Clinical Decision-Making and Factors in the Diagnosis and Management of Clinically Diagnosed Tuberculosis

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Despite national and WHO guidelines emphasizing bacteriological confirmation, reliance on Clinically Diagnosed TB (CDTB) remains common. This study aims to explore the factors and decision-making processes among healthcare providers in public and private settings in the Philippines. Methods This qualitative descriptive study explored diagnostic pathways and decision-making processes among healthcare providers in public, private, and public–private mix (PPM) facilities across four sites in the Philippines (Manila, Cavite, Mindoro, and Cagayan de Oro) from April to June 2025. Semi-structured interviews were conducted with 33 healthcare providers. Data were analyzed thematically using Braun and Clarke’s framework, and facilitated by NVivo version 15 software. Results Providers reported several common diagnostic pathways for CDTB. Decisions in diagnosing CDTB were influenced by health system-related barriers, patient-related factors, and facilitating factors. Conclusion Clinical and radiological diagnosis continues to play a significant role in TB care in the country. While CDTB diagnosis has become the pragmatic solution to the various health system gaps and patient barriers, strengthening diagnostic capacity, addressing systemic and patient-related barriers, and supporting providers through training and education are essential to ensure appropriate TB care. TB diagnosis health facility related barriers health system gaps patient related barriers Figures Figure 1 INTRODUCTION Tuberculosis (TB) remains a major global health challenge and one of the leading causes of infectious disease related deaths. In 2024, an estimated 10 million people developed TB globally, with increasing number since 2021 [ 1 ]. The Philippines ranks fourth globally in TB incidence, and in 2020 about 43% of cases were estimated to be undiagnosed [ 2 ]. In response, the government has strengthened efforts to improve case detection and diagnostic coverage. In the Philippines, TB treatment is provided in both public and private sectors, with 33.5% of symptomatic individuals seeking initial care from the private sector [ 3 ]. The public sector follows the Manual of Procedures for TB screening and diagnosis, whereas private sector practices vary. In order to expand TB diagnosis and access to diagnostic tools, the National TB Program strengthened public–private collaborations and mandated TB case notification across all health facilities [ 4 ]. In line with this, the Integrated Tuberculosis Information System (ITIS) was updated in in 2018 to also capture clinically diagnosed TB cases in addition to bacteriologically confirmed cases [ 5 ]. By 2019, private providers accounted for 18% of TB case notifications, but 97% were clinically diagnosed and treatment outcomes were not reported. Mandatory reporting improved private-sector reporting by 24%, yet over 90% of cases remained clinically diagnosed [ 6 , 7 ]. The increasing reporting of CDTB raises concerns about overdiagnosis, missed alternative diagnoses, inappropriate treatment, and increased risk of drug resistance. There is limited data on understanding the provider decision-making processes and the challenges faced, and the strategies to overcome them. This study aims to explore the diagnostic pathways and decision-making processes among healthcare providers in public and private settings in the Philippines when initiating treatment for clinically diagnosed TB. METHODS Study design This qualitative study employed a descriptive design to obtain direct insights from healthcare providers regarding the CDTB diagnostic procedures. Setting and Participants The study was conducted across four areas in the Philippines, which represent a mix of urban and peri-urban environments (Manila, Cavite, Mindoro, and Cagayan de Oro) from April to June 2025. Health facilities included public Directly Observed Treatment Short-course (DOTS) centers, private clinics, and facilities under the Private-Public Mix (PPM) initiative. A total of 33 healthcare providers were interviewed: 13 physicians, 14 nurses, 2 medical technologists, 2 senior treatment coordinators, and 2 TB Program Coordinators; 18 were from private facilities, 12 from public facilities, and 3 from PPM sites. Sampling Healthcare providers were purposively sampled to elicit information-rich accounts of their experiences, perspectives, and processes regarding CDTB. Eligible healthcare providers are at least 18 years of age, speak English or Filipino, currently work as a healthcare provider at a sampled health facility for at least 3 years, and have primary responsibilities that include screening, diagnosis, and or treatment. Data collection Data were collected through semi-structured interviews conducted between April to June 2025 across four study sites, with 8-9 participants interviewed per site to generate insights on the clinical diagnosis of TB following the principle of data saturation 8 . A qualitative interview guide was pre-tested and finalized to explore key topics, including challenges in diagnosing TB and decision-making processes in CDTB. A total of 19 data collectors – most are nurses, others include physicians, medical technologists, and social workers conducted the interviews, with 4-5 assigned per site. A consultant expert conducted three half-day training sessions covering interviewing, probing, transcription, and maintaining neutrality, followed by mock interviews to practice skills before data collection. Interviews were conducted via Zoom or face-to-face in a private room each lasting 30-45 minutes. These were audio-recorded with participant consent and transcribed verbatim in either English or Filipino, with Visaya interviews translated to English before analysis. To minimize social desirability bias, interviews were framed as non-evaluative conversations, emphasizing the confidentiality and independence of participants' responses. Data Analysis Collected data from the semi-structured interviews were transcribed by the data collectors to facilitate data analysis and preserve data accuracy by capturing verbal expression, tone, and sometimes non-verbal cues [9]. Data analysis proceeded following the process of thematic analysis of Clarke and Braun (2017) that aims to identify, analyze, and interpret patterns and meanings of responses about clinical diagnosis of TB [10]. Data analysis was facilitated using NVivo version 15 software, which supported the management of the coding process and thematic development, following the steps of thematic analysis [11,12]. The analysis was initiated by a qualitative research consultant who was not directly involved in data collection. Ethics statement Ethical approval was granted by Makati Medical Center IRB, IRB Protocol number MMCIRB2024-012-151. Informed consent was sought and obtained from all the participants, and anonymity and confidentiality were maintained throughout the research process. RESULTS The findings from 33 interviews were organized into five themes: the first three describe diagnostic processes and challenges, the fourth outline the CDTB diagnostic pathways, and the fifth theme highlight practices that support accurate TB diagnosis. Theme 1: Clinical Reasoning and Decision Making for the Diagnosis of CDTB Findings showed critical decision points in the diagnostic process include evaluation of signs and symptoms, interpretation of chest x-ray, differentiation from other diseases that overlap with TB presentation, and the availability of bacteriological confirmation. Patients