Fragility index of trials supporting approval of anti-cancer drugs in common solid tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 2055-2055
Author(s):  
Alexandra Desnoyers ◽  
Michelle Nadler ◽  
Ramy Saleh ◽  
Eitan Amir
Keyword(s):  
Solid Tumors ◽  
Randomized Trials ◽  
Statistical Significance ◽  
P Value ◽  
Inverse Association ◽  
Fragility Index ◽  
Real World Data ◽  
Number Of Patients ◽  
Lost To Follow Up

2055 Background: The Fragility Index (FI) quantifies the reliability of positive trials by estimating the number of events which would change statistically significant results to non-significant results. Here, we calculate the FI of trials supporting approval of drugs for common solid tumors. Methods: We searched Drugs@FDA to identify randomized trials (RCT) supporting drug approvals by the US Food and Drug Administration between January 2009 and December 2019 in lung, breast, prostate, gastric and colon cancers. We adapted the FI framework (Walsh et al. J Clin Epidemiol 2014) to allow use of time to event data. First, we reconstructed survival tables from reported data using the Parmar Toolkit (Parmar et al. Stat Med 1998) and then calculated the number of events which would result in a non-significant effect for the primary endpoint of each trial. The FI was then compared quantitatively to the number of patients in each trial who withdrew consent or were lost to follow-up. Multivariable linear regression was used to explore association between RCT characteristics and the FI. Results: We identified 69 RCT with a median of 669 patients (range 123-4804) and 358 primary outcome events (range 56-884). The median FI was 26 (range 1-322). The FI was ≤10 in 21 trials (30%) and ≤20 in 31 trials (45%). Among the 69 RCT, the median number of patients who withdrew consent or were lost to follow up was 27 (range, 6-317). The number of patients who withdrew consent or were lost to follow-up was equal or greater than the FI in 42 trials (61%). There was statistically significant inverse association between FI and trial hazard ratio (p0,001) and a positive association with number of patients who were lost to follow-up or withdrew consent (p0,001). There was no association between trial sample size, year of approval or reported p-value and the FI. Conclusions: Statistical significance of trials supporting drug approval in common solid tumors relies often on a small number of events. In most trials the FI was lower than the number of patients lost to follow up or withdrawing consent. Post-approval randomized trials or real-world data analyses should be performed to ensure that effects observed in registration trials are robust.

Analysis of robustness of the landmark Cardiovascular outcome trials of antidiabetic drugs – A systematic review

2021 ◽  
Vol 17 ◽  
Author(s):  
Debdipta Bose ◽  
Mahanjit Konwar
Keyword(s):  
Statistical Significance ◽  
Rank Correlation ◽  
Primary Objective ◽  
Antidiabetic Drugs ◽  
Cardiovascular Outcome ◽  
P Value ◽  
Fragility Index ◽  
Cardiovascular Outcome Trials ◽  
Lost To Follow Up

Background: It is essential for Randomized controlled trials [RCTs] to report its results in a comprehensive manner. Hence, it is necessary to assess the robustness of the trials with statistically significant and as well as non-significant results. Robustness can be evaluated using fragility index (FI) and reverse fragility index [RFI] is for trials with statistically significant and as well as non-significant results. The primary aim of this study was to calculate FI and RFI for cardiovascular outcome trials [CVOT]. Materials & Methods: PubMed/MEDLINE was searched to identify all RCTs of antidiabetic drugs where the primary objective was to evaluate the cardiovascular outcomes. We recorded the trial characteristics of each CVOT trial. The FI, RFI, Fragility quotient [FQ] and reverse fragility quotient [FQ] was calculated to evaluate the robustness of the trials. Spearman rank correlation test was used for correlation. Findings: A total of 889 studies were identified and 24 RCTs was included. Among the 24 trials, 12 [50%] trials achieved statistical significance. The median FI and RFI were 29 [4-12] and 22.5 [1-37] for trials with statistically significant and non-significant results. The median FQ and RFQ were 0.0075 [0.002-0.013] and 0.0003 [0.0001-0.004] for trials with statistically significant and non-significant results. The hazard ratio, p value and NNT-B had strong negative relation with FI. Interpretation: Our study showed that half of the trials showing superiority of cardioprotective benefits have favourable FI. The trials failed to show superiority also have a reasonable RFI indicating the robustness of these trials. But the results pf the trials where patients lost to follow-up exceed the FI of that trial demands caution during interpretation.

