A Conceptual Model of the Experience of Dyspnea and Functional Limitations in Chronic Obstructive Pulmonary Disease

Objectives:  Identify important patient-reported concepts of dyspnea and associated activities to develop a dyspnea-specific conceptual model for chronic obstructive pulmonary disease (COPD).
Methods:  Using grounded theory methodologies, we identified key concepts through interviews with 25 COPD patients, review of scientific literature, and input from 22 experts.
Results:  Constant comparative thematic analysis of data suggested five primary components of the dyspnea experience: breathlessness, fatigue, activity modification, activity limitation, and emotional response. Two major influences on dyspnea were described as individual exertion and exposure to environmental factors. Patients described a sense of dyspnea-related fear, and reported distress over the impact of dyspnea on health and activity limitation. They emphasized coping via behavioral strategies and medication, and reported that dyspnea caused the stopping or scaling back of activities, taking more time to do things and using adaptive measures or equipment. No existing model of dyspnea in COPD incorporated all of these concepts. We, therefore, developed a dyspnea-specific conceptual model in which the most proximal of concepts (dyspnea symptoms) can impair function and are mediated by personal and environmental factors.
Conclusion:  Patient and expert input guided the development of a comprehensive dyspnea-specific conceptual model for COPD which will inform the design of future patient-reported outcome measurement tools used to assess dyspnea and related functional limitations.     

Item Reduction and Psychometric Validation of the Oily Skin Self Assessment Scale (OSSAS) and the Oily Skin Impact Scale (OSIS)

IntroductionDeveloped using focus groups, the Oily Skin Self Assessment Scale (OSSAS) and Oily Skin Impact Scale (OSIS) are patient-reported outcome measures of oily facial skin.ObjectiveThe aim of this study was to finalize the item-scale structure of the instruments and perform psychometric validation in adults with self-reported oily facial skin.MethodsThe OSSAS and OSIS were administered to 202 adult subjects with oily facial skin in the United States. A subgroup of 152 subjects returned, 4 to 10 days later, for test–retest reliability evaluation.ResultsOf the 202 participants, 72.8% were female; 64.4% had self-reported nonsevere acne. Item reduction resulted in a 14-item OSSAS with Sensation (five items), Tactile (four items) and Visual (four items) domains, a single blotting item, and an overall oiliness item. The OSIS was reduced to two three-item domains assessing Annoyance and Self-Image. Confirmatory factor analysis supported the construct validity of the final item-scale structures. The OSSAS and OSIS scales had acceptable item convergent validity (item-scale correlations >0.40) and floor and ceiling effects (<20%). Cronbach's alpha coefficients ranged from 0.83 to 0.89 for the OSSAS and 0.82 to 0.87 for the OSIS, demonstrating excellent internal consistency. The a priori test–retest reliability criterion (intraclass correlation [ICC] ≥0.7) was met for one of the three OSSAS domains and one of the two OSIS domains. OSSAS and OSIS domains distinguished among groups that differed in patient-reported facial oily skin severity (P < 0.0001), and bother associated with oily skin (P < 0.0001).ConclusionsThe OSSAS and OSIS versions tested in this study have been found to have strong psychometric properties in this patient sample (adults with self-reported oily facial skin), as assessments of self-reported oily facial skin severity and its emotional impact, respectively.     

A Systematic Review of Generic Multidimensional Patient-Reported Outcome Measures for Children,Part II: Evaluation of Psychometric Performance of English-Language Versions in a General Population

ObjectivesThe objectives of this systematic review were 1) to identify studies that assess the psychometric performance of the English-language version of 35 generic multidimensional patient-reported outcome measures (PROMs) for children and young people in general populations and evaluate their quality and 2) to summarize the psychometric properties of each PROM.MethodsMEDLINE, EMBASE, and PsycINFO were searched. The methodological quality of the articles was assessed using the COnsensus-based Standards for selection of health Measurement INstruments checklist. For each PROM, extracted evidence of content validity, construct validity, internal consistency, test-retest reliability, proxy reliability, responsiveness, and precision was judged against standardized reference criteria.ResultsWe found no evidence for 14 PROMs. For the remaining 21 PROMs, 90 studies were identified. The methodological quality of most studies was fair. Quality was generally rated higher in more recent studies. Not reporting how missing data were handled was the most common reason for downgrading the quality. None of the 21 PROMs has had all psychometric properties evaluated; data on construct validity and internal consistency were most frequently reported.ConclusionsOverall, consistent positive findings for at least five psychometric properties were found for Child Health and Illness Profile, Healthy Pathways, KIDSCREEN, and Multi-dimensional Student Life Satisfaction Scale. None of the PROMs had been evaluated for responsiveness to detect change in general populations. Further well-designed studies with transparent reporting of methods and results are required.     

