Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain

Abstract Background Endometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often included as an endpoint in clinical trials. Objectives The study assessed the psychometric properties of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain. Methods In a phase III double-blind, placebo-controlled clinical trial (NCT01620528), women aged 18–49 years with moderate-to-severe endometriosis-related pain were randomized to elagolix 150 mg once daily, elagolix 200 mg twice daily, or placebo for 6 months. PROMIS Fatigue and dysmenorrhea and non-menstrual pelvic pain (NMPP) scores were assessed at baseline and months 1, 3, and 6, and Patient Global Impression of Change (PGIC) was assessed at months 1, 3, and 6. Reliability (internal consistency and test-retest reliability), construct validity (convergent and known groups validity), and responsiveness were evaluated. Results The analysis included 871 women, mean age 31.5 years. Internal consistency supported a single concept (Cronbach’s alpha 0.93). For the 238 patients with no change in PGIC at month 1, the intraclass correlation coefficient for the PROMIS Fatigue T-score was 0.7 and paired t-test statistically significant (2.84, p = 0.0049). Correlations with other measures were expected to be fairly low as concepts were not redundant. The PROMIS Fatigue discriminated among known groups with mean scores of 55.3, 62.3, and 65.8 at month 3 (PGIC improvement, no change, worsening, respectively). Statically significant discrimination, and change score responsiveness, were seen using clinically relevant anchors (dysmenorrhea and NMPP) at months 3 and 6 between responders and non-responders. Anchor-based (PGIC) responsiveness showed significant improvement from baseline to months 3 and 6 (p < 0.0001). Conclusions PROMIS Fatigue has good reliability, validity, and responsiveness in women with moderate-to-severe endometriosis-associated pain.

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Validation of the Spanish version of Migraine Disability Assessment questionnaire (MIDAS) in migraine university students.

10.21203/rs.2.19036/v1 ◽

2019 ◽

Author(s):

Daniel Rodríguez-Almagro ◽

Alexander Achalandabaso ◽

Alma Rus ◽

Esteban Obrero-Gaitán ◽

Noelia Zagalaz-Anula ◽

...

Keyword(s):

Factor Analysis ◽

Internal Consistency ◽

Short Form ◽

Intraclass Correlation ◽

Spanish Version ◽

Measuring Instruments ◽

Disability Assessment ◽

Good Reliability ◽

Cross Sectional ◽

Midas Questionnaire

Abstract Background. The Migraine Disability Assessment (MIDAS) questionnaire is widely used for determining headache-related disability. However, to the best of our knowledge, there is no validated Spanish version of the questionnaire. It is composed of seven items; the first five items constitute the main scale, while the sixth and seventh items refer respectively to the frequency and intensity of headache. The present study is aimed at analyzing the clinimetric properties of the Spanish version of the MIDAS questionnaire in a population of university students.Methods. We performed a cross-sectional study of validation of measuring instruments. One hundred fifty-three subjects participated in the study. We analyzed construct validity by factor analysis, test-retest reliability by the Intraclass Correlation Coeficient (ICC), internal consistency, and concurrent validity with respect to the 12-Item Short Form Health Survey (SF-12).Results. Factor analysis showed a two factors structure composed. The questionnaire presented good reliability for the MIDAS-main scale score ([ICC = 0.81; 95% CI: 0.63 – 0.90]), excellent reliability for headache frequency (ICC = 0.90; 95%; CI: [0.79 – 0.95]), and moderate reliability for headache intensity (ICC = 0.63; 95% CI: [0.34 – 0.80]). The analysis also showed good internal consistency results (α Cronbach = 0.797) and a moderate correlation between MIDAS-main scale and physical summary component of SF-12 (Rho = -0.326; p < 0.001).Conclusions. The Spanish version of the MIDAS questionnaire is a valid and reliable tool to measure headache-related disability in university subjects. The two additional items provide information that could help clinicians in making decisions.

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Validation of the Spanish version of Migraine Disability Assessment questionnaire (MIDAS) in migraine university students.

10.21203/rs.2.19036/v2 ◽

2020 ◽

Author(s):

Daniel Rodríguez-Almagro ◽

Alexander Achalandabaso ◽

Alma Rus ◽

Esteban Obrero-Gaitán ◽

Noelia Zagalaz-Anula ◽

...

