Despite widespread popularity, text messaging has rarely been used for data collection in clinical research. This paper reports on the development, feasibility, acceptability, validity, and discriminant utility of a single item depression rating scale, delivered weekly via an automated SMS system, as part of a large randomised controlled trial.

Objective: We aim to evaluate the effectiveness of electronic reminders (ERs) to improve the response rates and time to response of postal questionnaires in a health research setting.Study Design and Setting: This pragmatic randomized controlled trial (RCT) was nested within a multicenter RCT of yoga for lower back pain. Participants who provided an electronic mail address and/or mobile phone number were randomized to receive an ER or no reminder (controls) on the day they were due to receive a follow-up questionnaire.Results: One hundred twenty-five participants (32 males and 93 females) mean age 46 (standard deviation: 11, range: 20-65) were randomized to ER (n = 62) or controls (n = 63). Overall 85.6% of participants returned postal questionnaires (87.1% ER group and 84.1% from controls). No significant differences were found between the two groups for response rate (difference between groups = 3.0%, 95% confidence interval [CI] = -10, 16; P = 0.64) or time to response after adjusting for age, gender, and treatment allocation (chi(2)([3df]) = 7.10; P = 0.07).Conclusion: In the present RCT, we found little evidence for the effectiveness of ERs to increase response rates or time to respond for the return of questionnaires in this study population group. (C) 2011 Elsevier Inc. All rights reserved.

Objective: To assess the effect of electronic reminders (ERs) on response rate and time to response for the return of postal questionnaires.Study Design and Setting: This open randomized controlled trial (RCT) was conducted at the University of York. Participants who were taking part in an established RCT and who provided an electronic mail address and/or mobile telephone number were eligible to take part in the study. The intervention group received ERs on the day they were expected to receive postal questionnaires.Results: One hundred forty-eight participants (19 male and 129 female) aged 47 +/- 11 (range, 19-65) years were studied. About 89.2% of participants returned postal questionnaires. There was no difference in questionnaire response rates in control (64 of 74 [86.5%]) vs. intervention (68 of 74 [91.9%]), groups (relative risk = 1.063, 95% confidence interval: 0.949-1.189). Median questionnaire time to response was 4 days less in the intervention group (10.0 +/- 0.2; range, 10-14 days) compared with the control group (14.0 +/- 1.4; range, 10-23 days) (chi(2)(idr) = 5.27, P = 0.022).Conclusion: ERs are useful tools for reducing participant time to response for postal questionnaires. We found little evidence for an effect of ERs on response rate for postal questionnaires. (C) 2011 Elsevier Inc. All rights reserved.

Background Proximal humeral fractures, which occur mainly in older adults, account for approximately 4 to 5% of all fractures. Approximately 40% of these fractures are displaced fractures involving the surgical neck. Management of this group of fractures is often challenging and the outcome is frequently unsatisfactory. In particular it is not clear whether surgery gives better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform this decision. Methods/Design We aim to undertake a pragmatic UK-based multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of surgical versus standard non-surgical treatment for adults with an acute closed displaced fracture of the proximal humerus with involvement of the surgical neck. The choice of surgical intervention is left to the surgeon, who must use techniques that they are fully experienced with. This will avoid 'learning curve' problems. We will promote good standards of non-surgical care, similarly insisting on care-provider competence, and emphasize the need for comparable provision of rehabilitation for both groups of patients. We aim to recruit 250 patients from a minimum of 18 NHS trauma centres throughout the UK. These patients will be followed-up for 2 years. The primary outcome is the Oxford Shoulder Score, which will be collected via questionnaires completed by the trial participants at 6, 12 and 24 months. This is a 12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment. We will also collect data for other outcomes, including general health measures and complications, and for an economic evaluation. Additionally, we plan a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial, and their baseline characteristics, treatment preferences and intended treatment. Discussion This article presents the protocol for a multi-centre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity. Trial Registration Current Controlled Trials ISRCTN50850043

Poor response rates to postal questionnaires can introduce bias and reduce the statistical power of a study. To improve response rates in our trial in primary care we tested the effect of introducing an unconditional direct payment of £5 for the completion of postal questionnaires.

