Psychometric properties of medication adherence instruments in cardiovascular diseases and type 2 diabetes mellitus: a systematic review and meta-analysis

doi:10.21203/rs.3.rs-1859260/v1

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Research Article

Psychometric properties of medication adherence instruments in cardiovascular diseases and type 2 diabetes mellitus: a systematic review and meta-analysis

https://doi.org/10.21203/rs.3.rs-1859260/v1

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published 22 Nov, 2023

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Background

Medication adherence has a major impact on reducing mortality and healthcare costs related to the treatment of cardiovascular diseases and diabetes mellitus. The task of selecting the best PROM among the many available for this kind of patient is extremely important. This study aims to critically assess, compare and synthesize the quality of the measurement properties of patient-reported outcome measures to access medication adherence among patients with cardiovascular diseases and/or type 2 diabetes mellitus.

Methods

This review followed the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. The searches were performed in Web of Science, SCOPUS, PubMed, CINAHL, EMBASE, LILACS, PsycINFO, and ProQuest (gray literature).

Results

A total of 94 records including 24 different PROMs were included in the review. The records were published between 1986 and 2020, most of them were conducted in the United States, and in English language. The only PROM that reached the criteria of category A, e.g., that can be recommended for use and results obtained can be trusted is the ProMAS. The PROMs that shouldn’t be recommended for use (category “c”) are the MTA, LMAS-14, GMAS, MEDS, MNPS, MALMAS, ARMS-D, DOSE-Nonadherence, MGT, MARS-5, and A-14. The remaining PROMs, e.g., MMAS-8, SMAQ, DMAS-7, ARMS-12, MTA-OA, MTA-Insulin, ARMS-10, IADMAS, MAQ, MMAS-5, ARMS-7, and 5-item questionnaire were considered as having the potential to be recommended for use (category “b”).

Conclusion

ProMAS is the only PROM that could be considered trusted and recommended for use for patients with cardiovascular diseases and/or type 2 diabetes mellitus. However, another 12 PROMs has the potential to be recommended for use but need further studies to ensure their quality, according to COSMIN guideline for systematic reviews of PROMs.

Systematic review registration

PROSPERO CRD42019129109.

Medication adherence

Cardiovascular diseases

Diabetes mellitus

type 2

Patient reported outcome measures

Reproducibility of results

Psychometrics

Medication adherence has a major impact on reducing mortality and healthcare costs related to the treatment of noncommunicable diseases (NCDs), especially cardiovascular diseases (CVDs) and diabetes mellitus [1, 2].

Data from 2019 by the World Health Organization (WHO) shows that 7 of the top 10 causes of death in the world are noncommunicable diseases (NCDs) [3]. Ischaemic heart disease is the leading cause of death and the top 10 causes of death also include stroke, hypertensive heart disease, and diabetes mellitus [4]. The United Nations General Assembly established as a target for 2030 the reduction by one-third premature mortality from NCDs [5].

Since many patients do not adhere to treatment [6] it is paramount to measure medication adherence properly and take actions that increase patient’s adherence. Measure medication adherence is challenging because medication adherence behavior is complex, multifactorial, and influenced by different psychosocial variables such as motivation, self-efficacy, beliefs, and perceived barriers [7].

One of the most practical and low-cost ways to measure medication adherence is through the application of patient-reported outcome measures (PROMs). The task of selecting the best PROM among the many available for this kind of patient [8, 9] needs to take into account its conceptual structure and measurement properties.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative has recently published a guideline for conducting systematic reviews of studies evaluating the measurement properties of PROMs [10]. This guideline proposes the criteria to assess studies' methodological quality on measurement properties and the quality of the self-reported measurement itself.

No systematic review was found in the literature evaluating the quality of the measurement properties of medication adherence PROMs, according to COSMIN guidelines specifically in patients with CVDs and/or type 2 diabetes mellitus (T2DM).

Therefore, this systematic review aims to critically assess, compare, and synthesize the PROMs' quality properties for medication adherence assessment among patients with CVDs and/or T2DM.

Protocol development

This systematic review was reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) [11] (checklist available in Additional file 1) and the COSMIN guideline for systematic reviews of PROMs [10]. The protocol of this review was registered in the International Prospective Register of Systematic Reviews (PROSPERO CRD42019129109) and published in a scientific journal [12].

Eligibility criteria

Inclusion criteria:

Studies that aimed to develop or culturally adapt a PROM to assess medication adherence among patients with a CVD and/or T2DM and who were older than 18 years of age, regardless of the language and date of publication;
Studies reporting the assessment of one or more properties of the PROMs.

Exclusion criteria:

Studies in which a PROM was used to measure an outcome (e.g., randomized clinical trials);
Studies in which a PROM was used to validate another measure;
Studies that evaluated the measurement properties of PROMs that aimed to evaluate the factors related to medication adherence (self-efficacy, beliefs, intention, etc.);
Studies that not provided sufficient information on outcomes of interest, even after contacting authors.

