scholarly journals Development and validation of a set of patient reported outcome measures to assess effectiveness of asthma prophylaxis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yalini Guruparan ◽  
Thiyahiny S. Navaratinaraja ◽  
Gowry Selvaratnam ◽  
Nalika Gunawardena ◽  
Shalini Sri Ranganathan
Keyword(s):  
Asthma Control ◽  
Operating Characteristic ◽  
Characteristic Curve ◽  
Patient Reported Outcome ◽  
Forced Expiratory Volume ◽  
Alpha Coefficient ◽  
Focus Group Discussions ◽  
Group Discussions ◽  
Resource Limited ◽  
Patient Reported

Abstract Background In the local setting, asthma control is assessed by symptoms and signs elicited by clinicians because of the limited availability of spirometry. Hence, we intended to develop a patient reported outcome measure (PROM) with more holistic interpretation that could also serve as a tool to measure the asthma control in resource limited settings. Therefore, this study was carried out in Northern Sri Lanka to develop and validate the Asthma Control PROM (AC-PROM) Tamil to measure the effectiveness of asthma prophylaxis based on symptoms, exacerbation and limitation of activity which could also serve as an easy measure of asthma control to the provider. Methods The AC-PROM Tamil was developed in 3 steps: item generation, item reduction and psychometric evaluation. Items were generated through thematic analysis from focus group discussions among patients with asthma. Items were converted to an interviewer administered questionnaire in Tamil in the format of 5-point Likert scale. Item reduction was done by two rounds of online Delphi surveys among 10 experts and an exploratory factor analysis among 200 patients with asthma. The face and content validity were assessed by a panel of experts during Delphi survey and patients during the pre-test of the tool. Criterion validity of the tool was assessed against the forced expiratory volume in one second of 187 patients with asthma. The cut-off value to assess the asthma control was determined by receiver operating characteristic curve. Reliability was verified by Cronbach’s alpha coefficient. Results From thematic analysis of focus group discussions 10 items were generated. One item was removed during Delphi survey. Exploratory factor analysis indicated removal of another item with 8 items categorised into two factors. Cronbach’s alpha coefficient of factors 1 and 2 were 0.821 and 0.903 respectively, indicating good reliability. Observations made by experts and responses made by patients were incorporated to improve the clarity and relevance of the items. Criterion validity was demonstrated by significant correlation between the AC-PROM Tamil and forced expiratory volume in one second (r = 0.66, p = 0.001). The cut-off value of the AC-PROM Tamil to detect asthma control was 28.5 with 79% (95% CI 71.3–86.9) sensitivity and 71% (95% CI 61.9–79.6) specificity. The AC-PROM Tamil showed moderate accuracy (the area under the receiver operating characteristic curve = 0.796; 95% CI 0.73–0.86). Response rate of the AC-PROM Tamil was 100% and time taken to complete was 3–4 min. Conclusion The AC-PROM Tamil is a simple, feasible and reasonably accurate tool to assesses the effectiveness of asthma prophylaxis, particularly in resource limited settings.

scholarly journals Development and Validation of a Set of Patient Reported Outcome Measures to Assess Effectiveness of Asthma Prophylaxis

2021 ◽  
Author(s):  
Yalini Guruparan ◽  
Thiyahiny Sunil Navaratinaraja ◽  
Gowry Selvaratnam ◽  
Nalika Gunawardena ◽  
Shalini Sri Ranganat
Keyword(s):  
Factor Analysis ◽  
Asthma Control ◽  
Outcome Measures ◽  
Thematic Analysis ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Forced Expiratory Volume ◽  
Alpha Coefficient ◽  
Item Reduction ◽  
Patient Reported

