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1.

Purpose

The University of Washington Self-Efficacy Scale (UW-SES) was originally developed for people with multiple sclerosis (MS) and spinal cord injury (SCI). This study evaluates the measurement invariance of the 6-item short form of the UW-SES across four disability subgroups. Evidence of measurement invariance would extend the UW-SES for use in two additional diagnostic groups: muscular dystrophy (MD) and post-polio syndrome (PPS).

Methods

Multi-group confirmatory factor analysis was used to evaluate successive levels of measurement invariance of the 6-item short form, the UW-SES: (a) configural invariance, i.e., equivalent item-factor structures between groups; (b) metric invariance, i.e., equivalent unstandardized factor loadings between groups; and (c) scalar invariance, i.e., equivalent item intercepts between groups. Responses from the four groups with different diagnostic disorders were compared: MD (n = 172), MS (n = 868), PPS (n = 225), and SCI (n = 242).

Results

The results of this study support that the most rigorous form of invariance (i.e., scalar) holds for the 6-item short form of the UW-SES across the four diagnostic subgroups.

Conclusions

The current study suggests that the 6-item short form of the UW-SES has the same meaning across the four diagnostic subgroups. Thus, the 6-item short form is validated for people with MD, MS, PPS, and SCI.
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2.

Objectives

We propose the application of a bifactor model for exploring the dimensional structure of an item response matrix, and for handling multidimensionality.

Background

We argue that a bifactor analysis can complement traditional dimensionality investigations by: (a) providing an evaluation of the distortion that may occur when unidimensional models are fit to multidimensional data, (b) allowing researchers to examine the utility of forming subscales, and, (c) providing an alternative to non-hierarchical multidimensional models for scaling individual differences.

Method

To demonstrate our arguments, we use responses (N =  1,000 Medicaid recipients) to 16 items in the Consumer Assessment of Healthcare Providers and Systems (CAHPS©2.0) survey.

Analyses

Exploratory and confirmatory factor analytic and item response theory models (unidimensional, multidimensional, and bifactor) were estimated.

Results

CAHPS© items are consistent with both unidimensional and multidimensional solutions. However, the bifactor model revealed that the overwhelming majority of common variance was due to a general factor. After controlling for the general factor, subscales provided little measurement precision.

Conclusion

The bifactor model provides a valuable tool for exploring dimensionality related questions. In the Discussion, we describe contexts where a bifactor analysis is most productively used, and we contrast bifactor with multidimensional IRT models (MIRT). We also describe implications of bifactor models for IRT applications, and raise some limitations.
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3.

Purpose

Efficient management of fibromyalgia (FM) requires precise measurement of FM-specific symptoms. Our objective was to assess the measurement properties of the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue item bank (FIB) in people with FM.

Methods

We applied classical psychometric and item response theory methods to cross-sectional PROMIS-FIB data from two samples. Data on the clinical FM sample were obtained at a tertiary medical center. Data for the U.S. general population sample were obtained from the PROMIS network. The full 95-item bank was administered to both samples. We investigated dimensionality of the item bank in both samples by separately fitting a bifactor model with two group factors; experience and impact. We assessed measurement invariance between samples, and we explored an alternate factor structure with the normative sample and subsequently confirmed that structure in the clinical sample. Finally, we assessed whether reporting FM subdomain scores added value over reporting a single total score.

Results

The item bank was dominated by a general fatigue factor. The fit of the initial bifactor model and evidence of measurement invariance indicated that the same constructs were measured across the samples. An alternative bifactor model with three group factors demonstrated slightly improved fit. Subdomain scores add value over a total score.

Conclusions

We demonstrated that the PROMIS-FIB is appropriate for measuring fatigue in clinical samples of FM patients. The construct can be presented by a single score; however, subdomain scores for the three group factors identified in the alternative model may also be reported.
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4.

Purpose

In the absence of measurement invariance across measurement occasions, change scores based on pretest–posttest measurements may be inaccurate representations of real change on the latent variable. In this study, we examined whether measurement invariance held in the Dutch version of Outcome Questionnaire-45 (OQ-45).

