GRADE Evidence to Decision (EtD) frameworks : a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines

Funding: Work on this article has been partially funded by the European Commission FP7 Program (grant agreement 258583) as part of the DECIDE project. Sole responsibility lies with the authors; the European Commission is not responsible for any use that may be made of the information contained therein.Peer reviewedPublisher PD

GRADE Evidence to Decision (EtD) frameworks : A systematic and transparent approach to making well-informed healthcare choices. 1. Introduction

Funding: Work on this article has been partially funded by the European Commission FP7 Program (grant agreement 258583) as part of the DECIDE project. Sole responsibility lies with the authors; the European Commission is not responsible for any use that may be made of the information contained therein.Peer reviewedPublisher PD

Fertility and early pregnancy outcomes after conservative treatment for cervical intraepithelial neoplasia

BACKGROUND: Cervical intra-epithelial neoplasia (CIN) typically occurs in young women of reproductive age. Although several studies have reported the impact that cervical conservative treatment may have on obstetric outcomes, there is much less evidence for fertility and early pregnancy outcomes. OBJECTIVES: To assess the effect of cervical treatment for CIN (excisional or ablative) on fertility and early pregnancy outcomes. SEARCH METHODS: We searched in January 2015 the following databases: the Cochrane Gynaecological Cancer Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library, Issue 12, 2014), MEDLINE (up to November week 3, 2014) and EMBASE (up to week 52, 2014). SELECTION CRITERIA: We included all studies reporting on fertility and early pregnancy outcomes (less than 24 weeks of gestation) in women with a history of CIN treatment (excisional or ablative) as compared to women that had not received treatment. DATA COLLECTION AND ANALYSIS: Studies were classified according to the treatment method used and the fertility or early pregnancy endpoint. Pooled risk ratios (RR) and 95% confidence intervals (CI) were calculated using a random-effects model and inter-study heterogeneity was assessed with I(2). Two review authors (MK, AM) independently assessed the eligibility of retrieved papers and risk of bias. The two review authors then compared their results and any disagreements were resolved by discussion. If still unresolved, a third review author (MA) was involved until consensus was reached. MAIN RESULTS: Fifteen studies (2,223,592 participants - 25,008 treated and 2,198,584 untreated) that fulfilled the inclusion criteria for this review were identified from the literature search. The meta-analysis demonstrated that treatment for CIN did not adversely affect the chances of conception. The overall pregnancy rate was higher for treated (43%) versus untreated women (38%; RR 1.29, 95% CI 1.02 to 1.64; 4 studies, 38,050 participants, very low quality), although the inter-study heterogeneity was considerable (P < 0.01). The pregnancy rates in treated and untreated women with an intention to conceive (88% versus 95%, RR 0.93, 95% CI 0.80 to 1.08; 2 studies, 70 participants, very low quality) and the number of women requiring more than 12 months to conceive (14% versus 9%, RR 1.45, 95% CI 0.89 to 2.37; 3 studies, 1348 participants, very low quality) were no different. Although the total miscarriage rate (4.6% versus 2.8%, RR 1.04, 95% CI 0.90 to 1.21; 10 studies, 39,504 participants, low quality) and first trimester miscarriage rate (9.8% versus 8.4%, RR 1.16, 95% CI 0.80 to 1.69, 4 studies, 1103 participants, low quality) was similar for treated and untreated women, CIN treatment was associated with an increased risk of second trimester miscarriage, (1.6% versus 0.4%, RR 2.60, 95% CI 1.45 to 4.67; 8 studies, 2,182,268 participants, low quality). The number of ectopic pregnancies (1.6% versus 0.8%, RR 1.89, 95% CI 1.50 to 2.39; 6 studies, 38,193 participants, low quality) and terminations (12.2% versus 7.4%, RR 1.71, 95% CI 1.31 to 2.22; 7 studies, 38,208 participants, low quality) were also higher in treated women.The results should be interpreted with caution. The included studies were often small with heterogenous design. Most of these studies were retrospective and of low or very low quality (GRADE assessment) and were therefore prone to bias. Subgroup analyses for the individual treatment methods and comparison groups and analysis to stratify for the cone length was not possible. AUTHORS' CONCLUSIONS: This meta-analysis suggests that treatment for CIN does not adversely affect fertility, although treatment was associated with an increased risk of miscarriage in the second trimester. These results should be interpreted with caution as the included studies were non-randomised and many were of low or very low quality and therefore at high risk of bias. Research should explore mechanisms that may explain the increase in mid-trimester miscarriage risk and stratify this impact of treatment by the length of the cone and the treatment method used

Twelve years of clinical practice guideline development, dissemination and evaluation in Canada (1994 to 2005)

