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About the Authors:

Fania R. Gärtner

Roles Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Writing – original draft

* E-mail: [email protected]

Affiliation: Department of Medical Decision Making, Leiden University Medical Centre, Leiden, the Netherlands

ORCID http://orcid.org/0000-0002-0351-0204

Hanna Bomhof-Roordink

Roles Conceptualization, Formal analysis, Investigation, Methodology, Writing – review & editing

Affiliation: Department of Medical Decision Making, Leiden University Medical Centre, Leiden, the Netherlands

Ian P. Smith

Roles Investigation, Writing – review & editing

Affiliation: Department of Medical Decision Making, Leiden University Medical Centre, Leiden, the Netherlands

Isabelle Scholl

Roles Investigation, Writing – review & editing

Affiliations Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, United States of America

Anne M. Stiggelbout

Roles Conceptualization, Funding acquisition, Investigation, Methodology, Writing – review & editing

Affiliation: Department of Medical Decision Making, Leiden University Medical Centre, Leiden, the Netherlands

Arwen H. Pieterse

Roles Conceptualization, Formal analysis, Funding acquisition, Investigation, Methodology, Supervision, Writing – review & editing

Affiliation: Department of Medical Decision Making, Leiden University Medical Centre, Leiden, the Netherlands

Abstract

Objective

To inventory instruments assessing the process of shared decision making and appraise their measurement quality, taking into account the methodological quality of their validation studies.

Methods

In a systematic review we searched seven databases (PubMed, Embase, Emcare, Cochrane, PsycINFO, Web of Science, Academic Search Premier) for studies investigating instruments measuring the process of shared decision making. Per identified instrument, we assessed the level of evidence separately for 10 measurement properties following a three-step procedure: 1) appraisal of the methodological quality using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist, 2) appraisal of the psychometric quality of the measurement property using three possible quality scores, 3) best-evidence synthesis based on the number of studies, their methodological and psychometrical quality, and the direction and consistency of the results. The study protocol was registered at PROSPERO: CRD42015023397.

Results

We included 51 articles describing the development and/or evaluation of 40 shared decision-making process instruments: 16 patient questionnaires, 4 provider questionnaires, 18 coding schemes and 2 instruments measuring multiple perspectives. There is an overall lack of evidence for their measurement quality, either because validation is missing or methods are poor. The best-evidence synthesis indicated positive results for a major part of instruments for content validity (50%) and structural validity (53%) if these were evaluated, but negative results for a major part of instruments when inter-rater reliability (47%) and hypotheses testing (59%) were evaluated.

Conclusions

Due to the lack of evidence on measurement quality, the choice for the most appropriate instrument can best be based on the instrument’s content and characteristics such as the perspective that they assess. We recommend refinement and validation of existing instruments, and the use of COSMIN-guidelines to help guarantee high-quality evaluations.

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Citation: Gärtner FR, Bomhof-Roordink H, Smith IP, Scholl I, Stiggelbout AM, Pieterse AH (2018) The quality of instruments to assess the process of shared decision making: A systematic review. PLoS ONE 13(2): e0191747. https://doi.org/10.1371/journal.pone.0191747

Editor: Jacobus P. van Wouwe, TNO, NETHERLANDS

Received: June 29, 2017; Accepted: January 10, 2018; Published: February 15, 2018

Copyright: © 2018 Gärtner et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the paper and its Supporting Information files.

Funding: This study was supported by a grant from the Dutch Cancer Society, project number: UL2013-6108.

Competing interests: FG, IPS and HB declare that they have no competing interest. IS conducted one physician training in shared decision-making within a research project funded by Mundipharma GmBH (pharmaceutical company) and received travel compensation for this. AP and AS held lectures for pharmaceutical companies (Sanofi en Amgen) for which they received time and travel compensations. To prevent any conflict of interest based co-authorship of articles that were included in this review, members of our research team who were involved in the development and or validation of a specific instrument were not involved in the quality appraisal of these instruments: Isabelle Scholl was involved in the development and validation of the following instruments: SDM-Q-9 [29, 69], SDM-Q-9 (Spanish) [32], SDM-Q-9 (Dutch) [33], SDM-Q-9 Psy (Hebrew) [34], SDM-Q-Doc [35], SDM-Q-Doc (Dutch) [33]. Arwen H. Pieterse was involved in the development and validation of the following instruments: SDM-Q-9 (Dutch) [33], SDM-Q-Doc (Dutch), OPTION12 (Dutch) [56], OPTION5 (Dutch) [55]. Anne M. Stiggelbout was involved in the development and validation of the following instruments: SDM-Q-9 (Dutch) [33], SDM-Q-Doc (Dutch), OPTION12 (Dutch) [56], OPTION5 (Dutch) 56]. There are no patents, products in development, or marketed products to declare. This does not alter the authors’ adherence to all PLOS ONE policies on sharing data and materials. The specific roles of these authors are articulated in the ‘author contributions’ section.

1. Introduction

There is growing recognition that shared decision making (SDM) is imperative as a decision making model in clinical practice when more than one option is medically relevant or when patient preferences vary strongly. Various conceptual models describe what the process of SDM between health care providers and patients entails [1, 2]. Many of these models describe steps that have to be taken as part of SDM. In a recent paper, Stiggelbout and colleagues identify four key steps: “(1) the professional informs the patient that a decision is to be made and that the patient's opinion is important; (2) the professional explains the options and their pros and cons; (3) the professional and the patient discuss the patient's preferences and the professional supports the patient in deliberation; (4) the professional and patient discuss the patient’s wish to make the decision, they make or defer the decision, and discuss follow-up.” [2] SDM aims to promote patient autonomy, to limit practice variation, and ensure that treatment decisions reflect patient preferences [1, 3, 4]. Research shows that the occurrence of SDM in routine clinical practice is still limited [5, 6]. Current research agenda focuses on studies on the level of SDM seen in clinical care [5], effects of training and tools for healthcare providers and patients to promote SDM in the clinical practice [7, 8], and the effect of SDM on psychosocial and physical patient outcomes [9–11]. The quality of these studies highly depends on the availability of psychometrically sound instruments to assess the actual realization of SDM. It is notable that the SDM measures used vary greatly with regard to their characteristics, such as the source of the data and the perspective of the scorers (self-report questionnaires based on the experience of patients or providers versus coding schemes applied by independent raters to audio- or video-taped consultations) [12]. These differences can impact research outcomes, as might be the case for a review on the relationship between SDM and patient health outcomes which found that the perspective from which SDM is measured affects the associations found with health outcomes [8]. Furthermore, it is not clear if there are differences in measurement quality between different instruments. To assist researchers in their choice of the most feasible, reliable, and valid SDM measure, and to optimally improve existing instruments, insight into measurement quality of the existing measures is needed.

Previous literature reviews have provided an overview of existing instruments, but have not systematically appraised the quality of the instruments’ measurement properties in a process that accounts for the methodological quality of their validation [12–15] Concerning the instruments’ measurement quality, the existing reviews only presented results on reliability and validity testing in a descriptive manner. None of the previous reviews systematically appraised the quality of the measurement properties of existing instruments, taking into account the methodological quality of their validation studies. In any study, poor methodological quality can bias the results. Consequently, when drawing conclusions on the quality of measurement instruments, one should appraise and correct for the risk of bias arising from the methods applied in the validation studies of the instruments under investigation [16]. Therefore, we aim to perform a systematic literature review that presents an overview of all SDM process instruments and their measurement quality, by answering the following research question: What is the measurement quality of existing instruments measuring the process of SDM, taking into account the methodological quality of the available validation studies?

This systematic review was registered at PROSPERO: CRD42015023397 Available from: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=23397

2. Methods

2.1 Search strategy

Seven electronic databases (PubMed, Embase, Emcare, Cochrane, PsycINFO, Web of science, Academic Search Premier) were systematically searched for peer-reviewed articles in May 2015 and the search was updated on September 1, 2017. A librarian experienced in systematic searches of academic databases assisted the researchers in developing and performing the search strategy. Our search strategy was developed in line with recommendations and existing search filters specifically developed for systematic reviews, assessing the measurement quality of measurement instruments in the medical field, described by Terwee and colleagues [17]. We combined three search groups with the Boolean operator AND: Group I consisted of search terms presenting the construct of interest, i.e., SDM; group II consisted of search terms for instrument types, such as questionnaire and coding schemes; and group III consisted of search terms for measurement properties. Index terms specific for each database (such as MESH and Major terms in PubMed) were combined with free-text words. We added a fourth search group using the Boolean operator NOT, to exclude specific publication types such as editorials. The complete search strategy is presented in the Appendix. We then reviewed all articles citing the of articles that meet our inclusion criteria to check for additional relevant articles with a publication date prior to October 10, 2017. Furthermore, we contacted a network of SDM researchers via the Shared-l mailing list ([email protected]; http://www.psych.usyd.edu.au/mailman/listinfo/shared-l) and asked them to inform us of any ongoing studies related to the development or evaluation of instruments measuring the process of SDM.

