Digital Health Professions Education in the Field of Pediatrics: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration.

BACKGROUND: Reducing childhood morbidity and mortality is challenging, particularly in countries with a shortage of qualified health care workers. Lack of trainers makes it difficult to provide the necessary continuing education in pediatrics for postregistration health professionals. Digital education, teaching and learning by means of digital technologies, has the potential to deliver medical education to a large audience while limiting the number of trainers needed. OBJECTIVE: The goal of the research was to evaluate whether digital education can replace traditional learning to improve postregistration health professionals' knowledge, skills, attitudes, and satisfaction and foster behavior change in the field of pediatrics. METHODS: We completed a systematic review of the literature by following the Cochrane methodology. We searched 7 major electronic databases for articles published from January 1990 to August 2017. No language restrictions were applied. We independently selected studies, extracted data, and assessed risk of bias, and pairs of authors compared information. We contacted authors of studies for additional information if necessary. All pooled analyses were based on random effects models. We included individually or cluster randomized controlled trials that compared digital education with traditional learning, no intervention, or other forms of digital education. We assessed the quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria. RESULTS: Twenty studies (1382 participants) were included. Participants included pediatricians, physicians, nurses, and midwives. Digital education technologies were assessed including high-fidelity mannequins (6 studies), computer-based education (12 studies), mobile learning (1 study), and virtual reality (1 study). Most studies reported that digital education was either as effective as or more effective than the control intervention for outcomes including skill, knowledge, attitude, and satisfaction. High-fidelity mannequins were associated with higher postintervention skill scores compared with low-fidelity mannequins (standardized mean difference 0.62; 95% CI 0.17-1.06; moderate effect size, low-quality evidence). One study reported physician change in practicing behavior and found similar effects between offline plus online digital education and no intervention. The only study that assessed impact on patient outcome found no difference between intervention and control groups. None of the included studies reported adverse or untoward effects or economic outcomes of the digital education interventions. The risk of bias was mainly unclear or high. The quality of evidence was low due to study inconsistencies, limitations, or imprecision across the studies. CONCLUSIONS: Digital education for postregistration health professions education in pediatrics is at least as effective as traditional learning and more effective than no learning. High-fidelity mannequins were found to be more effective at improving skills than traditional learning with low-fidelity mannequins. Computer-based offline/online digital education was better than no intervention for knowledge and skill outcomes and as good as traditional face-to-face learning. This review highlights evidence gaps calling for more methodologically rigorous randomized controlled trials on the topic. TRIAL REGISTRATION: PROSPERO CRD42017057793; https://tinyurl.com/y5q9q5o6.

Interventions for recruiting smokers into cessation programmes.