scholarly journals The Statistical Fragility of Single-Bundle vs Double-Bundle Autografts for ACL Reconstruction: A Systematic Review of Comparative Studies

2021 ◽  
Vol 9 (12) ◽  
pp. 232596712110646
Author(s):  
Cooper B. Ehlers ◽  
Andrew J. Curley ◽  
Nathan P. Fackler ◽  
Arjun Minhas ◽  
Ariel N. Rodriguez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Comparative Studies ◽  
Statistical Significance ◽  
Double Bundle ◽  
Single Bundle ◽  
Bundle Versus ◽  
P Values ◽  
Number Of Patients ◽  
Lost To Follow Up

Background: The statistical significance of a given study outcome can be liable to small changes in findings. P values are common, but imperfect statistical methods to convey significance, and inclusion of the fragility index (FI) and fragility quotient (FQ) may provide a clearer perception of statistical strength. Purpose/Hypothesis: The purpose was to examine the statistical stability of studies comparing primary single-bundle to double-bundle anterior cruciate ligament reconstruction (ACLR) utilizing autograft and independent tunnel drilling. It was hypothesized that the study findings would be vulnerable to a small number of outcome event reversals, often less than the number of patients lost to follow-up. Study Design: Systematic review; Level of evidence, 2. Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, the authors searched PubMed for comparative studies and randomized controlled trials (RCTs) published in select journals, based on impact factor, between 2005 and 2020. Risk-of-bias assessment and methodology scoring were conducted for the included studies. A total of 48 dichotomous outcome measures were examined for possible event reversals. The FI for each outcome was determined by the number of event reversals necessary to alter significance. The FQ was calculated by dividing the FI by the respective sample size. Results: Of the 1794 studies screened, 15 comparative studies were included for analysis; 13 studies were RCTs. Overall, the mean FI and FQ were 3.14 (IQR, 2-4) and 0.050 (IQR, 0.032-0.062), respectively. For 72.9% of outcomes, the FI was less than the number of patients lost to follow-up. Conclusion: Studies comparing single-bundle versus double-bundle ACLR may not be as statistically stable as previously thought. Comparative studies and RCTs are at substantial risk for statistical fragility, with few event reversals required to alter significance. The reversal of fewer than 4 outcome events in a treatment group can alter the statistical significance of a given result; this is commonly less than the number of patients lost to follow-up. Future comparative study analyses might consider including FI and FQ with P values in their statistical analysis.

scholarly journals On clinical trial fragility due to patients lost to follow up

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Benjamin R. Baer ◽  
Stephen E. Fremes ◽  
Mario Gaudino ◽  
Mary Charlson ◽  
Martin T. Wells
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Intermediate State ◽  
Statistical Tests ◽  
Statistical Significance ◽  
Artery Bypass ◽  
Fragility Index ◽  
Lost To Follow Up ◽  
Statistical Results

Abstract Background Clinical trials routinely have patients lost to follow up. We propose a methodology to understand their possible effect on the results of statistical tests by altering the concept of the fragility index to treat the outcomes of observed patients as fixed but incorporate the potential outcomes of patients lost to follow up as random and subject to modification. Methods We reanalyse the statistical results of three clinical trials on coronary artery bypass grafting (CABG) to study the possible effect of patients lost to follow up on the treatment effect statistical significance. To do so, we introduce the LTFU-aware fragility indices as a measure of the robustness of a clinical trial’s statistical results with respect to patients lost to follow up. Results The analyses illustrate that clinical trials can either be completely robust to the outcomes of patients lost to follow up, extremely sensitive to the outcomes of patients lost to follow up, or in an intermediate state. When a clinical trial is in an intermediate state, the LTFU-aware fragility indices provide an interpretable measure to quantify the degree of fragility or robustness. Conclusions The LTFU-aware fragility indices allow researchers to rigorously explore the outcomes of patients who are lost to follow up, when their data is the appropriate kind. The LTFU-aware fragility indices are sensitivity measures in a way that the original fragility index is not.

