Central pathology review in multicenter trials and studies

BACKGROUND:

Central pathology review (CPR) is an important component of multicenter tumor trials. The authors retrospectively analyzed the quality of pathology material submitted to determine the benefits and limitations of rapid CPR.

METHODS:

Analysis of pathology specimens from previous renal tumors in children trials (1980‐2007) included the number of cases submitted, the number of slides per case, discrepancies in diagnosis and staging between institutional pathologists and CPR, and the impact of rapid CPR on treatment.

RESULTS:

The percentage of cases submitted for CPR increased from 76% in earlier trials to 100% in the current trial. The number of slides submitted rose from a median of 6 (International Pediatric Oncology Society [SIOP] 9301) to 25 for the SIOP‐UK Renal Tumors 2001 trial. Discrepancies between the institutional pathologists and CPR were as follows: diagnosis: SIOP 9, 17%; SIOP 93‐01, 14%; United Kingdom Wilms Tumour 3 Trial (UKWT3), 3.5%; SIOP‐UK 2001, 3.8%; staging: SIOP 6, 9%; SIOP 93‐01, 14%; UKWT3, 17%; SIOP‐UK 2001, 3.8% of cases. There were clinically significant discrepancies in diagnosis and/or stage in 30 of 152 (20%) cases submitted for delayed CPR in SIOP‐UK 2001.

CONCLUSIONS:

The number and quality of material submitted for CPR has markedly improved over time, predominantly due to the introduction of a simple standard operating procedure. Discrepancies in diagnosis and staging remain, but rapid review CPR allows clinicians to modify treatment if required. Benefits from the CPR system followed in SIOP‐UK 2001 have been clearly demonstrated, and similar systems should be considered for future trials of other tumors. Cancer 2009. © 2009 American Cancer Society.     

Tongue somatosensory-evoked potentials in microvascular decompression treated trigeminal neuralgia

Somatosensory-evoked potentials of the tongue (tSSEP) provide useful information about trigeminal-afferent pathway. The aim of this study was to evaluate tSSEP in trigeminal neuralgia (TN) treatment with microvascular decompression. Two patients with trigeminal neuralgia refractory to conservative treatment underwent microvascular decompression of the trigeminal nerve. tSSEP was performed a month prior to surgery and in the month after the surgery in both patients. Pain frequency and tSSEP were analyzed before and after surgery. In both patients, a complete resolution of pain occurred. In patient 1, tSSEP latencies became shorter than before surgery and wave N1 appeared. The intensity of stimulation necessary to reach the threshold was 4 mA before the surgery and 1 mA after the surgery. A complete recovery of tSSEP after the operation was achieved in patient 2. The results of present study demonstrate potential value of tSSEP in pre-surgery evaluation and post-surgery follow-up of TN patients.     

Diffusion of complex health innovations--implementation of primary health care reforms in Bosnia and Herzegovina

Most transition countries in Central and Eastern Europe and Central Asia are engaged in health reform initiatives aimed at introducing primary health care (PHC) centred on family medicine to enhance performance of their health systems. But, in these countries the introduction of PHC reforms has been particularly challenging; while some have managed to introduce pilots, many have failed to these scale up. Using an innovation lens, we examine the introduction and diffusion of family-medicine-centred PHC reforms in Bosnia and Herzegovina (BiH), which experienced bitter ethnic conflicts that destroyed much of the health systems infrastructure. The study was conducted in 2004-05 over a 18-month period and involved both qualitative and quantitative methods of inquiry. In this study we report the findings of the qualitative research, which involved in-depth interviews in three stages with key informants that were purposively sampled. In our research, we applied a proprietary analytical framework which enables simultaneous and holistic analysis of the context, the innovation, the adopters and the interactions between them over time. While many transition countries have struggled with the introduction of family-medicine-centred PHC reforms, in spite of considerable resource constraints and a challenging post-war context, within a few years, BiH has managed to scale up multifaceted reforms to cover over 25% of the country. Our analysis reveals a complex setting and bidirectional interaction between the innovation, adopters and the context, which have collectively influenced the diffusion process. Family-medicine-centred PHC reform is a complex innovation-involving organizational, financial, clinical and relational changes-within a complex adaptive system. An important factor influencing the adoption of this complex innovation in BiH was the perceived benefits of the innovation: benefits which accrue to the users, family physicians, nurses and policy makers. In the case of BiH, policies or the innovation are not simply disseminated, but rather assimilated into the health system. The assimilation and implementation of the new PHC model relied on the consensus of a diverse group of adopters; the changes brought by the reforms were aligned with the expectations of the adopters: this created a 'receptive context' for adoption and diffusion of the innovation. The new family-medicine-centred PHC service model had a major impact on professional identity, inter-professional relationships and organizational routines. The post-conflict context was perceived as an opportunity to introduce the new model and implement transformational change, while the complex government structure meant the process of diffusion was as important as the innovation itself. In BiH, a holistic approach-comprising multifaceted and simultaneous interventions at multiple levels of the health system-reduced 'policy resistance' and enhanced the adoption and diffusion of the PHC reforms.     

Surface characteristics and lesion depth and activity of suspicious occlusal carious lesions: Findings from The National Dental Practice-Based Research Network

Background

A lesion on an occlusal tooth surface with no cavitation and no radiographic radiolucency but in which caries is suspected owing to surface roughness, opacities, or staining can be defined as a suspicious occlusal carious lesion (SOCL). The authors' objective was to quantify the characteristics of SOCLs and their relationship to lesion depth and activity after these lesions were opened surgically.