BACKGROUND: Tobacco control is a top public health priority around the globe due to the high prevalence of cigarette smoking and its associated morbidity and mortality. Much effort has been focused on establishing the effectiveness of different smoking cessation strategies. This review, however, aims to address the initial challenge faced by smoking cessation programmes: recruitment of smokers. OBJECTIVES: The primary objective of this review was to determine the effectiveness of different strategies for recruiting smokers into cessation programmes. The secondary objective was to determine the impact that these strategies had on smoking cessation rates at least six months after enrolment into a cessation programme. SEARCH METHODS: We searched the specialised register of the Cochrane Tobacco Addiction Group using a search strategy which included the terms ('recruit$', 'invit$', 'enter', 'entry', 'enrolment') combined with ('smok$', 'cigarette', 'smoking cessation', 'tobacco') in the title, abstract or keyword fields. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), and registers of current and ongoing trials. We also searched the reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials and cluster randomised controlled trials that compared at least two different methods of recruiting current smokers into a smoking cessation programme. We also included those studies which focused on the effectiveness of a smoking cessation programme as long as the study involved multiple recruitment methods and reported results of the recruitment phase. DATA COLLECTION AND ANALYSIS: From each included study, we extracted data on the type of participants, type of recruitment strategies (i.e., setting, mode of communication used, intensity and duration) and comparisons, and on randomisation, allocation concealment, and blinding procedures.Our primary outcome was the proportion of smokers successfully recruited to each cessation programme compared to alternative modalities of recruitment. Our secondary outcome was smoking cessation for at least six months. Given the substantial heterogeneity across recruitment interventions and participants, we adopted a narrative synthesis approach for summarising results. MAIN RESULTS: This review includes 19 studies with a total of 14,890 participants. We categorised the included studies according to the modes used to deliver the recruitment strategy: head to head comparison of individual recruitment strategies; comparison of the same delivery mode but with different content or intensity; and the addition of another mode to an existing recruitment method.We identified three studies that made head-to-head comparisons of different types of recruitment strategies. Of these, only one study detected a significant effect, finding that a personal phone call was more effective than a generic invitation letter (RR 40.73, 95% CI 2.53 to 654.74). Five studies compared interventions using the same delivery modes but different content. Results showed that tailored messages through an interactive voice response system resulted in a higher recruitment rate than assessment of smoking status alone using the same system (RR 8.64, 95% CI 4.41 to 16.93), and that text messages indicating scarcity of places available were more effective than generic text message reminders (RR 1.45, 95% CI 1.07 to 1.96). One study compared interventions using the same delivery mode but different intensity and found that allowing for more phone call attempts to reach potential participants can result in better recruitment (RR 1.87, 95% CI 1.61 to 2.18). Finally, 10 studies investigated the effect of adding a recruitment mode to existing recruitment strategies. Findings showed that: adding a text message reminder or real quotes from participants to a personal phone call improved recruitment of participants (RR 3.38, 95% CI 1.26 to 9.08 and RR 29.07, 95% CI 1.74 to 485.70, respectively); that adding a personal phone call to an existing newsletter can also increase recruitment rates (RR 65.12, 95% CI 4.06 to 1045.4]); that a reactive-proactive recruitment phase is more effective than a proactive phase alone (63.8% versus 47.5%, RR not available); and that active recruitment at schools is more effective than passive recruitment (p < 0.001, denominator not available for calculation of RR). Additionally, a number of studies in this category showed that providing incentives can effectively increase the number of participants recruited into smoking cessation programmes.Out of the 19 included studies, only four reported on the effect of recruitment strategy on smoking cessation at six months or longer. Three of these studies compared strategies that used the same delivery mode with different content. Their results were non-significant. The remaining three studies evaluated adding an additional mode to an existing recruitment intervention. Only one of them showed a significant difference in the levels of smoking cessation that favoured the enhanced recruitment strategy, but this may have reflected the offer of incentives once in the programme rather than the recruitment strategy itself (RR at 15 or 18 months 2.60, 95% CI 1.48 to 4.56). AUTHORS' CONCLUSIONS: The substantial heterogeneity across the included studies restricts our ability to draw firm conclusions about the effectiveness of different recruitment strategies in relation to recruitment of participants into smoking cessation programmes or levels of smoking cessation. The limited evidence, however, suggests that the following elements may improve the recruitment of smokers into cessation programmes: personal, tailored interventions; recruitment methods that are proactive in nature; and more intensive recruitment strategies (i.e., those strategies that require increased contact with potential participants).

Male involvement for increasing the effectiveness of prevention of mother-to-child HIV transmission (PMTCT) programmes.

BACKGROUND: Despite efforts to increase the uptake of prevention of mother to child transmission of HIV (PMTCT) services, coverage is still lower than desired in developing countries. A lack of male partner involvement in PMTCT services is a major barrier for women to access these services. OBJECTIVES: To evaluate the impact of interventions which aim to enhance male involvement to increase women's uptake of PMTCT interventions in developing countries. SEARCH METHODS: We searched the following databases from the year 2000 to November 2011: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, the WHO Global Health Library, ClinicalTrials.gov, Current Controlled Trials, AEGIS, CROI, IAS, IAC web sites. SELECTION CRITERIA: We included randomised controlled trials (RCTs), cluster-randomised controlled trials, quasi-randomised controlled trials, controlled before and after studies and interrupted time series studies assessing interventions to increase male involvement for improvement of uptake PMTCT services in low- and middle-income countries.. DATA COLLECTION AND ANALYSIS: Two reviewers independently searched, screened, assessed study quality and extracted data. A third reviewer resolved any disagreement. MAIN RESULTS: Only one study met the inclusion criteria, an RCT conducted in Tanzania between May 2003 and October 2004. Women in the intervention group (n=760) received a letter for their male partners, which invited them to return together to receive Couple Voluntary Counselling and Testing (CVCT) for HIV. Women in the control group (n=761) received individual HIV VCT during their first ANC visit and then usual care. The percentages of women who received HIV VCT and collected their results were 48%, 45% and 39% in the intervention group and 93%, 78% and 71% in the control group (p <0,001). Only 33% of women in the intervention group returned with their male partners and only 47% of them went through the whole CVCT process. The proportion of women who received HIV prophylaxis at delivery was not different between the two arms (27% in the intervention and 22% in the control group). The study had a high risk of bias.   AUTHORS' CONCLUSIONS: We found only one eligible study that assessed the effectiveness of male involvement in improving women's uptake of PMTCT services, which only focused on one part of the perinatal PMTCT cascade. We urgently need more rigorously designed studies assessing the impact of male engagement interventions on women's uptake of PMTCT services to know if this intervention can contribute to improve uptake of PMTCT services and reduce vertical transmission of HIV in children.   

