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Rationale, aims and objectives Open-label extension (OLE) studies following blinded randomized controlled trials (RCTs) of pharmaceuticals are increasingly being carried out but do not conform to regulatory standards and questions surround the validity of their evidence. OLE studies are usually discussed as a homogenous group, yet substantial differences in study design still meet the definition of an OLE. We describe published papers reporting OLE studies focussing on stated objectives, design, conduct and reporting. Method A search of Embase and Medline databases for 1996 to July 2008 revealed 268 papers reporting OLE studies that met our eligibility criteria. A random sample of 50 was selected for detailed review. Results Over 80% of the studies had efficacy stated as an objective. The most common methods of allocation at the start of the OLE were for all RCT participants to switch to one active treatment or for only participants on the new drug to continue, but in three studies all participants were re-randomized at the start of the OLE. Eligibility criteria and other selection factors resulted in on average of 74% of participants in the preceding RCT(s) enrolling in the OLE and only 57% completed it. Conclusions Published OLE studies do not form a homogenous group with respect to design or retention of participants, and thus the validity of evidence from an OLE should be judged on an individual basis. The term 'open label' suggests bias through lack of blinding, but slippage in relation to the sample randomized in the preceding RCT may be the more important threat to validity. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: The potential bias introduced by surgeons' lack of comparable, relevant experience when performing the procedures in different arms of randomized controlled trials (RCTs) is arguably not well‐managed or reported. The aim of this work was to review the frequency and nature with which surgeons' relevant experience is reported in RCTs of total hip (THA) and total knee arthroplasty (TKA), and to relate this to other risk of bias domains for this study design. Methods: A systematic review of RCTs comparing different minimally invasive procedures for TKA and comparisons of THA and hemiarthroplasty (HA). We searched MEDLINE, EMBASE, Science Citation Index, The Cochrane Library, Conference Proceedings Citation Index‐Science (CPCI‐S), Current Controlled Trials, and Clinical Trials.gov. Results: Seventy‐five relevant RCTs were identified, 65 RCTs comparing minimally invasive with standard or other minimally invasive approaches to TKA, and 10 for THA compared with HA. Risk of bias based on the reported details of surgeons' relevant experience was categorized as low, high, or unclear. There was a clear distinction before and after 2009, with a substantial decrease in trials at high or unclear risk of bias after this date. There were no strong associations between this domain and other, standard risk of bias domains for RCTs. Conclusion: The surgeons' relevant experience in an evaluated procedure is often poorly reported but has improved since 2009. The variable is not adequately captured by any other risk of bias domain. Future work should concentrate on conducting research on a much larger sample of studies and in procedures other than knee and hip arthroplasty. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Systematic reviews, meta-analyses and clinical guidelines (reviews) are intended to inform clinical practice, and in this sense can be thought of as scientific truthmakers. High-quality controlled trials should align to this truth, and method quality markers should predict truth status. We sought to determine in what way controlled trial quality relates to scientific truth, and to determine predictive utility of trial quality and bibliographic markers. Method A sample of reviews in rehabilitation medicine was examined. Two scientific truth dimensions were established based on review outcomes. Quality and bibliographic markers were extracted from associated trials for use in a regression analysis of their predictive utility for trial truth status. Probability analysis was undertaken to examine judgments of future trial truth status. Results Of the 93 trials included in contemporaneous reviews, overall, n = 45 (48%) were true. Randomization was found more in true trials than false trials in one truth dimension ( P = 0.03). Intention-to-treat analysis was close to significant in one truth dimension ( P = 0.058), being more commonly used in false trials. There were no other significant differences in quality or bibliographic variables between true and false trials. Regression analysis revealed no significant predictors of trial truth status. Probability analysis reported that the reasonable chance of future trials being true was between 2 and 5%, based on a uniform prior. Conclusions The findings are at odds with what is considered gold-standard research methods, but in line with previous reports. Further work should focus on scientific dynamics within healthcare research and evidence-based practice constructs. [ABSTRACT FROM AUTHOR]

Rationale The prevention of human immunodeficiency virus/sexually transmitted diseases remains a significant global public health issue, especially among vulnerable populations. Aims and objectives To promote condom use skills among young urban African American men. Methods As a pilot study, a randomized controlled trial was conducted among 136 African American men aged 18-24 years recruited from urban communities in Chicago. Participants assigned to the intervention received 45-60 minutes of a one-on-one single-session condom promotion program delivered by trained facilitators while those assigned to the attention-matched comparison condition received a general health program. Longitudinally, 115 (85%) and 120 (88%) participants completed the 3-month and 6-month follow-up surveys, respectively. Results Overall, the study results indicate that positive effects were observed from baseline to 6-month follow-up for intervention participants relative to comparison condition participants for prior condom use (1.23-1.82 versus 1.34-0.97); condom use intention (2.51-3.19 versus 2.69-2.21); perceived condom availability (3.44-3.72 versus 3.42-3.38); positive reasons to use condoms (2.82-3.08 versus 2.95-1.99); favourable condom use attitude (2.41-2.69 versus 2.49-1.95); barriers to condom use (1.33-0.79 versus 1.25-1.85); and negative condom use attitude (1.45-0.66 versus 1.33-1.39), respectively. Conclusions We conclude that a brief single-session condom promotion program is effective in preventing high-risk sexual behaviours among urban young adult African American men. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Medication-prescribing errors with adverse drug events impose substantial harms on patients and health systems. Medication errors resulting in preventable adverse drug events most commonly occur at the ordering stage. Electronic prescribing may prevent such errors but its impact has not been rigorously evaluated. Methods We conducted a pragmatic cluster randomized controlled trial in academic hospital ambulatory clinics to evaluate the effects of a commercially available electronic prescribing software system on total prescription error ratio. Secondary outcomes included the number of callbacks for clarification from community pharmacies to physicians' clinics. Results Twenty-six physicians used the electronic prescribing system, writing 1980 prescriptions during 44 intervention weeks when the electronic prescribing system was available (7.6% of these were electronic, the remainder handwritten) and 973 prescriptions during 22 control weeks while the system was switched off (1.4% electronic, prescribed in the previous intervention week, but issued with delay). The total prescription error rate was 118/1980 (6.0%) in intervention weeks and 57/973 (5.9%) in control weeks ( P = 0.91). During the intervention period more callbacks requesting clarification were made to clinic administrators ( n = 83, 1.89 per week) than during control weeks ( n = 32, 1.45 per week; P < 0.001). Conclusion Implementation of the electronic prescribing system had no impact on total prescription error, and increased the callback rate. In spite of intensive user support, few prescriptions in intervention weeks were made using the electronic system. Given the costs, training requirements, workflow redesigns and regulatory hurdles, additional evaluations of outpatient prescribing on clinically important outcomes are needed. [ABSTRACT FROM AUTHOR]