Qualitative study of patients with venous malformations: symptom experiences and content validity of patient-reported outcome measures.

PURPOSE: To determine important symptoms and functional effects of venous malformations (VMs) to assess the content validity of commonly used patient-reported outcome (PRO) measures for use with VM patients. METHODS: This cross-sectional, qualitative study involved cognitive interviews with participants with VM aged ≥ 14 years. From February to June 2016, 11 participants (8 female) with a mean (± standard deviation) age of 31 ± 15 years were recruited from three clinical sites. The following subgroups were evaluated: 5 adults (aged ≥ 18) with trunk/extremity VMs; 3 adolescents (aged 14-17) with trunk/extremity VMs; and 3 adults with head/neck VMs. We evaluated the content validity of the Worst Pain Numeric Rating Scale (NRS), Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference 8-item short form, and PROMIS Physical Function 8-item short form. RESULTS: The most common participant-reported VM symptoms were swelling (n = 10), skin discoloration (n = 8), acute episodic pain (n = 8), chronic pain (n = 7), numbness (n = 7), and tingling/burning (n = 6). Participants reported that VMs affected their physical function (n = 10), appearance (n = 10), relationships/social activities (n = 7), and emotional health (n = 3). The Worst Pain NRS and PROMIS Pain Interference measures were relevant to all participants' VM experience. Only adults with head/neck VMs found the PROMIS Physical Function measure to be irrelevant. The assessed PRO measures did not address several symptoms commonly reported by VM patients (swelling, skin discoloration, numbness, and appearance). CONCLUSION: These results suggest that several VM symptoms are not assessed fully by commonly used PRO measures, and that the relevance of functional limitation questions may vary by VM location.

Are we "missing the big picture" in transitions of care? Perspectives of healthcare providers managing patients with unplanned hospitalization.

BACKGROUND: Healthcare providers play a critical role in the care transitions. Therefore, efforts to improve this process should be informed by their perspectives. AIM: The study objective was to explore the factors that negatively/positively influence care transitions following an unplanned hospitalization from the perspective of healthcare providers. METHODS: A qualitative study using semi-structured interviews conducted between February and September of 2016 at a single academic medical center. We enrolled fifteen healthcare providers from multiple disciplines involved in the management of patients experiencing an unplanned hospitalization. Respondents shared their experiences with care transitions and identified factors within and outside of the discharging health facility that impede or facilitate this process. Transcribed interviews were analyzed using emerging themes from the interviews. RESULTS: We identified six themes and associated subthemes from the interviews on factors that influence care transitions. Three themes focused on factors within the discharging healthcare facility: untailored and overloaded patient discharge information, timing of the post-discharge care conversation, provider-to-patient and provider-to-provider miscommunication. The other three themes were related to external factors including caregiver involvement, having a safe and stable housing environment, and access to healthcare and community resources. Providers discussed how these factors positively/negatively influence the hospital-to-home transition. CONCLUSIONS: Our study identifies factors within and outside the discharging healthcare facility that influence care transitions, ultimately affect patient-centered outcomes and provider satisfaction with delivered care. Strategies aimed at improving the quality of care transitions should address these barriers and actively engage healthcare providers who are pivotal in care transitions.

The Development of a Patient-Reported Outcome Measure for Assessment of Genital Psoriasis Symptoms: The Genital Psoriasis Symptoms Scale (GPSS).

INTRODUCTION: Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. METHODS: In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs. RESULTS: Relevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS. CONCLUSION: The GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs. FUNDING: Eli Lilly & Company. Plain language summary available for this article.

The Development of the Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) to Assess the Impact of Genital Psoriasis on Sexual Health.

INTRODUCTION: Patient-reported outcome measures (PROs) exist for psoriasis but not genital psoriasis (GenPs). METHODS: This cross-sectional, qualitative study in patients with moderate-to-severe GenPs was conducted to support development of a PRO for measuring the impact of GenPs on sexual activity and to establish content validity. The impacts of GenPs were identified in a literature review. Findings from the literature review were discussed with clinicians, and then patients with GenPs were interviewed. RESULTS: From the literature review, 52 articles, 44 abstracts, and 41 clinical trials met predefined search criteria. Of these, 11 concepts emerged as having theoretical support for use as measurable impacts of psoriasis symptoms on patients; these concepts included sexual functioning and general health-related quality of life (HRQoL). These concepts were confirmed and expanded upon by two clinicians who routinely care for patients with GenPs. Interviews were then conducted with GenPs patients (n = 20) to discuss the impact of GenPs on their HRQoL. Eighty percent of patients reported that GenPs impacted sexual frequency. The two-item GenPs Sexual Frequency Questionnaire (GenPs-SFQ) was developed to assess limitations on sexual activity frequency because of GenPs. Cognitive debriefing with an additional 50 patients with GenPs confirmed the utility and understandability of the GenPs-SFQ. CONCLUSION: The GenPs-SFQ may have utility in clinical trials involving GenPs patients and in routine clinical practice. FUNDING: Eli Lilly and Company. Plain language summary available for this article.