with classic TB symptoms typically receive a chest X-ray, and if results are positive with TB exposure or history, treatment is initiated. When symptoms are absent but X-ray findings suggest TB, providers often classify it as CDTB. Although most of the healthcare workers know the importance of confirming diagnosis with bacteriological tests. There are even cases where patients are asymptomatic, but the chest x-ray reveals findings suggestive of TB. – (Mindoro, Public Physician) “…as much as possible, [we aim for] bacteriological confirmation; only when all options are exhausted do we consider a clinical diagnosis.” — (Cavite, Pulmonologist) Another critical decision point is distinguishing TB from other diseases. There are several instances where patients’ signs and symptoms are similar to other diseases, but are not necessarily TB. “Not all [conditions] with hemoptysis are TB cases… especially in cases with cavitary lesions… if there are areas of cavities with some white in the middle, it could be Aspergilloma or Aspergillosis, which is a fungal infection.” — (Cagayan de Oro, Private Physician) “If the cough is more than 1 week… and if there are no comorbidities, I will treat it first with antibiotics [other than TB drugs].” — (Mindoro, Public Physician) Theme 2: Health System and Facility-Related Factors affecting CDTB diagnosis The most common health facility-related problem encountered by TB health workers is related to GeneXpert, its availability and accessibility. Across most areas, there was a problem encountered in the shortage of cartridges. “During that time, we had three months without GeneXpert. When we presented our cases, we noticed a significant decrease in the number of reported cases. Some people said, “Oh, it seems effective; we have controlled TB.” But that’s not true; we couldn’t conduct tests because there were no cartridges, which caused the drop in results”. - (Cagayan de Oro, Infection Control Nurse) “Our problem sometimes is that the GeneXpert is unavailable because of the lack of cartridges… sometimes we run out, so the patient cannot be managed right away.” — (Cavite, Private Physician) Other issues with GeneXpert also include power supply interruptions. There are also instances when the GeneXpert is not functioning. “When there’s a brownout, our MedTech says that if the power goes out while the machine is running a sample, the sputum has to be reprocessed again.” — (Manila, TB DOTS Nurse) In places where GeneXpert is present, a common experience reported is that results usually have a long turnaround time, hence delaying the treatment for the patients. Although most providers acknowledge the importance of bacteriological confirmation, delays in results led them to initiate treatment. “…for some…based on our experience, they really can’t get the results within 24 hours due to the high number of patients here” – (Cagayan de Oro, TB Program Coordinator) “…the signs and symptoms and X-ray… if cavitary, which is very suggestive… as included in Category 1 [Manual of Procedure] -- I will start the medication because the GeneXpert results take a long time to come.” — (Cagayan de Oro, Private Physician) In some areas, especially in the rural parts, there is a lack of access to GeneXpert. “It is not available… patients would sometimes refuse because the testing facility is far away… the issue is the patient's proximity to the rural health center and provincial hospital.” — (Mindoro, Private Pulmonologist) “If the GeneXpert is unavailable, an alternative is being done. If the GeneXpert is not available, we go back to basics — sputum AFB.” — (Mindoro, Public Health Practitioner) Theme 3: Patient-Related Factors Affecting CDTB diagnosis Among the most common patient-related concerns in diagnosing CDTB are the inability of the patient to produce sputum, perceived stigma, cost-associate diagnostics, and challenges in accessing diagnostic facilities. In very young, elderly, or severely ill patients, sputum collection is often difficult, leading to TB treatment initiation without bacteriologic confirmation since GeneXpert testing cannot be performed. Patients were often reluctant to visit TB-DOTS facilities due to stigma, particularly since centers are located within their own communities where they might be recognized. “Imagine sending them [patients] to their own place — they could be gossiped about for having TB, so they would rather go somewhere else; they prefer a private facility… [for some], even with the cost of P2,600, they were satisfied because of the privacy.” — (Cagayan de Oro, Private Nurse) “…there are patients who feel embarrassed and refuse to go to the DOT Center [for bacteriological confirmation], so clinical diagnosis becomes the route.” — (Manila, Public Physician) Another reason for not going to the facility or referral centers is because of financial barriers, which contribute to diagnostic delays. “We don’t prefer referring because not all patients can afford to go to the referral site… and we worry that they might not get back and won’t return to us.” — (Mindoro, Public Nurse) Theme 4: Clinical Pathways or Processes in CDTB Management Clinical diagnosis of TB showed several common decision-making patterns across providers. Figure 1 shows the diagnostic pathway that first establishes the presence of the cardinal signs and symptoms of TB. This clinical assessment is complemented by evaluating the history of TB exposure or previous TB disease, comorbidities, particularly Diabetes Mellitus and HIV. The process typically proceeds with chest X-ray examination, followed by GeneXpert testing. If the X-ray turns positive, even if GeneXpert is negative, physicians treat for TB. Second approach include use of some providers of empirical antibiotics for unclear cases, diagnosing CDTB if symptoms and X-ray findings persisted. A third approach applied to severely ill patients who could not produce sputum leading providers to diagnose clinically. Theme 5: Facilitating Factors for TB Diagnosis Facilitating factors in correct TB diagnosis identified by participants include regular training on the National TB Program guidelines, access to diagnostic tools, and effective patient counseling to reduce stigma and improve compliance. DISCUSSION This study analyzed 33 semi-structured interviews using an inductive thematic approach, generating five themes that illustrate how public- and private-sector providers navigate CDTB diagnosis. Themes evolved as patterns emerged, allowing the analysis to capture factors such as stigma and financial barriers shaping both patient behavior and provider decision-making. Our findings revealed that actual diagnostic practices slightly diverge from the NTP MOP guidelines [ 5 ]. For instance, some providers reported omitting the antibiotic trial, citing concerns that the participant may not return for follow-up. In severe cases, empirical TB treatment was started immediately, often without waiting for confirmatory diagnostic tests, to prevent clinical deterioration. It is important to emphasize that one of the reasons for the diagnosis of CDTB by health providers is to initiate timely treatment to prevent community transmission. Although healthcare workers recognize the importance of bacteriologic confirmation, several factors influence decision-making. The most common problem encountered is the intermittent shortage of cartridges, broken machines and long turnaround times for the results. In rural areas, there is still a shortage of GeneXpert machines and power outages. The findings in this study are consistent with Garfin et al. (2017), which emphasized the fragmented TB care pathways in the Philippines and the burden