Scientific quality of clinical research an analysis of 40 research projects in pharmacology/pharmacotherapy

Objective: The scientific quality of research is an important ethical issue. To clarify the quality of research projects in pharmacotherapy/pharmacology, 40 randomly selected research projects in pharmacotherapy/pharmacology submitted to a research ethics committee were reviewed. Results: Eight of the projects would not have contributed new knowledge nor were they necessary as controls for the results of previous research. Fifteen of the research protocols were of good quality, 15 could be used after revisions, and 10 were unfit for use. Eleven of the research projects were not finished 5 years after they were started. A written report was produced from 26 of the projects. Nine were of good quality and could be accepted for publication in a medical journal, 10 of the reports were in need of revision before publication, and 7 should not be accepted for publication. Conclusion: Research in this field ought to be improved, and ways to improve the standard of clinical trials in pharmacotherapy are dicussed. Received: 1 April 1996 / Accepted in revised form: 28 June 1996     

Medical management of chronic pancreatitis

慢性胰腺炎的临床表现包括疼痛、脂肪泻和糖尿病。在西方国家，慢性胰腺炎最常见的病因是酗酒。70％以上的病人在就诊时有疼痛的临床表现，而且，这些患者中又有75％以上会在几年之后出现疼痛减轻或完全消失。对于所有的慢性胰腺炎的病人来说，均应排除非胰源性疼痛和胆道梗阻、胰腺假性囊肿等胰腺局部并发症。应建议所有慢性胰腺炎病人戒烟、戒酒。阿片类镇痛剂仅应用于治疗疼痛严重的病人。尽管有报道认为胰酶替代治疗有助于止痛，但是，对于已经确诊的慢性胰腺炎病人来说，该疗法无效。激素类药物进行腹腔神经丛阻滞术可能有助于病人度过剧烈疼痛期。顽固性疼痛是进行胰液引流或胰腺切除的适应证。建议应用适量胰酶替代联合(或不联合)制酸剂治疗营养不良。慢性胰腺炎导致的糖尿病与原发性糖尿病的治疗原则相似。     

Pilot efficacy and tolerability: a randomized, placebo-controlled trial of levetiracetam for essential tremor.

The purpose of this pilot single-site study was to assess efficacy and safety of levetiracetam for essential tremor, using a placebo-controlled, double-blind, randomized crossover design with an interim analysis planned after completion of the first 10 to 15 subjects. The study was designed to detect a mean 30% reduction in composite tremor score, comparable to that of primidone or propranolol, which can be demonstrated with 30 or fewer subjects. Each treatment arm included baseline tremor assessments, a 4-week medication titration, 2 weeks of stable dose, and treatment tremor assessments. Levetiracetam was titrated to 3,000 mg/day or to a lower maximal tolerated dose. The median age was 72 years, with 28 years median tremor duration. There was no statistically significant difference in response between placebo and levetiracetam on any tremor rating scale or accelerometry measure. The 95% confidence interval for the true mean difference between placebo and levetiracetam treatments was +18.5 to -22.5%, which excludes the minimum 30% drop required to consider levetiracetam clinically effective to a degree comparable to primidone or propranolol. Whether levetiracetam has lesser-degree antitremor efficacy was not addressed in this pilot study.     

Clinical evaluation of a potassium nitrate dentifrice for the treatment of dentinal hypersensitivity

Abstract The effectiveness of a 5% potassium nitrate dentifrice as a daily home treatment for dentinal hypersensitivity was evaluated in a double-blind study in 36 Japanese subjects who complained of cold and/or tactile hypersensitivity. The subjects were divided into 2 groups, with 18 being given a 5% potassium nitrate dentifrice (treated group) and the other 18 a vehicle paste (control group). Both groups were instructed to brush their teeth 2 × a day. The hypersensitivity levels of the affected teeth were assessed by 2 stimuli, one tactile and the other cold air, and by the perception of pain. The results of all 3 assessment methods indicated that the potassium nitrate dentifrice significantly decreased the level of hypersensitivity at weeks 4, 8, and 12. In the treated group, a rapid decrease of positive scores for both the cold air stimulus and the subjective symptoms appeared from week 2. Although a significant decrease of the assessment score was also observed in the control group, the reduction rate of the score was much greater in the treated group by ail 3 assessment methods at weeks 4, 8, and 12. Complete relief of subjective symptoms throughout the 12 weeks’examination was noted in 67% of the subjects in the treated group, but in only 6% in the control group. These results suggest the usefulness of a 5% potassium nitrate dentifrice in Japanese patients with dentinal hypersensitivity.     

