Development and content validity of a gastroparesis cardinal symptom index daily diary

Background  The Gastroparesis Cardinal Symptom Index (GCSI) is a patient-reported outcome for gastroparesis using a two-week recall period. To minimize potential patient recall effects, a daily diary version of the GCSI (GCSI-DD) was developed.
Aims  To evaluate the content validity of GCSI-DD for the symptoms in patients with documented gastroparesis, to capture symptom variability over time and to compare responses of this GCSI-DD to the original GCSI.
Methods  In gastroparesis adults with delayed gastric emptying, cognitive debriefing interviews were conducted to elicit their perspective on relevant symptoms of gastroparesis and relevant recall periods and to evaluate patient understanding of GCSI-DD. Patients completed the GCSI-DD daily over a 2-week period and completed the GCSI at baseline and the 2-week follow-up visit.
Results  Twelve gastroparesis patients, of whom five were diabetic and nine women, reported nausea (100%), vomiting (100%), stomach fullness (75%), bloating (58%) and loss of appetite (50%) were important symptoms. All patients understood diary instructions and item content and reported that the diary captured their gastroparesis symptom experience; 83% considered response scales adequate. There was significant daily variability in GCSI-DD scores. Mean GCSI-DD subscale and total scores over 2 weeks correlated strongly (all r  > 0.90) with GCSI scores at 2-week follow-up.
Conclusions  The GCSI-DD includes symptoms relevant to patients with gastroparesis, captures daily variability of those symptoms and has psychometric properties consistent with a good patient-reported outcome endpoint for gastroparesis clinical trials.     

Development and validation of the Diabetes Bowel Symptom Questionnaire

BACKGROUND: Although gastrointestinal symptoms occur frequently, there is no validated measure of gastrointestinal symptoms in patients with diabetes mellitus. AIM: To develop the Diabetes Bowel Symptom Questionnaire. METHODS: A questionnaire derived from previously validated symptom measures was compiled to assess all relevant gastrointestinal and diabetes items. Face and content validity were ascertained by expert review. One hundred and sixty-eight patients with diabetes mellitus completed the instrument, and reliability was evaluated by a test-re-test procedure 1 week later. Concurrent validity was evaluated by an independent physician interview (n = 33). Measures of glycaemic control (glycated haemoglobin and plasma glucose) were compared with self-reported glycaemic control on a five-point Likert scale in diabetic out-patients (n = 166). RESULTS: The questionnaire had adequate face and content validity. There was good to excellent test-re-test reliability for the gastrointestinal and diabetes items (median kappa: 0.63 and 0.79, respectively); concurrent validity was good to excellent (median kappa: 0.47 and 0.65, respectively), except for the items assessing the severity of gastrointestinal symptoms. Both glycated haemoglobin (P < 0.0001) and plasma glucose (P = 0.005) correlated significantly with self-reported glycaemic control. CONCLUSION: The Diabetes Bowel Symptom Questionnaire appears to be a useful measure of gastrointestinal symptoms and glycaemic control in diabetes mellitus, and should have applicability in epidemiological and clinical studies.     

Development and initial validation of the alcohol-induced blackout measure

BackgroundBlackouts are common among young adults and predict alcohol-related harm. However, existing measures do not capture the range of alcohol-induced memory impairment involved in blackout experiences and do not differentiate between fragmentary and en bloc blackouts. This study aimed to develop and validate a brief, reliable measure of alcohol-induced blackouts among young adults.MethodsCollege students reporting alcohol-induced memory impairment in the past year were recruited via Qualtrics to participate in an online survey (N = 350, 56% female). A subsample (n = 109, 67% female) completed a one-month follow-up. Principal component analysis was used to determine the structure of the Alcohol-Induced Blackout Measure (ABOM), which was designed to reflect two components (fragmentary and en bloc blackouts). The reliability and validity of the total ABOM score was assessed.ResultsThe final five items fit in a two-component scale structure; however, a single principal component accounted for 73% of variance in blackout items, all of which demonstrated high component loadings and communalities. The total blackout score demonstrated strong internal consistency, test-retest reliability, and convergent and incremental validity. ABOM scores predicted alcohol-related consequences at baseline and one-month follow-up.ConclusionsThe ABOM is a brief and reliable, self-report measure that quantifies the frequency of a range of blackout experiences in the past 30 days. Accounting for this range of experiences improved predictive validity over single-item blackout measures. Blackout frequency is a strong, unique predictor of alcohol-related problems.     

