Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush).

BACKGROUND: Anti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis. OBJECTIVES: The primary objective of this review is to assess the relative effectiveness (clinical cure) of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. Secondary objectives include the assessment of the relative effectiveness in terms of mycological cure, in addition to safety, side effects, treatment preference, time to first relief of symptoms, and costs. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two trials registers on 29 August 2019 together with reference checking and citation searching. SELECTION CRITERIA: We included randomised controlled trials published in any language comparing at least one oral anti-fungal with one intra-vaginal anti-fungal in women (aged 16 years or over) with a mycological diagnosis (positive culture, microscopy for yeast, or both) of uncomplicated vulvovaginal candidiasis. We excluded trials if they solely involved participants who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as recommended by Cochrane. MAIN RESULTS: This review includes 26 trials (5007 participants). Eight anti-fungals are represented. All but three trials included participants with acute vulvovaginal candidiasis. Trials were conducted in Europe: UK (3), Croatia (2). Finland (2), the Netherlands (2), Germany (1), Italy (1), Sweden (1) and one trial across multiple European countries, USA (7) Thailand (2), Iran (2), Japan (1) and Africa (Nigeria) (1). The duration of follow-up varied between trials. The overall risk of bias of the included trials was high. There was probably little or no difference shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short-term follow-up (OR 1.14, 95% CI 0.91 to 1.43; 13 trials; 1859 participants; moderate-certainty evidence) and long-term follow-up (OR 1.07, 95% CI 0.77 to 1.50; 9 trials; 1042 participants; moderate-certainty evidence). The evidence suggests that if the rate of clinical cure at short-term follow-up with intra-vaginal treatment is 77%, the rate with oral treatment would be between 75% and 83%; if the rate of clinical cure at long term follow-up with intra-vaginal treatment is 84%, the rate with oral treatment would be between 80% and 89%. Oral treatment probably improves mycological cure over intra-vaginal treatment at short term (OR 1.24, 95% CI 1.03 to 1.50: 19 trials; 3057 participants; moderate-certainty evidence) and long-term follow-up (OR 1.29, 95% CI 1.05 to 1.60; 13 trials; 1661 participants; moderate-certainty evidence). The evidence suggests that if the rate of mycological cure at short-term follow-up with intra-vaginal treatment is 80%, the rate with oral treatment would be between 80% and 85%; if the rate of mycological cure at long-term follow-up with intra-vaginal treatment is 66%, the rate with oral treatment would be between 67% and 76%. In terms of patient safety, there is a low risk of participants withdrawing from the studies due to adverse drug effects for either treatment (23 trials; 4637 participants; high-certainty evidence). Due to the low certainty of evidence, it is undetermined whether oral treatments reduced the number of side effects compared with intra-vaginal treatments (OR 1.04, 95% CI 0.84 to 1.29; 16 trials; 3155 participants; low-certainty evidence). The evidence suggests that if the rate of side effects with intra-vaginal treatment is 12%, the rate with oral treatment would be between 10% and 15%. We noted that the type of side effects differed, with intra-vaginal treatments being more often associated with local reactions, and oral treatments being more often associated with systemic effects including gastro-intestinal symptoms and headaches. Oral treatment appeared to be the favoured treatment preference over intra-vaginal treatment or no preference (12 trials; 2206 participants), however the data were poorly reported and the certainty of the evidence was low. There was little or no difference in time to first relief of symptoms between oral and intra-vaginal treatments: four trials favoured the oral treatment, four favoured intra-vaginal, one study reported no difference and one was unclear. The measurements varied between the 10 trials (1910 participants) and the certainty of the evidence was low. Costs were not reported in any of the trials. AUTHORS' CONCLUSIONS: Oral anti-fungal treatment probably improves short- and long-term mycological cure over intra-vaginal treatment for uncomplicated vaginal candidiasis. Oral treatment was the favoured treatment preference by participants, though the certainty of this evidence is low. The decision to prescribe or recommend an anti-fungal for oral or intra-vaginal administration should take into consideration safety in terms of withdrawals and side effects, as well as cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's preference.

