Cancer Clinical Trial
Official title:
Validation of Modified Early Warning Score (MEWS) in Predicting Outcomes in Clinical Oncology Ward Adult Patients
This study is to validate the use of the modified early warning score (MEWS) in an adult
oncology ward as a predictor of 7 day mortality or intensive care unit (ICU) admission. It
is expected that either a MEWS score ≥4 or a change in score of ≥2 from the initial reading
will be associated with an increased risk of death or ICU admission, and should be regarded
as a MEWS Alarm. If MEWS is proof to be a reliable alternative tool, early diagnosis and
aggressive management of life-threatening complications in oncology patients, results in
dramatic improvements in overall survival rates.
This is a prospective, single centre, observational, cohort study. Objective of this study
is to investigate the ability of the Modified Early Warning Score (MEWS) to predict 7 day
mortality in adult clinical oncology ward patients.
The alternate hypothesis of this study is a significant difference in 7 day mortality
between adult oncology ward patients with a MEWS Alarm and adult oncology ward patients
without a MEWS alarm.
The null hypothesis is a no significant difference in 7 day mortality between adult oncology
ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm.
The primary outcome measure in this study is the number of patients who die within 7 days of
a MEWS Alarm (7 day mortality).
The secondary outcome measure in this study is the number of patients admitted to ICU within
7 days of a MEWS Alarm.
This study will be conducted in a 26-bedded clinical oncology ward, a university teaching
hospital in the Hong Kong Island of Hong Kong.
The patients consecutively admitted to clinical oncology ward from 18 January to 7 February
2015 are included in the study, the patients was counted 7 day mortality or 7 day ICU
admission from the on set of reaching the MEWS Alarm. The patients with incomplete MEWS or
discharge data are excluded.
A pilot study was conducted from 13 July at the time of 0am to 18 July at the time of 0am,
2014, 41 patients were admitted consecutively to the clinical oncology ward during the study
period. 10 of them were excluded because of their incomplete MEWS chart, leaving 31 patients
in the pilot study. 18 of them are male and 13 of them are female. 1 patient was transfer to
ICU on her second day from admission, as the MEWS score increased by 3 from initial. Six
patients had 7 day mortality with MEWS alarm and one patient had 7 day mortality without
MEWS alarm in the study period. According to the sample size formulas and the calculators,
the estimated sampling is 171 patients from 18 January to 7 February 2015.
MEWS is a standard nursing routine measurement by calculating the sum of five physiological
parameters: systolic blood pressure, pulse rate, respiratory rate, body temperature and
level of consciousness. The calculated MEWS score is being charted on an observation chart
sheet. Nursing staff routinely collect MEWS score on admission and then once every day
during hospital stay. The date of admission to ICU, and date of death are also collected .
In detail, blood pressure and pulse rate are measured electronically (Dinamap Pro 200
Critikon Vital Signs Monitor, U.S.A). The respiratory rate is counted over one minute. The
tympanic temperature is recorded (ThermoScan, Type 6014, Braun, Germany), and the level of
consciousness is based on the AVPU score: A is 'alert', V is 'response to verbal', P is
'response to pain' and U for 'unresponsive').
The MEWS score is counterchecked by doctors after doctors' assessment on admission and at
the doctors' round everyday.
An ethical approval will be acquired from the CUHK and Queen Mary Hospital Clinical Research
Ethics Committee. All the participants involved in the study will not experience any harm.
Potential participants will be given written information regarding the nature of the study
and the assurances confidentiality for the data collected. Written Consent will be signed.
All report copies collected will be kept confidential. Patient can choose whether or not to
be in this study. If they volunteer to be in this study, they may withdraw at any time
without consequences of any kind of loss or benefits.
For data analysis, the 7 day mortality with reaching MEWS Alarm will compare with the ones
without reaching MEWS Alarm by Chi-Squared Test. The relationship between MEWS and the
mortality is statistically significant if the P value is lower than 0.05. Besides, same
method of data analysis is used on ICU admission with or without reaching MEWS Alarm.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|