023) 32:1405–1425 infarction” 9 Miller KH, Cardiac surgery CSSI “to assess 26 Pre- and post- English (USA) No Internal con- Content valid- 2004 [36] symptom symptoms coronary sistency ity ­inventorya commonly artery bypass experienced surgery by patients symptoms with heart disease prior to surgery, and symp- toms often reported after coronary artery bypass surgery” 10 LaPier TK, Heart surgery HSSId “to assess the 76 General, car- English (USA) No Internal con- Content valid- 2006 [37] symptom impact of dis- diac, trunk, sistency ity inventory ease-specific lower extrem- Reproducibility Construct symptoms ity, and upper validity in patients extremity following symptoms coronary artery bypass surgery” 13 1411 Table 1  (continued) 1412 Publication: Instrument Acronym Aim Number Dimensions Original language Studies Reliability Validity Responsiveness Author, year of items and adaptations published last 13 [reference] 10 years 11 Nieveen JL, Cardiac symp- CSS “to examine 10 English (USA) Yes Internal con- Construct 2008 [38] tom survey symptoms + 1 language sistency validity (CSS) a and evalu- Reproducibility ate symptom management in patients who have undergone coronary artery bypass grafting” 12 Gilead Sci- Speak From The “to allow 7 English (USA) No ences, 2012 Heart Chronic patients to [39] Angina Check- share with list their health- care provider how angina is affecting their quality of life by logging informa- tion about each angina episode” 13e Lewin RJ, 2002 Cardiovascular CLASP “to capture 37 Symptom English (UK) Yes Internal con- Content valid- Yes [40] limitations symptoms subscales + 2 languages sistency ity and symptoms and func- (angina, Reproducibility Criterion valid- profile tioning in shortness of ity patients with breath, ankle Construct heart disease, swelling, and validity specifically tiredness) ischemic Functional heart disease limitations and/or con- (mobility, gestive heart social life and failure! leisure activi- ties, activities within the home, con- cerns/worries, and sex) Quality of Life Research (2023) 32:1405–1425 Table 1  (continued) Publication: Instrument Acronym Aim Number Dimensions Original language Studies Reliability Validity Responsiveness Author, year of items and adaptations published last [reference] 10 years 14f Hlatky MA, Duke Activity DASI “to measure 12 English (USA) Yes Internal con- Content valid- Yes 1989 [41] Status ­Indexb functional + 4 languages sistency ity capacity and Reproducibility Criterion valid- aspects of ity quality of Construct life” validity 15 f Spertus JA, Seattle Angina SAQ, SAQ-SF “to quantify the 19 Physical limita- English (USA) Yes Internal con- Content valid- Yes 1995 [42] Questionnaire physical and tion + 54 languages sistency ity Quality of Life Research (2023) 32:1405–1425 (estándar o emotional Angina stability Reproducibility Criterion valid- short form) b effects of cor- Angina fre- ity onary artery quency Construct disease” Treatment validity satisfaction Disease percep- tion Quality of life a Developed for the study b Different versions available c Instrument only applied to women d In this instrument all patients completed the first 3 sections (general, cardiac, and trunk), and those who had undergone saphenous vein or radial artery harvesting also completed the lower extremity or upper extremity sections, respectively e This instrument is considered a symptom and functional status scale f These instruments are considered functional status scales ? Number of items not reported 13 1413 Table 2  Characteristics of PROMs that assess HRQL 1414 Publication: Instrument Acronym Aim Structure (num- Original Studies Reliability Validity Responsiveness Author, year ber of items and language and published last 13 [reference] dimensions) adaptations 10 years 1 Wiklund I., 1988 Angina Pectoris APQLQ “to assess 22 items (4 Swedish (Swe- No Internal consist- Content validity [45] Quality of Life disease-specific dimensions) den) ency Construct valid- problems and + 8 languages ity cardiac symp- toms in angina pectoris” 2 Nissinnen A., Angina Impact AIQ “to supple- 17 items (4 Finnish (Finland) No Internal consist- 1991 [47] Questionnaire ment the dimensions) ency angina-related information of APQLQ and the Psycho- logical General Wellbeing index” 3 Wilson A., 1991 Summary Index Summary Index “a summary 51 items (7 Swedish (Swe- No Internal consist- Content validity Yes [46] for the Assess- measure for dimensions) den) ency Construct valid- ment of Quality quantifying Reproducibility ity of Life in relevant aspects Angina Pectoris of quality of life in angina pectoris” 4 Caine N., 1991 Questionnaire for “to measure spe- No. of items not English (UK) No Construct valid- [49] coronary artery cific HRQL” reported (5 ity bypass grafting dimensions) 5 Wiklund I., 1992 Cardiac Arrhyth- CAST “to assess 21 items (8 English (USA No Internal