Abstract Background: Several asthma patient reported outcome measures (PROMs) have been developed in developed countries. Since social and cultural differences may indirectly influence the PROM therefore, this study has been carried out in Northern Sri Lanka to develop an Asthma Control PROM (AC-PROM) Tamil in the local context. Methods: The AC-PROM Tamil was developed in 3 steps: item generation, item reduction and psychometric evaluation as guided by the USA Food and Drug Administration. Items were generated through thematic analysis from six focus group discussions among patients with asthma. Items were generated in Tamil and English Languages. A clinician and a clinical pharmacologist refined the items to suit the cultural context. Items were converted to an interviewer administered questionnaire in Tamil in the format of 5–point Likert scale. Item reduction was done by two rounds of online Delphi surveys among 10 experts and an exploratory factor analysis among 200 patients with asthma. Thus developed AC-PROM Tamil was assessed by experts for face and content validity. Criterion validity was evaluated against the forced expiratory volume in one second of 187 patients with asthma. Cut-off value for PROM to assess the asthma control was determined by receiver operating characteristic curve. Reliability was verified by Cronbach’s alpha coefficient. Results: From thematic analysis of FGD 10 items were generated and these items were refined and subjected to item reduction. During Delphi survey out of 10 items, one was removed. In exploratory factor analysis another one item was removed and remaining 8 items were categorised under 2 factors. Cronbach’s alpha coefficient for AC-PROM Tamil was 0.904, which indicated good reliability. Clarity and relevance of the content of the items were confirmed by the experts. Criterion validity was demonstrated significant correlation between AC-PROM Tamil and forced expiratory volume in one second (r = 0.66, p = 0.001). Cut-off value of AC-PROM Tamil to detect asthma control was 28.5 with sensitivity (79%) and specificity (71%). The AC-PROM Tamil has moderate accuracy (AUC =0.796; 95% CI: 0.73-0.86). Response rate of the AC-PROM Tamil was 100% with no missing data and time taken to complete the PROM was 3-4 minutes. Conclusion: The AC-PROM Tamil is a simple, reasonably accurate, reliable, objective and valid tool to assess effectiveness of asthma control in Tamil speaking patients during clinical practice and researches.

scholarly journals Investigating the patient acceptable symptom state cut-offs: longitudinal data from a community cohort using the shoulder pain and disability index

2019 ◽  
Vol 40 (4) ◽  
pp. 599-605 ◽  
Author(s):  
Gui Tran ◽  
Bright Dube ◽  
Sarah R. Kingsbury ◽  
Alan Tennant ◽  
Philip G. Conaghan ◽  
...  
Keyword(s):  
Shoulder Pain ◽  
Operating Characteristic ◽  
Characteristic Curve ◽  
Patient Reported Outcome ◽  
Percentile Method ◽  
Cumulative Response ◽  
Severity Scores ◽  
Patient Reported ◽  
Patient Acceptable Symptom State ◽  
First Time

AbstractThis prospective study aimed to determine the patient acceptable symptom state (PASS) cut-off for the patient reported outcome measure shoulder pain and disability index (SPADI), and evaluate predictors of PASS achievement following standard shoulder care. Patients with shoulder pain, referred for shoulder ultrasound were recruited from a community cohort. Patients completed both SPADI (scored 0–130) and a question on symptom state and followed-up at 6 months. PASS was calculated from Rasch-transformed scores using 2 methods: the 75th percentile of the cumulative response curve and the receiver operating characteristic curve (ROC). Logistic regression was used to identify factors associated with PASS. 304 participants (169 females, mean age 57.2 years) were included. At 6 months, 193 (63%) reported PASS. The association between SPADI at 6 months and PASS depended on baseline SPADI (interaction p = 0.036). Those with higher baseline scores had higher 6 months PASS cut-offs. Using the 75th percentile method, the 6 months total SPADI cut-off was 49.2 in those starting in the highest tertile at baseline compared to 39.4 in the lowest tertile: 46.4 vs. 36.7 for pain, 46.8 vs. 25.1 for disability. The ROC method yielded similar results. We have shown for the first time that the PASS cut-off for SPADI is dependent on baseline severity scores. Understanding the SPADI PASS threshold is important for clinical research to allow standardised reporting of shoulder intervention success at the patient level.

scholarly journals Validation of the 30 Second Asthma Test™ as a Measure of Asthma Control

2007 ◽  
Vol 14 (2) ◽  
pp. 105-109 ◽  
Author(s):  
Sara Ahmed ◽  
Pierre Ernst ◽  
Robyn Tamblyn ◽  
Neil Colman
Keyword(s):  
Disease Control ◽  
Asthma Control ◽  
Screening Tool ◽  
Asthma Management ◽  
Forced Expiratory Volume ◽  
Primary Objective ◽  
Diagnostic Validity ◽  
Airway Function ◽  
Patient Reported ◽  
Brief Screening

