In an attempt to curtail the rising morbidity and mortality from undiagnosed HCV (hepatitis C virus) in the United States, screening guidelines have been expanded to high-risk individuals and persons born 1945–1965. Community-based screening may be one strategy in which to reach such persons; however, the acceptance of HCV testing, when many high-risk individuals may not have access to HCV specific medications, remains unknown.
We set out to assess attitudes about HCV screening and knowledge about HCV disease at several community-based testing sites that serve high-risk populations. This assessment was paired with a brief HCV educational intervention, followed by post-education evaluation.
Participants (n = 140) were surveyed at five sites; two homeless shelters, two drug rehabilitation centers, and a women’s "drop-in" center. Personal acceptance of HCV testing was almost unanimous, and 90% of participants reported that they would still want to be tested even if they were unable to receive HCV treatment. Baseline hepatitis C knowledge was poor; however, the brief educational intervention significantly improved knowledge and increased acceptability of testing when medical access issues were explicitly stated.
Despite inconsistencies in access to care and treatment, high-risk communities want to know their HCV status. Though baseline HCV knowledge was poor in this population, a brief on-site educational intervention improved both knowledge and acceptability of HCV testing and care. These data support the establishment of programs that utilize community-based screening, and also provide initial evidence for acceptance of the implementation of the recently expanded screening guidelines among marginalized communities.
Health knowledge; Attitudes; Behaviors; Healthcare disparities; Hepatitis C; Patient education; Screening
Self-report measures of medication nonadherence confound the extent of and reasons for medication nonadherence. Each construct is assessed with a different type of psychometric model, which dictates how to establish reliability and validity.
To evaluate the psychometric properties of a self-report measure of medication nonadherence that assesses separately the extent of nonadherence and reasons for nonadherence.
Cross sectional survey involving the new measure and comparison measures to establish convergent, discriminant, and concurrent validity. The new measure was re-administered 2 to 21 days later.
202 veterans with treated hypertension were recruited from the Durham Veterans Affairs Medical Center.
A new self-report measure assessed the extent of nonadherence and reasons for nonadherence. Comparison measures included self-reported medication self-efficacy, beliefs about medications, impression management, conscientiousness, habit strength, and an existing nonadherence measure.
Three items assessing the extent of nonadherence produced reliable scores for this sample, alpha=0.84 (95% CI: 0.80, 0.87). Correlations with comparison measures provided evidence of convergent and discriminant validity. Correlations with systolic (r=0.27, p<.0001) and diastolic (r=0.27, p<.0001) blood pressure provided evidence of concurrent validity. Reasons for nonadherence was assessed with 21 independent items. Intraclass correlations (ICC) were 0.58 for the extent score and ranged from 0.07 to 0.64 for the reasons.
The dual conceptualization of medication nonadherence allowed a stronger evaluation of the reliability and validity than was previously possible with measures that confounded these two constructs. Measurement of self-reported nonadherence consistent with psychometric principles will enable reliable, valid evaluation of interventions to reduce nonadherence.
adherence; reliability; scale development; self-report
Dosing is potentially the most important decision that must be made when building or refining behavioral interventions. In this paper, we propose standardized terminology and reporting of dosing information, which would inform intervention development, refinement for dissemination, and systematic reviews of dose-response relationships. Dosing of interventions may be characterized by duration, frequency, and amount. To illustrate the value of operationalizing these three parameters to evaluate dose-response relationships, 31 published reports of behavioral interventions to increase adherence to antiretroviral therapy (ART) were reviewed. The ART literature was characterized by under-reporting of dosing parameters, heterogeneity in dosing schedules, and heterogeneity in type of control group, which complicate analysis of dose-response relationships in systematic review and determination of the optimal dose for intervention dissemination. Improved reporting of the three dosing parameters and comparison of intended to actual delivery can inform the identification of the most effective intervention doses and the efficient implementation of efficacious interventions in clinical practice.
clinical trial; randomized controlled trial; study characteristics; intervention studies; patient adherence; intervention dose
Medication nonadherence is a significant clinical problem in chronic disease management. Self-report measures have inadequate reliability and poor distributional properties. We demonstrate how two fundamental measurement issues have limited the usefulness of self-reported medication nonadherence measures and offer recommendations for improving measurement.
Study Design and Methods
We reviewed existing self-report measures of medication nonadherence in the context of hypertension, one of the most common chronic conditions in which medication nonadherence is a paramount concern. We evaluated these measures with regard to two issues: (1) conflation of causal indicators (which give rise to a latent construct) and effect indicators (which are determined by a latent construct), and (2) a lack of evidence regarding the stability of nonadherence over time.
