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1.  The Oxford Implementation Index: A new tool for incorporating implementation data into systematic reviews and meta-analyses 
Journal of clinical epidemiology  2013;66(8):874-882.
This article presents a new tool that helps systematic reviewers extract and compare implementation data across primary trials. Currently, systematic review guidance does not provide guidelines for the identification and extraction of data related to the implementation of underlying interventions.
Study Design and Setting
A team of systematic reviewers used a multi-staged consensus development approach to develop this tool. First, a systematic literature search on the implementation and synthesis of clinical trial evidence was performed. The team then met in a series of subcommittees to develop an initial draft index. Drafts were presented at several research conferences and circulated to methodological experts in various health-related disciplines for feedback. The team systematically recorded, discussed, and incorporated all feedback into further revisions. A penultimate draft was discussed at the 2010 Cochrane-Campbell Collaboration Colloquium to finalise its content.
The Oxford Implementation Index provides a checklist of implementation data to extract from primary trials. Checklist items are organised into four domains: intervention design, actual delivery by trial practitioners, uptake of the intervention by participants, and contextual factors. Systematic reviewers piloting the index at the Cochrane-Campbell Colloquium reported that the index was helpful for the identification of implementation data.
The Oxford Implementation Index provides a framework to help reviewers assess implementation data across trials. Reviewers can use this tool to identify implementation data, extract relevant information, and compare features of implementation across primary trials in a systematic review. The index is a work in progress, and future efforts will focus on refining the index, improving usability, and integrating the index with other guidance on systematic reviewing.
PMCID: PMC3746185  PMID: 23810026
systematic review; implementation; heterogeneity; generalisability; randomised controlled trial; reporting guideline
2.  Factors influencing mammography participation in Canada: an integrative review of the literature 
Current Oncology  2009;16(5):65-75.
This integrative review critically examines quantitative and qualitative evidence concerning factors influencing the participation of Canadian women in mammography. Empirical studies published between 1980 and 2006 were identified and retrieved by searching electronic databases and references listed in published studies. Among the 1461 citations identified and screened, 52 studies met the inclusion criteria and were independently appraised by two researchers. Extracted data were categorized, summarized, compared, and interpreted within and across studies. The presentation of barriers and facilitators to mammography was guided by the Pender Health Promotion Model. Findings from this review showed that no published studies were specific to settings in Saskatchewan, Nova Scotia, Prince Edward Island, Newfoundland and Labrador, and the three Canadian territories. The most common barriers to screening were membership in an ethnic minority and concerns about pain, radiation, and embarrassment. The recommendation of a health care provider for mammography was found to be the most common facilitator for the engagement of women in this health behaviour. The targeting of specific strategies aimed at overcoming identified barriers and the enhancement of facilitators are essential to improving mammography participation rates throughout Canada.
PMCID: PMC2768512  PMID: 19862363
Mammography; breast screening; Canada; integrative; review; barriers; facilitators
3.  The relative efficacy of two brief treatments for sleep problems in young learning disabled (mentally retarded) children: a randomised controlled trial 
Archives of Disease in Childhood  2004;89(2):125-130.
Background: Settling and night waking problems are particularly prevalent, persistent, and generally considered difficult to treat in children with a learning disability, although intervention trials are few. Scarce resources, however, limit access to proven behavioural treatments.
Aims: To investigate the efficacy of a media based brief behavioural treatment of sleep problems in such children by comparing (1) face-to-face delivered treatment versus control and (2) booklet delivered treatment versus controls.
Methods: The parents of 66 severely learning disabled children aged 2–8 years with settling and/or night waking problems took part in a randomised controlled trial with a wait-list control group. Behavioural treatments were presented either conventionally face-to-face or by means of a 14 page easy to read illustrated booklet. A composite sleep disturbance score was derived from sleep diaries kept by parents.
Results: Both forms of treatment were almost equally effective compared with controls. Two thirds of children who were taking over 30 minutes to settle five or more times per week and waking at night for over 30 minutes four or more times per week improved on average to having such settling or night waking problems for only a few minutes or only once or twice per week (H = 34.174, df = 2, p<0.001). These improvements were maintained after six months.
Conclusions: Booklet delivered behavioural treatments for sleep problems were as effective as face-to-face treatment for most children in this population.
PMCID: PMC1719807  PMID: 14736626
4.  Birth prevalence of Prader-Willi syndrome in Australia 
Archives of Disease in Childhood  2003;88(3):263-264.
PMCID: PMC1719461  PMID: 12598399
6.  Bioavailability and pharmacokinetic disposition of tacrine in elderly patients with Alzheimer's disease. 
The pharmacokinetic disposition of intravenous and oral doses of tacrine was determined in 5 elderly patients (aged 64 to 96 y) with the clinical diagnosis of Alzheimer's disease. The bioavailability of the oral formulation was low (9.9% to 36.4%), and the plasma half-life was not altered by route of drug delivery. These data indicate that tacrine elimination occurs by a 1st-order process. Plasma clearance of tacrine varied more than its half-life, which is consistent with a modulating effect of apparent volume of distribution (Vd). Our findings, together with other limited published studies, suggest that use of tacrine for the treatment of Alzheimer's disease (AD) will be confounded by the high interindividual variability in its kinetic disposition.