being placed on patients to navigate these pathways [ 13 ]. Providers frequently initiate treatment based on presenting symptoms, especially when laboratory access is limited or patient return is uncertain. The preference for immediate treatment shows a deep concern for public health, even when it comes at the cost of diagnostic certainty. Similar challenges were reported in other high-burden settings, such as in studies by Hamim et al. (2022), where diagnostic delays directly contributed to reliance on clinical judgement [ 14 ]. TB treatment initiation based on clinical confirmation is an issue because most of these patients may not have TB rather other diseases that mimic TB, and may suffer from other lung conditions. While TB remains a major problem, in some low- and middle-income countries, only 10–20% of patients presenting with a persistent cough have TB [ 15 ]. Participants in the study also noted that some patients are reluctant to undergo testing due to the fear of stigma. This mirrors findings from a study in the Southern Philippines, which described how stigma due to fear of transmission and discrimination can contribute to unsuccessful case detection and treatment. TB-related stigma disrupts care-seeking and adherence behaviors [ 16 ]. While there is a strong sense of community in the Philippines, it can also intensify the stigma towards those with diseases such as TB. Out-of-pocket expenses from diagnostic procedures such as chest X-rays, repeat consultations, or transportation to higher-level facilities pose significant barriers particularly those in lower socioeconomic groups. Despite these barriers, key facilitators support adherence to diagnostic protocols including regular training on Manual of Procedures and availability and accessibility of diagnostic tools. Providing clear instructions and proper education helped patients to return for follow-up and complete the treatment. Strengths and limitations A key strength of this study is its qualitative design, which captured the lived experiences of healthcare providers. The semi-structured interview approach allowed participants to share both challenges and strategies in their own words. Some participants’ responses may have been subject to social desirability bias however, the large volume of rich data and the recurrence of consistent themes minimized this. Input from data collectors was useful, although more frequent data collectors and investigators’ consultations could have improved consistency. The CDTB diagnostic pathways inferred from the participants should be regarded as illustrative frameworks rather than definitive routes, reflecting how diagnostic processes may vary across facilities and patient circumstances. CONCLUSION The study shows that clinical diagnosis of TB in the Philippines reflects pragmatic responses to systemic gaps rather than simple non-adherence to guidelines. Diagnosis based on clinical features and radiologic findings still plays a significant role in diagnosing TB patients due to the relevant challenges related to the varying circumstances of the health facilities and patients. Strengthening supply chains for GeneXpert cartridges and equipment, integrating real-world decision-making scenarios into provider training, as in MOP trainings, and addressing patient barriers such as stigma, distance, and cost are important to improve diagnostic accuracy and timely treatment. It is also essential to maximize facilitating factors in TB diagnosis, including regular trainings, and ensuring the availability of GeneXpert to address the factors affecting the diagnosis and management of CDTB. Abbreviations The following abbreviations are used in this manuscript: CDTB Clinically diagnosed TB CXR Chest X-ray DOH Department of Health DOTS Directly Observed Treatment – Short Course IRB Institutional Review Board NTP Philippine National Tuberculosis Control Program NTPS National TB Prevalence Survey SSI Semi-structured Interview TB Tuberculosis WHO World Health Organization Xpert GeneXpert MTB/RIF Declarations Ethical Approval This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by Makati Medical Center IRB, IRB Protocol number MMCIRB2024-012-151. Consent to participate Informed consent was sought and obtained from all the participants, and anonymity and confidentiality were maintained throughout the research process. Consent for publication Consent for publication was not explicitly obtained at the time of data collection. However, all data presented in this manuscript have been fully anonymized, no direct or indirect identifiers are included, and individual participants cannot be reasonably identified. As such, additional consent for publication was not required. Data Availability Statement The data supporting the findings of this study are not publicly available due to ethical restrictions and data privacy regulations related to human subjects but may be made available by the authors upon reasonable request and with appropriate ethical clearance. Funding This work was funded by ACCESS TB, sponsored by Philippine Business for Social Progress. Conflicts of Interest The authors declare no conflicts of interest. Author Contributions Conceptualization, MTS Gler.; Methodology, MTS Gler, AJF Bayot, CP Pagatpatan; Software, CP Pagatpatan; Validation, CP Pagatpatan; Formal Analysis, CP Pagatpatan; Investigation, AJF Bayot, CP Pagatpatan, JY Ganaden, KMS Taladua, RLC Goco, ED Santos, MTS Gler; Resources, CC Malbacias; Data Curation, AJF Bayot, CP Pagatpatan, JY Ganaden, KMS Taladua, RLC Goco, ED Santos, MTS Gler; Writing – Original Draft Preparation, CP Pagatpatan, AJF Bayot, MTS Gler; Writing – Review & Editing, AJF Bayot, CP Pagatpatan, JY Ganaden, KMS Taladua, RLC Goco, ED Santos, CC Malbacias, MT Gler; Supervision, AJF Bayot, MTS Gler; Project Administration, AJF Bayot, MTS Gler; Funding Acquisition, MTS Gler, CC Malbacias. All authors read and approved the final manuscript. References World Health Organization. Global tuberculosis report 2024 [Internet]. Geneva: World Health Organization; 2024 [cited 2025 Dec 20]. Available from: https://iris.who.int/server/api/core/bitstreams/7292c91e-ffb0-4cef-ac39-0200f06961ea/content Global Tuberculosis Report 2021. 1st ed. Geneva: World Health Organization; 2021. Lansang MAD, Alejandria MM, Law I, Juban NR, Amarillo MLE, Sison OT, et al. High TB burden and low notification rates in the Philippines: The 2016 national TB prevalence survey. Quinn F, editor. PLOS ONE [Internet]. 2021 Jun 4 [cited 2025 Sep 10];16(6): e0252240. Available from: https://dx.plos.org/10.1371/journal.pone.0252240 Republic Act No. 10767 - An Act Establishing a Comprehensive Philippine Plan of Action to Eliminate Tuberculosis as a Public Health Problem and Appropriatting Fund Therefore - Supreme Court E-Library [Internet]. [cited 2025 Sep 10]. Available from: https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/2/66781 NTP Manual of Procedures 6th Edition – National TB Control Program [Internet]. [cited 2025 Feb 11]. Available from: https://ntp.doh.gov.ph/download/ntp-mop-6th-edition/ Engaging Private Health Care Providers in TB Care and Prevention: A Landscape Analysis. 2nd ed. Geneva: World Health Organization; 2022. https://www.who.int/publications/i/item/9789240027039 (Accessed 2025 Dec 20) Stallworthy G, Dias HM, Pai M. Quality of tuberculosis care in the private health sector. J Clin Tuberc Mycobact Dis. 2020 Aug;20: 100171. Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, et al. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant [Internet]. 