Can an online clinical data management service help in improving data collection and data quality in a developing country setting?

Background: Data collection by Electronic Medical Record (EMR) systems have been proven to be helpful in data collection for scientific research and in improving healthcare. For a multi-centre trial in Indonesia and the Netherlands a web based system was selected to enable all participating centres to easily access data. This study assesses whether the introduction of a Clinical Trial Data Management service (CTDMS) composed of electronic Case Report Forms (eCRF) can result in effective data collection and treatment monitoring. Methods: Data items entered were checked for inconsistencies automatically when submitted online. The data were divided into primary and secondary data items. We analysed both the total number of errors and the change in error rate, for both Primary and Secondary items, over the first five month of the trial. Results: In the first five months 51 patients were entered. The Primary data error rate was 1.6%, whilst that for Secondary data was 2.7% against acceptable error rates for analysis of 1% and 2.5% respectively. Conclusion: The presented analysis shows that after five months since the introduction of the CTDMS the Primary and Secondary data error rates reflect acceptable levels of data quality. Furthermore, these error rates were decreasing over time. The digital nature of the CTDMS, as well as the online availability of that data, gives fast and easy insight in adherence to treatment protocols. As such, the CTDMS can serve as a tool to train and educate medical doctors and can improve treatment protocols.Maarten A Wildeman, Jeroen Zandbergen, Andrew Vincent, Camelia Herdini, Jaap M Middeldorp, Renske Fles, Otilia Dalesio, Emile van der Donk, I Bing Ta

Multicenter randomized crossover trial evaluating the provox luna in laryngectomized subjects

Objectives: The aim of this study was to compare the relative compliance and the dermatological and pulmonary outcomes when the Provox Luna system (Atos Medical, Malmö, Sweden) is added during the night to the usual tracheastoma care of laryngectomized subjects. Methods: This wa

Short-Term Effect of Different Teaching Methods on Nasopharyngeal Carcinoma for General Practitioners in Jakarta, Indonesia

In Indonesia, Nasopharyngeal Carcinoma (NPC) is the most frequent cancer of the head and neck region. At first presentation in the hospital most patients already have advanced NPC. Our previous study showed that general practitioners (GPs) working in Yogyakarta, Indonesia lack the knowledge necessary for early detection of NPC. By providing training on early symptoms of NPC we hope that the diagnosis and referral will occur at an earlier stage. Here we assess the current NPC knowledge levels of GPs in Jakarta, evaluate improvement after training, compare the effectiveness of two training formats, and estimate the loss of recall over a two week period

Effectiveness of a multicentre nasopharyngeal carcinoma awareness programme in Indonesia

Objective: To evaluate the effectiveness of a nasopharyngeal carcinoma (NPC) awareness programme on the short-term and long-term improvement of knowledge and referral of patients with NPC by primary healthcare centres (PHCCs) staff in Indonesia. Design: The NPC awareness programme consisted of 12 symposia including a Train-The-Trainer component, containing lectures about early symptoms and risk factors of NPC, practical examination and the referral system for NPC suspects. Before and after training participants completed a questionnaire. The Indonesian Doctors Association accredited all activities. Participants: 1 representative general practitioner (GP) from each PHCC attended an NPC awareness symposium. On the basis of the Train-The-Trainer principle, GPs received training material and were obligated to train their colleagues in the PHCC. Results: 703 GPs attended the symposia and trained 1349 staff members: 314 other GPs, 685 nurses and 350 midwives. After the training, respondents’ average score regarding the knowledge of NPC symptoms increased from 47 points (of the 100) to 74 points (p<0.001); this increase was similar between symposium and Train-The-Trainer component (p=0.88). At 1½ years after the training, this knowledge remained significantly increased at 59 points (p<0.001). Conclusions: The initial results of this NPC awareness programme indicate that the programme effectively increases NPC knowledge in the short and long term and therefore should be continued. Effects of the improved knowledge on the stage at diagnoses of the patients with NPC will still need to be scrutinised. This awareness programme can serve as a blueprint for other cancer types in Indonesia and for other developing countries

Primary treatment results of Nasopharyngeal Carcinoma (NPC) in Yogyakarta, Indonesia