Information sources and search strategy

The electronic literature searches were performed in the following databases without time limits: Web of Science, Scopus, PubMed (including Medline), CINAHL, EMBASE, LILACS, PsycINFO, and ProQuest (gray literature). Manual searches were performed in the reference lists of the articles in order to complement the main literature. The search strategy was based on the second version of the search filter for measurement properties proposed by the COSMIN initiative [13] and also included keywords and MeSH terms related to cardiovascular disease, type 2 diabetes mellitus, PROMs, medication adherence, and measurement properties. The search strategy used in each database was elaborated with the support of an experienced librarian and can be found in Additional file 2. The reference management was done in Rayyan QCRI online software [14].

Study selection and data extraction

The study selection was presented according to the PRISMA flow diagram model [11]. The step of evaluation of titles and abstracts followed the exclusion of duplicates was done independently by three pairs of reviewers (HCO, DH, SDLC, RCLB, MLSN, and CRSA) after verifying the inter-reviewer agreement in a 50 papers pilot. The inter-reviewer concordance percentage varied from 96–98% in each pair and it was observed an overall concordance of 94%. Next, the full-text assessment was done independently by two reviewers (HCO and DH). Disagreements were discussed until a consensus was obtained. In a final step, the list of references of the included studies was checked to identify other studies that haven’t been previously selected.

Data were independently extracted by two reviewers (HCO and RCMR) using the extraction form available in the COSMIN manual for systematic reviews of PROMs [15] and also including some other relevant information. The form contains information about the study design, sample size, participants’ demographic and clinical characteristics (gender, age, disease, disease duration, and number of taking medications), response rate, presence of conflicts of interest, funding, setting, country, and language, PROMs number of items and domains, mode of administration, recall period, response options, range of scores, original language, and available translations, number of studies evaluating the PROM, measurement properties (PROM development, content validity, structural validity, internal consistency, cross-cultural validity/measurement invariance, reliability, measurement error, criterion validity, hypothesis testing for construct validity and responsiveness), interpretability and feasibility and information to assess the studies’ methodological quality.

Methodological quality of the studies: risk of bias assessment

The studies' methodological quality was assessed independently by two reviewers (HCO and RCMR), using COSMIN Risk of Bias checklist for systematic reviews of PROMs [16, 17]. This checklist comprises items that assess the methodological quality of studies that evaluated the measurement properties of PROMs. Disagreements were discussed until a consensus was obtained and a third reviewer (NMCA) was consulted when the reviewers were the authors of the paper under evaluation. According to the COSMIN Risk of Bias checklist, items can be rated as 'very good', 'adequate', 'doubtful', 'inadequate', or 'not applicable' (NA) where each measurement property receives an overall rating based on the worst scored item [15, 17].

Quality of the results concerning the measurement properties

The results were assessed independently by two reviewers (HCO and RCMR) considering quality criteria for good measurement properties proposed by COSMIN [15, 17]. Disagreements were discussed until a consensus was obtained. A third reviewer (NMCA) was consulted when the reviewers were the authors of the paper under evaluation. The quality of the measurement properties of each assessed PROM was classified as sufficient (+), insufficient (-), inconsistent (±), or indeterminate (?), according to the criteria proposed [10, 15, 16, 17].

In the evaluation of the exploratory factor analysis (EFA) in structural validity, a different criterion was considered than previously proposed by the COSMIN team [18]. The COSMIN criteria consider a sufficient result in an EFA when the first factor accounts for at least 20% of the variability and the ratio of the variance explained by the first to the second factor is greater than four [18]. Since most PROMs included in our systematic review are one-dimensional, we considered a sufficient result when the total variance explained was at least 60% and when factor loadings were equal to or greater than 0.30 [19]. In addition to the structural feature of PROMS, our decision also considered the recommendation of the COSMIN manual that new criteria be proposed by reviewers if those established by the COSMIN team do not fully meet the evaluation of one or more properties of the measure [15].

In assessing the criterion validity, it was considered that the statistical results obtained in the assessment of the relationship between the PROM and the objective measures would be treated as a criterion validity result.

In the assessment of criterion validity, the statistical results obtained in evaluating the relationship between the PROMs and the objective measures of glycosylated hemoglobin and glycaemia (used to assess metabolic control in DM) and the measures of systolic and diastolic blood pressure (used for pressure control in hypertension) were treated as a result of criterion validity, despite how the authors named such validity in the primary studies.

Statistical analysis

Meta-analysis was performed to pool the results of internal consistency of the PROMs, estimated by Cronbach's alpha coefficient [20]. The analysis were performed considering a random effects model and a significance level of 5%. At first the Cronbach's alphas values of each study were transformed to Fisher's ɀ values according to the following equation [20]:

$$ɀ=1.1513 \left\{{log}_{10} \right[(1+ alpha)/(1- alpha)\left]\right\}$$

The next step was to calculate the average of ɀ weighting according to the sample size of the studies (n_j) [20]:

$$ɀ=\sum \left({n}_{j}-3\right){ɀ}_{j} /\sum \left({n}_{j}-3\right)$$

The final step consisted of the conversion of the average weighted ɀ to the estimative of the pooled Cronbach's alpha coefficient [20]:

$$pooled alpha= ({10}^{\text{ɀ}/1.1513}-1)/({10}^{\text{ɀ}/1.1513}+1)$$

These calculations were performed in the software SPSS 23 considering a SPSS Meta-Analysis Macro [21]. The heterogeneity was evaluated using the Chi-squared test and the I² coefficient.

