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1.
Health Qual Life Outcomes ; 17(1): 77, 2019 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-31053093

RESUMO

BACKGROUND: The purpose of the current study was to determine the final content validation, psychometric characteristics, clinically meaningful improvement, and responder thresholds of the Clostridium difficile infection (CDI)-Daily Symptoms (CDI-DaySyms™) patient-reported outcome (PRO) questionnaire. METHODS: This validation study was part of two phase III studies (NCT01987895 and NCT01983683) conducted in patients with mild-to-moderate or severe CDI who completed the CDI-DaySyms™ daily throughout the treatment period. The questionnaire was evaluated in three stages: final PRO item content validation (Stage I); psychometric evaluation of reliability and construct validity (Stage II); and determination of clinically meaningful improvement and responder thresholds using distribution-based methods (Stage III). RESULTS: The analysis included 168 patients. Most patients were female and Caucasian with mild-to-moderate CDI. The mean age was 57.1 years. Initial item analysis supported by confirmatory factor analysis demonstrated the relevance of 10 items grouped into three distinct domains (Diarrhea Symptoms, Abdominal Symptoms, and Systemic/Other Symptoms). Domain scores demonstrated acceptable internal consistency and test-retest reliability, were sensitive to change, and correlated in expected directions with other relevant symptom and disease-severity measures. Responder thresholds were defined as score changes of - 1.00, - 0.80, and - 0.70 in the Diarrhea Symptoms, Abdominal Symptoms, and Systemic/Other Symptoms domains, respectively. CONCLUSIONS: The CDI-DaySyms™ is a valid measure of patient-reported CDI symptoms, with good measurement properties, which supports its utility as an endpoint in clinical studies. Further studies confirming responder thresholds based on anchor-based methods are required. TRIAL REGISTRATION: NCT01987895 , registered November 20, 2013; NCT01983683 , registered November 14, 2013.


Assuntos
Infecções por Clostridium/fisiopatologia , Medidas de Resultados Relatados pelo Paciente , Adulto , Idoso , Infecções por Clostridium/complicações , Infecções por Clostridium/psicologia , Diarreia/etiologia , Análise Fatorial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria , Qualidade de Vida , Reprodutibilidade dos Testes
2.
Curr Med Res Opin ; 34(12): 2063-2073, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30016901

RESUMO

BACKGROUND: Lack of a global consensus on the definition of advanced Parkinson's disease (APD) and considerations for timing of device-aided therapies may result in heterogeneity in care. OBJECTIVES: To reach consensus among movement disorder specialists regarding key patient characteristics indicating transition to APD and guiding appropriate use of device-aided therapies in the management of PD symptoms. METHODS: A Delphi-panel approach was utilized to synthesize opinions of movement disorder specialists and build consensus. RESULTS: A panel was comprised of movement disorder specialists from 10 European countries with extensive experience of treating PD patients (mean =24.8 ± 7.2 years). Consensus on indicators of suspected APD and eligibility for device-aided therapies were based on motor symptoms, non-motor symptoms, and functional impairments. Key indicators of APD included: (i) motor-moderate troublesome motor fluctuations, ≥1 h of troublesome dyskinesia/day, ≥2 h "off" symptoms/day, and ≥5-times oral levodopa doses/day; (ii) non-motor-mild dementia, and non-transitory troublesome hallucinations; (iii) functional impairment-repeated falls despite optimal treatment, and difficulty with activities of daily living. Patients with good levodopa response, good cognition, and <70 years of age were deemed as good candidates for all three device-aided therapies. Patients with troublesome dyskinesia were considered good candidates for both levodopa-carbidopa intestinal gel and Deep Brain Stimulation (DBS). PD patients with levodopa-resistant tremor were considered good candidates for DBS. CONCLUSION: Identifying patients progressing to APD and suitable for device-aided therapies will enable general neurologists to assess the need for referral to movement disorder specialists and improve the quality of care and patient outcomes.

3.
Value Health ; 21(4): 441-448, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29680101

RESUMO

OBJECTIVES: To develop a patient-reported outcome (PRO) questionnaire for symptoms of Clostridium difficile infection (CDI) following the US Food and Drug Administration PRO guidelines. METHODS: Patients' experiences of CDI symptoms were elicited in open-ended discussions with patients and nurses at five US sites (stage 1). A draft PRO measure was developed after demonstration of concept saturation. Two rounds of cognitive interviews were conducted with patients at three US sites (stage 2), with revision of the draft measure after each round. All patients were 18 years or older, with confirmed CDI. The study was conducted with input from a panel of five CDI experts in Europe and North America. RESULTS: Stage 1 included interviews with 18 patients and supplementary interviews with 6 nurses; 16 additional patients were interviewed in stage 2. Patients were representative of the general CDI population and were diverse in age, sex, and disease severity. Concept saturation was reached in stage 1. Items were organized in a draft conceptual framework with five hypothesized domains: diarrhea, abdominal discomfort, tiredness, lightheadedness, and other symptoms. Stage 2 demonstrated initial content validity of the 13-item draft daily diary (CDI-DaySyms). Participants reported that the questions were clear, relevant, and comprehensive. They were able to use the instructions to complete the diary correctly and considered the 24-hour recall period appropriate. CONCLUSIONS: The CDI-DaySyms captures symptoms relevant to patients undergoing CDI, demonstrating initial content validity. Final content and psychometric validity are being evaluated in a substudy comprising patients from two ongoing international clinical trials (ClinicalTrials.gov identifiers NCT01987895 and NCT01983683).


