scholarly journals Neutral theory: applicability and neutrality of using generic health-related quality of life tools in diseases or conditions where specific tools are available

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ravi Jandhyala
Keyword(s):  
Rare Disease ◽  
Neutral Theory ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Sf 36 ◽  
Disease Condition ◽  
Related Quality ◽  
Health Related ◽  
Sensitivity Specificity

Abstract Background Health-related quality of life (HRQoL) tools are limited by the indicators included in the construct and variation in interpretation by different researchers. Neutral Theory describes the ideal construct that includes all relevant indicators and, therefore, complete accuracy, or neutrality. Neutral Theory can thereby provide the framework to develop or test constructs. To assess the application of Neutral Theory, the neutrality of generic tools (SF-36 and EQ-5D) at measuring HRQoL was compared to disease/condition-specific tools, with the latter considered surrogates for the Neutral construct. Methods Full descriptions of all disease/condition-specific HRQoL tools published on PubMed (to 01-Jul-19) were sourced. For each tool, the number of items with and without a direct match within the SF-36 and EQ-5D was recorded and the sensitivity/specificity calculated. Results The SF-36 and EQ-5D did not achieve a sensitivity/specificity both > 50% against any of the 163 disease/condition-specific tools identified. At 20% prevalence of poor HRQoL, the false positive rate (FPR) was > 75% for all but two tools against the SF-36 and six tools against the EQ-5D. Increasing poor HRQoL to 80%, 47 tools for the SF-36 and 48 tools for the EQ-5D had a FPR < 50%. For rare disease tools (< 1/2000 population; n = 17), sensitivity/specificity ranged from 0 to 40%/5–31% for the SF-36 and 0–22%/29–100% for the EQ-5D. For non-rare (n = 75) and symptom-specific tools (n = 71) sensitivity/specificity was: 0–100%/0–100% (SF-36) and 0–50%/0–100% (EQ-5D); and 0–60%/0–19% (SF-36) and 0–25%/0–100% (EQ-5D), respectively. No concordance was recorded for 18% (2/11) of results from studies of rare disease tools versus the SF-36 (no data vs EQ-5D). For non-rare, disease-specific tools, results were discordant for 30% (25/84) and 35% (23/65) of studies against the SF-36 and EQ-5D, respectively. For symptom-specific tools, corresponding results were 36% (24/66) and 16% (5/31). Conclusions Generic HRQoL tools appear poorly correlated with disease/condition-specific tools, which indicates that adoption of Neutral Theory in the development and assessment of HRQoL tools could improve their relevance, accuracy, and utility in economic evaluations of health interventions.

scholarly journals Neutral Theory: Applicability and Neutrality of Using Generic Health-related Quality of Life Tools in Diseases or Conditions Where Specific Tools Are Available

2020 ◽  
Author(s):  
Ravi Jandhyala
Keyword(s):  
Rare Disease ◽  
Neutral Theory ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Sf 36 ◽  
Disease Condition ◽  
Related Quality ◽  
Health Related ◽  
Sensitivity Specificity

Abstract Background:Health-related quality of life (HRQoL) tools are limited by the indicators included in the construct and variation in interpretation by different researchers. Neutral Theory describes the ideal construct that includes all relevant indicators and, therefore, complete accuracy, or Neutrality. Neutral Theory can thereby provide the framework to develop or test constructs. To assess the application of Neutral Theory, the Neutrality of generic tools (SF-36 and EQ-5D) at measuring HRQoL was compared to disease/condition-specific tools, with the latter considered surrogates for the Neutral construct. Methods:Full descriptions of all disease/condition-specific HRQoL tools published on PubMed (to 01-Jul-19) were sourced. For each tool, the number of items with and without a direct match within the SF-36 and EQ-5D was recorded and the sensitivity/specificity calculated. Results:The SF-36 and EQ-5D did not achieve a sensitivity/specificity both >50% against any of the 163 disease/condition-specific tools identified. At 20% prevalence of poor HRQoL, the false positive rate (FPR) was >75% for all but two tools against the SF-36 and six tools against the EQ-5D. Increasing poor HRQoL to 80%, 47 tools for the SF-36 and 48 tools for the EQ-5D had a FPR <50%. For rare disease tools (<1/2,000 population; n=17), sensitivity/specificity ranged from 0-40%/5-31% for the SF-36 and 0-22%/29-100% for the EQ-5D. For non-rare (n=75) and symptom-specific tools (n=71) sensitivity/specificity was: 0-100%/0-100% (SF-36) and 0-50%/0-100% (EQ-5D); and 0-60%/0-19% (SF-36) and 0-25%/0-100% (EQ-5D), respectively. No concordance was recorded for 18% (2/11) of results from studies of rare disease tools versus the SF-36 (no data vs EQ-5D). For non-rare, disease-specific tools, results were discordant for 30% (25/84) and 35% (23/65) of studies against the SF-36 and EQ-5D, respectively. For symptom-specific tools, corresponding results were 36% (24/66) and 16% (5/31).Conclusions:Generic HRQoL tools appear poorly correlated with disease/condition-specific tools, which indicates that adoption of Neutral Theory in the development and assessment of HRQoL tools could improve their relevance, accuracy, and utility in economic evaluations of health interventions.