Immunization for Children Living With HIV: A Scoping Review.

BACKGROUND: Immunosuppression secondary to human immunodeficiency virus (HIV) increases the risk of vaccine-preventable diseases in children living with HIV (CLHIV). Although vaccines are cost-effective interventions, their efficacy, immunogenicity, safety, and persistence of post-vaccination immunity in CLHIV receiving antiretroviral therapy (ART) is unclear. We aimed at identifying existing scientific evidence on immunization of CLHIV generated in the last 10 years to identify the need for a systematic review. METHODS: Studies were identified using a broad search strategy applied in multiple databases. Included studies involved CLHIV aged 0-10 years and presented outcomes on safety, efficacy, effectiveness, immunogenicity, and use of booster vaccines. RESULTS: Nineteen publications were identified. There was variable immunogenicity to and efficacy of vaccines by HIV and ART status. All vaccines were safe. CONCLUSION: The heterogeneity of available studies makes it complex to do a systematic review and meta-analysis. A more uniform approach to sampling and follow-up in future studies would make comparison and interpretation of results more robust.

Integrating prevention of mother-to-child HIV transmission (PMTCT) programmes with other health services for preventing HIV infection and improving HIV outcomes in developing countries.

BACKGROUND: Every year nearly 400,000 children are infected with HIV through mother-to-child transmission (MTCT), which is responsible for more than 90% of HIV infections in children. In high-income countries, the MTCT rate is less than 1% through perinatal prevention of mother-to-child HIV transmission (PMTCT) interventions. In low- and middle-income countries, PMTCT programme coverage remains low and consequently transmission rate high. The World Health Organisation recommends integration of PMTCT programmes with other healthcare services to increase access and improve uptake of these interventions. OBJECTIVES: To assess the effect of integration of perinatal PMTCT measures with other health care services on coverage and service uptake compared to stand-alone PMTCT programmes and healthcare services or partially integrated PMTCT interventions. SEARCH STRATEGY: We searched the following databases, for the time period of January 1990 to August 2010: MEDLINE, EMBASE, the WHO Global Health Library, CAB abstracts, CINAHL, POPLINE, PsycINFO, Sociological Abstracts, ERIC, AEGIS, Google Scholar, New York Academy of Medicine Grey Literature, Open SIGLE, British Library Catalogue, ProQuest Dissertation & Theses Database and U.S. National Library of Medicine Gateway system. We also searched the Cochrane Database of Systematic Reviews (the Cochrane Library 2010, Issue 7), the Cochrane Central Register of Controlled Trials (the Cochrane Library 2010, Issue 7), Database of Abstracts of Reviews on Effects (the Cochrane Library 2010, Issue 7). We also searched for ongoing trials in the WHO International Clinical Trials Registry and Controlled clinical trials (January 1990 to July 2010). We performed ISI Web of Knowledge Cited Reference Search and scanned the reference lists of the included articles for additional relevant studies. We contacted authors to locate additional eligible studies. To maximise sensitivity we did not employ any methodological filters. SELECTION CRITERIA: Randomised controlled trials (RCT), cluster-randomised controlled trials (cluster RCT), controlled clinical trials (CCT), controlled before and after (CBA) studies and interrupted time series (ITS) studies comparing integrated PMTCT interventions to non-integrated or partially integrated care for pregnant women, mothers and their infants in low- and middle-income countries. DATA COLLECTION AND ANALYSIS: Two review authors independently ran the searches, selected studies, assessed methodological quality, and extracted data. The third review author resolved any disagreements. MAIN RESULTS: Only one study met the inclusion criteria. A cluster-randomised trial (12 clusters, n=7664), compared mother-infant nevirapine coverage at labour ward between intervention clinics implementing rapid HIV testing with structured nevirapine assessment and control clinics implementing informal assessment of nevirapine adherence. The authors measured nevirapine coverage in all clinics at baseline and after the implementation of the intervention. An increase of 10% (range of difference in coverage from -10% to +33%) was observed in the intervention sites compared to 10% decline in mother-infant coverage in the control sites (range of difference in coverage from -13% to 0%). The study showed that the probability of nevirapine coverage of mothers and their infants in the intervention arm compared to control arm increased from 0.89 at baseline to 1.22 during the intervention period, representing a multiplicative effect of 1.37 upon the ratio of relative risks at baseline (RR 1.37, bootstrapped 95% CI, 1.041.77). The study had a low risk of bias. No studies were found that evaluated the effectiveness of integrating other perinatal PMTCT interventions with healthcare services. AUTHORS' CONCLUSIONS: We found only one study suggesting that integrating perinatal PMTCT interventions with other healthcare services in low- and middle-income countries increases the proportion of pregnant women, mothers and infants receiving PMTCT intervention. The weak evidence base does not enable making any inferences for other countries or contexts. The study that met the inclusion criteria assessed only the impact of integrating PMTCT intervention in labour ward on the proportion of mothers and their infants receiving nevirapine. The study showed significant improvement in intervention coverage but it only addressed the labour ward aspect of PMTCT programme. We did not find sufficient evidence to make definitive conclusions about the effectiveness of integration of these interventions with other health services rather than providing them as stand-alone services. Further research is urgently needed to assess the effect of integrating perinatal prevention of mother-to-child HIV transmission interventions with other health services on intervention coverage, service uptake, quality of care and health outcomes and the optimal integration modality.

