Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study

ObjectivesTo characterise postmarketing studies for drugs that were newly approved by the US Food and Drug Administration and the European Medicines Agency.Design and settingCross-sectional analysis of postmarketing studies registered in ClinicalTrials.gov until September 2014 for all novel drugs approved by both regulators between 2005 and 2010. Regulatory documents from both agencies were used.Primary and secondary outcome measuresAll identified postmarketing studies were classified according to planned enrolment, funding, status and geographical location, and we determined whether studies studied the originally approved indication.ResultsOverall, 69 novel drugs approved between 2005 and 2010 were eligible for inclusion. A total of 6679 relevant postmarketing studies were identified; 5972 were interventional (89.4%). The median number of studies per drug was 55 (IQR 33–119) and median number of patients to be enrolled per study was 60 (IQR 28–183). Industry was the primary sponsor of 2713 studies (40.6%) and was a primary or secondary sponsor in 4176 studies (62.5%). In all, 2901 studies (43.4%) were completed, 487 (7.3%) terminated, 1013 (15.2%) active yet not recruiting, 1895 (28.4%) recruiting and 319 (4.8%) not yet recruiting. A total of 80% of studies were conducted in only one country and 84.4% took place in Europe and/or North America; 2441 (36.5%) studied another indication than the originally approved indication. Studies designed in the originally approved indication were found to be more industry-sponsored than others 68.7%vs53.7%; P<0.0001.ConclusionsPostmarketing pharmaceutical research was highly variable and predominantly located in North America and Europe. Postmarketing studies were frequently designed to study indications other than the originally approved one. Although some findings were reassuring, others question the lack of coordination of postmarketing research.

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Changes in eyelid position after glaucoma filtering surgery

European Journal of Ophthalmology ◽

10.1177/11206721211063723 ◽

2021 ◽

pp. 112067212110637

Author(s):

Teresa Salvá-Palomeque ◽

Pablo Muñoz-Ramón ◽

Gema Rebolleda ◽

Victor Aguado-Casanova ◽

Cristina Ye-Zhu ◽

...

Keyword(s):

Case Reports ◽

Glaucoma Surgery ◽

Cross Sectional Study ◽

Secondary Outcome ◽

Palpebral Fissure ◽

Eyelid Retraction ◽

Upper Eyelid ◽

Cross Sectional ◽

Number Of Patients ◽

Significant Difference

Background While ptosis is a well-known consequence of glaucoma surgery, some isolated case reports point to the possibility of upper eyelid retraction occurring after glaucoma surgery. This study aims to analyze the occurrence of ptosis and eyelid retraction after glaucoma surgery and to evaluate factors contributing to these palpebral fissure changes. Methods Cross-sectional study including 100 eyes of 100 patients that had undergone unilateral glaucoma surgery. Upper eyelid height in the operated eye was measured by digital photography and compared with the fellow, non-operated eye. The main outcome was to determine if ptosis or retraction occurred in the operated eye in comparison with the fellow eye. The secondary outcome was to determine if any variable was associated with ptosis or retraction. A clinically significant difference (either toward ptosis or retraction) was defined as a difference ≥1 mm between both eyes. Results Of 100 eyes included 81 (81%) showed no change in eyelid height (−0.133 mm ± 0.496), 11 (11%) showed ptosis (−1.348 mm ± 0.387) and 8 eyes (8%) showed retraction (1.705 ± 0.634). A statistically significant relation was found between ptosis and pseudoexfoliation glaucoma (p = 0.003). A trend toward lower postoperative IOP and higher conjunctival blebs was found in eyes with postoperative eyelid retraction. Conclusions Eyelid retraction was present in 8% of patients and ptosis in 11%. Patients with eyelid retraction showed around a 3 mmHg lower postoperative IOP than eyes without retraction. The presence of pseudoexfoliation may be a risk factor for this complication. A prospective study with a large number of patients would be required to confirm these results.

