Enhancing opportunistic recruitment and retention in primary care trials: lessons learned from a qualitative study embedded in the Cranberry for Urinary Tract Infection (CUTI) feasibility trial.

BACKGROUND: Opportunistic recruitment in primary care is challenging due to the inherent unpredictability of incident conditions, and workload and time pressures. Many clinical trials do not recruit to target, leading to equivocal answers to research questions. Learning from the experiences of patients and recruiters to trials of incident conditions has the potential to improve recruitment and retention to future trials, thereby enhancing the quality and impact of research findings. The aim of this research was to learn from the trial experiences of UTI patients and recruiters to the Cranberry for UTI (CUTI) trial, to help plan an adequately powered trial of similar design. METHODS: One-to-one semi-structured interviews were embedded within the CUTI feasibility trial, an open-label, randomised feasibility trial of cranberry extract for symptoms of acute, uncomplicated Urinary Tract Infection (UTI) in primary care. Interviews were conducted with a sample of: CUTI trial participants; non-CUTI trial UTI patients; and, recruiters to the CUTI trial. Verbatim transcripts were analysed thematically. RESULTS: Twenty-six patients with UTI and eight recruiters (nurses and GPs) to the CUTI trial were interviewed. Three themes were developed around: reasons for participating in research; barriers to opportunistic recruitment; and, UTI patients' experiences of trial procedures. Recruiters found that targeted electronic prompts directed at healthcare practitioners based in clinics where patients with incident conditions were likely to present (e.g. minor illness clinic) were more effective than generic prompts (e.g. desk prompts) at filtering patients from their usual clinical pathway to research clinics. Using a script to explain the delayed antibiotic trial group to patients was found to be helpful, and may have served to boost recruitment. For UTI patients, using an electronic diary to rate their symptoms was considered an acceptable medium, and often preferable to using a paper diary or mobile phone application. CONCLUSIONS: The use of targeted prompts directed at clinicians, a script to explain trial groups that may be deemed less desirable, and an appropriate diary format for patient-reported outcomes, may help to improve trial recruitment and retention.

Non-antibiotic treatment of acute urinary tract infection in primary care: a qualitative study.

BACKGROUND: The views of women with acute, uncomplicated urinary tract infection (auUTI) on the acceptability of non-antibiotic treatment options are poorly understood. AIM: To establish women's thoughts on and experience of non-antibiotic treatment for auUTIs. DESIGN AND SETTING: Qualitative interview study with primary care patients in Oxfordshire, UK, embedded within the Cranberry for Urinary Tract Infection (CUTI) feasibility trial. METHOD: One-to-one, semi-structured interviews were conducted between August 2019 and January 2020 with some CUTI trial participants and some patients who were not part of the CUTI trial who had experienced at least one urinary tract infection (UTI) in the preceding 12 months in Oxfordshire, UK. Interviews were analysed using thematic analysis. RESULTS: In total, 26 interviews were conducted and analysed. Women expected to receive an immediate antibiotic for their UTI but were aware of the potential harms of this approach. They were keen to find a non-antibiotic, 'natural' alternative that could effectively manage their symptoms. In certain situations (early illness, milder illness, and with no important upcoming engagements), women indicated they would be prepared to postpone antibiotic treatment by up to 3 days, especially if offered an interim non-antibiotic option with perceived therapeutic potential. CONCLUSION: Many women with auUTIs are open to trying non-antibiotic treatments first in certain situations. There is scope for more dialogue between primary care clinicians and patients with auUTI around delaying antibiotic treatment and using non-antibiotic options initially, which could reduce antibiotic consumption for this common infection.

Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial.

