Jan Odgaard-Jensen

Growing Literature, Stagnant Science? Systematic Review, Meta-Regression and Cumulative Analysis of Audit and Feedback Interventions in Health Care

ABSTRACTBACKGROUNDThis paper extends the findings of the Cochrane systematic review of audit and feedback on professional practice to explore the estimate of effect over time and examine whether new trials have added to knowledge regarding how optimize the effectiveness of audit and feedback.METHODSWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE for randomized trials of audit and feedback compared to usual care, with objectively measured outcomes assessing compliance with intended professional practice. Two reviewers independently screened articles and abstracted variables related to the intervention, the context, and trial methodology. The median absolute risk difference in compliance with intended professional practice was determined for each study, and adjusted for baseline performance. The effect size across studies was recalculated as studies were added to the cumulative analysis. Meta-regressions were conducted for studies published up to 2002, 2006, and 2010 in which characteristics of the intervention, the recipients, and trial risk of bias were tested as predictors of effect size.RESULTSOf the 140 randomized clinical trials (RCTs) included in the Cochrane review, 98 comparisons from 62 studies met the criteria for inclusion. The cumulative analysis indicated that the effect size became stable in 2003 after 51 comparisons from 30 trials. Cumulative meta-regressions suggested new trials are contributing little further information regarding the impact of common effect modifiers. Feedback appears most effective when: delivered by a supervisor or respected colleague; presented frequently; featuring both specific goals and action-plans; aiming to decrease the targeted behavior; baseline performance is lower; and recipients are non-physicians.DISCUSSIONThere is substantial evidence that audit and feedback can effectively improve quality of care, but little evidence of progress in the field. There are opportunity costs for patients, providers, and health care systems when investigators test quality improvement interventions that do not build upon, or contribute toward, extant knowledge.

Effects of female genital cutting on physical health outcomes: a systematic review and meta-analysis

Objective Worldwide, an estimated 125 million girls and women live with female genital mutilation/cutting (FGM/C). We aimed to systematically review the evidence for physical health risks associated with FGM/C. Design We searched 15 databases to identify studies (up to January 2012). Selection criteria were empirical studies reporting physical health outcomes from FGM/C, affecting females with any type of FGM/C, irrespective of ethnicity, nationality and age. Two review authors independently screened titles and abstracts, applied eligibility criteria, assessed methodological study quality and extracted full-text data. To derive overall risk estimates, we combined data from included studies using the Mantel-Haenszel method for unadjusted dichotomous data and the generic inverse-variance method for adjusted data. Outcomes that were sufficiently similar across studies and reasonably resistant to biases were aggregated in meta-analyses. We applied the instrument Grading of Recommendations Assessment, Development and Evaluation to assess the extent to which we have confidence in the effect estimates. Results Our search returned 5109 results, of which 185 studies (3.17 million women) satisfied the inclusion criteria. The risks of systematic and random errors were variable and we focused on key outcomes from the 57 studies with the best available evidence. The most common immediate complications were excessive bleeding, urine retention and genital tissue swelling. The most valid and statistically significant associations for the physical health sequelae of FGM/C were seen on urinary tract infections (unadjusted RR=3.01), bacterial vaginosis (adjusted OR (AOR)=1.68), dyspareunia (RR=1.53), prolonged labour (AOR=1.49), caesarean section (AOR=1.60), and difficult delivery (AOR=1.88). Conclusions While the precise estimation of the frequency and risk of immediate, gynaecological, sexual and obstetric complications is not possible, the results weigh against the continuation of FGM/C and support the diagnosis and management of girls and women suffering the physical risks of FGM/C. Trial registration number This study is registered with PROSPERO, number CRD42012003321.

Intensive training of motor function and functional skills among young children with cerebral palsy: a systematic review and meta-analysis