BACKGROUND: The primary objective of asthma management is to help patients establish and maintain optimal disease control. Simple and efficient tools are needed to assess patient-reported symptoms so that they can be used with or without airway function to evaluate asthma control.OBJECTIVE: The objective of the present study was to evaluate the validity of The 30 Second Asthma Test (GlaxoSmithKline Inc, Canada), based on the Canadian Asthma Guidelines, by estimating its relationship with criterion measures of control.RESULTS: The discriminative and diagnostic validity of The 30 Second Asthma Test™ was examined in a sample of 81 patients with a confirmed diagnosis of asthma. Based on a cut-off score of two or greater on The 30 Second Asthma Test™, the overall agreement with specialist ratings was 65%, and 58% with per cent predicted forced expiratory volume in 1 s. The 30 Second Asthma Test™ scores distinguished between groups of patients who were classified based on the change in intensity of therapy.CONCLUSION: The results support the use of The 30 Second Asthma Test™ as a brief screening tool for asthma control.

scholarly journals Early responders within seven days of dupilumab treatment for severe asthma evaluated by patient-reported outcome: a pilot study

2021 ◽  
Vol 16 ◽  
Author(s):  
Nozomi Tani ◽  
Nobutaka Kataoka ◽  
Yusuke Kunimatsu ◽  
Yusuke Tachibana ◽  
Takumi Sugimoto ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Severe Asthma ◽  
Early Response ◽  
Patient Reported Outcome ◽  
Forced Expiratory Volume ◽  
Response To Treatment ◽  
Severe Atopic Dermatitis ◽  
Asthma Control Test ◽  
Rapid Improvement ◽  
Patient Reported

Background: The management of severe asthma-associated symptoms is essential since they are distressing to the affected patients, and also greatly impair their quality of life. Dupilumab, a monoclonal antibody, blocks interleukin (IL)-4 and IL-13 signaling, both of which are crucial in acquired and innate immunity pathways through fast signal transduction, leading to an early response to treatment. Although rapid improvement within 1–3 days after dupilumab treatment was observed in moderate-to-severe atopic dermatitis, an early response within 7 days of dupilumab treatment in severe asthma has not been reported. Methods: Twelve consecutive patients with severe asthma who were newly treated with dupilumab between July 2019 and April 2020 were retrospectively investigated. We evaluated the early response (within 7 days) of patients with severe asthma receiving dupilumab therapy. Asthma control test (ACT) and the daily ACT, which was modified from the ACT to evaluate daily symptoms associated with asthma, were adopted as patient-reported outcomes (PROs) at week 8 and within 7 days, respectively. Patients were stratified into early responders (7 days), late responders (week 8), and non-responders without significant improvement in PROs. Descriptive statistics were adopted due to the limited number of patients.Results: Four of these 12 patients were early responders, with the following baseline characteristics: body mass index, <25 kg/m2; without depression; baseline forced expiratory volume in 1 second, <1.50 L; and more than one exacerbation in 1 year. On the other hand, five were late responders, and 44.4% of the nine responders were early responders. The higher the eosinophilic count and/or FeNO did not show any relationship between the early responder and nonresponder.Conclusions: The effect of dupilumab on severe asthma in patients with atopic features could be started earlier than 2 weeks, similar to atopic dermatitis. Daily ACT may be useful in monitoring the early efficacy of dupilumab in treating severe asthma.

Anti-α-Gal antibodies detected by novel neoglycoproteins as a diagnostic tool for Old World cutaneous leishmaniasis caused byLeishmania major

Parasitology ◽  
2018 ◽  
Vol 145 (13) ◽  
pp. 1758-1764 ◽  
Author(s):  
Krishanthi S. Subramaniam ◽  
Victoria Austin ◽  
Nathaniel S. Schocker ◽  
Alba L. Montoya ◽  
Matthew S. Anderson ◽  
...  
Keyword(s):  
Cutaneous Leishmaniasis ◽  
Operating Characteristic ◽  
Leishmania Major ◽  
Characteristic Curve ◽  
Area Under The Curve ◽  
Old World ◽  
Logistic Regression Models ◽  
Resource Limited ◽  
Diagnostic Potential ◽  
Potential Area

AbstractOutbreaks of Old World cutaneous leishmaniasis (CL) have significantly increased due to the conflicts in the Middle East, with most of the cases occurring in resource-limited areas such as refugee settlements. The standard methods of diagnosis include microscopy and parasite culture, which have several limitations. To address the growing need for a CL diagnostic that can be field applicable, we have identified five candidate neoglycoproteins (NGPs): Galα (NGP3B), Galα(1,3)Galα (NGP17B), Galα(1,3)Galβ (NGP9B), Galα(1,6)[Galα(1,2)]Galβ (NGP11B), and Galα(1,3)Galβ(1,4)Glcβ (NGP1B) that are differentially recognized in sera from individuals withLeishmania majorinfection as compared with sera from heterologous controls. These candidates contain terminal, non-reducing α-galactopyranosyl (α-Gal) residues, which are known potent immunogens to humans. Logistic regression models found that NGP3B retained the best diagnostic potential (area under the curve from receiver-operating characteristic curve = 0.8). Our data add to the growing body of work demonstrating the exploitability of the human anti-α-Gal response in CL diagnosis.