OBJECTIVES: To determine the feasibility of conducting a randomised trial of the effectiveness of cranberry extract in reducing antibiotic use by women with symptoms of acute, uncomplicated urinary tract infection (UTI). DESIGN: Open-label feasibility randomised parallel group trial. SETTING: Four general practices in Oxfordshire. PARTICIPANTS: Women aged 18 years and above presenting to general practice with symptoms of acute, uncomplicated UTI. INTERVENTIONS: Women were randomly assigned using Research Electronic Data Capture in a 1:1:1 ratio to: (1) immediate antibiotics alone (n=15); (2) immediate antibiotics and immediate cranberry capsules for up to 7 days (n=15); or (3) immediate cranberry capsules and delayed antibiotics for self-initiation in case of non-improvement or worsening of symptoms (n=16). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measures were: rate of recruitment of participants; numbers lost to follow-up; proportion of electronic diaries completed by participants; and acceptability of the intervention and study procedures to participants and recruiters. Secondary outcomes included an exploration of differences in symptom burden and antibiotic use between groups. RESULTS: Four general practitioner practices (100%) were opened and recruited participants between 1 July and 2 December 2019, with nine study participants recruited per month on average. 68.7% (46/67) of eligible participants were randomised (target 45) with a mean age of 48.4 years (SD 19.9, range 18-81). 89.1% (41/46) of diaries contained some participant entered data and 69.6% (32/46) were fully complete. Three participants (6.5%) were lost to follow-up and two (4.4%) withdrew. Of women randomly assigned to take antibiotics alone (controls), one-third of respondents reported consuming cranberry products (33.3%, 4/12). There were no serious adverse events. CONCLUSIONS: It appears feasible to conduct a randomised trial of the use of cranberry extract in the treatment of acute, uncomplicated UTI in general practice. TRIAL REGISTRATION NUMBER: ISRCTN Registry (ID: 10399299).

Online supplementation for teaching evidence-based medicine: feasibility of a randomised-controlled trial.

BACKGROUND AND OBJECTIVES: As teaching technology advances, medical education is increasingly using digital mediums and exploring instructional models such as the flipped classroom and blended learning courses, where the in-class taught sessions are more groups on content delivered before class. Early evidence suggests lectures and foundational material can be equally provided online, but we have low-quality research to be convinced. We aim to test and develop an online evidence-based teaching resource that seeks to improve the availability and scalability of evidence-based medicine (EBM) learning tools. We evaluate the feasibility of a study design that could test for changes in academic performance in EBM skills using an online supplement. METHODS: Mixed-methods feasibility study of a randomised controlled trial (RCT) in an undergraduate medical student cohort. RESULTS: Of a small cohort (n=34), eight participants agreed to randomisation and completed the study. No study participant completed the EBM supplementary course in full. Students report time-management as a significant barrier in participation, and all aspects of the study and communications should be delivered with efficiency a key consideration. CONCLUSION: Randomising students to an online EBM supplement within a medical school programme presents challenges of recruitment and student motivation, but the study design is potentially feasible.

Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? Protocol for a feasibility study.

BACKGROUND: Consultations in primary care for symptoms of urinary tract infections (UTIs) are common and patients are frequently treated with antibiotics. Given increasing antimicrobial resistance, there has been interest in non-antibiotic treatment options for common infections. One such option is the use of cranberry extract to treat symptoms attributable to UTIs. METHODS: A target of 45 women consulting in primary care, with symptoms suggestive of an uncomplicated UTI for whom the practitioner would normally prescribe antibiotics, will be randomised to receive one of three treatment approaches: (1) immediate prescription for antibiotics; (2) immediate prescription for antibiotics plus a 7-day course of cranberry capsules and (3) cranberry capsules plus a delayed prescription for antibiotics to be used in case their symptoms do not get better, or get worse. Follow-up will be by daily rating of symptoms and recording of treatments used for 2 weeks in an online symptom diary. Interviews will be conducted with around 10-15 study participants, as well as with around 10-15 women who have experienced a UTI but have not been approached to take part in the study. Both groups will be asked about their experience of having a UTI, their thoughts on non-antibiotic treatments for UTIs and their thoughts on, or experience of, the feasibility trial. The primary objective is to assess the feasibility of undertaking a full trial in primary care of the effectiveness of cranberry extract to reduce antibiotic use for symptoms of acute uncomplicated UTI. The secondary objective is to conduct a preliminary assessment of the extent to which cranberry might reduce antibiotic use and symptom burden. DISCUSSION: This feasibility study with embedded interviews will inform the planning and sample size calculation of an adequately powered trial to definitively determine whether cranberry helps to alleviate the symptoms of acute uncomplicated UTIs in women and whether it can safely reduce antibiotic use. TRIAL REGISTRATION: ISRCTN registry, ID: 10399299. Registered on 24 January 2019.