The Statistical Fragility of Hamstring Versus Patellar Tendon Autografts for Anterior Cruciate Ligament Reconstruction: A Systematic Review of Comparative Studies

2020 ◽  
pp. 036354652096997
Author(s):  
Cooper B. Ehlers ◽  
Andrew J. Curley ◽  
Nathan P. Fackler ◽  
Arjun Minhas ◽  
Edward S. Chang
Keyword(s):  
Anterior Cruciate Ligament ◽  
Anterior Cruciate Ligament Reconstruction ◽  
Comparative Studies ◽  
Ligament Reconstruction ◽  
Cruciate Ligament ◽  
Statistical Significance ◽  
Number Of Patients ◽  
Anterior Cruciate ◽  
Lost To Follow Up

Background: Evidence-based medicine utilizes data to inform clinical decision making, despite the ability of a small number of outcome reversals to change statistical significance. P values are common measurements of statistical significance that possess inherent flaws. The inclusion of the fragility index (FI) and fragility quotient (FQ) may provide a clearer conveyance of statistical strength. Purpose/Hypothesis: The purpose was to examine the statistical stability of studies comparing hamstring tendon and bone–patellar tendon–bone autografts in primary single-bundle anterior cruciate ligament reconstruction with independent tunnel drilling. We hypothesized that the findings of these studies are vulnerable to a small number of outcome event reversals, often fewer than the number of patients lost to follow-up. Study Design: Systematic review. Methods: Comparative studies and randomized controlled trials (RCTs) published in 10 leading orthopaedic journals between 2000 and 2020 were analyzed. Statistical significance was defined as a P value ≤.05. FI for each outcome was determined by the number of event reversals necessary to alter significance. FQ was calculated by dividing the FI by the respective sample size. Results: Of the 1803 studies screened, 643 met initial search criteria, with 18 comparative studies ultimately included for analysis, 8 of which were RCTs. A total of 114 outcomes were examined. Overall, the mean (interquartile range) FI and FQ were 3.77 (2-4) and 0.040 (0.016-0.055), respectively. The FI was less than the number of patients lost to follow-up for 76.3% of outcomes. Conclusion: Studies examining graft choice for anterior cruciate ligament reconstruction may not be as statistically stable as previously thought. Comparative studies and RCTs are at substantial risk for statistical fragility, with few event reversals required to alter significance. The reversal of <4 outcome events in a treatment group can alter the statistical significance of a given result; this is commonly fewer than the number of patients lost to follow-up. Future comparative study analyses might consider including FI and FQ with P values in their statistical analysis.

scholarly journals Renal functional improvement after pediatric pyeloplasty in kidneys with split renal function less than 20%: a single institute experience

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Elsayed Salih ◽  
Ibrahim Abdelmaksoud ◽  
Mohamed Elfeky ◽  
Gamal Selmy ◽  
Hussein Galal ◽  
...  
Keyword(s):  
Renal Function ◽  
Statistical Significance ◽  
Functional Improvement ◽  
Renal Unit ◽  
Poor Renal Function ◽  
Split Renal Function ◽  
Renal Function Deterioration ◽  
Number Of Patients ◽  
The Mean

Abstract Background Pediatric pyeloplasty in ureteropelvic junction obstruction (UPJO) is indicated in renal impaired drainage or renal function deterioration. The improvement of renal function after pediatric pyeloplasty is still controversial in poorly functioning kidneys. Past studies on poorly functioning kidneys had a variable SRF specification, and these studies often had a limited number of patients so that they did not achieve statistical significance. The study aims to detect the renal functional improvement after pediatric Anderson-Hynes pyeloplasty (AHP) with split renal function (SRF) less than 20% (poor renal function). Results A retrospective study included 46 pediatric patients with unilateral UPJO who underwent open AHP with SRF < 20% on a renal isotope scan from August 2012 to October 2018. Success was defined based on either improvement in symptoms, improvement in drainage on postoperative renography, and/or improvement or stability in SRF on the renal scan done 6 months postoperatively and yearly thereafter. Deterioration of SRF by more than 5% was deemed to be deterioration. An increase in SRF of more than 5% was deemed to be an improvement. A total of 46 patients with a mean age of 32 months with poor renal function on isotope renogram (SRF < 20%) were included. All patients had an obstructive pattern on the preoperative radionuclide scans. The median preoperative SRF was 9.26%. The mean (range) follow-up was 30 months. The success rate was 91.3%. Three patients underwent redo pyeloplasty, whereas a secondary nephrectomy was necessary for one. The remaining (42) patients showed stability or improvement of SRF with no further symptoms. Renal scintigraphy at 6 and 12 months after surgery revealed significantly increased SRF compared to preoperative one. Conclusion Poorly functioning renal unit with SRF < 20% can show functional improvement and recoverability after pediatric pyeloplasty.