Method

Using secondary data analysis of a sample of N?=?540 Dutch outpatients, we tested the stability of the factorial structure (gamma change) and the metric and scalar invariance (beta change) across pretest and posttest measurements using a combination of factor analysis and item response theory methodology.

Results

Results revealed a stable factorial structure from pretest to posttest and minor violations of metric invariance for two items in the Dutch OQ-45.

Conclusion

Even though for two items the assumption of invariance was violated, results suggest that the effects of these violations on practical change assessment using the OQ-45 were negligible.
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5.

Purpose

The Profile of Mood States-Short Form (POMS-SF) is a well-validated tool commonly used in medical/clinical research. Less attention has been paid to the measurement invariance of the POMS—the degree to which the structure and items behave similarly for different groups (e.g., women and men). This study investigated the measurement invariance of the POMS Depression subscale across gender groups in a sample of cancer survivors.

Methods

The POMS Depression subscale has 8 items (Unhappy, Sad, Blue, Hopeless, Discouraged, Miserable, Helpless, and Worthless). Invariance was measured using multigroup confirmatory factor analysis. This study used data from American Cancer Society Studies of Cancer Survivors-II, a population-based survey of adult cancer survivors (n = 9170).

Results

We found factor structures and factor loadings were invariant for gender groups, but moderate differential item functioning (DIF) in the question containing the word blue.

Conclusion

With regard to cancer survivors’ gender, we found the Depression subscale of the POMS-SF had configural invariance, and partial metric and scalar invariance. This suggests that results should be interpreted with caution, especially when gender is considered important. More broadly, our finding suggests that questions with the word blue may introduce DIF into other measures of depressive mood. More research is needed to replicate these findings in other samples and with other instruments.
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6.

Purpose

Comparability of patient-reported outcome measures over different languages is essential to allow cross-national research. We investigate the comparability of the PROMIS Profile 29, a generic health-related quality of life measure, in general population samples in the UK, France, and Germany and present general population reference values.

Methods

A web-based survey was simultaneously conducted in the UK (n?=?1509), France (1501), and Germany (1502). Along with the PROMIS Profile 29, we collected sociodemographic information as well as the EQ-5D. We tested measurement invariance by means of multigroup confirmatory factor analysis (CFA). Differences in the health-related quality of life between countries were modeled by linear regression analysis. We present general population reference data for the included PROMIS domains utilizing plausible value imputation and quantile regression.

Results

Multigroup CFA of the PROMIS Profile 29 showed that factor means are insensitive to potential measurement bias except in one item. We observed significant differences in patient-reported health between countries, which could be partially explained by the differences in overall ratings of health. The physical function and pain interference scales showed considerable floor effects in the normal population in all countries.

Conclusions

Scores derived from the PROMIS Profile 29 are largely comparable across the UK, France, and Germany. Due to the use of plausible value imputation, the presented general population reference values can be compared to data collected with other PROMIS short forms or computer-adaptive tests.
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7.

Background

There has been a marked tendency for researchers, clinicians, and policy makers to shift their focus from risk to resilience. This should be assessed by comparing the outcome to a context specific reference group.The objectives of the study were to generate normative data for the BRCS for different age groups for men and women and to further investigate the construct validity and factor structure in a general population.

Methods

Nationally representative face-to face household surveys were conducted in Germany in 2013 (n?=?2508).

Results

Normative data for the BRCS were generated for men and women (53.2% female) and different age levels (mean age (SD) of 49.7 (18.0) years). Men had significantly higher mean scores compared with women (14.9 [SD?=?3.2] vs. 14.6 [SD?=?3.1]). The results of the EFA and CFA clearly indicate a unidimensional solution with one factor. Furthermore, the invariance of the one-factor model was tested for the whole sample across gender and six age groups.

Conclusions

The normative data provide a framework for the interpretation and comparisons of resilience with other populations.
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8.

Background

Stunting results from decreased food intake, poor diet quality, and a high burden of early childhood infections, and contributes to significant morbidity and mortality worldwide. Although food insecurity is an important determinant of child nutrition, including stunting, development of universal measures has been challenging due to cumbersome nutritional questionnaires and concerns about lack of comparability across populations. We investigate the relationship between household food access, one component of food security, and indicators of nutritional status in early childhood across eight country sites.