Nonadherence measurement could be improved by using effect indicators to assess the extent of nonadherence and causal indicators to assess reasons for nonadherence. Moreover, nonadherence should be assessed longitudinally, so that recent developments in statistical modeling can illuminate the extent to which medication nonadherence is transient vs. stable.
Attention to these measurement issues can improve the assessment of self-reported nonadherence, thereby allowing more accurate conclusions to be drawn about medication-taking behavior and informing the development of improved interventions that target medication nonadherence.
Adherence; Compliance; Psychometrics; Latent variable; Measurement; self-reports
Greater understanding of the mechanisms (mediators) by which behavioral change interventions work is critical to developing theory and refining interventions. Although systematic reviews have been advocated as a method for exploring mediators, this is rarely done. One challenge is that intervention researchers typically test only two paths of the mediational model: the effect of the intervention on mediators and on outcomes. We addressed this challenge by drawing information not only from intervention studies but also from observational studies, which provide data on associations between potential mediators and outcomes. We also reviewed qualitative studies of participants’ perceptions of why and how interventions worked. Using data from intervention (n= 37) and quantitative observational studies (n=55), we conducted a meta-analysis of the mediation effects of eight variables. Qualitative findings (n=6) contributed to more in-depth explanations for findings. The methods used have potential to contribute to understanding of core mechanisms of behavioral change interventions.
systematic review; mediation analysis; meta-analysis; antiretroviral therapy; treatment adherence
Mixed methods–mixed research synthesis is a form of systematic review in which the findings of qualitative and quantitative studies are integrated via qualitative and/or quantitative methods. Although methodological advances have been made, efforts to differentiate research synthesis methods have been too focused on methods and not focused enough on the defining logics of research synthesis—each of which may be operationalized in different ways—or on the research findings themselves that are targeted for synthesis. The conduct of mixed methods–mixed research synthesis studies may more usefully be understood in terms of the logics of aggregation and configuration. Neither logic is preferable to the other nor tied exclusively to any one method or to any one side of the qualitative/quantitative binary.
mixed research synthesis; systematic review; aggregation; configuration
We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes.
Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants.
A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling.
ClinicalTrials.gov Identifier NCT01060540
Genetic testing; Type II diabetes; Weight loss
Rationale, aims and objectives
Finding ways to incorporate disparate types of evidence into research syntheses has the potential to build a better evidence base for clinical practice and policy. Yet conducting such mixed research synthesis studies is challenging. Researchers have to determine whether and how to use adjusted and unadjusted quantitative findings in combination with each other and with qualitative findings.
Among quantitative findings, adjustment for confounding, either via study design or statistical analysis, can be a considerable source of heterogeneity. Yet there is no consensus about the best way to synthesize findings resulting from different methods for addressing confounding. When synthesizing qualitative and quantitative findings, additional considerations include determining whether findings are amenable to synthesis by aggregation or configuration, which, in turn, depends on the degree of interpretive transformation of findings.
Qualitative survey findings appear similar in form to unadjusted or minimally adjusted quantitative findings and, when addressing the same relationship, can be summed. More interpreted qualitative findings appear similar in form to adjusted findings found in, for example, structural equation models specifying the relationship among a host of latent variables. An option for synthesis of conceptually similar models is reciprocal translation.
These decisions will ultimately be judged on the meaningfulness of their results to practice or policy.
adjustment; confounding; meta-analysis; qualitative research; quantitative research; research synthesis
Caregiver interventions may help improve the quality of informal care. Yet the lack of a systematic framework specifying the targets and outcomes of caregiver interventions hampers our ability to understand what has been studied, to evaluate existing programs, and to inform the design of future programs. Our goal was to develop an organizing framework detailing the components of the caregiving activities and the caregiver and care recipient outcomes that should be affected by an intervention. In so doing, we characterize what has been measured in the published literature to date and what should be measured in future studies to enable comparisons across interventions and across time.
Our data set comprises 121 reports of caregiver interventions conducted in the United States and published between 2000 and 2009. We extracted information on variables that have been examined as primary and secondary outcomes. These variables were grouped into categories, which then informed the organizing framework. We calculated the frequency with which the interventions examined each framework component to identify areas about which we have the most knowledge and under-studied areas that deserve attention in future research.
The framework stipulates that caregiver interventions seek to change caregiving activities, which in turn affect caregiver and care recipient outcomes. The most frequently assessed variables have been caregiver psychological outcomes (especially depression and burden) and care recipient physical and health care use outcomes.