scholarly journals Results of early versus standard silicone stent removal following external dacryocystorhinostomy under local anesthesia

2020 ◽  
Vol 17 (3) ◽  
pp. 263-272
Author(s):  
Ben Limbu ◽  
Benjamin Sim ◽  
Mohan K. Shrestha ◽  
Geoffrey Tabin ◽  
Rohit Saiju
Keyword(s):  
Statistical Difference ◽  
Financial Burden ◽  
Controlled Trial ◽  
Silicone Tube ◽  
Number Of Patients ◽  
Tube Removal ◽  
Silicone Stent ◽  
External Dacryocystorhinostomy ◽  
Lost To Follow Up

Introduction: Many patients in Nepal travel vast distances to have their surgeries in Kathmandu. They often remain close by until their follow-up visit for their silicone tube removal, which contributes to a large financial burden on them and their families. Hence, reducing the time for which silicone tubes remain in situ following external dacryocystorhinostomy (DCR) provides significant benefits to patients. Furthermore, this is the first comparative study which has successfully demonstrated the earliest timeframe for which silicone tubes can be removed following DCR in the medical literature. Methods: A randomized controlled trial consisting of 144 patients was designed to compare patient outcomes after early (2 weeks postoperatively) versus standard (6 weeks postoperatively) removal of silicone stents. The success of their procedures was determined when patients were assessed both symptomatically and anatomically at their 6-month follow-up. Results: The surgical success in both groups was high at 97.8% collectively in both groups and there were only a small number of patients who were lost to follow-up (5 patients) at 6 months. There was no statistical difference at removing silicone stents at 2 or 6 weeks postoperatively. Conclusion: These results were consistent with our pilot study, which showed no statistical difference in long-term success following silicone tube removal at 2 and 6 weeks.

scholarly journals Association of single-nucleotide polymorphisms in the ESR2 and FSHR genes with poor ovarian response in infertile Jordanian women

2021 ◽  
Vol 48 (1) ◽  
pp. 69-79
Author(s):  
Amer Mahmoud Sindiani ◽  
Osamah Batiha ◽  
Esra’a Al-zoubi ◽  
Sara Khadrawi ◽  
Ghadeer Alsoukhni ◽  
...  
Keyword(s):  
Single Nucleotide Polymorphisms ◽  
Statistical Significance ◽  
Ovarian Response ◽  
Control Group ◽  
P Value ◽  
Case Group ◽  
Nucleotide Polymorphisms ◽  
Poor Ovarian Response ◽  
Single Nucleotide ◽  
Number Of Patients

Objective: Poor ovarian response (POR) refers to a subnormal follicular response that leads to a decrease in the quality and quantity of the eggs retrieved after ovarian stimulation during assisted reproductive treatment (ART). The present study investigated the associations of multiple variants of the estrogen receptor 2 (ESR2) and follicle-stimulating hormone receptor (FSHR) genes with POR in infertile Jordanian women undergoing ART.Methods: Four polymorphisms, namely ESR2 rs1256049, ESR2 rs4986938, FSHR rs6165, and FSHR rs6166, were investigated in 60 infertile Jordanian women undergoing ART (the case group) and 60 age-matched fertile women (the control group), with a mean age of 33.60±6.34 years. Single-nucleotide polymorphisms (SNPs) were detected by restriction fragment length polymorphism and then validated using Sanger sequencing.Results: The p-value of the difference between the case and control groups regarding FSHR rs6166 was very close to 0.05 (p=0.054). However, no significant differences were observed between the two groups in terms of the other three SNPs, namely ESR2 rs1256049, ESR2 rs4986938, and FSHR rs6165 (p=0.561, p=0.433, and p=0.696, respectively).Conclusion: The association between FSHR rs6166 and POR was not statistically meaningful in the present study, but the near-significant result of this experiment suggests that statistical significance might be found in a future study with a larger number of patients.