The meta-analysis was done only for the studies with good methodological quality, i.e. studies classified as adequate or very good. It was intended to apply a meta-analysis to the reliability results, but none of the included studies presented good methodological quality.

Quality of evidence: adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) by COSMIN

The overall quality of evidence of all studies was assessed considering an adaptation of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) proposed by the COSMIN initiative [10]. The quality of the evidence was classified as high, moderate, low, or very low considering the factors: risk of bias, inconsistency (of the results of the studies), imprecision (related to the sample size of the studies), and indirect results (evidence come from the studies that were performed in a different population or context than the ones established in the review) [15].

The risk of bias could be classified as serious, very serious, or extremely serious resulting in the downgrade of 1 to 3 levels, respectively (Table 1) [15].

Table 1

Instructions on downgrading for Risk of Bias
Risk of bias	Downgrading for Risk of Bias
No	There are multiple studies of at least adequate quality, or there is one study of very good quality available
Serious	There are multiple studies of doubtful quality available, or there is only one study of adequate quality
Very serious	There are multiple studies of inadequate quality, or there is only one study of doubtful quality available
Extremely serious	There is only one study of inadequate quality available
Source: Extracted from Mokkink et al., 2018 [15], p. 34.

Regarding the inconsistency, when the reviewers couldn’t find an explanation for inconsistent results observed across the studies, these results are considered inconsistent, consequently, the quality of evidence isn’t applicable. Concerning the imprecision, when the total sample size of the summarized studies is lower than 100 (serious) one level must be downgraded and when it is lower than 50 (very serious) two levels must be downgraded. For the indirectness, the reviewers can downgrade the level of evidence by one or two levels.

Thus, according to the GRADE approach, it was initially assumed that the summarized results were of high quality and, subsequently, downgraded by one or two levels per factor, considering the following aspects: risk of bias, inconsistency, imprecision, or indirect results. When the evidence was based on only one inadequate study (extremely serious risk of bias) quality of evidence was downgraded by three levels [15].

The results were assessed independently by two reviewers (HCO and RCMR). Disagreements were discussed until a consensus was obtained and a third reviewer (NMCA) was consulted when the reviewers were the authors of the paper under evaluation.

Recommendations for selecting a PROM

The review's final stage was the establishment of recommendations to select the most appropriate PROM. PROMs were classified into three categories:

PROMs that presented sufficient content validity and at least low quality of evidence for sufficient internal consistency;
PROMs that are not classified in categories (a) or (c);
PROMs that presented high-quality evidence for an insufficient measurement property.

A PROM that falls under category (a) means it is reliable and can be recommended. A PROM that falls under category (b) means it has the potential to be recommended, though further studies are needed to ensure its quality. A PROM classified under category (c) should not be recommended.

Study selection and data extraction

The results of the selection and data extraction of the studies are presented in the PRISMA flow diagram (Fig. 1). A total of 41,886 records, published between 1973 and June of 2020, were considered potentially eligible and retrieved from eight databases. We removed 14,826 records in the duplicate screening phase. Titles and abstracts of 27,060 records were peer-reviewed screened (a total of three pairs of reviewers participated in the process, which evaluated 9,020 records each). A total of 336 records were retained for full-text assessment and 86 records were included. Furthermore, after manually searching the reference lists of the included studies, eight relevant records were added, totalizing 94 records, and 24 different PROMs were included in the review (Fig. 1).

Study and PROMs characteristics

The included studies were published between 1986 and 2020, and most of them were conducted in the United States in the English language. The sample size of included studies ranged from 31 to 6,261 participants. The percentage of females ranged from 14.0–79.3% and the mean age ranged from 47.0 to 81.9 years. Most of the studies were conducted in the hospital setting (n = 46) and didn’t present information about the disease duration (n = 70) and the number of medications being taken (n = 70).

Of the total 24 PROMs included in the review, most are one-dimensional and composed of items with a Likert-type scale response. Seven PROMs were extracted from a total of 30 studies [22–51] conducted with patients only having TD2M, another seven PROMs were pulled from 46 studies [52–97] with patients only having CVD, and the remaining 10 PROMs were pulled from 18 studies with patients having both, T2DM and/or CVD [98–115]. The most prevalent original language was English and 11 PROMs, which original languages were English, German or Urdu, have been translated to another language (Table 2).