Establishing need and population priorities to improve the health of homeless and vulnerably housed women, youth, and men: A Delphi consensus study.

BACKGROUND: Homelessness is one of the most disabling and precarious living conditions. The objective of this Delphi consensus study was to identify priority needs and at-risk population subgroups among homeless and vulnerably housed people to guide the development of a more responsive and person-centred clinical practice guideline. METHODS: We used a literature review and expert working group to produce an initial list of needs and at-risk subgroups of homeless and vulnerably housed populations. We then followed a modified Delphi consensus method, asking expert health professionals, using electronic surveys, and persons with lived experience of homelessness, using oral surveys, to prioritize needs and at-risk sub-populations across Canada. Criteria for ranking included potential for impact, extent of inequities and burden of illness. We set ratings of ≥ 60% to determine consensus over three rounds of surveys. FINDINGS: Eighty four health professionals and 76 persons with lived experience of homelessness participated from across Canada, achieving an overall 73% response rate. The participants identified priority needs including mental health and addiction care, facilitating access to permanent housing, facilitating access to income support and case management/care coordination. Participants also ranked specific homeless sub-populations in need of additional research including: Indigenous Peoples (First Nations, Métis, and Inuit); youth, women and families; people with acquired brain injury, intellectual or physical disabilities; and refugees and other migrants. INTERPRETATION: The inclusion of the perspectives of both expert health professionals and people with lived experience of homelessness provided validity in identifying real-world needs to guide systematic reviews in four key areas according to priority needs, as well as launch a number of working groups to explore how to adapt interventions for specific at-risk populations, to create evidence-based guidelines.

Effectiveness of home-based records on maternal, newborn and child health outcomes: A systematic review and meta-analysis.

Home-based records (HBRs) may improve the health of pregnant women, new mothers and their children, and support health care systems. We assessed the effectiveness of HBRs on maternal, newborn and child health reporting, care seeking and self-care practice, mortality, morbidity and women's empowerment in low-, middle- and high-income countries. We conducted a systematic search in MEDLINE, EMBASE, CENTRAL, Health Systems Evidence, CINAHL, HTA database, NHS EED, and DARE from 1950 to 2017. We also searched the WHO, CDC, ECDC, JICA and UNAIDS. We included randomised controlled trials, prospective controlled trials, and cost-effectiveness studies. We used the Cochrane Risk of Bias tool to appraise studies. We extracted and analyzed data for outcomes including maternal, newborn and child health, and women's empowerment. We synthesized and presented data using GRADE Evidence Profiles. We included 14 studies out of 16,419 identified articles. HBRs improved antenatal care and reduced likelihood of pregnancy complications; improved patient-provider communication and enhanced women's feelings of control and empowerment; and improved rates of vaccination among children (OR: 2·39, 95% CI: 1.45-3·92) and mothers (OR 1·98 95% CI:1·29-3·04). A three-year follow-up shows that HBRs reduced risk of cognitive delay in children (p = 0.007). HBRs used during the life cycle of women and children in Indonesia showed benefits for continuity of care. There were no significant effects on healthy pregnancy behaviors such as smoking and consumption of alcohol during pregnancy. There were no statistically significant effects on newborn health outcomes. We did not identify any formal studies on cost or economic evaluation. HBRs show modest but important health effects for women and children. These effects with minimal-to-no harms, multiplied across a population, could play an important role in reducing health inequities in maternal, newborn, and child health.

Prevention and assessment of infectious diseases among children and adult migrants arriving to the European Union/European Economic Association: a protocol for a suite of systematic reviews for public health and health systems.