INTRODUCTION Nasopharyngeal Carcinoma (NPC) is a major health problem in southern and eastern Asia. In Indonesia NPC is the most frequent cancer in the head and neck area. NPC is very sensitive to radiotherapy resulting in 3-year disease-free and overall survival of approximately 70% and 80%, respectively. Here we present routine treatment results in a prospective study on NPC in a top referral; university hospital in Indonesia. METHODS All NPC patients presenting from September 2008 till January 2011 at the ear, nose and throat (ENT) department of the Dr. Sardjito General Hospital, Universitas Gadjah Mada, Yogyakarta, Indonesia, were possible candidates. Patients were included if the biopsy was a histological proven NPC without distant metastasis and were assessed during counselling sessions prior to treatment, as being able to complete the entire treatment. RESULTS In total 78 patients were included for treatment analysis. The median time between diagnosis and start of radiotherapy is 120 days. Forty-eight (62%) patients eventually finished all fractions of radiotherapy. The median duration of the radiotherapy is 62 days for 66 Gy. Median overall survival is 21 months (95% CI 18–35) from day of diagnosis. CONCLUSION The results presented here reveal that currently the treatment of NPC at an Indonesian hospital is not sufficient and cannot be compared to the treatment results in literature. Main reasons for these poor treatment results are (1) a long waiting time prior to the start of radiotherapy, (2) the extended overall duration of radiotherapy and (3) the advanced stage of disease at presentation.Maarten A. Wildeman, Renske Fles, Camelia Herdini, Rai S. Indrasari, Andrew D. Vincent, Maesadji Tjokronagoro, Sharon Stoker, Johan Kurnianda, Baris Karakullukcu, Kartika W. Taroeno- Hariadi, Olga Hamming-Vrieze, Jaap M. Middeldorp, Bambang Hariwiyanto, Sofia M. Haryana, I. Bing Ta

Polimerizacija, toplinska stabilnost i mehanizam razgradnje kopolimera (met)akril-dicikloheksiluree i (met)akril-diizopropiluree sa stirenom i α-metilstirenom (Polymerization, Thermal Stability and Degradation Mechanism of (Meth)acryl-Dicyclohexylurea and (Meth)acryl-Diisopropylurea Copolymers with Styrene and α-Methylstyrene)