Table 2

PROMs’ characteristics.
PROM	Target population	Recall period	(Sub)scale (s) (number of items)	Response options	Range of scores/scoring	Original language	Available translations
MMAS-8	DM and CVD	1 month	1 (8)	Dichotomous and Likert scale	0 to 8	English	16 languages
SMAQ	DM	NC	1 (6)	Dichotomous	6 to 12	English	1 language
MEDS	DM and CVD	6 months	5 (16)	Likert scale	16 to 80	English	None
MNPS	DM and CVD	1 year	1 (9)	Dichotomous	0 to 9	English	None
DMAS-7	DM	NC	3 (7)	Dichotomous	0 to 7	Arabic	None
ARMS-12	DM and CVD	NC	2 (12)	Likert scale	12 to 48	English	3 languages
MGT	DM and CVD	NC	1 (4)	Dichotomous	0 to 4	English	7 languages
MTA-OA	DM	NC	1 (7)	Likert scale	1 to 6	Portuguese	None
MTA - Insulin	DM	NC	1 (7)	Likert scale	1 to 6	Portuguese	None
LMAS-14	CVD	NC	4 (14)	Likert scale	0 to 42	Arabic	None
MTA	DM and CVD	NC	1 (7)	Likert scale	1 to 6	Portuguese	None
MARS-5	DM and CVD	NC	1 (5)	Likert scale	5 to 25	English	2 languages
A-14	CVD	NC	5 (14)	Likert scale	0 to 56	German	2 languages
ARMS-10	CVD	NC	2 (10)	Likert scale	10 to 40	English	1 language
MALMAS	DM	1 month	1 (8)	Dichotomous and Likert scale	0 to 8	English	1 language
ARMS-D	DM	NC	2 (11)	Likert scale	11 to 44	English	None
IADMAS	DM	NC	1 (8)	Dichotomous and Likert scale	0 to 8	Arabic	None
GMAS	DM and CVD	NC	3 (11)	Likert scale	0 to 33	Urdu	1 language
MAQ	CVD	NC	NC	NC	NC	Kannada, Malayalam	None
MMAS-5	CVD	1 month	1 (5)	Likert scale	No score	English	None

(continuation)

PROM	Target population	Recall period	(Sub)scale (s) (number of items)	Response options	Range of scores/scoring	Original language	Available translations
ProMAS	DM and CVD	NC	1 (18)	Dichotomous	0 to 18	Dutch	None
DOSE-Nonadherence	CVD	7 days	1 (3)	Likert scale	1 to 5	Engllish	1 language
ARMS‐7	DM and CVD	NC	2 (7)	Likert scale	7 to 28	English	1 language
5-item questionnaire	CVD	1 month	1 (5)	Dichotomous	0 to 1	English	None

Note: CVD = Cardiovascular diseases; DM = Diabetes mellitus; NC = Not clear; PROM = Patient-reported outcome measures.

A total of 35 studies reported a response rate for PROMs that ranged from 21.1–99.5%. Out of the 94 records, only 60.6% of the studies presented information about conflict of interests, and 67.0% informed if the research had any source of funding (Additional file 3).

The two reviewers (HCO and RCMR) are authors of one of the included studies [104]. The analysis of this article was done by a third reviewer (NMCA).

Summarized results of the PROMs' measurement properties

The summary of findings of measurement properties of the PROMs is presented in Table 3 and the summary of the risk of bias assessment is available on Additional files 4 and 5. The following are the results according to each of the measurement properties.

Content validity

The content validity resulted in overall ratings per PROM for relevance, comprehensiveness and comprehensibility, and overall content validity of the PROM. The indeterminate ratings for development or content validity studies were ignored in the overall rating assignment. All the PROM development studies were classified as of inadequate methodological quality and because of that none of them were considered in the overall rating assignment. In the development studies, although it has been reported how PROMS items were created, few studies have addressed the theoretical framework on which their creation was based [112, 114, 115]. Similarly, the target population's comprehensibility of the items created has rarely been assessed by cognitive interviews or debriefing [32, 107]. Regarding the quality of evidence, the studies where the results were not considered in the assignment of the overall ratings were also not considered in this step. According to the COSMIN, the criteria for recommending the use of a PROM is based on estimated content validity and at least low quality of evidence for internal consistency. The content validity encompasses the evaluation of aspects such as relevance, comprehensiveness, and comprehensibility of the PROM. The comprehensibility was the most evaluated aspect in the records, but incompletely. The most of the studies asked about comprehensibility of the items [22, 26, 38, 41, 51, 53, 58, 61, 62, 73, 76, 78, 85, 90, 91, 93, 95, 111, 113] but in a few studies the participants were asked about the comprehensibility of response options or recall periods [22, 38, 76, 85, 91, 93]. Relevance and comprehensiveness of PROMS were rarely evaluated among patients [46, 52, 90]. In some aspects the PROM overall rating was based only on the rating of the reviewers. The evaluation of the risk of bias of the development and content validity studies resulted in ratings doubtful or inadequate because some of the criteria evaluated in the COSMIN checklist weren’t clearly described in the records.

The PROM MGT showed moderate-quality evidence for sufficient content validity and the PROMs ARMS-10, MARS-5, ARMS-12, MALMAS, MTA, ARMS-7, MEDS, IADMAS, ProMAS and A-14 showed very low-quality evidence for sufficient content validity. The PROMs MMAS-8, MTA-OA, MTA - Insulin and GMAS showed inconsistent content validity. The remaining PROMs included in the review didn’t have their content validity evaluated in the selected papers.

Structural validity

The EFA was the statistical method most applied in the evaluation of structural validity of the PROMs [23, 25, 29, 31, 33, 34, 38, 40, 41, 44–46, 49, 51–53, 56, 60, 64, 66, 71–73, 78, 85, 93, 101, 103, 105, 107, 109, 111–113] followed by the confirmatory factor analysis [40, 46, 49, 51, 57, 58, 65, 72, 73, 88, 95, 98, 99, 103, 112, 113] and item response theory [22, 29, 77, 114].

