Evaluating patient-perceived control of atopic dermatitis: design,validation, and scoring of the Atopic Dermatitis Control Tool (ADCT)

Abstract

Objectives: The Atopic Dermatitis Control Tool (ADCT) was designed to evaluate patient-perceived AD control and facilitate patient–physician discussion on long-term disease control.

Methods: The study was performed in adult patients with AD. Development of the ADCT followed US Food and Drug Administration (FDA) guidelines on patient-reported outcome measures (PROMs). Qualitative research, including targeted literature review, interviews with clinical experts, and combined concept elicitation/cognitive debriefing with patients with AD, was conducted to provide a list of comprehensive concepts capturing AD control per physician and patient perspectives. Quantitative methods assessed psychometric properties of the instrument and defined the threshold for AD control.

Results: The resulting pilot six-item ADCT, reflecting key concepts related to AD control, had 7-day recall and assessed symptoms and impacts on patients’ everyday lives by severity and/or frequency. The ADCT showed good content validity (well understood by adult patients with AD), and quick completion time (<2?min). Psychometric analysis indicated no floor/ceiling effects for response distributions, particularly strong (r?≥?0.80) inter-item correlations for the six ADCT items, robust construct validity (r?>?0.50), and item-level discriminating ability (p?<?.03); this supported the derivation of a total score based on responses to all items. ADCT total score showed evidence of strong internal consistency reliability (Cronbach’s alpha >0.80). A score ≥7 points was identified as an optimum threshold to identify patients whose AD is “not in control.”

Conclusions: No single validated instrument has been available to holistically evaluate patient-perceived AD control. The newly developed ADCT displays good-to-excellent content validity, construct validity, internal consistency, reliability, and discriminating ability.     

Development of a family functioning scale for major depressive disorder

Abstract

Objective:

To better understand depression’s impact on family functioning from the perspectives of patients with major depressive disorder (MDD) and their partners; to develop and test patient and partner versions of a new self-reported measure, the Depression and Family Functioning Scale (DFFS), for use in clinical trials.     

抑郁症患者的家庭功能和对照料者生活质量的影响

目的探讨抑郁症患者的家庭功能及对照料者生活质量的影响。方法将抑郁症患者作为观察组,另选取一般家庭作为对照组,对患者家庭功能和照料者生活质量的评价采用家庭关怀度指数问卷及健康状况问卷进行调查,将其调查结果与一般家庭进行比较,对抑郁症的疾病负担进行评价。结果与对照组比较,抑郁症患者患病后家庭功能多存在障碍,两组间差异具有统计学意义(P<0.05);与患病前比较,抑郁症患者的家庭功能在患病后具有较高的出现障碍的比例,患病前后具有统计学意义(P<0.05);且其家庭关怀度指数问卷的总分及其各项观察指标得分在患病后明显低于患病前(P<0.05);对直接照料者的生活质量进行评定,与对照组进行比较,观察组的生理职能、一般健康、社会功能、情感职能及精神健康因子均具有较低的得分(P<0.05)。结论抑郁症对于患者家庭功能和直接照料者的生活质量会造成严重的影响,应该采取相应的措施给予积极的干预。     

The impact of antidepressant treatments on family functioning in adults with major depressive disorder: a post hoc comparison of vortioxetine and agomelatine

Objective: There is limited research on the impact of antidepressant treatment on family functioning. This study examines the impact of vortioxetine and agomelatine on family functioning using the Depression and Family Functioning Scale (DFFS).

Methods: The DFFS was included in REVIVE, a randomized, double-blind study of adults with major depressive disorder with inadequate response to antidepressant treatment who switched to vortioxetine or agomelatine. The prespecified DFFS analyses were performed using change from baseline to weeks 8 and 12, analyzed by mixed models for repeated measurements by treatment groups. Post hoc analyses compared DFFS scores for remitters and nonremitters. Patients were stratified into quartiles using DFFS scores, and scores on other clinical outcome assessments were compared.