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Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015–2017: a cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2020-038863 ◽

2020 ◽

Vol 10 (6) ◽

pp. e038863 ◽

Cited By ~ 1

Author(s):

Thomas J Moore ◽

James Heyward ◽

Gerard Anderson ◽

G Caleb Alexander

Keyword(s):

Clinical Trials ◽

Software Tool ◽

Cross Sectional Study ◽

Therapeutic Agents ◽

Secondary Outcome ◽

Sectional Study ◽

Cross Sectional ◽

Number Of Patients ◽

The Us ◽

Clinic Visits

ObjectivesLittle is routinely disclosed about the costs of the pivotal clinical trials that provide the key scientific evidence of the treatment benefits of new therapeutic agents. We expand our earlier research to examine why the estimated costs may vary 100-fold.DesignA cross-sectional study of the estimated costs of the pivotal clinical trials supporting the approval of 101 new therapeutic agents approved by the US Food and Drug Administration from 2015 to 2017.MethodsWe licensed a software tool used by the pharmaceutical industry to estimate the likely costs of clinical trials to be conducted by contract research organisations. For each trial we collected 52 study characteristics. Linear regression was used to assess the most important factors affecting costs.Primary and secondary outcome measuresThe mean and 95% CI of 225 pivotal clinical trials using varying assumptions. We also assessed median estimated costs per patient, per clinic visit and per drug.ResultsMeasured as pivotal trials cost per approved drug, the 101 new molecular entities had an estimated median cost of US$48 million (IQR US$20 million–US$102 million). The 225 individual clinical trials had a median estimate of US$19 million (IQR US$12 million–US$33 million) per trial and US$41 413 (IQR, US$29 894–US$75 047) per patient. The largest single factor driving cost was the number of patients required to establish the treatment effects and varied from 4 patients to 8442. Next was the number of trial clinic visits, which ranged from 2 to 166. Our statistical model showed trial costs rose exponentially with these two variables (R2=0.696, F=257.9, p<0.01).ConclusionsThe estimated costs are modest for measuring the benefits of new therapeutic agents but rise exponentially as more patients and clinic visits are required to establish a drug effect.

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Trends in acid suppressant drug prescriptions in primary care in the UK: a population-based cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2020-041529 ◽

2020 ◽

Vol 10 (12) ◽

pp. e041529

Author(s):

Devin Abrahami ◽

Emily Gibson McDonald ◽

Mireille Schnitzer ◽

Laurent Azoulay

Keyword(s):

Population Based ◽

Cross Sectional Study ◽

Prescribing Patterns ◽

Secondary Outcome ◽

Clinical Practice Research Datalink ◽

Sectional Study ◽

Cross Sectional ◽

Number Of Patients ◽

The Uk ◽

Over Time

ObjectiveTo examine proton pump inhibitor (PPI) and histamine-2 receptor antagonist (H2RA) prescribing patterns over a 29-year period by quantifying annual prevalence and prescribing intensity over time.DesignPopulation-based cross-sectional study.SettingMore than 700 general practices contributing data to the UK Clinical Practice Research Datalink (CPRD).ParticipantsWithin a cohort of 14 242 329 patients registered in the CPRD, 3 027 383 patients were prescribed at least one PPI or H2RA from 1 January 1990 to 31 December 2018.Primary and secondary outcome measuresAnnual prescription rates were estimated by dividing the number of patients prescribed a PPI or H2RA by the total CPRD population. Change in prescribing intensity (number of prescriptions per year divided by person-years of follow-up) was calculated using negative binomial regression.ResultsFrom 1990 to 2018, 21.3% of the CPRD population was exposed to at least one acid suppressant drug. During that period, PPI prevalence increased from 0.2% to 14.2%, while H2RA prevalence remained low (range: 1.2%–3.4%). Yearly prescribing intensity to PPIs increased during the first 15 years of the study period but remained relatively constant for the remainder of the study period. In contrast, yearly prescribing intensity of H2RAs decreased from 1990 to 2009 but has begun to slightly increase over the past 5 years.ConclusionsWhile PPI prevalence has been increasing over time, its prescribing intensity has recently plateaued. Notwithstanding their efficacy, PPIs are associated with a number of adverse effects not attributed to H2RAs, whose prescribing intensity has begun to increase. Thus, H2RAs remain a valuable treatment option for individuals with gastric conditions.