Eight years'' experience with a structured clinical examination

A structured clinical examination has been an integral component of the final-year examinations conducted by the Departments of Medicine and Surgery at the University of Adelaide for the last 8 years. It has been used as an alternative to the traditional clinical examination. This paper describes the results of ongoing student and examiner surveys carried out to determine their views and satisfaction with this new approach. It also briefly discusses the feasibility of introducing such an examination into a conventional medical school environment. The surveys showed a remarkable level of acceptance and support by both students and examiners. This positive reaction has been maintained over the 8-year period. The main reasons seem to be its perceived relevance and fairness. Students also appear to be directing their learning in a direction thought desirable by teachers. No significant problems have been encountered with the practical implementation of the method.     

Periodontal status of a subject sample of Yemen

Abstract From August to October 1991, the periodontal status of 1001 Yemenis representing the age groups 12-14, 15-19, 20-24 and 35-44 years was recorded and evaluated with preference to the CPITN, the calculus index and clinical attachment levels. The impact of chewing khat, the leaves of a cultivated, alkaloid shrub, and of using the traditional miswak chewing stick for oral hygiene purposes were investigated. The results show that 6.9% of the juvenile probands (15-19 years) had healthy periodontal tissue (CPITN 0). whereas bleeding on probing and calculus (CPITN 1+2) were registered in 86.2%. In the 35-44 year age group. 1.7% were periodontally healthy, whereas 84.5% displayed plaque retention or shallow pocketing (CPITN 2-3) and 12.5% deep pocketing (CPITN 4). The treatment needs in all age groups are confined primarily to calculus removal and instruction in oral hygiene. The clinical attachment level and the calculus index revealed age-related attachment loss and calculus formation, primarily among male probands. The higher khat consumption among the male population is reflected in its detrimental effect on the periodontal tissue, especially among younger probands. Oral hygiene aids have also an influence on periodontal status, with a toothbrush proving more efficient than the miswak. WHO efforts directed towards prophylactic programs need to be intensified but can be staffed by dental hygienists.     

Quantitative assessment of diagnostic ability

This paper describes variables critical to diagnostic thinking that are based on research by Bordage and Grant & Marsden on the diagnostic thinking of medical students and experienced doctors. The purpose of the study is to use their findings to develop an inventory of diagnostic thinking. A 56-item diagnostic thinking inventory was initially developed; each item contains a stem followed by a 6-point, semantic differential scale. The inventory is designed to measure two aspects of diagnostic thinking: the degree of flexibility in thinking and the degree of knowledge structure in memory. The specific goal of the study is to determine which items discriminate best between weaker and stronger diagnosticians and to reduce the inventory to only those items which significantly contribute to the overall score. Thirty subjects from nine groups, each representing a distinct phase of medical education and clinical practice, participated, namely first- and third-year clinical medical students, house officers, senior house officers, registrars, senior registrars, consultants, trainees in general practice, and general practitioners, all from the UK (n = 270). Discrimination indices were calculated for each item. The revised version of the inventory contains 41 items. All the subjects found the exercise meaningful and the resulting scores showed variance and discrimination. The inventory will eventually be used to assess individual student's and clinician's diagnostic thinking and to plan ways of improving their diagnostic thinking.     

Undergraduate medical education in obstetrics and gynaecology in the USA and Canada, 1985

Many factors have led to a movement from the emphasis of the 1960s and 1970s on departmental expansion towards an emphasis on cost-effective undergraduate medical education emphasizing the 'art' as well as the 'science' of medicine. In January 1985 a questionnaire was sent under the auspices of the Undergraduate Education Committee of the Association of Professors of Obstetrics and Gynecology to all chairmen of departments of obstetrics and gynecology in the USA and Canada seeking their opinions about these trends and information about the educational programmes in their departments. The information from this study indicates that the chairmen are aware of and responding to this new direction in medical education. A stabilization of teaching staff and clerkship sizes and the emphasis on clinical as well as cognitive evaluation, despite recognition of the cost of the former, shows active interventions towards these ends. An emphasis on education in 'basic' as compared to 'subspecialty' areas which is independent of the subspecialty of the academic chairman also supports this trend.     

Quality of life assessment and HIV infection: A review

In the last few years, survival of patients infected with human immunodeficiency virus (HIV) has been improved because of a decreased incidence of some opportunistic complications attributable to prophylactic treatments and antiretroviral drugs. The impact of these agents should also be reflected in the quality of life (QoL) of patients. We have reviewed this topic with an emphasis on different types of measurements such as Q-TWIST, MOS and the Spitzer score which seem to be most appropriate for this patient population. We do not think that a special type of assessment should be designed for HIV-infected persons. It would be less time-consuming to improve already existing validated scores focusing on HIV infection. QoL in intravenous drug users with HIV should be evaluated more often.