Methods

We administered a socioeconomic survey to 800 households in research sites in eight countries, including a recently validated nine-item food access insecurity questionnaire, and obtained anthropometric measurements from children aged 24 to 60 months. We used multivariable regression models to assess the relationship between household food access insecurity and anthropometry in children, and we assessed the invariance of that relationship across country sites.

Results

Average age of study children was 41 months. Mean food access insecurity score (range: 0–27) was 5.8, and varied from 2.4 in Nepal to 8.3 in Pakistan. Across sites, the prevalence of stunting (42%) was much higher than the prevalence of wasting (6%). In pooled regression analyses, a 10-point increase in food access insecurity score was associated with a 0.20 SD decrease in height-for-age Z score (95% CI 0.05 to 0.34 SD; p?=?0.008). A likelihood ratio test for heterogeneity revealed that this relationship was consistent across countries (p?=?0.17).

Conclusions

Our study provides evidence of the validity of using a simple household food access insecurity score to investigate the etiology of childhood growth faltering across diverse geographic settings. Such a measure could be used to direct interventions by identifying children at risk of illness and death related to malnutrition.
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9.

Purpose

The psychometric property of the Dermatology Life Quality Index (DLQI) is underappreciated in public health settings. Our study aimed to assess the reliability, validity, and measurement invariance of DLQI in a homogeneous population with arsenic-related skin lesions and symptoms.

Methods

A cross-sectional study was conducted in communities under lifetime arsenic exposure. The DLQI was measured through a face-to-face interview. Skin examinations were performed by certificated dermatologists. The intensity of itching was measured by a numerical rating scale. Reliability, structural validity, and measurement invariance were determined using classical and modern test theories, including confirmatory factor analysis and item response models.

Results

465 participants with arsenic-related skin lesions and symptoms completed the DLQI assessment. The Cronbach’s alpha was 0.79, and the split-half reliability was 0.77. A two-factor model exhibited the best model fit among models evaluated, but local dependencies among items were identified. The model showed good root mean square error of approximation (0.031) and acceptable Tucker–Lewis index (0.92). Multi-group confirmatory factor analysis showed no measurement invariance across subgroups of age, gender, ethnicity, and intensity of itching.

Conclusions

The DLQI had acceptable psychometric properties, but measurement invariance was not observed across different groups of participants.
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10.

Background

Bone complications, also known as skeletal-related events (SREs), are common in patients with bone metastases secondary to advanced cancers.

Objective

To provide a detailed estimate of the health resource utilization (HRU) burden associated with SREs across eight European countries.

Methods

Eligible patients from centers in Austria, the Czech Republic, Finland, Greece, Poland, Portugal, Sweden, and Switzerland with bone metastases or lesions secondary to breast cancer, prostate, or lung cancer or multiple myeloma who had experienced at least one SRE (defined as radiation to bone, long-bone pathologic fracture, other bone pathologic fracture, surgery to bone or spinal cord compression) were entered into this study. HRU data were extracted retrospectively from the patients’ charts from 3.5 months before the index SRE until 3 months after the index SRE (defined as an SRE preceded by an SRE-free period of at least 6.5 months).

Results

Overall, the mean number of inpatient stays per SRE increased from baseline by approximately 0.5–1.5 stays, with increases in the total duration of inpatient stays of approximately 6–37 days per event. All SREs were associated with substantial increases from baseline in the frequency of procedures and the number of outpatient and day-care visits.

Conclusions

SREs are associated with substantial HRU owing to considerable increases in the number and duration of inpatient stays, and in the number of procedures, outpatient visits, and day-care visits. These data collectively provide a valuable summary of the real-world SRE burden on European healthcare systems.
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11.

Purpose

In order to test the difference between group means, the construct measured must have the same meaning for all groups under investigation. This study examined the measurement invariance of responses to the patient-reported outcomes measurement information system (PROMIS) pain behavior (PB) item bank in two samples: the PROMIS calibration sample (Wave 1, N = 426) and a sample recruited from the American Chronic Pain Association (ACPA, N = 750). The ACPA data were collected to increase the number of participants with higher levels of pain.