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Associations between multimorbidity and glycaemia (HbA1c) in people with type 2 diabetes: cross-sectional study in Australian general practice

BMJ Open ◽

10.1136/bmjopen-2020-039625 ◽

2020 ◽

Vol 10 (11) ◽

pp. e039625

Author(s):

Jason I Chiang ◽

John Furler ◽

Frances Mair ◽

Bhautesh D Jani ◽

Barbara I Nicholl ◽

...

Keyword(s):

Type 2 Diabetes ◽

General Practice ◽

Cross Sectional Study ◽

Secondary Outcome ◽

Linear Regression Models ◽

Sectional Study ◽

Cross Sectional ◽

Long Term Conditions ◽

Australian General Practice

ObjectivesTo explore the prevalence of multimorbidity as well as individual and combinations of long-term conditions (LTCs) in people with type 2 diabetes (T2D) attending Australian general practice, using electronic health record (EHR) data. We also examine the association between multimorbidity condition count (total/concordant(T2D related)/discordant(unrelated)) and glycaemia (glycated haemoglobin, HbA1c).DesignCross-sectional study.SettingAustralian general practice.Participants69 718 people with T2D with a general practice encounter between 2013 and 2015 captured in the MedicineInsight database (EHR Data from 557 general practices and >3.8 million Australian patients).Primary and secondary outcome measuresPrevalence of multimorbidity, individual and combinations of LTCs. Multivariable linear regression models used to examine associations between multimorbidity counts and HbA1c (%).ResultsMean (SD) age 66.42 (12.70) years, 46.1% female and mean (SD) HbA1c 7.1 (1.4)%. More than 90% of participants with T2D were living with multimorbidity. Discordant conditions were more prevalent (83.4%) than concordant conditions (69.9 %). The three most prevalent discordant conditions were: painful conditions (55.4%), dyspepsia (31.6%) and depression (22.8%). The three most prevalent concordant conditions were hypertension (61.4%), coronary heart disease (17.1%) and chronic kidney disease (8.5%). The three most common combinations of conditions were: painful conditions and hypertension (38.8%), painful conditions and dyspepsia (23.1%) and hypertension and dyspepsia (22.7%). We found no associations between any multimorbidity counts (total, concordant and discordant) or combinations and HbA1c.ConclusionsMultimorbidity was common in our cohort of people with T2D attending Australian general practice, but was not associated with glycaemia. Although we did not explore mortality in this study, our results suggest that the increased mortality in those with multimorbidity and T2D observed in other studies may not be linked to glycaemia. Interestingly, discordant conditions were more prevalent than concordant conditions with painful conditions being the second most common comorbidity. Better understanding of the implications of different patterns of multimorbidity in people with T2D will allow more effective tailored care.

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How do delirium motor subtypes differ in phenomenology and contributory aetiology? a cross-sectional, multisite study of liaison psychiatry and palliative care patients

BMJ Open ◽

10.1136/bmjopen-2020-041214 ◽

2021 ◽

Vol 11 (4) ◽

pp. e041214

Author(s):

Kevin Glynn ◽

Frank McKenna ◽

Kevin Lally ◽

Muireann O’Donnell ◽

Sandeep Grover ◽

...

Keyword(s):

Palliative Care ◽

Rating Scale ◽

Symptom Burden ◽

Systemic Infection ◽

International Study ◽

Cross Sectional Study ◽

Secondary Outcome ◽

Liaison Psychiatry ◽

Cross Sectional ◽

Hypoactive Delirium

ObjectivesTo investigate whether delirium motor subtypes differ in terms of phenomenology and contributory aetiology.DesignCross-sectional study.SettingInternational study incorporating data from Ireland and India across palliative care, old age liaison psychiatry and general adult liaison psychiatry settings.Participants1757 patients diagnosed with delirium using criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM IV).Primary and secondary outcome measuresHyperactive, mixed and hypoactive delirium subtypes were identified using the abbreviated version of the Delirium Motor Subtype Scale. Phenomenology was assessed using the Delirium Rating Scale Revised. Contributory aetiologies were assessed using the Delirium Aetiology Checklist (DEC), with a score >2 indicating that the aetiology was likely or definitely contributory.ResultsHypoactive delirium was associated with dementia, cerebrovascular and systemic infection aetiologies (p<0.001) and had a lower overall burden of delirium symptoms than the other motor subtypes. Hyperactive delirium was associated with younger age, drug withdrawal and the DEC category other systemic aetiologies (p<0.001). Mixed delirium showed the greatest symptom burden and was more often associated with drug intoxication and metabolic disturbance (p<0.001). All three delirium motor subtypes had similar levels of impairment in attention and visuospatial functioning but differed significantly when compared with no subtype (p<0.001).ConclusionsThis study indicates a pattern of aetiology and symptomatology of delirium motor subtypes across a large international sample that had previously been lacking. It serves to improve our understanding of this complex condition and has implications in terms of early detection and management of delirium.

