|Year : 2021 | Volume
| Issue : 6 | Page : 2184-2194
Diagnostic accuracy of screening tools for chronic obstructive pulmonary disease in primary health care: Rapid evidence synthesis
Jyoti Tyagi, Sandeep Moola, Soumyadeep Bhaumik
The George Institute for Global Health, New Delhi, India
|Date of Submission||19-Nov-2020|
|Date of Decision||02-Feb-2021|
|Date of Acceptance||17-Mar-2021|
|Date of Web Publication||02-Jul-2021|
Dr. Jyoti Tyagi
308-309, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre, New Delhi - 110 025
Source of Support: None, Conflict of Interest: None
Background: Chronic obstructive pulmonary disease (COPD) contributed significantly to burden of diseases in India, with missed , incorrect, and delayed diagnosis in primary care. We conducted a rapid evidence synthesis, to summarize the evidence on accuracy of the screening tests for COPD in primary health care on request form State Health Resource Centre, Chhattisgarh. Methods: Considering the rapid nature of decision making, our approach was to first search for existing systematic reviews. We identified one existing systematic review on the topic with the search conducted until 2014. We updated the review by searching in two major databases screened, title/abstracts, and full texts of studies as per eligibility criteria and extracted relevant data. A narrative synthesis was conducted. Results: We retrieved 7,007 and included five new studies, to add to 10 studies of the existing systematic review. Overall, 13 studies assessed diagnostic accuracy of screening questionnaires [e.g., COPD Diagnostic Questionnaire (CDQ)], five assessed handheld flow meters (COPD6 and PICO-6), and four assessed the combination of both the tests. The CDQ questionnaire using a score threshold ≥16.5 or >17 demonstrated comparatively a higher sensitivity both in pooled result for ever-smokers [87.5% (95% CI 83.1--90.9%)] and among the adults >35 years [73.8--93% (95% CI 69--98%)] when compared to a different score threshold of CDQ and other questionnaires. Handheld flow meters reported a pooled high sensitivity of 79.9% (95% CI 74.2--84.7%) in ever-smokers and 87.9% in adults with age >35 years. Conclusions: The need for better diagnosis of COPD in primary healthcare can be addressed by using of COPD Diagnostic Questionnaire alone or in combination with hand-held flow meters. There is scope for more implementation research on the domain.
Keywords: Chronic obstructive pulmonary disease, diagnostic test accuracy, primary health care, screening, sensitivity, specificity, spirometry
|How to cite this article:|
Tyagi J, Moola S, Bhaumik S. Diagnostic accuracy of screening tools for chronic obstructive pulmonary disease in primary health care: Rapid evidence synthesis. J Family Med Prim Care 2021;10:2184-94
|How to cite this URL:|
Tyagi J, Moola S, Bhaumik S. Diagnostic accuracy of screening tools for chronic obstructive pulmonary disease in primary health care: Rapid evidence synthesis. J Family Med Prim Care [serial online] 2021 [cited 2021 Sep 26];10:2184-94. Available from: https://www.jfmpc.com/text.asp?2021/10/6/2184/320461
| Introduction|| |
Chronic obstructive pulmonary disease (COPD) is a major contributor to disease burden globally in spite of being preventable and treatable. Globally, 261 million cases of COPD were reported in 2016, with an estimated 3.17 million deaths in 2015., The burden of COPD in low-and middle-income countries (LMICs) is continually increasing, posing a substantial public health burden. Smoking cessation and early detection of this disease can prevent its development and limit its mortality and morbidity. The Global Burden of Disease study reported that the prevalence of COPD in India increased by 39.4% in 2017 posing a significant public health threat.,
The requester [State Health Resource Centre (SHRC)] in Chhattisgarh had identified the high burden of COPD in Chhattisgarh and the need to improve identification of COPD patients and subsequent care of COPD patients in the primary care. Globally it is known that primary care providers often missed early diagnosis of COPD, when symptoms are mild and the disease is often diagnosed at an advanced stage, when lung changes are no longer fully reversible.