Assuntos
Clostridium difficile/patogenicidade , Enterocolite Pseudomembranosa/diagnóstico , Medidas de Resultados Relatados pelo Paciente , Dor Abdominal/microbiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Diarreia/microbiologia , Tontura/microbiologia , Enterocolite Pseudomembranosa/complicações , Enterocolite Pseudomembranosa/microbiologia , Fadiga/microbiologia , Feminino , Nível de Saúde , Humanos , Entrevistas como Assunto , Masculino , Saúde Mental , Pessoa de Meia-Idade , Medição da Dor , Valor Preditivo dos Testes , Psicometria , Pesquisa Qualitativa , Qualidade de Vida , Índice de Gravidade de Doença , Estados Unidos , Adulto Jovem
4.
Chest ; 154(4): 848-861, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29705220

RESUMO

BACKGROUND: Disease-specific patient-reported outcome (PRO) instruments are important in assessing the impact of disease and treatment. The Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire is the first instrument for quantifying pulmonary arterial hypertension (PAH) symptoms and impacts developed according to the 2009 US Food and Drug Administration PRO guidance; previous qualitative research in patients with PAH supported its initial content validity. METHODS: Content finalization and psychometric validation were conducted by using data from A Study of Macitentan in Pulmonary Arterial Hypertension to Validate the PAH-SYMPACT (SYMPHONY), a single-arm, 16-week trial with macitentan 10 mg in US patients with PAH. Item performance, Rasch analysis, and factor analyses were used to select the final item content of the PRO and to define its domain structure. Internal consistency, test-retest reliability, known-group and construct validity, sensitivity to change, and influence of oxygen on item performance were evaluated. RESULTS: Data from 278 patients (79% female; mean age: 60 years) were analyzed. Following removal of redundant/misfitting items, the final questionnaire has 11 symptom items across two domains (cardiopulmonary and cardiovascular symptoms) and 11 impact items across two domains (physical and cognitive/emotional impacts). Differential item function analysis confirmed that PRO scoring is unaffected by oxygen use. For all four domains, internal consistency reliability was high (Cronbach's alpha > 0.80), and scores were highly reproducible in stable patients (intraclass correlation coefficient: 0.84-0.94). Correlations with the Cambridge Pulmonary Hypertension Outcome Review questionnaire and the 36-item Medical Outcomes Study Short Form Survey were moderate to high ([r] = 0.34-0.80). The questionnaire differentiated well between patients with varying disease severity levels and was sensitive to improvements in clinician- and patient-reported disease severity. CONCLUSIONS: The Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire is a brief, disease-specific PRO instrument possessing good psychometric properties that can be administered in clinical practice and clinical studies. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01841762; URL: www.clinicaltrials.gov.

5.
Patient Prefer Adherence ; 12: 35-44, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29343947

RESUMO

Purpose: The purpose of this study was to assess patient preferences regarding pharmacological treatment attributes for bipolar depression using a discrete choice experiment (DCE). Methods: Adult members of an Internet survey panel with a self-reported diagnosis of bipolar depression were invited via e-mail to participate in a web-based DCE survey. Participants were asked to choose between hypothetical medication alternatives defined by attributes and levels that were varied systematically. The six treatment attributes included in the DCE were time to improvement, risk of becoming manic, weight gain, risk of sedation, increased blood sugar, and increased cholesterol. Attributes were supported by literature review, expert input, and results of focus groups with patients. Sawtooth CBC System for Choice-Based Conjoint Analysis was used to estimate the part-worth utilities for the DCE analyses. Results: The analytical sample included 185 participants (50.8% females) from a total of 200 participants. The DCE analyses found weight gain to be the most important treatment attribute (relative importance =49.6%), followed by risk of sedation (20.2%), risk of mania (13.0%), increased blood sugar (8.3%), increased cholesterol (5.2%), and time to improvement (3.7%). Conclusion: Results from this DCE suggest that adults with bipolar depression considered risks of weight gain and sedation associated with pharmacotherapy as the most important attributes for the treatment of bipolar depression. Incorporating patient preferences in the treatment decision-making process may potentially have an impact on treatment adherence and satisfaction and, ultimately, patient outcomes.