Methods

Multi-group confirmatory factor analysis (MG-CFA) and two item response theory (IRT)-based differential item functioning (DIF) approaches were employed to evaluate the existence of measurement invariance.

Results

MG-CFA results supported metric invariance of the PROMIS–PB, indicating unstandardized factor loadings with equal across samples. DIF analyses revealed that impact of 6 DIF items was negligible.

Conclusions

Based on the results of both MG-CFA and IRT-based DIF approaches, we recommend retaining the original parameter estimates obtained from the combined samples based on the results of MG-CFA.
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12.

Background

Although health technology assessment (HTA) systems base their decision making process either on economic evaluations or comparative clinical benefit assessment, a central aim of recent approaches to value measurement, including value based assessment and pricing, points towards the incorporation of supplementary evidence and criteria that capture additional dimensions of value.

Objective

To study the practices, processes and policies of value-assessment for new medicines across eight European countries and the role of HTA beyond economic evaluation and clinical benefit assessment.

Methods

A systematic (peer review and grey) literature review was conducted using an analytical framework examining: (1) ‘Responsibilities and structure of HTA agencies’; (2) ‘Evidence and evaluation criteria considered in HTAs’; (3) ‘Methods and techniques applied in HTAs’; and (4) ‘Outcomes and implementation of HTAs’. Study countries were France, Germany, England, Sweden, Italy, Netherlands, Poland and Spain. Evidence from the literature was validated and updated through two rounds of feedback involving primary data collection from national experts.

Results

All countries assess similar types of evidence; however, the specific criteria/endpoints used, their level of provision and requirement, and the way they are incorporated (e.g. explicitly vs. implicitly) varies across countries, with their relative importance remaining generally unknown. Incorporation of additional ‘social value judgements’ (beyond clinical benefit assessment) and economic evaluation could help explain heterogeneity in coverage recommendations and decision-making.

Conclusion

More comprehensive and systematic assessment procedures characterised by increased transparency, in terms of selection of evaluation criteria, their importance and intensity of use, could lead to more rational evidence-based decision-making, possibly improving efficiency in resource allocation, while also raising public confidence and fairness.
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13.

Purpose

A number of studies have reported differences in sense of mastery and perceived control across different subgroups. Yet, few have examined measurement invariance, an important prerequisite for valid comparisons. This study examines the factorial structure and measurement invariance of the perceived constraints (PC) facet of Pearlin and Schooler’s (1981) Sense of Mastery Scale (SM) which is a commonly used short form of the widely used SM scale.

Methods

Confirmatory factor analyses using AMOS and Mplus were conducted to explore dimensionality and test for measurement invariance in factor structure, factor loadings, intercepts, and residual variances across gender, age, education, income, and employment status in a large (N = 19,858), nationally representative sample of Norwegian males and females aged 16–100.

Results

The data supported a modified unidimensional model specifying correlations between the error terms of items 4 and 5, or possibly two highly correlated dimensions (r = 0.90). Metric invariance of the scale was shown for age, education, and employment, whereas invariance at the strong and strict levels was shown for gender and income. Partial invariance at the strong level was shown for age.

Conclusions

This Norwegian study supported a modified unidimensional structure for the abbreviated SM scale. Invariance testing indicated that comparisons across genders and income levels are unproblematic, whilst comparing mean scores across education and employment status is not justified. Latent, but not sum score means are comparable across age. Future studies using all 7 items of SM scale should provide more information on dimensionality and measurement invariance.
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14.

Background

A common hypothesis is that caregiving is deleterious to women’s mental health. International studies continue to emphasize the importance of mental health issues for women. Yet only a few researchers have used population-based surveys to explore the association between caregiving and depressive symptomatology in the context of the community, and even less is known about this aspect of Baby Boomer women in a global context.

Methods

The present study uses eight international surveys covering nineteen nations (N?=?15,100) and uses multilevel logistic models to examine possible linkages between caregiving and the likelihood of depressive symptoms among Baby Boomer women, when taking individual-level and country-level social factors into consideration.