2018 Jul [cited 2025 Aug 5];52(4):1893–907. Available from: http://link.springer.com/10.1007/s11135-017-0574-8 McLellan E, MacQueen KM, Neidig JL. Beyond the Qualitative Interview: Data Preparation and Transcription. Field Methods [Internet]. 2003 Feb [cited 2025 Aug 5];15(1):63–84. Available from: https://journals.sagepub.com/doi/10.1177/1525822X02239573 Clarke V, Braun V. Thematic analysis. J Posit Psychol [Internet]. 2017 May 4 [cited 2025 Aug 5];12(3):297–8. Available from: https://www.tandfonline.com/doi/full/10.1080/17439760.2016.1262613 Van TT, The HD, Van TV, Van MD. Applying qualitative research in management studies - theory and practical experiences: Using NVivo 15. Int J Innov Res Sci Stud [Internet]. 2025 Apr 23 [cited 2025 Oct 30];8(2):4617–26. Available from: https://www.ijirss.com/index.php/ijirss/article/view/6406 Dhakal K. NVivo. J Med Libr Assoc [Internet]. 2022 Apr 26 [cited 2025 Oct 30];110(2). Available from: https://jmla.pitt.edu/ojs/jmla/article/view/1271 Garfin C, Mantala M, Yadav R, Hanson CL, Osberg M, Hymoff A, et al. Using Patient Pathway Analysis to Design Patient-centered Referral Networks for Diagnosis and Treatment of Tuberculosis: The Case of the Philippines. J Infect Dis [Internet]. 2017 Nov 6 [cited 2025 Aug 5];216(suppl_7):S740–7. Available from: https://academic.oup.com/jid/article/216/suppl_7/S740/4595556 Hamim A, Seddiq MK, Sayedi SM, Rashid MK, Qader GQ, Manzoor L, et al. The contribution of private health facilities to the urban tuberculosis program of Afghanistan. Indian J Tuberc [Internet]. 2023 Jan [cited 2025 Aug 5];70(1):8–11. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0019570722000221 Jayasooriya S, Jobe A, Badjie S, Owolabi O, Rachow A, Sutherland J, et al. The burden of non-TB lung disease presenting to TB clinics in The Gambia: preliminary data in the Xpert® MTB/Rif era. Public Health Action [Internet]. 2019 Dec 21 [cited 2025 Sep 15];9(4):166–8. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6945736/ Adiong SJ, A. Bangcola A, Macalnas A. Exploring Social Stigma and Awareness Towards Tuberculosis in a Municipality in Southern Philippines: A Mixed-Methods Study. Malays J Nurs [Internet]. 2023 [cited 2025 Oct 30];14(03):94–101. Available from: https://ejournal.lucp.net/index.php/mjn/article/view/1723 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8665033","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":592458761,"identity":"7ccc437f-fa8d-43d1-b0b0-d81fe0d38147","order_by":0,"name":"Arielle Jana Bayot","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+0lEQVRIiWNgGAWjYDAC5jNgSo5BgofhAIMBXPwAbi1sOSDSwJiHZC2JPUAtyAC3Fv423oOfeSr+pO+X7j14mKfALp+BvffxC8Ydd3BqkTjGlyzNc8Ygt0fmXMJhHoNkywae42YWjGee4XbY/R4Dad42oBaJHIODMwwOGDBIpLEZMLYdxqlD/hiP8W+glnQeorUYHOMxA9mSANJy4ANEC/MDfFoMj/GlWc45Y2zYc+cMSEuyARvPMTaGxDO4tcgd4z18402FnDz77B7jDwl/7Az42duYP3zcgVsLCDChxAgbEEkkNuDVwcD4A02A+QMjAS2jYBSMglEwogAAfgxSmcyh07wAAAAASUVORK5CYII=","orcid":"","institution":"TB HIV Innovations and Clinical Research Foundation","correspondingAuthor":true,"prefix":"","firstName":"Arielle","middleName":"Jana","lastName":"Bayot","suffix":""},{"id":592458763,"identity":"240baa2a-9c5d-4f4d-801a-504e67317e61","order_by":1,"name":"Celso Pagatpatan","email":"","orcid":"","institution":"De La Salle Medical and Health Sciences Institute","correspondingAuthor":false,"prefix":"","firstName":"Celso","middleName":"","lastName":"Pagatpatan","suffix":""},{"id":592458764,"identity":"62666faf-d6eb-4519-917a-23cf7decbd75","order_by":2,"name":"Judith Anne Rose Ganaden","email":"","orcid":"","institution":"TB HIV Innovations and Clinical Research Foundation","correspondingAuthor":false,"prefix":"","firstName":"Judith","middleName":"Anne Rose","lastName":"Ganaden","suffix":""},{"id":592458767,"identity":"a7b7223c-2a03-4c4e-abc6-4f529357faf8","order_by":3,"name":"Kristy Michelle Taladua","email":"","orcid":"","institution":"Capitol Medical University Center","correspondingAuthor":false,"prefix":"","firstName":"Kristy","middleName":"Michelle","lastName":"Taladua","suffix":""},{"id":592458768,"identity":"20ba7129-bb3f-4846-b277-0ee73216b166","order_by":4,"name":"Robert Leonard Goco","email":"","orcid":"","institution":"Oriental Mindoro Provincial Hospital","correspondingAuthor":false,"prefix":"","firstName":"Robert","middleName":"Leonard","lastName":"Goco","suffix":""},{"id":592458769,"identity":"80d68b3c-20e2-49f9-aa80-a243b29ec6d9","order_by":5,"name":"Ellen Santos","email":"","orcid":"","institution":"Ospital ng Sampaloc","correspondingAuthor":false,"prefix":"","firstName":"Ellen","middleName":"","lastName":"Santos","suffix":""},{"id":592458770,"identity":"c3276789-786f-45ba-b75c-f888e283f956","order_by":6,"name":"Charisse Malbacias","email":"","orcid":"","institution":"Department of Health","correspondingAuthor":false,"prefix":"","firstName":"Charisse","middleName":"","lastName":"Malbacias","suffix":""},{"id":592458771,"identity":"7665ba60-49e3-4db5-8f85-7022fb504d3c","order_by":7,"name":"Ma. Tarcela Gler","email":"","orcid":"","institution":"TB HIV Innovations and Clinical Research Foundation","correspondingAuthor":false,"prefix":"","firstName":"Ma.","middleName":"Tarcela","lastName":"Gler","suffix":""}],"badges":[],"createdAt":"2026-01-22 04:08:39","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8665033/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8665033/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":102992728,"identity":"ddb6b882-88e8-481c-a8fb-a54798c667c1","added_by":"auto","created_at":"2026-02-19 11:41:08","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":28943,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8665033/v1/eb2c8618dbd11dfcf5822913.png"},{"id":107707712,"identity":"b3458f3e-edb1-4097-97ec-d92d3b55967b","added_by":"auto","created_at":"2026-04-24 09:20:58","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":216736,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8665033/v1/8f747667-4e62-4aa1-9ff6-e594435b7058.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Clinical Decision-Making and Factors in the Diagnosis and Management of Clinically Diagnosed Tuberculosis","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eTuberculosis (TB) remains a major global health challenge and one of the leading causes of infectious disease related deaths. In 2024, an estimated 10\u0026nbsp;million people developed TB globally, with increasing number since 2021 [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The Philippines ranks fourth globally in TB incidence, and in 2020 about 43% of cases were estimated to be undiagnosed [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In response, the government has strengthened efforts to improve case detection and diagnostic coverage.\u003c/p\u003e \u003cp\u003eIn the Philippines, TB treatment is provided in both public and private sectors, with 33.5% of symptomatic individuals seeking initial care from the private sector [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. The public sector follows the Manual of Procedures for TB screening and diagnosis, whereas private sector practices vary. In order to expand TB diagnosis and access to diagnostic tools, the National TB Program strengthened public\u0026ndash;private collaborations and mandated TB case notification across all health facilities [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. In line with this, the Integrated Tuberculosis Information System (ITIS) was updated in in 2018 to also capture clinically diagnosed TB cases in addition to bacteriologically confirmed cases [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eBy 2019, private providers accounted for 18% of TB case notifications, but 97% were clinically diagnosed and treatment outcomes were not reported. Mandatory reporting improved private-sector reporting by 24%, yet over 90% of cases remained clinically diagnosed [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The increasing reporting of CDTB raises concerns about overdiagnosis, missed alternative diagnoses, inappropriate treatment, and increased risk of drug resistance. There is limited data on understanding the provider decision-making processes and the challenges faced, and the strategies to overcome them.