Short-Term Health-Related Quality of Life After Abdominal Surgery: A Conceptual Framework

Abstract Funding Acknowledgements Type of funding sources: None. Introduction/Purpose: Patent foramen ovale (PFO) is common in asymptomatic adults and is associated with cryptogenic stroke (CS). We sought to evaluate the impact of PFO closure in health-related quality of life (HRQoL) in PFO patients with CS. Method In this pilot study, 19 patients (mean age 47 ± 7.7; 13 male) who underwent PFO closure at our center were invited to a short-term clinical follow up (mean follow-up period 6-10 months). All patients had suffered an ischaemic stroke and their disability level was assessed using the Modified Rankin Scale (MRS, no significant disability 63%). HRQoL was assessed using the 36-Item Short Form Survey (SF-36) and the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) preoperatively and at follow-up. Results Both SF36 and EQ-5D scores improved after the operation as shown by the self-rating scores (20,67% and 40,52% higher scores, respectively). Patients with major mobility problems were more likely to be current smokers (r = 0.481) and those who had lower scores on the MRS scale (r=-0.571) rated higher their scale diagram. The categories of energy/fatigue (r = 0.459; p = 0.048), social functioning (r = 0.547; p = 0.015) and pain (r = 0.550; p = 0.015) were positively correlated with physical function. Finally, there was a positive correlation between role limitations due to emotional problems and energy/fatigue (r = 0,519; p = 0.023), and between energy/fatigue and emotional well-being (r = 0.519; p = 0,023). Conclusions The results of our study indicate that shortly after PFO, subjects perceive improvements in their QoL. However, it seems that poorly rated physical function was more common in active smokers, and affects patients" social life and their emotional state. Health care professionals should encourage these patients to participate in rehabilitation and psychological support programs postoperatively.

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Development of a conceptual framework to underpin a health-related quality of life outcome measure in paediatric chronic fatigue syndrome/myalgic encephalopathy (CFS/ME): prioritisation through card ranking

Quality of Life Research ◽

10.1007/s11136-019-02399-z ◽

2020 ◽

Vol 29 (5) ◽

pp. 1169-1181

Author(s):

Roxanne M. Parslow ◽

Nina Anderson ◽

Danielle Byrne ◽

Kirstie L. Haywood ◽

Alison Shaw ◽

...

Keyword(s):

Quality Of Life ◽

Conceptual Framework ◽

Outcome Measure ◽

Chronic Fatigue ◽

Health Related Quality ◽

Fatigue Syndrome ◽

Related Quality ◽

Health Related ◽

Ranking Exercise

Abstract Purpose Chronic fatigue syndrome (CFS)/myalgic encephalopathy (ME) is relatively common in children and is disabling at an important time in their development. This study aimed to develop a conceptual framework of paediatric CFS/ME using the patient-perspective to ensure that the content of a new outcome measure includes the outcomes most important to young people. Methods We developed a child-centred interactive card ranking exercise that included health-related quality of life (HRQoL) outcomes identified from a previous review of the literature as well as qualitative work. Adolescents and their parents selected and ranked the outcomes most important to them and discussed each outcome in further detail. Adolescents were purposively sampled from a single specialist paediatric CFS/ME service in England. Interviews were audio recorded and transcribed verbatim, and thematic framework analysis was used to develop the final conceptual framework. Results We interviewed 43 participants in which there are 21 adolescents, 12–17 years of age with mild–moderate CFS/ME and their parents (20 mothers and 2 fathers). ‘Symptoms’, ‘tiredness’, ‘payback and crashing’ and ‘activities and hobbies’ were ranked most important to improve by both children and parents. Children ranked ‘school’ higher than parents and parents ranked ‘mood’ higher than children. A youth- specific CFS/ME conceptual framework of HRQoL was produced that included 4 outcome domains and 11 subdomains: sleep, tiredness, problems concentrating, individual symptoms, fluctuation and payback, daily and general activities, participation in school, leisure and social life, mood, anxiety and self-esteem. Conclusions An interactive card ranking exercise worked well for adolescents aged 12–17 to elicit the most important outcomes to them and explore each domain in further detail. We developed a final conceptual framework of HRQoL that forms the basis of a new paediatric patient-reported outcome measure (PROM) in CFS/ME.