2.2 Selection of eligible articles

The search aimed to include all articles that describe the development or evaluation of instruments that measure the SDM process, which is an assessment of the actual realization of SDM in clinical practice. Articles that evaluate instruments measuring antecedents of SDM (e.g., preferred role in decision making) or SDM outcomes (such as decisional regret) were not included. The inclusion criteria are presented in detail in Table 1. To check eligibly for inclusion, each article retrieved in the search was independently assessed by two members of the research team (MB, HB-R, FG, IPS, IS, AP). In a twofold process, researchers reviewed the titles and abstracts of each article. If these indicated potential inclusion, the full-text of the article was assessed using the inclusion criteria. Disagreements were resolved in consensus between the two reviewers and a third reviewer was consulted if necessary.

[Figure omitted. See PDF.]

Table 1. Eligibility criteria.

https://doi.org/10.1371/journal.pone.0191747.t001

2.3 Data extraction

For each included article we extracted data on the methods (setting, healthcare provider sample, patient sample, data collection and coders in case of observer-based data), and results for 10 measurement properties (see Table 2). In case an article describes the evaluation of multiple instruments, the data extraction was performed separately for each instrument under investigation. The extracted data is presented in the online Supporting Information (S1 Table); this data is a summary of the methods and results of the included validation studies and informs the quality appraisals that we performed, as described in section 2.5. For each instrument identified by the included articles we extracted i) the instrument’s measurement aim and construct, ii) the measurement characteristics, i.e., underlying measurement model, number of subscales and items, response scale, and score range, and iii) details on the development process. For each included article, the data was extracted by one and checked by a second project team member (HB-R, FG, IS, ISCH, AP, AS); disagreements between these two were discussed until consensus was reached. In case of doubt a third researcher was consulted. Only information listed in the included article was extracted and considered for assessment, unless the article specifically referred to some other source for this information.

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Table 2. Definition of measurement properties based on COSMIN [20] and Terwee et al.[21].

https://doi.org/10.1371/journal.pone.0191747.t002

2.4 Quality appraisal of measurement properties of SDM instruments

For each instrument, we appraised the quality of ten measurement properties (see Table 2) described in the validation studies in two ways. First, we rated the quality of the methods used to evaluate the measurement properties of an instrument; from here on referred to as the appraisal of methodological quality. Second, we rated the measurement properties based on the results of the validation studies. Data from these two appraisals were combined to provide a best-evidence synthesis of the quality of the measurement properties for each instrument included.

2.4.1 Appraisal of methodological quality.

To appraise the methodological quality we used the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist [20, 22, 23]. The COSMIN checklist describes how ten different measurement properties should ideally be evaluated and provides scoring criteria for the methodological quality appraisal. For each measurement property, the quality of the methods used to evaluate it is scored by a number of items (ranging from 4 to 18) on a four-point rating scale: “excellent”, “good”, “fair”, or “poor”. For some items, the lowest response options were “good” or “fair”. The scoring criteria for each category on the rating scale are uniquely defined per item. The overall score per measurement property was determined by taking the lowest item-level score for that specific measurement property. That is, if one item in a property was rated as “poor” then the entire property was rated as “poor”. For instruments following item response theory (IRT), specific IRT criteria were scored, instead of internal consistency and structural validity. There are no COSMIN criteria to appraise methodological quality for the property interpretability. Therefore, for interpretability we only inventoried if two aspects of interpretability were evaluated, i.e., floor and ceiling effects, and minimal important change value. More information on COSMIN and the checklist items can be found on http://COSMIN.nl.

The 10 measurement properties and their definitions based on COSMIN [20] and Terwee et al.[21] are presented in Table 2. Due to variability in the field regarding names used for measurement properties, we classified the measurement properties evaluated in included articles using the terminology and definitions of COSMIN [20] and Terwee et al.[21] (see Table 2) rather than the labels given by the authors of the articles. For example, if authors used the term ‘convergent validity testing’ to designate the testing of hypotheses about the relationship of the instrument under investigation with another existing instrument measuring related constructs, we extracted and evaluated this information using COSMIN criteria for hypotheses testing.

We scored reliability separately for test-retest reliability (applicable to questionnaires only), inter-rater reliability, and intra-rater reliability (the latter two being applicable to coding schemes only). Items about reliability that were not applicable to the inter-rater reliability and intra-rater reliability of coding schemes, were omitted in the rating of the methodological quality of validation studies evaluating coding schemes, i.e., for intra-rater reliability item 7 (Were patients stable in the interim period on the construct to be measured?); for inter-rater validity: item 6 (Was the time interval stated?), item 7 (Were patients stable in the interim period on the construct to be measured?), and item 8 (Was the time interval appropriate?).

We applied two modifications to the COSMIN rating. First, we diminished the impact of the item “Was there a description of how missing items were handled?” on the total score for a measurement property. This item is included in the rating of most measurement properties and often received the lowest possible score, a “fair” rating. This score often was the lowest score on the measurement property and would then obscure how the other methodological aspects for that measurement property were rated. We therefore decided to let this item have less impact on the final score by upgrading the total score on a measurement property in case the score on this specific item was the lowest of all scores. E.g., if all items for the measurement property had received “good” or “excellent” rating, and the score on this specific item was a “fair”, the total score was set on “good”, or: if all items had been rated as “excellent” and the score on this specific item was a “fair”, the total score was set at “good”.

Second, we adapted the rating of content validity. The COSMIN checklist requires that for content validity testing, three types of relevance should be assessed, regarding a) the construct to be measured, b) the study population, and c) the purpose of the measurement instrument. These requirements are quite stringent and therefore we have adapted the scoring of these three items as follows: If one or two types of relevance were missing, the concerning items were not scored. The score for items concerning the type of relevance that was assessed was downgraded by one score. That is, an excellent score for content validity testing was only possible when two or more types of relevance had been assessed.

2.4.2 Appraisal of the measurement properties.

To rate the measurement property of an instrument within a particular study, we used three possible quality scores: a positive rating (labeled +), an inconclusive rating (labeled?), and a negative rating (labeled -). The criteria we used were based on Terwee et al.[21] and Schellingerhout et al. [24, 25] and are presented in Table 3.

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Table 3. Quality criteria for results on measurement properties based on Terwee et al.[21].

https://doi.org/10.1371/journal.pone.0191747.t003

2.4.3 Best-evidence synthesis.

As recommended by Terwee et al [16] we determine the overall quality of a particular measurement property of an instrument. We used the approach of Schellingerhout and colleagues [24, 25], in which the results from the different articles are synthesized for each instrument by combining: the appraisal of methodological quality of the studies (see 2.5.1), the appraisal of the measurement property (see 2.5.2), the number of studies assessing the property, and the consistency of the results in case of multiple validation studies. For this overall rating, five levels of evidence were applied: unknown evidence (?), conflicting evidence (+/-), limited (+ or -), moderate (++ or--), and strong evidence (+++ or---). The latter three could point in either a positive or negative direction, which we indicated by respectively using the plus sign and minus sign. The scoring criteria are presented in Table 4.

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Table 4. Levels of evidence for the best-evidence synthesis.

https://doi.org/10.1371/journal.pone.0191747.t004

Two members of the research team (HB-R, FG, IPS IS, AP) rated the methodological quality and measurement properties of each article, with discrepancies discussed until consensus was reached. In case of doubt a third team member was consulted. For the methodological quality appraisal, consensus had to be reached on the item-level, not only on the total scores per measurement property rated. One team member performed the best-evidence synthesis (FG) and a second (AP) checked it. Team members who were co-author of an included article were not involved in data extraction and quality appraisals of that article. For instruments consisting of multiple subscales, we performed the quality appraisals of the methods and properties separately for each subscale. To provide an overall score for a measurement property for these instruments, we used the lowest subscale scores as input for the data synthesis.

3. Results

3.1 Search results

The primary search in seven databases retrieved 13.026 articles, of which, after removing duplicates, 7484 unique hits were screened for inclusion. Another 1104 unique articles were identified by the citation check of all articles that were eligible for inclusion in this systematic review. After title abstract screening, 217 articles were assessed for eligibility based on their full-text. In total, fifty one articles met our inclusion criteria (Fig 1), of which forty-five derived from the primary search, one from the citation check, 4 through the call in the e-mail list of SDM researchers and 1 via hand search. The 51 included articles describe the development and/or evaluation of 40 unique instruments that assess the process of SDM (Fig 2). In total 21 instruments were originally developed versions, 4 were revised versions, and 15 were translated versions. In Table 5, we describe the characteristics of the instruments. Most instruments were observer-based coding schemes (N = 18), followed by patient questionnaires (N = 16) and provider questionnaires (N = 4); two were mixed, including two or more instruments assessing multiple perspectives: the dyadic OPTION, consisting of a patient and a provider questionnaire [26] and the Mappin’SDM, consisting of a patient questionnaire, a provider questionnaire, and a coding scheme [27]. For the quality appraisal of mixed instruments, we rated the measurement quality of mixed instruments separately for each perspective; result in a total number of instruments for which we performed a best evidence synthesis of N = 43. The number of validation studies per instrument varied between zero and four. For most instruments (N = 28), one validation article has been published.