PMCID: PMC1188798  PMID: 8973053
7.  Impact of a formulary on personal care homes in Manitoba. 
OBJECTIVE: To assess the impact of a formulary on drug expenditures and prescribing trends in personal care homes (nursing homes). DESIGN: Quasi-experimental analysis of a drug prescription database before and after implementation of the formulary. SETTING: Personal care homes in Manitoba. PATIENTS: Residents occupying the 6848 beds of the 88 personal care homes that did not already have a formulary. INTERVENTION: Formulary, introduced Apr. 1, 1987. MAIN OUTCOME MEASURES: Drug expenditures from Apr. 1, 1985, to Mar. 31, 1990; proportion of residents receiving a prescription by drug class and rate of prescriptions of nonformulary drugs in the year before and 2 years after the formulary was introduced. MAIN RESULTS: The total drug expenditures per bed remained constant during the first year after the formulary was implemented, even though the annual drug inflation rate was 9.8% on average during the study period. Expenditures 2 and 3 years after implementation rose by 9.4% and 5.8% respectively. Those for specific agents and drug classes targeted as being inappropriate for long-term care decreased greatly because of reduced prescribing. Expenditures for some other drug classes increased mainly because newer, more expensive agents were used. The mean drug expenditure per bed varied widely between homes; neither size nor location were found to correlate with drug expenditure, but adherence to the formulary did predict personal care homes with decreased expenditures. CONCLUSIONS: A formulary in personal care homes can improve therapeutic management. The impact on cost containment was not as strong after the first year, although expenditures remained less than the rate of inflation for drug costs.
PMCID: PMC1336963  PMID: 8174030
8.  A truncated intracellular HER2/neu receptor produced by alternative RNA processing affects growth of human carcinoma cells. 
Molecular and Cellular Biology  1993;13(4):2247-2257.
Cloned sequences encoding a truncated form of the HER2 receptor were obtained from cDNA libraries derived from two HER2-overexpressing human breast cancer cell lines, BT-474 and SK-BR-3. The 5' 2.1 kb of the encoded transcript is identical to that of full-length 4.6-kb HER2 transcript and would be expected to produce a secreted form of HER2 receptor containing only the extracellular ligand binding domain (ECD). The 3' end of the truncated transcript diverges 61 nucleotides before the receptor's transmembrane region, reads through a consensus splice donor site containing an in-frame stop codon, and contains a poly(A) addition site, suggesting that the truncated transcript arises by alternative RNA processing. S1 nuclease protection assays show a 40-fold variation in the abundance of the truncated 2.3-kb transcript relative to full-length 4.6-kb transcript in a panel of eight HER2-expressing tumor cell lines of gastric, ovarian, and breast cancer origin. Expression of this truncated transcript in COS-1 cells produces both secreted and intracellular forms of HER2 ECD; however, immunofluorescent labeling of HER2 ECD protein in MKN7 tumor cells that natively overexpress the 2.3-kb transcript suggests that transcriptionally generated HER2 ECD is concentrated within the perinuclear cytoplasm. Metabolic labeling and endoglycosidase studies suggest that this HER2 ECD (100 kDa) undergoes differential trafficking between the endoplasmic reticulum and Golgi compartments compared with full-length (185-kDa) HER2 receptor. Transfection studies indicate that excess production of HER2 ECD in human tumor cells overexpressing full-length HER2 receptor can result in resistance to the growth-inhibiting effects of anti-HER2 monoclonal antibodies such as muMAb4D5. These findings demonstrate alternative processing of the HER2 transcript and implicate a potentially important growth regulatory role for intracellularly sequestered HER2 ECD in HER2-amplified human tumors.
PMCID: PMC359545  PMID: 8096058
9.  Soluble glycoprotein D blocks herpes simplex virus type 1 infection of rat eyes. 
Journal of Virology  1992;66(9):5183-5189.
Herpes simplex virus type 1 (HSV-1) ocular infection in rats was blocked by treating the eyes with UV-inactivated virions containing glycoprotein D (gD) prior to ocular challenge. In contrast, rats treated with UV-inactivated virions lacking gD were not protected. A soluble, truncated form of HSV-2 gD (gD-2t) also protected against ocular infection. Treatment with gD-2t not only reduced mortality but also restricted progression of pathology and reduced the amount of viral antigen in the cornea. Host antibody or alpha/beta interferon responses to the gD-2t treatment were not detected. These results are similar to those observed in cell culture (D. C. Johnson, R. L. Burke, and T. Gregory, J. Virol. 64:2569-2576, 1990). The in vivo effect of exogenous gD is consistent with blocking of a cell surface gD receptor or with an inhibitory interaction of gD with virions.