scholarly journals Impact of malnutrition on health-related quality of life in persons receiving dialysis: a prospective study

2021 ◽  
pp. 1-24
Author(s):  
Daniela Viramontes-Hörner ◽  
Zoe Pittman ◽  
Nicholas M Selby ◽  
Maarten W Taal
Keyword(s):  
Quality Of Life ◽  
Prospective Study ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
The Impact ◽  
Over Time

Abstract Health-related quality of life (HRQoL) is severely impaired in persons receiving dialysis. Malnutrition has been associated with some measures of poor HRQoL in cross-sectional analyses in dialysis populations, but no studies have assessed the impact of malnutrition and dietary intake on change in multiple measures of HRQoL over time. We investigated the most important determinants of poor HRQoL and the predictors of change in HRQoL over time using several measures of HRQoL. We enrolled 119 haemodialysis and 31 peritoneal dialysis patients in this prospective study. Nutritional assessments (Subjective Global Assessment [SGA], anthropometry and 24-hour dietary recalls) and HRQoL questionnaires (Short Form-36 [SF-36] mental [MCS] and physical component scores [PCS] and European QoL-5 Dimensions [EQ5D] health state [HSS] and visual analogue scores [VAS]) were performed at baseline, 6 and 12 months. Mean age was 64(14) years. Malnutrition was present in 37% of the population. At baseline, malnutrition assessed by SGA was the only factor independently (and negatively) associated with all four measures of HRQoL. No single factor was independently associated with decrease in all measures of HRQoL over 1 year. However, prevalence/development of malnutrition over one year was an independent predictor of 1-year decrease in EQ5D HSS and 1-year decrease in fat intake independently predicted the 1-year decline in SF-36 MCS and PCS, and EQ5D VAS. These findings strengthen the importance of monitoring for malnutrition and providing nutritional advice to all persons on dialysis. Future studies are needed to evaluate the impact of nutritional interventions on HRQoL and other long-term outcomes.

scholarly journals Serum Amyloid A Is a Biomarker of Disease Activity and Health-Related Quality-of-Life in Patients with Antineutrophil Cytoplasmic Antibody-Associated Vasculitis

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Taejun Yoon ◽  
Sung Soo Ahn ◽  
Juyoung Yoo ◽  
Jason Jungsik Song ◽  
Yong-Beom Park ◽  
...  
Keyword(s):  
Disease Activity ◽  
Serum Amyloid A ◽  
Antineutrophil Cytoplasmic Antibody ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Amyloid A ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Serum amyloid A (SAA) is one of the acute phase proteins synthesized in hepatocytes and secreted by various inflammation or infectious stimuli. We investigated the clinical implication of measuring SAA in patients with antineutrophil cytoplasmic antibody- (ANCA-) associated vasculitis (AAV). Seventy-five patients who had been classified as AAV and enrolled in our prospective observational cohort for AAV patients were included. Clinical and laboratory data were obtained on the day of blood sampling, and SAA was measured by ELISA kits. Birmingham Vasculitis Activity Score (BVAS) and Short-Form 36-Item Health Survey (SF-36) were assessed for disease activity and health-related quality-of-life (HRQoL) measures. We stratified patients into having high BVAS when the BVAS was over the median values, and those with either low SF-36 PCS or low SF-36 MCS were defined as having poor HRQoL. Multivariate logistic regression analysis was conducted to estimate independent predictors of high BVAS. The relative risk (RR) was analyzed using the contingency tables and the chi-squared test. SAA was positively correlated with BVAS ( r = 0.642 ) and FFS ( r = 0.367 ) and was inversely correlated with both the SF-36 physical component summary ( r = − 0.456 ) and mental component summary scores ( r = − 0.394 ). Furthermore, SAA was significantly correlated with acute phase reactants ESR ( r = 0.611 ) and CRP ( r = 0.629 ). Patients with high BVAS exhibited significantly higher SAA than those with low BVAS (1317.1 ng/mL vs. 423.1 ng/mL). In multivariable logistic regression analysis, serum albumin (odds ratio (OR) 0.132) and SAA > 1173.6   ng / mL (OR 15.132) were independently associated with high BVAS. The risk of having high BVAS and poor HRQoL in patients with SAA > 1173.6   ng / mL was higher than in those with SAA ≤ 1173.6   ng / mL (RR 3.419 and 1.493). Our results suggest that SAA might be a useful biomarker in assessing disease activity and HRQoL in AAV.