INTRODUCTION: The European Centre for Disease Prevention and Control is developing evidence-based guidance for voluntary screening, treatment and vaccine prevention of infectious diseases for newly arriving migrants to the European Union/European Economic Area. The objective of this systematic review protocol is to guide the identification, appraisal and synthesis of the best available evidence on prevention and assessment of the following priority infectious diseases: tuberculosis, HIV, hepatitis B, hepatitis C, measles, mumps, rubella, diphtheria, tetanus, pertussis, poliomyelitis (polio), Haemophilus influenza disease, strongyloidiasis and schistosomiasis. METHODS AND ANALYSIS: The search strategy will identify evidence from existing systematic reviews and then update the effectiveness and cost-effectiveness evidence using prospective trials, economic evaluations and/or recently published systematic reviews. Interdisciplinary teams have designed logic models to help define study inclusion and exclusion criteria, guiding the search strategy and identifying relevant outcomes. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. ETHICS AND DISSEMINATION: There are no ethical or safety issues. We anticipate disseminating the findings through open-access publications, conference abstracts and presentations. We plan to publish technical syntheses as GRADEpro evidence summaries and the systematic reviews as part of a special edition open-access publication on refugee health. We are following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols reporting guideline. This protocol is registered in PROSPERO: CRD42016045798.

Interventions to improve outpatient referrals from primary care to secondary care.

BACKGROUND: The primary care specialist interface is a key organisational feature of many health care systems. Patients are referred to specialist care when investigation or therapeutic options are exhausted in primary care and more specialised care is needed. Referral has considerable implications for patients, the health care system and health care costs. There is considerable evidence that the referral processes can be improved. OBJECTIVES: To estimate the effectiveness and efficiency of interventions to change outpatient referral rates or improve outpatient referral appropriateness. SEARCH STRATEGY: We conducted electronic searches of the Cochrane Effective Practice and Organisation of Care (EPOC) group specialised register (developed through extensive searches of MEDLINE, EMBASE, Healthstar and the Cochrane Library) (February 2002) and the National Research Register. Updated searches were conducted in MEDLINE and the EPOC specialised register up to October 2007. SELECTION CRITERIA: Randomised controlled trials, controlled clinical trials, controlled before and after studies and interrupted time series of interventions to change or improve outpatient referrals. Participants were primary care physicians. The outcomes were objectively measured provider performance or health outcomes. DATA COLLECTION AND ANALYSIS: A minimum of two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Seventeen studies involving 23 separate comparisons were included. Nine studies (14 comparisons) evaluated professional educational interventions. Ineffective strategies included: passive dissemination of local referral guidelines (two studies), feedback of referral rates (one study) and discussion with an independent medical adviser (one study). Generally effective strategies included dissemination of guidelines with structured referral sheets (four out of five studies) and involvement of consultants in educational activities (two out of three studies). Four studies evaluated organisational interventions (patient management by family physicians compared to general internists, attachment of a physiotherapist to general practices, a new slot system for referrals and requiring a second 'in-house' opinion prior to referral), all of which were effective. Four studies (five comparisons) evaluated financial interventions. One study evaluating change from a capitation based to mixed capitation and fee-for-service system and from a fee-for-service to a capitation based system (with an element of risk sharing for secondary care services) observed a reduction in referral rates. Modest reductions in referral rates of uncertain significance were observed following the introduction of the general practice fundholding scheme in the United Kingdom (UK). One study evaluating the effect of providing access to private specialists demonstrated an increase in the proportion of patients referred to specialist services but no overall effect on referral rates. AUTHORS' CONCLUSIONS: There are a limited number of rigorous evaluations to base policy on. Active local educational interventions involving secondary care specialists and structured referral sheets are the only interventions shown to impact on referral rates based on current evidence. The effects of 'in-house' second opinion and other intermediate primary care based alternatives to outpatient referral appear promising.

Economic evaluation of cardiac rehabilitation: a systematic review.