Results: Sizeable improvements in DFFS scores were observed from baseline to week 8 (?10.8, ?7.9 for vortioxetine and agomelatine, respectively), with further improvements at week 12 (?13.5, ?11.0). Vortioxetine (n?=?189) was superior to agomelatine (n?=?187) by 2.9 DFFS points at week 8 (p?p?n?=?142) and nonremitters (n?=?233) differed by 11 DFFS points; at week 12, remitters (n?=?183) and nonremitters (n?=?121) differed by almost 12 DFFS points. Patients stratified into baseline DFFS quartiles showed trends on clinical outcomes such that better family functioning was associated with better functional status and depressive symptoms.

Conclusions: Vortioxetine was significantly superior to agomelatine in terms of family functioning and partner relationships, as well as social functioning, health status, and depression symptoms at weeks 8 and 12. Depressed patients with impaired family functioning showed worse overall functioning, health status, and depression symptoms, suggesting that more attention should be given to family functioning of depressed patients.     

Preliminary Psychometric Evaluation of the Hamilton Depression Rating Scale in Methamphetamine Dependence

Objective: The purpose of this study was to test the initial psychometric properties of the 17-item Hamilton Depression Rating Scale (HAM-D) in individuals with and without major depressive disorder who use methamphetamine. We used data from two completed studies and two ongoing clinical trials. The HAM-D has well established reliability and validity in a variety of populations. However, there are no published reports of reliability and validity of the HAM-D in a methamphetamine-using population. Methods: HAM-D and depression status data were extracted from four separate studies for this psychometric assessment. Using these data, we evaluated three measures of construct validity: internal consistency, contrasted group validity, and factorial validity. Results: We found potential concerns with the construct validity of the HAM-D in users of methamphetamine. Intercorrelations between items were primarily less than 0.20 and the Cronbach's alpha value in this sample was 0.58, indicating potential issues with internal consistency. The results of two-sample t-tests suggest concerns with contrasted group validity, as no significant difference in average scores were found for nine items. Consistent with previous studies, a principal component analysis indicates that the HAM-D is multidimensional. Conclusions: The 17-item HAM-D might not reliably and validly measure depression severity in a methamphetamine-using population. Given our small sample, additional research is needed, though, to further test the psychometric properties of the HAM-D in individuals who use methamphetamine.     

Family functioning and gambling problems in young adulthood: the role of the concordance of values

Background: Although young adult men are at an elevated risk for gambling problems (GP), compared to adolescents and adults in general this group is still largely unresearched. The current study investigates whether family functioning, which is associated with reduced risk for GP in adolescence, also affects gambling in young adults, who are more independent than minors. It analyses the relationship between GP and two core components of family functioning, the effectiveness of problem-solving in the family and perceived concordance of values.

Methods: Data came from the baseline, 12- and 24-month follow-up assessments of Munich Leisure-time Study (MLS), a longitudinal online study in young male gamblers. Young men were recruited via the Munich citizens’ registry (n?=?2,693) and Facebook invites (n?=?105). In total, n?=?173 individuals positively screened for frequent and/or regular gambling participated in the study. The hypothesised relations between problem-solving, concordance of values and GP were investigated with a path model controlling for non-planning impulsiveness and psychological distress.

Results: Higher concordance of family values was significantly related to less GP in cross-sectional and longitudinal analyses. It mediated the relation between the effectiveness of problem-solving and GP.

Conclusions: While previous studies indicated good family functioning as a factor preventive of GP, the current results indicate that this association is mediated by the perceived concordance of family values. In families with effective problem-solving, common family values might facilitate recognition of and reaction to first signs of problems. Perceived discordance may lead to feelings of shame and concealment of GP.     