Keyword(s):

Factor Analysis ◽

University Students ◽

Internal Consistency ◽

Short Form ◽

Intraclass Correlation ◽

Spanish Version ◽

Disability Assessment ◽

Good Reliability ◽

Cross Sectional ◽

Midas Questionnaire

Abstract Background. The Migraine Disability Assessment (MIDAS) questionnaire is widely used to determine the degree of migraine-related disability of subjects. So far, and to the best of our knowledge, no Spanish version of this tool has been validated. The questionnaire comprises seven items, with the first five constituting the main scale while the sixth and seventh items referring, respectively, to the frequency and intensity of headache. The present study aims to analyze the clinimetric properties of the Spanish version of the MIDAS questionnaire in a population of university students. Methods. We performed a cross-sectional study of validation for this measuring instrument. A total of 153 subjects participated in the study. We analyzed construct validity using factor analysis, test-retest reliability by the Intraclass Correlation Coeficient (ICC), internal consistency, and concurrent validity with respect to the 12-Item Short Form Health Survey (SF-12). Results. Factor analysis revealed a two-factor structure. The questionnaire has good reliability for the MIDAS main-scale score ([ICC=0.81; 95% CI: 0.63 – 0.90]), excellent reliability for headache frequency (ICC=0.90; 95%; CI: [0.79 – 0.95]), and moderately good reliability for headache intensity (ICC=0.63; 95% CI: [0.34 – 0.80]). The analysis also yielded good internal consistency results (α Cronbach=0.797) and a moderate correlation between MIDAS-main scale and the physical summary component of SF-12 (Rho=-0.326; p < 0.001). Conclusions. The Spanish version of the MIDAS questionnaire is a valid and reliable tool to measure migraine-related disability in university subjects. The two additional items provide information that could help clinicians in making decisions.

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Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Long-Acting Methylphenidate for Cancer-Related Fatigue: North Central Cancer Treatment Group NCCTG-N05C7 Trial

Journal of Clinical Oncology ◽

10.1200/jco.2010.28.1444 ◽

2010 ◽

Vol 28 (23) ◽

pp. 3673-3679 ◽

Cited By ~ 105

Author(s):

Amanda R. Moraska ◽

Amit Sood ◽

Shaker R. Dakhil ◽

Jeff A. Sloan ◽

Debra Barton ◽

...

Keyword(s):

Short Form ◽

Phase Iii ◽

Secondary Outcome ◽

Controlled Study ◽

Symptom Experience ◽

Double Blind ◽

Time Curve ◽

Cancer Related Fatigue ◽

Significant Difference ◽

Long Acting

Purpose Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. Patients and Methods Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. Results In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. Conclusion This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.

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High-Dose Intravenous Immunoglobulin Is Effective in Painful Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

Pain Medicine ◽

10.1093/pm/pnz331 ◽

2020 ◽

Vol 21 (3) ◽

pp. 576-585 ◽

Cited By ~ 3

Author(s):

Stefano Jann ◽

Raffaella Fazio ◽

Dario Cocito ◽

Antonio Toscano ◽

Angelo Schenone ◽

...

Keyword(s):

Placebo Group ◽

Intravenous Immunoglobulin ◽

Short Form ◽

Diabetic Polyneuropathy ◽

Multicenter Trial ◽

Diabetic Patients ◽

High Dose ◽

Double Blind ◽

Clinical Patient ◽

Global Impression Of Change

Abstract Objectives The efficacy and safety of high-dose intravenous immunoglobulin (IVIG) in treatment-resistant diabetic painful polyneuropathy (DPN) were assessed. Design This was a randomized, double-blind, placebo-controlled, multicenter trial (EudraCT 2010–023883–42). Setting This trial was conducted at eight sites in Italy with a neurology specialist level of care. Subjects Twenty-six diabetic patients with DPN who reported baseline severity of pain >60 units (mm) on a VAS scale at enrollment and were resistant to antidepressants and antiepileptic drugs were enrolled; 23 were randomized (11 in the IVIG arm and 12 in the placebo arm). All patients completed the study and were evaluated. All patients were Caucasian, 15 were male, and 21 had a diagnosis of type II diabetes. Methods IVIG (0.4 g/kg/d) or placebo was given for five consecutive days. Pain intensity (visual analog scale, Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey, Clinical/Patient Global Impression of Change questionnaires) assessments were performed at visits: baseline, start of therapy (one week later), end of therapy (five days later), and follow-up (four and eight weeks later). Results The study achieved its prespecified primary end point of ≥50% pain reduction at four weeks after IVIG, achieved in seven of 11 patients (63.6%) in the IVIG group vs zero of 12 in the placebo group (P = 0.0013). Only two adverse events were reported during the study: one patient in the treatment arm reported a mild “dermatitis psoriasiform,” whereas one patient from the placebo group reported a mild “influenza.” Conclusions Treatment with IVIG at the dose given was efficacious and safe for patients with DPN resistant to standard therapies.