6.
Hepatology ; 68(1): 155-165, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29152767

RESUMO

Primary sclerosing cholangitis (PSC) is a chronic liver disease associated with inflammation and biliary fibrosis that leads to cholangitis, cirrhosis, and impaired quality of life. Our objective was to develop and validate a PSC-specific patient-reported outcome (PRO) instrument. We developed a 42-item PSC PRO instrument that contains two modules (Symptoms and Impact of Symptoms) and conducted an external validation. Reliability and validity were evaluated using clinical data and a battery of other validated instruments. Test-retest reliability was assessed in a subgroup of patients who repeated the PSC PRO after the first administration. One hundred two PSC subjects (44 ± 13 years; 32% male, 74% employed, 39% with cirrhosis, 14% with a history of decompensated cirrhosis, 38% history of depression, and 68% with inflammatory bowel disease [IBD]) completed PSC PRO and other PRO instruments (Short Form 36 V2 [SF-36], Chronic Liver Disease Questionnaire [CLDQ], Primary Biliary Cholangitis - 40 [PBC-40], and five dimensions [5-D Itch]). PSC PRO demonstrated excellent internal consistency (Cronbach alphas, 0.84-0.94) and discriminant validity (41 of 42 items had the highest correlations with their own domains). There were good correlations between PSC PRO domains and relevant domains of SF-36, CLDQ, and PBC-40 (R = 0.69-0.90; all P < 0.0001), but lower (R = 0.31-0.60; P < 0.001) with 5-D Itch. Construct validity showed that PSC PRO can differentiate patients according to the presence and severity of cirrhosis and history of depression (P < 0.05), but not by IBD (P > 0.05). Test-retest reliability was assessed in 53 subjects who repeated PSC PRO within a median (interquartile range) of 37 (27-47) days. There was excellent reliability for most domains with intraclass correlations (0.71-0.88; all P < 0.001). CONCLUSION: PSC PRO is a self-administered disease-specific instrument developed according to U.S. Food and Drug Administration guidelines. This preliminary validation study suggests good psychometric properties. Further validation of the instrument in a larger and more diverse sample of PSC patients is needed. (Hepatology 2018;68:155-165).

7.
Dialogues Clin Neurosci ; 16(2): 127-35, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25152652

RESUMO

Health-related quality of life (HRQoL) is a multidimensional concept that includes subjective reports of symptoms, side effects, functioning in multiple life domains, and general perceptions of life satisfaction and quality. Rather than estimating it from external observations, interview, or clinical assessment, it is best measured by direct query. Due to a perception that respondents may not be reliable or credible, there has been some reluctance to use self-report outcomes in psychiatry. More recently, and increasingly, HRQoL assessment through direct patient query has become common when evaluating a range of psychiatric, psychological, and social therapies. With few exceptions, psychiatric patients are credible and reliable reporters of this information. This article summarizes studies that highlight the development, validation, and application of HRQoL measures in psychiatry. Thoughtful application of these tools in psychiatric research can provide a much-needed patient perspective in the future of comparative effectiveness research, patient-centered outcomes research, and clinical care.


Assuntos
Transtornos Mentais , Psiquiatria , Qualidade de Vida , Resultado do Tratamento , Humanos , Transtornos Mentais/diagnóstico , Transtornos Mentais/psicologia , Transtornos Mentais/terapia , Avaliação de Resultados (Cuidados de Saúde) , Autorrelato
8.
Health Qual Life Outcomes ; 12: 111, 2014 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-25017455

RESUMO

OBJECTIVES: Sleep disturbance is a common experience in fibromyalgia (FM). The field lacks a sleep specific patient reported outcome (PRO) measure developed and validated in a FM population. The study objective is to gain an in-depth understanding of sleep in FM and to develop a PRO measure of it. METHODS: Research involved the following stages: 1) A literature review conducted to identify key concepts associated with FM patient experience of sleep and PRO measures that have been used to assess this; 2) Qualitative interviews with therapeutic area experts; 3) Focus groups with FM patients who experienced sleep disturbance; 4) Development of a conceptual framework and the Fibromyalgia Sleep Diary (FMSD); and 5) Cognitive interviews with patients to explore content validity of the FMSD. RESULTS: The literature review and expert interviews supported sleep disturbance being an important aspect of the FM patient experience, and underscored the need for a new FM specific sleep PRO measure. Results from the focus groups demonstrated that FM patients experience sleep disturbances that they attribute to their FM symptoms, such as pain and stiffness, confirming the importance of understanding more about sleep changes. Aspects of sleep raised by FM patients included poor sleep quality and insufficient quantity including difficulty with falling asleep, getting comfortable, and staying asleep; restlessness; light sleep; not feeling rested upon awakening; and difficulty starting the day. Cognitive interview results showed that the 8-item FMSD, developed to reflect the concepts identified above, was relevant to FM patients with content that was interpreted as intended. CONCLUSIONS: The FMSD was developed in line with the recommendations of the FDA PRO guidance and ISPOR PRO Task Force. The qualitative evidence generated thus far strongly supports the content validity of the FMSD as a PRO measure of sleep disturbance in FM populations. Psychometric evaluation of the FMSD to demonstrate reliability, validity and sensitivity to change is recommended as a next step.


