Evidence map›Paper›PMID 33267826›Full record

ArticleBMC infectious diseases2020

"Side effects--part of the package": a mixed methods approach to study adverse events among patients being programmatically treated for DR-TB in Gujarat, India.

Arjunkumar Jakasania, Kalpita Shringarpure, Dixit Kapadia, Radhika Sharma, Kedar Mehta, Arpit Prajapati, Soundappan Kathirvel

Open access · goldAbstract read
In one paragraph

Article in BMC infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.1field-weighted citation impact, top 44% of its field
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

6 citing papers in PubMed, 9 citations in OpenAlex.

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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

7 authors at 6 institutions in 1 country.

Arjunkumar JakasaniaDepartment of Community Medicine, MGIMS, Sewagram, Wardha, Maharashtra, India. aarrjjuunn999@Gmail.com.ORCID http://orcid.org/0000-0003-3749-1993
Kalpita ShringarpureDepartment of Preventive and Social Medicine, Medical College Baroda, Vadodara, Gujarat, India.
Dixit KapadiaDistrict Tuberculosis officer, Ahmedabad, Gujarat, India.
Radhika SharmaDepartment of Community Medicine, BJ Medical College, Ahmedabad, Gujarat, India.
Kedar MehtaGMERS medical college, Gotri, Vadodara, Gujarat, India.
Arpit PrajapatiDepartment of Community Medicine, GCS Medical College, Ahmedabad, Gujarat, India.
Soundappan KathirvelDepartment of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
B.J. Medical College · INGujarat Cancer Society · INMahatma Gandhi Institute of Medical Sciences · INNew Delhi Tuberculosis Center · INPost Graduate Institute of Medical Education and Research · INSir Sayajirao General Hospital Medical College · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHigh rates of Adverse Events (AEs) during treatment is one of the leading causes of unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs.

methodsThis mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staff (treatment supervisors, medical officer and district program managers).

resultsTotal 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre.

conclusionThe incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems is the need of the hour. An efficient real-time reporting and management of AE should be developed and tested for effective DR-TB control.

Indexed as

AdultAntitubercular AgentsDelivery of Health CareFemaleFollow-Up StudiesHealth PersonnelHumansIncidenceIndiaMaleMiddle AgedMycobacterium tuberculosisPatientsReferral and ConsultationRetrospective StudiesSurveys and QuestionnairesAntitubercular AgentsAdverse drug eventDrug resistant tuberculosisIncidenceIndiaOperational research

Identifiers

PMID33267826
PMCPMC7709264
OpenAlexW3107980509

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.