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Nα -Methyl Histamine Safety and Efficacy in Migraine Prophylaxis: Phase III Study

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques ◽

10.1017/s0317167100004960 ◽

2006 ◽

Vol 33 (2) ◽

pp. 195-199 ◽

Cited By ~ 22

Author(s):

Rebeca O. Millán-Guerrero ◽

Rebeca Isais-Millán ◽

Trujillo-Hernández Benjamín ◽

Carlos E. Tene

Keyword(s):

Therapeutic Potential ◽

International Headache Society ◽

Pharmacological Study ◽

Subcutaneous Administration ◽

Migraine Prophylaxis ◽

Phase Iii ◽

Controlled Clinical Trial ◽

Double Blind ◽

Adverse Experiences ◽

Phase Iii Study

ABSTRACT:Background:The histamine catabolite, Nα-methylhistamine, possesses a selective affinity for H3 receptors. For this reason, we considered evaluating the efficacy of this histaminergic H3 agonist in migraine prophylactic treatment.Objective:To study the therapeutic potential of the subcutaneous administration of Nα-methylhistamine in migraine prophylaxis, in a Phase III clinical pharmacological study.Methods:Using a controlled double-blind, placebo controlled clinical trial for 12 weeks, 60 patients with migraine, who fit the criteria established by the International Headache Society, were selected. The efficacy of subcutaneous administration of Nα-methylhistamine 1 to 3 ng twice a week against placebo was studied, evaluating the outcome of headache intensity, frequency, duration, and analgesic intake.Results:Comparison between the groups treated with placebo (n=30) and Nα-methylhistamine (n=30), on data collected for the 4th, 8th and 12th weeks of treatment, revealed that Nα-methylhistamine exerted a significant (p<0.0001) reduction (compared to placebo) in intensity, frequency, and duration of migraine attacks, as well as on the use of analgesic intake. No significant (p>0.05) adverse experiences or side effects developed in either group.Conclusions:The present study provides evidence of the efficacy of Nα-methylhistamine, given subcutaneously at doses of 1 to 3 ng twice a week, offering a new therapeutic alternative and laying the clinical and pharmacological groundwork for the use of histaminergic H3-agonists in migraine prophylaxis, which may specifically inhibit the neurogenic edema response involved in migraine pathophysiology.

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Transcultural reliability and validity of an Italian language version of the Constant–Murley Score

Journal of Orthopaedics Trauma and Rehabilitation ◽

10.1177/2210491720945327 ◽

2020 ◽

Vol 27 (2) ◽

pp. 186-191

Author(s):

Matteo Carosi ◽

Giovanni Galeoto ◽

Stefano Di Gennaro ◽

Anna Berardi ◽

Donatella Valente ◽

...

Keyword(s):

Correlation Coefficient ◽

Internal Consistency ◽

Intraclass Correlation ◽

Reliability And Validity ◽

Italian Population ◽

Good Reliability ◽

Language Version ◽

Shoulder Dysfunction ◽

Constant Murley Score ◽

Good Internal Consistency

Purpose: The present study was designed to carry out an Italian translation of the Constant–Murley Score (CMS-IT) and, subsequently, evaluate its reliability and validity. Methods: This study included adults diagnosed with any type of clinical shoulder dysfunction who could read and respond to the questionnaires. Those individuals who underwent surgeries of any kind on the affected shoulder during the previous 12 months and individuals with shoulder instabilities were excluded. All of the participants were evaluated by two operators, and the CMS-IT, Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and visual analog scale (VAS) were administered. The internal consistency was evaluated using Cronbach’s α, whereas the intra-rater and inter-rater reliabilities were evaluated using the intraclass correlation coefficient (ICC). The validity of the construction was evaluated using Pearson’s correlation coefficient between the scores of the administered scales. Results: A population of 72 individuals participated in this study. The internal consistency of the CMS-IT showed a value of 0.81. The ICC values showed that inter- and intra-rater reliability were 0.994 and 0.963, respectively. CMS-IT is inversely correlated with the VAS (−0.55) and DASH (−0.47) scales. Conclusions: This study revealed that the CMS-IT contained good internal consistency and good reliability. The results suggested that the CMS-IT questionnaire is a reliable and valid tool for assessing the shoulder dysfunctions of the Italian population, and it deserves broad applications in both clinical practice and research contexts. The scale can also be used as an alternative to the current “gold standard” VAS and DASH.