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Fig 1. Flow diagram of article selection process.

https://doi.org/10.1371/journal.pone.0191747.g001

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Fig 2. Number of included articles and instrument.

https://doi.org/10.1371/journal.pone.0191747.g002

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Table 5. Characteristics of the instruments measuring the process of SDM regarding the construct and the instruments’ measurement features.

https://doi.org/10.1371/journal.pone.0191747.t005

3.2 Best-evidence synthesis

In Table 6, we present the best-evidence synthesis for each measurement property per instrument, (N = 43). For seven instruments (all of which questionnaires), moderate or strong positive evidence was found for at least one type of reliability (internal consistency, test-retest reliability, intra-rater reliability, inter-rater reliability, or measurement error) and one type of validity (structural validity, hypotheses testing, cross-cultural validity, or criterion validity): the FPI [28], the SDM-Q-9 original German version [29], the SDM-Q-9 Spanish version [30–32] the SDM-Q-9 Dutch version,[33] the SDM-Q-9-PSY in Hebrew [34], the SDM-Q-doc original German version,[35] and the SDM-Q-doc Dutch version [33]. Of these instruments however, the SDM-Q-9 Spanish version [30–32], the SDM-Q-9-PSY in Hebrew[34] and the SDM-Q-doc original German version,[35] are the only instruments without any negative evidence on other measurement properties. In the online Supporting Information (S2 Table), we present the separate ratings for each included article, for both the appraisal of the methodological quality and the quality of measurement properties.

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Table 6. Best level of evidence for each measurement property per instrument measuring the process of SDM (N = 38).

https://doi.org/10.1371/journal.pone.0191747.t006

3.3 Overall results for the quality of validation studies and measurement properties

In the next three sections we will describe overall results on the quality of included studies and instruments, beginning with an overview of measurement properties that have been evaluated for the included instruments (section 3.3.1), the overall results on the methodological quality of the included validation studies (section 3.3.2), and overall results on the best-evidence synthesis (section 3.3.3). To allow for generalization, we present overall results only for measurement properties that have been evaluated in at least five studies (section 3.3.2) or for at least five instruments (section 3.3.3). We do not present overall results on the quality rating of measurement properties (see Methods section 2.4.2), because we regard them as being irrelevant without the correction for methodological quality. The results on the measurement properties evaluation for each included article and each instrument evaluated in the articles can be found in the online Supporting Information (S1 Table)

3.3.1 Overall results on which measurement properties are evaluated.

The measurement property evaluation results are presented in Table 7. The number of instruments for which each of the different measurement properties have been evaluated, taking into account whether the property was applicable or not, is presented in Table 7, column 2 and 3. Two measurement properties were evaluated in more than two-thirds of the instruments: hypotheses testing, and intra-rater reliability in case of coding schemes. Seven measurement properties were evaluated for in less than one-third of instruments: Test-retest reliability, measurement error, content validity, cross-cultural validity, criterion validity, responsiveness, and the floor and ceiling effects and minimal important change values, both aspects of interpretability. Of note, internal consistency and structural validity were evaluated for a majority of questionnaires, but a minority of coding schemes.

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Table 7. Overall results on best-evidence synthesis per measurement property of instruments measuring the process of SDM (N = 43).

https://doi.org/10.1371/journal.pone.0191747.t007

3.3.2 Overall results on the methodological quality of included validation studies.

The methodological quality used was excellent or good in at least half of the studies for the measurement properties of content validity (50%) and structural validity (82%) (Table 8). The methodological quality was poor in at least half of the studies for the measurement properties of internal consistency (52%), inter-rater reliability (53%), intra-rater reliability (75%), and content validity (50%). The quality of validation studies was more often good or excellent for questionnaires than for coding schemes with regard to internal consistency (58% in case of questionnaires, none in case of coding schemes) and structural validity (92% in case of questionnaires, 40% in case of coding schemes). A rating of “poor” in the quality assessment of internal consistency testing was most often due to a lack of factor analysis (COSMIN checklist for internal consistency, item 5) or lack of an internal consistency statistic for subscales (COSMIN checklist for internal consistency, item 7). For inter- and intra-rater reliability testing, a rating of “poor” was most often due to small sample sizes (COSMIN checklist for reliability, item 3) or to the application of statistical methods that were inappropriate for the measurement level of the scale (COSMIN checklist for reliability, items 11–14).

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Table 8. Overall results on methodological quality of the studies that evaluated measurement properties of instruments measuring the process of SDM, as based on COSMIN checklist scoring.

https://doi.org/10.1371/journal.pone.0191747.t008

3.3.3 Overall results on the best evidence synthesis of included instruments.

The best available evidence was unknown for 50% or more of the instruments for the measurement properties of internal consistency, intra-rater reliability, and content validity due to poor methods (Table 7). For two measurement properties, the best available evidence indicated positive results (limited, moderate, or strong) for 50% or more of the instruments: Content validity and structural validity. The best available evidence indicated negative results (limited, moderate, or strong) for hypotheses testing for 59% of the instruments and for intra-rater reliability for 47% of the instruments. Results for questionnaires were overall more positive and for coding-schemes more often unknown regarding internal consistency and structural validity.

4. Discussion

The aim of this systematic review was to provide an overview of the measurement quality of existing instruments measuring the process of SDM. In total, 40 instruments were included in our analysis; primarily patient questionnaires or observer-based coding schemes, but also a few provider questionnaires and ‘mixed’ instruments. There is a general lack of evidence for the appraisal of most measurement properties. This is either because the property was not evaluated, or because the methodology applied was of poor quality. The best-evidence synthesis indicated positive results for at least half of the instruments that have investigated content validity (50%) and structural validity (53%), but negative results for a major part of instruments that have been evaluated for inter-rater reliability (47%) and hypotheses testing (59%). We will highlight the results that in our opinion are most relevant for further validation of existing instruments and the development of new instruments, and provide recommendations for future research.

4.1 Lack of detailed description and assessment of the construct

During data extraction, we noticed that instrument developers often only provided a vague definition of the construct being measured or none at all. Furthermore, or as a consequence of this, for only 14% of the instruments content validity testing was described, (including assessment of item relevance and comprehensiveness of the item set for the measured construct). Additionally, the underlying measurement model was made explicit for only two instruments, with a formative model applied in both instances. The major difference between reflective and formative models is the direction of causality between the construct and its items. In formative models the latent construct of interest is a result of independent items measured (causal indicators), whereas in reflective models the latent construct determines the items (effect indicators) being measured [78, 79]. Therefore, exploratory factor analysis and internal consistency are only relevant for reflective models. In 2011, Wollschläger called upon the SDM field to reach consensus on the most suitable underlying model [80], but it appears that the field is only slowly responding to this call. For most questionnaires, the authors apparently assumed a reflective model, as they assessed factor structure and/or internal consistency. However, this practice may have resulted from a lack of a clear definition of the construct, which is needed to correctly specify the underlying measurement model (see Jarvis et al 2003, Table 3) [78], or from the assumption that assessing these properties is required, even when inappropriate. Following the steps Jarvis presents to decide on the most suitable model, we suggest that it may be more suitable to assume a formative model to measure the process of SDM. Definitions of the SDM process often contain required but independent steps, each of which do not necessarily relate to each other. Changes in one or more of these steps result in changes in levels of SDM, but changes in SDM are not necessarily reflected in changes in all items. That is, a physician explaining that a decision has to be made will increase measures of the SMD process, but increases in the SDM process will not necessarily be reflected in a physician explaining that a decision has to be made. Choosing a formative model has implications for the development of an instrument, as factor structure and internal consistency are not relevant to determine validity of instruments with formative models, and thus cannot inform the selection of the items. For instrument with formative models, content validity testing is therefore even more relevant to make the final selection of items. We want to stress the importance of a clear construct definition and sound content validity testing as a first step in the development and validation of measurement instruments. In any case, the choice of the underlying model should be explicitly described.

4.2 Lack of stability

Test-retest evaluations of questionnaires were performed infrequently (for 17% of questionnaires). The main barrier might be that it cannot be assumed that patients’ and providers’ views are stable between test and retest. Decisions might have been made and/or acted upon which can bias how participants look back on decision processes. Despite these barriers, from a psychometric point of view, lack of stability evaluations of the questionnaires compromises the interpretation of questionnaire results. As an alternative, the developers of the CollaboRATE used analogue patients to determine the intra-rater reliability of their questionnaire [70]. Investigating the validity of this and other methods as possible equivalents for test-retest reliability testing may prove valuable for psychometric testing of SDM measures.