\u003c/p\u003e \u003cp\u003eThis study aims to explore the diagnostic pathways and decision-making processes among healthcare providers in public and private settings in the Philippines when initiating treatment for clinically diagnosed TB.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cem\u003eStudy design\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis qualitative study employed a descriptive design to obtain direct insights from healthcare providers regarding the CDTB diagnostic procedures.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSetting and Participants\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe study was conducted across four areas in the Philippines, which represent a mix of urban and peri-urban environments (Manila, Cavite, Mindoro, and Cagayan de Oro) from April to June 2025. Health facilities included public Directly Observed Treatment Short-course (DOTS) centers, private clinics, and facilities under the Private-Public Mix (PPM) initiative. A total of 33 healthcare providers were interviewed: 13 physicians, 14 nurses, 2 medical technologists, 2 senior treatment coordinators, and 2 TB Program Coordinators; 18 were from private facilities, 12 from public facilities, and 3 from PPM sites.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSampling\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eHealthcare providers were purposively sampled to elicit information-rich accounts of their experiences, perspectives, and processes regarding CDTB. Eligible healthcare providers are at least 18 years of age, speak English or Filipino, currently work as a healthcare provider at a sampled health facility for at least 3 years, and have primary responsibilities that include screening, diagnosis, and or treatment.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eData collection\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eData were collected through semi-structured interviews conducted between April to June 2025 across four study sites, with 8-9 participants interviewed per site to generate insights on the clinical diagnosis of TB following the principle of data saturation\u003csup\u003e8\u003c/sup\u003e. A qualitative interview guide was pre-tested and finalized to explore key topics, including challenges in diagnosing TB and decision-making processes in CDTB.\u003c/p\u003e\n\u003cp\u003eA total of 19 data collectors – most are nurses, others include physicians, medical technologists, and social workers conducted the interviews, with 4-5 assigned per site. A consultant expert conducted three half-day training sessions covering interviewing, probing, transcription, and maintaining neutrality, followed by mock interviews to practice skills before data collection.\u003c/p\u003e\n\u003cp\u003eInterviews were conducted via Zoom or face-to-face in a private room each lasting 30-45 minutes. These were audio-recorded with participant consent and transcribed verbatim in either English or Filipino, with Visaya interviews translated to English before analysis. To minimize social desirability bias, interviews were framed as non-evaluative conversations, emphasizing the confidentiality and independence of participants' responses.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eData Analysis\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eCollected data from the semi-structured interviews were transcribed by the data collectors to facilitate data analysis and preserve data accuracy by capturing verbal expression, tone, and sometimes non-verbal cues [9].\u003c/p\u003e\n\u003cp\u003eData analysis proceeded following the process of thematic analysis of Clarke and Braun (2017) that aims to identify, analyze, and interpret patterns and meanings of responses about clinical diagnosis of TB [10].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eData analysis was facilitated using NVivo version 15 software, which supported the management of the coding process and thematic development, following the steps of thematic analysis [11,12]. The analysis was initiated by a qualitative research consultant who was not directly involved in data collection.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eEthics statement\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval was granted by Makati Medical Center IRB, IRB Protocol number MMCIRB2024-012-151. Informed consent was sought and obtained from all the participants, and anonymity and confidentiality were maintained throughout the research process.\u0026nbsp;\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eThe findings from 33 interviews were organized into five themes: the first three describe diagnostic processes and challenges, the fourth outline the CDTB diagnostic pathways, and the fifth theme highlight practices that support accurate TB diagnosis.\u003c/p\u003e\n\u003ch3\u003eTheme 1: Clinical Reasoning and Decision Making for the Diagnosis of CDTB\u003c/h3\u003e\n\u003cp\u003eFindings showed critical decision points in the diagnostic process include evaluation of signs and symptoms, interpretation of chest x-ray, differentiation from other diseases that overlap with TB presentation, and the availability of bacteriological confirmation.\u003c/p\u003e \u003cp\u003ePatients with classic TB symptoms typically receive a chest X-ray, and if results are positive with TB exposure or history, treatment is initiated. When symptoms are absent but X-ray findings suggest TB, providers often classify it as CDTB. Although most of the healthcare workers know the importance of confirming diagnosis with bacteriological tests.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003eThere are even cases where patients are asymptomatic, but the chest x-ray reveals findings suggestive of TB. \u0026ndash; (Mindoro, Public Physician)\u003c/em\u003e \u003c/p\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;as much as possible, [we aim for] bacteriological confirmation; only when all options are exhausted do we consider a clinical diagnosis.\u0026rdquo; \u0026mdash; (Cavite, Pulmonologist)\u003c/em\u003e \u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eAnother critical decision point is distinguishing TB from other diseases. There are several instances where patients\u0026rsquo; signs and symptoms are similar to other diseases, but are not necessarily TB.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;Not all [conditions] with hemoptysis are TB cases\u0026hellip; especially in cases with cavitary lesions\u0026hellip; if there are areas of cavities with some white in the middle, it could be Aspergilloma or Aspergillosis, which is a fungal infection.\u0026rdquo; \u0026mdash; (Cagayan de Oro, Private Physician)\u003c/em\u003e \u003c/p\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;If the cough is more than 1 week\u0026hellip; and if there are no comorbidities, I will treat it first with antibiotics [other than TB drugs].\u0026rdquo; \u0026mdash; (Mindoro, Public Physician)\u003c/em\u003e \u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eTheme 2: Health System and Facility-Related Factors affecting CDTB diagnosis\u003c/h2\u003e \u003cp\u003eThe most common health facility-related problem encountered by TB health workers is related to GeneXpert, its availability and accessibility. Across most areas, there was a problem encountered in the shortage of cartridges.