Practice variation in the use of tests in UK primary care: a retrospective analysis of 16 million tests performed over 3.3 million patient years in 2015/16.

BACKGROUND: The UK's National Health Service (NHS) is currently subject to unprecedented financial strain. The identification of unnecessary healthcare resource use has been suggested to reduce spending. However, there is little very research quantifying wasteful test use, despite the £3 billion annual expenditure. Geographical variation has been suggested as one metric in which to quantify inappropriate use. We set out to identify tests ordered from UK primary care that are subject to the greatest between-practice variation in their use. METHODS: We used data from 444 general practices within the Clinical Practice Research Datalink to calculate a coefficient of variation (CoV) for the ordering of 44 specific tests from UK general practices. The coefficient of variation was calculated after adjusting for differences between practice populations. We also determined the tests that had both a higher-than-average CoV and a higher-than-average rate of use. RESULTS: In total, 16,496,218 tests were ordered for 4,078,091 patients over 3,311,050 person-years from April 1, 2015, to March 31, 2016. The tests subject to the greatest variation were drug monitoring 158% (95%CI 153 to 163%), urine microalbumin (52% (95%CI 49.9 to 53.2%)), pelvic CT (51% (95%CI 50 to 53%)) and Pap smear (49% (95%CI 48 to 51%). Seven tests were classified as high variability and high rate (clotting, vitamin D, urine albumin, prostate-specific antigen (PSA), bone profile, urine MCS and C-reactive protein (CRP)). CONCLUSIONS: There are wide variations in the use of common tests, which is unlikely to be explained by clinical indications. Since £3 billion annually are spent on tests, this represents considerable variation in the use of resources and inefficient management in the NHS. Our results can be of value to policy makers, researchers, patients and clinicians as the NHS strives towards identifying overuse and underuse of tests.

Effectiveness of curcuminoids in the treatment of knee osteoarthritis: a systematic review and meta-analysis of randomized clinical trials.

AIM: To critically appraise and evaluate the evidence for effectiveness of curcuminoids in the treatment of osteoarthritis (OA) in adults. METHODS: We conducted electronic searches in Medline, Embase, AMED, Cinahl and the Cochrane library. We included randomized controlled trials (RCTs) that investigated the effectiveness of orally-administered curcuminoids in OA in adults, and assessed risk of bias using the Cochrane risk of bias criteria. We used a random-effect model for meta-analysis. RESULTS: We included seven studies with a total of 797 participants with primarily knee OA. All studies were conducted in Asia. The overall risk of bias was moderate. Compared with placebo, curcuminoids significantly reduced knee pain (visual analogue scale): (standardized mean difference: -3.45; 95% CI: -5.52 to -1.38; I2  = 95% P = 0.001), and improved quality of life (Lequesne pain-function index): (mean difference: -2.69; 95% CI: -3.48 to -1.90; I2  = 0% P < 0.00001). There were significantly fewer effects on pain relief, knee stiffness and physical function with curcuminoids compared with ibuprofen. Significant improvements in Western Ontario and McMaster Universities Arthritis Index total scores, with significant reductions in the use of rescue medication were also observed with curcuminoids. No serious adverse events were reported. CONCLUSIONS: Curcuminoids may have some beneficial effects on knee pain and quality of life in patients with knee OA. However, they are less effective at relieving pain compared with ibuprofen. Curcuminoids appear safe on the short-term, and may reduce the need for rescue medication. Published RCTs vary in reporting quality, are characterized by small sample sizes, and have all been conducted in Asia. Further clinical trials are therefore warranted.