Outcomes Among Children Enrolled in HIV Care in Mozambique 2009-2013.

BACKGROUND: Scale-up of HIV care and antiretroviral therapy (ART) services for children has expanded access, but significant gaps and challenges remain. We examined lost to follow-up (LTF) and mortality in a large cohort of children enrolled in HIV care in Mozambique. METHODS: Routinely collected medical data on children 0-14 years enrolled in care 2009-2013 at ICAP-supported health facilities in 5 provinces of Mozambique were used. Children not receiving ART (pre-ART) were considered LTF if they did not a have a visit within 12 months of the end of data collection; for those receiving ART, LTF was no visit within 6 months. Competing risk and Kaplan-Meier estimators were used, respectively, to estimate pre-ART and on ART LTF and mortality. RESULTS: A total of 13,695 children enrolled in HIV care at 64 health facilities (48.6%, <2 years), and 7733 (56.5%) initiated ART during follow-up. Cumulative incidence of pre-ART LTF was 32.9% [95% confidence interval (CI): 32.1-33.7] and 34.4% (95% CI: 33.6-35.2) by 12 and 24 months, respectively, and was highest in children <5 years (12-month LTF in children 2-4 years, 34.2%, 95% CI: 32.6-35.9). Pre-ART mortality at 12 months was 3.3% (95% CI: 3.0-3.6) and was highest in children <2 years (4.1%, 95% CI: 3.6-4.6). On ART, LTF was 28.6% (95% CI: 27.6-29.7) and 37.6 (95% CI: 36.4-38.8) at 12 and 24 months, and 12 months mortality after ART was 8.0% (95% CI: 7.3-8.7). CONCLUSIONS: High rates of LTF were observed in this large cohort of HIV-infected children accessing care in Mozambique both before and after ART initiation highlighting the urgent need for interventions to improve retention in routine care settings.

How Can the Health System Retain Women in HIV Treatment for a Lifetime? A Discrete Choice Experiment in Ethiopia and Mozambique.

INTRODUCTION: Option B+, an approach that involves provision of antiretroviral therapy (ART) to all HIV-infected pregnant women for life, is the preferred strategy for prevention of mother to child transmission of HIV. Lifelong retention in care is essential to its success. We conducted a discrete choice experiment in Ethiopia and Mozambique to identify health system characteristics preferred by HIV-infected women to promote continuity of care. METHODS: Women living with HIV and receiving care at hospitals in Oromia Region, Ethiopia and Zambézia Province, Mozambique were shown nine choice cards and asked to select one of two hypothetical health facilities, each with six varying characteristics related to the delivery of HIV services for long term treatment. Mixed logit models were used to estimate the influence of six health service attributes on choice of clinics. RESULTS: 2,033 women participated in the study (response rate 97.8% in Ethiopia and 94.7% in Mozambique). Among the various attributes of structure and content of lifelong ART services, the most important attributes identified in both countries were respectful provider attitude and ability to obtain non-HIV health services during HIV-related visits. Availability of counseling support services was also a driver of choice. Facility type, i.e., hospital versus health center, was substantially less important. CONCLUSIONS: Efforts to enhance retention in HIV care and treatment for pregnant women should focus on promoting respectful care by providers and integrating access to non-HIV health services in the same visit, as well as continuing to strengthen counseling.