consist- Construct valid- [50] mia Suppres- aspects of dimensions) and Canada) ency ity sion Trial quality of life and Swedish (CAST) in the Cardiac Arrhythmia Suppression Trial in patients following an acute myocar- dial infarction” 6 Bliley AV., 1993 Ferrans and Pow- QLI- cardiac “to measure 70 items (4 English (USA) Yes Internal consist- Content validity Yes [24] ers QLI-cardiac version quality of life dimensions) + 10 languages ency Criterion valid- version in terms of Reproducibility ity satisfaction Construct valid- with life” ity Quality of Life Research (2023) 32:1405–1425 Table 2  (continued) Publication: Instrument Acronym Aim Structure (num- Original Studies Reliability Validity Responsiveness Author, year ber of items and language and published last [reference] dimensions) adaptations 10 years 7 Velasco JA., Cuestionario de CCVPPI “to assess HRQL 44 items (9 Spanish (Spain) Yes Internal consist- Construct valid- 1993[51] Calidad de Vida in post-infarc- dimensions) + 1 language ency ity de Velasco-del tion patients” Reproducibility Barrio 8 Lim LL-Y., 1993 MacNew QLMI MacNew “to evaluate 27 items English Yes Internal consist- Content validity Yes (QLMI) [53], the impact of (3 dimensions) (Canada, Aus- ency Criterion valid- Valentí L., treatment for tralia) Reproducibility ity 1996 (Mac- patients with + 82 languages Construct valid- Quality of Life Research (2023) 32:1405–1425 New) [52] myocardial ity infarction, angina pectoris, and heart failure” 9 Rukholm E., Cardiac Quality CQLI “to assess quality 20 items (5 English (Canada) No Internal consist- Content validity 1994 [54] of Life Index of life in car- dimensions) ency Construct valid- diac patients” Reproducibility ity 10 Avís, NE., 1996 Multidimensional MILQ “a multidi- 35 items (9 English (USA) Yes Internal consist- Content validity [55] Index of Life mensional dimensions) + 1 language ency Criterion valid- Quality measure of Reproducibility ity health-related Construct valid- quality of life ity appropriate for patients with cardiovascular disease” 11 Wahrborg, P., Cardiac Health CHP-cad “to assess HRQL 19 items (3 parts) Swedish (Swe- Yes Internal consist- Construct valid- Yes 1996 [56] Profile-cor- in patients with den) ency ity onary artery cardiovascular + 13 languages Reproducibility disease disease” 12 GISSI-Nursing, GISII-nursing GISII-nursing “to evaluate 29 items (9 Italian (Italy) No Content validity 1997 [57] HRQL on dimensions) acute myocar- dial infarction patients” 13 Wolinsky FD., Chronic heart CHF-modified “a disease- 16 items (4 English (Canada) No Internal consist- Construct valid- 1998 [58] failure-modified specific health dimensions) ency ity for ­CHDa status measure adapted for CHD where chest pain is a dominant symptom” 13 1415 Table 2  (continued) 1416 Publication: Instrument Acronym Aim Structure (num- Original Studies Reliability Validity Responsiveness Author, year ber of items and language and published last 13 [reference] dimensions) adaptations 10 years 14 Martin AL., Utility Based UBQ-H “to assess utility- 32 items (4 English (Aus- Yes Internal consist- Content validity Yes 1999 [59] Quality of life- based quality dimensions) tralia) ency Criterion valid- Heart question- of life on Reproducibility ity naire cardiovascular Construct valid- patients” ity 15 Buchner DA., ITG Health- ITG-HRQL-SF “to develop a 24 and 13 items English (USA) No Internal consist- Content validity 2001 [60] Related questionnaire (4 dimensions) ency Construct valid- Quality-of-Life brief enough ity long and short- for monitoring forms Measure patients with CAD in eve- ryday clinical practice” 16 Thompson DR., Myocardial MIDAS-35 “to develop a 35 items (7 English (UK) Yes Internal consist- Content validity Yes 2002 [61] Infarction short measure dimensions) + 6 languages ency Criterion valid- Dimensional of health status Reproducibility ity Assessment for individu- Construct valid- Scale -35 als with acute ity myocardial infarction” 17 Schroter S., Coronary CROQ “to evaluate 33 items pre- (4 English (UK) + 4 Yes Internal consist- Content validity Yes 2004, 2017 revasculariza- health status in dimensions) languages ency Construct valid- [33] tion outcomes patients under- and 52 post- Reproducibility ity questionnaire going coronary coronary artery artery bypass bypass grafting grafting and 47 items and percutaneous post-percutane- transluminal ous translumi- coronary angio- nal coronary plasty” angioplasty 18 Oldridge N., HeartQolb HeartQol “to assess CHD- 14 items (2 Initially devel- Yes Internal consist- Content validity Yes 2014 [62, 66] specific HRQL dimensions) oped in 15 lan- ency Construct valid- for making guages* + 16 Reproducibility ity between- languages diagnosis comparisons following inter- ventions that are routinely used in more than one CHD diagnosis” Quality of Life Research (2023) 32:1405–1425 Table 2  (continued) Publication: Instrument Acronym Aim Structure (num- Original Studies Reliability Validity Responsiveness Author, year ber of items and language and published last [reference] dimensions) adaptations 10 years 19 Wan CH., 2014 Quality of Life QLICD-CHD “to assess 16 items (3 Chinese (China) Yes Internal consist- Content validity Yes [64] Instruments symptoms, dimensions) ency Construct valid- for Chronic side effects and Reproducibility ity Diseases- special mental Coronary Heart health of CHD” Disease 20 Chuanmeng Z., Patient-reported PROISCD-CHD “an evaluation 30 (general Chinese (China) Yes Content validity Yes 2018 [37]c outcomes tool for China's module) Construct valid- Quality of Life Research (2023) 32:1405–1425 instruments sys- patient reported + 15 (specific ity tem for chronic outcome with module) diseases- CHD” Coronary Heart Disease 21 Soh SE., 2019 Monash Univer- MC-PROM “to assess symp- 5 items English (Aus- Yes Internal consist- Content validity [65] sity cardiac toms and feel- tralia) ency Construct valid- patient-reported ings following ity outcome meas- percutaneous ure intervention” a This instrument was initially developed for Heart Failure, although it was modified for one study to be applied to CHD b HearQol was initially developed in Danish, Dutch, English (Australia, Canada, Ireland, United Kingdom, the United States of America), French, Flemish, German (Austria, Germany, and Swit- zerland), Hungarian, Italian, Norwegian, Polish, Portuguese, Russian, Spanish (Cuba and Spain), Swedish, and Ukrainian c Only abstract available 13 1417 1418 Quality of Life Research (2023) 32:1405–1425 patients, and nowadays there are 7 language versions. The for the assessment of several constructs, such as activities CROQ was specifically designed to evaluate health status of daily living, anxiety, treatment motivation, and work in patients undergoing coronary artery disease grafting and capacity. percutaneous transluminal coronary angioplasty, and pre- sents different versions according to the moment of admin- istration (pre- or post-intervention) and the type of inter- Discussion vention (coronary artery disease grafting or percutaneous transluminal coronary angioplasty). The HeartQoL (2014) Facilitating the selection of the most appropriate PROM for was developed simultaneously in 15 countries and has sub- a specific aim is the first step needed to increase patient- sequently been translated into another 16 languages. The centered approaches in CHD, an area where only around original aim was to assess CHD-specific HRQL for making 29% of trials report using these measures [12]. The most between-diagnosis comparisons following interventions that important characteristic to be considered in this decision are routinely used in more than one CHD diagnosis. process should be what is the construct of interest for the Regarding the content of the dimensions, all instruments study, program, or initiative implemented. cover physical and emotional domains, and most of them Reviews of PROMs for CHD have been primarily focused also include a social dimension (Table 3). Nine of these on instruments measuring HRQL or symptoms [12, 14–17, questionnaires have a specific domain related to disease 20]. Through a systematic review we have identified 56 symptoms, treatments, or their side effects: APQLQ, Angina PROMs to be applied to patients with CHD, covering dif- Impact Questionnaire (AIQ), Questionnaire for coronary ferent constructs: HRQL, symptoms, functional status, or artery bypass grafting, CAST, Cardiac Quality of Life Index several psychological or behavioral aspects. (CQLI), MIDAS-35, CROQ, Quality of Life Instruments for A few reviews have included various constructs, but they Chronic Diseases-Coronary Heart Disease (QLICD-CHD), were not exclusively centered on CHD. There is a scoping and MC-PROM. Moreover, 13 out of the 21 instruments review of all existing disease-specific PROMs for patients have a domain covering specific issues such as sleep prob- with heart disease, including heart diseases in general, lems in the APQLQ and Cuestionario de Calidad de Vida ischemic heart disease, heart failure, arrhythmia, valve dis- de Velasco-del Barrio (CCVPPI), financial aspects in the ease, and/or grown-up congenital heart disease [19], which Questionnaire for coronary artery bypass grafting and Mul- only identified 9 instruments for ischemic heart disease and tidimensional Index of Life Quality (MILQ), alertness in 5 for heart disease in general. The low number of PROMs the Summary index and CCVPPI, or occupational aspects identified by this scoping review was probably due to the in the Questionnaire for coronary artery bypass grafting, exclusion criteria of PROMs measuring single symptoms or CAST or MILQ. domains, because its purpose was mapping the items con- Supplementary Table 4 shows 20 specific PROMs for tained