Validation of a 7-point Global Overall Symptom scale to measure the severity of dyspepsia symptoms in clinical trials

BACKGROUND: Currently there is no consensus on the optimal method to measure the severity of dyspepsia symptoms in clinical trials. AIM: To validate the 7-point Global Overall Symptom scale. METHODS: The Global Overall Symptom scale uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem. Validation was performed in two randomized-controlled trials (n = 1121 and 512). Construct validity: Global Overall Symptom was compared with the Quality of Life in Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and 10 specific symptoms using Spearman correlation coefficients. Test-retest reliability: The Intraclass Correlation Coefficient was calculated for patients with stable dyspepsia defined by no change in Overall Treatment Effect score over two visits. Responsiveness: effect size and standardized response mean were also calculated. RESULTS: Construct validity: Change in Global Overall Symptom score correlated significantly with Quality of Life for Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and specific symptoms (all P < 0.0002). Reliability: The Intraclass Correlation Coefficient was 0.62 (n = 205) and 0.42 (n = 270). Responsiveness: There was a positive correlation between change in Global Overall Symptom and change in symptom severity. The effect size and standardized response mean were 1.1 and 2.1, respectively. CONCLUSION: The Global Overall Symptom scale is a simple, valid outcome measure for dyspepsia treatment trials.     

Development and validation of a questionnaire to measure moral distress in community pharmacists

International Journal of Clinical Pharmacy - Background Pharmacists work within a highly-regulated occupational sphere, and are bound by strict legal frameworks and codes of professional conduct....     

Development and validation of the Japanese version of the problem gambling severity index

BackgroundThe Problem Gambling Severity Index (PGSI) has been the most frequently used instrument for prevalence studies of problem gambling in the 2010s. However, the Japanese version of the PGSI has yet to be developed.ObjectiveTo develop the Japanese version of the PGSI and to investigate its reliability and validity.Materials and methodsWe translated and back-translated the original version of the PGSI into Japanese. The author of the original PGSI confirmed the semantic equivalence between the original PGSI and its Japanese version. We examined the reliability and validity of the Japanese version of the PGSI using data from a nationwide prevalence study of problem gambling conducted in Japan in 2017.ResultsUsable responses were obtained from 5365 residents. The PGSI had excellent internal consistency (Cronbach's alpha coefficient: 0.89) and moderate test-retest reliability after 45–60 days (intraclass coefficient: 0.54). Exploratory factor analysis revealed the unidimensionality of the PGSI. As for criterion validity, using the diagnosis of gambling disorder in DSM-5 as a reference standard, the stratum specific likelihood ratios of the PGSI score of 0 = non-problem; 1–2 = low risk; 3–7 = moderate risk; and 8–27 = problem gambling were 0.00; 0.68 (95% confidence interval: 0.21 to 2.22); 8.71 (5.2 to 14.5); and 67.9 (35.6 to 129.5) respectively.ConclusionsWe recommend including the PGSI in future prevalence studies of problem gambling in Japan.     

Development and initial validation of a measure of motives for pregaming in college students

Objective

Pregaming (i.e., drinking alcohol prior to going out) is a common and risky drinking practice on college campuses. Yet, little is known about what motivates students to pregame as no motives measure exists specifically targeting pregaming. The current study describes the development and initial validation of a measure to assess motives for pregaming and to evaluate associations between these motives and pregaming behavior.

Method

In a multi-stage process using three different college samples, both qualitative (i.e., focus groups) and quantitative methods were used to derive the Pregaming Motives Measure (PGMM). After initial item generation (Stage I: N = 43, 74% male) and refinement with exploratory factor analysis (Stage II: N = 206, 61% male), a confirmatory factor analysis was performed to establish the structure of the PGMM (Stage III: N = 321, 34% male). The pattern of associations of the derived factors, pregaming behavior, and general drinking motives was explored to provide evidence for initial construct validity. Last, the indirect effect of pregaming motives on alcohol problems via pregaming behavior was assessed.

Results

Findings indicated that the PGMM differed both in content from general drinking motives and that the PGMM items generated load on factors labeled Inebriation/Fun, Instrumental, and Social Ease. Moreover, the Inebriation/Fun and Instrumental motives were significantly associated with pregaming behavior. PGMM motives also both directly and indirectly predicted alcohol-related consequences.

Conclusions

Findings corroborate other data on pregaming, suggesting that this behavior may be driven by desires for quick inebriation and conviviality and related to problems only via increased drinking. The PGMM offers targeted assessment of pregaming and other social drinking behavior that can lead to deleterious outcomes.     