Change in Cognitive Function in the Month After Hospitalization for Acute Coronary Syndromes: Findings From TRACE-CORE (Transition, Risks, and Actions in Coronary Events-Center for Outcomes Research and Education).

BACKGROUND: Cognitive function is often impaired during hospitalization, but whether this impairment resolves or persists after discharge is unknown. METHODS AND RESULTS: We enrolled (April 2011-May 2013) and interviewed during hospitalization and 1-month post-discharge 1521 nondemented acute coronary syndrome survivors enrolled in TRACE (Transitions, Risks and Actions in Coronary Events). Cognitive function was assessed using the Telephone Interview of Cognitive Status (range: 0-41) at both time points. Patients reported demographic and psychosocial characteristics and medical records were abstracted. Using the Telephone Interview of Cognitive Status cut point of ≤28, we defined 4 groups of cognitive change based on cognitive status during hospitalization and 1 month later: consistently impaired, transiently impaired, newly impaired, and consistently nonimpaired. Characteristics associated with cognitive change categories were examined using multinomial logistic regression. Participants were 67% male, 84% non-Hispanic white, with mean age±SD 62±11 years; 16% (n=237) were cognitively impaired during hospitalization, and 11% (n=174) were impaired 1 month after discharge. Overall, 80% were consistently nonimpaired, 9% transiently impaired, 7% consistently impaired, and 4% newly impaired. Lower education level, minority status, low health literacy and numeracy, and higher severity of disease were independently associated with cognitive impairment during and after hospitalization. Male sex was associated with increased risk of cognitive impairment after hospital discharge. CONCLUSIONS: Cognitive function changes during the transition from hospital to home after acute coronary syndrome are less favorable for men and those with psychosocial vulnerability. Assessing cognitive status both in hospital and post-discharge is important for detecting patients who could benefit from tailored transitional care including early follow-up and booster discharge instructions.

Psychometric evaluation of a daily gastro-oesophageal reflux disease symptom measure.

OBJECTIVE: The objective of this study was to evaluate the validity of the Heartburn Reflux Dyspepsia Questionnaire (HRDQ), a newly developed measure of gastro-oesophageal reflux disease (GORD) symptoms. Specifically, the HRDQ was developed for patients, who still experience symptoms with proton pump inhibitor (PPI) treatment. MATERIAL AND METHODS: The psychometric properties of HRDQ were evaluated based on data from two clinical trials of patients with GORD with a partial response to PPIs, one from the UK and one from Denmark and Germany. RESULTS: The HRDQ had good internal consistency (Cronbach's alpha range .83-.88) and test-retest reliability (intraclass correlation coefficient range .71-.90). Convergent and discriminant validity were supported by high correlations with ReQuest™ and ability to differentiate between groups based on ReQuest™ cut-off values. Responsiveness of HRDQ was demonstrated by moderate to high correlations with ReQuest™ change scores and time with symptoms. An HRDQ cut-off value of 0.70 for definition of 'bad day' was also evaluated. CONCLUSIONS: Based on existing evidence, the HRDQ is a valid and reliable measure of GORD symptoms that can be used as a study outcome in clinical trials.

Perceiving one's heart condition to be cured following hospitalization for acute coronary syndromes: Implications for patient-provider communication.