in WHO’s International Classification of Function- CHD that measured some construct other than symptoms, ing, Disability, and Health (ICF). A systematic review of functional status or HRQL, for example, psychological cardiovascular-specific PROMs identified 26 instruments and behavioral aspects such as depression, anxiety, anger, for patients undergoing elective coronary revascularization, or distress (measured by 5 instruments), self-efficacy (4 although specific PROMs applied to other procedures were instruments), attitudes, perceptions, threats, and expecta- not included [18]. tions about the treatment (3 instruments), knowledge (2 Symptoms and functional status were also commonly instruments), adjustment or limitation to work (2 instru- included in the CHD studies, and 15 PROMs have been ments), social support (2 instruments), or self-care (1 instru- developed. A literature review of PROMs assessing symp- ment). Most of these instruments were developed in the last toms for different cardiovascular diseases found 14 symp- 20 years and have been used recently, with at least one pub- toms instruments for various acute coronary syndromes and lication in the last 10 years. Those with the most language 10 specifically for patients with angina [20]. versions developed are the CDS and the SC-CHDI, which Typically, the quantification method of symptoms and are available in 9 and 11 languages, respectively. Regarding functioning in CHD has been the Canadian Cardiovascular psychometric properties, for the majority of these instru- Society (CCS) classification system, which is determined ments only internal consistency and construct or content by the clinician rather than the patient [25]. Almost 40 years validity have been assessed, being CDS the exception as its of research have documented substantial limitations in the reproducibility and responsiveness have also been assessed. CCS classification system [26, 27]: the data collectively Deserving a special mention is the RehaCAT-Cardio suggest a need for more consistent, systematic, and accu- project for the development and validation of a computer rate means to quantify the frequency and burden of angina adaptive test (CAT) for cardiac patients undergoing rehabili- from the patient’s perspective. In this sense, 12 symptoms tation, which has designed different item banks and scales [28–39] and 3 functional status instruments [40–42] have 13 Quality of Life Research (2023) 32:1405–1425 1419 Table 3  Dimensions measured by HRQL scales Instrument Physical dimension Emotional or psycho- Social dimension Other Disease-related issues logical dimension 1 APQLQ Physical limitations Emotions (5) Symptoms (6) (6) Life satisfaction (5) 2 AIQa Physical activities Self-control Impact of disease Sleep disorder 3 Summary Index Physical exertion (9) Vitality (5) Impact of angina in Self-control (5) daily life (9) Emotional function (18) Alertness (4) 4 Questionnaire for Home, leisure, and Working life Symptoms coronary artery social and sexual Financial aspects bypass ­graftinga activities Overall quality of life 5 CAST Physical function- Mental health (1) Social functioning Life events (1) Symptoms (1) ing (1) (3) Work status (9) Perceived social sup- Life satisfaction (1) port (1) Social integration (3) 6 QLI-IV cardiac Health and function- Psychological and Social and economic version ing (15) spiritual status (7) aspects (8) Family and social relationships (5) 7 CCVPPI Health (8) Emotional behavior Social relationships Mobility (6) (3) (8) Sleep and rest (3) Concerns to the Communication (4) future (3) Work and leisure Alertness (3) time (6) 8 Macnewb Physical scale (14) Emotional scale (14) Social scale (13) 9 CQLI Physical wellbeing Psychosocial wellbe- Nutrition (2) Symptoms (2) (4) ing (8)c Worry (3) 10 MILQ Physical health (4) Mental health (4) Social functioning Financial status (4) Physical function- Cognitive function- (4) Relationship with ing (4) ing (4) Intimacy (4) health profession- als (4) Productivity (3) 11 CHP-cadad Somatic function- Emotional function- Social functioning Control over his/her ing (3) ing (6) (3) situation (1) Conative function- ing (5) 12 GISII-nursing Physical limitations Emotional limita- Social activity (3) Functional status (6) (4) tions (3) Quality of life (1)* Pain (2) Mental health (5) General health (1)* Vitality (4) 13 CHF-modified Fatigue (4) Emotional (7) Dyspnea (5) 14 UBQ-H Physical ability (4) Psychological dis- Social-usual activi- tress (16) ties (5) Self-care (4) 15 ITG-HRQL-SF Extent of chest pain Functioning and Social functioning (4, 3)d wellbeing (7, 3)d (6, 4)d Physical functioning (7. 