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CRITICAL THINKING IN EPIDEMIOLOGY“Diabetes Mellitus is Strongly Associated with

Tuberculosis in Indonesia”

Anggota :

1. Ellis Sepianessi (10101001019)

2. Rizka Isti Qomarya (10101001023)

3. Kurnia Putri A. (10101001033)

4. Mareta Ramadhona (10101001039)

5. Della Agustina (10101001049)

6. Sthevani Eka Purnama (10101001056)

7. Kaltriani Lestari (10101001066)

Dosen Pengasuh :

Najmah S.KM, M.PH

FAKULTAS KESEHATAN MASYARAKATUNIVERSITAS SRIWIJAYA

TAHUN 2013STROBE Statement – Checklist yang seharusnya dilaporkan dalam penelitian dengan desain kasus kontrol (case-control studies).

ItemNo

Recommendation Reported on page

Judul dan Abstrak 1 a. Studi desain yang digunakan dicantumkan di abstrak atau judul.

Abstrak : Dicantumkan di design studynya yaitu, ‘Case-control study comparing the prevalence of diabetes mellitus (fasting blood glucose level >126 mg/dl) among newly diagnosed pulmonary TB patients and matched neighbourhood controls.

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b. Bagian abstrak terdiri dari ringkasan informatif terhadap apa yang sudah dilakukan dan ditemukan (Terdapat latar belakang, tujuan, design studi, hasil, kesimpulan)

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PendahuluanLatar Belakang/Rasionalisasi

2 Latar belakang dari studi terdapat di paragraf pertama yaitu pada kalimat :“The Prevalence of diabetes mellitus is increasing worldwide, especially in Asia, where tuberculosis (TB) is highly endemic. Most textbooks statethat diabetes is a risk factor for TB, but little is known about the nature and strength of this relationship. Original studies on this subject were mostly conducted more than 40 years ago,...”

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Tujuan 3 Tujuan dari studi ini dicantumkan pada akhir kalimat paragraf pertama, yaitu :“We therefore examined to what extent diabetes is associated with an increased risk of TB in Indonesia.”

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MetodeDesain Penelitian 4 Desain studi yang dicantumkan pada

bagian design terdapat pada kalimat:

“Case-control study comparing the prevalence of diabetes mellitus (fasting blood glucose level >126 mg/dl) among newly diagnosed pulmonary TB patients and matched neighbourhood controls”.

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Setting 5 Gambaran dari : Lokasi : Untuk case penelitian

dilakukan Jakarta Tengah dan Rumah Sakit Hasan Sadikin Bandung, yang tercantum pada kalimat pertama di bagian Methods :”... an out-patient TB clinic in central Jakarta, and Hasan Sadikin General Hospital, Bandung...” Sedangkan untuk control penelitian merupakan masyarakt Indonesia yang berada di lingkup RT, seperti yang tercantum pada kalimat : “...selected a control subject of the same sex and age (±10%) living within the same rukun tetangga, the smallest residential unit in Indonesia, which consists of 15–30 households...”

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Periode rekruitmen, exposure, follow-up, dan pengumpulan data terdapat pada bagian Results pada kalimat, “Between March 2001 and March 2005, 481 new PTB patients were recruited...” (paragraf 1, kalimat pertama). Kemudian hasil penelitian dapat diketahui pada bagian yang sama di kalimat, “Patients presented after a median of 3 months (range 1 week to over 1 year) with cough (98.9%)...” (paragraf 1 kalimat kelima).

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Partisipan/Responden 6 a. Kriteria responden yang memenuhi kriteria sebagai :

Case : “...an out-patient TB clinic in central Jakarta, and Hasan Sadikin General Hospital, Bandung, consecutive new PTB patients aged over 15 years of age were included in the study” (kalimat pertama bagian Methods).

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Control : “...randomly selected a control subject of the same sex and age (±10%) living within the same rukun tetangga, the smallest residential unit in Indonesia, which consists of 15–30 households. First-degree relatives of patients were excluded. Control subjects with signs and symptoms suggesting active TB or a history of prior anti-tuberculosis treatment were also excluded” (kalimat pertama paragraf pertama).

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b. Tidak ditemukan pada jurnal penelitian ini.

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Variables 7 Variabel pada penelitian ini adalah :

Diabetes Mellitus: FBG >126 mg/dl dan diantara >110 dan <126 mg/dl (WHO Criteria).