Development and validation of a measure and a model of general practitioner attitudes toward collaboration with pharmacists

BackgroundCollaboration between general practitioners (GPs) and community pharmacists has been shown to be effective in improving patient outcomes. However, little is known about GP attitudes toward collaborating with their pharmacist counterparts and variables that influence this interprofessional collaboration.ObjectivesTo develop and validate, in the context of primary care in Australia 1) an instrument to measure GP attitudes toward collaborating with pharmacists and 2) a model that illustrates how GP attitudes (and other variables) influence GP-pharmacist collaborative behavior.MethodsThe “Attitudes Toward Collaboration Instrument for GPs” (ATCI-GP) was developed to measure GP attitudes toward GP-pharmacist collaboration based on existing literature and qualitative interviews with GPs and community pharmacists. The ATCI-GP and a previously validated behavioral measure “Frequency of Interprofessional Collaboration Instrument for GPs” (FICI-GP) were included in a survey and administered to a sample of 1145 GPs in 12 divisions of general practice across Australia. Principal component analysis (PCA) was used to assess the structure of the ATCI-GP. Structural equation modeling was used to determine how attitudes (measured by the ATCI-GP) and other variables, influence collaborative behavior (measured by the FICI-GP).ResultsThree hundred and seventy-six surveys were completed and returned for a response rate of 33%. PCA of the ATCI-GP suggested a two factor (“interactional and practitioner determinants” and “role for pharmacist in medication management”) solution accounting for 66.2% of the variance. The model for GP-pharmacist collaboration demonstrated adequate fit (χ²/df = 2.27, CFI = .99, RMSEA = .060, 90% CI [.052–.069]). Factors found to predict collaboration included: 1) Interactional and practitioner determinants 2) environmental determinants and 3) GP perception of the pharmacists' role in medication management.ConclusionsThe study provides evidence for the validity of the ATCI-GP for measuring GP-pharmacist collaboration from the GPs perspective and supports a model for collaboration in which collaborative behavior is influenced by a number of variables.     

Development and psychometric validation of a novel measure of sensory expectancies associated with E-cigarette use

IntroductionE-cigarette dependence measures largely focus on e-cigarette use (“vaping”) that is linked to nicotine use, and measures assessing sensory aspects of vaping that may influence use (e.g., taste) are limited in scope. Thus, we developed the novel Sensory E-cigarette Expectancies Scale (SEES).MethodsIn Summer 2017, 610 adult e-cigarette users (48.7% male, 84.9% White, 37.41[±12.15] years old) completed an online survey that included 23 SEES items. Psychometric analyses included evaluating latent structure, internal consistency, measurement invariance, mean differences, and test-criterion relationships.ResultsFactor analyses supported a 9-item, 3-subscale structure (taste/smell, pleasure/satisfaction, vapor cloud production). Subscales evidenced internal consistency and scalar invariance by sex, race, smoking status (current/not), vaping status (daily/not), e-liquid nicotine content (yes/no), and device type (cig-a-likes/vape-pens/Advanced Personal Vaporizers [APVs]/Mods). Women and daily e-cigarette users reported stronger SEEs for taste/smell and pleasure than their counterparts. Non-white participants reported stronger SEEs for cloud production than White participants. Cig-a-like users reported the weakest SEEs for taste/smell and weaker SEEs linked to cloud production than APV/mod users. SEES scores evidenced convergence with nicotine dependence (mean r = .36). Finally, SEES scores predicted vaping frequency and habitual vaping concurrently and incrementally beyond nicotine dependence.ConclusionsThe SEES evidenced good psychometric properties, suggesting that the measure can be used to assess sensory vaping expectancies in adults. Importantly, SEES scores indicated that sensory expectancies are related, yet distinct, from nicotine dependence. Future research should evaluate how SEEs relate to product characteristic preferences and patterns of vaping including the development and maintenance of addiction.     

The 12 Step Affiliation and Practices Scale: Development and initial validation of a measure assessing 12 step affiliation

Objective

Research on instruments designed to measure endorsement of 12 step beliefs and practices among individuals with substance use disorders is virtually nonexistent. The goal of this study was to examine the psychometric properties of a novel instrument called the 12 Step Affiliation and Practices Scale (TSAPS) using a sample of young adults receiving 12 step-based residential treatment for alcohol and drug dependence.

Method

As part of a naturalistic treatment outcome study, 300 young adults receiving residential treatment completed the TSAPS and several other assessments during and after treatment. Analyses of the TSAPS examined its factor structure, internal consistency, sensitivity to change over time, and convergent and predictive validity.