Results

The various analyses found a significant variation in the likelihood of depressive symptoms among these Boomer women across the nations investigated and across both individual-level and country-level characteristics. The significant association of caregiving by women and the likelihood of depressive symptoms is related to their social status in some nations (OR?=?1.30; p?<?0.001). Boomer women living in countries with high rates of female participation in managerial/professional work (OR?=?1.04; p?<?0.05) and living in countries where women are often in vulnerable employment (OR?=?1.01; p?<?0.05) are at greater risk of depressive symptomatology.

Conclusions

These findings demonstrate that the depressive consequences of caregiving by women are, to some degree, contingent upon social context and structure. Policies aimed at promoting mental health among female Baby Boomers should therefore be context specific.
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15.

Background

Several Central and Eastern European (CEE) countries require cost-utility analyses (CUAs) to support reimbursement formulary listing. However, CUAs informed by local evidence are often unavailable, and the cost-effectiveness of the several currently reimbursed biologicals is unclear.

Aim

To estimate the cost-effectiveness as multiples of per capita GDP/quality adjusted life years (QALY) of four biologicals (infliximab, etanercept, adalimumab, golimumab) currently reimbursed in six CEE countries in six inflammatory rheumatoid and bowel disease conditions.

Methods

Systematic literature review of published cost-utility analyses in the selected conditions, using the United Kingdom (UK) as reference country and with study selection criteria set to optimize the transfer of results to the CEEs. Prices in each CEE country were pro-rated against UK prices using purchasing power parity (PPP)-adjusted per capita GDP, and local GDP per capita/QALY ratios estimated.

Results

Central and Eastern European countries list prices were 144–333 % higher than pro rata prices. Out of 85 CUAs identified by previous systematic literature reviews, 15 were selected as a convenience sample for estimating the cost-effectiveness of biologicals in the CEE countries in terms of per capita GDP/QALY. Per capita GDP/QALY values varied from 0.42 to 6.4 across countries and conditions (Bulgaria: 0.97–6.38; Czech Republic: 0.42–2.76; Hungary: 0.54–3.54; Poland: 0.59–3.90; Romania: 0.77–5.07; Slovakia: 0.55–3.61).

Conclusion

While results must be interpreted with caution, calculating pro rata (cost-effective) prices and per capita GDP/QALY ratios based on CUAs can aid reimbursement decision-making in the absence of analyses using local data.
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16.

Purpose

Measurement invariance issues should be considered during test construction. In this paper, we provide a conceptual overview of measurement invariance and describe how the concept is implemented in several different statistical approaches. Typical applications look for invariance over things such as mode of administration (paper and pencil vs. computer based), language/translation, age, time, and gender, to cite just a few examples. To the extent that the relationships between items and constructs are stable/invariant, we can be more confident in score interpretations.

Methods

A series of simulated examples are reported which highlight different kinds of non-invariance, the impact it can have, and the effect of appropriately modeling a lack of invariance. One example focuses on the longitudinal context, where measurement invariance is critical to understanding trends over time. Software syntax is provided to help researchers apply these models with their own data.

Results

The simulation studies demonstrate the negative impact an erroneous assumption of invariance may have on scores and substantive conclusions drawn from naively analyzing those scores.

Conclusions

Measurement invariance implies that the links between the items and the construct of interest are invariant over some domain, grouping, or classification. Examining a new or existing test for measurement invariance should be part of any test construction/implementation plan. In addition to reviewing implications of the simulation study results, we also provide a discussion of the limitations of current approaches and areas in need of additional research.
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17.

Purpose

Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric forms measure symptoms and function of pediatric patients experiencing chronic disease by using the same measures. Comparability is one of the most important purposes of the PROMIS initiative. This study aimed to test the factorial structures of four symptom measures (i.e., Anxiety, Depression, Fatigue, and Pain Interference) in the original English and the Chinese versions and examine the measurement invariance of the measures across two cultures.

