scholarly journals International guidelines for self-report and proxy completion of paediatric health-related quality of life measures: a protocol for a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052049
Author(s):  
Christine Mpundu-Kaambwa ◽  
Gang Chen ◽  
Kim Dalziel ◽  
Nancy Devlin ◽  
Julie Ratcliffe

IntroductionMeasures of health-related quality of life (HRQoL), accompanied by the values (or utilities) required to estimate quality-adjusted life-years, are crucial for determining health benefits within economic evaluation and health technology assessment. Several generic and condition-specific measures or instruments of HRQoL, accompanied by values, currently exist for application with child populations. However, there is a lack of a structured summary of guidelines and recommendations for applying these measures in practice. This protocol describes a systematic review of guidelines and recommendations for child and proxy completion of child-specific measures of HRQoL. The aims of the review are to (1) identify and summarise published guidelines and recommendations for existing child-specific measures of HRQoL, (2) determine whether the identified guidelines and recommendations differ by instrument and child characteristics, (3) identify current gaps in these guidelines and recommendations and (4) identify best practices for child self and proxy assessment in paediatric HRQoL measurement for economic evaluation and health technology assessment.Methods and analysisThe review will identify, collate and synthesise published guidelines and recommendations for existing child-specific utility measures of HRQoL. Electronic databases to be searched include the Cochrane Library, Medline, Scopus, Web of Science, EconLit, PsycINFO, CINAHL, Embase and Informit. The search will be extended to websites of (1) international organisations for health technology assessment, (2) regulation, health economics and HRQoL outcomes research and (3) instrument developers. Three reviewers will independently screen titles and abstracts against the inclusion criteria. A narrative synthesis will describe the key features of the guidelines identified.Ethics and disseminationEthical approval is not required as the proposed systematic review will not use primary data. A paper of the systematic review will be submitted to a peer-reviewed journal for publication.PROSPERO registration numberCRD42020207160.

2016 ◽  
Vol 12 (5) ◽  
pp. 323 ◽  
Author(s):  
Johannes FX Hofmann, PhD ◽  
Arun Lal, MSc, MBA ◽  
Maike Steffens ◽  
Robert Boettger

Objective: To perform a systematic comparison of tapentadol prolonged release (PR) and oxycodone controlled release (CR) using patient-relevant endpoints of efficacy, safety, and health-related quality of life (HRQoL) according to criteria used in health technology assessment. To derive a minimal important difference (MID) for the EQ-5D from three pivotal trials to measure patient-relevant changes in HRQoL.Design: Randomized, double-blind, placebo and active controlled. Setting: Outpatient primary care.Participants: Patients with severe chronic osteoarthritis pain (two pivotal studies) and severe lower-back pain (one pivotal study) were enrolled. The intent-to-treat population of the three studies comprised a total of 2,968 patients (tapentadol PR arms: 978, oxycodone CR arms: 999, and in the placebo arms: 991).Interventions: Tapentadol PR (100-250 mg bid), oxydodone CR (20-50 mg bid), or placebo over a period of 15 weeks (3 weeks titration plus 12 weeks maintenance).Outcome Measures: Patient-relevant endpoints of efficacy, safety, tolerability, and HRQoL.Results: Tapentadol PR demonstrated significant added benefits as compared to oxycodone CR in meta-analyses of the patient-relevant outcomes 30 percent pain relief (Realtive risk [RR]: 0.80 [0.75, 0.87]), treatment discontinuations (RR: 0.55 [0.363, 0.825]), safety (RR: 0.652 [0.599, 0.710]), and HRQoL (RR: 0.78 [0.64, 0.96]) based on a MID derived for the EQ-5D summary index.Conclusions: Added benefit of tapentadol in all endpoint categories suggests that it may be beneficial to initiate treatment of chronic severe nonmalignant pain with tapentadol rather than oxycodone.


Author(s):  
Fedrico Riva ◽  
Mariana Seoane ◽  
Michael Eduardo Reichenheim ◽  
Georgios Tsakos ◽  
Roger Keller Celeste

Author(s):  
Carlos Zaror ◽  
Andrea Matamala‐Santander ◽  
Montse Ferrer ◽  
Fernando Rivera‐Mendoza ◽  
Gerardo Espinoza‐Espinoza ◽  
...  

2020 ◽  
Vol 49 (Supplement_1) ◽  
pp. i34-i36
Author(s):  
F E Martin ◽  
T Kalsi ◽  
J K Dhesi ◽  
J S L Partridge

Abstract Introduction Older women are increasingly undergoing surgery for gynaecological malignancies. Although survival data is available other outcomes such as functional recovery are less well described. However older people are both more vulnerable to changes in function and often prioritise function over survival. There is limited published research examining function outside of context of sexual or urodynamic function following gynaeoncology surgery but a large body or research exists examining health-related quality of life (HrQOL) both as a pre-operative risk factor for survival and as a post-treatment outcome measure in its own right. HRQOL tools may report on physical function as a subcomponent within composite tools. This systematic review and narrative synthesis describes functional recovery after gynae-oncology surgery with respect to baseline characteristics which - if identified – could enable pre- or post-operative risk reduction. Methods Systematic search of MEDLINE and EMBASE databases and Cochrane Library between 1974-2018. Two reviewers independently reviewed abstracts/papers for inclusion against the following criteria:Mean/median age >60Gynaeoncological treatment includes surgery (RCTs, observational or mixed methods studies).Any measure of functional ability as defined by WHO ICF classification section D1–D7 inclusive, D855, D860-79 and D9 using validated tool.Minimum pre-operative and one post-operative measure. Results analysed and presented using narrative synthesis. Results Sixteen studies identified (7 Endometrial, 2 Ovarian, 2 Vulval, 6 mixed cancer types). 1/16 used a standalone functional assessment tool, 15/16 used Health-Related Quality of Life tools (EORTC QLQ C30 (10), FACT-G (3), SF-36 (3)) comprising items describing function. More studies showed full recovery to baseline (n=11) than incomplete recovery (n=5 including 2 reporting age as a negative association). Recovery was more likely and occurred faster in minimally-invasive surgery. 1 study demonstrated failure to recover baseline functional independence by 12 months.


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