住院抑郁症患者采用开放式家庭护理对其生活质量影响

目的探讨住院抑郁症患者采用开放性家庭式护理模式后,对其生活质量的影响。方法将符合入组标准的110例住院抑郁症患者随机分为实验组和对照组,各55例。两组均给予常规的抗抑郁药物治疗,实验组采用开放性家庭式护理模式,对照组则采用常规的护理模式。使用生活质量评定量表（QOL-100）作为评价工具,分别于入组时和治疗8周后进行评定。结果入组时两组患者的（QOL-100）各因子得分及总评分比较均无统计学意义（P〉0．05）,治疗8周后,实验组患者的生活质量总评分及生活、心理、独立性、社会关系领域、环境领域得分均优于对照组（P〈0．01）。结论开放性家庭护理模式能明显改善住院抑郁症患者的生活质量,有利于患者及早回归社会。     

Psychometric validation of the electronic chronic pain questions (eCPQ) in a primary care setting

Objective: Collecting data that helps evaluate different types of pain may improve physicians’ decision-making with regard to treatment selection and on-going monitoring of patients. To date, no chronic pain assessments have been widely implemented in primary care. The aim of this study was to psychometrically validate the electronic Chronic Pain Questions (eCPQ) in a primary care setting.

Research design and methods: All men and women ≥18 years arriving at two similar primary care clinics in southeastern Michigan were invited to participate. Clinic staff verbally administered the eCPQ to patients and recorded their answers into the electronic medical record (EMR) prior to physician consultation with results available for physician review. Concurrent validity was assessed using Spearman correlations between eCPQ and patient-completed ancillary measures. Known-group validity was assessed by stratifying patients on self-reported chronic pain as well as by pain diagnosis (i.e. ICD-9 codes). To compare patients with chronic pain versus no chronic pain t-tests and chi-square tests were performed. Reproducibility was assessed between interviewer- and self-administration over time.

Results: A total of 534 patients were invited to participate and 455 patients consented to take part in the study (85.2% response rate); 395 patients had analyzable eCPQ data; 70.1% were Caucasian; 68.1% female; mean age was 43.4; 52.7% (n?=?208) self-reported chronic pain. Correlations between eCPQ and ancillary measures supported concurrent validity. Excellent discrimination between groups was evidenced based on self-reported chronic pain and ICD-9 diagnosis. Patients with self-reported chronic pain reported significantly (p?Key limitations: Discriminant validity was determined by comparing participants based on ICD codes. Utilizing ICD codes to identify individuals with chronic pain may not be a reliable approach as it is dependent upon providers accurately and consistently entering chronic pain diagnoses in the EMR.

Conclusions: The eCPQ has sound psychometric measurement properties, including concurrent validity, discriminant validity, and reproducibility. The eCPQ appears to be useful to identify patients with chronic pain and to assess and monitor symptoms over time.     

Development of the Rheumatoid Arthritis Symptom Questionnaire (RASQ): a patient reported outcome scale for measuring symptoms of rheumatoid arthritis

Background: Rheumatoid arthritis (RA), a chronic, progressive inflammatory, autoimmune disease, can substantially reduce health-related quality of life (HRQoL) and lead to severe disability and early mortality. Patient-reported outcome (PRO) instruments are used to assess the patient experience of RA symptoms and impacts, and can capture RA treatment effects. To address limitations in existing PRO instruments, this research aimed to establish the content validity of a new instrument, the Rheumatoid Arthritis Symptom Questionnaire (RASQ), to assess the signs and symptoms of RA.

Method: The most important and relevant sign and symptom concepts for RA patients were identified through a targeted review of the published literature, expert opinion, and concept elicitation patient interviews. Cognitive interviews were conducted with patients to test the comprehensibility and comprehensiveness of the RASQ.

Results: Seven symptoms emerged consistently across the conceptual research: joint pain, joint swelling, joint stiffness, joint tenderness, joint warmth, muscle pain, and tiredness. Draft item content was developed to assess these symptoms, in addition to a single impact item, resulting in three RASQ versions: two utilizing a 7?day recall period (one assessing symptoms at their worst, the other on average) and a third using a 24?hour recall period assessing symptoms at their worst. Cognitive interview results demonstrated patient understanding and ability to use the instrument.