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Government management capacities and the containment of COVID-19: a repeated cross-sectional study across Chinese cities

BMJ Open ◽

10.1136/bmjopen-2020-041516 ◽

2021 ◽

Vol 11 (4) ◽

pp. e041516

Author(s):

Wenchao Li ◽

Jing Li ◽

Junjian Yi

Keyword(s):

Outcome Measures ◽

Cross Sectional Study ◽

Control Measures ◽

Secondary Outcome ◽

Cross Sectional ◽

Travel Restrictions ◽

Government Management ◽

The Government ◽

Laws And Policies ◽

Novel Coronavirus

ObjectivesBetter understanding of the dynamics of the COVID-19 (2019 novel coronavirus disease) pandemic to curb its spread is now a global imperative. While travel restrictions and control measures have been shown to limit the spread of the disease, the effectiveness of the enforcement of those measures should depend on the strength of the government. Whether, and how, the government plays a role in fighting the disease, however, has not been investigated. Here, we show that government management capacities are critical to the containment of the disease.SettingWe conducted a statistical analysis based on cross-city comparisons within China. China has undergone almost the entire cycle of the anticoronavirus campaign, which allows us to trace the full dynamics of the outbreak, with homogeneity in standards for statistics recording.Primary and secondary outcome measuresOutcome measures include city-specific COVID-19 case incidence and recoveries in China.ResultsThe containment of COVID-19 depends on the effectiveness of the enforcement of control measures, which in turn depends on the local government’s management capacities. Specifically, government efficiency, capacity for law enforcement, and the transparency of laws and policies significantly reduce COVID-19 prevalence and increase the likelihood of recoveries. The organisation size of the government, which is not closely related to its capacity for management, has a limited role.

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Prevalence of dysmenorrhoea, associated risk factors and its relationship with academic performance among graduating female university students in Ethiopia: a cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2020-043814 ◽

2021 ◽

Vol 11 (3) ◽

pp. e043814

Author(s):

Mesfin Tadese ◽

Andargachew Kassa ◽

Abebaw Abeje Muluneh ◽

Girma Altaye

Keyword(s):

Risk Factors ◽

Academic Performance ◽

University Students ◽

Cross Sectional Study ◽

Secondary Outcome ◽

Sectional Study ◽

Cross Sectional ◽

Grade Point ◽

Significant Difference ◽

Associated Risk Factors

ObjectivesThe study aimed to provide an association between dysmenorrhoea and academic performance among university students in Ethiopia. Further, the study attempts to determine the prevalence and associated risk factors of dysmenorrhoea.Design and methodInstitution-based cross-sectional study was conducted from 1 April to 28 April 2019. A semistructured and pretested self-administered questionnaire was used to collect data. Binary logistic regression analysis and one-way analysis of variance were performed to model dysmenorrhoea and academic performance, respectively.Setting and participantsEthiopia (2019: n=647 female university students).OutcomesThe primary outcome is dysmenorrhoea, which has been defined as painful menses that prevents normal activity and requires medication. The self-reported cumulative grade point average of students was used as a proxy measure of academic performance, which is the secondary outcome.ResultsThe prevalence of dysmenorrhoea was 317 (51.5%). The educational status of father (adjusted OR (AOR) (95% CI) 2.64 (1.04 to 6.66)), chocolate consumption (AOR (95% CI) 3.39 (95% 1.28 to 8.93)), daily breakfast intake (<5 days/week) (AOR (95% CI) 0.63 (0.42 to 0.95)), irregular menstrual cycle AOR (95% CI) 2.34 (1.55 to 3.54)) and positive family history of dysmenorrhoea AOR (95% CI) 3.29 (2.25 to 4.81)) had statistically significant association with dysmenorrhoea. There was no statistically significant difference in academic performance among students with and without dysmenorrhoea (F (3611)=1.276, p=0.28)).ConclusionsDysmenorrhoea was a common health problem among graduating University students. However, it has no statistically significant impact on academic performance. Reproductive health officers should educate and undermine the negative academic consequences of dysmenorrhoea to reduce the physical and psychological stress that happens to females and their families.