Regarding to the assessment of the methodological quality of EFA, some studies were classified as of doubtful quality, since they didn’t report the rotation method used in the analysis [23, 33, 66, 71, 101].

In the evaluation of the EFA, some studies were classified as indeterminate because they didn’t report the percentage of variance explained [23, 29, 33, 34, 66, 78, 101] or the factor loadings [29, 66, 105]. One study didn’t report the results of the indices used to evaluate the confirmatory factor analysis [73] and another study [29] didn’t present the results of the indices of the item response theory analysis.

Some of the PROMs included in this review such as MEDS, MNPS, GMAS, DOSE-Nonadherence, ProMAS, and ARMS-7 showed high-quality evidence for sufficient structural validity. The PROMs such as DMAS-7, LMAS-14, MARS-5, ARMS-10, and ARMS-10 showed moderate-quality evidence for a sufficient structural validity and it was observed a high-quality evidence for insufficient structural validity for the MTA.

However, the structural validity of the MMAS-8, MGT, and the ARMS-12 were classified as inconsistent. The MMAS-8 presented results with one or two-factor solutions and also sufficient, insufficient, and indeterminate ratings. Similarly, the ARMS-12 presented sufficient and insufficient results in two or three-factor solutions, while the MGT presented only one-dimensional solution, but with sufficient, insufficient, and indeterminate ratings. An overall rating indeterminate was attributed to SMAQ, since the only study included for this PROM was classified as indeterminate [23]. The remaining PROMs included in the systematic review didn’t have their structural validity evaluated in the selected records.

Internal consistency

Regarding the analysis of the internal consistency property, the original factor structure of the PROM was considered in order to evaluate if Cronbach's alpha should be calculated for the total scale and or subscales or domains. One included study [76] was classified as of doubtful methodological quality, since the authors excluded four items from the PROM because of the low Cronbach's alpha coefficient obtained, without considering other reliability or validity estimates. In two studies [59, 115] it was not clear the number of the subscales of the PROM and in another two studies, the Cronbach’s alpha was not calculated for each of the subscales [23, 60].

The four PROMs (MEDS, MNPS, ARMS-D, DOSE-Nonadherence, and ProMAS) showed high-quality evidence for sufficient internal consistency. However, it was observed a very low-quality evidence for a sufficient internal consistency for the ARMS-10, while the PROMS such as DMAS-7 and ARMS-7 showed moderate quality evidence for an insufficient internal consistency. The three PROMs (MGT, LMAS-14 and GMAS) showed high quality evidence for an insufficient internal consistency. The internal consistency of the ten PROMs (MMAS-8, SMAQ, ARMS-12, MTA-OA, MTA-Insulin, MTA, A-14, MALMAS, IADMAS, and MAQ) were classified as indeterminate. The remaining PROMs included in the review didn’t have their internal consistency evaluated in the selected papers.

Cross-cultural validity\measurement invariance

The cross-cultural validity\measurement invariance was evaluated only for the MTA in a single included study [57]. The study presented a very good methodological quality and it was observed high-quality evidence for a sufficient cross-cultural validity\measurement invariance.

Reliability

All included studies that evaluated the reliability of PROMs were classified as of doubtful or inadequate methodological quality [27, 28, 32, 35, 39–41, 44, 46, 48, 49, 54, 60–62, 64, 67, 71–73, 78, 79, 82, 88, 90, 101, 103, 107, 111–113] as they didn't provide enough data to address items 4 (“Did the professional(s) administer the measurement without knowledge of scores or values of other repeated measurement(s) in the same patients?”) and 5 (“Did the professional(s) assign scores or determine values without knowledge of the scores or values of other repeated measurement(s) in the same patients?”) of the risk of bias checklist [116].

In addition, some studies [27, 28, 32, 35, 39, 46, 48, 54, 61, 62, 64, 71, 101, 103, 107, 112] used the correlation coefficient instead of the intraclass correlation coefficient (ICC) to evaluate reliability and in other studies [40, 41, 46, 71–73, 78, 101, 111], the measurement conditions (item 3 of the risk of bias – “Were the measurement conditions similar for the repeated measurements – except for the condition being evaluated as a source of variation?”) were considered inadequate.

The analyses applied in the evaluation of the reliability were ICC, kappa and correlation coefficients. The results of some studies were classified as indeterminate because it was calculated a correlation coefficient instead of ICC [27, 28, 32, 35, 39, 46, 48, 54, 61, 62, 64, 71, 101, 103, 107, 112].

ARMS-10 showed low-quality evidence for sufficient reliability. The PROMs MAQ and ARMS-7 showed very low-quality evidence for sufficient reliability. GMAS showed moderate and DOSE-Nonadherence showed low-quality evidence for insufficient reliability. The ARMS-7 showed moderate-quality evidence for an insufficient internal consistency. The reliability of the ARMS-12, MGT, MARS-5, MALMAS, and IADMAS were classified as indeterminate. The reliability of the MMAS-8 was rated as inconsistent.