Inter-rater reliability of coding scheme scores has often been assessed but these assessments frequently show negative results, raising questions about the stability of the scores. Caution should be applied when comparing observer scores between studies when intra-rater reliability is poor. Training might improve agreement between the coders within a study. However, training does not automatically improve inter-rater agreement between research groups. More detailed definitions of items and response scales and more frequent consensus discussions throughout the coding process limit the opportunity for subjective interpretation of the items, and thus might improve inter-rater reliability further.

4.3 Hypotheses testing: Poor results or poor hypotheses?

The best-evidence synthesis showed that results on hypotheses testing, as a means to assess construct validity, indicated negative results for more than half of the instruments for which this had was evaluated. The hypotheses tested (see online supporting information S1 Table) that were not confirmed often assessed relationships with instruments that measure (slightly) different constructs (e.g., satisfaction with decision, patients’ information seeking preference, anxiety). Also, hypotheses about relationships with instruments that measure the same construct, whether measured from the same or from a different perspective, were often not confirmed or did not reach the threshold for positive results for correlation coefficients of ≥0.50. This leads us to conclude that poor results for hypotheses testing might reveal methodological problems regarding the suitability of comparators that authors have chosen–which is not accounted for in our COSMIN rating. Until we reach consensus on how to define the process of SDM and on whether SDM viewed from the perspective of the provider, patient, or observer can be regarded as the same construct, authors should be careful in formulating hypotheses for construct validity testing. A good alternative for hypotheses testing about the relationship between instruments that define the construct differently or that measure the same construct but from another perspective could be to assess known group differences.

4.4 Lack of insight into the ability to measure change and to interpret change

Measurement properties relevant to the validity and interpretation of change scores have barely been studied. This is in line with what Scholl et al. already concluded in 2011. Measurement error, responsiveness (evaluated once but using poor methods [70]) and minimal important change values are unknown for the instruments included, even though they are indispensable for interpreting results of intervention studies. Anchor-based methods that make use of an external criterion [81] are well-suited to determine which change is regarded as relevant in terms of important improvements or deteriorations of the process of SDM. Another obstacle however is that the determination of measurement error is essential for the interpretation of minimal important change values, but its determination might face the same barriers as the test-retest evaluation.

4.5 Strengths and limitations of the review

A first strength of our study was the comprehensive search in multiple online databases, for which we set no time limits on publication date, nor did we exclude any type of instrument (i.e. patient questionnaires, provider questionnaires or observer based coding schemes). Second, two raters and when necessary three, evaluated the eligibility of articles, extracted the data, and performed the quality appraisal for each measurement property. We therefore expect our results to be highly valid. Third, to provide an unbiased appraisal of the measurement quality of included instruments, we took into account the results and methodological quality of all their validation studies for the best-evidence synthesis and we rated methodological quality based on the widely-accepted COSMIN standards. Fourth, due to the high number of included instruments, we were able to provide insight into overall trends on the existence of measurement property evaluations, their quality, and the overall quality of instruments. This insight makes it possible to provide general recommendations on how to improve the quality of SDM process instruments and their validation studies.

Our study has some limitations. First, to be eligible for inclusion an article must describe a study that aimed to develop a SDM-process instrument or that validates a SDM-process instrument. We might have missed relevant articles if development or validation of an instrument was not explicitly mentioned in either its title or its abstract. Second, an overrepresentation of data may have biased our best-evidence synthesis. That is, the number of validation studies influences the rating of the best level of evidence and strictly speaking, one should correct this number for those instances when validation studies have been performed once, but authors have published about the same data in multiple articles, but with slightly different foci. After contacting authors, we corrected for this phenomenon twice, i.e., for the DAS-O and the Mappin’SDM (see the footnotes underneath Table 6). However, we cannot state with certainty that overrepresentation is not at stake for other instruments. We recommend more explicit reporting of multiple data use when publishing secondary analyses. Third, our analysis was limited to the evaluation of the measurement properties of existing SDM process instruments. It does not include a detailed analysis of the content of these instruments. To gain more insight into what exactly they measure and what not, further research on the operationalization of existing SDM process instruments is needed. Furthermore, our quality evaluation of SDM process instruments is only applicable for research settings and at a group level. No conclusions can be drawn on the suitability of these instruments for other purposes, such as for the evaluation of individual healthcare providers’ SDM skills. With the current emphasis on value-based healthcare, the applicability of instruments measuring the process of SDM within routine clinical settings needs to be investigated in future research.

4.6 Conclusions

A large number of instruments are available to assess the SDM process, but, evidence is lacking regarding the measurement quality of these instruments, partly because measurement properties have not been evaluated at all, partly because the validation studies are of poor quality. Clearly, this does not imply that existing instruments measuring the process of SDM are of poor quality, but that often their quality is unknown. In practice, the choice for the most appropriate instrument can therefore best be based on the content of the instrument and other characteristics of the instruments that suit best the aim of the study and the resources available for the study, such as the perspective that is assessed and the number of items. We suggest the following recommendations for quality improvement of existing instruments and their validation studies:

* Provide a clear definition of the construct of SDM process.

* Perform content validity analyses prior to further validation.

* Include large-enough sample sizes in validation studies; improvement of sample sizes is especially needed for inter- and intra-rater reliability testing of coding schemes.

* Seek alternative ways to evaluate test-retest reliability of questionnaires for the process of SDM.

* Find ways to improve inter-rater reliability of coding schemes; e.g., by providing more detailed descriptions of coding scheme items.

* Include constructs that are as similar as possible to the process of SDM when formulating hypotheses to evaluate construct validity, and, alternatively, make use of known-group differences testing.

* Determine minimal important change values to inform the interpretation of change scores in intervention studies.

Above all, we recommend to further evaluate and refine existing instruments and to adhere as best as possible to the COSMIN guidelines [20, 21, 23] to help guarantee high-quality evaluations.

Appendix A: Search strategy

PubMed

((("Decision Making"[majr:noexp] OR decision making[tiab] OR decision making[ot] OR decisionmaking[tiab] OR decisionmaking[ot]) AND (professional-patient relations[majr] OR ((Patient[tiab]) AND (provider[tiab] OR physician[tiab] OR professional[tiab] OR doctor[tiab]) AND (relation[tiab] OR relations[tiab] OR contact[tiab] OR communication[tiab] OR interaction[tiab] OR interactions[tiab])) OR ((Patient[ot]) AND (provider[ot] OR physician[ot] OR professional[ot] or doctor[ot]) AND (relation[ot] OR relations[ot] OR contact[ot] OR communication[ot] OR interaction[ot] OR interactions[ot])) OR Patient participation[majr] OR Patient Participation[tiab] OR patient participation[ot] OR patients participation[tiab] OR patients participation[ot] OR patient's participation[tiab] OR patient's participation[ot] OR patient involvement[tiab] OR patient involvement[ot] OR patients involvement[tiab] OR patients involvement[ot] OR patient's involvement[tiab] OR patient's involvement[ot] OR consultation*[tiab] OR encounter[tiab] OR consultation*[ot] OR encounter[ot])) OR shared decision[tiab] OR shared decision[ot] OR shared decisions[tiab] OR shared decisions[ot] OR shared decisionmaking[tiab] OR shared decisionmaking[ot] OR SDM[tiab] OR SDM[ot] OR Shared medical decision[tiab] OR Shared medical decision[ot] OR Shared treatment decision[tiab] OR Shared treatment decision[ot] OR Shared medical decisions[tiab] OR Shared medical decisions[ot] OR Shared treatment decisions[tiab] OR Shared treatment decisions[ot] OR Shared clinical decision[tiab] OR Shared clinical decision[ot] OR Shared clinical decisions[tiab] OR Shared clinical decisions[ot])

AND

(Health Care Surveys [majr:noexp] OR "Outcome and Process Assessment (Health Care)"[majr:noexp] OR "Outcome Assessment(Health Care)"[majr:noexp] OR "Patient Outcome Assessment"[majr:noexp] OR "Questionnaires"[majr] OR scale[tiab] OR scale[ot] OR scales[tiab] OR scales[ot] OR instrument[tiab] OR instrument[ot] OR instruments[tiab] OR instruments[ot] OR questionnaire[tiab] OR questionnaire[ot] OR questionnaires[tiab] OR questionnaires[ot] OR survey[tiab] OR survey[ot] OR surveys[tiab] OR surveys[ot] OR assess*[tiab] OR assess*[ot] OR coding scheme[tiab] OR coding scheme[ot] OR coding schemes[tiab] OR codingscheme[tiab] OR codingscheme[ot] OR codingschemes[tiab] OR codingschemes[ot] OR rating[tiab] OR rating[ot] OR ratings[tiab] OR ratings[ot] OR selfreport[tiab] OR selfreport[ot] OR self report[tiab] OR self report[ot] OR selfreports[tiab] OR selfreports[ot] OR self reports[tiab] OR self reports[ot] OR "Checklist"[majr] OR measure[tiab] OR measure[ot] OR measures[tiab] OR measures[ot] OR "observation"[majr] OR observation[tiab] OR observation[ot] OR observations[tiab] OR observations[ot])