The efficacy of supplementation with the novel medical food, Souvenaid, in patients with Alzheimer's disease: A systematic review and meta-analysis of randomized clinical trials.

BACKGROUND AND RATIONALE: Certain nutritional supplements are being marketed for the management of Alzheimer's disease (AD), but the evidence for their effectiveness is not established. The objective of this review was to evaluate the evidence from randomized clinical trial (RCTs) examining the effect of Souvenaid in patients with AD. METHODS: We conducted electronic searches in Medline, Embase, PsychINFO, CINAHL, and The Cochrane Library. The reporting quality of the included studies was determined using the Cochrane collaboration tool for assessing the risk of bias. Two reviewers independently determined eligibility, assessed the reporting quality of included studies and extracted data. RESULTS: Three studies with a total of 1011 participants were included. All were of good reporting quality. Meta-analyses revealed non-significant differences in cognition (ADAS-cog scores MD: 0.08, 95% CI: -0.71 to 0.88) and function (ADCS-ADL scores MD: 0.36, 95% CI: -0.54 to 1.25) between Souvenaid and placebo. One study showed significant increase in neuropsychological test battery composite z-score with Souvenaid compared with placebo, and another reported significant improvement in delayed verbal recall for a subgroup of patients with very mild AD. There was no significant effect on global clinical function. No serious adverse events were observed. CONCLUSIONS: The evidence from published clinical trials does not show that supplementation with Souvenaid has beneficial effects on functional ability, behaviour, or global clinical change. Souvenaid may cause improvements in verbal recall in patients at early stages of AD. Few RCTs examining the effect of Souvenaid have been conducted, and they are all funded by same manufacturer. Future research should include using unified tools to measure cognition, function, and behaviour in AD.

Effect of oil pulling in promoting oro dental hygiene: A systematic review of randomized clinical trials.

AIM: To critically appraise and evaluate the evidence from randomized clinical trials (RCTs) examining the effectiveness of oil pulling on oro dental hygiene. METHODS: We conducted electronic searches in Medline, Embase, Amed, The Cochrane Library and Cinahl databases from inception to February 2015, and assessed reporting quality using the Cochrane risk of bias criteria. We included RCTs that compared oil pulling using conventional cooking oils with a control intervention. Our primary outcomes were measures of oro dental hygiene using validated scales. RESULTS: Electronic searches yielded 26 eligible studies, of which five RCTs comprising a total of 160 participants were included. The studies varied in reporting quality, lasted between 10 and 45 days, and compared oil pulling with chlorhexidine, placebo or routine dental hygiene practice. Three studies reported no significant differences in post intervention plaque index scores between oil pulling and control groups (Chlorhexidine mouthwash +/- Placebo): p=0.28, 0.94, and 0.38, respectively. Two studies reported no significant difference in post-intervention modified gingival index score between oil pulling and Chlorhexidine mouthwash groups (p=0.32 and 0.64). CONCLUSION: The limited evidence to date from clinical trials suggests that oil pulling may have beneficial effects on oro dental hygiene as seen for the short period of time investigated. Given that this is a potentially cost-effective intervention, this practice might be of particular benefit. Future clinical trials should be more rigorous and better reported.

Yoga in adult cancer: an exploratory, qualitative analysis of the patient experience.