Assuntos
Fibromialgia/complicações , Indicadores Básicos de Saúde , Registros Médicos , Avaliação de Resultados da Assistência ao Paciente , Autorrelato , Transtornos do Sono-Vigília/diagnóstico , Adulto , Idoso , Feminino , Fibromialgia/psicologia , Grupos Focais , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria , Pesquisa Qualitativa , Qualidade de Vida , Reprodutibilidade dos Testes , Transtornos do Sono-Vigília/etiologia , Transtornos do Sono-Vigília/psicologia , Inquéritos e Questionários
9.
Patient ; 7(4): 413-26, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24890711

RESUMO

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. COPD is characterized by poor treatment adherence, and patient medication preferences may contribute to adherence. METHODS: A discrete choice experiment with an internet panel drawn from the USA was used to evaluate preference and willingness to pay (WTP) of COPD patients for long-acting maintenance medications. Key attributes derived from earlier qualitative research (brief literature review and focus groups) with COPD patients on maintenance therapy included symptom relief, speed of feeling medication start to work, inhaler ease of use, rescue medication use, side effects, and monthly out-of-pocket co-pay. Patients were presented with hypothetical medications with different profiles and asked which they preferred. Utilities and marginal WTP in monthly co-pay dollars were estimated for all patients and by severity. RESULTS: Utilities for 515 participants were in the expected direction and highest for the most favorable attribute levels. Each attribute evaluated was important, and participants were willing to pay a premium to obtain each benefit. On average, WTP was as high as $US64 for complete symptom relief, $US59 for no side effects, $US32 to rarely use rescue medication, $US16 for a quick and easy to use inhaler, and $US13 for feeling medication work quickly (within 5 min; average WTP $US18/month for patients with severe/very severe COPD). CONCLUSION: As expected, efficacy and safety were most valued by patients; however, this study showed that other COPD medication attributes, such as rescue medication, ease of use, and feeling medication work quickly, are also important in patient preferences.


Assuntos
Broncodilatadores/economia , Broncodilatadores/uso terapêutico , Aceitação pelo Paciente de Cuidados de Saúde , Preferência do Paciente , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Broncodilatadores/efeitos adversos , Feminino , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Pesquisa Qualitativa , Fatores Sexuais , Fatores Socioeconômicos , Inquéritos e Questionários
10.
Behav Sleep Med ; 11(1): 23-36, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23347114

RESUMO

This article describes qualitative research conducted with patients with clinical diagnoses of insomnia and focuses on the development of a conceptual framework and endpoint model that identifies a hierarchy and interrelationships of potential outcomes in insomnia research. Focus groups were convened to discuss how patients experience insomnia and to generate items for patient-reported questionnaires on insomnia and associated daytime consequences. Results for the focus group produced two conceptual frameworks: one for sleep and one for daytime impairment. Each conceptual framework consists of hypothesized domains and items in each domain based on patient language taken from the focus group. These item pools may ultimately serve as a basis to develop new questionnaires to assess insomnia.


Assuntos
Modelos Psicológicos , Pesquisa Qualitativa , Autorrelato , Distúrbios do Início e da Manutenção do Sono/fisiopatologia , Distúrbios do Início e da Manutenção do Sono/psicologia , Atitude Frente a Saúde , Feminino , Grupos Focais , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Distúrbios do Início e da Manutenção do Sono/diagnóstico , Inquéritos e Questionários
11.
Health Qual Life Outcomes ; 10: 92, 2012 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-22871087