The uptake of integrated perinatal prevention of mother-to-child HIV transmission programs in low- and middle-income countries: a systematic review.

BACKGROUND: The objective of this review was to assess the uptake of WHO recommended integrated perinatal prevention of mother-to-child transmission (PMTCT) of HIV interventions in low- and middle-income countries. METHODS AND FINDINGS: We searched 21 databases for observational studies presenting uptake of integrated PMTCT programs in low- and middle-income countries. Forty-one studies on programs implemented between 1997 and 2006, met inclusion criteria. The proportion of women attending antenatal care who were counseled and who were tested was high; 96% (range 30-100%) and 81% (range 26-100%), respectively. However, the overall median proportion of HIV positive women provided with antiretroviral prophylaxis in antenatal care and attending labor ward was 55% (range 22-99%) and 60% (range 19-100%), respectively. The proportion of women with unknown HIV status, tested for HIV at labor ward was 70%. Overall, 79% (range 44-100%) of infants were tested for HIV and 11% (range 3-18%) of them were HIV positive. We designed two PMTCT cascades using studies with outcomes for all perinatal PMTCT interventions which showed that an estimated 22% of all HIV positive women attending antenatal care and 11% of all HIV positive women delivering at labor ward were not notified about their HIV status and did not participate in PMTCT program. Only 17% of HIV positive antenatal care attendees and their infants are known to have taken antiretroviral prophylaxis. CONCLUSION: The existing evidence provides information only about the initial PMTCT programs which were based on the old WHO PMTCT guidelines. The uptake of counseling and HIV testing among pregnant women attending antenatal care was high, but their retention in PMTCT programs was low. The majority of women in the included studies did not receive ARV prophylaxis in antenatal care; nor did they attend labor ward. More studies evaluating the uptake in current PMTCT programs are urgently needed.

Assessing the effectiveness of strategies to implement clinical guidelines for the management of chronic diseases at primary care level in EU Member States: a systematic review.

PURPOSE AND SETTING: This review aimed to evaluate the effectiveness of strategies to implement clinical guidelines for chronic disease management in primary care in EU Member States. METHODS: We conducted a systematic review of interventional studies assessing the implementation of clinical guidelines. We searched five databases (EMBASE, MEDLINE, CENTRAL, Eppi-Centre and Clinicaltrials.gov) following a strict Cochrane methodology. We included studies focusing on the management of chronic diseases in adults in primary care. RESULTS: A total of 21 studies were found. The implementation strategy was fully effective in only four (19%), partially effective in eight (38%), and not effective in nine (43%). The probability that an intervention would be effective was only slightly higher with multifaceted strategies, compared to single interventions. However, effect size varied across studies; therefore it was not possible to determine the most successful strategy. Only eight studies evaluated the impact on patients' health and only two of those showed significant improvement, while in five there was an improvement in the process of care which did not translate into an improvement in health outcomes. Only four studies reported any data on the cost of the implementation but none undertook a cost-effectiveness analysis. Only one study presented data on the barriers to the implementation of guidelines, noting a lack of awareness and agreement about clinical guidelines. CONCLUSION: Our results reveal that there are only a few rigorous studies which assess the effectiveness of a strategy to implement clinical guidelines in Europe. Moreover, the results are not consistent in showing which strategy is the most appropriate to facilitate their implementation. Therefore, further research is needed to develop more rigorous studies to evaluate health outcomes associated with the implementation of clinical guidelines; to assess the cost-effectiveness of implementing clinical guidelines; and to investigate the perspective of service users and health service staff.

Systematic review of the methodological quality of clinical guideline development for the management of chronic disease in Europe.