BACKGROUND: Some patients receiving treatment in conventional health care systems access therapeutic yoga outside their mainstream care to improve cancer symptoms. Given the current knowledge gap around patient preferences and documented experiences of yoga in adult cancer, this study aimed to describe patient-reported benefits, barriers and characteristics of programming for yoga practice during conventional treatment. METHODS: In depth semi-structured interviews (n=10) were conducted in men and women recruited from cancer care clinics in Vancouver, Canada using a purposive sampling technique. The exploratory interviews were audio-recorded, transcribed and analyzed using Interpretive Description methodology and constant comparative analysis methods. RESULTS: Four themes emerged from the data to address our research objectives: patient-perceived benefits of yoga, reasons and motivations for practising yoga, hurdles and barriers to practising yoga, and advice for effective yoga program delivery in adult cancer. Several patients reported yoga reduced stress and other symptoms associated with cancer treatment. Thematic analysis found the social dimension of group yoga was important, as well as yoga's ability to encourage personal empowerment and awareness of physical body and self. Barriers to yoga adherence from the patient perspective included lack of time, scheduling conflicts and worries about financial burden. CONCLUSION: This small, diverse sample of patients reported positive experiences and no adverse effects following yoga practice for management of cancer and its symptoms. Results of this qualitative study identified patient-reported preferences, barriers and characteristics of yoga intervention optimal during adult cancer treatment.

Yoga for Health-Related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Study.

An increase in patient-led uptake of complementary therapies in adult cancer has led to a need for more rigorous study of such interventions and their outcomes. This study therefore aimed to evaluate the feasibility and acceptability of a yoga intervention in men and women receiving conventional treatment for a cancer diagnosis. Prospective, mixed methods feasibility trial allocated participants to receive one of three yoga interventions over a four-week study period. Data collection was completed through online survey of QOL-CA/CS and customized surveys. Fifteen participants were included (11 female) undergoing treatment for breast, prostate, colorectal, brain, and blood and lung cancer. Two participants dropped out and complete qualitative and quantitative data sets were collected from 12 participants and four yoga instructors. Other outcome measures included implementation costs patient-reported preferences for yoga intervention and changes in QOL-CA/CS. Three types of yoga intervention were safely administered in adult cancer. Mixed methods, cost-efficiency, QOL-CA/CS, and evidence-based design of yoga intervention have been used to establish feasibility and patient-preferences for yoga delivery in adult caner. Results suggest that, with some methodological improvements, a large-scale randomized controlled trial is warranted to test the efficacy of yoga for male and female cancer patients. This trial is registered with Clinicaltrials.gov NCT02309112.

The effect of cactus pear (Opuntia ficus-indica) on body weight and cardiovascular risk factors: a systematic review and meta-analysis of randomized clinical trials.

OBJECTIVES: Hundreds of dietary supplements are currently marketed as weight loss supplements. However, the advertised health claims of effectiveness for most of these have not been proven. The aim of this study was to critically appraise and evaluate the evidence for effectiveness of cactus pear, Opuntia ficus-indica (OFI), using data from published randomized clinical trials. METHODS: We conducted electronic searches in Medline, Embase, Amed, Cinahl, and the Cochrane Library. No restrictions on age, time, or language were imposed. The risk for bias in the studies included was assessed using the Cochrane Collaboration criteria. Two reviewers independently determined the eligibility of included studies, assessed reporting quality, and extracted data. RESULTS: We identified seven eligible studies, of which five were included. The studies varied in design and reporting quality. Meta-analysis revealed a nonsignificant difference in body weight between OFI and controls (mean difference = -0.83 kg; 95% confidence interval, -2.49 to 0.83; I(2) = 93%). Significant reductions in body mass index, percentage body fat, systolic and diastolic blood pressures, and total cholesterol were observed. Adverse events included gastric intolerance and flu symptoms. CONCLUSION: The evidence from randomized clinical trials does not indicate that supplementation with OFI generates statistically significant effects on body weight. Consumption of OFI can cause significant reductions in percentage body fat, blood pressure, and total cholesterol. Few clinical trials evaluating the effects of OFI have been published. They vary in design and methodology, and are characterized by inconsistent quality of reporting. Further clinical trials evaluating the effects of OFI on body composition and metabolic parameters are warranted.