BACKGROUND: Magnetic resonance imaging (MRI) of the knee for meniscus and ligament injuries is an accurate diagnostic test. Early and accurate diagnosis of patients with knee problems may prevent the onset of chronic problems such as osteoarthritis, a common cause of disability in older people consulting their GP. AIM: To assess the effect of early access to MRI, compared with referral to an orthopaedic specialist, on GPs' diagnoses and treatment plans for patients with knee problems. DESIGN OF STUDY: A multi-centre, pragmatic, randomised controlled trial. SETTING: Five hundred and fifty-three patients with knee problems were recruited from 163 general practices across the UK from November 2002 to October 2004. METHOD: Eligible patients were randomised to MRI or consultation with an orthopaedic specialist. GPs made a concomitant provisional referral to orthopaedics for patients who were allocated to imaging. GPs recorded patients' diagnoses, treatment plans, and their confidence in these decisions at trial entry and follow-up. Data were analysed as intention to treat. RESULTS: There was no significant difference between MRI and orthopaedic groups for changes in diagnosis (P = 0.79) or treatment plans (P = 0.059). Significant changes in diagnostic and therapeutic confidence were observed for both groups with a greater increase in diagnostic confidence (P<0.001) and therapeutic confidence (P = 0.002) in the MRI group. There was a significant increase in within-group changes in diagnostic and therapeutic confidence. CONCLUSION: Access to MRI did not significantly alter GPs' diagnoses or treatment plans compared with direct referral to an orthopaedic specialist, but access to MRI significantly increased their confidence in these decisions.

Objective: To test the effect of postal randomization on recruitment of patients into a randomized trial in primary care.Study Design and Setting: General practices used a telephone service to randomize patients in our trial. Delays in the start of recruitment at some sites led us to modify the randomization procedure. When new practices took part patients completed and posted baseline materials to the Trial Secretary in York who performed the randomization and informed those concerned of the allocation.Results: Of the 647 practices who were invited to take part, 130 (45%) of 288 agreed to participate using telephone randomization and 155 (43%) of 359 using the postal method. These practices recruited 553 patients from November 2002 to October 2004 across 11 sites in the United Kingdom. The postal method reduced the number of patients recruited by a factor of 0.86 (95% confidence interval = 0.62-1.20), or 14%. The number of general practitioners working in a practice significantly increased patient recruitment by a factor of 1.12 (1.05-1.20), whereas practice distance from hospital significantly decreased recruitment by a factor of 0.98 (0.97-0.99).Conclusion: Postal randomization had no significant effect on recruitment of patients into our trial. (C) 2007 Elsevier Inc. All rights reserved.

Although bilateral fimbria-fornix (FF) lesioning impairs spatial performance in animals, the literature is equivocal regarding its effects on hippocampal long-term potentiation (LTP). We examined the effects of FF lesioning on LTP induction in the Schaffer collateral-CA1 pathway in vivo with a protocol that delivered theta burst stimulation (TBS) trains of increasing length until a sufficient length was reached to induce LTP of the monosynaptic field excitatory postsynaptic potential (fEPSP). Experiments were performed in urethan-anesthetized Long-Evans rats either 4 or 12-16 wk after lesioning. In sham-operated controls, TBS trains ranging from 4 to 12 bursts were sufficient to induce robust LTP [170 +/- 10% (mean +/- SF) of control fEPSP slope; n = 8]. Four-week post -FF-lesioned animals also displayed clear LTP (167 +/- 12% of control fEPSP slope; n = 4) that did not differ from the shams (P > 0.05). In contrast, animals in the 12- to 16-wk post-lesion group showed a highly significant deficit in LTP induction (95 +/- 3% of control fEPSP slope; n = 8; < or =28 burst TBS trains tested; P < 0.001 vs. sham- and 4-wk post-FF-lesion groups). Other quantitative measures of synaptic excitability (i.e., baseline fEPSP slope and input-output relation) did not differ between the sham- and the 12- to 16-wk post-FF-lesion groups. These results indicate that the FF lesion leads to an enduring defect in hippocampal long-term synaptic plasticity that may relate mechanistically to the cognitive deficits characterized in this model.