Based on the organizing framework, we make three key recommendations to guide interventions and inform research and policy. First, all intervention studies should assess quality and/or quantity of caregiving activities to help understand to what extent and how well the intervention worked. Second, intervention studies should assess a broad range of caregiver and care recipient outcomes, including considering whether expanding to economic status and health care use of the caregiver can be accommodated, to ease subsequent economic evaluations of caregiving. Third, intervention studies should measure a common set of outcomes to facilitate cross-time and cross-study comparisons of effectiveness.
This paper is a report of a synthesis of evidence on implementation of interventions to improve adherence to antiretroviral therapy.
Evidence on efficacy must be supplemented with evidence on how interventions were implemented in practice and on how that implementation varied across populations and settings.
Sixty-one reports were reviewed of studies conducted in the United States of America in the period 2001 to December 2008. Fifty-two reports were included in the final analysis: 37 reporting the effects of interventions and 15 reporting intervention feasibility, acceptability, or fidelity.
An adaptation of Pawson’s realist synthesis method was used, whereby a provisional explanatory model and associated list of propositions are developed from an initial review of literature. This model is successively refined to the point at which it best explains empirical findings from the reports reviewed.
The final explanatory model suggests that individuals with HIV will be more likely to enrol in interventions that protect their confidentiality, to attend when scheduling is responsive to their needs, and both to attend and continue with an intervention when they develop a strong, one-to-one relationship with the intervener. Participants who have limited prior experience with antiretroviral therapy will be more likely to continue with an intervention than those who are more experienced. Dropout rates are likely to be higher when interventions are integrated into existing delivery systems than when offered as stand-alone interventions.
The explanatory model developed in this study is intended to provide guidance to clinicians and researchers on the points in the implementation chain that require strengthening.
literature review; implementation; Antiretroviral Therapy; Adherence; Interventions; Realist Synthesis of Evidence; Nursing; Pawson’s method
To assess the feasibility of a culturally tailored behavioral intervention for improving hypertension-related health behaviors in Hispanic/Latino adults.
Feasibility pilot study in a community health center and a Latino organization in Durham, North Carolina (NC).
The culturally adapted behavioral intervention consisted of 6 weekly group sessions incorporating motivational interviewing techniques. Goals included weight loss if overweight, adoption of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, and increased physical activity. Participants were also encouraged to monitor their daily intake of fruits, vegetables, dairy and fat, and to record physical activity. Cultural adaptations included conducting the study in familiar places, using Spanish-speaking interventionist, culturally-appropriate food choices, and physical activity.
Systolic blood pressure, weight, body mass index (BMI), exercise, and dietary pattern were measured at baseline and at 6 weeks follow-up. Qualitative evaluations of the recruitment process and the intervention were also conducted.
There were 64 potential participants identified via health care provider referrals (33%), printed media (23%), and direct contact (44%). Seventeen participants completed the intervention and had main outcome data available. Participants “strongly agreed/ agreed” that the group sessions provided them with the tools they needed to achieve weight loss, blood pressure control, and the possibility of sustaining the lifestyle changes after completing the intervention. At the end of the intervention, all physiological, diet, and exercise outcomes were more favorable, with the exception of fat. After 6 weeks, systolic blood pressure decreased an average of −10.4 ± 10.6 mmHg, weight decreased 1.5 ± 3.2 lbs, BMI decreased 0.3 ± 0.5, and physical activity increased 40 minutes per week.
Our findings suggest that lifestyle interventions for preventing and treating hypertension are feasible and potentially effective in the Hispanic/Latino population.
Hypertension; Hispanic; Latino; non pharmacologic interventions; blood pressure control; weight loss; DASH dietary pattern; lifestyle intervention
The possible utility of Bayesian methods for the synthesis of qualitative and quantitative research has been repeatedly suggested but insufficiently investigated. In this project, we developed and used a Bayesian method for synthesis, with the goal of identifying factors that influence adherence to HIV medication regimens. We investigated the effect of 10 factors on adherence. Recognizing that not all factors were examined in all studies, we considered standard methods for dealing with missing data and chose a Bayesian data augmentation method. We were able to summarize, rank, and compare the effects of each of the 10 factors on medication adherence. This is a promising methodological development in the synthesis of qualitative and quantitative research.