We received a request from SHRC to conduct a review of the evidence (within 6 weeks) on screening tests for diagnosing COPD in primary healthcare facilities.
| Methods|| |
Approach for the study
Based on an initial scoping of literature, we identified a systematic review published in 2015 which address the review question of interest. It provided relevant details from included studies (published until 2014) on diagnostic accuracy of screening tests for identifying undiagnosed COPD. Hence, our approach was updating the systematic review by searching for studies of any quantitative design that evaluated screening tests conducted in PHC.
The article is a review of published literature and did not involve any living participant. As such, no ethical approval was necessary.
We included studies which met the following criteria.:
- Population: Studied which included individuals aged ≥35 years with no prior diagnosis of COPD.
- Index test: Screening questionnaires (any), handheld flow meters/handheld spirometer (e.g., Piko-6 or COPD-6), peak flow meters/micro spirometry, risk prediction models , decision aids, and chest radiography, either used alone or in combination with any of the aforementioned tests.
- Reference Standard Presence of airflow obstruction measured by prebronchodilator or postbronchodilator spirometry.
- Diagnosis of interest: Identification of COPD.
- Study designs: Studies of any quantitative design.
- Setting: Studies conducted in PHC context (including general practices and community pharmacies) were considered.
We searched two electronic databases (Medline and EMBASE) from January 2014 to March 2020 [Appendix 1]. The search was restricted to studies published in the English language.
Study selection and data collection process:
The primary reviewer independently applied the inclusion criteria to the retrieved publications. The titles and abstracts of studies for inclusion were screened. For the studies deemed relevant, full texts were retrieved and screened for eligibility as per the eligibility criteria. We included studies which specifically mentioned the target condition as COPD, identified by the use of of airflow obstruction, with prebronchodilator or postbronchodilator spirometry as the reference standard. No assessment of methodological quality of the studies was conducted.
Data collection process
A pre-designed template for data extraction was developed. The primary reviewer independently extracted all relevant outcome data. We extracted data on several key parameters including: 1) Study type, 2) Countries where studies were conducted, 3) Participants (number) and details of setting, 4) Index and reference tests, 5) Outcome measures (sensitivity and specificity).
Synthesis of results
Relevant outcome data were extracted and tabulated from selected reviews. A narrative synthesis was presented that addressed the review question documenting the relevant data and findings from all,,,,,,,,,,,,,, the included studies. The findings of meta-analyses conducted in the existing systematic review were presented, wherever relevant. On account of considerable heterogeneity, additional five,,,, studies were precluded from meta-analyses.
We used the PRISMA extension for Diagnostic Test Accuracy (DTA) [Appendix 2] for reporting the study.
| Results|| |
We retrieved 7,007 articles after electronic databases search. Following the removal of one duplicate, the titles/abstracts of 7,006 studies were screened based on the pre-set eligibility criteria. Full texts of 44 potentially eligible articles were obtained and were reviewed for further examination. Only five of the 44 studies were included in the final report.
We thus added five new studies,,,, to the existing 10 studies,,,,,,,,, of the systematic review by Haroon et al. [Figure 1] depicts the study selection process in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram.
|Figure 1: The study selection process in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram|
Click here to view
The review reported 10 studies,,,,,,,,, from existing systematic review and additional five studies,,,, were supplemented with updated search. Overall, 15 studies,,,,,,,,,,,,,, accounting for 35,429 participants were included in the review. The review examined evidence on diagnostic accuracy of screening tests mainly measured by sensitivity and specificity of the test for detecting COPD. Majority of the studies were of cross-sectional diagnostic test accuracy design. The mean age of the participants ranged from 49 years to 69.5 years. Most of the studies were conducted in developed countries like UK, US, Australia, European countries, except one which was conducted in Vietnam. Four studies ,,, used a paired design and compared two screening tests (screening questionnaires and handheld flow meters), while the remaining studies used single screening method followed by spirometry as reference test. Meta-analyses were conducted in five,,,, studies from the systematic review by Haroon et al. Rest of the studies were excluded from the meta-analyses on the account of heterogeneity in the studies. The methodological quality of 10 studies from the systematic review was assessed using QUADAS-2 tool,,,,,,,,,, however, the additional five studies were not appraised.,,,, Key characteristics of all the included studies are presented in Appendix 3.