PMCID: PMC289070  PMID: 1380093
13.  Glycoprotein D protects mice against lethal challenge with herpes simplex virus types 1 and 2. 
Infection and Immunity  1984;43(2):761-764.
Glycoprotein D is a virion envelope component of herpes simplex virus types 1 and 2. Sets of mice were immunized with purified gD-1 or gD-2 and were challenged with a lethal dose of herpes simple virus, either type 1 or type 2. All or virtually all of the immunized mice survived challenge with either agent, whereas challenge of sham-immunized mice was almost always fatal. Serum samples taken before challenge contained gD-specific antibodies which had 50% neutralization titers ranging from 1:16 to 1:512 against homologous and heterologous virus types. We conclude that either gD-1 or gD-2 is a potential candidate for a subunit vaccine against herpetic infections.
PMCID: PMC264368  PMID: 6319291
14.  Characterization of an antibody directed against a surface component of normal and pleomorphic cells of Streptococcus sanguis. 
Infection and Immunity  1975;12(3):668-678.
Whole cells of Streptococcus sanguis were utilized as an immunoadsorbent to purify large quantities of an antibody (S1) directed against a cell surface component. The S-1 antibody was isolated from antisera to normal (N) and pleomorphic (O) cells by a similar adsorption-elution procedure. The S-1 antibody isolated from antisera to N cells reacted in gel diffusion in identify with the S-1 antibody to O cells, indicating that the antigen which binds S-1 antibody (Ag-1) may not be radically altered when cells become pleomorphic. The S-1 antibodies directed against both N and O cells had restricted heterogeneity, indicating that for both types of cell Ag-1 may have a simple repeating structure. However, N cells were agglutinated to a greater extent by S-1 antibody than O cells. In addition the distribution of the bound S-1 antibody became altered as the cells became pleomorphic. Utilizing the technique of indirect immunofluorescence we observed that the S-1 antibody was distributed evenly on the surface of N cells. As the cells became pleomorphic, the antibody appeared to bind preferentially at the cell poles (capping). Later, as the cells became more grossly deformed, additional bands of immunofluorescence appeared to bisect the cells. Electron microscopic analysis indicated that the bound antibody was not associated with septal notches. The results suggest that the arrangement rather than the immunological properties of Ag-1 became altered as cells became pleomorphic.
PMCID: PMC415338  PMID: 809362
15.  Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial 
Objective To assess the effectiveness and safety of melatonin in treating severe sleep problems in children with neurodevelopmental disorders.
Design 12 week double masked randomised placebo controlled phase III trial.
Setting 19 hospitals across England and Wales.
Participants 146 children aged 3 years to 15 years 8 months were randomised. They had a range of neurological and developmental disorders and a severe sleep problem that had not responded to a standardised sleep behaviour advice booklet provided to parents four to six weeks before randomisation. A sleep problem was defined as the child not falling asleep within one hour of lights out or having less than six hours’ continuous sleep.
Interventions Immediate release melatonin or matching placebo capsules administered 45 minutes before the child’s bedtime for a period of 12 weeks. All children started with a 0.5 mg capsule, which was increased through 2 mg, 6 mg, and 12 mg depending on their response to treatment.
Main outcome measures Total sleep time at night after 12 weeks adjusted for baseline recorded in sleep diaries completed by the parent. Secondary outcomes included sleep onset latency, assessments of child behaviour, family functioning, and adverse events. Sleep was measured with diaries and actigraphy.
Results Melatonin increased total sleep time by 22.4 minutes (95% confidence interval 0.5 to 44.3 minutes) measured by sleep diaries (n=110) and 13.3 (−15.5 to 42.2) measured by actigraphy (n=59). Melatonin reduced sleep onset latency measured by sleep diaries (−37.5 minutes, −55.3 to −19.7 minutes) and actigraphy (−45.3 minutes, −68.8 to −21.9 minutes) and was most effective for children with the longest sleep latency (P=0.009). Melatonin was associated with earlier waking times than placebo (29.9 minutes, 13.6 to 46.3 minutes). Child behaviour and family functioning outcomes showed some improvement and favoured use of melatonin. Adverse events were mild and similar between the two groups.
Conclusions Children gained little additional sleep on melatonin; though they fell asleep significantly faster, waking times became earlier. Child behaviour and family functioning outcomes did not significantly improve. Melatonin was tolerable over this three month period. Comparisons with slow release melatonin preparations or melatonin analogues are required.
Trial registration ISRCT No 05534585.
PMCID: PMC3489506  PMID: 23129488
16.  White Overnight? 
British Medical Journal  1967;1(5535):300.
PMCID: PMC1840664
18.  Psoriasis in Association with Hypocalcæmia 
PMCID: PMC1898247  PMID: 14244891

Results 1-18 (18)