This paper describes the polymerization of N-acryl-N,N'-dicyclohexylurea (A-DCU), N-methacryl- N,N'-dicyclohexylurea (MA-DCU) and N-methacryl-N,N'-diisopropylurea (MA-DiPrU) monomers with styrene (St) and α-methylstyrene (α-MeSt), thermal stability and degradation mechanism of prepared copolymers. Free-radical initiated polymerization was performed to low conversion by using dibenzoyl peroxyde (Bz₂O₂) in butanone at 70 °C under nitrogen stream. It was found that the pendant group in (meth)acrylic monomers have high influence to the polymerization as well as to the copolymer properties. A-DCU readily homopolymerized and copolymerized with St and r_1,A-DCU = 0.72 and r_2,α-MeSt= 0.07, while MA-DCU does not homopolymerized or copolymerized with α-MeSt under the same conditions, but copolymerized with St to randomly composed copolymers after a long heating of comonomers. Copolymers A-DCU with α-MeSt prepared under different monomer-to monomer-ratios in the feed have random composition with an azeotropic point at ratio of 0.75 (A-DCU) to 0.25 (St). The initial rate of copolymerization indicates that the rate increases almost linearly with the increase of ratio of A-DCU in the comonomer feed. Reactivity ratios determined by the Kelen-Tüdös method are: r_1,A-DCU = 0.72 and r_2,α-MeSt = 0.07. Molar mass of copolymers increased from 8.5 to 30 (kg mol^-1) when mole ratio of A-DCU to α-MeStin the feed increased from 0.1 to 0.9. Poly(A-DCU) and copolymers with α-MeSt decomposed by two-step mechanism. Under TGA (nitrogen,10 °C min^-1) conditions in the first step between 180 °C and 250 °C a quantitative yield of cyclohexylisocyanate (C₆H₁₁NCO) separated by a decomposition of dicyclohexylurea (DCU). The thermally stable residue represented poly(acryl-cyclohexylamide), poly(A-CHA), and copolymer with α-MeSt, poly(A-CHA-co-α-MeSt). Glass transition temperature (T_g) of poly(A-DCU) was at 184 °C and T_g of residue, poly(A-CHA), was at 161 °C. T_g's of the copolymers are higher for the copolymer with higher A-DCU content. T_g's of residue are increased also when the content of A-CHA in copolymer increased. Copolymers of A-DCU with St have a random composition with an azeotropic point at a ratio of 0.73 (A-DCU) to 0.27 (St). The rate of copolymerization of A-DCU with St increases by the increase of A-DCU in the feed. The reactivity ratio are: r_1,A-DCU = 0.80 and r_{2, St} = 0.50. Molar mass of copolymer, prepared at equimolar ratio of monomers in the feed, is Mw = 78.6 kg/mol^-1. These copolymers decompose in TGA conditions by two-step mechanism, which correspond to the mechanism explained for the copolymers of A-DCU with α-MeSt. MA-DCU copolymerized with St to randomly composed copolymers. The reactivity ratio determined by the KT method are: r_{1, MA-DCU} = 0.18 and r_{2, St} = 4.84. These values indicate that MA-DCU favors cross-propagation over homopolymerization, while St favors homopolymerization as opposite to cross-propagation. It also shows, that since St is more reactive than MA-DCU, copolymers contain a higher proportion of St units. It was found, that the rate of copolymerization of MA-DCU with St is slower than the rate of copolymerization of A-DCU with St, and that the rate of copolymerization decreases by increasing the amount of MA-DCU in the feed. Molar mass of copolymer prepared at equimolar ratios of comonomers in the feed is Mw=12 kg mol^-1. Thermal properties of poly(MA-DCU-co-St) are similar to those previously described in the decomposition of poly[A-DCU-co-St(α-MeSt)]. The results have also shown quite a big influence of DiPrU group in MA-iPrU to the polymerization with St and α -MeSt. Namely, MA-DiPrU does not homopolymerized or copolymerized with α -MeSt, but can polymerize with St only after a long heating of comonomers at 70 °C. The copolymerization of MA-DiPrU with St is a statistical reaction in which regardless of monomer-tomonomer ratios in the feed, an excess of St was in the copolymer. The reactivity ratios (KT method) are: r_{1, MA-DiPrU} = 0.39 and r_{2, St}= 1.03. The obtained data indicate a monomer tendency to alternating structure. The initial rate of copolymerization decreases with increasing the content of MA-DiPrU monomer in the feed. Molar mass of all copolymers are approximately of the same values, Mw = 12 - 8 kg mol^-1 and Mn = 8.7 - 6.2 kg mol<sup>-1<sup>. Thermal behavior of those copolymers correspond to the behavior of acrylic and methacrylic polymers containing DCU as pendant group. Namely, all copolymers decompose under TGA conditions by a two-step mechanism. In the first step between 180 °C and 250 °C isopropylisocyanate (C₃H₇NCO) separates by degradation of diisopropylurea (DiPrU) in the side chain. The thermally stable residue represents the copolymer of methacryl-isopropylamide with St, which decompose by one-step mechanism between 280 °C and 450 °C

Phase behaviour in blends of poly[styrene-co-ortho(para)-bromostyrene] and phenylsulfonated poly(2,6-dimethyl-1,4-phenylene oxide) copolymers

Random copolymers of styrene with ortho- or para-bromostyrene differ substantially in their blend behaviour with partly sulfonylated poly(2,6-dimethyl-l,4-phenylene oxide) (SPPO). Copolymers of styrene with ortho­bromostyrene exhibit a very narrow window of miscibility in comparison with styrene-para-bromostyrene copolymer blends with SPPOs. The experimental results can be accounted for on the basis of individual segmental interaction parameters by applying mean-field theory

A multiplex PCR predictor for aCGH success of FFPE samples.

Formalin-fixed, paraffin-embedded (FFPE) tissue archives are the largest and longest time-spanning collections of patient material in pathology archives. Methods to disclose information with molecular techniques, such as array comparative genomic hybridisation (aCGH) have rapidly developed but are still not optimal. Array comparative genomic hybridisation is one efficient method for finding tumour suppressors and oncogenes in solid tumours, and also for classification of tumours. The fastest way of analysing large numbers of tumours is through the use of archival tissue samples with first, the huge advantage of larger median follow-up time of patients studied and second, the advantage of being able to locate and analyse multiple tumours, even across generations, from related individuals (families). Unfortunately, DNA from archival tissues is not always suitable for molecular analysis due to insufficient quality. Until now, this quality remained undefined. We report the optimisation of a genomic-DNA isolation procedure from FFPE pathology archives in combination with a subsequent multiplex PCR-based quality-control that simply identified all samples refractory to further DNA-based analyses