Author's response to reviews Title: Quality the diagnostic process for tuberculosis in primary health centers (PHC) in Sidoarjo district, East Java, Indonesia Authors: Chatarina CU Wahyuni (chatrin03@yahoo.com) Budiono Budiono (budiono_ph@yahoo.com) Lutfia LD Rahariyani (chatrin03@yahoo.com) Muji M Sulistyowati (chatrin03@yahoo.com) Tety T Rachmawati (chatrin03@yahoo.com) Djuwari Djuwari (chatrin03@yahoo.com) Sri S Yuliwati (chatrin03@yahoo.com) Marieke MJ van der Werf (vanderwerfm@kncvtbc.nl) Version: 2 Date: 13 June 2007 see over Author's response to reviews:
Dear editor, Below we provide a point by point reaction to the suggestions and comments the two reviewers. Reviewer 1 Reviewer: In the background, the problem the case the low case detection rate 28 %, instead the target 70%, has to be considered and discussed more in-depth. In fact, quite ten the calculated incidence is overestimated and explains in part the low detection rates, as it is the case in other countries. Authors: We agree with the reviewer that also an inaccurate estimate the TB incidence can result in a low case detection rate. The following text has been included in the background section: A low CDR can be the result an inaccurate too high estimate the incidence new smear positive TB. The incidence estimate Indonesia was obtained from information local TB prevalence surveys conducted between 1979 and 1982 who were not performed with the aim obtaining an unbiased national estimate (Dye et al., 1999, Soemantri et al., 2007). Furthermore, only persons who reported cough 2 weeks were asked for one sputum sample. The fact that the incidence estimate is obtained from relatively old data that were not collected to obtain an unbiased national estimate and for which an insensitive screening method was used may have resulted in an inaccurate estimate TB incidence for Indonesia. Reviewer: This research considers only the public sector. It is important for the reader to know if there is a private sector or not in the considered district fering diagnostic process for TB pulmonary cases. Authors: We have included the following text in the background section: In Sidoarjo district there are five private hospitals that have all implemented the DOTS strategy in 2004 for diagnosis and treatment TB for patients visiting the general policlinic. Method diagnosis and treatment patients that visit the specialist polyclinic depends on the doctor. Reviewer: 2) Are the methods appropriate and well described, and are there sufficient details provided to replicate the work? The methods i.e. a research action process during a teaching are well described, quite original and details are provided to be able to replicate the work. It will maybe be interesting to ask the main authors to be available to be contacted by mail for considering more details the replication process their original approach. Authors: The author Marieke J. van der Werf (KNCV Tuberculosis Foundation) was responsible for facilitating the process. She is happy to provide information about the process to all those who are interested. Reviewer: 3) Is the data sound and well controlled (corresponding authors)? There are some issues related to the data presentation that need to be corrected. The chapter the quality smear examinations is not clear enough. It is not described how many the 10 used to evaluate the reading reliability were positive or negative, and much more important, as outlined in discussions, the way they calculate the false positive and the false negative cases is not really stated in the results presentation. It is important to ask the authors to review this part their results presentation. i.e. in discussions page 8, 4 started with:"with 19% false negative and 17% false positive, the performance the laboratory." It will be useful to have a specific table presenting these results smear reading reliability, with all the results described because this point is very important and, for me, was the main discovery in this research about TB diagnostic process. Authors: We have included a table with the results the quality smear examinations. Table 5. Quality smear examination in 11 health care facilities with a laboratory in Sidoarjo district.