scholarly journals Health-related quality of life in ICU survivors—10 years later

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
José G. M. Hofhuis ◽  
Augustinus J. P. Schrijvers ◽  
Tjard Schermer ◽  
Peter E. Spronk
Keyword(s):  
Effect Size ◽  
Reference Population ◽  
Health Related Quality ◽  
Sf 36 ◽  
Icu Discharge ◽  
Related Quality ◽  
Health Related ◽  
Surgical Icu

AbstractMany Intensive Care (ICU) survivors experience long lasting impairments in physical and psychological health as well as social functioning. The objective of our study was to evaluate these effects up to 10 years after ICU discharge. We performed a long-term prospective cohort study in patients admitted for longer than 48 h in a medical-surgical ICU. We evaluated health-related quality of life (HRQOL) before ICU admission using the Short-form-36 (SF-36), at ICU discharge, at hospital discharge and at 1, 2, 5 and 10 years follow up (all by patients). Changes in HRQOL were assessed based on linear mixed modeling. We included a total of 749 patients (from 2000 to 2008). During 10 years 475 (63.4%) patients had died, 125 (16.7%) patients were lost to follow up and 149 (19.9%) patients could be evaluated. The mean scores of four HRQOL dimensions (i.e., physical functioning (p < 0.001; mean 54, SD 32, effect size 0.77, 95% CI [0.54–1.0]), role-physical (p < 0.001; mean 44, SD 47, effect size 0.65, 95% CI [0.41–0.68] general health (p < 0.001; mean 52, SD 27, effect size 0.48; 95% CI 0.25–0.71) and social functioning (p < 0.001; mean 72, SD 32, effect size 0.41, 95% CI [0.19–0.64]) were still lower 10 years after ICU discharge compared with pre-admission levels (n = 149) and with an age reference population. Almost all SF-36 dimensions changed significantly over time from ICU discharge up to 10 years after ICU discharge. Over the 10 year follow up physical functioning of medical-surgical ICU survivors remains impaired compared with their pre-admission values and an age reference population. However, effect sizes showed no significant differences suggesting that surviving patients largely regained their age-specific HRQOL at 10 years.

scholarly journals FRI0128 FILGOTINIB PROVIDED RAPID AND SUSTAINED IMPROVEMENTS IN FUNCTIONAL STATUS, PAIN, HEALTH-RELATED QUALITY OF LIFE, AND FATIGUE IN PATIENTS WITH RHEUMATOID ARTHRITIS AND INADEQUATE RESPONSE TO METHOTREXATE: RESULTS FROM THE FINCH 1 STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 645.2-646
Author(s):  
A. Kivitz ◽  
Y. Tanaka ◽  
S. Lee ◽  
L. Ye ◽  
H. Hu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Pain Scale ◽  
Inadequate Response ◽  
Health Related Quality ◽  
Research Support ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
Time Point