BackgroundYoung children with cerebral palsy (CP) receive a variety of interventions to prevent and/or reduce activity limitations and participation restrictions. Some of these interventions are intensive, and it is a challenge to identify the optimal intensity. Therefore, the objective of this systematic review was to describe and categorise intensive motor function and functional skills training among young children with CP, to summarise the effects of these interventions, and to examine characteristics that may contribute to explain the variations in these effects.MethodsTen databases were searched for controlled studies that included young children (mean age less than seven years old) with CP and assessments of the effects of intensive motor function and functional skills training. The studies were critically assessed by the Risk of bias tool (RoB) and categorised for intensity and contexts of interventions. Standardised mean difference were computed for outcomes, and summarised descriptively or in meta-analyses.ResultsThirty-eight studies were included. Studies that targeted gross motor function were fewer, older and with lower frequency of training sessions over longer training periods than studies that targeted hand function. Home training was most common in studies on hand function and functional skills, and often increased the amount of training. The effects of constraint induced movement therapy (CIMT) on hand function and functional skills were summarised in six meta-analyses, which supported the existing evidence of CIMT. In a majority of the included studies, equal improvements were identified between intensive intervention and conventional therapy or between two different intensive interventions.ConclusionsDifferent types of training, different intensities and different contexts between studies that targeted gross and fine motor function might explain some of the observed effect variations. Home training may increase the amount of training, but are less controllable. These factors may have contributed to the observed variations in the effectiveness of CIMT. Rigorous research on intensive gross motor training is needed.Systematic review registration numberCRD42013004023.

An updated systematic review and meta-analysis of the obstetric consequences of female genital mutilation/cutting.

In our recent systematic review in Obstetrics and Gynecology International of the association between FGM/C and obstetric harm we concluded that FGM/C significantly increases the risk of delivery complications. The findings were based on unadjusted effect estimates from both prospective and retrospective studies. To accommodate requests by critics, we aimed to validate these results through additional analyses based on adjusted estimates from prospective studies. We judged that 7 of the 28 studies included in our original systematic review were prospective. Statistical adjustments for measured confounding factors were made in eight studies, including three prospective studies. The adjusted confounders differed across studies in number and type. Results from meta-analyses based on adjusted estimates, with or without data from retrospective studies, consistently pointed in the same direction as our earlier findings. There were only small differences in the sizes or the level of statistical significance. Using GRADE, we assessed that our confidence in the effect estimates was very low or low for all outcomes. The adjusted estimates generally show similar obstetric harms from FGM/C as unadjusted estimates do. Thus, the current analyses confirm the findings from our previous systematic review. There are sufficient grounds to conclude that FGM/C, with respect to obstetric circumstances, involves harm.

The impact of an intervention programme employing a hands-on technique to reduce the incidence of anal sphincter tears: interrupted time-series reanalysis

Objective To re-evaluate previously published findings from an uncontrolled before–after evaluation of an intervention programme to reduce the incidence of anal sphincter tears. A key component of the programme was the use of a hands-on technique where the birth attendant presses the neonates head during the final stage of delivery while simultaneously supporting the womans perineum with the other hand. Design Interrupted time-series analysis using segmented regression modelling. Setting Obstetric departments of five Norwegian hospitals. Participants All women giving births vaginally in the study hospitals, 2002–2008. Methods The main data source was the Medical Birth Registry of Norway. We estimated the change in incidence of anal sphincter tears before and after implementation of the intervention in the five intervention hospitals, taking into account the trends in incidence before and after implementation. Main outcome measures Incidence of anal sphincter tears and episiotomies. Results There were 75 543 registered births at the five included hospitals. We found a 2% absolute reduction in incidence of anal sphincter tears associated with the hospital intervention programme, representing almost a halving in the number of women experiencing serious anal sphincter tears. This is a substantially smaller estimate than previously reported. However, it does represent a highly significant decrease in anal sphincter injuries. The programme was also associated with a significant increase in episiotomies. Conclusions The intervention programme was associated with a significant reduction in the incidence of obstetric anal sphincter tears. Still, the findings should be interpreted with caution as they seem to contradict the findings from randomised controlled studies of similar interventions.

Tailored interventions to implement recommendations for elderly patients with depression in primary care: a study protocol for a pragmatic cluster randomised controlled trial

BackgroundThe prevalence of depression is high and the elderly have an increased risk of developing chronic course. International data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. Although recommendations for the treatment of elderly patients with depression exist, health-care professionals adhere to these recommendations to a limited degree only. We conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. We identified and prioritised the determinants of practice related to the implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. The objective of this study is to evaluate the effectiveness of these tailored interventions for the six recommendations for the management of elderly patients with depression in primary care.Methods/designWe will conduct a pragmatic cluster randomised trial comparing the implementation of the six recommendations using tailored interventions with usual care. We will randomise 80 municipalities into one of two groups: an intervention group, to which we will deliver tailored interventions to implement the six recommendations, and a control group, to which we will not deliver any intervention. We will randomise municipalities rather than patients, individual clinicians or practices, because we will deliver the intervention for the first three recommendations at the municipal level and we want to minimise the risk of contamination across GP practices for the other three recommendations. The primary outcome is the proportion of actions taken by GPs that are consistent with the recommendations.DiscussionThis trial will investigate whether a tailored implementation approach is an effective strategy for improving collaborative care in the municipalities and health-care professionals’ practice towards elderly patients with depression in primary care. The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.Trial registrationClinicalTrials.gov: NCT01913236

Evaluation of a web portal for improving public access to evidence-based health information and health literacy skills: a pragmatic trial.