RESUMO

BACKGROUND: Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Some CHC symptoms and impacts may be difficult to evaluate through objective clinical testing, and more easily measured through patient self-report. This literature review identified concepts raised by CHC patients related to symptoms, impacts, and treatment effects, and evaluated integration of these concepts within patient-reported outcome (PRO) measures. The goal of this work was to provide recommendations for incorporation of PRO measurement of concepts that are relevant to the CHC experience into CHC clinical trial design. METHODS: A three-tiered literature search was conducted. This included searches on concepts of importance, PRO measures used in clinical trials, and existing PRO measures. The PRO Concept Search focused on reviewing issues raised by CHC patients about CHC symptoms, disease impact, and treatment effects. The CHC Trials with PRO Endpoints Search reviewed clinical trials with PRO endpoints to assess differences between treatments over time. The PRO Measure Search reviewed existing PRO measures associated with the concepts of interest. RESULTS: This multi-tiered approach identified five key concepts of interest: depression/anxiety, fatigue, flu-like symptoms, cognitive function, insomnia. Comparing these five concepts of interest to the PRO measures in published CHC clinical trials showed that, while treatment of CHC may decrease health-related quality of life in a number of mental and physical domains, the PRO measures that were utilized in published clinical trials inadequately covered the concepts of interest. Further review of 18 existing PRO measures of the concepts of interest showed only four of the 18 were validated in CHC populations. CONCLUSIONS: This review identified several gaps in the literature regarding assessment of symptoms and outcomes reported as important by CHC patients. Further research is needed to ensure that CHC clinical trials evaluate concepts that are important to patients and include measures that have evidence supporting content validity, reliability, construct validity, and responsiveness.


Assuntos
Hepatite C Crônica/tratamento farmacológico , Avaliação de Resultados (Cuidados de Saúde)/métodos , Autorrelato , Ensaios Clínicos como Assunto , Nível de Saúde , Hepatite C Crônica/psicologia , Humanos , Qualidade de Vida
12.
Qual Life Res ; 21(7): 1255-66, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-21987032

RESUMO

PURPOSE: To develop a patient-reported outcome instrument for measuring anemia symptoms and their impact in patients with chemotherapy-induced anemia (CIA). METHODS: Qualitative research was conducted using six focus groups and 24 interviews with 46 CIA patients, eight interviews in patients receiving chemotherapy with no CIA history and two interviews in patients successfully treated for CIA. Atlas.ti 5.0 was used to organize key concepts. Cognitive interviews with 16 CIA patients and assessment of relevance of each item to CIA by 10 clinicians were also conducted to evaluate content validity. RESULTS: Most CIA patients were white (76%) and female (83%), and the average age was 60 years. The most common cancer types were breast cancer (54%) and lung cancer (17%). Tiredness was the most prevalent symptom and rated as the most important by 83% of CIA patients; weakness, shortness of breath, lightheadedness, and dizziness were ranked next in importance. The final anemia impact measure (AIM) contains: (1) daily CIA symptom diary (9 items), and (2) impact of CIA-related tiredness (29 items covering daily living activities, social activities, cognitive function, and emotions). Cognitive interviews found that the AIM was relevant and easy to understand. CONCLUSIONS: The AIM assesses important patient-perceived CIA symptoms and their impact and was developed using extensive patient qualitative data.


Assuntos
Anemia/induzido quimicamente , Anemia/fisiopatologia , Qualidade de Vida , Atividades Cotidianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Grupos Focais , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Psicometria/instrumentação
13.
J Pediatr Gastroenterol Nutr ; 52(5): 514-22, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21464757

RESUMO

OBJECTIVES: The Pediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) represents 2 related age-stratified tools developed to assess pediatric gastroesophageal reflux disease (GERD). These include the PGSQ-Cp (for children ages 2 to 8 years, parent/caregiver report) and the PGSQ-A (for adolescents ages 9-17 years). The objective of the present study was to develop and evaluate PGSQ measurement properties. MATERIALS AND METHODS: The PGSQ items were generated based on information from focus groups, expert clinician review, and cognitive debriefing interviews. The symptoms of pediatric GERD and the effect of these symptoms were addressed. The tools were evaluated in a 3-week psychometric evaluation with participants from 11 clinical sites in the United States. The study included other measures such as the Pediatric Quality of Life questionnaire (PedsQL) and clinician-rated GERD severity. After item reduction, internal consistency, reproducibility, construct validity, known-group validity, and responsiveness were assessed. RESULTS: The 231 participants included 75 parents of children ages 2 to 8 years and 75 children ages 9 to 17 years with GERD and 41 parents of children and 40 children ages 9 to 17 years without GERD. Exploratory factor analysis demonstrated 4 symptom subscales for the PGSQ-Cp and 3 symptom subscales for the PGSQ-A. Both had subscales for total impact and school impact. High to moderate internal consistency was observed, ranging from 0.76 to 0.96 for the PGSQ-Cp and from 0.67 to 0.94 for the PGSQ-A. The PGSQ significantly differentiated between patients with GERD and controls (P < 0.0001, PGSQ-Cp; P < 0.0022-0.0001, PGSQ-A) and demonstrated responsiveness. CONCLUSIONS: These results support the reliability, validity, and responsiveness of both versions of the PGSQ. The instruments should be useful for clinical studies.


