Objective To assess whether supplementation with calcium and cholecaliferol (vitamin D 3 ) reduces the risk of fracture in women with one or more risk factors for fracture of the hip. Design Pragmatic open randomised controlled trial. Setting Practice nurse led clinics in primary care. Participants 3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight ( < 58 kg), smoker, family history of hip fracture, or fair or poor self reported health. Intervention Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group). Main outcome measures Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment, falls, and quality of life (measured with the SF-12). Results 69% of the women who completed the follow-up questionnaire at 24 months were still taking supplements (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for hip fracture was 0.75 (0.31 to 1.78). The odds of a woman having a fall at six and 12 months was 0.99 and 0.98, respectively. Quality of life did not significantly differ between the groups. Conclusion We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture. Registration ISRCTN26118436, controlled trials registry.

This study is the largest RCT of hip protectors to date and provides no evidence of an effect of hip protectors among women living independently and at high risk of fracture.

Older women with the clinical risk factors identified in this study should be investigated for osteoporosis or offered preventive treatment.

Health care and educational trials face similar methodological challenges. Methodological reviews of health care trials have shown that a significant proportion have methodological flaws. Whether or not educational trials have a similar proportion of poor-quality trials is unknown. The authors undertook a methodological comparison between health care and educational trials published since 1990. The authors aimed (1) to assess whether the quality of trial reports in education and health care are similar; and (2) to assess whether trial reporting quality is improving. The characteristics of a sample of trials, published since 1990, were taken from health and educational journals. Trials were assessed using the following quality criteria: rationale for sample size; concealment of allocation; blinded follow-up; use of confidence intervals; adequate sample size. Ninety-six placebo drug trials and 54 non-drug trials published in major general journals were identified. These were compared with 54 trials in specialist health journals and 84 trials in educational journals. No educational trial used concealed allocation or reported the rationale for sample size calculation and only one trial used confidence intervals. There was a trend for the reporting of health care trials to improve with time, whilst the reporting quality of educational trials declined. The authors concluded that poor quality of trial reporting is more prevalent in educational journals than in health care journals.

This paper reports a systematic review of the trial literature in the field of adult literacy and numeracy. The review was undertaken to investigate the effectiveness of teaching strategies and pedagogies designed to increase adult literacy and numeracy. The objectives were to search for and locate, synthesise and quality appraise all the randomised controlled trials aiming to evaluate interventions in adult literacy and/or numeracy, published between 1980 and 2002. Fifty-nine papers were included in the descriptive map. Twelve papers were included that contained nine randomised controlled trials. All of the trials included in the review were of high quality in the sense that they had adopted an appropriate study design for assessing effectiveness. However, within that study design many of the studies had methodological problems, for example: small sample size and lack of justification of sample size calculation; unclear method of random allocation; high attrition rate and lack of 'intention to teach' analysis. There was evidence of publication bias. Pooling three studies that compared teaching against no teaching showed a strong, positive and statistically significant effect on outcome. Two other studies examined the use of computerassisted instruction (CAI) on literacy among imprisoned adults. Pooling these two studies showed a modest but not statistically significant benefit. There is a dearth of rigorous RCTs in the field of adult literacy and numeracy. The evidence is suggestive of a benefit of adult literacy and numeracy interventions; however, because of the heterogeneity of studies, the precise role of any intervention is uncertain and this finding may be undermined by the presence of substantial publication bias. We recommend that a series of large, well-designed and well-conducted randomised trials should be undertaken in the field of adult literacy and numeracy.Poor adult literacy and numeracy skills are recognised as an important problem in society. Low literacy and numeracy are associated with higher unemployment and lower incomes for those in employment compared with those with higher levels of basic skills. Within the United Kingdom the publication of the Moser Report A Fresh Start (DfEE,