Number Type Number positive provided Number negative provided Number positive identified Number negative identified Sensitivity Specificity 1 PRM 8 2 4 2 50 100.0 2 PRM 4 6 4 4 100 66.7 3 PRM 4 6 3 6 75 100.0 4 PRM 8 2 6 2 75 100.0 5 PRM 8 2 5 2 62.5 100.0 6 PRM 4 6 4 5 100 83.3 7 PRM 4 6 4 4 100 66.7 8 PRM 4 6 4 5 100 83.3 9 PRM 8 2 7 1 87.5 50.0 10 PPM 4 6 4 6 100 100.0 11 PPM 4 6 4 5 100 83.3 Total 86.4 84.8 We also included the following text in the results section: Of the 60 positive provided to the 11 laboratories 11 (18%) were not identified as such and 50 negative 8 (16%) were identified as positive. Reviewer: In the background part this paper (page 3), it is stated (3 ) that there is an adequate budget for the TB control program. However, in the results report on page 6, in the parts : "Support in PHC for the TB diagnostic process", it is stated that, (2nd ), "There was no specific budget available for activities such as committee health education, active case finding", etc. and only two heads PHC considered the budget available for the TB program sufficient. There is thus contradiction between the background and the results presentation concerning the support for the TB control program and no explanation is given about this. This must be included in the discussion and it is important in the conclusion also. Authors: We have added the following text in the discussion section: According to the Sidoarjo health fice there is an adequate budget for TB control (Sidoarjo Health Office, 2003). The majority the heads the PHCs reported that there was no specific budget for TB control in the PHC and only 2 heads PHCs considered the budget available for the TB program sufficient. Also, there was no specific budget available for activities such as community health education, active case finding, transportation fee for staff and patients, and extra food for patients. The results the interviews with the heads the PHCs thus show a contradiction with the opinion the district health authorities. A discussion between the heads the PHCs and the district health authorities on this may help in getting an adequate budget for TB control. Reviewer: 4) Does the manuscript adhere to the relevant standards for reporting and data submission. Yes the tables are clearly presented, the differences are made between the primary health care with and without microscopic resources, however, as stated before in point 3, another table must be built presenting the results the quality smear examinations with the calculation false positive and false negative rates. Authors: We have included the requested table in the manuscript.
Reviewer: 5) Are discussions and conclusions well balanced and adequately supported by the data. Regarding discussions about false negative and false positive, this is not very clear because, as already stated, data was not clearly presented in the results. For the conclusions, I believe that much more emphasis has to be put on the problem lack reading smear reliability i.e. the problem false positive and false negative which are very impressive. The top priority for the district will be to improve the quality smear reading process trying to decrease false positive as well as false negative results. Authors: We have included a table with the details the assessment the quality the laboratory diagnosis. The results are based on assessment only 10 sputum. Therefore, we consider it not appropriate to put too much emphasis on the problem lack quality the reading. We have added the following sentence to the discussion section: Since only a limited number were used to assess the quality the laboratory a more comprehensive evaluation the laboratory is needed and introduction rigorous supervision and a quality control system. Reviewer: This weakness must be also corrected in the conclusions. Authors: We have added the following sentence to the conclusions: The quality the laboratory diagnosis should be more thoroughly assessed and if necessary improved. Reviewer: 6) Do the title and abstract accurately convey what has been found? Yes without any problem. For the abstract, the part concerning the results must be more clear about the false positive and the false negative issue. Authors: We have adjusted the text in the abstract into: Fifty-five percent the 11 laboratory technicians correctly identified all positive as positive and 45% correctly identified 100% the negative as negative. Reviewer 2 Reviewer: Language The language used is having problems with grammar and spelling errors. These must be addressed before the manuscript acceptance for publication. Authors: The manuscript has been reviewed for English language by a person not involved in the preparation the manuscript. Reviewer: Title: I suggest the following tiltle Obstacles for Optimal TB case detection in primary health centers (PHC) in Sidoarjo district, East Java, Indonesia. Authors: We have revised the title the manuscript according to the suggestion the reviewer. Reviewer: Methods Contain information that can be shifted to the background section. For example: The district Sidoarjo had a population 1,629,311 and reported 4,529 TB suspects (21.4% the expected 21,181 cases) and 292 sputum smear positive TB patients (13.8% the expected 2,118 cases) in 2003 (Sidoarjo Health Office, 2003). Authors: As suggested by the reviewer we have moved the sentence to the background section and adjusted the text into: The district Sidoarjo had a population 1,629,311 in 2003. The district notified a low number TB suspects (4,529, 21.4% the expected 21,181 cases) and sputum smear positive TB patients (292,