Reliability and validity of the Functional Assessment of Cancer Therapy General (FACT-G) in French cancer patients

This report describes the reliability and validity of a French version of the Functional Assessment of Cancer Therapy – General (FACT-G) with a French sample of 493 cancer patients. The FACT-G consists of 27 items and four subscales: Physical (PWB), Functional (FWB), Social/Family (SFWB) and Emotional well-being (EWB). The study sample includes 64% with localized disease, 26% with metastases, 11% in remission, and 71% receiving radiation/chemotherapy. Internal consistency Cronbach alphas of the global FACT-G scale (0.90) and subscales (>0.75) are satisfactory (n =126). Test-retest reproducibility is satisfactory for all subscales and the global scale (n =87 to 93, r=0.74 to 0.90). ANOVA models show that PWB differentiated between the three disease stages; the global FACT-G and FWB discriminated between patients with metastases and others with localized disease or in remission; EWB only discriminated between metastases and localized disease; while SFWB did not discriminate between groups at different stages of cancer. Only the PWB subscale discriminated between patients with no history from those receiving chemotherapy (p 0.05). None of the scales discriminated between groups based on radiotherapy. These results may be useful in the design and interpretation of clinical trials involving French patients when the FACT-G is the outcome measure.     

Development of EMPRO: A Tool for the Standardized Assessment of Patient-Reported Outcome Measures

Objective:  This study was aimed to develop a tool for the standardized assessment of patient-reported outcomes (PROs) to assist the choice of instruments.
Methods:  An expert panel adapted the eight attributes proposed by the Medical Outcomes Trust as evaluation review criteria, created items to evaluate them, and included a response scale for each item. A pilot test was designed to test the new tool's feasibility and to obtain preliminary information concerning its psychometric properties. The Spanish versions of five measures were selected for assessment: the SF-36 Health Survey, the Nottingham Health Profile, the COOP-WONCA charts, the EuroQol-5D, and the Quality of Life Questionnaire EORTC-QLQ-C30. We assessed the new tool's reliability (Cronbach's alpha and intraclass correlation coefficient [ICC]) and construct validity.
Results:  The new EMPRO (Evaluating the Measurement of Patient-Reported Outcomes) tool has 39 items covering eight key attributes: conceptual and measurement model, reliability, validity, responsiveness, interpretability, burden, alternative modes of administration, and cross-cultural and linguistic adaptations. Internal consistency was high (α = 0.95) as was interrater concordance (ICC: 0.87–0.94). Positive associations consistent with a priori hypotheses were observed between EMPRO attribute scores and the number of articles identified for the measures, the years elapsed since the publication of the first article, and the number of citations.
Conclusion:  A new tool for the standardized assessment of PRO measures is available. It has shown good preliminary reliability and validity and should be a useful aid to investigators who need to choose between alternative measures. Further assessment of the tool is necessary.     

General population and cancer patient norms for the Functional Assessment of Cancer Therapy-General (FACT-G)

Given the number of new cancer cases diagnosed each year and the increases in survival rates, the importance of having a clinically useful health-related quality of life (HRQOL) instrument has increased. The Functional Assessment of Cancer Therapy-General (FACT-G) is one such instrument that has been used worldwide to assess HRQOL. Previously, the use of the FACT-G had been limited because of a lack of published normative data. Normative data are useful for consumers to place their results in an appropriate context by comparing their scores of individuals or group of individuals to a reference group. Here, we present normative data for the FACT-G for two reference groups: (a) a sample of the general U.S. adult population and (b) a large, heterogeneous sample of adult patients with cancer. In addition, we demonstrate various uses of the normative data.     

