Background
Lung cancer is the leading cause of cancer death all over the world, which is reported continuously as having the highest mortality rate [
1‐
3]. Two main categories exist for lung cancers: small cell lung cancer, which accounts for 15% of the cases, and Non-small cell lung cancer (NSCLC), which accounts for the other 85% [
4]. In past decades, significantly novel advances in diagnosis and treatment of NSCLC have been made and their effectiveness was supported by strong clinical evidence [
5,
6]. Thereafter, clinical practice guidelines incorporating the latest medical advances for cancer care were updated and issued every year in China to guide the practice for NSCLC patients. However, studies showed that a slight increase, instead of an evident drop, could be seen in the mortality rate of lung cancers from 2002 to 2011 in China [
7], which cast a doubt on whether more advanced guidelines could lead to better quality of care.
Quality of care (QOC) is defined as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge [
8,
9]. As stated by several studies, a wide gap between actual practice and clinical practice guidelines was observed in quality of care for many diseases including NSCLC [
10‐
14]. For example, it has been reported that many patients with early-stage NSCLC do not undergo surgery or adjuvant chemotherapy, which is suggested by most guidelines of NSCLC [
15,
16]. It is also reported that reducing the gap between best evidence and clinical practice is associated with reductions in patient morbidity and mortality [
11,
12,
17‐
19], and reduced healthcare costs [
20]. To bridge the gap, current QOC must be assessed and efforts should be made based on the observations from the results of assessment. In 1999, the institute of medicine of USA issued a landmark report which called for attention to quality of cancer care in USA, and subsequently recommended consecutive steps to improve quality of cancer care, among which development of quality indicators was recognized to be the essential and first step for quality improvement [
21]. Quality indicators are measurement tools of practice performance, for which there is evidence or consensus that they can be used to assess QOC of a particular health care process [
22,
23]. Many countries such as America, Canada and Netherlands have already taken actions to establish multi-dimensional quality indicators to assess QOC in areas like breast cancer, colorectal cancer as well as lung cancer and most of them witnessed a remarkable improvement of care quality [
24‐
26].
In China, concerning quality measurement for cancer care are indicators like concordance rate of admitting and discharging diagnosis and readmission rate, which can only assess limited process of cancer care. Considering the complex nature of NSCLC and the characteristics of Chinese healthcare system and referring to the results of other similar studies, we intend to set up a more comprehensive framework of indicators. The new framework should be able to assess aspects QOC as detailed and comprehensive as possible, which could help us get deeper insight into the current QOC. Based on such a framework, we can discover the specific drawbacks during the care of NSCLC and light up a direction for quality improvement. Moreover, due to the similar complexity of all cancers, the new framework is expected to act as a reference for other cancer assessment programs to validate its usefulness not only in china but also in other countries around the world.
The main goal of this study is to establish a new indicator framework for NSCLC care based on the classic structure-process-outcome framework and systematically develop a set of quality indicators specifically suitable for China using a modified Delphi process. The resulting set of indicators would serve as standard tools for measuring and monitoring quality of NSCLC care and act as guidance for quality improvement.
Discussion
As far as we know, this is the first study focusing on the development of quality indicators for NSCLC in the context of Chinese heath care system and it is also the first study building and using the new indicator framework, which should be further tested by similar studies in other countries for its validity. After three round of modified Delphi process, a set of 21 indicators was developed. This set of indicators are supposed to quantify and visualize the gap between clinical practice and evidence-based guidelines; help us get a deeper and more comprehensive understanding of the current situation of NSCLC care in China thus put forward a clear direction of improvement. Under the guidance of the improvement direction, we can make effective interventions to bridge the gap in order to get better quality of care for NSCLC. We can also use these indicators to discover disparities of NSCLC care quality among hospitals, which is anticipated helpful to clinician, researchers, government administrators, and others who want to make decisions, policies, and changes based on the information.
Most previous studies developed indicators based on “structure-process-outcome” framework. There was a group from Netherlands who did it from professional, organizational, and patient-oriented perspectives and patient-oriented indicators made up almost half of the indicators [
30]. This is a relatively new perspective of developing indicators. However, it is considered subjective and unreliable when using data from patients’ recall.
