Evidence map›Paper›PMID 39935535›Full record

Observational studyF1000Research2022

Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India.

Harsh Shah, Sandul Yasobant, Jay Patel, Priya Bhavsar, Somen Saha, Yogesh Patel, Deepak Saxena, Anish Sinha

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in F1000Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Harsh ShahDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, India.ORCID 0000-0003-3349-7562
Sandul YasobantDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, India.ORCID 0000-0003-1770-8745
Jay PatelDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, India.ORCID 0000-0003-1486-0821
Priya BhavsarDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, India.
Somen SahaDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, India.ORCID 0000-0002-8043-3388
Yogesh PatelDepartment of CGC Project, World Health Partners, Noida, Uttar Pradesh, 201301, India.
Deepak SaxenaDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, India.
Anish SinhaDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, India.

Funding

United States Agency for International Development 72038620CA00012
6 · The paper itself

Abstract

Background Tuberculosis (TB) continues to pose a serious threat to the public health system in India. Although the National Tuberculosis Elimination Program (NTEP) is providing a wide range of interventions from early diagnosis to complete treatment to reduce morbidity and mortality from TB, adverse drug reactions (ADR) remain a challenge in treatment adherence and completion. Methods An observational cross-sectional study was conducted in selected districts of Gujarat state. A total of 593 reported TB patients were recruited with an adjusted unified distribution based on the type of cases, site of diseases, and service facility through a simple random sampling method. A semi-structured questionnaire tool was used to collect socio-demographic, clinical, and ADR-related data from the TB patients. Data was analyzed for the frequency, percentage, chi-squared, and adjusted odds ratio to find the association between the variables. Results The majority of the study participants were male (87.2%), aged 15 to 60 (57.8%), daily laborers (22.4%), and married (64.2%). Over 75% of individuals had pulmonary TB, with 87% having experienced their first episode, 83% being new cases, and 44.7% having a history of addiction. ADR with mild symptoms was reported by more than a quarter (29%) of TB patients during the intensive phase (77%). The association between ADR experience and drug susceptibility was significant (p<0.005) and drug-resistant TB patients experience two times more ADRs than drug-sensitive TB patients (OR 2.04). Binomial logistic regression was carried out to describe the association between various variables and occurrence of ADRs. Conclusion The study highlighted a need to enhance health care providers' capacity and program structure for managing ADRs among TB patients. In order to completely eliminate TB across the country, it also emphasized the attention for a holistic and all-encompassing strategy for managing TB patients at the field level.

Indexed as

Antitubercular AgentsDrug-Related Side Effects and Adverse ReactionsTuberculosisAdolescentAdultCross-Sectional StudiesFemaleHumansIndiaMaleMiddle AgedRisk FactorsYoung AdultAntitubercular AgentsAdverse Drug ReactionsIndiaNational TB ProgramTuberculosis

Identifiers

PMID39935535
PMCPMC11811607

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.