BACKGROUND: Economic evaluation is an important tool in the evaluation of competing healthcare interventions. Little is known about the economic benefits of different cardiac rehabilitation program delivery models. DESIGN: The goal of this study was to review and evaluate the methodological quality of published economic evaluations of cardiac rehabilitation services. METHODS: Electronic databases were searched for English language evaluations (trials, modeling studies) of the economic impact of cardiac rehabilitation. A review of study characteristics and methodological quality was completed using standardized tools. All costs are adjusted to 2004 US dollars. RESULTS: Fifteen economic evaluations were identified which met eligibility criteria but which displayed wide variation in the use of comparators, evaluation type, perspective and design. Evidence to support the cost-effectiveness of supervised cardiac rehabilitation in myocardial infarction and heart failure patients was identified. The range of cost per life year gained was estimated as from 2193 dollars to 28,193 dollars and from - 668 dollars to 16,118 dollars per quality adjusted life year gained. The level of evidence supporting the economic value of home-based cardiac rehabilitation interventions is limited to partial economic analyses. CONCLUSIONS: Evidence to support the cost-effectiveness of supervised cardiac rehabilitation compared with usual care in myocardial infarction and heart failure was identified. Further trials are required to support the cost-effectiveness of cardiac rehabilitation in cardiac patients who have under gone revascularization. The literature evaluating home-based and alternative delivery models of cardiac rehabilitation was insufficient to draw conclusions about their relative cost-effectiveness. The overall quality of published economic evaluations of cardiac rehabilitation is poor and further well-designed trials are required.

Impact of program duration and contact frequency on efficacy and cost of cardiac rehabilitation: results of a randomized trial.

BACKGROUND: Secondary prevention through cardiac rehabilitation (CR) has been recommended for most patients with coronary artery disease (CAD). Although generally reimbursed for 3 months, to date, optimal CR program duration and frequency of patient contact has yet to be identified. This study compared standard (33 sessions for 3 months) versus distributed (33 sessions for 12 months) CR for effects on exercise variables, risk factors, health-related quality of life (HRQL), depressive symptoms, and direct costs to the cardiac health care system. METHODS: We randomly assigned 392 patients to either standard CR (n = 196) or distributed CR (n = 196). Outcomes were cardiorespiratory fitness, daily physical activity, coronary risk factors, generic and heart disease HRQL, and depressive symptoms, measured 12 and 24 months after program intake. Secondary outcomes included these variables measured after 3 months. Costs to the cardiac health care system were determined 2 years after program initiation. RESULTS: Both groups showed improvements over time in cardiorespiratory fitness, daily physical activity, low-density lipoprotein cholesterol, generic and heart disease HRQL, and depressive symptoms. Over time, blood pressure and body mass index values worsened. Smoking status, high-density lipoprotein cholesterol, and triglyceride levels remained unchanged. There were no clinically meaningful or statistically significant between group differences for outcomes at 12 or 24 months. The costs of the programs to the cardiac health care system were not different. CONCLUSIONS: From a clinical standpoint, this study indicates that both standard and distributed program formats serve patients with CAD equally well over the longer term. Programs could use either program delivery model (standard or distributed) depending on patient or program needs. Costs to the cardiac health care system are similar.

Age, gender, and urban-rural differences in the correlates of physical activity.

BACKGROUND: The majority of the population is inactive, and strategies to date for promoting regular physical activity have been limited in their effectiveness. Further research is needed to identify correlates of physical activity in different subgroups to design more efficacious interventions. This study sought to identify correlates of physical activity across men and women, urban and rural geographical locations, and four distinct age groups (18-25; 26-45; 46-59; and 60+). METHODS: This study employed data from a large provincial household random sample (N = 20,606) of Canadians. Analyses were utilized to examine the amount of variance explained in self-reported physical activity by a number of demographic and/or biological, psychological, behavioral, social, and environmental variables within each subgroup. RESULTS: Proportion of friends who exercise, injury from past physical activity, educational level, perceived health status, and alcohol consumption were among the strongest correlates across subgroups. CONCLUSIONS: A number of correlates were identified as being significant across all subgroups examined. Most differences in the correlates of physical activity were found within different age groups rather than among urban and rural residents and gender.