OBJECTIVE: We examined the proportion of patients perceiving their heart condition to be cured following hospitalization for ACS and identified characteristics associated with these perceptions. METHODS: We conducted a prospective cohort study of adults hospitalized with ACS (N=396). Patient interviews during hospitalization and one week post-discharge provided demographic and psychosocial characteristics. Medical records provided clinical characteristics. At one week, patients who rated "My heart condition is cured" as "definitely true" or "mostly true" were considered to perceive their heart condition cured. RESULTS: Participants were aged 60.7 (SD:11.0) years, 26.5% female, and 89.0% non-Hispanic white; 16.7% had unstable angina, 59.6% NSTEMI, and 23.7% STEMI. One week post-discharge, 30.3% perceived their heart condition to be cured. Characteristics associated with cure perceptions were older age (OR=2.2; 95% CI: 1.2-4.0 for ≥65 years vs <55 years), male sex (OR=2.4; 95%CI: 1.3-4.2), history of hypertension (OR=1.8; 95%CI: 1.1-3.1), history of stroke (OR=4.2; 95%CI: 1.1-16.7), no history of CHD (OR=2.8; 95%CI: 1.6-4.9), and receipt of CABG during hospitalization (OR=4.8, 95%CI: 1.9-12.0 vs medical management). CONCLUSION: One week post-discharge, 3 in 10 patients perceived their heart condition to be cured. PRACTICE IMPLICATIONS: Conversations with patients should frame ACS as a chronic disease and dispel cure perceptions.

Testing item response theory invariance of the standardized Quality-of-life Disease Impact Scale (QDIS(®)) in acute coronary syndrome patients: differential functioning of items and test.

PURPOSE: The Quality-of-life (QOL) Disease Impact Scale (QDIS(®)) standardizes the content and scoring of QOL impact attributed to different diseases using item response theory (IRT). This study examined the IRT invariance of the QDIS-standardized IRT parameters in an independent sample. METHOD: The differential functioning of items and test (DFIT) of a static short-form (QDIS-7) was examined across two independent sources: patients hospitalized for acute coronary syndrome (ACS) in the TRACE-CORE study (N = 1,544) and chronically ill US adults in the QDIS standardization sample. "ACS-specific" IRT item parameters were calibrated and linearly transformed to compare to "standardized" IRT item parameters. Differences in IRT model-expected item, scale and theta scores were examined. The DFIT results were also compared in a standard logistic regression differential item functioning analysis. RESULTS: Item parameters estimated in the ACS sample showed lower discrimination parameters than the standardized discrimination parameters, but only small differences were found for thresholds parameters. In DFIT, results on the non-compensatory differential item functioning index (range 0.005-0.074) were all below the threshold of 0.096. Item differences were further canceled out at the scale level. IRT-based theta scores for ACS patients using standardized and ACS-specific item parameters were highly correlated (r = 0.995, root-mean-square difference = 0.09). Using standardized item parameters, ACS patients scored one-half standard deviation higher (indicating greater QOL impact) compared to chronically ill adults in the standardization sample. CONCLUSION: The study showed sufficient IRT invariance to warrant the use of standardized IRT scoring of QDIS-7 for studies comparing the QOL impact attributed to acute coronary disease and other chronic conditions.

Psychometric evaluation of the Care Transition Measure in TRACE-CORE: do we need a better measure?

BACKGROUND: The quality of transitional care is associated with important health outcomes such as rehospitalization and costs. The widely used Care Transitions Measure (CTM-15) was developed with a classic test theory approach; its short version (CTM-3) was included in the CAHPS Hospital Survey. We conducted a psychometric evaluation of both measures and explored whether item response theory (IRT) could produce a more precise measure. METHODS AND RESULTS: As part of the Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education, 1545 participants were interviewed during an acute coronary syndrome hospitalization, providing information on general health status (Short Form-36), CTM-15, health utilization, and care process questions at 1 month postdischarge. We used classic and IRT analyses and compared the measurement precision of CTM-15-, CTM-3-, and CTM-IRT-based score using relative validity. Participants were 79% non-Hispanic white and 67% male, with an average age of 62 years. The CTM-15 had good internal consistency (Cronbach's α=0.95) but demonstrated acquiescence bias (8.7% participants responded "Strongly agree" and 19% responded "Agree" to all items) and limited score variability. These problems were more pronounced for the CTM-3. The CTM-15 differentiated between patient groups defined by self-reported health status, health care utilization, and care transition process indicators. Differences between groups were small (2 to 3 points). There was no gain in measurement precision from IRT scoring. The CTM-3 was not significantly lower for patients reporting rehospitalization or emergency department visits. CONCLUSION: We identified psychometric challenges of the CTM, which may limit its value in research and practice. These results are in line with emerging evidence of gaps in the validity of the measure.