AND

(instrumentation[sh] OR methods[sh] OR Validation Studies[pt] OR Comparative Study[pt] OR "psychometrics"[82] OR psychometr*[tw] OR clinimetr*[tw] OR clinometr*[tw] OR "outcome assessment (health care)"[82] OR outcome assessment[tw] OR outcome measure*[tw] OR "observer variation"[82] OR observer variation[tiab] OR "Health Status Indicators"[82] OR "reproducibility of results"[82] OR reproducib*[tiab] OR "discriminant analysis"[82] OR reliab*[tiab] OR unreliab*[tiab] OR valid*[tiab] OR coefficient[tiab] OR homogeneity[tiab] OR homogeneous[tiab] OR "internal consistency"[tiab] OR (cronbach*[tiab] AND (alpha[tiab] OR alphas[tiab])) OR (item[tiab] AND (correlation*[tiab] OR selection*[tiab] OR reduction*[tiab])) OR agreement[tiab] OR precision[tiab] OR imprecision[tiab] OR "precise values"[tiab] OR test–retest[tiab] OR (test[tiab] AND retest[tiab]) OR (reliab*[tiab] AND (test[tiab] OR retest[tiab])) OR stability[tiab] OR interrater[tiab] OR inter-rater[tiab] OR intrarater[tiab] OR intra-rater[tiab] OR intertester[tiab] OR inter-tester[tiab] OR intratester[tiab] OR intra-tester[tiab] OR interobserver[tiab] OR inter-observer[tiab] OR intraobserver[tiab] OR intra-observer[tiab] OR intertechnician[tiab] OR inter-technician[tiab] OR intratechnician[tiab] OR intra-technician[tiab] OR interexaminer[tiab] OR inter-examiner[tiab] OR intraexaminer[tiab] OR intra-examiner[tiab] OR interassay[tiab] OR inter-assay[tiab] OR intraassay[tiab] OR intra-assay[tiab] OR interindividual[tiab] OR inter-individual[tiab] OR intraindividual[tiab] OR intra-individual[tiab] OR interparticipant[tiab] OR inter-participant[tiab] OR intraparticipant[tiab] OR intra-participant[tiab] OR kappa[tiab] OR kappa’s[tiab] OR kappas[tiab] OR repeatab*[tiab] OR ((replicab*[tiab] OR repeated[tiab]) AND (measure[tiab] OR measures[tiab] OR findings[tiab] OR result[tiab] OR results[tiab] OR test[tiab] OR tests[tiab])) OR generaliza*[tiab] OR generalisa*[tiab] OR concordance[tiab] OR (intraclass[tiab] AND correlation*[tiab]) OR discriminative[tiab] OR "known group"[tiab] OR factor analysis[tiab] OR factor analyses[tiab] OR dimension*[tiab] OR subscale*[tiab] OR (multitrait[tiab] AND scaling[tiab] AND (analysis[tiab] OR analyses[tiab])) OR item discriminant[tiab] OR interscale correlation*[tiab] OR error[tiab] OR errors[tiab] OR "individual variability"[tiab] OR (variability[tiab] AND (analysis[tiab] OR values[tiab])) OR (uncertainty[tiab] AND (measurement[tiab] OR measuring[tiab])) OR "standard error of measurement"[tiab] OR sensitiv*[tiab] OR responsive*[tiab] OR ((minimal[tiab] OR minimally[tiab] OR clinical[tiab] OR clinically[tiab]) AND (important[tiab] OR significant[tiab] OR detectable[tiab]) AND (change[tiab] OR difference[tiab])) OR (small*[tiab] AND (real[tiab] OR detectable[tiab]) AND (change[tiab] OR difference[tiab])) OR meaningful change[tiab] OR "ceiling effect"[tiab] OR "floor effect"[tiab] OR "Item response model"[tiab] OR IRT[tiab] OR Rasch[tiab] OR "Differential item functioning"[tiab] OR DIF[tiab] OR "computer adaptive testing"[tiab] OR "item bank"[tiab] OR "cross-cultural equivalence"[tiab])

NOT

("addresses"[Publication Type] OR "biography"[Publication Type] OR "case reports"[Publication Type] OR "comment"[Publication Type] OR "directory"[Publication Type] OR "editorial"[Publication Type] OR "festschrift"[Publication Type] OR "interview"[Publication Type] OR "lectures"[Publication Type] OR "legal cases"[Publication Type] OR "legislation"[Publication Type] OR "letter"[Publication Type] OR "news"[Publication Type] OR "newspaper article"[Publication Type] OR "patient education handout"[Publication Type] OR "popular works"[Publication Type] OR "congresses"[Publication Type] OR "consensus development conference"[Publication Type] OR "consensus development conference, nih"[Publication Type] OR "practice guideline"[Publication Type]) NOT ("animals"[MeSH Terms] NOT "humans"[MeSH Terms])

Embase

(((*"Decision Making"/ OR decision making.ti,ab OR decisionmaking.ti,ab) AND ("doctor patient relation"/ OR "nurse patient relationship"/ OR ((Patient.ti,ab) AND (provider.ti,ab OR physician.ti,ab OR professional.ti,ab OR doctor.ti,ab) AND (relation.ti,ab OR relations.ti,ab OR contact.ti,ab OR communication.ti,ab OR interaction.ti,ab OR interactions.ti,ab)) OR ((Patient.mp) AND (provider.mp OR physician.mp OR professional.mp OR doctor.mp) AND (relation.mp OR relations.mp OR contact.mp OR communication.mp OR interaction.mp OR interactions.mp)) OR *"Patient participation"/ OR Patient Participation.ti,ab OR patients participation.ti,ab OR patient's participation.ti,ab OR patient involvement.ti,ab OR patients involvement.ti,ab OR patient's involvement.ti,ab OR consultation*.ti,ab OR encounter.ti,ab)) OR shared decision.ti,ab OR shared decisions.ti,ab OR shared decisionmaking.ti,ab OR SDM.ti,ab OR Shared medical decision.ti,ab OR Shared treatment decision.ti,ab OR Shared medical decisions.ti,ab OR Shared treatment decisions.ti,ab OR Shared clinical decision.ti,ab OR Shared clinical decisions.ti,ab)

AND

(*"Health Care Survey"/ OR *"Outcome Assessment"/ OR exp *"Questionnaire"/ OR scale.ti,ab OR scale.mp OR scales.ti,ab OR scales.mp OR instrument.ti,ab OR instrument.mp OR instruments.ti,ab OR instruments.mp OR questionnaire.ti,ab OR questionnaire.mp OR questionnaires.ti,ab OR questionnaires.mp OR survey.ti,ab OR survey.mp OR surveys.ti,ab OR surveys.mp OR assess*.ti,ab OR assess*.mp OR coding scheme.ti,ab OR coding scheme.mp OR coding schemes.ti,ab OR codingscheme.ti,ab OR codingscheme.mp OR codingschemes.ti,ab OR codingschemes.mp OR rating.ti,ab OR rating.mp OR ratings.ti,ab OR ratings.mp OR selfreport.ti,ab OR selfreport.mp OR self report.ti,ab OR self report.mp OR selfreports.ti,ab OR selfreports.mp OR self reports.ti,ab OR self reports.mp OR "self report"/ OR *"Checklist"/ OR measure.ti,ab OR measure.mp OR measures.ti,ab OR measures.mp OR *"Observation"/ OR observation.ti,ab OR observation.mp OR observations.ti,ab OR observations.mp)