Background:In the FINCH 1 study, filgotinib (FIL)—an oral, potent, selective Janus kinase 1 inhibitor—in combination with methotrexate (MTX) provided significant improvements in the signs and symptoms of rheumatoid arthritis (RA) in patients (pts) with inadequate response to MTX.1While EULAR guidelines recommend a treat-to-target approach focusing on reducing inflammation to prevent joint damage, physical disability, and mortality, pts consider control of pain and fatigue, along with maintenance of physical function and health-related quality of life (HRQoL), to be important aspects for their care.2,3Objectives:To evaluate the rate and magnitude of change in patient-reported outcomes (PROs) from FINCH 1.Methods:In the FINCH 1 study (NCT02889796), pts with active RA received oral FIL 200 mg + MTX, FIL 100 mg + MTX, PBO + MTX, or subcutaneous adalimumab (ADA) 40 mg + MTX for up to 52 weeks (W); pts receiving PBO at W24 were rerandomised 1:1 to FIL 100 or 200 mg. PROs included the HAQ-DI and VAS pain scale, SF-36, and FACIT-Fatigue questionnaire. The change from baseline (CFB) at each time point was assessed up to W52 for each treatment group. The mixed-effects model for repeated measures was used to compare each FIL group with PBO for the CFB at each time point through W24. The logistic regression model was used to compare each FIL group with PBO for the proportion of pts achieving the minimum clinically important difference (MCID) of ≥0.22 reduction in CFB in HAQ-DI at each time point through W24.Results:Of 1755 pts randomised and treated (475 FIL 200 mg + MTX; 480 FIL 100 mg + MTX; 325 ADA + MTX; and 475 PBO + MTX), 1417 (80.7%) received study drug through W52. As early as W2 through W24, pts receiving either dose of FIL experienced nominally significantly greater (p <0.001) CFB in HAQ-DI and VAS pain scale than those receiving PBO; CFB improvements were maintained through W52 (Fig 1A, B). At W2, compared with PBO (40.2%), a nominally significantly greater proportion of pts achieved the HAQ-DI MCID in both the FIL 200 (52.5%; p <0.001) and 100 mg (46.7%; p = 0.043) groups. This benefit vs PBO was maintained up to W24 and the proportion of pts who achieved a HAQ-DI reduction of ≥0.22 remained ≥75.8% in the FIL 200 mg group and ≥71.5% in the FIL 100 mg group from W12 through W52. FIL provided nominally significantly greater improvement in HRQoL vs PBO at W4 and W12 for both the CFB of the SF-36 Physical Component Summary (PCS) (p <0.001) and Mental Component Summary (MCS) (p ≤0.006); nominal significance was also seen at W24 for CFB of SF-36 PCS (Fig 2A, B). By W4, pts receiving either dose of FIL reported a nominally significantly greater mean CFB in FACIT-Fatigue scores vs PBO (p <0.001); significance was maintained through W24 and improvement in reported fatigue continued through W52 in the FIL groups (Fig 2C). In general, CFB for HAQ-DI, VAS pain scale, and FACIT-Fatigue observed for the FIL groups was higher or comparable to ADA at various time points (Fig 1, 2).Conclusion:Both doses of FIL provided rapid and sustained improvements in functional status, pain, HRQoL, and fatigue compared with PBO for pts with RA and inadequate response to MTX throughout the 52-week period.References:[1]Combe BG, et al.Ann Rheum Dis.2019;78 (Suppl 2):A77.[2]Fautrel B, et al.Rheumatol Int.2018;38:935–47.[3]Smolen JS, et al.Ann Rheum Dis.2017;76:960–77.Disclosure of Interests:Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim,,Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin, Susan Lee Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Lei Ye Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Hao Hu Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Robin Besuyen Shareholder of: Galapagos, Employee of: Galapagos, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB

scholarly journals Effect of multimorbidity patterns on the decline in health-related quality of life: a nationwide prospective cohort study in Japan

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047812
Author(s):  
Takuya Aoki ◽  
Shunichi Fukuhara ◽  
Yasuki Fujinuma ◽  
Yosuke Yamamoto
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Clinical Outcomes ◽  
Prospective Cohort ◽  
Summary Score ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

ObjectivesLongitudinal studies, which consider multimorbidity patterns, are useful for better clarifying the effect of multimorbidity on health-related quality of life (HRQoL) and for identifying the target population with poorer clinical outcomes among patients with multimorbidity. This study aimed to examine the effects of different multimorbidity patterns on the decline in HRQoL.DesignNationwide prospective cohort study.SettingJapanese adult residents.ParticipantsResidents aged ≥50 years selected by the quota sampling method.Primary outcome measureClinically relevant decline in HRQoL was defined as a 0.50 SD (5-point) decrease in the 36-Item Short Form Health Survey (SF-36) component summary scores for 1 year.ResultsIn total, 1211 participants completed the follow-up survey. Among the multimorbidity patterns identified using confirmatory factor analysis, multivariable logistic regression analyses revealed that high cardiovascular/renal/metabolic and malignant/digestive/urologic pattern scores were significantly associated with the clinically relevant decline in SF-36 physical component summary score (adjusted OR (aOR)=1.25, 95% CI: 1.08 to 1.44 and aOR=1.28, 95% CI: 1.04 to 1.58, respectively). High cardiovascular/renal/metabolic pattern score was also significantly associated with the clinically relevant decline in SF-36 role/social component summary score (aOR=1.23, 95% CI: 1.06 to 1.42).ConclusionsOur study revealed that multimorbidity patterns have different effects on the clinically relevant decline in HRQoL for 1 year. These findings can be useful in identifying populations at high risk and with poor clinical outcomes among patients with chronic diseases and multimorbidity for efficient resource allocation.