INTRODUCTION: The use of evidence-based clinical guidelines is an essential component of chronic disease management. However, there is well-documented concern about variability in the quality of clinical guidelines, with evidence of persisting methodological shortcomings. The most widely accepted approach to assessing the quality of guidelines is the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. We have conducted a systematic review of the methodological quality (as assessed by AGREE) of clinical guidelines developed in Europe for the management of chronic diseases published since 2000. METHODS: The systematic review was undertaken in accordance with the Cochrane methodology. The inclusion criteria were that studies should have appraised European clinical guidelines for certain selected chronic disorders using the AGREE instrument. We searched five databases (Cab Abstracts, EMBASE, MEDLINE, Trip and EPPI). RESULTS: Nine studies reported in 10 papers, analysing a total of 28 European guidelines from eight countries as well as pan-European, were included. There was considerable variation in the quality of clinical guidelines across the AGREE domains. The least well addressed domains were 'editorial independence' (with a mean domain score of 41%), 'applicability' (44%), 'stakeholder involvement' (55%), and 'rigour of development' (64%), while 'clarity of presentation' (80%) and 'scope and purpose' (84%) were less problematic. CONCLUSION: This review indicates that there is considerable scope for improvement in the methods used to develop clinical guidelines for the prevention, management and treatment of chronic diseases in Europe. Given the importance of decision support strategies such as clinical guidelines in chronic disease management, improvement measures should include the explicit and transparent involvement of key stakeholders (especially scientific experts, guideline users and methodological specialists) and consideration of the implications for guideline implementation and applicability early on in the process.

Integrating prevention of mother-to-child HIV transmission programs to improve uptake: a systematic review.

BACKGROUND: We performed a systematic review to assess the effect of integrated perinatal prevention of mother-to-child transmission of HIV interventions compared to non- or partially integrated services on the uptake in low- and middle-income countries. METHODS: We searched for experimental, quasi-experimental and controlled observational studies in any language from 21 databases and grey literature sources. RESULTS: Out of 28 654 citations retrieved, five studies met our inclusion criteria. A cluster randomized controlled trial reported higher probability of nevirapine uptake at the labor wards implementing HIV testing and structured nevirapine adherence assessment (RRR 1.37, bootstrapped 95% CI, 1.04-1.77). A stepped wedge design study showed marked improvement in antiretroviral therapy (ART) enrolment (44.4% versus 25.3%, p<0.001) and initiation (32.9% versus 14.4%, p<0.001) in integrated care, but the median gestational age of ART initiation (27.1 versus 27.7 weeks, p = 0.4), ART duration (10.8 versus 10.0 weeks, p = 0.3) or 90 days ART retention (87.8% versus 91.3%, p = 0.3) did not differ significantly. A cohort study reported no significant difference either in the ART coverage (55% versus 48% versus 47%, p = 0.29) or eight weeks of ART duration before the delivery (50% versus 42% versus 52%; p = 0.96) between integrated, proximal and distal partially integrated care. Two before and after studies assessed the impact of integration on HIV testing uptake in antenatal care. The first study reported that significantly more women received information on PMTCT (92% versus 77%, p<0.001), were tested (76% versus 62%, p<0.001) and learned their HIV status (66% versus 55%, p<0.001) after integration. The second study also reported significant increase in HIV testing uptake after integration (98.8% versus 52.6%, p<0.001). CONCLUSION: Limited, non-generalizable evidence supports the effectiveness of integrated PMTCT programs. More research measuring coverage and other relevant outcomes is urgently needed to inform the design of services delivering PMTCT programs.

Clinical guidelines in the European Union: mapping the regulatory basis, development, quality control, implementation and evaluation across member states.

INTRODUCTION: Clinical guidelines are advocated to improve the quality of care, especially for chronic diseases. However, the regulatory basis of clinical guidelines, their development, quality control, implementation and use as well as evaluation within countries across the European Union is not systematically known. METHODS: Using information collected from key informants in each country by means of a structured questionnaire, this mapping exercise illustrates the varied status of guideline production in European Union countries. RESULTS: Most European Union countries have an established national, regional or local clinical guideline programme, and a substantial proportion have developed guidelines on the prevention and management of chronic diseases. Several countries have mechanisms in place to ensure the quality of scientific evidence used for the development of guidelines is high and that the process is consistent and transparent. Others are only now taking an interest in guideline development and are taking the first steps towards establishing ways of implementing them. The majority of countries have no legal basis for the development of guidelines and those that have well established systems mostly implement them on a voluntary basis. The process of guideline development varies in its degrees of decentralisation across countries with many different types of organisations taking on this responsibility. There is general acceptance of the value of the instrument developed by the AGREE collaboration for evaluating the methodological robustness of guidelines. However, the extent to which guidelines are implemented in Europe is unknown, as there is no systematic data collection and, in most countries, no structure to enable it. There are few examples of formal evaluations of the development, quality, implementation and use of guidelines. CONCLUSIONS: Our findings call for renewed efforts to respond to the severe lack of standardized guideline terminology and accessibility as well as rigorous studies to evaluate the relationship between different ways to develop guidelines and their methodological quality, between their quality and the actual implementation and usage, and finally between implementation and health outcomes.