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POS1274 THERAPEUTIC MANAGEMENT OF RHEUMATOLOGISTS VERSUS OTORHINOLARYNGOLOGISTS OF CERVICOGENIC DIZZINESS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.2230 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 921.2-922

Author(s):

M. Yasmine ◽

K. Maatallah ◽

H. Ferjani ◽

W. Triki ◽

D. Ben Nsib ◽

...

Keyword(s):

Physical Therapy ◽

Treatment Approach ◽

Cross Sectional Study ◽

Treatment Modalities ◽

Sectional Study ◽

Cross Sectional ◽

Standard Assessment ◽

Number Of Patients ◽

Cervicogenic Dizziness ◽

No Gold Standard

Background:The treatment of patients presenting with cervicogenic dizziness (CGD) may be challenging. Indeed, there is no consensual treatment approach for CGD, nor is there no gold-standard assessment for diagnosis.Objectives:Our study aimed to assess the management of CGD by rheumatologists versus otorhinolaryngologists.Methods:We conducted a cross-sectional study including Tunisian doctors dealing with CGD. Rheumatologists (RTO) and otorhinolaryngologists (ORL) were invited to answer a questionnaire via google form about CGD daily management. Outcomes of interest were treatment modalities.Results:The study included 30 RTO and 32 ORL. Most of the doctors (RTO, vs ORL) were females (88.3%, vs 56.3%), aged between 35 and 45 (43.3%, vs 62.5%), and worked at a private practice (33.3%, vs 59.4%). The number of patients diagnosed with CGD by RTO was as follows: 1-2 per year (33.3%), 1-2 per month (18.8%), 1-2 per week (20%), less than one patient a year (10%) and none in 3.3% of cases. The number of patients diagnosed with CGD by ORL was as follows: 1-2 per year (50%), 1-2 per month (33.3%), 1-2 per week (6.2%), less than one patient a year (15.7%) and none (9.4%). Most patients presenting with CGD were females in both groups (93.1%, vs 82.8% respectively) with a mean age between 36 and 65 (79.3%, vs 82.1%). Most of the respondents declared treating patients with CGD (93.1%, vs 79.1%). Regarding treatment modalities, physical therapy was the most prescribed in both specialties (81.5% and 48.3%, respectively). Only RTO (18.5%) prescribed manual therapy. Concerning medical treatment, anti-inflammatory were the most prescribed drugs in both groups (92.6, and 34.5%, respectively). Sixty-seven percent of RTO prescribed anti-vertigo medication. Interestingly, it was the least prescribed drug by ORL (6.9%). Only RTO (59.3%) prescribed Muscle relaxants.Conclusion:Despite the disparities in the management of CGD, physical therapy remains the first prescribed treatment by Tunisian doctors. Further studies are needed to establish a consensus to treat CGD.Disclosure of Interests:None declared

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Misconceptions about COVID-19 among older Rohingya (forcefully displaced Myanmar nationals) adults in Bangladesh: findings from a cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2021-050427 ◽

2021 ◽

Vol 11 (5) ◽

pp. e050427

Author(s):

Sabuj Kanti Mistry ◽

A R M Mehrab Ali ◽

Uday Narayan Yadav ◽

Saruna Ghimire ◽

Md. Belal Hossain ◽

...