Effect of the novel functional fibre, polyglycoplex (PGX), on body weight and metabolic parameters: A systematic review of randomized clinical trials.

BACKGROUND & AIMS: Hundreds of dietary supplements are marketed as weight loss pills, but the evidence for effectiveness for most is unproven. The objective of this review was to critically appraise and evaluate the evidence from published randomized clinical trials (RCTs) examining the effectiveness of polyglycoplex (PGX), a novel functional fibre, on body weight and metabolic parameters. METHODS: We conducted electronic searches in Medline, Embase, Amed, Cinahl and The Cochrane Library. Only double-blinded RCTs were considered for inclusion. The reporting quality of included studies was assessed using the Cochrane criteria. Two reviewers independently determined eligibility, assessed the quality of reporting, and extracted the data. RESULTS: We included four RCTs with a total of 217 participants. The RCTs varied in the quality of their reporting. The evidence from the RCTs suggested that PGX has no significant effects on body weight; however, significant reductions were noted for total and LDL cholesterol. Adverse events reported included diarrhea and abdominal bloating. CONCLUSION: The evidence from available RCTs does not indicate that PGX intake causes reductions in body weight. PGX may cause reductions in total and LDL cholesterol. Few trials examining the effects of PGX have been conducted; they are characterized by small sample sizes, deficiencies in reporting quality, and are funded by a single manufacturer. Future clinical trials evaluating its effect should be adequately powered and better reported.

Effect of the natural sweetener, steviol glycoside, on cardiovascular risk factors: a systematic review and meta-analysis of randomised clinical trials.

INTRODUCTION: Many different dietary supplements are currently marketed for the management of hypertension and diabetes, but the evidence for effectiveness is mixed. The objective of this systematic review was to critically appraise and evaluate the evidence for effectiveness of steviol glycosides (stevioside and rebaudioside A) on cardiovascular risk factors, using data from randomised clinical trials (RCTs). METHODS: Electronic searches were conducted in Medline, Embase, Amed, Cinahl and The Cochrane Library. We also searched Google Scholar, and hand searched the bibliography of retrieved full texts. The reporting quality of included studies was assessed using the Cochrane criteria. Two reviewers independently determined the eligibility, assessed the reporting quality, and extracted the data. RESULTS: Nine studies with a total of 756 participants were included. There was a variation in the reporting quality of included studies. Meta-analysis revealed a non-significant difference in systolic blood pressure between steviol glycoside and placebo, mean difference (MD): -2.98 mm Hg (-6.23 to 0.27). Significant reductions in diastolic blood pressure and fasting blood glucose were observed. There was no significant effect on blood lipid profile. Heterogeneity was significant. Adverse events included abdominal fullness, epigastric pain, and dizziness. CONCLUSION: The evidence from published RCTs suggests that stevioside may generate reductions in blood pressure and fasting blood glucose. The sizes of the effects are small, and the substantial heterogeneity limits the robustness of any conclusions. Rebaudioside A does not appear to have any significant effects on blood pressure or cardiovascular risk factors. Available clinical trials vary in design and reporting quality, and some are characterised by inadequate sample sizes. In addition, the participants in most of the trials have high cardiovascular risk. Further clinical trials and regulatory assessments are warranted.

Vitamin K for improved anticoagulation control in patients receiving warfarin.