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;During that time, we had three months without GeneXpert. When we presented our cases, we noticed a significant decrease in the number of reported cases. Some people said, \u0026ldquo;Oh, it seems effective; we have controlled TB.\u0026rdquo; But that\u0026rsquo;s not true; we couldn\u0026rsquo;t conduct tests because there were no cartridges, which caused the drop in results\u0026rdquo;. - (Cagayan de Oro, Infection Control Nurse)\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;Our problem sometimes is that the GeneXpert is unavailable because of the lack of cartridges\u0026hellip; sometimes we run out, so the patient cannot be managed right away.\u0026rdquo; \u0026mdash; (Cavite, Private Physician)\u003c/em\u003e \u003c/p\u003e \u003cp\u003eOther issues with GeneXpert also include power supply interruptions. There are also instances when the GeneXpert is not functioning.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;When there\u0026rsquo;s a brownout, our MedTech says that if the power goes out while the machine is running a sample, the sputum has to be reprocessed again.\u0026rdquo; \u0026mdash; (Manila, TB DOTS Nurse)\u003c/em\u003e \u003c/p\u003e \u003cp\u003eIn places where GeneXpert is present, a common experience reported is that results usually have a long turnaround time, hence delaying the treatment for the patients. Although most providers acknowledge the importance of bacteriological confirmation, delays in results led them to initiate treatment.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;for some\u0026hellip;based on our experience, they really can\u0026rsquo;t get the results within 24 hours due to the high number of patients here\u0026rdquo; \u0026ndash; (Cagayan de Oro, TB Program Coordinator)\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;the signs and symptoms and X-ray\u0026hellip; if cavitary, which is very suggestive\u0026hellip; as included in Category 1 [Manual of Procedure] -- I will start the medication because the GeneXpert results take a long time to come.\u0026rdquo; \u0026mdash; (Cagayan de Oro, Private Physician)\u003c/em\u003e \u003c/p\u003e \u003cp\u003eIn some areas, especially in the rural parts, there is a lack of access to GeneXpert.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;It is not available\u0026hellip; patients would sometimes refuse because the testing facility is far away\u0026hellip; the issue is the patient's proximity to the rural health center and provincial hospital.\u0026rdquo; \u0026mdash; (Mindoro, Private Pulmonologist)\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;If the GeneXpert is unavailable, an alternative is being done. If the GeneXpert is not available, we go back to basics \u0026mdash; sputum AFB.\u0026rdquo; \u0026mdash; (Mindoro, Public Health Practitioner)\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eTheme 3: Patient-Related Factors Affecting CDTB diagnosis\u003c/h2\u003e \u003cp\u003eAmong the most common patient-related concerns in diagnosing CDTB are the inability of the patient to produce sputum, perceived stigma, cost-associate diagnostics, and challenges in accessing diagnostic facilities.\u003c/p\u003e \u003cp\u003eIn very young, elderly, or severely ill patients, sputum collection is often difficult, leading to TB treatment initiation without bacteriologic confirmation since GeneXpert testing cannot be performed.\u003c/p\u003e \u003cp\u003ePatients were often reluctant to visit TB-DOTS facilities due to stigma, particularly since centers are located within their own communities where they might be recognized.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;Imagine sending them [patients] to their own place \u0026mdash; they could be gossiped about for having TB, so they would rather go somewhere else; they prefer a private facility\u0026hellip; [for some], even with the cost of P2,600, they were satisfied because of the privacy.\u0026rdquo; \u0026mdash; (Cagayan de Oro, Private Nurse)\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;there are patients who feel embarrassed and refuse to go to the DOT Center [for bacteriological confirmation], so clinical diagnosis becomes the route.\u0026rdquo; \u0026mdash; (Manila, Public Physician)\u003c/em\u003e \u003c/p\u003e \u003cp\u003eAnother reason for not going to the facility or referral centers is because of financial barriers, which contribute to diagnostic delays.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;We don\u0026rsquo;t prefer referring because not all patients can afford to go to the referral site\u0026hellip; and we worry that they might not get back and won\u0026rsquo;t return to us.\u0026rdquo; \u0026mdash; (Mindoro, Public Nurse)\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eTheme 4: Clinical Pathways or Processes in CDTB Management\u003c/h2\u003e \u003cp\u003eClinical diagnosis of TB showed several common decision-making patterns across providers. Figure\u0026nbsp;1 shows the diagnostic pathway that first establishes the presence of the cardinal signs and symptoms of TB. This clinical assessment is complemented by evaluating the history of TB exposure or previous TB disease, comorbidities, particularly Diabetes Mellitus and HIV. The process typically proceeds with chest X-ray examination, followed by GeneXpert testing. If the X-ray turns positive, even if GeneXpert is negative, physicians treat for TB. Second approach include use of some providers of empirical antibiotics for unclear cases, diagnosing CDTB if symptoms and X-ray findings persisted. A third approach applied to severely ill patients who could not produce sputum leading providers to diagnose clinically.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eTheme 5: Facilitating Factors for TB Diagnosis\u003c/h2\u003e \u003cp\u003eFacilitating factors in correct TB diagnosis identified by participants include regular training on the National TB Program guidelines, access to diagnostic tools, and effective patient counseling to reduce stigma and improve compliance.\u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study analyzed 33 semi-structured interviews using an inductive thematic approach, generating five themes that illustrate how public- and private-sector providers navigate CDTB diagnosis. Themes evolved as patterns emerged, allowing the analysis to capture factors such as stigma and financial barriers shaping both patient behavior and provider decision-making.\u003c/p\u003e \u003cp\u003eOur findings revealed that actual diagnostic practices slightly diverge from the NTP MOP guidelines [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. For instance, some providers reported omitting the antibiotic trial, citing concerns that the participant may not return for follow-up. In severe cases, empirical TB treatment was started immediately, often without waiting for confirmatory diagnostic tests, to prevent clinical deterioration. It is important to emphasize that one of the reasons for the diagnosis of CDTB by health providers is to initiate timely treatment to prevent community transmission.\u003c/p\u003e \u003cp\u003eAlthough healthcare workers recognize the importance of bacteriologic confirmation, several factors influence decision-making. The most common problem encountered is the intermittent shortage of cartridges, broken machines and long turnaround times for the results. In rural areas, there is still a shortage of GeneXpert machines and power outages.