Associations Between Patient-Reported Outcome Measures of Asthma Control and Psychosocial Symptoms

2018 ◽  
Vol 58 (3) ◽  
pp. 307-312
Author(s):  
ChangWon C. Lee ◽  
Faye F. Holder-Niles ◽  
Linda Haynes ◽  
Jenny Chan Yuen ◽  
Corinna J. Rea ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Asthma Control ◽  
Outcome Measures ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Multivariable Analysis ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Primary Care Center ◽  
Patient Reported

There is growing emphasis on using patient-reported outcome measures to enhance clinical practice. This study was a retrospective review of scores on the Childhood Asthma Control Test (C-ACT) and the Pediatric Symptom Checklist-17 (PSC-17) at a pediatric primary care center in Boston, Massachusetts. A total of 218 patients were selected at random using billing codes for well-child (WC) care and asthma, excluding complex medical conditions. Cutoff scores were used to identify uncontrolled asthma (C-ACT ⩽19) and clinically significant psychosocial symptoms (+PSC-17). Multiple logistic regression was used to measure associations between C-ACT ⩽19 and +PSC-17, adjusting for covariates. In multivariable analysis, C-ACT ⩽19 at WC visits was associated with +PSC-17 at WC visits (adjusted odds ratio = 3.2 [95% confidence interval = 1.3-8.6]). C-ACT ⩽19 at non-WC visits was also associated with +PSC-17 at WC visits (adjusted odds ratio = 3.1 [95% confidence interval = 1.2-8.9]). Patient-reported outcome measures of asthma control and psychosocial symptoms were positively correlated in this sample.

scholarly journals Patient-reported experience measure in sickle cell disease

2018 ◽  
Vol 103 (12) ◽  
pp. 1104-1109 ◽  
Author(s):  
Subarna Chakravorty ◽  
Amy Tallett ◽  
Cara Witwicki ◽  
Harriet Hay ◽  
Catherine Mkandawire ◽  
...  
Keyword(s):  
Focus Group ◽  
Sickle Cell ◽  
Cognitive Testing ◽  
Cell Disease ◽  
Focus Group Discussions ◽  
Group Discussions ◽  
Pilot Survey ◽  
Experience Of Care ◽  
Patient Reported ◽  
Experience Measure

ObjectivesTo develop patient-reported experience measure surveys for patients with sickle cell disease (SCD) to understand their healthcare and lived experience in the UK and for their use in future to inform healthcare service development.DesignPicker methodology was used as follows: (1) qualitative scoping by focus group discussions; (2) questionnaire development through stakeholder consultations; (3) construct validation of questionnaires through cognitive testing; and (4) further assessment of construct validity by a nationwide pilot survey.SettingPatients with SCD and their carers were eligible. Focus group discussions took place in non-hospital settings, arranged out of hours. Cognitive testing took place in specialist sickle cell clinics. The pilot survey was available to UK participants only and was administered through web-based questionnaires, face-to face completion and in sickle cell community events.ParticipantsThirty-three patients and carers took part in the focus groups, 21 participants undertook cognitive testing and 722 respondents completed the pilot survey.ResultsFindings highlighted a widespread prevalence of poor knowledge about SCD among healthcare providers and the public. Poorer experience of care was present in the emergency setting compared with planned care, of which lack of timely provision of pain relief was of concern. Adolescents and young people reported significantly poorer experience of care in several domains compared with children or adults.ConclusionsThe new surveys functioned well, with good evidence of validity, and were accessible to the SCD patient population, supporting their future use in assessing patient experience to inform service delivery and improvements in care quality.

scholarly journals Measuring tuberculosis medication adherence: a comparison of multiple approaches in relation to urine isoniazid metabolite testing within a cohort study in India