Keyword(s):

Primary Outcome ◽

Health Workers ◽

Multiple Linear Regression Model ◽

Cross Sectional Study ◽

Secondary Outcome ◽

Cross Sectional ◽

Factors Associated ◽

Cumulative Score ◽

Low Health Literacy ◽

Communication Frequency

ObjectivesDue to low health literacy and adverse situation in the camps, there are possibilities of misconceptions related to COVID-19 among the older Rohingya (forcefully displaced Myanmar nationals or FDMNs) adults in Bangladesh. The present research aimed to assess the level of misconceptions and the factors associated with it among the older FDMNs in Bangladesh.DesignCross-sectional.SettingA selected Rohingya camp situated in Cox’s Bazar, a southeastern district of Bangladesh.ParticipantsInformation was collected from 416 conveniently selected FDMNs who were aged 60 years and above.Primary and secondary outcome measuresThe primary outcome was misconceptions related to the spread, prevention and treatment of COVID-19. Information on 14 different locally relevant misconceptions was gathered, each was scored as one, and obtained a cumulative score, ranging from 0 to 14, with a higher score indicating a higher level of misconceptions. A multiple linear regression model explored the factors associated with misconceptions.ResultsThe participants had an average of five misconceptions. The most prevalent misconceptions were: everyone should wear personal protective equipment when outside (84.6%) and its prevention by nutritious food (62.5%) and drinking water (59.3%). Other notable misconceptions included the spread of COVID-19 through mosquito bites (42%) and its transmissions only to the non/less religious person (31.4%). In regression analyses, memory or concentration problems, communication frequency with social networks, pre-existing conditions and receiving information from health workers were significantly associated with higher COVID-19 misconceptions. These misconceptions were less likely among those overwhelmed by COVID-19, having COVID-19 diagnosed friends or family members and receiving information from friends and family.ConclusionsOverall, we found that misconceptions were prevalent among the older FDMNs in Bangladesh. The associations have important implications for programmes to prevent and manage COVID-19 in these settings. Health workers need to be adequately trained to provide clear communication and counter misconceptions.

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Evaluation of the performance of clinical predictors in estimating the probability of pulmonary tuberculosis among smear-negative cases in Northern Ethiopia: a cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2020-037913 ◽

2020 ◽

Vol 10 (11) ◽

pp. e037913

Author(s):

Mala George ◽

Geert-Jan Dinant ◽

Efrem Kentiba ◽

Teklu Teshome ◽

Abinet Teshome ◽

...

Keyword(s):

Pulmonary Tuberculosis ◽

Cross Sectional Study ◽

Clinical Suspicion ◽

Secondary Outcome ◽

Northern Ethiopia ◽

Sectional Study ◽

Cross Sectional ◽

Smear Negative ◽

Culture Positive ◽

Culture Negative

ObjectivesTo evaluate the performance of the predictors in estimating the probability of pulmonary tuberculosis (PTB) when all versus only significant variables are combined into a decision model (1) among all clinical suspects and (2) among smear-negative cases based on the results of culture tests.DesignA cross-sectional study.SettingTwo public referral hospitals in Tigray, Ethiopia.ParticipantsA total of 426 consecutive adult patients admitted to the hospitals with clinical suspicion of PTB were screened by sputum smear microscopy and chest radiograph (chest X-ray (CXR)) in accordance with the Ethiopian guidelines of the National Tuberculosis and Leprosy Program. Discontinuation of antituberculosis therapy in the past 3 months, unproductive cough, HIV positivity and unwillingness to give written informed consent were the basis of exclusion from the study.Primary and secondary outcome measuresA total of 354 patients were included in the final analysis, while 72 patients were excluded because culture tests were not done.ResultsThe strongest predictive variables of culture-positive PTB among patients with clinical suspicion were a positive smear test (OR 172; 95% CI 23.23 to 1273.54) and having CXR lesions compatible with PTB (OR 10.401; 95% CI 5.862 to 18.454). The regression model had a good predictive performance for identifying culture-positive PTB among patients with clinical suspicion (area under the curve (AUC) 0.84), but it was rather poor in patients with a negative smear result (AUC 0.64). Combining all the predictors in the model compared with only the independent significant variables did not really improve its performance to identify culture-positive (AUC 0.84–0.87) and culture-negative (AUC 0.64–0.69) PTB.ConclusionsOur finding suggests that predictive models based on clinical variables will not be useful to discriminate patients with culture-negative PTB from patients with culture-positive PTB among patients with smear-negative cases.

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