Assessment of the upper limb in acute stroke: The validity of hierarchal scoring for the Motor Assessment Scale

Background/aim: Stroke is the greatest contributor to disability in Australian adults and much of this disability results from a stroke‐affected upper limb. This study aimed to determine the validity of hierarchal scoring for the upper limb subscale of the Motor Assessment Scale (UL‐MAS) in acute stroke using Rasch analysis. Method: This study applied Rasch analysis to 40 UL‐MAS assessment results across 25 subjects to determine the validity of the hierarchy of the three upper limb subsets: upper arm function (six), hand movements (seven) and advanced hand activities (eight). Rasch analysis examines the relationship between ‘item difficulty’ and ‘person ability’ and produces an output which represents the difficulty of each item in relation to each other. Results: As hypothesised, the hierarchy was upheld within subset 6. In subset 7, the hierarchy was not upheld. Results indicated that item 3 was the least difficult, followed by items 1, 4, 2, 5 and 6 in order of increasing difficulty. In subset 8 the hierarchy was not upheld. Results indicated that item 1 was the least difficult, followed by item 6, then 2 and 5 of equal value and then 3 and 4 of equal value. Conclusions: The hierarchal scoring is not supported for subsets 7 and 8 and future research is required to explore the validity of alternate scoring methods. At present, the authors recommend that the UL‐MAS should be scored non‐hierarchally, meaning that every item within the subsets should be scored regardless of its place within the hierarchy (UL‐MAS‐NH).     

Patient Experiences of Continuity of Cancer Care: Development of a New Medical Care Questionnaire (MCQ) for Oncology Outpatients

Objectives:  To adapt the Components of Primary Care Index (CPCI) to be applicable to oncology outpatients and to assess the reliability and validity of the adapted instrument (renamed the Medical Care Questionnaire [MCQ]).
Methods:  The development and validation of the MCQ took place in four phases. Phase 1 reviewed the literature and examined existing measures. In Phase 2, the selected instrument (CPCI) was reviewed by a panel of experts using a stepwise consensus procedure. In Phase 3, the adapted 21-item MCQ was administered to 200 outpatients attending oncology appointments. The instrument was refined to 15 items and in Phase 4, it was completed by 477 oncology outpatients. The psychometric properties of the new instrument were assessed using exploratory factor analysis (EFA), confirmatory factor analysis, multitrait scaling analysis, and by comparing MCQ scores between known groups.
Results:  EFA of the 15-item MCQ suggested three subscales with acceptable to good reliability: "Communication"α = 0.69; "Coordination"α = 0.84; and "Preferences"α = 0.75. Comparing known groups showed that patients who saw fewer doctors during their clinic visits reported stronger "Preferences" to see their usual doctor and rated "Communication" with their doctors as better than patients who saw more doctors during their clinic visits.
Conclusion:  The MCQ demonstrates good psychometric properties in the target population. It is a brief and simple-to-use instrument, which provides a valid perspective on patients' experiences of communicating with doctors and their perceptions of the continuity and coordination of their cancer care.     

Psychometric Development of the Individualized Retinopathy-Dependent Quality of Life Questionnaire (RetDQoL)

Objectives:  Psychometric development of the Retinopathy-Dependent Quality of Life (RetDQoL) questionnaire in a cross-sectional study of 207 German patients with diabetic retinopathy. Forty patients (19%) also had clinically significant macular edema.
Methods:  Principal component analyses identified factor structure, and Cronbach's alpha assessed internal consistencies. Construct validity was examined by testing the additional impact of macular edema and expected relationships of RetDQoL scores with visual impairment, stage of diabetic retinopathy, subscales of the SF-12, and scores of the Retinopathy Treatment Satisfaction Questionnaire (RetTSQ). Analyses were conducted using the RetDQoL's AWI score (average weighted impact of diabetic retinopathy on 26 life domains) and its two overview items (present QoL in general and retinopathy-specific QoL). Content validity was investigated using an open-ended question to identify any additional items needed.
Results:  A forced one-factor solution of the 26 specific weighted impact ratings showed all items except working life (applicable to 27%) to load >0.55, and Cronbach's alpha was 0.96, showing very high reliability. Greater impairment, worse diabetic retinopathy, and macular edema were associated with greater negative impact on scores. AWI correlated as expected more highly with retinopathy-specific QoL ( r  = 0.71, P  < 0.01) than with present QoL ( r  = 0.28, P  < 0.01). RetDQoL scores correlated moderately with SF-12 subscales ( r  = 0.22–0.51, P  < 0.01) and RetTSQ scores ( r  = 0.27–0.51, P  < 0.01). For six domains, >60% of patients reported no impact. No additional domains were needed.
Conclusions:  The RetDQoL is valid and reliable for patients with diabetic retinopathy with or without macular edema. It may be shortened if findings are confirmed cross-culturally.     