Index and reference tests
Index tests included screening questionnaires (n = 13),,,,,,,,,,,, handheld flow meters (n = 6).,,,,, Prebronchodilator spirometry was used as the reference standard test in two, studies while 13,,,,,,,,,,,, studies used both pre and postbronchodilator spirometry.
Thirteen studies,,,,,,,,,,,, assessed four screening questionnaires on 15,182 participants. Among all the questionnaires, the CDQ was the most widely used screening tool (n = 8),,,,,,, followed by other screening questionnaires. The CDQ is also referred to as the Respiratory Health Screening Questionnaire (RHSQ) or International Primary Care Airways Group (IPAG) questionnaire. Few studies reported using more than one questionnaire as their screening tool.,,
No new studies were found which had evaluated CDQ as screening tool (using a threshold of ≥19.5, ≥16.5 or >17) in ever-smokers and the meta-analysis of four studies,,, was done by the Haroon et al.. Remaining studies,,, were precluded from conducting meta-analysis as a result of the heterogeneity in their threshold of score and the participants. The pooled sensitivity and specificity reported for the score threshold of ≥19.5 was 64.5% [95% Confidence Interval (CI) 59.9--68.8%)] and 65.2% (95% CI 52.9--75.8%), respectively. While the pooled sensitivity reported for the score threshold of ≥16.5 was higher at 87.5% (83.1 to 90.9), the specificity was quite low at 38.8% (27.7 to 51.3).
The un-pooled sensitivities and specificities in adults >35 years and ever-smokers for different threshold score were reported separately [Table 1]. At a score threshold of <19.5, the sensitivity and specificity reported was 36% (CI 11--61%) and 93% (CI 89--96%), respectively. The sensitivities and specificities using a score threshold ≥19.5 ranged from 59 to 73% and 54 to 77%, respectively. At a score threshold ≥16.5 or ≥17, the sensitivities ranged from 73.8 to 93%, while specificities were reported in the range of 24--57%.
The pooled,,, result for ever-smokers and among the adults >35 years,,,,,, reported a comparative high sensitivity for COPD diagnostic questionnaire (CDQ) using a score threshold ≥16.5 or >17 as compared to a different score threshold of CDQ and other questionnaires signifying a lower percentage of missed positive cases [as summarized in [Table 1]]. Likewise, the pooled Negative Predictive Value (NPV) of CDQ reported at the same threshold score 98.2% probability that the subject with negative result is truly free of disease.
|Table 1: Accuracy of Different Diagnostic Tests for COPD,,,,,,,,,,,,,,|
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Studies using Lung Function Questionnaire (LFQ), COPD Population Screener (COPD-PS), and Two screening questions (2SQ) reported a significant heterogeneity in their design, and therefore were not eligible to be included in a meta-analysis.
The COPD-PS screening questionnaire across the three studies,, in adults >35 years reported (using a score threshold ≥4 or ≥5) sensitivities ranging from 20 to 80.4% and specificities from 47.7 to 90%, respectively.
Lung Function Questionnaire,,, at a score of ≤18 reported sensitivity ranging from 79 to 93% which was again suggestive of a lower percentage of missed positive cases while the specificity reported was between the range of 25 and 71%.
Other screening questionnaires were assessed in = 2 studies, which reported sensitivity range of 57--87% and specificity ranging between 71-80%.
Handheld flow meter
Handheld flowmeter is a device intended for measuring lung function. FEV1 and FEV6 is a measure of forced expiratory volume in 1 and 6 s, respectively. The test is repeated three times with the highest values recorded. Five studies evaluated the diagnostic accuracy of handheld flow meter in 2,052 participants.,,,,, The mean age of the participants ranged from 52 to 65.3 years. Four studies used it without a bronchodilator.,,,, The handheld meter used were COPD6 and PICO-6. An FEV1/FEV6 cut off <0.7 provided a range of sensitivity from 79 to 87.9% and specificity from 71 to 99% for COPD screening.