3)d 16 MIDAS-35 Physical activity (12) Insecurity (9) Diet (3) Concerns over medi- Emotional reaction cation (2) (4) Side effects (2) Dependency (3) 13 1420 Quality of Life Research (2023) 32:1405–1425 Table 3  (continued) Instrument Physical dimension Emotional or psycho- Social dimension Other Disease-related issues logical dimension 17 CROQ Physical function- Psychological func- Satisfaction (6)e Symptoms (7) ing (8) tioning (14) Adverse effects (11 Cognitive function- Coronary Artery ing (3) Bypass Grafting, 6 Percutaneous Trans- luminal Coronary Angioplasty)e 18 HeartQol Physical scale (10) Emotional scale (4) 19 QLICD-CHD Effect on mental Symptom (6) health and daily Effect of medicine (1) life (9) 20 PROISCD-CHDa Physical health Mental health Social health Beliefs Beliers 21 MC-PROMf Overall score (5) The number of items in each dimension is in parentheses a Information about the number of items in each dimension is not reported b Some items of this instrument score in more than one dimension c This dimension could be in the psychological-emotional or in the social domains d Number of items for the long and short forms e These dimensions are only in the post-revascularizations versions of the instrument been developed, but only 5 symptoms and 2 functional status instruments specific for patients with CHD usually include scales have been used in the last 10 years. This is probably a physical and an emotional domain, quite frequently also the consequence of some of them having been established as a social domain, and the most recent ones add dimensions “gold standards” and used consistently due to the accumu- for measuring self-care, dependency, or satisfaction. Con- lated evidence of well-established validity, reproducibility, sidering the most frequently used instruments in the last prognostic importance, and sensitivity to clinical change 10 years (APQLQ, QLI-cardiac version, MacNew, MIDAS- [25]. This would be the case of the RAQ for symptom rec- 35, CROQ, and HeartQol), differences among the number ognition or the DASI and the SAQ for functional status of items (22 to 70) and domains are important. Half of them assessment [9]. were developed with the aim of evaluating the impact of The RAQ was constructed in the 1960s for assessing the treatments (MacNew, CROQ, and HeartQol), allowing for population burden of angina, and positive screening in RAQ comparisons among interventions, a relevant aspect for predicts myocardial infarction and cardiovascular disease shared decision making. [43]. The DASI, although initially developed for cardiac In recent decades, there has been a growing interest in patients to assess usual physical activities and cardiopul- patient-centered approaches that open the scope to other monary fitness, has been shown to be useful for non-car- constructs like self-care, attitudes, or psychological aspects diac disease to improve the identification of patients at an specifically related to the disease. Our review has found 20 elevated risk for myocardial infarction [44]. The SAQ was scales [67–91] to measure mood symptoms, perception, endorsed as a performance measure by the AMA/ACC/AHA expectation regarding the disease (beliefs, attitudes, risk Physicians’ Consortium for Performance Improvement in the perception, or knowledge) or coping strategies (self-efficacy, 1990s, and it has been more extensively applied in clinical self-care, adjustment, or social support). CHD often involves trials than adopted in clinical practice [27]. The International mood symptoms of distress, anxiety, or depression, which, in Consortium for Health Outcomes Measurement (ICHOM), turn, are risk factors for CHD [92, 93]. However, it should an organization with the mission to unlock the potential of be noted that information on their metric properties has not value-based healthcare, recommends the short version of the been reported yet for many of these instruments, with a con- SAQ in the CHD standard sets of outcome measures. siderable gap regarding their sensitivity to change. CDS is Instruments focused on HRQL are the largest group with the only instrument with evidence on reliability, validity, 21 PROMs [24, 33, 45–66], making it difficult to select the and responsiveness. In the United States, the proportion most appropriate instrument, yet this is one of the most of depression in patients with acute myocardial infarction interesting constructs for clinicians and researchers. HRQL is three times higher than in the general population, and 13 Quality of Life Research (2023) 32:1405–1425 1421 anxiety is almost twice [94, 95]. Aware of these data, the In conclusion, this review has practical significance, as it American Heart Association (AHA) recommends routine summarizes relevant information that may help clinicians, screening for depression, allowing effective treatment for researchers, and other healthcare stakeholders to choose the improving health outcomes [96]. Conversely, the assess- most adequate instrument for incorporating the patients’ per- ment of protective factors such as self-care, self-efficacy, spective