Conclusions: Content validity of the RASQ was established in accordance with instrument development guidelines. The RASQ fills a measurement gap by assessing the RA signs and symptoms most important to patients. Research evaluating the RASQ’s psychometric properties is underway.     

Influence of organizational functioning on client engagement in treatment

This study focused on the relationship between organizational functioning factors measured in a staff survey using the Texas Christian University (TCU) Organizational Readiness for Change assessment and client-level engagement measured by the TCU Client Evaluation of Self and Treatment in drug treatment programs. The sample consisted of 531 clinical and counseling staff and 3,475 clients from 163 substance abuse treatment programs located in nine states from three regional Addiction Technology Transfer Centers. Measures of client engagement in treatment (rapport, satisfaction, and participation) were shown to be higher in programs with more positive staff ratings of organizational functioning. In particular, these programs had fewer agency needs and more favorable ratings for their resources, staff attributes, and climate. These findings help establish the importance of addressing organizational factors as part of an overall strategy for improving treatment effectiveness.     

抑郁症患者自尊相关因素研究

目的:探讨抑郁症患者自尊与家庭环境的关系.方法:采用家庭环境量表和自尊量表(SES)对90例抑郁症患者进行调查问卷,然后进行数据统计分析.结果:抑郁症患者的家庭环境与国内常模比较差异有显著性(P＜0.01).其中抑郁症患者在家庭亲密度、成功性、文化性、娱乐性和组织性方面显著低于国内常模,且矛盾性明显为高.抑郁症患者的家庭亲密度、情感表达、独立性、成功性与自尊之间呈正相关(P＜0.01～0.05).结论:抑郁症患者的自尊水平与家庭环境有关.     

Family functioning as a predictor of progress in substance abuse treatment

This study tested the hypothesis that the level of family functioning is related to changes in the patient's progress while in treatment. We studied the relation of family functioning, as measured by the Family Adaptability and Cohesion Scales' (FACES II) dimensions of cohesion and adaptability, to 7 dimensions of the severity of patient drug use, as measured by the Addiction Severity index (ASI). The results indicated that family functioning, the cohesion dimension in particular, predicts severity of patient's dysfunction resulting from drug use and family and psychological problems. In particular, 28% of the variability in the ASI Drug Problems, 52% of the variability in the ASI Family Problems, and 29% of the variability in the ASI Psychological Problems were accounted for by the FACES II cohesion score. Although the study has several limitations, it supports the relevance of family factors in the treatment of drug-addicted patients.     

浅析药品生产设备的清洁验证

2011年国家颁布新修订的《药品生产质量管理规范》,对药品生产中如何防止污染与交叉污染提出了更加明确的要求。药品生产后必须对相应设施采取一定的程序进行清洗,防止药物成分残留到下一批产品中,形成交叉污染,影响产品质量,甚至造成质量事故。而清洁验证是证实清洗程序合理性的必要技术手段。目前,部分药品生产企业在清洁验证实施中存在着验证目标产品选择不当、残留限度确定不准确、验证状态难以保持等多方面的问题。本文从清洁验证的范围、常规要求、残留物接受限度的确定、产品与设备评估等方面对清洁验证进行全面的阐述。     

Assessment of symptom change from improvement curves on the Hamilton depression scale in trials with antidepressants