Transitions, Risks, and Actions in Coronary Events--Center for Outcomes Research and Education (TRACE-CORE): design and rationale.

BACKGROUND: Cardiovascular disease continues to cause significant morbidity, mortality, and impaired quality of life, with unrealized health gains from the underuse of available evidence. The Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education (TRACE-CORE) aims to advance the science of acute coronary syndromes by examining the determinants and outcomes of the quality of transition from hospital to community and by quantifying the impact of potentially modifiable characteristics associated with decreased quality of life, rehospitalization, and mortality. METHODS AND RESULTS: TRACE-CORE comprises a longitudinal multiracial cohort of patients hospitalized with acute coronary syndromes, 2 research projects, and development of a nucleus of early stage investigators. We are currently enrolling 2500 adults hospitalized for acute coronary syndromes at 6 hospitals in the northeastern and southeastern United States. We will follow these patients for 24 months after hospitalization through medical record abstraction and 5 patient interviews focusing on quality of life, cardiac events, rehospitalizations, mortality, and medical, behavioral, and psychosocial characteristics. The Transitions Project studies determinants of and disparities in outcomes of the quality of patients' transition from hospital to community. Focusing on potentially modifiable factors, the Action Scores Project will develop and validate action scores to predict recurrent cardiac events, death, and quality of life, describe longitudinal variation in these scores, and develop a dashboard for patient and provider action on the basis of these scores. CONCLUSIONS: In TRACE-CORE, sound methodologic principles of observational studies converge with outcomes and effectiveness research approaches. We expect that our data, research infrastructure, and research projects will inform the development of novel secondary prevention approaches and underpin the careers of cardiovascular outcomes researchers.

Development of an item bank and computer adaptive test for role functioning.

OBJECTIVES: Role functioning (RF) is a key component of health and well-being and an important outcome in health research. The aim of this study was to develop an item bank to measure impact of health on role functioning. METHODS: A set of different instruments including 75 newly developed items asking about the impact of health on role functioning was completed by 2,500 participants. Established item response theory methods were used to develop an item bank based on the generalized partial credit model. Comparison of group mean bank scores of participants with different self-reported general health status and chronic conditions was used to test the external validity of the bank. RESULTS: After excluding items that did not meet established requirements, the final item bank consisted of a total of 64 items covering three areas of role functioning (family, social, and occupational). Slopes in the bank ranged between .93 and 4.37; the mean threshold range was -1.09 to -2.25. Item bank-based scores were significantly different for participants with and without chronic conditions and with different levels of self-reported general health. CONCLUSIONS: An item bank assessing health impact on RF across three content areas has been successfully developed. The bank can be used for development of short forms or computerized adaptive tests to be applied in the assessment of role functioning as one of the common denominators across applications of generic health assessment.

Assessing the factor structure of a role functioning item bank.

PURPOSE: Role functioning (RF) is an important part of health-related quality of life, but is hard to measure due to the wide definition of roles and fluctuations in role participation. This study aims to explore the dimensionality of a newly developed item bank assessing the impact of health on RF. METHODS: A battery of measures with skip patterns including the new RF bank was completed by 2,500 participants answering only questions on social roles relevant to them. Confirmatory factor analyses were conducted for the participants answering items from all conceptual domains (N = 1193). Conceptually based dimensionality and method effects reflecting positively and negatively worded items were explored in a series of models. RESULTS: A bi-factor model (CFI = .93, RMSEA = .08) with one general and four conceptual factors (social, family, occupation, generic) was retained. Positively worded items were excluded from the final solution due to misfit. While a single factor model with methods factors had a poor fit (CFI = .88, RMSEA = .13), high loadings on the general factor in the bi-factor model suggest that the RF bank is sufficiently unidimensional for IRT analysis. CONCLUSIONS: The bank demonstrated sufficient unidimensionality for IRT-based calibration of all the items on a common metric and development of a computerized adaptive test.

Health and role functioning: the use of focus groups in the development of an item bank.