Assuntos
Atividades Cotidianas , Refluxo Gastroesofágico , Psicometria/métodos , Qualidade de Vida , Inquéritos e Questionários , Adolescente , Adulto , Criança , Pré-Escolar , Refluxo Gastroesofágico/complicações , Humanos , Pais , Pediatria/métodos , Reprodutibilidade dos Testes , Instituições Acadêmicas , Índice de Gravidade de Doença , Inquéritos e Questionários/normas , Estados Unidos
14.
Int Clin Psychopharmacol ; 25(2): 51-9, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-20061962

RESUMO

The objective of this study was to assess the reliability and validity of the presence and severity of eight symptoms rated on the Patient-Rated Troubling Symptoms for Depression (PaRTS-D) instrument used in a risperidone augmentation trial. PaRTS-D total score (sum of four most severe symptoms) and global total score (sum of all eight symptoms) were determined weekly. Clinician-rated and patient-rated instruments were completed at selected time points. Statistical tests of reliability and validity were performed. The frequency of symptoms rated as one of the four most troubling were sadness, 73.5%; trouble concentrating, 70.9%; reduced involvement, 61.9%; tense/uptight, 56.0%; reduced sleep, 52.2%; negative thoughts, 42.9%; inability to feel emotion, 26.5%; and reduced appetite, 13.1%. Evidence of two factors (somatic-related and depression-related) was observed in the exploratory factor analysis. Baseline PaRTS-D total score correlated with the Quality of Life Enjoyment and Satisfaction Questionnaire and the Sheehan Disability Scale. PaRTS-D global total score showed high internal consistency reliability. PaRTS-D total score and global total score distinguished between patients with high and low-Hamilton Rating Scale for Depression Scores and were responsive to Patient Global Improvement Scale changes. The PaRTS-D total score minimal important difference was 4-5 points. In conclusion, PaRTS-D may be useful in symptom presence and severity assessments from the patient's perspective and as an adjunctive to other instruments in major depressive disorder diagnosis and response to treatment.


Assuntos
Transtorno Depressivo/psicologia , Escalas de Graduação Psiquiátrica/normas , Psicometria/normas , Adulto , Idoso , Antidepressivos/uso terapêutico , Ensaios Clínicos como Assunto , Transtorno Depressivo/diagnóstico , Transtorno Depressivo/tratamento farmacológico , Avaliação da Deficiência , Método Duplo-Cego , Quimioterapia Combinada , Análise Fatorial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Qualidade de Vida , Reprodutibilidade dos Testes , Projetos de Pesquisa , Risperidona/uso terapêutico , Antagonistas da Serotonina/uso terapêutico , Adulto Jovem
15.
Curr Med Res Opin ; 25(6): 1563-71, 2009 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-19445651

RESUMO

OBJECTIVE: The purpose of this study was to determine if empirically observed differences in patient perception of, and satisfaction with, onset of effect between an active maintenance treatment and placebo are clinically meaningful to practicing clinicians. A secondary objective was to determine the lowest threshold for a clinically meaningful difference in terms of both between-group differences and maximum acceptable placebo effect. METHODS: Twelve community-based healthcare professionals participated in a Delphi consensus panel. Panelists were provided with blinded results of two clinical trials showing statistically significant treatment effects for treatment A (budesonide/formoterol [Symbicort*]) over placebo in the proportion of patients who could perceive the medication working right away and the proportion of patients satisfied with this perception. Panelists were then asked to respond to a series of questions to identify a threshold for clinically important differences in patient-perceived onset of effect and satisfaction with speed of onset of effect. All expert panelists participated in two rounds of the Delphi process. RESULTS: Panelists were unanimous in their conclusion that the statistically significant results from the two trials were clinically meaningful. According to these practitioners, the empirical results presented to them, showing that patients could feel a maintenance inhaler therapy work right away, were meaningful to clinical decision-making, and the attribute could potentially improve patient adherence with therapy. A group consensus was reached that a minimum active treatment response for these outcomes should range from 50% to 75% and be 2-3 times larger than the placebo response, with a maximum placebo effect of 26-40%. CONCLUSION: A Delphi panel study of practitioners was used to establish a meaningful range of response and a minimal important difference for interpreting results of clinical trials in which patient perception of onset of effect and satisfaction with this perception are tested. While the views of this panel may not be generalized to the entire population of practitioners in the United States, results provide insight into how a typical practitioner is likely to view clinical trial results and how the information might be used in clinical practice.