\u003c/p\u003e \u003cp\u003eThe findings in this study are consistent with Garfin et al. (2017), which emphasized the fragmented TB care pathways in the Philippines and the burden being placed on patients to navigate these pathways [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Providers frequently initiate treatment based on presenting symptoms, especially when laboratory access is limited or patient return is uncertain. The preference for immediate treatment shows a deep concern for public health, even when it comes at the cost of diagnostic certainty. Similar challenges were reported in other high-burden settings, such as in studies by Hamim et al. (2022), where diagnostic delays directly contributed to reliance on clinical judgement [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. TB treatment initiation based on clinical confirmation is an issue because most of these patients may not have TB rather other diseases that mimic TB, and may suffer from other lung conditions. While TB remains a major problem, in some low- and middle-income countries, only 10\u0026ndash;20% of patients presenting with a persistent cough have TB [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eParticipants in the study also noted that some patients are reluctant to undergo testing due to the fear of stigma. This mirrors findings from a study in the Southern Philippines, which described how stigma due to fear of transmission and discrimination can contribute to unsuccessful case detection and treatment. TB-related stigma disrupts care-seeking and adherence behaviors [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. While there is a strong sense of community in the Philippines, it can also intensify the stigma towards those with diseases such as TB. Out-of-pocket expenses from diagnostic procedures such as chest X-rays, repeat consultations, or transportation to higher-level facilities pose significant barriers particularly those in lower socioeconomic groups.\u003c/p\u003e \u003cp\u003eDespite these barriers, key facilitators support adherence to diagnostic protocols including regular training on Manual of Procedures and availability and accessibility of diagnostic tools. Providing clear instructions and proper education helped patients to return for follow-up and complete the treatment.\u003c/p\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eStrengths and limitations\u003c/h2\u003e \u003cp\u003eA key strength of this study is its qualitative design, which captured the lived experiences of healthcare providers. The semi-structured interview approach allowed participants to share both challenges and strategies in their own words. Some participants\u0026rsquo; responses may have been subject to social desirability bias however, the large volume of rich data and the recurrence of consistent themes minimized this. Input from data collectors was useful, although more frequent data collectors and investigators\u0026rsquo; consultations could have improved consistency. The CDTB diagnostic pathways inferred from the participants should be regarded as illustrative frameworks rather than definitive routes, reflecting how diagnostic processes may vary across facilities and patient circumstances.\u003c/p\u003e \u003c/div\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThe study shows that clinical diagnosis of TB in the Philippines reflects pragmatic responses to systemic gaps rather than simple non-adherence to guidelines. Diagnosis based on clinical features and radiologic findings still plays a significant role in diagnosing TB patients due to the relevant challenges related to the varying circumstances of the health facilities and patients. Strengthening supply chains for GeneXpert cartridges and equipment, integrating real-world decision-making scenarios into provider training, as in MOP trainings, and addressing patient barriers such as stigma, distance, and cost are important to improve diagnostic accuracy and timely treatment. It is also essential to maximize facilitating factors in TB diagnosis, including regular trainings, and ensuring the availability of GeneXpert to address the factors affecting the diagnosis and management of CDTB.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eThe following abbreviations are used in this manuscript:\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"524\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eCDTB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eClinically diagnosed TB\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eCXR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eChest X-ray\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDOH\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDepartment of Health\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDOTS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDirectly Observed Treatment – Short Course\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eIRB\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eInstitutional Review Board\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eNTP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePhilippine National Tuberculosis Control Program\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eNTPS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eNational TB Prevalence Survey\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSSI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSemi-structured Interview\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTuberculosis\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWHO\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWorld Health Organization\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eXpert\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eGeneXpert MTB/RIF\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical Approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by Makati Medical Center IRB, IRB Protocol number MMCIRB2024-012-151.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformed consent was sought and obtained from all the participants, and anonymity and confidentiality were maintained throughout the research process.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsent for publication was not explicitly obtained at the time of data collection. However, all data presented in this manuscript have been fully anonymized, no direct or indirect identifiers are included, and individual participants cannot be reasonably identified. As such, additional consent for publication was not required.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data supporting the findings of this study are not publicly available due to ethical restrictions and data privacy regulations related to human subjects but may be made available by the authors upon reasonable request and with appropriate ethical clearance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was funded by ACCESS TB, sponsored by Philippine Business for Social Progress.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflicts of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflicts of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization, MTS Gler.; Methodology, MTS Gler, AJF Bayot, CP Pagatpatan; Software, CP Pagatpatan; Validation, CP Pagatpatan; Formal Analysis, CP Pagatpatan; Investigation, AJF Bayot, CP Pagatpatan, JY Ganaden, KMS Taladua, RLC Goco, ED Santos, MTS Gler; Resources, CC Malbacias; Data Curation, AJF Bayot, CP Pagatpatan, JY Ganaden, KMS Taladua, RLC Goco, ED Santos, MTS Gler; Writing – Original Draft Preparation, CP Pagatpatan, AJF Bayot, MTS Gler; Writing – Review \u0026amp; Editing, AJF Bayot, CP Pagatpatan, JY Ganaden, KMS Taladua, RLC Goco, ED Santos, CC Malbacias, MT Gler; Supervision, AJF Bayot, MTS Gler; Project Administration, AJF Bayot, MTS Gler; Funding Acquisition, MTS Gler, CC Malbacias. All authors read and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWorld Health Organization. Global tuberculosis report 2024 [Internet]. Geneva: World Health Organization; 2024 [cited 2025 Dec 20]. Available from: https://iris.who.int/server/api/core/bitstreams/7292c91e-ffb0-4cef-ac39-0200f06961ea/content\u003c/li\u003e\n\u003cli\u003eGlobal Tuberculosis Report 2021. 