Factors Affecting Health-Related Quality of Life After the Arterial Switch Operation

2021 ◽  
Vol 12 (3) ◽  
pp. 344-351
Author(s):  
Julie Cleuziou ◽  
Anna-Katharina Huber ◽  
Martina Strbad ◽  
Masamichi Ono ◽  
Alfred Hager ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Arterial Switch Operation ◽  
Health Related Quality ◽  
Switch Operation ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
Cardiac Medication

Background: Long-term morbidity and mortality outcomes of the arterial switch operation (ASO) in patients with transposition of the great arteries and Taussig-Bing anomaly are excellent. With an increasing number of patients reaching adolescence and adulthood, more attention is directed toward quality of life. Our study aimed to determine the health-related quality of life (hrQoL) outcomes in patients after the ASO and identify factors influencing their hrQoL. Methods: In this cross-sectional study, hrQoL of patients after ASO was assessed with the German version of the Short Form-36 (SF-36) and the potential association of specified clinical factors was analyzed. Patients of at least 14 years of age who underwent ASO in our institution from 1983 were considered eligible. Results: Of the 355 questionnaires sent to eligible patients, 261 (73%) were available for analysis. Compared to the reference population, patients who had undergone ASO had a significantly higher score in all subscales of the SF-36 except for vitality ( P < .01). Patients with an implanted pacemaker ( P = .002), patients who required at least one reoperation ( P < .001), and patients currently taking cardiac medication ( P < .004) or oral anticoagulation ( P = .036) had lower physical component scores compared to patients without these factors. Conclusions: Patients’ self-assessed and self-reported hrQoL after ASO (using German version of the Short Form 36) is very good. In this population, hrQoL is influenced by reoperation, the need for a pacemaker, and current cardiac medication or anticoagulant use. The development of strategies designed to mitigate or minimize the requirements for, and/or impact of these factors may lead to better hrQoL in this patient population.

scholarly journals Reduced Health-Related Quality of Life in Body Constitutions of Yin-Xu, and Yang-Xu, Stasis in Patients with Type 2 Diabetes: Taichung Diabetic Body Constitution Study

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Chia-I Tsai ◽  
Yi-Chang Su ◽  
Shih-Yi Lin ◽  
I-Te Lee ◽  
Cheng-Hung Lee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 2 Diabetes ◽  
Health Related Quality ◽  
Body Constitution ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
The Impact

Aim. To evaluate how health-related quality of life (HRQOL) and traditional Chinese medicine (TCM) constitutions of Yin-Xu, Yang-Xu, and Stasis are related in type 2 diabetes patients. Method. Seven hundred and five subjects were recruited in 2010 for this study from a Diabetes Shared Care Network in Taiwan. Generic and disease-specific HRQOL were assessed by the short form 36 (SF-36) and the diabetes impact measurement scale (DIMS). Constitutions of Yin-Xu, Yang-Xu, and Stasis were then assessed by the body constitution questionnaire (BCQ), a questionnaire consisting of 44 items that evaluate the physiological state based on subjective symptoms and signs. Results. Estimated effects of the Ying-Xu and Stasis on all scales of the SF-36 were significantly negative, while estimated effects of the Yang-Xu on all scales (except for SF, RE, MH, and MCS) were significantly negative. For DIMS, the estimated effects of the Ying-Xu and Stasis on all scales were significantly negative except for Stasis on well-being, while Yang-Xu has a significantly negative effect only on symptoms. Conclusions. This study demonstrates that TCM constitutions of Yin-Xu, Yang-Xu, and Stasis are closely related to a reduction in HRQOL. These findings support the need for further research into the impact of intervention for TCM constitutions on HRQOL in patients with type 2 diabetes.

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