BACKGROUND: Effective use of warfarin involves keeping the international normalised ratio (INR) within a relatively narrow therapeutic range. However, patients respond widely to their dose of warfarin. Overcoagulation can lead to an increased risk of excessive bleeding, while undercoagulation can lead to increased clot formation. There is some evidence that patients with a variable response to warfarin may benefit from a concomitant low dose of vitamin K. OBJECTIVES: To assess the effects of concomitant supplementation of low-dose oral vitamin K for anticoagulation control in patients being initiated on or taking a maintenance dose of warfarin. SEARCH METHODS: To identify previous reviews, we searched the Database of Abstracts of Reviews of Effects (DARE via The Cochrane Library, Wiley) (Issue 2, 2011). To identify primary studies, we searched the Cochrane Central Register of Controlled Trials (CENTRAL via The Cochrane Library, Wiley) (Issue 2, 2014), Ovid MEDLINE (R) In-Process & Other Non-Indexed Citations database and Ovid MEDLINE (R) (OvidSP) (1946 to 25 February 2014), Embase (OvidSP) (1974 to week 8 of 2014), Science Citation Index Expanded™ & Conference Proceedings Citation Index - Science (Web of Science™) (1945 to 27 February 2014), and the NHS Economics Evaluations Database (NHS EED) (via The Cochrane Library, Wiley) (Issue 2, 2014). We did not apply any language or date restrictions. We used additional methods to identify grey literature and ongoing studies. SELECTION CRITERIA: Randomised controlled trials comparing the addition of vitamin K versus placebo in patients initiating warfarin or already taking warfarin. DATA COLLECTION AND ANALYSIS: Two review authors independently selected and extracted data from included studies. When disagreement arose, a third author helped reached a consensus. We also assessed risk of bias. MAIN RESULTS: We identified two studies with a total of 100 participants for inclusion in the review. We found the overall risk of bias to be unclear in a number of domains. Neither study reported the time taken to the first INR in range. Only one study (70 participants) reported the mean time in therapeutic range as a percentage. This study found that in the group of participants deemed to have poor INR control, the addition of 150 micrograms (mcg) oral vitamin K significantly improved anticoagulation control in those with unexplained instability of response to warfarin. The second study (30 participants) reported the effect of 175 mcg oral vitamin K versus placebo on participants with high variability in their INR levels. The study concluded that vitamin K supplementation did not significantly improve the stability of anticoagulation for participants on chronic anticoagulation therapy. However, the study was only available in abstract form, and communication with the lead author confirmed that there were no further publications. Therefore, we interpreted this conclusion with caution. Neither study reported any thromboembolic events, haemorrhage, or death from the addition of vitamin K supplementation. AUTHORS' CONCLUSIONS: Two included studies in this review compared whether the addition of a low dose (150 to 175 mcg) of vitamin K given to participants with a high-variability response to warfarin improved their INR control. One study demonstrated a significant improvement, while another smaller study (published in abstract only) suggested no overall benefit. Currently, there are insufficient data to suggest an overall benefit. Larger, higher quality trials are needed to examine if low-dose vitamin K improves INR control in those starting or already taking warfarin.

Evidence of effectiveness of health care professionals using handheld computers: a scoping review of systematic reviews.

BACKGROUND: Handheld computers and mobile devices provide instant access to vast amounts and types of useful information for health care professionals. Their reduced size and increased processing speed has led to rapid adoption in health care. Thus, it is important to identify whether handheld computers are actually effective in clinical practice. OBJECTIVE: A scoping review of systematic reviews was designed to provide a quick overview of the documented evidence of effectiveness for health care professionals using handheld computers in their clinical work. METHODS: A detailed search, sensitive for systematic reviews was applied for Cochrane, Medline, EMBASE, PsycINFO, Allied and Complementary Medicine Database (AMED), Global Health, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases. All outcomes that demonstrated effectiveness in clinical practice were included. Classroom learning and patient use of handheld computers were excluded. Quality was assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. A previously published conceptual framework was used as the basis for dual data extraction. Reported outcomes were summarized according to the primary function of the handheld computer. RESULTS: Five systematic reviews met the inclusion and quality criteria. Together, they reviewed 138 unique primary studies. Most reviewed descriptive intervention studies, where physicians, pharmacists, or medical students used personal digital assistants. Effectiveness was demonstrated across four distinct functions of handheld computers: patient documentation, patient care, information seeking, and professional work patterns. Within each of these functions, a range of positive outcomes were reported using both objective and self-report measures. The use of handheld computers improved patient documentation through more complete recording, fewer documentation errors, and increased efficiency. Handheld computers provided easy access to clinical decision support systems and patient management systems, which improved decision making for patient care. Handheld computers saved time and gave earlier access to new information. There were also reports that handheld computers enhanced work patterns and efficiency. CONCLUSIONS: This scoping review summarizes the secondary evidence for effectiveness of handheld computers and mhealth. It provides a snapshot of effective use by health care professionals across four key functions. We identified evidence to suggest that handheld computers provide easy and timely access to information and enable accurate and complete documentation. Further, they can give health care professionals instant access to evidence-based decision support and patient management systems to improve clinical decision making. Finally, there is evidence that handheld computers allow health professionals to be more efficient in their work practices. It is anticipated that this evidence will guide clinicians and managers in implementing handheld computers in clinical practice and in designing future research.