Assuntos
Antiasmáticos/uso terapêutico , Asma/diagnóstico , Asma/tratamento farmacológico , Prova Pericial , Satisfação do Paciente , Percepção/fisiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Corticosteroides/uso terapêutico , Asma/psicologia , Budesonida/uso terapêutico , Combinação Budesonida e Fumarato de Formoterol , Consenso , Combinação de Medicamentos , Etanolaminas/uso terapêutico , Humanos , Placebos , Competência Profissional , Prognóstico , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Índice de Gravidade de Doença , Método Simples-Cego , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento
16.
J Affect Disord ; 118(1-3): 139-46, 2009 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19321206

RESUMO

BACKGROUND: The Patient-Rated Troubling Symptoms of Depression (PaRTS-D) instrument assesses the presence and troublesomeness of 8 commonly reported depression-related symptoms from the patient's perspective. A post hoc analysis of a double-blind, randomized risperidone augmentation to antidepressant therapy trial in patients with major depressive disorder explored the relationship between the PaRTS-D instrument and other clinician- and patient-rating scales. METHODS: Patients completed the PaRTS-D; the Patient Global Improvement Scale (PGIS), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and the Sheehan Disability Scale (SDS), while clinicians completed the Hamilton Rating Scale for Depression (HRSD-17), and the Clinical Global Impressions of Severity (CGI-S) at baseline and at pre-determined study weeks. RESULTS: In the PaRTS-D instrument, the four most frequently reported and troublesome symptoms were sadness (73.5%, severity 6.8), trouble concentrating (70.9%, 7.3), reduced involvement in pleasurable activities (61.9%, 7.3), and being tense or uptight (56.0%, 6.7). The improvement in PaRTS-D total score was significantly greater in risperidone-augmented compared with placebo-augmented patients at week 4 (p=0.034) and week 6 (p=0.007). Pearson correlations between the PaRTS-D scores and the measures of HRSD-17, CGI-S, PGIS, Q-LES-Q, and SDS were significant at both baseline and at week 6 LOCF (p<0.001 for each comparison). LIMITATIONS: Results are from a post hoc analysis. CONCLUSIONS: Significant correlations were observed between the PaRTS-D and other clinician- and patient-rated measures, with PaRTS-D being sensitive to the effects of treatment. These findings suggest that the PaRTS-D instrument is a reliable scale to assess antidepressant activity as experienced by the patients.


Assuntos
Antipsicóticos/uso terapêutico , Transtorno Depressivo Maior/tratamento farmacológico , Determinação da Personalidade/estatística & dados numéricos , Inventário de Personalidade/estatística & dados numéricos , Risperidona/uso terapêutico , Adulto , Idoso , Antidepressivos/efeitos adversos , Antidepressivos/uso terapêutico , Antipsicóticos/efeitos adversos , Transtorno Depressivo Maior/psicologia , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos Testes , Risperidona/efeitos adversos , Adulto Jovem
17.
Schizophr Res ; 107(2-3): 275-85, 2009 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19013769

RESUMO

Existing measures for functional assessment do not adequately address the relationship between cognitive impairment and function. The Schizophrenia Outcomes Functioning Interview (SOFI) was developed to measure community functioning related to cognitive impairment and psychopathology. Following review of existing measures and discussion with experts, caregivers, and patients, content was generated for four domains: 1) living situation; 2) IADLs; 3) productive activities; and 4) social functioning. The final SOFI was constructed with items informing domain scores, and an interviewer-completed global rating for each domain. Psychometric characteristics of the SOFI were evaluated in a sample of 104 community residing patients with schizophrenia and their informants. Test-retest reliability was evaluated in a sub-sample of patient-informant dyads using ICC; all values were >0.70 for both patient-interviews (SOFI-P) and informant-interviews (SOFI-I). Inter-rater reliability ICCs ranged from 0.50 to 0.79 on a different sub-sample. The SOFI demonstrated adequate construct validity based on correlations with the PSP (range 0.58 to 0.76; p<0.0001) and the QLS (p<0.001). Some correlations between SOFI and PETiT scores were low to moderate (p<0.05). Discriminant validity was supported based on SOFI score comparisons for patient groups based on PANSS and BACS scores (p<0.05); SOFI scores differed between borderline and moderately ill patients as measured by the CGI-S (p<0.05). The SOFI expands on existing measures and more comprehensively captures functioning of patients in the real world than other performance-based (proxy) measures. The SOFI has good evidence supporting reliability and construct validity, and may be a useful measure of functional outcomes in schizophrenia.


Assuntos
Atividades Cotidianas/psicologia , Transtornos Cognitivos/diagnóstico , Entrevista Psicológica , Escalas de Graduação Psiquiátrica/estatística & dados numéricos , Reabilitação Vocacional , Esquizofrenia/diagnóstico , Psicologia do Esquizofrênico , Meio Social , Socialização , Adolescente , Adulto , Idoso , Transtornos Cognitivos/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Psicometria/estatística & dados numéricos , Qualidade de Vida/psicologia , Reprodutibilidade dos Testes , Esquizofrenia/reabilitação , Adulto Jovem
18.
Psychopharmacol Bull ; 41(3): 68-90, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18779777

