CRITICAL APPRAISAL Judul Jurnal : Investigation of possible risk factors in the development of seasonal allergic conjunctivitis Publikasi : Int J Ophthalmol 2018;11(9):1508-1513 Critical appraisal checklist Did the study address a clearly focused issue? ( - The population studied - The risk factors studied - The outcomes considered - Is it clear whether the study tried to detect a beneficial or harmful effect?) This Paper: Yes [ √ ] No [ ] Unclear [ ] Comment: Pada halaman 1508-1509 mengenai Subjek dan Metode, penulis mencantumkan dengan jelas mengenai populasi yang digunakan dalam penelitian. “The SAC group included 75 patients (30 females and 45 males) with SAC aged between 7 to 30 years old, who were admitted to the Abant Izzet Baysal University Medical Faculty Ophthalmology Clinic between March 2016 and December 2016. The control group (CG) was comprised of 71 patients (29 females and 42 males) aged between 8 to 29 years old” Pada halaman 1508 pada akhir paragraf Introduction, peneliti menjelaskan bahwa penelitian ini bertujuan untuk untuk menidentifikasi faktor predisposisi dari konjungtivitis alergi. “The aim of this study was to develop proposals for the identification of predisposing factors of SAC.” The two groups being studied are selected from source populations that are comparable in all respects other than the factor under investigation. The study indicates how many of the people asked to take part did so, in each of the groups being studied This Paper: Yes [ √ ] No [ ] Unclear [ ] Comment: Pada halaman 1508-1509 peneliti menjelaskan bahwa subjek penelitian terdiri dari kelompok pasien yang didiagnosis dengan Konjungtivitis alergi yang dirawat di Fakultas Kedokteran Ophthalmology Clinic Universitas Abant Izzet Baysal antara Maret 2016 hingga Desember 2016. The likelihood that some eligible subjects might have the outcome at the time of enrolment is assessed and taken into account in the analysis. What percentage of individuals or clusters recruited into each arm of the study dropped out before the study was completed? This Paper: Yes [ ] No [√ ] Unclear [ ] Comment: Pada penelitian ini tidak disebutkan berapa jumlah subjek penelitian yang di drop out dari penelitian Comparison is made between full participants and those lost to follow up, by exposure status. This Paper: Yes [ ] No [√ ] Unclear [ ] Comment: Karena tidak ada data mengenai jumlah subjek penelitan yang di drop out dari penelitian jadi perbandingan antara dua kelompok ini tidak ditentukan. Was the cohort recruited in an acceptable way (Was the cohort representative of a defined population? · Was there something special about the cohort? · Was everybody included who should have been included?) This Paper: Yes [ ] No [ ] Unclear [√ ] Comment: Pada penelitian ini peneliti tidak mencantumkan jenis penelitian yang dilakukan. Namun berdasarkan literature yang ada, penelitian mengarah ke cohort study. Semua pasien mata dengan diagnosis SAC dan yang masuk dalam kriteria inklusi semua di cantumkan dalam penelitian ini, seperti yang dijelaskan oleh peneliti pada halaman 1508-1509 mengenai subjek penelitian. Was the exposure accurately measured to minimise bias? (Did they use subjective or objective measurements? · Do the measurements truly reflect what you want them to (have they been validated)? · Were all the subjects classified into exposure groups using the same procedure) This Paper: Yes [√ ] No [ ] Unclear [ ] Comment: Penilaian dilakukan melalui pemeriksaan fisik dan oftalmologi. Seperti yang dijelaskan peneliti pada halaman 1509 “All participants underwent detailed physical and ophthalmologic examinations. The diagnosis of SAC was made from evaluation of the complaints and the findings of itching, tearing, redness, chemosis and eyelid edema” Selain itu peneliti juga memberikan kuisioner dan melakukan pengujian terhadap kandungan air mata dan serum darah pasien dengan menggunakan analisis biokimia. Seperti yang dijelaskan pada halaman 1509 “Tears of the patients were collected into the 75 μL hematocrit tubes HaemotocritKapillaren, Hirschmann Laborgerate, Germany). The hematocrit tubes were placed in the lateral cantus to collect from the inferior tear meniscus. The samples were stored at -80℃ in air proof microcentrifuge tubes.” Semua subjek penelitian mendapatkan perlakuan yang sama dari peneliti. Was the outcome accurately measured to minimise bias? [Did they use subjective or objective measurements? · Do the measures truly reflect what you want them to (have they been validated)? · Has a reliable system been established for detecting all the cases (for measuring disease occurrence)? · Were the measurement methods similar in the different groups? · Were the subjects and/or the outcome assessor blinded to