Glycosuria, menggunakan indikator ukur (Combur Test, Roche, Jakarta, Indonesia).

Urine Glucose Concentration : abnormal jika >30 mg/dl

Plasma Creatinine : abnormal jika normal value <90 mmol/l (wanita) dan <110 mmol/l (pria).

HIV : menggunakan indikator test HIV ((Determine, Abbott

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Diagnostics, Hoofddorp, The Netherlands).\

Umur : diklasifikasikan menjadi 4 kelompok umur yaitu ≤19 tahun, 20-29 tahun, 30-39 tahun, dan ≥40 tahun.

Pendapatan : diklasifikasikan menjadi 3 kelompok yaitu <1, 1-2, dan >2 US $/capita/day.

Kepadatan hunian rumah : dikategorikan padat jika terdapat >2 individu di setiap kamar.

Riwayat kontak TB

Body Mass Index : penentuan batas indikator berdasarkan median untuk setiap case dan control.

697 (Table 1)

697 (Table 1)

697 (Table 1)

697 (Table 1)

697 (Table 1)

Sumber Data/Pengukuran

8* a. Sumber Data

Case : “...an out-patient TB clinic in central Jakarta, and Hasan Sadikin General Hospital, Bandung, consecutive new PTB patients aged over 15 years of age were included in the study. Diagnosis was based on clinical presentation and chest X-ray examination, confirmed by microscopic detection of acid-fast bacilli. Treatment consisted of a standard regimen, 2HRZE/4H3R3...(kalimat pertama bagian Methods)”

Control : “...randomly selected a control subject of the same sex and age (±10%) living within the same rukun tetangga, the smallest residential unit in Indonesia, which consists of 15–30

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households. First-degree relatives of patients were excluded. Control subjects with signs and symptoms suggesting active TB or a history of prior anti-tuberculosis treatment were also excluded” (kalimat pertama paragraf pertama).

b. Pengukuran, baik untuk case dan control menggunakan cara yang sama Diabetes Mellitus: teknik

kuantitatif dengan sebelumnya pasien berpuasa 48 jam terlebih dahulu , standar yang digunakan adalah standar WHO. Konsentrasi FBG diukur sebelum dan sesudah pengobatan anti TB. Dapat dilihat pada kalimat berikut : “No anti-diabetic agents were taken within 48 h before blood sampling for measurement of fasting blood glucose (FBG) concentrations... In all patients, FBG concentrations were measured before and after one month of anti-tuberculosis treatment..”

Glycosuria, teknik semi kuantitaif, dapat dilihat pada kalimat : “Semi-quantitative measurement of glycosuria was done using urine dipsticks..”

Urine Glucose Concentration : teknik kuantitatif dengan mengukur konsentrasi urine glucose.

Plasma Creatinine : teknik kuantitatif, dengan mengukur plasma creatine.

HIV : “...(HIV) testing was

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conducted using the dipstick test..”

Bias 9 Adanya recall bias ketika mewawancarai informan, hal ini dapat terlihat dari pernyataan : “Adjustment for the higher frequency of TB contacts among the cases did not lower the risk estimates. This difference may have been due to recall bias” (bagian Discussion paragraf ketiga).

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Ukuran Studi 10 Untuk case penelitian dilakukan Jakarta Tengah dan Rumah Sakit Hasan Sadikin Bandung, yang tercantum pada kalimat pertama di bagian Methods :”... an out-patient TB clinic in central Jakarta, and Hasan Sadikin General Hospital, Bandung...” Sedangkan untuk control penelitian merupakan masyarakt Indonesia yang berada di lingkup RT, seperti yang tercantum pada kalimat : “...selected a control subject of the same sex and age (±10%) living within the same rukun tetangga, the smallest residential unit in Indonesia, which consists of 15–30 households...”

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Variabel Kuantitatif 11 Diabetes Mellitus: teknik kuantitatif dengan sebelumnya pasien berpuasa 48 jam terlebih dahulu , standar yang digunakan adalah standar WHO. Konsentrasi FBG diukur sebelum dan sesudah pengobatan anti TB. Dapat dilihat pada kalimat berikut : “No anti-diabetic agents were taken within 48 h before blood sampling for measurement of fasting blood glucose (FBG) concentrations...

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In all patients, FBG concentrations were measured before and after one month of anti-tuberculosis treatment..”