Background - Despite the growing availability of clinical practice guidelines since the early 1990's, little is known about how guideline development and dissemination may have changed over time in Canada. This study compares Canadian guideline development, dissemination, and evaluation in two six year periods from 1994–1999 and 2000–2005. // Methods - Survey of guideline developers who submitted their clinical practice guidelines to the Canadian Medical Association Infobase (a Canadian guideline repository) between 1994 and 2005. Survey items included information about the developers, aspects of guideline development, and dissemination and evaluation activities. // Results - Surveys were sent to the developers of 2341 guidelines in the CMA Infobase over the 12 year period, 1664 surveys were returned (response rate 71%). Of these, 730 unique guidelines were released from 1994–1999, and 630 were released from 2000–2005. Compared to the earlier period, more recent guidelines were being produced in English only. There has been little change in the type of organizations developing guidelines with most developed by provincial and national organizations. In the recent period, developers were more likely to report using computerized search strategies (94% versus 88%), publishing the search strategy (42% versus 34%), reaching consensus using open discussion (95% versus 78%), and evaluating effectiveness of the dissemination strategies (12% versus 6%) and the impact of the CPGs on health outcomes (24% versus 5%). Recent guidelines were less likely to be based on literature reviews (94% versus 99.6%) and were disseminated using fewer strategies (mean 4.78 versus 4.12). // Conclusion - Given that guideline development processes have improved in some areas over the past 12 years yet not in others, ongoing monitoring of guideline quality is required. Guidelines produced more recently in Canada are less likely to be based on a review of the evidence and only about half discuss levels of evidence underlying recommendations. Guideline dissemination and implementation activities have actually decreased. Unfortunately, the potential positive impact on patient health outcomes will not be realized until the recommendations are adopted and acted upon

Extending an evidence hierarchy to include topics other than treatment: revising the Australian 'levels of evidence'

Background: In 1999 a four-level hierarchy of evidence was promoted by the National Health and Medical Research Council in Australia. The primary purpose of this hierarchy was to assist with clinical practice guideline development, although it was co-opted for use in systematic literature reviews and health technology assessments. In this hierarchy interventional study designs were ranked according to the likelihood that bias had been eliminated and thus it was not ideal to assess studies that addressed other types of clinical questions. This paper reports on the revision and extension of this evidence hierarchy to enable broader use within existing evidence assessment systems. Methods: A working party identified and assessed empirical evidence, and used a commissioned review of existing evidence assessment schema, to support decision-making regarding revision of the hierarchy. The aim was to retain the existing evidence levels I-IV but increase their relevance for assessing the quality of individual diagnostic accuracy, prognostic, aetiologic and screening studies. Comprehensive public consultation was undertaken and the revised hierarchy was piloted by individual health technology assessment agencies and clinical practice guideline developers. After two and a half years, the hierarchy was again revised and commenced a further 18 month pilot period. Results: A suitable framework was identified upon which to model the revision. Consistency was maintained in the hierarchy of "levels of evidence" across all types of clinical questions; empirical evidence was used to support the relationship between study design and ranking in the hierarchy wherever possible; and systematic reviews of lower level studies were themselves ascribed a ranking. The impact of ethics on the hierarchy of study designs was acknowledged in the framework, along with a consideration of how harms should be assessed. Conclusion: The revised evidence hierarchy is now widely used and provides a common standard against which to initially judge the likelihood of bias in individual studies evaluating interventional, diagnostic accuracy, prognostic, aetiologic or screening topics. Detailed quality appraisal of these individual studies, as well as grading of the body of evidence to answer each clinical, research or policy question, can then be undertaken as required.Tracy Merlin, Adele Weston and Rebecca Toohe

Impact of quality of evidence on the strength of recommendations: an empirical study

<p>Abstract</p> <p>Background</p> <p>Evidence is necessary but not sufficient for decision-making, such as making recommendations by clinical practice guideline panels. However, the fundamental premise of evidence-based medicine (EBM) rests on the assumed link between the quality of evidence and "truth" and/or correctness in making guideline recommendations. If this assumption is accurate, then the quality of evidence ought to play a key role in making guideline recommendations. Surprisingly, and despite the widespread penetration of EBM in health care, there has been no empirical research to date investigating the impact of quality of evidence on the strength of recommendations made by guidelines panels.</p> <p>Methods</p> <p>The American Association of Blood Banking (AABB) has recently convened a 12 member panel to develop clinical practice guidelines (CPG) for the use of fresh-frozen plasma (FFP) for 6 different clinical indications. The panel was instructed that 4 factors should play a role in making recommendation: quality of evidence, uncertainty about the balance between desirable (benefits) and undesirable effects (harms), uncertainty or variability in values and preferences, and uncertainty about whether the intervention represents a wise use of resources (costs). Each member of the panel was asked to make his/her final judgments on the strength of recommendation and the overall quality of the body of evidence. "Voting" was anonymous and was based on the use of GRADE (Grading quality of evidence and strength of recommendations) system, which clearly distinguishes between quality of evidence and strength of recommendations.</p> <p>Results</p> <p>Despite the fact that many factors play role in formulating CPG recommendations, we show that when the quality of evidence is higher, the probability of making a strong recommendation for or against an intervention dramatically increases. Probability of making strong recommendation was 62% when evidence is "moderate", while it was only 23% and 13% when evidence was "low" or "very low", respectively.</p> <p>Conclusion</p> <p>We report the first empirical evaluation of the relationship between quality of evidence pertinent to a clinical question and strength of the corresponding guideline recommendations. Understanding the relationship between quality of evidence and probability of making (strong) recommendation has profound implications for the science of quality measurement in health care.</p