exposure (does this matter)?] This Paper: Yes [ ] No [ ] Unclear [√ ] Comment: Hasil penelitian diuji dengan menggunakan SPSS 22 dengan menggunakan tes Student-t dan Mann-Whitney U test digunakan untuk membandingkan masingmasing kelompok dan uji korelasi Spearman digunakan untuk menganalisis korelasi. Semua variable pada setiap kategori dibandingkan pada masing-masing kelompok menggunakan uji Chi-square. Seperti yang dicantumkan pada halaman 1510 “For the statistical analysis, the Student-t test and Mann-Whitney U test were used to compare the groups and the Spearman correlation test was used for the correlation analysis. All categorical variables were compared between the groups using Chi-square test. SPSS 22 (IBM SPSS Statistics; IBM, Armonk, NY, USA) were used to perform statistical analyses.” Namun pada penelitian ini peneliti tidak menyebutkan apakah data sudah di validasi atau belum. Have the authors identified all important confounding factors? Have they taken account of the confounding factors in the design and/or analysis? (Look for restriction in design, and techniques e.g. modelling, stratified-, regression-, or sensitivity analysis to correct, control or adjust for confounding factors). This Paper: Yes [ ] No [√ ] Unclear [ ] Comment: Dalam penelitian ini peneliti tidak mencantumkan mengenai faktor-faktor yang membingungkan penelian ini. The outcomes are clearly defined. The assessment of outcome is made blind to exposure status. If the study is retrospective this may not be applicable. Where blinding was not possible, there is some recognition that knowledge of exposure status could have influenced the assessment of outcome This Paper: Yes [√ ] No [ ] Unclear [ ] Comment: Penelitian merincinkan hasil penelitian dengan jelas The method of assessment of exposure is reliable. Evidence from other sources is used to demonstrate that the method of outcome assessment is valid and reliable. Exposure level or prognostic factor is assessed more than once. This Paper: Yes [ ] No [√ ] Unclear [ ] Comment: Peneliti tidak menjelaskan validitas dan reliabitias pada penelitian ini Was the follow up of subjects complete enough? Was the follow up of subjects long enough? (The good or bad effects should have had long enough to reveal Themselves. The persons that are lost to follow-up may have different outcomes than those available for assessment. In an open or dynamic cohort, was there anything special about the outcome of the people leaving, or the exposure of the people entering the cohort?) This Paper: Yes [√ ] No [ ] Unclear [ ] Comment: Follow up yang dilakukan pada penelitian ini sesuai dengan konsep dan tujuan penelitian The main potential confounders are identified and taken into account in the design and analysis. Have confidence intervals been provided? This Paper: Yes [ ] No [√ ] Unclear [ ] Comment: What are the results of this study? [What are the bottom line results? · Have they reported the rate or the proportion between the exposed/unexposed, the ratio/the rate difference? · How strong is the association between exposure and outcome (RR,)? · What is the absolute risk reduction (ARR)?] This Paper: Yes [ ] No [√ ] Unclear [ ] Comment: Seperti yang tercantum pada halaman 1050, pada penelitian ini didapatkan Penggunaan parasetamol oleh ibu selama kehamilan secara signifikan lebih tinggi pada kelompok SAC dibandingkan dengan kontrol (P <0,001) Demikian juga, penggunaan suplemen vitamin D selama masa bayi secara signifikan lebih lama pada kelompok kontrol dibandingkan dengan kelompok SAC (P <0,001). Asma sering terjadi (24,3%), rinitis alergi (73%) dan sindrom alergi oral (17,6%) hadir pada pasien dengan SAC pada tingkat signifikan lebih tinggi dibandingkan dengan kontrol (P <0,001). Ibu dan saudara kandung dari pasien SAC menunjukkan tingkat konjungtivitis yang lebih tinggi secara signifikan (masing-masing 5,4% dan 5,4%, P = 0,047). Demikian juga, ayah pasien SAC menunjukkan tingkat rinitis alergi yang lebih tinggi secara signifikan (14,9%, P = 0,003) How precise are the results? Look for the range of the confidence intervals, if given. Comment: Jika di suruh menilai dari skala 1-10 maka penulis menilai hasil penelitian ini dengan skala 6. Karena penelitian ini masih memiliki banyak sekali kekurangan. Do you believe the results? [Big effect is hard to ignore! · Can it be due to bias, chance or confounding? · Are the design and methods of this study sufficiently flawed to make the results unreliable? · Bradford Hills criteria (e.g. time sequence, dose-response gradient, biological plausibility, consistency)] This Paper: Yes [√ ] No [ ] Unclear [ ] Comment: Hasil penelitian ini sangat mungkin menjadi bias. Selain peneliti tidak menjelaskan mengenai teknik pengambilan sampel, peneliti