Meta-analysis; Meta-synthesis; Synthesis; Cross-design synthesis; Bayesian data augmentation; Missing data; Gibbs sampling
We examined the extent to which studies aimed at testing interventions to improve antiretroviral adherence have targeted the facilitators of and barriers known to affect adherence. Of the 88 reports reviewed, 41 were reports of descriptive studies conducted with U.S. HIV-positive women and 47 were reports of intervention studies conducted with U.S. HIV-positive persons. We extracted from the descriptive studies all findings addressing any factor linked to antiretroviral adherence and from the intervention studies, information on the nature of the intervention, the adherence problem targeted, the persons targeted for the intervention, and the intervention outcomes desired. We discerned congruence between the prominence of substance abuse as a factor identified in the descriptive studies as a barrier to adherence and its prominence as the problem most addressed in those reports of intervention studies that specified the problems targeted for intervention. We also discerned congruence between the prominence of family and provider support as factors identified in the descriptive studies as facilitators of adherence and the presence of social support as an intervention component and outcome variable. Less discernible in the reports of intervention studies was specific attention to other factors prominent in the descriptive studies, which may be due to the complex nature of the problem, individualistic and rationalist slant of interventions, or simply the ways interventions were presented. Our review raises issues about niche standardization and intervention tailoring, targeting, and fidelity.
To assess the accuracy of an NCI-developed colorectal cancer screening questionnaire.
We conducted 36 cognitive interviews and made iterative changes to the questionnaire to improve comprehension. The revised questionnaire was administered face-to-face to 201 participants. The primary outcome was agreement between questionnaire responses and medical records for whether or not a participant was up-to-date for any colorectal cancer screening test.
Comprehension of descriptions and questions was generally good; however, the barium enema description required several revisions. The sensitivity of the questionnaire for up-to-date screening status was 94%, specificity was 63%, and concordance was 88%.
The modified questionnaire was highly sensitive for determining if a person was up-to date for any colorectal cancer screening test, although the specificity was low. Given the difficulty of obtaining all relevant records, self-report using this questionnaire is a reasonable option for identifying people who have undergone testing.
colorectal neoplasms; mass screening; validation studies; questionnaires
Mixed research synthesis is the latest addition to the repertoires of mixed methods research and systematic review. Mixed research synthesis requires that the problems generated by the methodological diversity within and between qualitative and quantitative studies be resolved. Three basic research designs accommodate this diversity, including the segregated, integrated, and contingent designs. Much work remains to be done before mixed research synthesis can secure its place in the repertoires of mixed methods research and systematic review, but the effort is well worth it as it has the potential to enhance both the significance and utility for practice of the many qualitative and quantitative studies constituting shared domains of research.
Reports of qualitative studies typically do not offer much information on the numbers of respondents linked to any one finding. This information may be especially useful in reports of basic, or minimally interpretive, qualitative descriptive studies focused on surveying a range of experiences in a target domain, and its lack may limit the ability to synthesize the results of such studies with quantitative results in systematic reviews. Accordingly, the authors illustrate strategies for deriving plausible ranges of respondents expressing a finding in a set of reports of basic qualitative descriptive studies on antiretroviral adherence and suggest how the results might be used. These strategies have limitations and are never appropriate for use with findings from interpretive qualitative studies. Yet they offer a temporary workaround for preserving and maximizing the value of information from basic qualitative descriptive studies for systematic reviews. They show also why quantitizing is never simply quantitative.
mixed-methods research; qualitative; quantitizing; research synthesis
Quantitizing, commonly understood to refer to the numerical translation, transformation, or conversion of qualitative data, has become a staple of mixed methods research. Typically glossed are the foundational assumptions, judgments, and compromises involved in converting disparate data sets into each other and whether such conversions advance inquiry. Among these assumptions are that qualitative and quantitative data constitute two kinds of data, that quantitizing constitutes a unidirectional process essentially different from qualitizing, and that counting is an unambiguous process. Among the judgments are deciding what and how to count. Among the compromises are balancing numerical precision with narrative complexity. The standpoints of “conditional complementarity,” “critical remediation,” and “analytic alternation” clarify the added value of converting qualitative data into quantitative form.
quantitizing; qualitative data; mixed methods research
Bayesian meta-analysis is a frequently cited but very little-used method for synthesizing qualitative and quantitative research findings. The only example published to date used qualitative data to generate an informative prior probability and quantitative data to generate the likelihood. We developed a method to incorporate both qualitative and quantitative evidence in the likelihood in a Bayesian synthesis of evidence about the relationship between regimen complexity and medication adherence.
Data were from 11 qualitative and six quantitative studies. We updated two different non-informative prior distributions with qualitative and quantitative findings to find the posterior distribution for the probabilities that a more complex regimen was associated with lower adherence and that a less complex regimen was associated with greater adherence.
