Introducing Vi polysaccharide typhoid fever vaccine to primary school children in North Jakarta, Indonesia, via an existent school-based vaccination platform

OBJECTIVES: To report results on coverage, safety and logistics of a large-scale, school-based Vi polysaccharide immunization campaign in North Jakarta. METHODS: Of 443 primary schools in North Jakarta, Indonesia, 18 public schools were randomly selected for this study. Exclusion criteria were fever 37.5 degrees C or higher at the time of vaccination or a known history of hypersensitivity to any vaccine. Adverse events were monitored and recorded for 1 month after immunization. Because this was a pilot programme, resource use was tracked in detail. RESULTS: During the February 2004 vaccination campaign, 4828 students were immunized (91% of the target population); another 394 students (7%) were vaccinated during mop-up programmes. Informed consent was obtained for 98% of the target population. In all, 34 adverse events were reported, corresponding to seven events per 1000 doses injected; none was serious. The manufacturer recommended cold chain was maintained throughout the programme. CONCLUSIONS: This demonstration project in two sub-districts of North Jakarta shows that a large-scale, school-based typhoid fever Vi polysaccharide vaccination campaign is logistically feasible, safe and minimally disruptive to regular school activities, when used in the context of an existing successful immunization platform. The project had high parental acceptance. Nonetheless, policy-relevant questions still need to be answered before implementing a widespread Vi polysaccharide vaccine programme in Indonesia.     

Implementation of good clinical practice guidelines in vaccine trials in developing countries

The practicalities when applying the ICH GCPs (International Conference on Harmonization 1996 Good Clinical Practices [EU, MHLW, FDA. International Conference on Harmonization Guideline for Good Clinical Practice; 1997] in less developed countries (ldcs) are seldom discussed and we found no guidelines as how to "adapt" them. Below we illustrate how ICH GCP principles can be implemented in different settings. We have recently conducted in Asia (Hechi, China; Karachi, Pakistan; Hue, Vietnam; North Jakarta, Indonesia and Kolkata, India) large-scale cluster-randomized effectiveness evaluations of the Vi polysaccharide typhoid fever vaccine (Vi PS project) among approximately 200,000 individuals(1)[Acosta CJ, Galindo CM, Ali M, Abu-Elyazeed R, Ochiai RL Danovaro-Holliday MC et al. A multi-country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: rationale and design. TMIH 2005;10(12):1219-1228]. There is no doubt on the importance of ICH GCP in its contribution to ethical and scientifically sound clinical research. However, when the ICH GCP is implemented in ldcs some considerations must be made in order to adequately tailor them. Vaccine trials in ldcs are a frequent setting for such challenges because of the increased global interest conducting health research in such countries. The ICH GCP principles are discussed below within the framework of this recent typhoid fever vaccine study experience.     

Traumatic Allogenic Bone Implantation

Abstract   Traumatic allogenic bone implantation is becoming increasingly common in the setting of road trauma and suicide bombings. We present a unique case where a large bony fragment from one individual became embedded in the arm of another person following a “head-on” collision involving two motorbikes. Several management issues are outlined.     

Correction: The burden of diarrhoea, shigellosis, and cholera in North Jakarta, Indonesia: findings from 24 months surveillance

This is a correction of an earlier published article.     

A multi-country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: rationale and design

Phase-III vaccine efficacy trials typically employ individually randomized designs intended to ensure that measurements of vaccine protective efficacy reflect only direct vaccine effects. As a result, decisions about introducing newly licensed vaccines into public health programmes often fail to consider the substantially greater protection that may occur when a vaccine is deployed in public health programmes, due to the combination of direct plus indirect vaccine protective effects. Vaccine total protection can be better evaluated with cluster randomized trials. Such a design was considered to generate policy relevant data to accelerate the rationale introduction of the licensed typhoid fever Vi polysaccharide (PS) vaccine in Asia by the Diseases of the Most Impoverished (DOMI) typhoid fever programme. The DOMI's programme multi-country study is one of the largest cluster randomized vaccine trials ever mounted in Asia, which includes approximately 200,000 individuals. Its main objective is to determine the effectiveness of a licensed Vi PS vaccine. The rationale and design of this study are discussed. Preliminary results are presented that determined the final planning of the trial before immunization. Important methodological and practical issues regarding vaccine cluster randomized designs are illustrated.     

Sacral chordoma: clinical experience of a series of 11 patients over 18 years

European Journal of Orthopaedic Surgery & Traumatology - Sacral chordoma are rare low-to-intermediate grade malignant tumours that occur most commonly within the sacrum. Sacrectomy with wide...     