Urine Glucose Concentration : teknik kuantitatif dengan mengukur konsentrasi urine glucose.

Plasma Creatinine : teknik kuantitatif, dengan mengukur plasma creatine.

Umur : diklasifikasikan menjadi 4 kelompok umur yaitu ≤19 tahun, 20-29 tahun, 30-39 tahun, dan ≥40 tahun.

Pendapatan : diklasifikasikan menjadi 3 kelompok yaitu <1, 1-2, dan >2 US $/capita/day.

Kepadatan hunian rumah : dikategorikan padat jika terdapat >2 individu di setiap kamar.

Riwayat kontak TB (Ya dan Tidak)

Body Mass Index : penentuan batas indikator berdasarkan median untuk setiap case dan control.

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697 (Table 1)

697 (Table 1)

697 (Table 1)

697 (Table 1)

697 (Table 1)

Metode Statistik 12 a. Ditemukan pada kalimat, “Crude and adjusted odds ratios (ORs) were calculated as estimates of the relative risks with corresponding 95% confidence intervals (CI) and a logistic regression model. Adjusted ORs reflect the risk of TB for people with diabetes mellitus compared to normal individuals after

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adjustment for variables including: sex, age, body mass index (BMI, calculated as kg/m2), presence of TB contact in the family or household, income and number of individuals per household.

b. Ditemukan pada kalimat, “Possible confounding of the relationship between diabetes and TB was examined using logistic regression. Sex, income and overcrowding did not alter the OR significantly. History of TB contact was significantly more common among cases than controls (Table 1); however, adjustment to this variable didnot reduce the risk estimates. TB patients had a lower BMI than controls, but adjustment”

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c. Tidak ditemukan dalam bagian metode dalam jurnal

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d. Tidak ditemukan dalam bagian metode dalam jurnal

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e. Tidak ditemukan dalam bagian metode dalam jurnal

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HasilPartisipan 13* a. Untuk case dapat dilihat pada

kalimat berikut, “...481 new PTB patients were recruited, of whom 454 were included for further analysis. Twenty-seven were excluded because of a past history of TB (n= 6) and incomplete data (n =21). le (Table 1).” (bagian Results paragraf pertama).

Sedangkan untuk control dapat

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dilihat dari, “Six hundred and twenty-two subjects were recruited as matched controls. Sixty-six were excluded for further analysis because of suspected TB (n = 22), history of TB treatment (n =7) or incomplete data (n =37)” (bagian Results paragraf kedua).

b. Penyebab partisipan dikeluarkan dari penelitian Case ditemukan pada kalimat,

“Twenty-seven were excluded because of a past history of TB (n= 6) and incomplete data (n =21) (bagian Results paragraf pertama).

Control ditemukan pada kalimat, “Sixty-six were excluded for further analysis because of suspected TB (n = 22), history of TB treatment (n =7) or incomplete data (n =37)” (bagian Results paragraf kedua).

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c. Tidak terdapat diagram alur di jurnal

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Data Deskriptif 14* a. Karakteristik studi partisipan

Case, dapat dilihat pada kalimat, “Patients had a median age of 30.0 years (range 15–75), and 238 (52.4%) were male. Cases had a median BMI of 17.7 kg/m2 (range 11.2–31.4)” (bagian Results paragraf pertama).

Control, dapat dilihat pada kalimat, “The remaining 556 controls had a similar sex distribution, age (median 30.0 years; range 15–76) and socio-economic background as the

697 & Table 1

697 & Table 1

patients (Table 1). Control subjects had a higher body weight than patients, while history of TB contact was less common (Table 1)” (bagian Results paragraf kedua).

b. Tidak ditemukan data yang hilang (missing data) baik untuk case maupun control pada jurnal.

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Data Hasil 15* Case, dapat dilihat pada kalimat, “All were newly diagnosed with PTB confirmed by sputum microscopy. Mycobacterium tuberculosis culture results were available in 373 patients, and were positive in 328 (87.9%). Patients presented after a median of 3 months (range 1 week to over 1 year) with cough (98.9%), haemoptysis (42.5%), shortness of breath (66.1%), fever (77.3%) and weight loss (84.1%). Cases had a median BMI of 17.7 kg/m2 (range 11.2–31.4). Antibodies against HIV were present in 6 of 402 TB patients examined (1.5%) and none of the 40 controls tested. Mild elevation of plasma creatinine was found in one of 234 cases examined” (bagian Results paragraf pertama).