In this study, we pioneer the new indicator framework including five domains: structure, communication, process, management of symptoms or treatment toxicity, and outcome. The domain communication was built based on the consideration that good communication between doctors and patients plays an important role in quality improvement since patients tend to be more compliable to the treatment decision and prescription of doctors when they have better understanding of their illness thus making the process of care more smoothly. Some experts of other organizations also noticed the issue. In NCCN Oncology Policy Summit in 2013, panelists emphasized the importance of the communication between all doctors, nurses, and staff and patients as well as their families. They discussed how providing the “right” amount of information to patients and their families is a difficult task for physicians and nurses, but is critical to the patient experience. They also discussed how the overall culture of a hospital, or how patients and their families are received, all contribute to defining a quality experience [
31]. As to the domain of management of symptoms or treatment toxicity, we consider that treatment side effects and toxicity are common in the process of cancer care, of which necessary management would have positive effect on prognosis and quality of life after discharging. In this study, four indicators related to this domain were selected in the first round of Delphi but all eliminated in the second round of rating. “The assessment of pain intensity” and “the reassessment of pain intensity” were excluded for not meeting any of the six criteria, suggesting that panelists did not think there were scientific evidence or the other five properties. The other two indicators “postoperative incentive spirometry” and “atrial fibrillation treated after lung resection within 45 minutes” were excluded because several experts thought that they lacked validity (the indicator can measure the quality of care and has potential for improvement) and preventability (the indicator has the ability of preventing adverse outcomes). Despite such a result, we still hold the point that the domain of “management of symptoms or treatment toxicity” is an important component of the proposed framework which aims to cover various aspects of care process. With the continuously updating guidelines, the indicators will be updated accordingly as well. The completeness of the framework also ensures that we follow the same methodology every time we renewal indicators. Experts from the Delphi process in this study may think the domain not as vital as others. However, the importance of this part for cancer care is undeniable. Another study of our team for cancer indicator development also validated the usefulness of this framework [
32].
The Delphi process used in this study was consistent with previous studies [
33‐
35]. However, some indicators developed in our study differed from those of others. Danish National Indicator project [
36,
37] produced evidence-based indicators for eight diseases (including lung cancer) in 2000. The result included 9 indicators, all of which were outcome indicators. However, the result of this study had only one outcome indicator “postoperative complications”. Indicators presented in Danish study that did not pass rating in our project included “1-year survival rate” and “5-year survival rate”. The possible reasons are listed as followed: The first is that we put more emphasis on the comprehensiveness of indicators and the overall process of care in the current study; second, the follow-up information is inquired mainly by telephone in China. However, there is not yet a completed follow-up plan in all hospitals which means some hospitals have follow-up information while others do not and the register systems are not connected among hospitals; third, there is such a phenomenon in China that when patients are dead, their families are unwilling to tell strangers including doctors about the misfortune on the phone.
The result of the study includes 16 process indicators which cover four stages of NSCLC and almost every phase of care process including diagnosis, neo-adjuvant chemotherapy, surgery, adjuvant chemotherapy, radiotherapy, and documentation of pathology report. These process indicators are either evidence-based therapies or essential elements for appropriate treatment for NSCLC cancer patients and compliance to these indicators is supposed to improve the quality of care and decrease recurrence and mortality rate for patients.
The strengths of this study include a comprehensive review of evidence-based guidelines; a rigorous rating procedure that included criteria of scientific evidence, validity, interpretability, usefulness, preventability, and feasibility. The most unique feature that makes this study different from others is developing a new structure of indicators “structure, communication, process, management of symptoms or treatment toxicity, outcome”.
In the next step of the study, we will make a questionnaire to collect data from electronic medical records based on the final set of indicators and compute performance scores using appropriate statistical methods for each indicator of each hospital that are enrolled in this study. Feedback will be sent back to hospitals and doctors to help them make improvement strategies. The performance after feedback will be reassessed to examine the effect of intervention. We believe that aiming at the improvement of performance of selected indicators will lead to improved patient outcomes.
There are several limitations to this study. The first is that we only chose experts in lung cancer care because the process of developing indicators required a detailed understanding of the evidence base and clinical practice. Other perspectives like the ones of patients are also important because they are the receivers of care and their interests may vary from those of lung cancer experts; the second is that the indicators were determined by a group of experts, another group of experts with different discipline structure may rate the same potential indicators differently; the last limitation, which is also to be solved in our next step, is that the indicators should be up to date to reflect ever-changing medical progress in NSCLC and in Chinese healthcare system.
Acknowledgements
We would like to thank the clinical experts from The Third Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, The Fourth Affiliated Hospital of Harbin Medical University, Affiliated Ruijin Hospital of Shanghai Jiao Tong University, School of Medicine, Cancer Hospital of Tianjin Medical University, Beijing Cancer Hospital, Peking Union Medical College Hospital, Cancer Hospital of Chinese Academy of Medical Science for their support and contributions to our study.