13.8% the expected 2,118 cases) even though having sufficient human resources, a solid recording and reporting system, and an adequate budget for the TB control program (Sidoarjo Health Office, 2003). Reviewer: What does the author mean by the following sentences: 1) 9 Puskesmas Rujukan Mikroskopis does this sentence means laboratory referral health center? and 2) Puskesmas Pelaksana Mandiri does it mean independent laboratory health center? and 14 Puskesmas Satelit does it mean satellite health center?. Authors: We have adjusted the text. The English name the type health center is now mentioned first and the Indonesian name and abbreviation is given between brackets. There are 25 primary health care centers (PHCs) in Sidoarjo, including 9 laboratory referral health centers (Puskesmas Rujukan Mikroskopis = PRM), 2 independent laboratory health centers (Puskesmas Pelaksana Mandiri = PPM) and 14 satellite health centers (Puskesmas Satelit = PS). Reviewer: Analysis The sample size is small making the statistical tests provided unnecessary. Authors: We agree with the reviewer that the sample size is small and that this makes the results the statistical tests less relevant. However, since quantitatively trained readers are used to having the results a statistical test when comparing two or more groups we decided to keep the statistical tests in the results section. Reviewer: Results Some sentences in the results section are phrased like conclusions. e.g. Knowledge other symptoms was less good. Especially among nurses the knowledge about the cause TB, complications TB and the duration infectiousness after start treatment was not good. Authors: This sentence has been changed into: Eighty percent the nurses and 84% the TB workers knew that cough >3 weeks can be a symptom TB. Only 40% the nurses knew the cause TB, few could mention complications TB and none could mention the duration infectiousness after start treatment. Reviewer: Most heads PHC considered the performance the staff working in the TB program not optimal. The authors should give summary with the actual percentages instead generalizing. Authors: We have revised the sentence into: Fifty-two percent the heads PHC considered the performance the staff working in the TB program not optimal. We checked the results section and where appropriate included actual percentages. Reviewer: What is the TB workload for the technicians in the district? Authors: We have added the following text to the results section: In total, 56% the laboratory technicians were involved in other programs besides the TB program. Only 2 (18%) those working in the PRMs and PPMs were involved in other programs and almost all (86%) in the PSs. In most cases they were involved in programs outside the primary health center such as the school health program, posyandu, and the national immunization program. Reviewer: Headings for the titles and statements for key variable in table 3 and 4 need to be phrased properly to give price meanings. e.g. in table 3, Heading for the first column could be "Technicians and type Health education they would Given to TB suspects Authors: We adjusted the heading the first column into: Type health education laboratory technicians would give to TB suspects
Reviewer: " and, under reasons for sputum examination, what do you mean by to motivate the patients?, Other Authors: To make this clearer we have adjusted the row heading into explained about sputum examination. We have deleted the rows for diagnosis, to motivate others, and other. And we have added the following text to the results section: They mentioned that an explanation is important because sputum examination is essential for the correct diagnosis TB patients (32%), because it motivates TB suspects to provide sputum (16%), or for other reasons (4%). Reviewer: Table 4: Heading the first column could be " Health education given by the nurses and TB workers to TB suspects" Add sample size to each sub group, like Nurse n =?, TB workers n =? Authors: We have adjusted table 4 according to the suggestions by the reviewer. All other headings were checked and adjusted if considered necessary Reviewer: Discussion Discussion should include the implications poor performance the laboratory technicians the eleven health centre.. Authors: To illustrate the implications the poor performance the laboratory technicians we have included the following sentence in the discussion section: The high false negative rate gives that smear positive TB patients do not get appropriate treatment, whereas the high false positive rate gives that patients receive treatment unnecessarily. Reviewer: What are the limitations the study? This is not expressed in the discussion. Authors: We have added limitations the study in the discussion section: Since only a limited number were used to assess the quality the laboratory a more comprehensive evaluation the laboratory is needed and introduction rigorous supervision and a quality control system. This study was performed in Sidoarjo district. Therefore, the results are only applicable to Sidoarjo district. Since the organization primary health care is comparable in other districts and provinces in Indonesia it is likely that an assessment the quality the diagnostic process in other districts will yield comparable findings. The quality the diagnostic process was assessed by interviews with key staff in the health care facility. It is possible that the health workers provided socially desirable answers instead the correct answers. A study in which the actions the health workers are observed may prevent this. However, the presence an observer is also likely to change the behavior the health worker. Reviewer: Conclusions Author should conclude by giving main obstacle for TB case detection identified by the study. What is provided as conclusion is recommendation. Authors: We have changed the word conclusion in recommendation. There is not a main obstacle in the diagnostic process. To make this clear we have changed the recommendation into: The quality the diagnostic process for tuberculosis at PHC in Sidoarjo district should be improved on all levels, i.e. identification TB suspects, collection sputum samples, and examination sputum samples. Training in TB control all general nurses and the laboratory technicians that have not received training would be a good first step to enhance diagnosis TB and to improve the case detection rate. The quality the laboratory diagnosis should be more thoroughly assessed and if necessary improved.