Criterion validity

The analyses applied in the evaluation of the criterion validity were area under the curve, sensitivity, specificity, and some hypothesis tests. Some of the included studies didn’t report sensitivity and specificity analyses [23, 37, 38, 93, 101, 105, 107, 112, 113] and one study [56] didn’t provide an area under the curve analysis and because of that were classified as of inadequate methodological quality.

The PROMs DMAS-7, GMAS, and 5-item questionnaire showed high-quality evidence for a sufficient criterion validity. The PROMs MMAS-8, MEDS, MNPS, MGT, MTA, MARS-5, MALMAS, ARMS-D, and DOSE-Nonadherence showed high-quality evidence for an insufficient criterion validity. IADMAS, ARMS-12, and LMAS-14 showed moderate, low, and very low-quality evidence for insufficient criterion validity, respectively. SMAQ had its criterion validity classified as indeterminate. The remaining PROMs included in the review didn’t have their criterion validity evaluated in the selected papers.

Hypotheses testing

There were four included studies in which the methodological quality regarding the convergent validity of the PROMs was considered inadequate. In two of them [44, 89], it was rated inadequate because the comparator instrument had insufficient measurement properties. In the other two studies [26, 56], the statistical tests applied were not optimal or appropriate. One study was classified as of indeterminate quality, because the PROMs being correlated were not applied to the same participants [27].

Concerning to the known-groups validity, there was one included study that didn’t report description of the important characteristics of the groups being compared [112].

The analysis applied by the included studies were mainly correlation coefficients, regression models, and comparison and association tests.

The PROMs MMAS-8, MEDS, DMAS-7, ARMS-12, MALMAS, ARMS-D, GMAS, DOSE-Nonadherence, ProMAS, and 5-item questionnaire showed high-quality evidence for a sufficient construct validity. IADMAS and LMAS-14 showed moderate and low-quality evidence for a sufficient construct validity, respectively. MTA - OA and MTA – Insulin showed very low-quality evidence for a sufficient construct validity. The PROMs MGT, MTA, MARS-5 and A-14 showed high-quality evidence for insufficient construct validity. The remaining PROMs included in the review didn’t have their construct validity evaluated in the selected papers.

Responsiveness

Responsiveness was evaluated only for the MMAS-5 in a single study [83]. The study reported a very good methodological quality and it was observed a high-quality evidence for a sufficient responsiveness.

Meta-analysis

Considering the results obtained in the meta-analysis, the PROM GMAS showed high-quality evidence for an insufficient internal consistency. The PROMs MMAS-8, ARMS-12, and MGT were classified as indeterminate because its structural validity was classified as indeterminate. The MTA was classified as indeterminate because its structural validity didn’t show at least low evidence for sufficient structural validity and MALMAS didn’t have its structural validity evaluated in the included studies. It was observed moderate and high I² values [117] for the PROMs MMAS-8, ARMS-12, MGT, and GMAS (Table 4).

Table 4

Summarized results of the meta-analysis, heterogeneity, and quality of evidence of internal consistency of the PROMS included in this analysis.
PROM	Pooled alpha (CI 95%)	Sample size	p-value (χ² test)	I²	Overall rating	Quality of evidence
MMAS-8	0.68 (0.63–0.72)	9,235	< 0.0001	92.24	?	No information
ARMS-12 (subscale 1)	0.91 (0.57–0.98)	714	< 0.0001	99.24	?	No information
ARMS-12 (subscale 2)	0.72 (0.55–0.83)	714	0.0001	93.09	?	No information
MGT	0.59 (0.50–0.67)	8,382	< 0.0001	94.02	?	No information
MTA	0.66 (0.59–0.72)	701	0.1466	47.92	?	No information
MALMAS	0.62 (0.54–0.69)	279	0.4233	0.00	?	No information
GMAS (subscale 1)	0.77 (0.71–0.82)	528	0.0766	61.09	-	High
GMAS (subscale 2)	0.75 (0.65–0.82)	528	0.0088	78.88
GMAS (subscale 3)	0.47 (0.18–0.68)	528	< 0.0001	93.05

Note: CI = Confidence interval; PROM = Patient-reported outcome measures; “−” = Insufficient; “?” = Indeterminate.

Interpretability and Feasibility

It was not possible to identify the information needed to evaluate the interpretability and feasibility in most of the included records. Considering that the evaluation of these aspects would be incomplete because of the lack of information, the reviewers decided to don’t evaluate these aspects.

Recommendations for selecting a PROM

According to the results of our systematic review, the ProMAS was the only PROM that reached the criteria of category “a”, i.e., the results obtained across the studies can be trusted and the PROM can be recommended for use. This PROM was the only one with evidence for sufficient content validity and at least low-quality evidence for sufficient internal consistency.

The PROMs, such as MTA, LMAS-14, GMAS, MEDS, MNPS, MALMAS, ARMS-D, DOSE-Nonadherence, MGT, MARS-5, and A-14, were categorized as not recommended for use (category “c”), because they presented high-quality evidence for at least one insufficient measurement property.

