Measuring quality of life in patients with resistant bacterial infections (part of developing the tools to fight drug-resistant bacteria)
| ISRCTN | ISRCTN68194223 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68194223 |
| Secondary identifying numbers | 965265 |
- Submission date
- 16/03/2022
- Registration date
- 21/03/2022
- Last edited
- 09/04/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Antibiotic resistance is one of the foremost concerns of modern medicine. While antibiotics have saved countless lives, emerging resistant bacteria (for which many antibiotics do not work) are endangering the well-being of future generations. We need to take action to reduce the effects of these infections. However, healthcare budgets are limited and we need to ensure the programmes in hospitals are providing value, especially in publically funded healthcare. To be able to justify potentially expensive measures that prevent infections with these bacteria, we need to better understand the (long-term) impact of these infections on the quality of life of patients. The REVERSE-QoL study is contained within the larger REVERSE study (ISRCTN12956554) which aims to accurately measure the quality of life in patients with and without infections with resistant bacteria.
Who can participate?
Adult inpatients aged 18 years and over admitted to participating wards in the 24 hospitals
What does the study involve?
Short questionnaires will be filled out by the participant or their representative. These questionnaries will be repeated at 1, 3, 6, and 12 months to see if the participants' quality of life changes.
What are the possible benefits and risks of participating?
The risks are small as this is an observational study. The participant or representative may experience some anxiety recalling the hospital stay or how it impacted their lives. There are no direct benefits to the participants or their representatives, but this information can be used to help patients in the future.
Where is the study run from?
University of Zurich (Switzerland)
When is the study starting and how long is it expected to run for?
July 2021 to June 2026
Who is funding the study?
European Union Horizon 2020 research and innovation programme
Who is the main contact?
Ashlesha Sonpar
reverse@usz.ch
Contact information
Scientific
University Hospital Zurich
Clinic for Infectious Diseases and Hospital Hygiene
Rämistrasse 100
Zurich
8091
Switzerland
 ORCID ID |
0000-0003-1676-1384 |
|---|---|
| Phone | +41 (0)44 255 4310 |
| ashlesha.sonpar@usz.ch |
Scientific
Nuffield Department of Population Health
Richard Doll Building
Old Road Campus
Oxford
OX3 7LF
United Kingdom
| ORCID ID |
0000-0001-7097-8950 |
|---|---|
| Phone | +44 (0)749 046 3358 |
| koen.pouwels@ndph.ox.ac.uk |
Principal Investigator
University Hospital Zurich
Clinic for Infectious Diseases and Hospital Hygiene
Rämistrasse 100
Zurich
8091
Switzerland
| Phone | +41 (0)43 253 03 52 |
|---|---|
| walter.zingg@usz.ch |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | 41365_PIS_participants_V1.1_14Mar22.pdf |
| Scientific title | pREVention and management tools for rEducing antibiotic Resistance in high prevalence SEttings: Quality of Life study (REVERSE QoL) |
| Study acronym | REVERSE QoL |
| Study objectives | To enable comparisons between different, potentially unrelated, interventions competing for the same budget ideally health-economic analyses would be expressed in terms of cost per quality-adjusted life year(QALY). This allows for maximising the quality of life of the population given a fixed budget by prioritising interventions that cost less per QALY and are affordable given the budget. QALYs represent a measure of both morbidity and mortality. However, there is a severe lack of data on the impact of different infections of interest on morbidity, as measured by health-related quality of life. To address this knowledge gap, a matched cohort study (REVERSE-QoL) will be nested in the randomised trial with the primary objective of estimating the impact of hospital-acquired infections caused by carbapenem-resistant enterobacteriales (CRE), carbapenem-resistant Pseudomonas aeruginosa (CRPA), or carbapenem-resistant Acinetobacter baumannii (CRAB) on patients’ health-related quality of life (HRQoL) during their hospitalisations and 1-, 3-, 6-, and 12-months after their infection. |
| Ethics approval(s) | Approved 07/01/2022, Kantonale Ethikkommission (Stampfenbachstrasse 121, 8090 Zürich, Switzerland; +41 (0)43 259 79 70; info.kek@kek.zh.ch), ref: AO-2021-00078 |
| Health condition(s) or problem(s) studied | Antimicrobial resistance and health-related quality of life |
| Intervention | Using a matched cohort study nested in the RCT (REVERSE - ISRCTN12956554) the researchers will compare quality of life among patients acquiring key pathogens of interest versus patients with a similar reason for admission (randomly sampled from the same ward) to estimate the impact of acquiring these infections on quality of life during the hospitalisation and 1, 3, 6, and 12 months post-discharge using EuroQol-5D (EQ-5D) and 36-Item Short-Form Health Survey (SF-36) health-related quality of life questionnaires. These validated questionnaires are available in local languages (Italian, Romanian, Greek and Spanish) and English for patients and proxies. The primary outcome of this study will be health-related quality of life over time as measured using the EQ-5D questionnaire. Secondary outcomes include health-related quality of life over time as measured using the SF-36 questionnaire, and differences in separate domains of both health-related quality of life questionnaires (EQ-5D and SF-36). The researchers aim to recruit consenting adult patients (REVERSE only recruits adult patients) that acquire a CRE, CRPA, or CRAB hospital-acquired infection (main outcome of the RCT) during their hospital stay. Mixed-effects models with optimal type of mixed-effects model (e.g. mixed-effects linear model or mixed-effects beta-regression) determined by model fit. Exposed patients (infected with organism of interest) and unexposed