RESUMO

BACKGROUND: The majority of clinical outcome assessments developed for generalized anxiety disorder (GAD) may not efficiently and sensitively reflect heterogeneous symptom clusters from a patient perspective. The Patient-Rated Troubling Symptoms Scale for Anxiety (PaRTS-A) instrument was developed to provide an individualized assessment of patient relevant GAD symptoms. OBJECTIVE: The objective of this analysis was to evaluate the psychometric characteristics of the PaRTS-A. METHODS: Data were taken from a 6-week clinical trial evaluating the efficacy of adjunctive risperidone therapy in GAD patients undergoing standard treatment. Patients completed the PaRTS-A, the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and the Sheehan Disability Scale (SDS) as well as impressions of improvement. Physicians completed the Hamilton Anxiety Rating Scale (HAM-A). A instrument characteristics were assessed through statistical tests of reliability, reproducibility, construct and discriminant validity, and responsiveness. RESULTS: In the item response theory (IRT) analysis, the PaRTS-A items fit into a single construct of anxiety. Internal consistency reliability exceeded 0.70. The PaRTS-A total score was moderately correlated with the Q-LES-Q and the SDS. The PaRTS-A distinguished between patients with high and low HAM-A scores (p<0.001). The PaRTS-A was responsive to changes in clinical status and the minimal important difference was identified. CONCLUSION: The PaRTS-A provides a unique patient-rated assessment of anxiety symptoms. The instrument may provide clinicians with useful information regarding patient's self-rated anxiety disorder symptoms and the hierarchy of symptoms that they considered most troubling. Our analysis suggests that the PaRTS-A is an internally consistent, valid, and responsive instrument that may be a beneficial adjunct to other instruments in clinical trials.


Assuntos
Transtornos de Ansiedade/psicologia , Ensaios Clínicos como Assunto , Escalas de Graduação Psiquiátrica , Psicometria/métodos , Adolescente , Adulto , Idoso , Transtornos de Ansiedade/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Risperidona/uso terapêutico
19.
Qual Life Res ; 15(7): 1223-32, 2006 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-16972162

RESUMO

INTRODUCTION: Gastrointestinal (GI) side-effects occur frequently as a result of immunosuppressant regimens used in renal transplant patients. Little effort has been made to quantify the impact of these side-effects on patients' health-related quality of life and symptom severity. OBJECTIVE: To assess the psychometric characteristics of two GI-specific outcome instruments (the Gastrointestinal Rating Scale (GSRS) and the Gastrointestinal Quality of Life Index (GIQLI)) for use in post-renal transplant patients. METHODS: Cross-sectional study conducted at 5 clinical centers in 4 countries. Patients were required to be on mycophenolate mofetil and a calcineurin inhibitor. Patients completed the GSRS, GIQLI and two generic instruments (the Psychological General Well-Being Index and the EQ-5D) at one timepoint. Reliability, construct and known groups validity were assessed. RESULTS: In general the GSRS and the GIQLI demonstrated Cronbach's alphas higher than 0.70. The GIQLI was moderately to highly correlated with the PGWB and EQ-5D. Correlations among the GSRS and generic instruments were slightly lower. The GSRS and GIQLI both distinguished between patients with and without GI complaints (all p<0.05). CONCLUSIONS: The GSRS and the GIQLI are appropriate for use in a post-renal transplant population. Scores on both instruments demonstrated significant differences between renal transplant patients with GI complications and without GI complications.


Assuntos
Trato Gastrointestinal/efeitos dos fármacos , Transplante de Rim/imunologia , Avaliação de Resultados (Cuidados de Saúde) , Qualidade de Vida , Adulto , Estudos Transversais , Países Desenvolvidos , Feminino , Trato Gastrointestinal/fisiopatologia , Humanos , Imunossupressores/efeitos adversos , Masculino , Pessoa de Meia-Idade , Psicometria
20.
Curr Gastroenterol Rep ; 8(3): 230-6, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16764789

RESUMO

Pediatric gastroesophageal reflux disease (GERD) is common in infants and children; diagnosis is often based on symptom presentation. This paper reviews psychometric characteristics and approaches to validation of currently available pediatric GERD questionnaires. Patient-reported outcomes allow disease and treatment to be characterized in meaningful ways to patients and clinicians. Outcome measures must demonstrate reliability and validity for use in practice and in clinical trials. Reliability assesses the consistency of measures, whereas validity examines whether the instrument measures what it is purported to measure. Development of questionnaires for use with children also requires consideration regarding the respondent. Measures of pediatric GERD symptoms include the GERQ, GERQ-R, and GSQ. These measures have advantages and disadvantages with regard to feasibility, reliability, and validity. Questionnaires are lacking for children older than 4 years.


Assuntos
Refluxo Gastroesofágico/diagnóstico , Inquéritos e Questionários/normas , Criança , Diagnóstico Diferencial , Humanos , Psicometria/métodos , Reprodutibilidade dos Testes
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