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A phase III randomised, double-blind, active comparator-controlled clinical trial to study the safety and efficacy of lurasidone in subjects with schizophrenia (PEARL 3 extension study)

http://isrctn.org/> ◽

10.1186/isrctn44297014 ◽

2012 ◽

Author(s):

Kaushik Sarma

Keyword(s):

Clinical Trial ◽

Phase Iii ◽

Extension Study ◽

Controlled Clinical Trial ◽

Double Blind ◽

Safety And Efficacy ◽

Active Comparator

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Longterm Therapeutic Response to Milnacipran Treatment for Fibromyalgia. A European 1-Year Extension Study Following a 3-Month Study

The Journal of Rheumatology ◽

10.3899/jrheum.101025 ◽

2011 ◽

Vol 38 (7) ◽

pp. 1403-1412 ◽

Cited By ~ 18

Author(s):

JAIME C. BRANCO ◽

PATRICK CHERIN ◽

AGNES MONTAGNE ◽

ATHMANE BOUROUBI

Keyword(s):

Fibromyalgia Impact Questionnaire ◽

Change Score ◽

Extension Study ◽

Therapeutic Effects ◽

Double Blind ◽

Quality Of Life Measures ◽

Common Drug ◽

Patient Global Impression ◽

Global Impression Of Change

Objective.This double-blind, 1-year extension study investigated the longterm efficacy and safety of milnacipran 100, 150, and 200 mg/day in the treatment of fibromyalgia (FM) in completers of a 3-month European double-blind lead-in study of milnacipran 200 mg/day versus placebo.Methods.A total of 468 patients with FM successfully completing the lead-in study were either blindly maintained on milnacipran 200 mg/day (MLN200:MLN200, n = 198) or (if previously receiving placebo) rerandomized to milnacipran 100 mg/day (PBO:MLN100, n = 91), 150 mg/day (PBO:MLN150, n = 92), or 200 mg/day (PBO:MLN200, n = 87) for an additional 12 months (including a 4-week dose escalation). The main efficacy endpoint was a 2-measure composite responder rate (relative to lead-in study baseline) incorporating the weekly-recall pain score recorded on a visual analog scale and the Patient Global Impression of Change score. A panel of other assessments including the Fibromyalgia Impact Questionnaire explored the multidimensional aspects of FM. Descriptive analyses using the last observation carried forward approach were performed.Results.At the 1-year endpoint, the proportion of composite responders (relative to the lead-in study baseline) ranged from 27.5% (PBO:MLN100) to 35.9% (MLN200:MLN200), and had increased from the extension study baseline by 15.2% (PBO:MLN150) to 20.7% (PBO:MLN200 and MLN200:MLN200). At endpoint, an improvement from both baselines was shown in all groups on pain, fatigue, sleep, and quality of life measures. Up to 1 year, all doses of milnacipran were safe and well tolerated. The most common drug-related adverse events were hyperhidrosis and nausea.Conclusion.Over 1 year, milnacipran 100, 150, and 200 mg/day exhibited sustained and safe therapeutic effects on predominant symptoms of FM. Registered as trial no.NCT00757731.

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Psychometric testing of the Norwegian Diabetes Health Profile (DHP-18) in patients with type 1 diabetes

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2018-000541 ◽

2018 ◽

Vol 6 (1) ◽

pp. e000541

Author(s):

Lars-Petter Jelsness-Jørgensen ◽

Øystein Jensen ◽

Charlotte Gibbs ◽

Ragnar Bekkhus Moe ◽

Dag Hofsø ◽

...

Keyword(s):

Type 1 Diabetes ◽

Internal Consistency ◽

Convergent Validity ◽

Short Form ◽

Descriptive Analysis ◽

Intraclass Correlation ◽

Psychometric Testing ◽

Health Profile ◽

Sf 36

ObjectiveThe Diabetes Health Profile-18 (DHP-18) was developed to measure disease-specific health-related quality of life. It has been translated into Norwegian but remains invalidated. The purpose of this paper was to examine the psychometric properties of the Norwegian DHP-18.Research design and methodsParticipants with type 1 diabetes were recruited from three outpatient clinics in Norway. Clinical and sociodemographic data were collected, and participants completed the DHP-18 and the Short-Form 36 (SF-36). Descriptive analysis, frequencies, t-tests and the chi-squared tests were used. Principal axis factoring (PAF) and confirmatory factor analysis (CFA) were used. Convergent validity was tested using Spearman’s correlation between the DHP-18 and SF-36. Reliability was tested using Cronbach’s alpha and intraclass correlation coefficient.ResultsIn total, 288 patients were included. No floor and ceiling effects were found. A forced PAF analysis revealed that three questions had an eigenvalue below 0.40. In the unforced PAF analysis, one question loaded below 0.40, while three questions loaded into a fourth factor. The correlation between the DHP-18 and SF-36 dimensions was low to moderate. Problematic internal consistency was observed for the disinhibited eating dimension in the forced PAF and in the suggested fourth dimension in the unforced PAF. CFA revealed poor fit. The test–retest reliability displayed good to excellent values, but responsiveness was limited.ConclusionsProblematic issues were identified regarding factor structure, item loadings, internal consistency and responsiveness. Further evaluation of responsiveness is particularly recommended, and using a revised 14-item DHP version is suggested.

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