Methods

Four PROMIS Pediatric measures were used to assess symptoms, respectively, in Chinese (n = 232) and American (n = 200) children and adolescents (8–17 years old) in treatment for cancer or in survivorship. The categorical confirmatory factor analysis (CCFA) model was used to examine factorial structures, and multigroup CCFA was applied to test measurement invariance of these measures between the Chinese and American samples.

Results

The CCFA models of the four PROMIS Pediatric symptom measures fit the data well for both the Chinese and American children and adolescents. Minor partial measurement invariance was identified. Factor means and factor variances of the four PROMIS measures were not significantly different between the two populations.

Conclusions

Our results provide evidence that the four PROMIS Pediatric symptom measures have valid factorial structures and a statistical property of measurement invariance across American and Chinese children and adolescents with cancer. This means that the items of these measures were interpreted in a conceptually similar manner by two groups. They could be readily used for meaningful cross-cultural comparisons involving pediatric oncology patients in these two countries.
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18.

Background

This study examines the construct validity of the Areas of Worklife Short Scale, a practical instrument to measure employees’ perceptions of their work environments in the sample of secondary obligatory education teachers in Spain.

Methods

Conducted in 33 centers of secondary obligatory education in Spain (N?=?677). Confirmatory Factor analysis for 3 different models for the 29-items version and 1 model for the 18-items version was tested.

Results

Results confirmed that the short AWS short version had the best fit to the data than any other model proposed (GFI-Satorra-Bentler scaled chi-squared?=?320.19, ×?2/df?=?2.337) and good fit indices (CFI?=?0.911; RMSEA?=?0.046).

Conclusions

This analysis ultimately supports the appropriateness of AWS short version to explore areas of worklife and therefore can indicate the factors that contribute to burnout in the sample of secondary obligatory education teachers in Spain. Therefore it has been confirmed that this tool is able to assess the 6 domains of work environment of secondary schools teachers.
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19.

Background

Occupational exposure is known to play a role in the aetiology of lymphomas. The aim of the present work was to explore the occupational risk of the major B-cell lymphoma subtypes using a case–control study design.

Methods

From 2009 to 2014, we recruited 158 lymphoma cases and 76 controls in the provinces of Bari and Taranto (Apulia, Southern Italy). A retrospective assessment of occupational exposure based on complete work histories and the Carcinogen Exposure (CAREX) job-exposure matrix was performed.

Results

After adjusting for major confounding factors, farmers showed an increased risk of diffuse large B-cell lymphoma (DLBCL) [odds ratio (OR)?=?10.9 (2.3–51.6)] and multiple myeloma (MM) [OR?=?16.5 (1.4–195.7)]; exposure to the fungicide Captafol was significantly associated with risk of non-Hodgkin lymphoma (NHL) [OR?=?2.6 (1.1–8.2)], particularly with the risk of DLBCL [OR?=?5.3 (1.6–17.3)].

Conclusions

Agricultural activity seems to be a risk factor for developing lymphoma subtypes, particularly DLBCL, in the provinces of Bari and Taranto (Apulia Region, Southern Italy). Exposure to the pesticides Captafol, Paraquat and Radon might be implicated.

Trial registration

Protocol number UNIBA 2207WEJLZB_004 registered 22/09/2008.
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20.

Objective

Compare the response of basic periodontal therapy in diabetes patients with diabetes type 1 and type 2.

Materials and methods

We selected 70 patients with periodontitis; these were divided into three groups: the control group (n?=?11), systemically healthy patients; test group 1 (n?=?14), patients with type 1 diabetes mellitus; test group 2 (n?=?27), patients with type 2 diabetes mellitus. The groups received basic periodontal treatment after clinical examination. The analyses were performed at 0, 3 and 6 months; clinical parameters included the amount of periodontal and gingival crevicular fluid. Glycated hemoglobin (HbA1c) levels and prostaglandin E2 (PGE2) expression were measured.

Results

All clinical periodontal parameters evaluated improved in both groups, as did the amount of gingival crevicular fluid. A more significant decrease in HbA1c and PGE2 expression (p?<?0.05) occurred in test group 1 after 6 months.

Conclusion

The basic periodontal treatment was more effective for glycemic control in patients with type 1 diabetes mellitus.
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