AND

(exp "intermethod comparison"/ OR exp "data collection method"/ OR exp "validation study"/ OR exp "feasibility study"/ OR exp "pilot study"/ OR exp "psychometry"/ OR exp "reproducibility"/ OR reproducib*.ti,ab OR "audit".ti,ab OR psychometr*.mp OR clinimetr*.ti,ab OR clinometr*.ti,ab OR exp "observer variation"/ OR "observer variation".ti,ab OR exp "discriminant analysis"/ OR exp "validity"/ OR reliab*.ti,ab OR valid*.ti,ab OR "coefficient".ti,ab OR "internal consistency".ti,ab OR (cronbach*.ti,ab AND ("alpha".ti,ab OR "alphas".ti,ab)) OR "item correlation".ti,ab OR "item correlations".ti,ab OR "item selection".ti,ab OR "item selections".ti,ab OR "item reduction".ti,ab OR "item reductions".ti,ab OR "agreement".ti,ab OR "precision".ti,ab OR "imprecision".ti,ab OR "precise values".ti,ab OR "test-retest".ti,ab OR ("test".ti,ab AND "retest".ti,ab) OR (reliab*.ti,ab AND ("test".ti,ab OR "retest".ti,ab)) OR "stability".ti,ab OR "interrater".ti,ab OR "inter-rater".ti,ab OR "intrarater".ti,ab OR "intra-rater".ti,ab OR "intertester".ti,ab OR "inter-tester".ti,ab OR "intratester".ti,ab OR "intra-tester".ti,ab OR "interobeserver".ti,ab OR "inter-observer".ti,ab OR "intraobserver".ti,ab OR "intra-observer".ti,ab OR "intertechnician".ti,ab OR "inter-technician".ti,ab OR "intratechnician".ti,ab OR "intra-technician".ti,ab OR "interexaminer".ti,ab OR "inter-examiner".ti,ab OR "intraexaminer".ti,ab OR "intra-examiner".ti,ab OR "interassay".ti,ab OR "inter-assay".ti,ab OR "intraassay".ti,ab OR "intra-assay".ti,ab OR "interindividual".ti,ab OR "inter-individual".ti,ab OR "intraindividual".ti,ab OR "intra-individual".ti,ab OR "interparticipant".ti,ab OR "inter-participant".ti,ab OR "intraparticipant".ti,ab OR "intra-participant".ti,ab OR "kappa".ti,ab OR "kappas".ti,ab OR "coefficient of variation".ti,ab OR repeatab*.ti,ab OR (replicab*.ti,ab OR "repeated".ti,ab AND ("measure".ti,ab OR "measures".ti,ab OR "findings".ti,ab OR "result".ti,ab OR "results".ti,ab OR "test".ti,ab OR "tests".ti,ab)) OR generaliza*.ti,ab OR generalisa*.ti,ab OR "concordance".ti,ab OR ("intraclass".ti,ab AND correlation*.ti,ab) OR "discriminative".ti,ab OR "known group".ti,ab OR "factor analysis".ti,ab OR "factor analyses".ti,ab OR "factor structure".ti,ab OR "factor structures".ti,ab OR "dimensionality".ti,ab OR subscale*.ti,ab OR "multitrait scaling analysis".ti,ab OR "multitrait scaling analyses".ti,ab OR "item discriminant".ti,ab OR "interscale correlation".ti,ab OR "interscale correlations".ti,ab OR ("error".ti,ab OR "errors".ti,ab AND (measure*.ti,ab OR correlat*.ti,ab OR evaluat*.ti,ab OR "accuracy".ti,ab OR "accurate".ti,ab OR "precision".ti,ab OR "mean".ti,ab)) OR "individual variability".ti,ab OR "interval variability".ti,ab OR "rate variability".ti,ab OR "variability analysis".ti,ab OR ("uncertainty".ti,ab AND ("measurement".ti,ab OR "measuring".ti,ab)) OR "standard error of measurement".ti,ab OR sensitiv*.ti,ab OR responsive*.ti,ab OR ("limit".ti,ab AND "detection".ti,ab) OR "minimal detectable concentration".ti,ab OR interpretab*.ti,ab OR (small*.ti,ab AND ("real".ti,ab OR "detectable".ti,ab) AND ("change".ti,ab OR "difference".ti,ab)) OR "meaningful change".ti,ab OR "minimal important change".ti,ab OR "minimal important difference".ti,ab OR "minimally important change".ti,ab OR "minimally important difference".ti,ab OR "minimal detectable change".ti,ab OR "minimal detectable difference".ti,ab OR "minimally detectable change".ti,ab OR "minimally detectable difference".ti,ab OR "minimal real change".ti,ab OR "minimal real difference".ti,ab OR "minimally real change".ti,ab OR "minimally real difference".ti,ab OR "ceiling effect".ti,ab OR "floor effect".ti,ab OR "item response model".ti,ab OR "irt".ti,ab OR "rasch".ti,ab OR "differential item functioning".ti,ab OR "dif".ti,ab OR "computer adaptive testing".ti,ab OR "item bank".ti,ab OR "cross-cultural equivalence".ti,ab OR exp Comparative Study/ OR "Outcome assessment"/ OR outcome assessment.mp OR outcome measure*.mp OR exp "Health Status Indicators"/ OR homogeneity.ti,ab OR homogeneous.ti,ab)

NOT

("editorial"/ OR "letter"/ OR conference abstract.pt OR conference review.pt) NOT (exp "Animals"/ NOT exp "humans"/)

Emcare

AND

NOT

("editorial"/ OR "letter"/ OR conference abstract.pt OR conference review.pt) NOT (exp "Animals"/ NOT exp "humans"/)

Cochrane

((("Decision Making" OR decision making OR decisionmaking) AND ("doctor patient relation" OR "nurse patient relationship" OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR "Patient participation" OR Patient Participation OR patients participation OR patient's participation OR patient involvement OR patients involvement OR patient's involvement OR consultation* OR encounter)) OR shared decision OR shared decisions OR shared decisionmaking OR SDM OR Shared medical decision OR Shared treatment decision OR Shared medical decisions OR Shared treatment decisions OR Shared clinical decision OR Shared clinical decisions)

AND

("Health Care Survey" OR "Outcome Assessment" OR "Questionnaire" OR scale OR scale OR scales OR scales OR instrument OR instrument OR instruments OR instruments OR questionnaire OR questionnaire OR questionnaires OR questionnaires OR survey OR survey OR surveys OR surveys OR assess* OR assess* OR coding scheme OR coding scheme OR coding schemes OR codingscheme OR codingscheme OR codingschemes OR codingschemes OR rating OR rating OR ratings OR ratings OR selfreport OR selfreport OR self report OR self report OR selfreports OR selfreports OR self reports OR self reports OR "self report" OR "Checklist" OR measure OR measure OR measures OR measures OR "Observation" OR observation OR observation OR observations OR observations)

AND

("intermethod comparison" OR "data collection method" OR "validation study" OR "feasibility study" OR "pilot study" OR "psychometry" OR "reproducibility" OR reproducib* OR "audit" OR psychometr* OR clinimetr* OR clinometr* OR "observer variation" OR "observer variation" OR "discriminant analysis" OR "validity" OR reliab* OR valid* OR "coefficient" OR "internal consistency" OR (cronbach* AND ("alpha" OR "alphas")) OR "item correlation" OR "item correlations" OR "item selection" OR "item selections" OR "item reduction" OR "item reductions" OR "agreement" OR "precision" OR "imprecision" OR "precise values" OR "test-retest" OR ("test" AND "retest") OR (reliab* AND ("test" OR "retest")) OR "stability" OR "interrater" OR "inter-rater" OR "intrarater" OR "intra-rater" OR "intertester" OR "inter-tester" OR "intratester" OR "intra-tester" OR "interobeserver" OR "inter-observer" OR "intraobserver" OR "intra-observer" OR "intertechnician" OR "inter-technician" OR "intratechnician" OR "intra-technician" OR "interexaminer" OR "inter-examiner" OR "intraexaminer" OR "intra-examiner" OR "interassay" OR "inter-assay" OR "intraassay" OR "intra-assay" OR "interindividual" OR "inter-individual" OR "intraindividual" OR "intra-individual" OR "interparticipant" OR "inter-participant" OR "intraparticipant" OR "intra-participant" OR "kappa" OR "kappas" OR "coefficient of variation" OR repeatab* OR (replicab* OR "repeated" AND ("measure" OR "measures" OR "findings" OR "result" OR "results" OR "test" OR "tests")) OR generaliza* OR generalisa* OR "concordance" OR ("intraclass" AND correlation*) OR "discriminative" OR "known group" OR "factor analysis" OR "factor analyses" OR "factor structure" OR "factor structures" OR "dimensionality" OR subscale* OR "multitrait scaling analysis" OR "multitrait scaling analyses" OR "item discriminant" OR "interscale correlation" OR "interscale correlations" OR ("error" OR "errors" AND (measure* OR correlat* OR evaluat* OR "accuracy" OR "accurate" OR "precision" OR "mean")) OR "individual variability" OR "interval variability" OR "rate variability" OR "variability analysis" OR ("uncertainty" AND ("measurement" OR "measuring")) OR "standard error of measurement" OR sensitiv* OR responsive* OR ("limit" AND "detection") OR "minimal detectable concentration" OR interpretab* OR (small* AND ("real" OR "detectable") AND ("change" OR "difference")) OR "meaningful change" OR "minimal important change" OR "minimal important difference" OR "minimally important change" OR "minimally important difference" OR "minimal detectable change" OR "minimal detectable difference" OR "minimally detectable change" OR "minimally detectable difference" OR "minimal real change" OR "minimal real difference" OR "minimally real change" OR "minimally real difference" OR "ceiling effect" OR "floor effect" OR "item response model" OR "irt" OR "rasch" OR "differential item functioning" OR "dif" OR "computer adaptive testing" OR "item bank" OR "cross-cultural equivalence" OR Comparative Study OR "Outcome assessment" OR outcome assessment OR outcome measure* OR "Health Status Indicators" OR homogeneity OR homogeneous)

PsycINFO

TI(((("Decision Making" OR decision making OR decisionmaking) AND ("doctor patient relation" OR "nurse patient relationship" OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR "Patient participation" OR Patient Participation OR patients participation OR patient's participation OR patient involvement OR patients involvement OR patient's involvement OR consultation* OR encounter)) OR shared decision OR shared decisions OR shared decisionmaking OR SDM OR Shared medical decision OR Shared treatment decision OR Shared medical decisions OR Shared treatment decisions OR Shared clinical decision OR Shared clinical decisions)