The remaining PROMs, i.e., MMAS-8, SMAQ, DMAS-7, ARMS-12, MTA-OA, MTA-Insulin, ARMS-10, IADMAS, MAQ, MMAS-5, ARMS-7 and 5-item questionnaire were considered as having the potential to be recommended for use (category “b”) because didn’t reach the criteria of the categories “a” or “c”.

This systematic review objective was to critically assess, compare, and synthesize the PROMs' quality properties for medication adherence assessment among patients with CVDs and/or T2DM. The results obtained allowed the identification of which instruments presented the best measurement properties in the population considered in this review. According to the COSMIN guidelines used in this systematic review, of the 24 PROMs extracted from the 94 included studies, only one PROM was recommended for use, 12 PROMs were considered to have the potential to be recommended and 11 PROMs were not recommended for use, as they did not meet the minimum criteria, i.e., demonstrate sufficient content validity and at least low quality of evidence for internal consistency. The summarized results of the meta-analysis and quality of evidence of internal consistency showed that only the GMAS has a high-quality evidence for an insufficient internal consistency.

The findings of this systematic review about summarizing the data on the content validity of medication adherence PROMs showed that there were deficits and high heterogeneity of data in the included studies that investigated this property of the measure. The checklist for evaluation of methodological quality and the criteria for evaluation of the results related to the content validity of the PROMs proposed by the COSMIN initiative [118] are detailed in a large set of items, which were not covered by most of the studies included in the review. The reporting and data on the content validity of the included PROMs were extremely brief, with little information about the procedures performed, which hindered an adequate evaluation of this measurement property.

One difficulty observed in the evaluation of content validity was the absence of information about the evaluation of relevance and comprehensiveness by the Expert Committee, as well as the comprehensibility by the target population, in primary studies. In most of the included studies, it was not informed which one was investigated, and when informed, there was great heterogeneity in the way they were evaluated, implying inconclusive content validity. Our findings are congruent with previous systematic review and meta-analysis that has used the COSMIN guidelines to evaluate the evidence on measurement properties of the Hip disability and Osteoarthritis Outcome Score - Physical function Shortform (HOOS-P) and the Knee Injury and Osteoarthritis Outcome Score Physical function Shortform (KOOS-PS) [119], in which aspects such as the appropriateness of the response options and recall period and the relevance of the construct and context of the use were not evaluated in the primary studies, as it was found in our review.

The internal consistency is an important measurement property that was included as an essential criterion to determine the recommendation for use of the PROM. However, the internal consistency of 11 PROMs of the included studies was rated as indeterminate. These results can be explained by the absence of at least low evidence for sufficient structural validity for these PROMS or because the structural validity of these measures was not performed in the included studies. The results of the meta-analysis and quality of evidence of internal consistency of the six PROMS included in this analysis showed that only the GMAS has high-quality evidence for an insufficient internal consistency, while the other five PROMs showed indeterminate results

In the evaluation of the structural validity, the PROMs MMAS-8, ARMS-12, and MGT were rated as inconsistent. This rating was attributed because it was observed different factor solutions, i.e., different number of factors across the included records. Furthermore, five PROMs (ARMS-12, MGT, MARS-5, MALMAS, and IADMAS) had their reliability rated as inconsistent because the results of the included records it wasn’t presented the results of the expected coefficients, i.e., ICC or Kappa, for the evaluation of this measurement property.

As previously described, in the evaluation of the criterion validity, the review team considered that the obtained statistical results in the assessment of the relation between the PROMs and objective measures should be treated as a result of criterion validity, despite how the authors considered it in the study. The reviewers considered that this change in the evaluation of the results would be beneficial as it would produce a standardization in the assessments. The findings showed that most of the evaluated PROMs presented an insufficient criterion validity and a sufficient overall rating in the hypothesis testing evaluation.

Another measurement property that had its evaluation compromised was the reliability. As mentioned before some items of the checklist for evaluation of the methodological quality weren’t described in the included studies which resulted in studies being rated as doubtful or inadequate methodological quality.

The evaluation of the measurement properties of the PROM’s included in this review indicated that only the ProMAS could be considered trusted and recommended for use according to the criteria proposed by the COSMIN initiative. However, the interpretation of this finding must consider a few points: the first point is related to the complexity of the medication adherence construct itself, which has challenged researchers in obtaining a PROM with good measurement properties [7]. The second aspect refers to the number of included studies in which each selected PROM was used. The evaluation of the measurement properties of a given PROM in several studies included in this review contributed to some measurement properties being rated as indeterminate because of the observed heterogeneity in the results of that PROM. The MMAS-8, for example, was the PROM for which measurement properties were evaluated in 37 studies included in this review. On the other hand, the PRoMAS’ measurement properties were evaluated in only two studies. The other aspect that had a huge impact on the results was the evaluation of content validity, since this was one of the major gaps in the measurement properties of the medication adherence instruments, due to the scarcity of data in primary studies, as previously mentioned.

One of the strengths of this systematic review was the careful application of the methodology proposed by the COSMIN initiative for the conduction of the systematic reviews in the evaluation of measurement properties of PROMs [15]. Another strength is the number of databases included in the literature searches which contributed to a more complete result. The review team also should be highlighted because it was composed of professionals from different areas including nurses, a statistician, and also from other areas which contributed to a better evaluation of the studies.