A total of 97 patients, who participated in two studies on the relationship between the clinical effect and plasma levels of imipramine and clomipramine, were examined for improvement curves by use of weekly ratings on the Hamilton Depression Scale (HDS). Although we confirmed that our six-item HDS subscale, in contrast to the total 17-item HDS, was a one-dimensional measure of depression, the Rasch analysis showed that the weekly improvement in subscale scores only applied to the individual patient, i.e. an average improvement curve for a group of depressed patients is an abstraction to which the individual curves cannot be transferred. Our results indicate, however, that when the subscale scores are transformed into three clinical categories of depression: no, mild (minor), moderate/-severe (major) they could be described by a common improvement curve for all patients. This is illustrated by the percentage of patients who, week to week, changed from major to minor or no depression, or from minor to no depression. We found no specific improvement pattern for imipramine or clomipramine which could be used diagnostically. There is reason to assume that patients completing a controlled trial necessarily will follow a monotonic improvement curve, and the improvement pattern of all patients fulfilling the entry criteria should, therefore, always be reported. The present study thus indicates that calculation of average improvement curves is neither clinically nor statistically meaningful, and should be replaced by measures of changes in number of patients in different main severity categories, or by the final rating score. No difference in outcome between imipramine and clomipramine was shown neither on the subscale nor on the 17-item HDS.     

Psychometric validation of the Patient Symptom Assessment in Lung Cancer instrument for small cell lung cancer

ABSTRACT

Objective: Patient Symptom Assessment in Lung Cancer (PSALC) is a symptom scale developed for use in patients with small cell lung cancer (SCLC) to assess nine lung cancer symptoms (shortness of breath, cough, chest pain, hemoptysis, appetite loss, sleep interference, hoarseness, fatigue, interference with daily activities) scored from 1 (not at all) to 4 (very much). This study aims to retrospectively evaluate the psychometric properties of PSALC using clinical trial data.

Methods: Data were analyzed from a randomized, open-label, multicenter trial with 211 patients with SCLC receiving IV topotecan versus cyclophosphamide, doxorubicin, and vincristine. PSALC was evaluated at baseline and at 3-week intervals. Internal consistency, reliability, construct validity, and responsiveness were evaluated.

Results: Factor analysis indicated that one factor could represent all symptom items, so a PSALC total score (PSALC-TS) was used for psychometric validation. Internal consistency was supported by Cronbach's alpha of 0.74. Reliability of PSALC was supported by an intraclass correlation coefficient of 0.61 and concordance correlation coefficient of 0.72. Construct validity was supported by associations of lower PSALC-TS (less severe symptoms) with better ECOG performance status (?p < 0.0001), and of PSALC-TS changes with clinical response. PSALC?TS was responsive to tumor progression (responsiveness statistic = 0.64).

Limitations: The validation was performed retro­spectively and was limited by small sample sizes at later assessment timepoints due to disease progression.

Conclusions: A retrospective analysis suggests that the PSALC is a reliable, valid, and responsive instrument for measuring SCLC symptoms. If feasible in this population, a prospective validation study could be used to further evaluate these findings.     

家庭功能在初发脑卒中后抑郁病人病耻感与不良情绪间的中介作用分析

目的 探讨家庭功能在初发脑卒中后抑郁（PSD）病人病耻感与不良情绪间的中介作用,为促进PSD病人身心健康提供临床依据。方法 选取2019年1月至2021年5月在石家庄市妇幼保健院收治的231例初发PSD病人作为研究对象,采用激惹、抑郁和焦虑自评量表（IDA）、脑卒中病人病耻感量表（SSS）及家庭功能评价量表（APGAR）评估研究对象不良情绪、病耻感及家庭功能状况,并采用Pearson法分析三者间的相关性,结构方程模型进一步检验家庭功能在病耻感与负性情绪间的中介效应。结果 初发PSD病人IDA评分（62.32±5.85）分,SSS评分（57.69±4.10）分,APGAR评分（4.56±2.10）分;Pearson相关性分析得知,PSD病人APGAR评分与SSS评分呈负相关（r=-0.44,P<0.001）,与IDA评分呈负相关（r=-0.49,P<0.001）,SSS评分与IDA评分呈正相关（r=0.47,P<0.001）;中介模型提示,家庭功能在病耻感与不良情绪间起中介作用（β=0.36,P<0.001）。本研究中,间接效应>直接效应,中介效应占总效应的...