AND

SU(((("Decision Making" OR decision making OR decisionmaking) AND ("doctor patient relation" OR "nurse patient relationship" OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR "Patient participation" OR Patient Participation OR patients participation OR patient's participation OR patient involvement OR patients involvement OR patient's involvement OR consultation* OR encounter)) OR shared decision OR shared decisions OR shared decisionmaking OR SDM OR Shared medical decision OR Shared treatment decision OR Shared medical decisions OR Shared treatment decisions OR Shared clinical decision OR Shared clinical decisions)

AND

MA(((("Decision Making" OR decision making OR decisionmaking) AND ("doctor patient relation" OR "nurse patient relationship" OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR "Patient participation" OR Patient Participation OR patients participation OR patient's participation OR patient involvement OR patients involvement OR patient's involvement OR consultation* OR encounter)) OR shared decision OR shared decisions OR shared decisionmaking OR SDM OR Shared medical decision OR Shared treatment decision OR Shared medical decisions OR Shared treatment decisions OR Shared clinical decision OR Shared clinical decisions)

AND

(AB(((("Decision Making" OR decision making OR decisionmaking) AND ("doctor patient relation" OR "nurse patient relationship" OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR "Patient participation" OR Patient Participation OR patients participation OR patient's participation OR patient involvement OR patients involvement OR patient's involvement OR consultation* OR encounter)) OR shared decision OR shared decisions OR shared decisionmaking OR SDM OR Shared medical decision OR Shared treatment decision OR Shared medical decisions OR Shared treatment decisions OR Shared clinical decision OR Shared clinical decisions)

AND

"Health Care Survey" OR "Outcome Assessment" OR "Questionnaire" OR scale OR scale OR scales OR scales OR instrument OR instrument OR instruments OR instruments OR questionnaire OR questionnaire OR questionnaires OR questionnaires OR survey OR survey OR surveys OR surveys OR assess* OR assess* OR coding scheme OR coding scheme OR coding schemes OR codingscheme OR codingscheme OR codingschemes OR codingschemes OR rating OR rating OR ratings OR ratings OR selfreport OR selfreport OR self report OR self report OR selfreports OR selfreports OR self reports OR self reports OR "self report" OR "Checklist" OR measure OR measure OR measures OR measures OR "Observation" OR observation OR observation OR observations OR observations

"intermethod comparison" OR "data collection method" OR "validation study" OR "feasibility study" OR "pilot study" OR "psychometry" OR "reproducibility" OR reproducib* OR "audit" OR psychometr* OR clinimetr* OR clinometr* OR "observer variation" OR "observer variation" OR "discriminant analysis" OR "validity" OR reliab* OR valid* OR "coefficient" OR "internal consistency" OR (cronbach* AND ("alpha" OR "alphas")) OR "item correlation" OR "item correlations" OR "item selection" OR "item selections" OR "item reduction" OR "item reductions" OR "agreement" OR "precision" OR "imprecision" OR "precise values" OR "test-retest" OR ("test" AND "retest") OR (reliab* AND ("test" OR "retest")) OR "stability" OR "interrater" OR "inter-rater" OR "intrarater" OR "intra-rater" OR "intertester" OR "inter-tester" OR "intratester" OR "intra-tester" OR "interobeserver" OR "inter-observer" OR "intraobserver" OR "intra-observer" OR "intertechnician" OR "inter-technician" OR "intratechnician" OR "intra-technician" OR "interexaminer" OR "inter-examiner" OR "intraexaminer" OR "intra-examiner" OR "interassay" OR "inter-assay" OR "intraassay" OR "intra-assay" OR "interindividual" OR "inter-individual" OR "intraindividual" OR "intra-individual" OR "interparticipant" OR "inter-participant" OR "intraparticipant" OR "intra-participant" OR "kappa" OR "kappas" OR "coefficient of variation" OR repeatab* OR (replicab* OR "repeated" AND ("measure" OR "measures" OR "findings" OR "result" OR "results" OR "test" OR "tests")) OR generaliza* OR generalisa* OR "concordance" OR ("intraclass" AND correlation*) OR "discriminative" OR "known group" OR "factor analysis" OR "factor analyses" OR "factor structure" OR "factor structures" OR "dimensionality" OR subscale* OR "multitrait scaling analysis" OR "multitrait scaling analyses" OR "item discriminant" OR "interscale correlation" OR "interscale correlations" OR ("error" OR "errors" AND (measure* OR correlat* OR evaluat* OR "accuracy" OR "accurate" OR "precision" OR "mean")) OR "individual variability" OR "interval variability" OR "rate variability" OR "variability analysis" OR ("uncertainty" AND ("measurement" OR "measuring")) OR "standard error of measurement" OR sensitiv* OR responsive* OR ("limit" AND "detection") OR "minimal detectable concentration" OR interpretab* OR (small* AND ("real" OR "detectable") AND ("change" OR "difference")) OR "meaningful change" OR "minimal important change" OR "minimal important difference" OR "minimally important change" OR "minimally important difference" OR "minimal detectable change" OR "minimal detectable difference" OR "minimally detectable change" OR "minimally detectable difference" OR "minimal real change" OR "minimal real difference" OR "minimally real change" OR "minimally real difference" OR "ceiling effect" OR "floor effect" OR "item response model" OR "irt" OR "rasch" OR "differential item functioning" OR "dif" OR "computer adaptive testing" OR "item bank" OR "cross-cultural equivalence" OR Comparative Study OR "Outcome assessment" OR outcome assessment OR outcome measure* OR "Health Status Indicators" OR homogeneity OR homogeneous)))

Web of science

(TI = ((("Decision Making" OR decision making OR decisionmaking) AND ("doctor patient relation" OR "nurse patient relationship" OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR "Patient participation" OR Patient Participation OR patients participation OR patient's participation OR patient involvement OR patients involvement OR patient's involvement OR consultation* OR encounter)) OR shared decision OR shared decisions OR shared decisionmaking OR SDM OR Shared medical decision OR Shared treatment decision OR Shared medical decisions OR Shared treatment decisions OR Shared clinical decision OR Shared clinical decisions)

AND

TI = ("Health Care Survey" OR "Outcome Assessment" OR "Questionnaire" OR scale OR scale OR scales OR scales OR instrument OR instrument OR instruments OR instruments OR questionnaire OR questionnaire OR questionnaires OR questionnaires OR survey OR survey OR surveys OR surveys OR assess* OR assess* OR coding scheme OR coding scheme OR coding schemes OR codingscheme OR codingscheme OR codingschemes OR codingschemes OR rating OR rating OR ratings OR ratings OR selfreport OR selfreport OR self report OR self report OR selfreports OR selfreports OR self reports OR self reports OR "self report" OR "Checklist" OR measure OR measure OR measures OR measures OR "Observation" OR observation OR observation OR observations OR observations)

AND

TS = ("intermethod comparison" OR "data collection method" OR "validation study" OR "feasibility study" OR "pilot study" OR "psychometry" OR "reproducibility" OR reproducib* OR "audit" OR psychometr* OR clinimetr* OR clinometr* OR "observer variation" OR "observer variation" OR "discriminant analysis" OR "validity" OR reliab* OR valid* OR "coefficient" OR "internal consistency" OR (cronbach* AND ("alpha" OR "alphas")) OR "item correlation" OR "item correlations" OR "item selection" OR "item selections" OR "item reduction" OR "item reductions" OR "agreement" OR "precision" OR "imprecision" OR "precise values" OR "test-retest" OR ("test" AND "retest") OR (reliab* AND ("test" OR "retest")) OR "stability" OR "interrater" OR "inter-rater" OR "intrarater" OR "intra-rater" OR "intertester" OR "inter-tester" OR "intratester" OR "intra-tester" OR "interobeserver" OR "inter-observer" OR "intraobserver" OR "intra-observer" OR "intertechnician" OR "inter-technician" OR "intratechnician" OR "intra-technician" OR "interexaminer" OR "inter-examiner" OR "intraexaminer" OR "intra-examiner" OR "interassay" OR "inter-assay" OR "intraassay" OR "intra-assay" OR "interindividual" OR "inter-individual" OR "intraindividual" OR "intra-individual" OR "interparticipant" OR "inter-participant" OR "intraparticipant" OR "intra-participant" OR "kappa" OR "kappas" OR "coefficient of variation" OR repeatab* OR (replicab* OR "repeated" AND ("measure" OR "measures" OR "findings" OR "result" OR "results" OR "test" OR "tests")) OR generaliza* OR generalisa* OR "concordance" OR ("intraclass" AND correlation*) OR "discriminative" OR "known group" OR "factor analysis" OR "factor analyses" OR "factor structure" OR "factor structures" OR "dimensionality" OR subscale* OR "multitrait scaling analysis" OR "multitrait scaling analyses" OR "item discriminant" OR "interscale correlation" OR "interscale correlations" OR ("error" OR "errors" AND (measure* OR correlat* OR evaluat* OR "accuracy" OR "accurate" OR "precision" OR "mean")) OR "individual variability" OR "interval variability" OR "rate variability" OR "variability analysis" OR ("uncertainty" AND ("measurement" OR "measuring")) OR "standard error of measurement" OR sensitiv* OR responsive* OR ("limit" AND "detection") OR "minimal detectable concentration" OR interpretab* OR (small* AND ("real" OR "detectable") AND ("change" OR "difference")) OR "meaningful change" OR "minimal important change" OR "minimal important difference" OR "minimally important change" OR "minimally important difference" OR "minimal detectable change" OR "minimal detectable difference" OR "minimally detectable change" OR "minimally detectable difference" OR "minimal real change" OR "minimal real difference" OR "minimally real change" OR "minimally real difference" OR "ceiling effect" OR "floor effect" OR "item response model" OR "irt" OR "rasch" OR "differential item functioning" OR "dif" OR "computer adaptive testing" OR "item bank" OR "cross-cultural equivalence" OR Comparative Study OR "Outcome assessment" OR outcome assessment OR outcome measure* OR "Health Status Indicators" OR homogeneity OR homogeneous))