Results

A maximum likelihood estimation factor analysis using oblique rotation produced 4 factors accounting for 61.16% of the variance. Internal consistency was very high and scores on the TSAPS significantly increased across the course of treatment. Convergent validity was demonstrated by relationships with scales of treatment attitudes, twelve step expectancies and commitment to sobriety. Predictive validity was also found, as evidenced by a relationship between total TSAPS score at 3 months post-treatment and percent of abstinent days at 6 months post-treatment.

Conclusions

The TSAPS shows promise as a psychometrically sound, internally reliable measure of 12 step affiliation and practices among individuals with substance dependence.     

Development and validation of a diabetes mellitus severity index: a risk-adjustment tool for predicting health care resource use and costs

STUDY OBJECTIVE: To develop and validate a diabetes mellitus-specific risk-adjustment tool--the diabetes severity index (DSI)--to assist in predicting health care costs and resources within populations of patients with diabetes. DESIGN: Retrospective analysis of clinical and resource use for patients with a diagnosis of diabetes mellitus. Model estimation was conducted with half the sample, and validation analysis was conducted with the other half. SETTING: Southern Arizona Veterans Affairs Health Care System. PATIENTS: Seven hundred thirty-four patients with diabetes (710 men, 24 women; mean age 66 yrs). MEASUREMENTS AND MAIN RESULTS: Clinical measures of diabetes severity (known as the DSI) were used to predict three health care resource outcomes: risk of hospitalization, and total and ambulatory health care costs. Validity of the DSI was assessed by comparing the DSI with the revised chronic disease score (CDS). The DSI weights ranged from -471.5-3081.2 for total health care costs, from -304.3-1582.1 for outpatient costs, and -0.19-0.93 for risk of hospitalization. The DSI explained 6-8% of the variance in total and ambulatory costs and performed significantly (p<0.05) better than demographics alone, but was similar to the CDS. When the DSI was used with the CDS, up to 8% of variability in costs and use were explained. CONCLUSION: The DSI was developed to stratify veterans with diabetes according to diabetes severity and comorbidity. Since additional variance in medical care costs were explained by combining the DSI and CDS, the two indexes may explain different dimensions of a patient's severity of diabetes. However, the utility of such an index based on clinical measures to predict short-term use may be limited due to low yet significant variability explained in the outcomes.     

The Patient Health Questionnaire 12 Somatic Symptom scale as a predictor of symptom severity and consulting behaviour in patients with irritable bowel syndrome and symptomatic diverticular disease

Background Anxiety, depression and nongastrointestinal symptoms are often prominent in irritable bowel syndrome (IBS), but their relative value in patient management has not been quantitatively assessed. We modified the Patient Health Questionnaire 15 (PHQ‐15) by excluding three gastrointestinal items to create the PHQ‐12 Somatic Symptom (PHQ‐12 SS) scale. Aims To compare the value of the PHQ‐12 SS scale with the Hospital Anxiety and Depression (HAD) scale in predicting symptoms and patient behaviour in IBS and diverticular disease. Methods We compared 151 healthy volunteers (HV), 319 IBS patients and 296 patients with diverticular disease (DD), 113 asymptomatic [ASYMPDD] and 173 symptomatic DD (SYMPDD). Results Patient Health Questionnaire 12 SS scores for IBS and SYMPDD were significantly higher than HV. Receiver–operator curves showed a PHQ‐12 SS >6, gave a sensitivity for IBS of 66.4% with a specificity of 94.7% and a positive likelihood ratio (PLR) = 13.2, significantly better than that associated with an HAD anxiety score >7, PLR = 3.0 and depression score >7 PLR = 6.5. PHQ‐12 SS correlated strongly with IBS severity scale and GP visits in both IBS and DD. Conclusion The PHQ‐12 SS scale is a useful clinical tool which correlates with patient behaviour in both IBS and symptomatic DD.     

Development and validation of standardized severity rating scale to assess the consistency of drug-drug interaction severity among various drug information resources