Overview of systematic reviews: yoga as a therapeutic intervention for adults with acute and chronic health conditions.

Objectives. Overview the quality, direction, and characteristics of yoga interventions for treatment of acute and chronic health conditions in adult populations. Methods. We searched for systematic reviews in 10 online databases, bibliographic references, and hand-searches in yoga-related journals. Included reviews satisfy Oxman criteria and specify yoga as a primary intervention in one or more randomized controlled trials for treatment in adults. The AMSTAR tool and GRADE approach evaluated the methodological quality of reviews and quality of evidence. Results. We identified 2202 titles, of which 41 full-text articles were assessed for eligibility and 26 systematic reviews satisfied inclusion criteria. Thirteen systematic reviews include quantitative data and six papers include meta-analysis. The quality of evidence is generally low. Sixteen different types of health conditions are included. Eleven reviews show tendency towards positive effects of yoga intervention, 15 reviews report unclear results, and no, reviews report adverse effects of yoga. Yoga appears most effective for reducing symptoms in anxiety, depression, and pain. Conclusion. Although the quality of systematic reviews is high, the quality of supporting evidence is low. Significant heterogeneity and variability in reporting interventions by type of yoga, settings, and population characteristics limit the generalizability of results.

Device-guided breathing exercises in the control of human blood pressure: systematic review and meta-analysis.

OBJECTIVE: To evaluate whether device-guided breathing (DGB) lowers blood pressure (BP) in adults. DESIGN: Systematic review and meta-analysis. DATA SOURCES: We searched Medline (1950-2010), Embase (1980-2010), the Cochrane Library including the Cochrane Central register of Controlled Trials (CENTRAL), AMED (1985-2010), CINAHL (1980-2010) and the Current Controlled Trials registry (as of October 2010). OUTCOME MEASURES: Primary outcomes included the mean change in SBP and DBP. Secondary outcomes included change in heart rate, quality of life, compliance with the device and any side effects of the device. RESULTS: We included eight trials of the Resperate device (InterCure Ltd, Lod, Israel), consisting of 494 adult patients. Use of this device resulted in significantly reduced SBP by 3.67 mmHg [95% confidence interval (CI) = -5.99 to -1.39; P = 0.002] and decreased DBP by 2.51 mmHg (95% CI = -4.15 to -0.87; P = 0.003). However, sensitivity analysis was carried out excluding the five trials sponsored by or involving the manufacturers of the device, which revealed no overall effect on BP using the device. The maximum trial duration was 9 weeks and no overall effect was seen on heart rate or quality of life using the device. CONCLUSION: There is evidence that short-term use of DGB may reduce both DBP and DBP. However, five of the eight trials were sponsored by or involved the manufactures of the device. When these trials were excluded we found no overall effect. We conclude that longer term, independent trials are required to validate this intervention.