juga tidak mencantumkan validitas dari penelitian ini. Can the results be applied to the local population? (A cohort study was the appropriate method to answer this question · The subjects covered in this study could be sufficiently different from your population to cause concern · Your local setting is likely to differ much from that of the study · You can quantify the local benefits and harms). This Paper: Yes [√ ] No [ ] Unclear [ ] Comment: Penelitian ini melibatkan pria dan wanita dengan rentang usia 7-30 tahun. Sebagaimana di jelaskan oleh peneliti pada halaman 1050 “The SAC group included 75 patients (30 females and 45 males) with SAC aged between 7 to 30 years old, who were admitted to the Abant Izzet Baysal University Medical Faculty Ophthalmology Clinic between March 2016 and December 2016. The control group (CG) was comprised of 71 patients (29 females and 42 males) aged between 8 to 29 years old” Dengan demikian hasil penelitian ini dapat diaplikasikan pada populasi local. What are the implications of this study for practice? (One observational study rarely provides sufficiently robust evidence to recommend changes to clinical practice or within health policy decision making · For certain questions observational studies provide the only evidence · Recommendations from observational studies are always stronger when supported by other evidence) This Paper: Yes [√ ] No [ ] Unclear [ ] Comment: Hasil penelitian ini dapat diaplikasikan dalam kehidupan sehari-hari, sebagiamana disebutkan oleh peneliti pada halaman 1508 bahwa Pemakaian parasetamol selama kehamilan oleh ibu dan singkatnya penggunaan suplemen vitamin D setelah kelahiran berperan dalam perkembangan SAC. Menghindari penggunaan parasetamol yang tidak perlu dan konsumsi suplemen vitamin D selama dalam kandungan dapat mengurangi onset perkembangan SAC “Prenatal maternal paracetamol exposure and shorter duration of vitamin D supplementation in the postnatal period may play a role in development of SAC. Therefore prevention of unnecessary gestational paracetamol intake and vitamin D supplementation during infancy could potentially reduce the onset and development of SAC.” Do the results of this study fit with other available evidence? This Paper: Yes [√ ] No [ ] Unclear [ ] Comment: Penelitian lain menyebutkan bahwa Insiden SAC didapatkan tinggi pada pasien dengan asma akibat alergi dan rinitis alergi. Selain itu, peran vitamin D, yang merupakan aktifator sistem imunitas yang sering digunakan dalam pengobatan kanker dalam beberapa tahun terakhir, tetap menjadi kontroversi dalam mengurangi insiden SAC. Dengan demikian hasil penelitian ini cocok dengan penelitian yang telah dilakukan sebelum-sebelumnya How well was the study done to minimise the risk of bias or confounding? This Paper: Yes [ ] No [ ] Unclear [√ ] Comment: Penelitian ini cukup bagus dengan adanya kriteria eksklusi pada penelitian. Namun peneliti sendiri menyebutkan kemungkinan terjadinya bias pada penelitian ini seperti yang disebutkan pada halaman 1512 “One of the main limitations of our study may be over- orunder-reporting due to recollection bias” Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, do you think there is clear evidence of an association between exposure and outcome? This Paper: Yes [ ] No [ ] Unclear [√ ] Comment: Hasil penelitian ini cukup jelas menggambarkan faktor predisposisi yang mungkin pada perkembangan konjungtivitis alergi musiman. Namun karena peneliti tidak menjelaskan secara rinci mengenai teknik pengambilan sampel, uji validitas, maka penulis merasa penelitian ini memiliki kelemahan yang cukup kuat Can the results be applied to your organization? This Paper: Yes [ ] No [√ ] Unclear [ ] Comment: Peneliti menyebutkan pada halaman 1512 bahwa penelitian ini dilakukan pada kawasan industri di negara berkembang. “The current study was conducted in an industrialized and developing region and a high rate of allergic diseases were detected,” Beberapa daerah di provinsi Sumatera Utara termasuk dalam lingkungan peindustrian. Selain itu Indonesia merupakan negara berkembang. Namun hasil penelitian ini belum tentu dapat digunakan mengingat ras subjek penelitian pada penelitian berbeda dengan ras orang indonesia Conflicts of interest are declared. This Paper: Yes [√ ] No [ ] Unclear [ ] Comment: Pada halaman 1512 peneliti menuliskan tentang conflict of interest Rate the overall methodological quality of the study, using the following as a guide: - High quality (++): Majority of criteria met. Little or no risk of bias. - Low quality (-): Either most criteria not met, or significant flaws relating to key aspects of study design. - Reject (0): Poor quality study with significant flaws. Wrong study type. Not relevant to guideline