BACKGROUND: Role functioning is an important part of health-related quality of life. However, assessment of role functioning is complicated by the wide definition of roles and by fluctuations in role participation across the life-span. The aim of this study is to explore variations in role functioning across the lifespan using qualitative approaches, to inform the development of a role functioning item bank and to pilot test sample items from the bank. METHODS: Eight focus groups were conducted with a convenience sample of 38 English-speaking adults recruited in Rhode Island. Participants were stratified by gender and four age groups. Focus groups were taped, transcribed, and analyzed for thematic content. RESULTS: Participants of all ages identified family roles as the most important. There was age variation in the importance of social life roles, with younger and older adults rating them as more important. Occupational roles were identified as important by younger and middle-aged participants. The potential of health problems to affect role participation was recognized. Participants found the sample items easy to understand, response options identical in meaning and preferred five response choices. CONCLUSIONS: Participants identified key aspects of role functioning and provided insights on their perception of the impact of health on their role participation. These results will inform item bank generation.

Development and preliminary testing of a computerized adaptive assessment of chronic pain.

UNLABELLED: The aim of this article is to report the development and preliminary testing of a prototype computerized adaptive test of chronic pain (CHRONIC PAIN-CAT) conducted in 2 stages: (1) evaluation of various item selection and stopping rules through real data-simulated administrations of CHRONIC PAIN-CAT; (2) a feasibility study of the actual prototype CHRONIC PAIN-CAT assessment system conducted in a pilot sample. Item calibrations developed from a US general population sample (N = 782) were used to program a pain severity and impact item bank (kappa = 45), and real data simulations were conducted to determine a CAT stopping rule. The CHRONIC PAIN-CAT was programmed on a tablet PC using QualityMetric's Dynamic Health Assessment (DYHNA) software and administered to a clinical sample of pain sufferers (n = 100). The CAT was completed in significantly less time than the static (full item bank) assessment (P < .001). On average, 5.6 items were dynamically administered by CAT to achieve a precise score. Scores estimated from the 2 assessments were highly correlated (r = .89), and both assessments discriminated across pain severity levels (P < .001, RV = .95). Patients' evaluations of the CHRONIC PAIN-CAT were favorable. PERSPECTIVE: This report demonstrates that the CHRONIC PAIN-CAT is feasible for administration in a clinic. The application has the potential to improve pain assessment and help clinicians manage chronic pain.

Development and validation of transtheoretical model measures for Bulgarian adolescent non-smokers.

The goal of this study was to develop, translate, and evaluate measures for decisional balance and situational temptations for Bulgarian adolescent nonsmokers and to test the predicted relationships with stages of change. Students in the last grades of high school (15-19 years old) recruited in 12 randomly selected schools participated in the study. Data from the 369 nonsmokers (61.8% female, mean age 16.4 years, 97.1% Bulgarian) were used in the measurement development. A two-factor model for decisional balance (CFI=.94) and a hierarchical three-factor model for temptations (CFI=.90) demonstrated the best fit. The predicted crossover pattern for decisional balance and decreasing trend for temptations across the stages of change was verified. Both measures demonstrated tau-equivalent invariance across gender, in addition to good psychometric properties. These results, with the caveat of the noted limitations, support the cross-cultural validity of these transtheoretical model (TTM) constructs and indicate that they can be used as a basis for development of smoking prevention interventions.

Identifying cluster subtypes for the prevention of adolescent smoking acquisition.

School-based smoking prevention programs are typically identical for all students. Tailoring prevention materials to focus on individual needs with an emphasis on students at highest risk is a promising alternative. Recent prevention programs have tailored materials based on the Stages of Acquisition, an extension of the Stages of Change used to tailor smoking cessation materials effectively for adults. Three stages of acquisition have been identified: Acquisition Precontemplation (aPC), Acquisition Contemplation (aC) and Acquisition Preparation (aPR). However, about 90% of nonsmoking adolescents classify themselves in the aPC stage. A cluster analysis was performed, using the Decisional Balance and Situational Temptations scales, for three random subsamples of adolescents within the aPC stage (N(1)=N(2)=N(3)=514). Four distinct subtypes were identified in each subsample: High Risk, Protected, Ambivalent, and Risk Denial. External validity was established using family support for nonsmoking, peer variables, and stage classification at follow-up assessment (12, 24, and 36 months). Family support for nonsmoking was related to subtype much more strongly than peer interactions. Subjects in the Protected subgroup were the most likely to remain in the aPC stage at each follow-up assessment. Subtype membership, along with membership in the aC and aPR stages, provides important additional information for tailoring smoking prevention materials. Tailored interventions can focus on those adolescents at highest risk and limit or avoid expending resources on those at very low risk.

Development and validation of Decisional Balance and Temptations measures for Bulgarian adolescent smokers.