A limitation of our study can be first considered the elevated number of retrieved studies in the database searches. The search strategy used in this systematic review has been proved to don’t be specific enough. Another limitation was the lack of information needed in many studies to evaluate some measurement properties, especially the content validity. This characteristic observed in the studies hampered the evaluation of many PROMs which resulted in many of them being poorly evaluated.

In conclusion, our systematic review showed that the construct of medication adherence is difficult to measure as most of the PROMs evaluated didn’t present enough results to be considered trusted and recommended for use. The results indicated that the future studies of the properties of the PROMS measures must have a more detailed description of the results, mainly the content validity.

The conclusion of this systematic review is that ProMAS is the only PROM that could be considered trusted and recommended for use for patients with cardiovascular diseases and/or type 2 diabetes mellitus. However, another 12 PROMs have the potential to be recommended for use but need further studies to ensure their quality, according to COSMIN guidelines for systematic reviews of PROMs. Furthermore, the findings showed that it is key to improve the reporting of results in PROM validation studies, especially with regard to content validity.

ARMS: Adherence to Refills and Medication Scale; AUC: Area under the curve; CFA: Confirmatory factor analysis; CINAHL: Cumulative index to nursing and allied health literature; COSMIN: Consensus-based standards for the selection of health measurement instruments; CVDs: Cardiovascular diseases; DMAS-7: 7-item Diabetes Medication Adherence Scale; DOSE-Nonadherence: Domains of Subjective Extent of Nonadherence; EFA: Exploratory factor analysis; EMBASE: Excerpta medica database; GMAS: General Medication Adherence Scale; GRADE: Grading of recommendations assessment, development, and evaluation; HOOS-P: Hip disability and osteoarthritis outcome score - physical function shortform; IADMAS: Iraqi Anti-Diabetic Medication Adherence Scale; ICC: Intraclass correlation coefficient; IRT: Item response theory; KOOS-PS: Knee injury and osteoarthritis outcome score physical function shortform; LILACS: Literatura latino-americana e do Caribe em ciências da saúde; LMAS-14: Fourteen-item Lebanese Medication Adherence Scale; MALMAS: Malaysian Medication Adherence Scale; MAQ: Medication Adherence Questionnaire; MARS-5: 5-item Medication Adherence Report Scale; MEDS: Medication Adherence Estimation and Differentiation Scale; MGT: Morisky-Green test; MMAS-8: 8-item Morisky Medication Adherence Scale; MNPS: Medication Non-persistence Scale; MTA: Measurement of Treatment Adherence; MTA-Insulin: Measurement of Treatment Adherence - Insulin; MTA-OA: MTA-Oral Antidiabetics; NCDs: Noncommunicable diseases; NPV: Negative predictive value; ProMAS: Probabilistic Medication Adherence Scale; PPV: Positive predictive value; PRISMA: Preferred reporting items for systematic review and meta-analysis; PROMs: Patient-reported outcome measures; PROSPERO: International prospective register of systematic reviews; SMAQ: Simplified Medication Adherence Questionnaire; T2DM: Type 2 diabetes mellitus; WHO: World Health Organization

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors have no competing interests to declare.

Funding

The authors acknowledge the following financial support: Fundo de Apoio ao Ensino, Pesquisa e Extensão - FAEPEX, University of Campinas – Unicamp, São Paulo, Brazil (grant: 3056/18; No. 519.292), Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq (grant No. 312367/2017-1), and Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) – Finance Code 001 - PrInt - Programa Institucional de Internacionalização (Process number: 23038.016333/2017-85).

Authors' contributions

The authors HCO, NMCA and RCMR conceived and developed this research. PABR contributed to the methodological design, analysis, and review of the manuscript. HCO, DHN, SDLC, RCLB, CRSA and MLSN evaluated the titles and abstracts. Full-text assessment was done by HCO and DH. Data extraction, risk of bias and results assessment were done by HCO and RCMR. All authors contributed to the improvement, revised and approved the final manuscript.

Acknowledgements

We would like to thank the Fundo de Apoio ao Ensino, Pesquisa e Extensão - FAEPEX, University of Campinas – Unicamp, Conselho Nacional de Desenvolvimento Científico e Tecnológico – CNPq, and Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) – Finance Code 001 - PrInt - Programa Institucional de Internacionalização for the funding support to this research.

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Psychometric properties of medication adherence instruments in cardiovascular diseases and type 2 diabetes mellitus: a systematic review and meta-analysis

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Background

Methods

Protocol development

Eligibility criteria

Information sources and search strategy

Study selection and data extraction

Methodological quality of the studies: risk of bias assessment

Quality of the results concerning the measurement properties

Statistical analysis

Quality of evidence: adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) by COSMIN

Recommendations for selecting a PROM

Results

Study selection and data extraction

Study and PROMs characteristics

Summarized results of the PROMs' measurement properties

Content validity

Structural validity

Internal consistency

Cross-cultural validity\measurement invariance

Reliability

Criterion validity

Hypotheses testing

Responsiveness

Meta-analysis

Interpretability and Feasibility

Recommendations for selecting a PROM

Discussion

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