Control, dapat dilihat pada kalimat, “Control subjects had a higher body weight than patients, while history of TB contact was less common”(bagian Results paragraf kedua).

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Hasil Utama 16 a. Dapat ditemukan pada kalimat :

Diabetes mellitus was more common in patients with TB than 698 &

in control subjects (Figure). Sixty TB patients (13.2%) had diabetes compared with 18 (3.2%) controls (OR 4.7, 95%CI 2.7–8.1) (Table 2). Impaired FBG was present in 15 TB patients (3.3%) and five controls (0.9%, OR 4.2, 95%CI 1.5–11.7). Glycosuria was present in 43 of 415 TB cases (10.4%)and 16 of 413 controls (3.6%), corresponding to an OR of 3.1 (95%CI 1.7–5.6) (Table 2).

The median age of TB patients with diabetes, impaired FBG and no diabetes was 45.0, 45.0 and 27.1 years, respectively (P < 0.001). The median BMI was 21.2, 16.9 and 17.8 kg/m2, respectively (Figure, A).

Diabetes was newly diagnosed in 36/60 patients (60.0%) and 12/18 controls (66.7%) with diabetes. Among 24 patients with a history of diabetes, only 19 (79.2%) were being treated, all with oral hypoglycaemic agents.

Repeated measurement during TB treatment showed normalisation of FBG in 2/53 (3.7%) patients who initially had FBG >126 mg/dl, and conversion to diabetesin 6/295 (2.0%) patients with normal FBG before TB treatment.

Table 2

698 & Figure A

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b. Ditemulan pada kalimat, “Possible confounding of the relationship between diabetes and TB was examined using logistic regression. Sex, income and overcrowding did not alter the OR significantly. History of TB contact was significantly more

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common among cases than controls (Table 1); however, adjustment to this variable didnot reduce the risk estimates. TB patients had a lower BMI than controls, but adjustment”c. Tidak ditemukan dalam jurnal penelitian ini.

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Analisis Lainnya 17 Tidak ditemukan dalam jurnal penelitian ini.

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DiskusiHasil/Informasi Penting

18 Ditemukan pada kalimat, “We have found a strong association of TB and diabetes in two urban clinics in Indonesia. We believe this is the first study to examine this association in Indonesia, where more than 10% of the world’s TB patients live,2 and one of the first in South-East Asia” (bagian Discussion, paragraf pertama dan kalimat pertama).

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Keterbatasan 19 Ditemukan pada kalimat, “As the study subjects were very poor, with limited access to regular health care, the proportion with undiagnosed diabetes may in fact have been higher” (paragraf pertama).

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Interpretasi 20 Ditemukan pada kalimat :

Immunological studies support the hypothesis that diabetes is a risk factor for TB. Production of interferon-gamma, which is crucial for host defence agains TB, has been found to be low in diabetic mice infected with M. tuberculosis, and it has been shown that alveolar macrophage in TB patients with diabetes show less activation.

Cohort studies performed in Europe and th United States in the 1930s also support this

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hypothesis: diabetics showed a three- to four-fold increased risk of developing TB.

A recent case-control study of TB patients in Mexico reported a higher risk estimate than ours: the prevalence of diabetes was 29.6%, which was 6.8- fold higher than the background prevalence of diabetes in the study area. Previous studies from Korea, Europe and the US in which diabetes patients were prospectively followed, reported risk estimates similar to ours.

If diabetes, as our study suggests, is such a strong risk factor for TB, this may have significant clinical and epidemiological implications. In 2025, 75% of diabetics will live in developing countries where more than 90% of TB cases reside.

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Generalisasi 21 Ditemukan pada kalimat, “Based on our study, we would recommend screening all TB patients above 35 years of age at least once, and looking for symptoms of diabetes inyounger patients. Screening and earlier management of diabetes may reduce the risk of developing active TB.”

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Informasi LainnnyaFunding 22 Ditemukan pada kalimat, “This study

is an indirect result of the project ‘Immunogenetic basis of susceptibility to and disease

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manifestations of mycobacterial infections’, conducted within the ‘Scientific Programme Indonesia Netherlands’ (SPIN) and supported by the Royal Academy of Arts and Sciences (KNAW)...” (bagian Acknowledgements).

*Give information separately for cases and controls