The goal of this study was to develop measures for Decisional Balance and Situational Temptations for Bulgarian adolescent smokers and to test predicted theoretical relationships with Stages of Change in the same population. Consistent with previous findings for other populations, a 3-factor model for Decisional Balance (CFI = .95) and a hierarchical 4-factor model for Temptations (CFI = .90) best fit the data. The predicted crossover pattern for Decisional Balance and a decreasing trend for Temptations across the Stages of Change were verified. Both measures demonstrated good levels of factorial invariance across gender and across random split-half cross-validation samples. These results support the cross-cultural validity of the TTM constructs and indicate that they can be used as a basis for development of interventions for the population under study.

Replication of subtypes for smoking cessation within the precontemplation stage of change.

The Transtheoretical Model constructs have been used in the development of effective tailored interventions for smoking cessation. Recent studies have suggested the existence of clusters within each stage of change, based on measures of the Pros, Cons and the Situational Temptations. The goal of this study is to replicate cluster subtypes within the Precontemplation stage of change in a secondary analysis of data from a sample of current smokers (N=3967). Four random samples ranging from 312 to 400 participants were selected from the Precontemplators subgroup. The cluster analyses were performed using Ward's Method on the standard scores from the three scales. Interpretability of the pattern, pseudo F test, and dendograms were used to determine the number of clusters. Four cluster subtypes were found and replicated across samples. The ten processes of change and two smoking behavior variables were used in the external validation of clusters. Statistically significant multivariate effects were found for the processes of change (p<.05) and the smoking behavior variables (p<.001) in all samples. The cluster patterns closely replicate earlier findings and provide evidence for the existence of clusters subtypes within the Precontemplation stage of change.

Replication of subtypes for smoking cessation within the Preparation stage of change.

OBJECTIVE: Recent cluster analyses based on the Pros and Cons and the Situational Temptations measures performed within the stages of change defined by the Transtheoretical Model have suggested the existence of distinct cluster subtypes. The goal of this study is to replicate cluster subtypes within the Preparation stage of change in a secondary analysis of data from a sample of current smokers (N=3967). Identification of stable cluster subtypes would permit the development of tailored interventions focusing on these subtypes. METHOD: Two random samples of approximately 340 subjects were selected from the 686 participants in the Preparation stage. The cluster analyses were performed using the Pros, Cons and Situational Temptations. Interpretability of the pattern, pseudo F test, and dendograms were used to determine the number of clusters. RESULTS: Four distinct cluster subtypes (Classic, Progressing, Early Preparation, and Disengaged) were found and replicated across samples. The clusters were externally validated using the ten processes of change and two smoking behavior variables. Statistically significant (p<0.05) multivariate effects were found for the ten processes of change and the smoking behavior variables (p<0.001) in the two samples. CONCLUSIONS: The cluster patterns replicate earlier findings and provide evidence for the existence of clusters subtypes within the Preparation stage of change.

Replication of subtypes for smoking cessation within the contemplation stage of change.

OBJECTIVE: Tailored interventions based on stage of change and other Transtheoretical Model constructs have been effective for promoting smoking cessation. Recent cluster analyses based on the Pros and Cons from the Decisional Balance and the Situational Temptations measures performed within the stages have suggested the existence of distinct cluster subtypes. Cluster subtypes would permit the development of tailored interventions focusing on these subtypes. This study attempts to replicate cluster subtypes within the Contemplation stage of change in a secondary analysis of data from a sample of current smokers (N=3967). METHOD: Four random samples of 400 were selected from the 1734 Contemplators. The cluster analyses were performed using the Pros, Cons, and Situational Temptations. Interpretability of the pattern, pseudo-F-test, and dendograms were used to determine the number of clusters. RESULTS: Four distinct cluster subtypes (Classic Contemplators, Progressing, Early Contemplators, and Disengaged) were found and replicated across samples. The clusters were externally validated using the 10 Processes of change and 2 smoking behavior variables (cigarettes per day and time before first morning cigarette). Statistically significant (p<0.05) multivariate effects were found for the 10 Processes of change in all four samples. The cluster groups differed on 7 or more of the processes in each sample. Significant multivariate effects were also found for the smoking behavior variables in all samples (p<0.001). CONCLUSIONS: The cluster patterns closely replicate earlier findings and provide evidence for the existence of clusters subtypes within the Contemplation stage of change.