and promote a model of shared decision making in or social support, among other constructs related to cop- a trend towards value-based healthcare [99]. ing strategies, could help to promote lifestyle changes in Supplementary Information The online version contains supplemen- patients and increase the level of compliance with medical tary material available at https://d​ oi.o​ rg/1​ 0.1​ 007/s​ 11136-0​ 22-0​ 3260-6. recommendations. In general, there is a tendency to develop short versions Acknowledgements The authors acknowledge the collaboration and of the original instrument or to develop a renewed version. contribution of Itxaso Alayo for her assistance in the database manage- ment. Moreover, the authors thank Dave Macfarlane and Aurea Martin Such is the case of the RAQ, which has multiple modified for their support in English editing, proofreading, and preparing this versions, or the MacNew, which was initially developed in manuscript for submission. 1993 for myocardial infarction (QLMI) and extended its applicability to other conditions in the current version pub- Author contributions All authors have actively participated in the study and have made a substantial contribution to (1) either concep- lished in 1996. The SAQ, with an original version of 19 tion and design, or acquisition of data, or analysis and interpretation of items, has a shorter 7-item version developed to reduce its data; as well as (2) the drafting of the article or its critical revision for response burden and to provide a single summary score to important intellectual content; and (3) the final approval of the version facilitate its adoption in clinical care [97]. to be published. Funding This study was supported by grants from the Instituto de Strengths and limitations Salud Carlos III FEDER: Fondo Europeo de Desarrollo Regional (grant number PI16/00130); Generalitat de Catalunya, Spain (grant number and 2017 SGR 452); and the Centro de Investigación Biomédica en Red This is the first systematic review of specific PROMs applied de Epidemiología y Salud Pública (CIBER of Epidemiology and Public in CHD patients, including all the constructs measured, and Health). The funders of the study had no role in the study design and without restrictions regarding language and year of pub- conduct, data collection, management, analysis, or interpretation; they also had no role in the preparation, writing, reviewing, and submission lication. It was registered at PROSPERO and follows the of this manuscript. PRISMA guidelines for the systematic review of reviews, a research procedure nowadays recommended to increase Data availability Data and material are available from the correspond- transparency and reproducibility and decrease reporting ing author upon reasonable request. bias. Code availability Not applicable. The results of the present systematic review should be interpreted in the light of their principal limitation. The Declarations authors acknowledge that more PROMs might have been identified if other databases had been searched in addition to Conflict of interest The authors declared that they have no conflict of interest. MEDLINE, Scopus, and the Cochrane Database. However, additional manual screening of reference lists from relevant Consent to participate Not applicable. articles and targeted searches in PROQOLID and BiblioPRO still yielded a relatively large number of PROMs. Consent for publication Not applicable. Open Access This article is licensed under a Creative Commons Attri- bution 4.0 International License, which permits use, sharing, adapta- tion, distribution and reproduction in any medium or format, as long Conclusions and practical implications 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 A wide variety of instruments has been developed to assess were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated patient-reported outcomes in CHD, covering several con- otherwise in a credit line to the material. If material is not included in structs which may be of special interest. The first step to the article's Creative Commons licence and your intended use is not increase patient-centered approaches in CHD is to identify, permitted by statutory regulation or exceeds the permitted use, you will classify, and describe the existing PROMs, including the 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/. evidence on their metric properties. The second step on the continuum towards value-based healthcare [98] may be the evaluation of PROMs’ implementation in different set- tings, to report the usability and utility of these measures for patients, carers, and health professionals. 13 1422 Quality of Life Research (2023) 32:1405–1425 References (Clinical Research Edition), 341, c5707. https://d​ oi.o​ rg/1​ 0.1​ 136/​ bmj.​c5707 12. Mark, D. B. (2016). 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