Abstract MP57: A South Asian Mediterranean-style Diet Pattern Is Associated With Favorable Measures Of Adiposity And A Lower Risk Of Incident Diabetes: Findings From The Masala Study

Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Sharan K Rai ◽  
Alka M Kanaya ◽  
Namratha Kandula ◽  
Qi Sun ◽  
Shilpa N Bhupathiraju
Keyword(s):  
South Asian ◽  
South Asians ◽  
Subclinical Atherosclerosis ◽  
Cultural Beliefs ◽  
P Value ◽  
Inverse Association ◽  
Processed Meats ◽  
Lower Likelihood ◽  
Diet Pattern

Introduction: South Asians are at a disproportionately high risk for cardiometabolic disease. The Mediterranean diet is associated with reduced risks of type 2 diabetes (T2D) and cardiovascular disease in certain populations, although data among South Asians are lacking. Therefore, we evaluated the association between a novel South Asian Mediterranean style (SAM) diet pattern and a broad panel of cardiometabolic markers from the MASALA study, an ongoing prospective cohort of South Asians in the US. Methods: We included 891 participants who completed the baseline visit (2010-13) with reliable responses to a validated ethnic-specific food frequency questionnaire (mean age 55 y; 47% female). We created the SAM score by grouping foods including those specific to this population’s cuisine into 9 pre-defined categories (vegetables, fruits, legumes, nuts, whole grains, red/processed meats, fish, alcohol, and monounsaturated to saturated fat ratio). Participants above the median intake received 1 point per category; red/processed meats were reverse scored and those with alcohol intake 5-25 g/d received 1 point. We summed these for a score from 0-9, with higher scores reflecting greater adherence to a Mediterranean style diet. Participants underwent a clinical exam, carotid ultrasound, cardiac and abdominal CT, and fasting blood tests. We used multivariable linear and logistic regression to examine cross-sectional associations between the SAM score and cardiometabolic risk, adjusting for age, sex, calories, physical activity, smoking status, medical history, income, education level, and cultural beliefs. We additionally adjusted for body mass index (BMI) in the full model. Finally, we examined the association between the SAM score and incident T2D at follow-up (~5 y later). Results: Participants with higher SAM scores tended to be older, more likely to have a bachelor’s degree, less likely to report experiences of discrimination, and less likely to be smokers. At baseline, the SAM score was inversely associated with pericardial fat volume (-1.22 ± 0.55 cm 3 per 1-unit increase in SAM score; p value=0.03) in the fully adjusted model. We observed an inverse association between the SAM score and visceral fat, but it was attenuated after additionally adjusting for BMI. There were no associations with subclinical atherosclerosis, glycemia measures, lipids, inflammatory markers, or uric acid. The SAM score was associated with a lower likelihood of obesity (odds ratio [OR] 0.88, 95% confidence interval [CI] 0.79 to 0.98) and fatty liver (OR 0.82, 95% CI 0.68 to 0.98), but not with hypertension. Finally, the SAM score was associated with lower odds of incident T2D (OR 0.75, 95% CI 0.59 to 0.95) at follow-up. Conclusion: A greater intake of a Mediterranean style diet that incorporates traditional South Asian foods was associated with favorable measures of adiposity and a lower likelihood of incident T2D.

Role of ctDNA to predict risk of recurrence following potentially curative resection of biliary tract and pancreatic malignancies.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 336-336
Author(s):  
Angela Lamarca ◽  
Mairead Geraldine McNamara ◽  
Richard Hubner ◽  
Juan W. Valle
Keyword(s):  
Relapse Rate ◽  
Curative Resection ◽  
Cox Regression ◽  
Statistical Significance ◽  
Molecular Profiling ◽  
P Value ◽  
Relapse Risk ◽  
Baseline Characteristics