AND

TS = ("Health Care Survey" OR "Outcome Assessment" OR "Questionnaire" OR scale OR scale OR scales OR scales OR instrument OR instrument OR instruments OR instruments OR questionnaire OR questionnaire OR questionnaires OR questionnaires OR survey OR survey OR surveys OR surveys OR assess* OR assess* OR coding scheme OR coding scheme OR coding schemes OR codingscheme OR codingscheme OR codingschemes OR codingschemes OR rating OR rating OR ratings OR ratings OR selfreport OR selfreport OR self report OR self report OR selfreports OR selfreports OR self reports OR self reports OR "self report" OR "Checklist" OR measure OR measure OR measures OR measures OR "Observation" OR observation OR observation OR observations OR observations)

AND

TI = ("intermethod comparison" OR "data collection method" OR "validation study" OR "feasibility study" OR "pilot study" OR "psychometry" OR "reproducibility" OR reproducib* OR "audit" OR psychometr* OR clinimetr* OR clinometr* OR "observer variation" OR "observer variation" OR "discriminant analysis" OR "validity" OR reliab* OR valid* OR "coefficient" OR "internal consistency" OR (cronbach* AND ("alpha" OR "alphas")) OR "item correlation" OR "item correlations" OR "item selection" OR "item selections" OR "item reduction" OR "item reductions" OR "agreement" OR "precision" OR "imprecision" OR "precise values" OR "test-retest" OR ("test" AND "retest") OR (reliab* AND ("test" OR "retest")) OR "stability" OR "interrater" OR "inter-rater" OR "intrarater" OR "intra-rater" OR "intertester" OR "inter-tester" OR "intratester" OR "intra-tester" OR "interobeserver" OR "inter-observer" OR "intraobserver" OR "intra-observer" OR "intertechnician" OR "inter-technician" OR "intratechnician" OR "intra-technician" OR "interexaminer" OR "inter-examiner" OR "intraexaminer" OR "intra-examiner" OR "interassay" OR "inter-assay" OR "intraassay" OR "intra-assay" OR "interindividual" OR "inter-individual" OR "intraindividual" OR "intra-individual" OR "interparticipant" OR "inter-participant" OR "intraparticipant" OR "intra-participant" OR "kappa" OR "kappas" OR "coefficient of variation" OR repeatab* OR (replicab* OR "repeated" AND ("measure" OR "measures" OR "findings" OR "result" OR "results" OR "test" OR "tests")) OR generaliza* OR generalisa* OR "concordance" OR ("intraclass" AND correlation*) OR "discriminative" OR "known group" OR "factor analysis" OR "factor analyses" OR "factor structure" OR "factor structures" OR "dimensionality" OR subscale* OR "multitrait scaling analysis" OR "multitrait scaling analyses" OR "item discriminant" OR "interscale correlation" OR "interscale correlations" OR ("error" OR "errors" AND (measure* OR correlat* OR evaluat* OR "accuracy" OR "accurate" OR "precision" OR "mean")) OR "individual variability" OR "interval variability" OR "rate variability" OR "variability analysis" OR ("uncertainty" AND ("measurement" OR "measuring")) OR "standard error of measurement" OR sensitiv* OR responsive* OR ("limit" AND "detection") OR "minimal detectable concentration" OR interpretab* OR (small* AND ("real" OR "detectable") AND ("change" OR "difference")) OR "meaningful change" OR "minimal important change" OR "minimal important difference" OR "minimally important change" OR "minimally important difference" OR "minimal detectable change" OR "minimal detectable difference" OR "minimally detectable change" OR "minimally detectable difference" OR "minimal real change" OR "minimal real difference" OR "minimally real change" OR "minimally real difference" OR "ceiling effect" OR "floor effect" OR "item response model" OR "irt" OR "rasch" OR "differential item functioning" OR "dif" OR "computer adaptive testing" OR "item bank" OR "cross-cultural equivalence" OR Comparative Study OR "Outcome assessment" OR outcome assessment OR outcome measure* OR "Health Status Indicators" OR homogeneity OR homogeneous))

(TS = ((("Decision Making" OR decision making OR decisionmaking) AND ("doctor patient relation" OR "nurse patient relationship" OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR "Patient participation" OR Patient Participation OR patients participation OR patient's participation OR patient involvement OR patients involvement OR patient's involvement OR consultation* OR encounter)) OR shared decision OR shared decisions OR shared decisionmaking OR SDM OR Shared medical decision OR Shared treatment decision OR Shared medical decisions OR Shared treatment decisions OR Shared clinical decision OR Shared clinical decisions)

AND

Academic Search Premier

AND

KW(((("Decision Making" OR decision making OR decisionmaking) AND ("doctor patient relation" OR "nurse patient relationship" OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR ((Patient) AND (provider OR physician OR professional OR doctor) AND (relation OR relations OR contact OR communication OR interaction OR interactions)) OR "Patient participation" OR Patient Participation OR patients participation OR patient's participation OR patient involvement OR patients involvement OR patient's involvement OR consultation* OR encounter)) OR shared decision OR shared decisions OR shared decisionmaking OR SDM OR Shared medical decision OR Shared treatment decision OR Shared medical decisions OR Shared treatment decisions OR Shared clinical decision OR Shared clinical decisions)

AND

Supporting information

[Figure omitted. See PDF.]

S1 Table. Extracted data.

https://doi.org/10.1371/journal.pone.0191747.s001

(XLSX)

S2 Table. Methodological quality and quality of measurement properties of each article per measurement property and instrument version.

Note: Measurement error is not presented as one of the measurement properties because it has not been evaluated in any of the articles. M = result of the methodological quality appraisal with a score on the 4-point rating scale based on the COSMIN: poor, fair, good, excellent R = result of the quality of measurement property appraisal with three possible categories: + = positive,? = inconclusive,— = negative; n.i. = not investigated, n.a. = not applicable, m = missing, CFA = confirmative factor analysis **Reference [43] also presents results of the development and validation for the SMDMQ (Taiwanese), however the results seem the exact same as presented in[42]; reference [43] was therefore left out in the data extraction and analysis and also not included in the number of included articles. ** The negative score is based on hypotheses that were not confirmed because correlations were high instead of medium-sized, thus, hypotheses testing actually showed that there is a strong relationship with instruments measuring the same construct.

https://doi.org/10.1371/journal.pone.0191747.s002

(DOCX)

Acknowledgments

We thank Jan Schoones (Walaeus Library, Leiden University Medical Center, Leiden, the Netherlands) for his assistance in performing the search, Monique Baas (Department of Medical Decision making, Leiden University Medical Center, Leiden, the Netherlands) for her contribution during the selection of eligible studies and Dr. C.B. Terwee (Department of Epidemiology and Biostatistics and the EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands) for her advice on questions concerning the interpretation and application of the COSMIN guidelines.

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© 2018 Gärtner et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

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Objective

To inventory instruments assessing the process of shared decision making and appraise their measurement quality, taking into account the methodological quality of their validation studies.

Methods

Results

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Title

The quality of instruments to assess the process of shared decision making: A systematic review

Author

Gärtner, Fania R; Hanna Bomhof-Roordink; Smith, Ian P; Scholl, Isabelle; Stiggelbout, Anne M; Pieterse, Arwen H

First page

e0191747

Section

Research Article

Publication year

2018

Publication date

Feb 2018

Publisher

Public Library of Science

e-ISSN

19326203

Source type

Scholarly Journal

Language of publication

English

DOI

https://doi.org/10.1371/journal.pone.0191747

ProQuest document ID

2002481305

The quality of instruments to assess the process of shared decision making: A systematic review

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