Clinical and radiological outcomes of open versus minimally invasive transforaminal lumbar interbody fusion

Study design

Prospective observational cohort study.

Objective

Comparison of clinical and radiological outcomes of single-level open versus minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF) at 6 months and 2-year follow-up.

Summary of background data

There is recognition that more data are required to ascertain the benefits and risks of MIS vis-a-vis open TLIF. This study aims to report on one of the largest currently available series comparing the clinical and radiological outcomes of the two procedures with a minimum follow-up of 2 years.

Methods

From January 2002 to March 2008, 144 single-level open and MIS TLIF were performed at our centre, with 72 patients in each group. Clinical outcomes were based on patient-reported outcome measures recorded at the Orthopaedic Diagnostic Centre by independent assessors before surgery, at 6 months and 2 years post-operatively. These were visual analogue scores (VAS) for back and leg pain, Oswestry disability index (ODI), short form-36 (SF-36), North American Spine Society (NASS) scores for neurogenic symptoms, returning to full function, and patient rating of the overall result of surgery. Radiological fusion based on the Bridwell grading system was also assessed at 6 months and 2 years post-operatively by independent assessors.

Results

In terms of demographics, the two groups were similar in terms of patient sample size, age, gender, body mass index (BMI), spinal levels operated, and all the clinical outcome measures (p > 0.05). Perioperative analysis revealed that MIS cases have comparable operative duration (open: 181.8 min, MIS: 166.4 min, p > 0.05), longer fluoroscopic time (open: 17.6 s, MIS: 49.0 s, p < 0.05), less intra-operative blood loss (open: 447.4 ml, MIS: 50.6 ml, p < 0.05) and no post-operative drainage (open: 528.9 ml, MIS: 0 ml, p < 0.05). MIS patients needed less morphine (open: 33.5 mg, MIS: 3.4 mg, p < 0.05) and were able to ambulate (open: 3.4 days, MIS: 1.2 days, p < 0.05) and be discharged from hospital earlier (open: 6.8 days, MIS: 3.2 days, p < 0.05). At 6 months, clinical outcome analysis showed both groups improving significantly (>50.0 %) and similarly in terms of VAS, ODI, SF-36, return to full function and patient rating (p > 0.05). Radiological analysis showed similar grade 1 fusion rates (open: 52.2 %, MIS: 59.4 %, p > 0.05) with small percentage of patients developing asymptomatic cage migration (open: 8.7 %, MIS: 5.8 %, p > 0.05). One major complication (open: myocardial infarction, MIS: screw malpositioning requiring subsequent revision) and two minor complications in each group (open: pneumonia and post-surgery anemia, MIS: incidental durotomy and pneumonia) were noted. At 2 years, continued improvements were observed in both groups as compared to the preoperative state (p > 0.05), with 50.8 % of open and 58 % of MIS TLIF patients returning to full function (p > 0.05). Almost all patients have Grade 1 fusion (open: 98.5 %, MIS: 97.0 %, p > 0.05) with minimal new cage migration (open: 1.4 %, MIS: 0 %, p > 0.05).

Conclusions

MIS TLIF is a safe option for lumbar fusion, and when compared to open TLIF, has similar operative duration, good clinical and radiological outcomes, with additional significant benefits of less perioperative blood loss and pain, earlier rehabilitation, and a shorter hospitalization.     

Physician's knowledge,attitudes, and practices regarding seasonal influenza,pandemic influenza,and highly pathogenic avian influenza A (H5N1) virus infections of humans in Indonesia

Indonesia has reported highest number of fatal human cases of highly pathogenic avian influenza (HPAI) A (H5N1) virus infection worldwide since 2005. There are limited data available on seasonal and pandemic influenza in Indonesia. During 2012, we conducted a survey of clinicians in two districts in western Java, Indonesia, to assess knowledge, attitudes, and practices (KAP) of clinical diagnosis, testing, and treatment of patients with seasonal influenza, pandemic influenza, or HPAI H5N1 virus infections. Overall, a very low percentage of physician participants reported ever diagnosing hospitalized patients with seasonal, pandemic, or HPAI H5N1 influenza. Use of influenza testing was low in outpatients and hospitalized patients, and use of antiviral treatment was very low for clinically diagnosed influenza patients. Further research is needed to explore health system barriers for influenza diagnostic testing and availability of antivirals for treatment of influenza in Indonesia.