Health-Related Quality of Life for individuals with hepatitis C: A narrative review.

BACKGROUND The assessment of Health-Related Quality of Life (HRQoL) in hepatitis C (HCV) infected individuals continues to gain importance. However, rarely do reviews of this literature consider quantitative and qualitative accounts of HRQoL collectively, which only allows partial insight into the topic. This narrative review aims to address this gap in the literature. METHODS Literature searches were conducted using seven databases with two separate search strategies, and results assessed for eligibility using specific inclusion/exclusion criteria; a data extraction sheet was used to identify the dominant themes for each research paradigm which were then distilled to key findings to construct the narrative. RESULTS Quantitative investigation reveals a low HRQoL in individuals with HCV due to a complex multifactorial cause. During treatment for HCV, a further transient reduction is observed, followed by improvement if a sustained virological response is achieved. Qualitative data provide a recognisable voice to the everyday challenges experienced by individuals with HCV including insights into diagnosis and stigmatisation, contextualising how a reduced HRQoL is experienced day-to-day. Methodological limitations of these findings are then discussed. Much of the quantitative data has little relevance to current substance users as they are excluded from most trials, and appraisal of the qualitative literature reveals a marked difference in the lived experience of HCV infected current substance users and that of other HCV groups. CONCLUSION Concurrent analysis of quantitative and qualitative paradigms provides a deeper understanding of the true burden of HCV illness on HRQoL. Greater utilisation of qualitative research within international clinical guidelines is likely to be of benefit in identifying relevant HRQoL outcomes for substance users.

Health-related quality of life: implications for critical care interventional studies and why we need to collaborate with patients.

Purpose of review: Health-related quality of life (HRQoL) is an important patient-reported outcome measure following critical illness. ‘Validated’ and professionally endorsed generic measures are widely used to evaluate critical care intervention and guide practice, policy and research. Although recognizing that they are ‘here to stay’, leading QoL researchers are beginning to question their ‘fitness for purpose’. It is therefore timely to review critiques of their limitations in the wider healthcare and social science literatures and to examine the implications for critical care research including, in particular, emerging interventional studies in which HRQoL is the primary outcome of interest. Recent findings: Generic HRQoL measures have provided important yet limited insights into HRQoL among survivors of critical illness. They are rarely developed or validated in collaboration with patients and cannot therefore be assumed to reflect their experiences and perspectives. Summary: Collaboration with patients is advocated in order to improve the interpretation and utility of such data. Failure to do so may result in important study effects being overlooked and the dismissal of potentially useful interventions.

A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial.

Background: increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause on going disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and content of rehabilitation programmes. There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period. This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness. The intervention is currently being evaluated in a randomised trial (ISRCTN09412438; funder Chief Scientists Office, Scotland). Methods: the intervention was developed using the Medical Research Council (MRC) framework for developing complex healthcare interventions. We ensured representation from a wide variety of stakeholders including content experts from multiple specialties, methodologists, and patient representation. The intervention construct was initially based on literature review, local observational and audit work, qualitative studies with ICU survivors, and brainstorming activities. Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline (No. 83), publicly available patient stories (Healthtalkonline), a stakeholder event in collaboration with the James Lind Alliance, and local piloting. Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant (GRA) role. Several rounds of external peer review during successive funding applications also contributed to development. Results: the final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains (physiotherapy, dietetics, occupational therapy, and speech/language therapy), with specific training in post-critical illness issues. The intervention was from ICU discharge to 3 months post-discharge, including inpatient and post-hospital discharge elements. Clear strategies to provide information to patients/families were included. A detailed taxonomy was developed to define and describe the processes undertaken, and capture them during the trial. The detailed process measure description, together with a range of patient, health service, and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions. Conclusions: the MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention. Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting. These data will be useful when interpreting the results of the randomised trial, will increase internal and external trial validity, and help others implement the intervention if the intervention proves clinically and cost effective.

Increased hospital-based physical rehabilitation and information provision after intensive care unit discharge: the RECOVER randomized clinical trial.

Importance: critical illness results in disability and reduced health-related quality of life (HRQOL), but the optimum timing and components of rehabilitation are uncertain. Objective: to evaluate the effect of increasing physical and nutritional rehabilitation plus information delivered during the post–intensive care unit (ICU) acute hospital stay by dedicated rehabilitation assistants on subsequent mobility, HRQOL, and prevalent disabilities. Design, Setting, and Participants: a parallel group, randomized clinical trial with blinded outcome assessment at 2 hospitals in Edinburgh, Scotland, of 240 patients discharged from the ICU between December 1, 2010, and January 31, 2013, who required at least 48 hours of mechanical ventilation. Analysis for the primary outcome and other 3-month outcomes was performed between June and August 2013; for the 6- and 12-month outcomes and the health economic evaluation, between March and April 2014. Interventions: during the post-ICU hospital stay, both groups received physiotherapy and dietetic, occupational, and speech/language therapy, but patients in the intervention group received rehabilitation that typically increased the frequency of mobility and exercise therapies 2- to 3-fold, increased dietetic assessment and treatment, used individualized goal setting, and provided greater illness-specific information. Intervention group therapy was coordinated and delivered by a dedicated rehabilitation practitioner. Main Outcomes and Measures: the Rivermead Mobility Index (RMI) (range 0-15) at 3 months; higher scores indicate greater mobility. Secondary outcomes included HRQOL, psychological outcomes, self-reported symptoms, patient experience, and cost-effectiveness during a 12-month follow-up (completed in February 2014). Results: median RMI at randomization was 3 (interquartile range [IQR], 1-6) and at 3 months was 13 (IQR, 10-14) for the intervention and usual care groups (mean difference, −0.2 [95% CI, −1.3 to 0.9; P = .71]). The HRQOL scores were unchanged by the intervention (mean difference in the Physical Component Summary score, −0.1 [95% CI, −3.3 to 3.1; P = .96]; and in the Mental Component Summary score, 0.2 [95% CI, −3.4 to 3.8; P = .91]). No differences were found for self-reported symptoms of fatigue, pain, appetite, joint stiffness, or breathlessness. Levels of anxiety, depression, and posttraumatic stress were similar, as were hand grip strength and the timed Up & Go test. No differences were found at the 6- or 12-month follow-up for any outcome measures. However, patients in the intervention group reported greater satisfaction with physiotherapy, nutritional support, coordination of care, and information provision. Conclusions and Relevance: post-ICU hospital-based rehabilitation, including increased physical and nutritional therapy plus information provision, did not improve physical recovery or HRQOL, but improved patient satisfaction with many aspects of recovery.