Quality indicators for Palliative Day Services: A modified Delphi study

BACKGROUND: The goal of Palliative Day Services is to provide holistic care that contributes to the quality of life of people with life threatening-illness and their families. Quality indicators provide a means by which to describe, monitor and evaluate the quality of Palliative Day Services provision, and act as a starting point for quality improvement. However, currently, there are no published quality indicators for Palliative Day Services. AIM: To develop and provide the first set of quality indicators that describe and evaluate the quality of Palliative Day Services. DESIGN AND SETTING: A modified Delphi technique was used to combine best available research evidence derived from a systematic scoping review with multi-disciplinary expert appraisal of the appropriateness and feasibility of candidate indicators. The resulting indicators were compiled into ‘toolkit’, and tested in five UK Palliative Day Service settings. RESULTS: A panel of experts independently reviewed evidence summaries for 182 candidate indicators and provided ratings on appropriateness, followed by a panel discussion and further independent ratings of appropriateness, feasibility, and necessity. This exercise resulted in the identification of 30 indicators which were used in practice testing. The final indicator set comprised 7 structural indicators, 21 process indicators, and 2 outcome indicators. CONCLUSIONS: The indicators fulfil a previously unmet need among Palliative Day Service providers by delivering an appropriate and feasible means to assess, review, and communicate the quality of care, and to identify areas for quality improvement

Psychological interventions for improving adherence to oral hygiene instructions in adults with periodontal diseases

Background: Adherence to oral hygiene is an important aspect of the treatment of periodontal disease. Traditional educational interventions have been shown to be of little value in achieving long term behaviour change. Objectives: The aim of this review was to determine the impact of interventions aimed to increase adherence to oral hygiene instructions in adult periodontal patients based on psychological models and theoretical frameworks. This review considered the following outcomes:Observational measures of oral health related behaviourSelf reported oral health related behaviours, beliefs and attitudes towards oral health related behaviourClinical markers of periodontal disease. Search methods: The Cochrane Oral Health Group's Trials Register (2005), CENTRAL (The Cochrane Library 2004, Issue 4), MEDLINE (from 1966 to December 2004), EMBASE (from 1980 to December 2004), PsycINFO (from 1966 to December 2004), Ingenta (from 1998 to December 2004) and CINAHL (from 1966 to December 2004). Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information. No language restriction was applied. Selection criteria: Randomised controlled trials testing the effectiveness of interventions based on psychological models compared with educational, attention or no active intervention controls to improve adherence to oral hygiene in adults with either gingivitis or periodontitis. Data collection and analysis: Titles and abstracts of studies that were potentially relevant to the review were independently screened by two review authors. Those that were clearly ineligible were rejected. For the remaining studies, the full paper was reviewed by two review authors and where necessary further information was sought from the author to verify eligibility. Included studies were assessed on their quality using standard criteria. Main results: The review identified four studies (including 344 participants) in which a psychological model or theory had been explicitly used as the basis for the design of the intervention. The overall quality of trials was low. Due to the heterogeneity between studies, both in terms of outcome measures and psychological models adopted, a meta-analysis was not possible. The four studies adopted four different theoretical frameworks, though there was some overlap in that three of the studies incorporated elements of Operant and Classical Conditioning. Psychological interventions resulted in improved plaque scores in comparison to no intervention groups, and in one study in comparison to an attention control group. One study found decreased gingival bleeding in the active intervention group but no change in pocket depth or attachment loss after 4 months. Psychological interventions were associated with improved self reported brushing and flossing in both studies which assessed these behaviours. Only one study explored the impact of psychological interventions on beliefs and attitudes, the psychological intervention, in comparison to educational and no intervention controls, showed improved self efficacy beliefs in relation to flossing, but no effect on dental knowledge or self efficacy beliefs in relation to tooth brushing. Authors' conclusions: There is tentative evidence from low quality studies that psychological approaches to behaviour management can improve oral hygiene related behaviours. However, the overall quality of the included trials was low. Furthermore, the design of the interventions was weak and limited, ignoring key aspects of the theories. Thus, there is a need for greater methodological rigour in the design of trials in this area

Music therapy for people with substance use disorders (Protocol)

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: Main objective To assess the effects of music therapy, as a primary or a supportive intervention, compared to standard care, wait-list control or no treatment, for people with substance use disorders, to reduce substance use,the severity of substance dependence/abuse, psychological symptoms, and substance craving; to enhance motivation for change/treatment; and for retention in treatment. Secondary objective To assess the impact of the number of music therapy sessions on study outcome