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The Effect of Sport-Related Concussion Injuries on Concussion Symptoms and Health-Related Quality of Life in Male and Female Adolescent Athletes: A Prospective Study

The American Journal of Sports Medicine ◽

10.1177/0363546519880175 ◽

2019 ◽

Vol 47 (14) ◽

pp. 3514-3520

Author(s):

Timothy A. McGuine ◽

Adam Pfaller ◽

Stephanie Kliethermes ◽

Allison Schwarz ◽

Scott Hetzel ◽

...

Keyword(s):

Quality Of Life ◽

High School ◽

Health Related Quality ◽

High School Athletes ◽

Short Term ◽

Female Patients ◽

Severity Scores ◽

Related Quality ◽

Health Related

Background: Sport-related concussions (SRCs) are associated with short-term disablement, characterized as increased concussion symptoms and lower health-related quality of life (HRQoL). However, there are limited longitudinal data detailing how an SRC affects disablement beyond short-term injury recovery. Purpose: To longitudinally assess the effect of SRCs on symptoms and HRQoL in high school athletes through the 12 months after injury. Study Design: Cohort study; Level of evidence, 2. Methods: The 125 participants included high school athletes who sustained an SRC (female patients, 36%; mean ± SD age, 15.9 ± 1.1 years). The Post-concussion Symptom Scale (PCSS) from the Sport Concussion Assessment Tool–3 and the Pediatric Quality of Life Inventory 4.0 (PedsQL) were completed at enrollment and repeated at 24 to 72 hours (onset) and at 7 days (D7) after the SRC; on the date of return to play (RTP); and at 3, 6, and 12 months (M12) after the SRC. Scores at each time point were compared with the athletes’ own baseline via linear mixed models for repeated measures, controlling for age, sex, and history of previous SRC and with patient as a random effect. Results: Relative to baseline, female patients reported higher PCSS symptom and severity scores at onset ( P < .001) and D7 ( P < .001), while scores were not higher ( P > .05) for RTP through M12. As compared with baseline, male patients reported higher PCSS scores at onset ( P < .001) and D7 ( P = .003) and severity scores at onset ( P < .001) and D7 ( P = .016), while the symptom and severity scores were not higher ( P > .05) at RTP through M12. Female participants reported lower PedsQL physical scores at onset ( P = .006), while scores were not lower ( P > .05) from D7 through M12. Female psychosocial scores were not lower ( P > .05) at any time after the SRC, while the total PedsQL score was lower at onset ( P = .05) but not from D7 through M12. Male physical scores were lower at onset ( P < .001) and D7 ( P = .001) but not lower ( P > .05) from RTP through M12. Male psychosocial and PedsQL scores were unchanged ( P > .05) from baseline at onset through M12. Conclusion: After an SRC, high school athletes reported initial disablement (increased symptoms and lower HRQoL) through their RTP. However, after RTP, no similar disablement was detected through 12 months after injury.

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Toward Patient-Centered Innovation

Clinical Journal of the American Society of Nephrology ◽

10.2215/cjn.00110120 ◽

2020 ◽

Vol 15 (10) ◽

pp. 1522-1530

Author(s):

Jennifer E. Flythe ◽

Tandrea S. Hilliard ◽

Kourtney Ikeler ◽

San Keller ◽

Debbie S. Gipson ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trials ◽

Conceptual Framework ◽

Drug Administration ◽

Food And Drug Administration ◽

Health Related Quality ◽

Patient Reported ◽

Related Quality ◽

Health Related

Individuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.

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