Three studies,, enrolling ever-smokers from the existing systematic review were deemed eligible for conducting meta-analysis as a result of their homogeneity. Handheld flow meters,, when used under the supervision of trained nurses and health professionals reported a pooled high sensitivity of 79.9% (95% CI 74.2--84.7%) and a specificity of 84.4% (95% CI 68.9--93.0%), respectively [Table 1].
In adults with age >35 years and ever-smokers, the un-pooled,,,,, sensitivities and specificities were reported in the range of 79--87.9% and 71--99%, respectively.
Combined screening tests
The combined diagnostic test accuracy of a handheld flow meter along with a questionnaire was assessed in four studies.,,, However, the combined results for the diagnostic accuracy was reported by only two studies.,
Sichletidis et al. found that the combined senstivity of a screening questionnaire (CDQ) with a handheld flow meter was 74.4% (95% CI 64--83%), and specificity 97% (95% CI 95--98%). The NNV was reported as 98.5% for combined usage . This is suggestive of an improved diagnostic accuracy of screenings tests when used in combination, thereby potentially reducing number of diagnostic assessments required.
Likewise, Shirley et al. reported the combined results for screening questionnaire (COPD-PS) and handheld flow meter. The tests together yielded a sensitivity of 20% and specificity of 92.9%. The individual test accuracy of other two studies, has been aforementioned in the above sections.
| Discussion|| |
The rapid evidence synthesis is an update of an existing systematic review examining the evidence on diagnostic accuracy of screening tests and overall we incorporated evidence from 15 studies. Of all the screening questionnaires, CDQ was the most extensively used screening tool and was found to have acceptable sensitivity and specificity . Combined usage of handheld flow meters and the CDQ questionnaire lead to higher sensitivity and specificity compared to the CDQ screening questionnaire alone when used under the supervision of trained nurses or general practitioners. A higher sensitivity and specificity of handheld flow meter (80% and 79.8%, respectively) alone when compared to COPD-PS questionnaire (20% and 78.6%, respectively) was also reported . These results indicate that the use of a simple, validated, easy to administer tool in primary healthcare context is an effective method to facilitate early diagnosis of patients at a risk of COPD s. However, the use of handheld flow meter requires training, underlying the need for further investments on this regards, particularly in resource-scarce settings. However, it is expected that such an early diagnosis focused strategy would be more cost-effective than the current scenario wherein delayed diagnosis leads to high costs of treatment in the secondary and tertiary care sectors as well as high mortality and morbidity. Formal cost-effectiveness evaluations might be mandated . There are, however, implementation challenges expected, including but not limited to addressing demand-side barriers, human resource and technical capacity issues, and issues around governance and financing. There is need for implementation research in the domain. There is also need for understanding care pathways for COPD in different countries to enable better planning.
We acknowledge the limitation of searching only in electronic databases with no search for identifying grey/unpublished literature and the lack of conduct of risk of bias assessment in this update but contend this would not change the findings of the study and its implications majorly.
| Conclusion|| |
The problem of misdiagnosis or underdiagnosis of COPD in primary care can be resolved through usage of handheld flow meters along with COPD questionnaires. There is need for more implementation research on this domain.
The authors would also like to acknowledge and thank Dr Prabir Chatterjee and Mr Narayan Tripathi, State Health Resource Centre, Chhattisgarh, India for placing the request to TGI-RES team to conduct a rapid review of the evidence.
Financial support and sponsorship
This gratis rapid evidence synthesis was made possible due to the support from World Health Organization, Alliance for Health Policy and Systems Research. The funder did not have a role in drafting, revising or approving the content of the policy brief.
Conflicts of interest
There are no conflicts of interest.
| Appendices|| |
| Appendix 1: Search strategies|| |
| Embase|| |
| Appendix 2: Prisma Dta Checklist|| |
| Appendix 3: Characteristics of included studies|| |
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