Functional Assessment of Cancer Therapy (FACT-G): Non-response to individual questions

The purpose of this investigation is to examine methods of scoring the FACT-G when there is nonresponse to individual questions. Using completed questionnaires from 350 patients, random and nonrandom missing responses where simulated. Seven methods of scoring the FACT-G are compared on the basis of accuracy (bias and precision) of both population estimates and prediction of individual scores. Substituting the mean of the completed items in the subscale when more than 50% are completed is generally the most unbiased and precise approach. Case deletion is the worst approach and results in clinically significant bias when the missing responses were non-random and a lack of precision when the rate of non-response was high.Supported by grants from the National Cancer Institute, DHHSCA-23318, CA-51926, and American Cancer Society #PBR6132.     

Cross-cultural validation of an international questionnaire,the General Measure of the Functional Assessment of Cancer Therapy scale (FACT-G), for Japanese

The General Measure of the Functional Assessment of Cancer Therapy scale (FACT-) was developed in an English-speaking culture (USA). To determine if FACT-G could be used in Japan, a cross-cultural validation was performed. The Japanese version was created through an iterative forward-backward translation sequence used throughout the FACT multi-lingual translation project. In evaluating psychometric testing, its construct validated was investigated by factor analysis and multi-trait scaling analysis clinical validity was estimated by known-groups comparison using stage, performance score (PS) and patient location, and validated longitudinally by PS. The FACT-G (version 3) was given to 180 patients with lung cancer. Analyses showed that the scales of Physical, Functional, Emotional Well-Being, and Relationship with Doctors were constructively valid in Japan. Japanese patients felt that familial relationships were different than those with friends and neighbors, indicating that the Social/Family Well-Being scale needed cultural adaptation. Two items concerning coping with illness and acceptance of illness did not load predictably onto their respective scales and were considered to be cross-culturally problematic. However, clinical validity demonstrated its sensitivity. Japanese version 4 has been improved to address the weakness in an attempt to become an instrument that is applicable across cultures. This revised version was published online in June 2006 with corrections to the Cover Date.     

Peer Reviewed: Validation of the Spanish Translation of the Patient Assessment of Chronic Illness Care (PACIC) Survey

Introduction

The Patient Assessment of Chronic Illness Care (PACIC) survey is a patient-centered instrument for evaluating the quality and patient-centeredness of chronic illness care received according to the Chronic Care Model paradigm. This study validates the Spanish translation of the PACIC in an urban, Spanish-speaking population.

Methods

One hundred Spanish-speaking patients with diabetes completed the translated PACIC and sociodemographic and cultural questionnaires. Test-retest reliability was assessed in a subset of 20 patients who completed the questionnaire 2 to 4 months later. Internal consistency was evaluated with Cronbach α. PACIC score and subscale associations with sociodemographic characteristics were examined.

Results

Test-retest reliability for the overall translated PACIC scale was 0.77. Scores were not associated with patient sociodemographic characteristics, including age, country of birth, years living in the United States, or education level (P >.05).

Conclusion

The Spanish translation of the PACIC survey demonstrated high reliability, internal consistency, and test-retest reliability. Scores showed no association with sociodemographic or cultural characteristics. The Spanish version can reliably be used to assess care delivered according to the Chronic Care Model in a heterogeneous Spanish-speaking population.     

Quality of Life in the General Norwegian Population, Measured by the Quality of Life Scale (QOLS-N)

The main aim of the present study was to derive norms or reference values from the general Norwegian population for the Norwegian version of the Quality of Life Scale (QOLS-N). In addition, associations between socio-demographic and health variables on the level of quality of life were examined. The sample consisted of 1893 subjects from a total of 4000 randomly selected Norwegian citizens representative of the entire Norwegian population, aged 19-81. The subjects received a mailed questionnaire containing the QOLS-N. Results show that the mean quality of life score was 84.1 (SD 12.5). Women reported a higher quality of life than men. People with higher levels of education reported a higher quality of life. Those who were married or cohabitating reported the highest quality of life and those who were unemployed reported a lower quality of life than those who worked. In addition, people reporting long-term diseases or health problems scored significantly lower on quality of life. These results could serve as reference values for the level of quality of life, as measured by the QOLS-N in the Norwegian population.     

Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system

There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29–49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9–20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds.Supported by grants from Amgen Incorporated, Bristol-Myers Squibb Company, Eli Lilly International Corporation, Rhone-Poulenc Rorer Pharmaceuticals Incorporated and Sandoz Pharmaceuticals.     