The posterior mode for the qualitative findings regarding more complex regimen and lesser adherence (using the uniform prior with Jeffreys' prior yielding highly similar estimates) was 0.588 (95% credible set limits 0.519, 0.663) and for the quantitative findings was 0.224 (0.203, 0.245); due to non-overlapping credible sets, we did not combine them. The posterior mode for the qualitative findings regarding less complex regimen and greater adherence was 0.288 (0.214, 0.441) and for the quantitative findings was 0.272 (0.118, 0.437); the combined estimate was 0.299 (0.267, 0.334).
The utility of Bayesian methods for synthesizing qualitative and quantitative research findings at the participant level may depend on the nature of the relationship being synthesized and on how well the findings are represented in the individual reports.
Systematic review is typically viewed in the health sciences as the most objective—that is, rigorous, transparent, and reproducible—method for summarizing the results of research. Yet, recent scholarship has shown systematic review to involve feats of interpretation producing less certain, albeit valuable, results. We found this to be the case when we tried to overcome the resistance to synthesis of a set of qualitative and quantitative findings on stigma in HIV-positive women. These findings were difficult to combine largely because of fuzzy conceptualizations of stigma and the volume of unique quantitative findings. Our encounter with findings resistant to synthesis heightened our awareness of the extent to which all systematic reviews are accomplished by practices that paradoxically “distort [research findings] into clarity.”
HIV-positive women; qualitative research synthesis; quantitative research synthesis; research methods; research synthesis; stigma; systematic review
Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans.
Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support.
The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C.
Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes.
The ClinicalTrials.gov registration number is NCT00321789.
The synthesis of qualitative and quantitative research findings is increasingly promoted, but many of the conceptual and methodological issues it raises have yet to be fully understood and resolved. In this article, we describe how we handled issues encountered in efforts to synthesize the findings in forty-two reports of studies of antiretroviral adherence in HIV-positive women in the course of an ongoing study to develop methods to synthesize qualitative and quantitative research findings in common domains of health-related research. Working with these reports underscored the importance of looking past method claims and ideals and directly at the findings themselves, differentiating between aggregative syntheses in which findings are assimilated and interpretive syntheses in which they are configured, and understanding the judgments involved in designating relationships between findings as confirmatory, divergent, or complementary.
antiretroviral adherence; HIV/AIDS; qualitative research; quantitative research; research synthesis; systematic review; women
The new imperative to be more methodologically inclusive has generated a burgeoning interest in synthesizing the findings of qualitative and quantitative studies, or mixed research synthesis. Yet, the very diversity seen to define the mixed research synthesis enterprise is also considered to defy it as it intensifies the problem of comparing the seemingly incomparable to enable the combination of the seemingly uncombinable. We propose here that the research synthesis enterprise, in general, and the mixed research synthesis enterprise, in particular, entail comparability work whereby reviewers impose similarity and difference on the studies to be reviewed. The very study diversity requiring management does not exist a priori but rather is itself an outcome of comparability work already done whereby judgments have been made about what constitutes methodological and topical diversity and uniformity. Conceiving the research synthesis process as defined by comparability work moves the backstage interpretive work of systematic review to center stage and, thereby, sets a new stage for addressing the methodological issues involved. These issues are explored by reference to the synthesis of empirical studies of antiretroviral adherence in HIV-positive women in the US.
Comparability work; Evidence-based practice; Research synthesis; Systematic review; HIV
Time and timeliness are key issues in appraising and ensuring the clinical relevance of systematic reviews. Time considerations entering the systematic review process include the history of the clinical problem, disease, or treatment that is the target of the review, and the history of the research conducted to address it. These considerations guide: (i) formulation of the research problems and questions; (ii) setting of parameters for the search and retrieval of studies; (iii) determination of inclusion and exclusion criteria; (iv) appraisal of the clinical relevance of findings; (v) selection of the findings that will be synthesized; and (vi) interpretation of the results of that synthesis.
antiretroviral medication adherence; clinical relevance; HIV/AIDS; quantitative research; systematic reviews
The new imperative in the health disciplines to be more methodologically inclusive has generated a growing interest in mixed research synthesis, or the integration of qualitative and quantitative research findings. Qualitative metasummary is a quantitatively oriented aggregation of qualitative findings originally developed to accommodate the distinctive features of qualitative surveys. Yet these findings are similar in form and mode of production to the descriptive findings researchers often present in addition to the results of bivariate and multivariable analyses. Qualitative metasummary, which includes the extraction, grouping, and formatting of findings, and the calculation of frequency and intensity effect sizes, can be used to produce mixed research syntheses and to conduct a posteriori analyses of the relationship between reports and findings.
qualitative research synthesis; quantitative research synthesis; systematic review