Cost-effectiveness review of inpatient lung cancer care

ISRCTN ISRCTN25595562
DOI https://doi.org/10.1186/ISRCTN25595562
Secondary identifying numbers N/A
Submission date
22/06/2017
Registration date
27/06/2017
Last edited
26/11/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Lung cancer is one of the most common cancers worldwide. Routine inpatient care (RIC) for lung cancer consists of a combination of procedures. Each of these procedures not only affects disease outcomes but also incur considerable costs. Due to free selection of hospitals and lack of referral and follow-up mechanisms in China, physicians at individual hospitals cannot link their routine diagnosis and treatment with patients’ mid- and long-term outcomes. This study examines RIC for lung cancer patients and explores paths of combinations of RIC procedures and their contributions to patient outcomes taking costs into consideration.

Who can participate?
Patients aged 18 and over with lung cancer, from rural Anhui province, China

What does the study involve?
The participants’ medical records from all their inpatient care at different hospitals due to cancer are retrieved. The RIC procedures and their costs are extracted from the records and patient outcomes (e.g., survival time, quality of life) are collected through a follow-up survey.

What are the possible benefits and risks of participating?
The results of this study will help to improve treatment by improving outcomes and/or lowering costs.

Where is the study run from?
Anhui Medical University (China)

When is the study starting and how long is it expected to run for?
July 2017 to June 2019

Who is funding the study?
Anhui Provincial Government (China)

Who is the main contact?
Miss Xingrong Shen
xinrongshen@sina.com

Contact information

Miss Xinrong Shen
Public

81 Meishan Road
Hefei
230032
China

Phone +86 (0)551 5116395
Email xinrongshen@sina.com

Study information

Study designRetrospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA cost-effectiveness evaluation of routine inpatient care for lung cancer patients in rural Anhui, China: methods and measures
Study objectivesThere is a general paucity of and an urgent need for data on the cost-effectiveness of complex combinations of routine inpatient care (RIC) procedures for cancer patients which not only affect disease outcomes but also incur considerable costs. This study examines RIC for lung cancer patients in rural Anhui, China and explores paths of combinations of RIC procedures and their contributions to patient outcomes taking costs into consideration.
Ethics approval(s)Anhui Medical University Biomedical Ethics Committee, 23/03/2017, ref: 20170311
Health condition(s) or problem(s) studiedLung cancer
InterventionThe study adopts a retrospective cohort study design and proceeds in 5 steps. Step 1 defines 4 main categories of study variables including clinical procedures, direct cost and effectiveness of the procedures, and factors affecting use of the procedures and their cost and effectiveness. Step 2 selects a cohort of 5000 lung cancer patients diagnosed between 01/07/2014 and 30/06/2015 from rural Anhui by clustered randomization. Step 3 retrieves the records of all the inpatient care episodes incurred by the cohort for treating their lung cancer and extracts data about RIC procedures, immediate patient outcomes (e.g., Karnofsky performance status, symptom score, lung function score) and influencing factors (e.g., stage of cancer, age, gender) by two independent researchers using a pre-developed worksheet. Step 4 estimates the direct cost of each of the RIC procedures identified using micro-costing and collects data about long-term patient outcomes (e.g., progression-free survival, quality of life) through a follow-up survey of patients or their relatives. Step 5 analyzes data collected and explores paths of RIC procedures and their relations with patient outcomes, costs and a whole range of clinical and socio-demographic factors using frequency-cost tabulation, procedure-outcome trees, multivariate regression models and others.
Intervention typeOther
Primary outcome measure1. Gains in months of survival per unit cost
2. Gains in months of progression-free survival per unit cost
Measured at endpoint of the study, i.e., some 2 to 2.5 years after first diagnosis of lung cancer
Secondary outcome measures1. Gains in quality of life score per unit cost
2. Gains in Karnofsky Performance status (KPS) per unit cost
3. Per unit cost gains in compiled indices of symptoms (e.g., chronic cough, chest pain, dysphonia, wasting syndrome, fever)
4. Lung functions (e.g., forced vital capacity, forced expiratory volume in one second, TLCO-SB)
5. Imaging findings (e.g., number of nodes identified in the lung, maximum size of the nodes, presence of abnormalities with the mediastinum or hilum, presence of pleura or pericardial effusion)
6. Biological test findings (e.g., value of CEA, CA125, proGRP, SCC, NSE)
7. Complications and comorbidities (e.g., presence of superior vena cava syndrome, superior vena cava syndrome, cerebral thrombosis or cerebral hemorrhage, chronic fibrous pneumonia, pulmonary embolism, cardiac insufficiency, arrhythmi)
Measured at each episode of hospitalization, i.e., at 4 to 6 time points after the first diagnosis of lung cancer depending on actual times of hospitalization due to the lung cancer by individual patients
Overall study start date01/07/2017
Completion date30/06/2019

Eligibility

Participant type(s)Patient
Age groupAll
SexBoth
Target number of participants5000
Key inclusion criteria1. Lung cancer patients diagnosed between 01/07/2014 and 30/06/2015 from rural Anhui
2. Aged 18 or older
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/07/2017
Date of final enrolment31/12/2017

Locations

Countries of recruitment

  • China

Study participating centre

Anhui Medical University
Meishan Road 81
Hefei
230000
China

Sponsor information

Anhui Medical University
University/education

81 Meishan Road
Hefei
230032
China

Website http://www.ahmu.edu.cn
ROR logo "ROR" https://ror.org/03t1yn780

Funders

Funder type

Government

Anhui Provincial Government

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a peer reviewed journal(s) between 2018 and 2019.
IPD sharing planThe datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/02/2018 26/11/2020 Yes No

Editorial Notes

26/11/2020: Publication reference added.