绝经综合征评定量表的信度、效度、反应度研究

目的 评价绝经综合征评定量表的可行性、信度、效度和反应度.方法 采用横断面调查,以方便抽样方法抽取绝经综合征患者和更年期非绝经综合征人群,调查绝经综合征评定量表、Kupperman Index、WHO牛存质量量表简表、更年期生存质景量表.反应度研究采用自身前后对照,纳入绝经综合征患者经中药治疗12周,治疗前后采用绝经综合征评定量表进行评价.结果在8家医院共进行3343有效人次的流行病学调查.该量表的回收率为100%,完成率为99.7%,完成时间平均为10.30 rain.绝经综合征评定量表及躯体维度、心理维度、社会维度的克朗巴赫(Cronbach's)a系数分别为0.93、0.87、0.89、0.73;分半信度分别为0.92、0.89、0.86、0.73;重测信度分别为0.88、0.91、0.85、0.77.绝经综合征评定量表编制根据绝经综合征疾病特点和内涵,经历了严格的步骤,量表适宜绝经综合征患者理解和填写,代表性好,具有良好的内容效度.探索性因子分析提取公因子结构与理论构想较吻合,结构效度良好.绝经综合征评定量表同KI、WHOQOL-BREF、MENQOL之间存在良好关联,效标效度较理想.量表能够区分不同绝经综合征患者和更年期正常人群,具有较好的区分效度.采用中药治疗174名绝经综合征患者,量表能反映出治疗前后的变化,具有反应度.结论绝经综合征评定量表具有较好的可行性、信度、效度和反应度,可以应用于绝经综合征的临床疗效评价.     

大学生防艾生活技能评估量表的开发研究

目的　开发《大学生防艾生活技能评估量表》,对量表的信效度进行评价。方法　以成都市两所高校的2843名大学生为研究对象,采用头脑风暴、专家咨询的定性方法和区分度分析、克朗巴赫α系数法和因子分析等定量方法,按照标准化量表编制程序进行量表编制。结果　编制的大学生防艾生活能力量表含毒品严重性感知、艾滋病严重性感知、易感性感知、寻求帮助能力、协商能力、拒绝能力、安全套使用倾向、知觉行为控制8个维度,共计30个条目。量表的Cronbach’s α系数为0.749,重测信度系数为0.804,专家积极系数为100%,专家权威系数为0.829,结构效度的模型评价结果 2/df为4.071,近似误差均方根（RMSEA）为0.057,模型拟合合理。结论　该量表能较全面的反映大学生艾滋病防治的生活技能,具有较好的信度和合适的效度,可作为测量大学生防艾生活技能工具。     

《手消毒剂通用要求》(GB 27950-2020)标准解读

《手消毒剂通用要求》(GB 27950-2020)于2020年11月1日起实施.本标准规定了手消毒剂的原料要求、技术要求、检验方法、使用方法、标识.本文对标准主要内容进行解读,以帮助标准使用者正确理解和使用标准.     

Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR PRO Good Research Practices for the Assessment of Children and Adolescents Task Force

BackgroundPatient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label.ObjectiveThe purpose of the current task force report is to recommend good practices for pediatric PRO research that is conducted to inform regulatory decision making and support claims made in medical product labeling. The recommendations are based on the consensus of an interdisciplinary group of researchers who were assembled for a task force associated with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). In those areas in which supporting evidence is limited or in which general principles may not apply to every situation, this task force report identifies factors to consider when making decisions about the design and use of pediatric PRO instruments, while highlighting issues that require further research.Good Research PracticesFive good research practices are discussed: 1) Consider developmental differences and determine age-based criteria for PRO administration: Four age groups are discussed on the basis of previous research (<5 years old, 5–7 years, 8–11 years, and 12–18 years). These age groups are recommended as a starting point when making decisions, but they will not fit all PRO instruments or the developmental stage of every child. Specific age ranges should be determined individually for each population and PRO instrument. 2) Establish content validity of pediatric PRO instruments: This section discusses the advantages of using children as content experts, as well as strategies for concept elicitation and cognitive interviews with children. 3) Determine whether an informant-reported outcome instrument is necessary: The distinction between two types of informant-reported measures (proxy vs. observational) is discussed, and recommendations are provided. 4) Ensure that the instrument is designed and formatted appropriately for the target age group. Factors to consider include health-related vocabulary, reading level, response scales, recall period, length of instrument, pictorial representations, formatting details, administration approaches, and electronic data collection (ePRO). 5) Consider cross-cultural issues.ConclusionsAdditional research is needed to provide methodological guidance for future studies, especially for studies involving young children and parents’ observational reports. As PRO data are increasingly used to support pediatric labeling claims, there will be more information regarding the standards by which these instruments will be judged. The use of PRO instruments in clinical trials and regulatory submissions will help ensure that children’s experience of disease and treatment are accurately represented and considered in regulatory decisions.