336 Background: The potential role of ctDNA to identify residual disease after potentially curative resection has been suggested in some malignancies; its role in resected pancreatico(P)-biliary(B) malignancies is unknown. Methods: Patients diagnosed with PB malignancies underwent molecular profiling (ctDNA) using FoundationMedicine Liquid (72 cancer-related genes) following potentially curative resection. Baseline patient characteristics and molecular profiling outcomes, including mutant allele frequency (MAF) for pathological alterations were extracted. Primary objective: prevalence of ctDNA identification and its correlation with recurrence (relapse-free survival (RFS) and relapse rate). Results: Total of 11 individuals had ctDNA analysed following potentially curative resection for PB malignancies: 8 B (4 extra-hepatic cholangiocarcinoma (eCCA), 2 ampulla, 1 intrahepatic cholangiocarcinoma (iCCA), 1 gallbladder cancer (GBC)) and 3 P. Baseline characteristics: 6 female (54.55%), median age 71.59 years (range 39.98-81.19). Most were pT2 (45.45%), pN0 (54.55%) and R0 (63.64%). Following surgery, 6 patients were started on adjuvant chemotherapy; at the end of follow-up (data cut-off 25/6/2020; median follow-up 11.15 months (range 5.45-13.52); 5 relapsed (45.45%) and 2 died (18.18%). Estimated median RFS was 11.43 months (95% CI 2.28-not reached); median overall survival was not reached. No sample failed ctDNA analysis; presence of ctDNA was identified in 3/11 (27.27%) of the samples; 2 and 1 samples had 2 and 1 pathological alterations identified, respectively: ALK fusion (1 sample; GBC), TP53 mutation (2 samples; eCCA and GBC), CHEK2 mutation (1 sample; pancreas), IDH2 mutation (1 sample; eCCA). Mean maximum MAF was 1.47 (2 in biliary; 0.43 in pancreas). Variants of unknown significance were identified in 72.73% of the samples (87.5% in B; 33.33% in P; p-value 0.152). None of the baseline characteristics explored correlated with presence of ctDNA. There was a trend towards increased relapse risk in the patients with ctDNA present following potentially curative surgery; Cox regression for RFS [HR 2.64 (95% CI 0.36-19.31); median RFS 11.44 months (95% CI 2.28-not reached) vs 10.87 (95% CI 2.21-not reached)]; relapse rate 37.5% (ctDNA absent) vs 66.67% (ctDNA present); statistical significance was not reached (p-value 0.340 and p-value 0.545, respectively). Conclusions: This pilot study demonstrates the feasibility of testing for ctDNA following potentially curative resection in PB malignancies. Presence of ctDNA may be associated with increased relapse risk; further studies are required to increase sample size and assess clinical implications.

Treatment Outcomes of Childhood Tuberculosis in Three Districts of Balochistan, Pakistan: Findings from a Retrospective Cohort Study

2020 ◽  
Author(s):  
Abid Abdullah ◽  
Nafees Ahmad ◽  
Muhammad Atif ◽  
Shereen Khan ◽  
Abdul Wahid ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Treatment Outcomes ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
P Value ◽  
Childhood Tb ◽  
Study Sites ◽  
Lost To Follow Up

Abstract Background This study aimed to evaluate treatment outcomes and factors associated unsuccessful outcomes among pediatric tuberculosis (TB) patients (age ≤14 years). Methods This was a retrospective cohort study conducted at three districts (Quetta, Zhob and Killa Abdullah) of Balochistan, Pakistan. All childhood TB patients enrolled for treatment at Bolan Medical Complex Hospital (BMCH) Quetta and District Headquarter Hospitals of Zhob and Killa Abdullah from 1 January 2016 to 31 December 2018 were included in the study and followed until their treatment outcomes were reported. Data were collected through a purpose developed standardized data collection form and analyzed by using SPSS 20. A p-value &lt;0.05 was considered statistically significant. Results Out of 5152 TB patients enrolled at the study sites, 2184 (42.4%) were children. Among them, 1941 childhood TB patients had complete medical record were included in the study. Majority of the study participants were &lt;5 years old (66.6%) and had pulmonary TB (PTB; 65%). A total of 45 (2.3%) patients were cured, 1680 (86.6%) completed treatment, 195 (10%) lost to follow-up, 15 (0.8%) died, 5 (0.3%) failed treatment and 1 (0.1%) was not evaluated for outcomes. In multivariate binary logistic regression analysis, treatment at BMCH Quetta (OR = 25.671, p-value &lt; 0.001), rural residence (OR = 3.126, p-value &lt; 0.001) and extra-PTB (OR = 1.619, p-value = 0.004) emerged as risk factors for unsuccessful outcomes. Conclusion The study sites collectively reached the World Health Organization’s target of treatment success (&gt;85%). Lost to follow-up was the major reason for unsuccessful outcomes. Special attention to patients with identified risk factors for unsuccessful outcomes may improve outcomes further.

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