2021 ◽  
Author(s):  
Ramnath Subbaraman ◽  
Beena E Thomas ◽  
J Vignesh Kumar ◽  
Maya Lubeck-Schricker ◽  
Amit Khandewale ◽  
...  
Keyword(s):  
Home Visit ◽  
Operating Characteristic ◽  
Characteristic Curve ◽  
Routine Care ◽  
Objective Measures ◽  
Operating Characteristics ◽  
Patient Reported ◽  
Operating Characteristic Curve ◽  
Poor Outcomes ◽  
Urine Testing

Abstract Background Nonadherence to tuberculosis medications is associated with poor outcomes. However, measuring adherence in practice is challenging. In this study, we evaluated the accuracy of multiple tuberculosis adherence measures. Methods We enrolled adult Indians with drug-susceptible tuberculosis who were monitored using 99DOTS, a cellphone-based technology. During an unannounced home visit with each participant, we assessed adherence using a pill estimate, four-day dose recall, a last missed dose question, and urine isoniazid metabolite testing. We estimated the area under the receiver operating characteristic curve (AUC) for each alternate measure in comparison to urine testing. 99DOTS data were analyzed using patient-reported doses alone and patient- and provider-reported doses, the latter reflecting how 99DOTS is implemented in practice. We assessed each measure’s operating characteristics, with particular interest in specificity—i.e., the percentage of participants detected as being nonadherent by each alternate measure, among those who were nonadherent by urine testing. Results Compared to urine testing, alternate measures had the following characteristics: 99DOTS patient-reported doses alone (AUC 0.65, specificity 70%, 95%CI:58—81%), 99DOTS patient- and provider-reported doses (AUC 0.61, specificity 33%, 95%CI: 22—45%), pill estimate (AUC 0.55, specificity 21%, 95%CI:12—32%), four-day recall (AUC 0.60, specificity 23%, 95%CI: 14—34%), and last missed dose question (AUC 0.65, specificity 52%, 95%CI:40—63%). Conclusions Alternate measures missed detecting at least 30% of people who were nonadherent by urine testing. The last missed dose question performed similarly to 99DOTS using patient-reported doses alone. Tuberculosis programs should evaluate the feasibility of integrating more accurate, objective measures, such as urine testing, into routine care.

Preoperative Patient-Reported Outcome Measures Relationship With Postoperative Outcomes in Flexible Adult-Acquired Flatfoot Deformity

2020 ◽  
pp. 107110072096307
Author(s):  
Matthew S. Conti ◽  
Kristin C. Caolo ◽  
Joseph T. Nguyen ◽  
Jonathan T. Deland ◽  
Scott J. Ellis
Keyword(s):  
Physical Function ◽  
Operating Characteristic ◽  
Area Under The Curve ◽  
Patient Reported Outcome ◽  
Postoperative Outcomes ◽  
Pain Interference ◽  
Patient Reported ◽  
Adult Acquired Flatfoot Deformity ◽  
Postoperative Improvement ◽  
Preoperative Patient

Background: Previous studies have demonstrated that procedure-specific thresholds using preoperative patient-reported outcome scores may be used to predict postoperative outcomes. The primary purpose of this study was to determine if preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) thresholds could be used to predict which patients would clinically improve at 2 years postoperatively following reconstruction of their flexible adult-acquired flatfoot deformity (AAFD). Methods: PROMIS physical function, pain interference, and depression scores were prospectively collected preoperatively and at a minimum of 2 years postoperatively for 75 feet with flexible AAFD. Minimal clinically important differences (MCIDs) were calculated to establish significant postoperative improvement. Receiver operating characteristic curves and area under the curve analyses were employed to determine whether preoperative PROMIS scores could be used to predict postoperative outcomes. Results: The PROMIS physical function receiver operating characteristic curve analysis (area under the curve = 0.913, P < .001) found that a preoperative PROMIS physical function score greater than 45.7 resulted in a 14.3% probability of achieving the MCID, whereas a preoperative score of less than 40.8 had a 97.7% probability of achieving the MCID. A preoperative PROMIS pain interference score (area under the curve = 0.799, P < .001) less than 54.1 had only a 23.1% probability of achieving the MCID at 2 years postoperatively. Conclusions: Preoperative PROMIS physical function and pain interference scores could be used to predict postoperative improvement in patients with flexible AAFD. These results may help surgeons counsel patients regarding the anticipated benefit of surgery. Level of Evidence: Level III, retrospective comparative series.

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