patients will be matched on ward, time in hospital before index date, and age (categorical: 18-44, 45-64, 65-74, 75+ years). The analysis will include fixed effects for the matching variables and the following additional covariates: sex, comorbidities (Charlson Comorbidity Index), surgical procedure within 30 days before the index date (date of matching), antibiotic use within 30 days before the index date. Time will also be included as a covariate to model changes over time, with an interaction with the exposures of interest to model potential time-varying effects of the exposure. Total quality of life losses will be estimated and compared by obtaining the area under the curves for exposed and unexposed groups using Simpson’s rule (quadratic interpolation). A cluster-specific and patient-specific random effect will be considered to model the repeated measurements on the same cluster and patient. Supportive analyses considering more complex random effects structures will also be investigated. (e.g., time within clusters, wards within hospitals). The interaction between time and interventions will also be added as a fixed effect to model a possible time-varying intervention effect. It is possible that a limited number of individuals that are recruited as uninfected controls will attract a CRE/CRPA/CRAB infection at a later point during their hospitalisation. This is necessary to avoid bias introduced when selecting controls that will never be infected (conditioning on the future). In expectation, the number of people acquiring such infections is small and measurements on or after the day of infection in those patients originally assigned to the control group will be censored. |
| Intervention type | Other |
| Primary outcome measure | Health-related quality of life measured using the EQ-5D questionnaire at 0, 1, 3, 6, and 12 months |
| Secondary outcome measures | 1. Health-related quality of life measured using the SF-36 questionnaire at 0, 1, 3, 6, and 12 months 2. Differences in separate domains of both health-related quality of life questionnaires (EQ-5D and SF-36) at 0, 1, 3, 6, and 12 months |
| Overall study start date | 01/07/2021 |
| Completion date | 01/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 4500 |
| Key inclusion criteria | 1. Adult patient (≥18 years) admitted to a participating hospital on a participating ward 2. Able to speak/understand the local language or English well enough to fill out the surveys 3. Hospital-acquired infection caused by CRE/CRPA/CRAB or control from the same ward |
| Key exclusion criteria | 1. Unable to speak/understand one of the survey languages or English 2. Admitted to a ward or hospital not participating in REVERSE 3. Under 18 years of age 4. Admitted with infection caused by CRE/CRPA/CRAB (community-acquired infection) |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 01/02/2026 |
Locations
Countries of recruitment
- Greece
- Italy
- Romania
- Spain
Study participating centres
Verona
37134
Italy
Rome
00168
Italy
Bologna
40138
Italy
Milan
20142
Italy
Via Francesco Sforza 35
Milan
20122
Italy
Jerez de la Frontera
11407
Spain
Cordoba
14004
Spain
Palma
07120
Spain
Barcelona
08003
Spain
Alicante
03010
Spain
Vigo
36213
Spain
Athens
11527
Greece
Athens
11527
Greece
Thessaloniki
54621
Greece
Ioannina
45500
Greece
Chaidari
12462
Greece
Bucharest
010825
Romania
Bucharest
050098
Romania
Timisoara
300254
Romania
Targu Mures
540103
Romania
Sibiu
550245
Romania
Bucharest
022328
Romania
Marousi
151 26
Greece
Sponsor information
University/education
Rämistrasse 71
Zurich
8006
Switzerland
| Phone | +41 (0)44 634 11 11 |
|---|---|
| reverse@usz.ch | |
| Website | http://www.uzh.ch/index_en.html |
"ROR" |
https://ror.org/02crff812 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 30/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Results will be published in peer-reviewed journals with open access policies where possible. 2. Periodic reports will be distributed to stakeholders and the funding agency 3. Aggregate data will be available upon request |
| IPD sharing plan | The following applies to persons outside of the REVERSE consortium. The data will be available after publication. The project email can be used to contact the coordinating team regarding data requests (reverse@usz.ch). Data will be made available where possible to support further research under FAIR principles, except for data that are confidential or cannot be shared under the GDPR regulations. De-identified and aggregate data from the cohort study needed to verify results will also be available for approximately 5 years after the project ends. Please note, participant-level data from the cohort study will not be available due to patient-level confidential information. The researchers will share data electronically with other research groups conducting meta-analyses or reviews on Infection Prevention and Control (IPC), Antibiotic Stewardship (ABS), or Microbiology and Diagnostic Stewardship (MDS) interventions. This adheres to the data-sharing rules outlined in the Grant Agreement with the European Commission. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participants version 1.1 |
14/03/2022 | 16/03/2022 | No | Yes |
| Participant information sheet | Representatives version 1.1 |
14/03/2022 | 16/03/2022 | No | Yes |
| Protocol file | version 1.2 | 14/03/2022 | 16/03/2022 | No | No |
| Protocol file | version 1.4 | 01/06/2023 | 05/02/2024 | No | No |
| Statistical Analysis Plan | 09/04/2024 | No | No |
Additional files
Editorial Notes
09/04/2024: The statistical analysis plan was uploaded as an additional file.
05/02/2024: A protocol file was added.
01/04/2022: The recruitment start date has been changed from 01/04/2022 to 01/05/2022.
29/03/2022: The following changes were made to the trial record:
1. The trial participating centre Genimatas Hospital was removed.
2. The trial participating centre Sismanoglio General Hospital was added.
16/03/2022: Trial's existence confirmed by the European Commission. This study is contained within the larger REVERSE study (https://www.isrctn.com/ISRCTN12956554).