1st ed. Geneva: World Health Organization; 2021. \u003c/li\u003e\n\u003cli\u003eLansang MAD, Alejandria MM, Law I, Juban NR, Amarillo MLE, Sison OT, et al. High TB burden and low notification rates in the Philippines: The 2016 national TB prevalence survey. Quinn F, editor. \u003cem\u003ePLOS ONE\u003c/em\u003e [Internet]. 2021 Jun 4 [cited 2025 Sep 10];16(6): e0252240. Available from: https://dx.plos.org/10.1371/journal.pone.0252240\u003c/li\u003e\n\u003cli\u003eRepublic Act No. 10767 - An Act Establishing a Comprehensive Philippine Plan of Action to Eliminate Tuberculosis as a Public Health Problem and Appropriatting Fund Therefore - Supreme Court E-Library [Internet]. [cited 2025 Sep 10]. Available from: https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/2/66781\u003c/li\u003e\n\u003cli\u003eNTP Manual of Procedures 6th Edition \u0026ndash; National TB Control Program [Internet]. [cited 2025 Feb 11]. Available from: https://ntp.doh.gov.ph/download/ntp-mop-6th-edition/\u003c/li\u003e\n\u003cli\u003eEngaging Private Health Care Providers in TB Care and Prevention: A Landscape Analysis. 2nd ed. Geneva: World Health Organization; 2022. https://www.who.int/publications/i/item/9789240027039 (Accessed 2025 Dec 20)\u003c/li\u003e\n\u003cli\u003eStallworthy G, Dias HM, Pai M. Quality of tuberculosis care in the private health sector. \u003cem\u003eJ Clin Tuberc Mycobact Dis.\u003c/em\u003e 2020 Aug;20: 100171. \u003c/li\u003e\n\u003cli\u003eSaunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, et al. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant [Internet]. 2018 Jul [cited 2025 Aug 5];52(4):1893\u0026ndash;907. Available from: http://link.springer.com/10.1007/s11135-017-0574-8\u003c/li\u003e\n\u003cli\u003eMcLellan E, MacQueen KM, Neidig JL. Beyond the Qualitative Interview: Data Preparation and Transcription. Field Methods [Internet]. 2003 Feb [cited 2025 Aug 5];15(1):63\u0026ndash;84. Available from: https://journals.sagepub.com/doi/10.1177/1525822X02239573\u003c/li\u003e\n\u003cli\u003eClarke V, Braun V. Thematic analysis. \u003cem\u003eJ Posit Psychol\u003c/em\u003e [Internet]. 2017 May 4 [cited 2025 Aug 5];12(3):297\u0026ndash;8. Available from: https://www.tandfonline.com/doi/full/10.1080/17439760.2016.1262613\u003c/li\u003e\n\u003cli\u003eVan TT, The HD, Van TV, Van MD. Applying qualitative research in management studies - theory and practical experiences: Using NVivo 15. \u003cem\u003eInt J Innov Res Sci Stud\u003c/em\u003e [Internet]. 2025 Apr 23 [cited 2025 Oct 30];8(2):4617\u0026ndash;26. Available from: https://www.ijirss.com/index.php/ijirss/article/view/6406\u003c/li\u003e\n\u003cli\u003eDhakal K. NVivo. \u003cem\u003eJ Med Libr Assoc\u003c/em\u003e [Internet]. 2022 Apr 26 [cited 2025 Oct 30];110(2). Available from: https://jmla.pitt.edu/ojs/jmla/article/view/1271\u003c/li\u003e\n\u003cli\u003eGarfin C, Mantala M, Yadav R, Hanson CL, Osberg M, Hymoff A, et al. Using Patient Pathway Analysis to Design Patient-centered Referral Networks for Diagnosis and Treatment of Tuberculosis: The Case of the Philippines. \u003cem\u003eJ Infect Dis\u003c/em\u003e [Internet]. 2017 Nov 6 [cited 2025 Aug 5];216(suppl_7):S740\u0026ndash;7. Available from: https://academic.oup.com/jid/article/216/suppl_7/S740/4595556\u003c/li\u003e\n\u003cli\u003eHamim A, Seddiq MK, Sayedi SM, Rashid MK, Qader GQ, Manzoor L, et al. The contribution of private health facilities to the urban tuberculosis program of Afghanistan. \u003cem\u003eIndian J Tuberc\u003c/em\u003e [Internet]. 2023 Jan [cited 2025 Aug 5];70(1):8\u0026ndash;11. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0019570722000221\u003c/li\u003e\n\u003cli\u003eJayasooriya S, Jobe A, Badjie S, Owolabi O, Rachow A, Sutherland J, et al. The burden of non-TB lung disease presenting to TB clinics in The Gambia: preliminary data in the Xpert\u0026reg; MTB/Rif era. \u003cem\u003ePublic Health Action\u003c/em\u003e [Internet]. 2019 Dec 21 [cited 2025 Sep 15];9(4):166\u0026ndash;8. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6945736/\u003c/li\u003e\n\u003cli\u003eAdiong SJ, A. Bangcola A, Macalnas A. Exploring Social Stigma and Awareness Towards Tuberculosis in a Municipality in Southern Philippines: A Mixed-Methods Study. \u003cem\u003eMalays J Nurs\u003c/em\u003e [Internet]. 2023 [cited 2025 Oct 30];14(03):94\u0026ndash;101. Available from: https://ejournal.lucp.net/index.php/mjn/article/view/1723\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"TB diagnosis, health facility related barriers, health system gaps, patient related barriers","lastPublishedDoi":"10.21203/rs.3.rs-8665033/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8665033/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eIntroduction\u003c/h2\u003e \u003cp\u003eTuberculosis (TB) remains a major public health challenge globally and in the Philippines. Despite national and WHO guidelines emphasizing bacteriological confirmation, reliance on Clinically Diagnosed TB (CDTB) remains common. This study aims to explore the factors and decision-making processes among healthcare providers in public and private settings in the Philippines.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis qualitative descriptive study explored diagnostic pathways and decision-making processes among healthcare providers in public, private, and public\u0026ndash;private mix (PPM) facilities across four sites in the Philippines (Manila, Cavite, Mindoro, and Cagayan de Oro) from April to June 2025. Semi-structured interviews were conducted with 33 healthcare providers. Data were analyzed thematically using Braun and Clarke\u0026rsquo;s framework, and facilitated by NVivo version 15 software.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eProviders reported several common diagnostic pathways for CDTB. Decisions in diagnosing CDTB were influenced by health system-related barriers, patient-related factors, and facilitating factors.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eClinical and radiological diagnosis continues to play a significant role in TB care in the country. While CDTB diagnosis has become the pragmatic solution to the various health system gaps and patient barriers, strengthening diagnostic capacity, addressing systemic and patient-related barriers, and supporting providers through training and education are essential to ensure appropriate TB care.\u003c/p\u003e","manuscriptTitle":"Clinical Decision-Making and Factors in the Diagnosis and Management of Clinically Diagnosed Tuberculosis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-19 11:39:23","doi":"10.21203/rs.3.rs-8665033/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d37c461d-a54d-4e82-94c5-b0e585d3ac94","owner":[],"postedDate":"February 19th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-04-23T15:41:05+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-19 11:39:23","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8665033","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8665033","identity":"rs-8665033","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}