BackgroundThe consistency in reporting the severity of drug interactions across the drug information resources is important in guiding the appropriate clinical use of drug-pairs, to minimize the associated adverse events. This necessitates the need of a standardized severity rating scale, that can accommodate the different severity ratings of the same interacting drug-pair into a reasonable severity category, that can ease the consistency assessment among different drug information resources.ObjectiveTo develop and validate a standardized severity rating scale that can ease the consistency assessment among the various drug information resources.MethodsThe definitions of various severity rating categories as documented in the eight drug information resources was consolidated to develop a standardized severity rating scale. Thus developed rating scale was validated using twenty commonly used drug-pairs. Fleiss' kappa score was used as an indicator for assessing overall consistency among various drug information resources, whereas, Cohen's kappa was used as an indicator of level of consistency between two drug information resources and between individual drug information resource and newly developed standardized severity rating scale.ResultsThe newly developed standardized severity rating scale classifies the severity of drug-drug interactions into three categories namely mild, moderate and major. The Fleiss' kappa score was improved from 0.047 to 0.176, indicating improved strength of agreement [Average pairwise agreement: 16% Vs 36.7%] among various drug information resources. The average pairwise Cohen's kappa was 0.082 [Strength of agreement: poor] in original severity ratings whereas it was improved to 0.198 [Strength of agreement: almost equal to fair] in standardized severity rating scale.ConclusionThe newly developed standardized severity rating scale can be used as a tool to assess the consistency of severity rating categories among the various drug information resources.     

Development and validation of an instrument to measure physicians' attitudes toward the clinical pharmacist's role

A scale to measure physicians' attitudes toward clinical pharmacy was developed and validated. Based on physician-clinical pharmacist interactions, statements were written and edited into tentative subscales. A preliminary test resulted in a reduction in the number of items and subscales. The final field test, based on responses from 166 physicians, after factor analysis, yielded 23 items in 5 subscales, with a scale reliability of 0.94. As additional measures of validity, physicians' responses showed significant differences in attitudes between subscales and differences by specialty. Differences also were demonstrated by physician status and age. No differences were shown by amount of exposure to clinical pharmacists. Reliability and validity of the scale have been supported and additional research into the concurrent validity of the scale is suggested.     

Assessing the responsiveness of a quality-of-life instrument and the measurement of symptom severity in essential hypertension

A pilot study was conducted to compare symptoms elicited with an open-ended question versus a checklist and to measure the responsiveness of quality-of-life measures to symptom severity. The pilot study was part of a multicentre, randomised, double-blind, placebo-controlled study of clentiazem, a calcium channel blocker, in the treatment of essential hypertension. Symptom and quality-of-life data were obtained from 88 patients at baseline and after 10 weeks of therapy by a trained telephone interviewer. Comparison of the symptom checklist and open-ended question method suggests that both methods are necessary to capture severe symptomatology. The 24-item checklist failed to elicit approximately 50% of the severe symptoms reported on the open question list. On the other hand, only 18% of the most severe symptoms subsequently reported on the checklist were first reported by the open question method. The responsiveness of quality-of-life measures to symptom severity was tested using a 20% change in symptom severity obtained from the checklist as the minimal clinically significant difference. Using Guyatt's formula, a minimum sample size of approximately 428 (alpha = 0.05, beta = 0.10) patients per treatment group is required to detect differences in measures of general health perception, anxiety, depression and limitations in social activities. A larger sample is required to show differences in leisure activities. Differences in limitations of the capability to perform house or yard work might be demonstrable with as few as 17 patients per group. This pilot study demonstrated that the severity of symptoms associated with hypertension, and the side effects of its treatment with drugs, are adequately captured by a symptom checklist preceded by an open-ended method of questioning. Responsiveness testing estimated the sample size required to show a statistically significant difference, assuming a 20% change in symptom severity.     

Reasons for alcohol use in young adulthood: validation of a three-dimensional measure

OBJECTIVE: To evaluate the reliability and validity of a measure of reasons for use, which is based on a cognitive mediational view of alcohol use as a means for affect regulation. METHOD: Data for this study were obtained from the Rutgers Health and Human Development Project. Self-reports of young men and women aged 25 to 31 years (N = 1,176; 598 women) were used to obtain measures of reasons for use, coping use, sex-enhancing use, use intensity and use problems. Regression analyses and structural equation modeling were used to assess a hypothesized model of relationships between these variables. RESULTS: Factor analysis of 33 reasons for use yielded three hypothesized dimensions: social reasons, disinhibition reasons and suppression reasons. Although moderately correlated with each other, they exhibited distinct relationships with other use variables. Increases in social reasons were related to decelerating increases in use intensity, but increases in disinhibition and suppression reasons were associated with accelerating increases in use intensity Social reasons did not relate to use problems, whereas suppression reasons were strongly related to use problems even when controlling for use intensity. CONCLUSIONS: Suppression reasons not only motivate reactive coping use in response to the appraisal of stressful situations, they are also likely to instigate "prophylactic" or proactive coping use in anticipation of the possible occurrence of stressors, thereby blunting the emotional impact of encounters that would otherwise have been appraised as stressful and aversive.