Background Using the conceptual framework of shared decision-making and evidence-based practice, a web portal was developed to serve as a generic (non disease-specific) tailored intervention to improve the lay publics health literacy skills. Objective To evaluate the effects of the web portal compared to no intervention in a real-life setting. Methods A pragmatic randomised controlled parallel trial using simple randomisation of 96 parents who had children aged <4 years. Parents were allocated to receive either access to the portal or no intervention, and assigned three tasks to perform over a three-week period. These included a searching task, a critical appraisal task, and reporting on perceptions about participation. Data were collected from March through June 2011. Results Use of the web portal was found to improve attitudes towards searching for health information. This variable was identified as the most important predictor of intention to search in both samples. Participants considered the web portal to have good usability, usefulness, and credibility. The intervention group showed slight increases in the use of evidence-based information, critical appraisal skills, and participation compared to the group receiving no intervention, but these differences were not statistically significant. Conclusion Despite the fact that the study was underpowered, we found that the web portal may have a positive effect on attitudes towards searching for health information. Furthermore, participants considered the web portal to be a relevant tool. It is important to continue experimenting with web-based resources in order to increase user participation in health care decision-making. Trial Registration ClinicalTrials.gov NCT01266798

Nonrandomized studies are not always found even when selection criteria for health systems intervention reviews include them: a methodological study

OBJECTIVE Systematic reviews within the Cochrane Effective Practice and Organisation of Care Group (EPOC) can include both randomized and nonrandomized study designs. We explored how many EPOC reviews consider and identify nonrandomized studies, and whether the proportion of nonrandomized studies identified is linked to the review topic. STUDY DESIGN AND SETTING We recorded the study designs considered in 65 EPOC reviews. For reviews that considered nonrandomized studies, we calculated the proportion of identified studies that were nonrandomized and explored whether there were differences in the proportion of nonrandomized studies according to the review topic. RESULTS Fifty-one (78.5%) reviews considered nonrandomized studies. Forty-six of these reviews found nonrandomized studies, but the proportion varied a great deal (median, 33%; interquartile range, 25--50%). Reviews of health care delivery interventions had lower proportions of nonrandomized studies than those of financial and governance interventions. CONCLUSION Most EPOC reviews consider nonrandomized studies, but the degree to which they find them varies. As nonrandomized studies are believed to be at higher risk of bias and their inclusion entails a considerable effort, review authors should consider whether the benefits justify the inclusion of these designs. Research should explore whether it is more useful to consider nonrandomized studies in reviews of some intervention types than others.

Effects of a conductive education course in young children with cerebral palsy:A randomized controlled trial

ABSTRACT Purpose: To evaluate the effects of a conductive education (CE) course followed by conventional practice, on gross motor function, other functional skills, quality of life, and parents’ experiences of family-centered services in young children with cerebral palsy (CP). Methods: Twenty-one children with CP, 3–6 years old, were randomized to one 3-week CE course followed by conventional practice or conventional practice on a waiting list. Outcomes were measured 4 months after baseline. A web-based log collected data on the conventional practice. Results: No additional improvements in the children’s outcome were found. However, parents in the CE group reported that they received more information than parents in the waiting list group (p = 0.01). Children in both groups performed high amount of conventional practice at home. Conclusions: A 3-week CE course did not add any improvements in the children’s functioning, possibly explained by the large amount of conventional practice reported of both groups.

Multiple treatment comparison of seven new drugs for patients with advanced malignant melanoma: a systematic review and health economic decision model in a Norwegian setting

Objective To assess the relative effectiveness and cost-effectiveness of seven new drugs (cobimetinib, dabrafenib, ipilimumab, nivolumab, pembrolizumab, trametinib and vemurafenib) used for treatment of patients with advanced malignant melanoma in the Norwegian setting. Design A multiple technology assessment. Patients Patients with advanced malignant melanoma aged 18 or older. Data sources A systematic search for randomised controlled trials in relevant bibliographic databases. Methods We performed network meta-analyses using both direct and indirect evidence with dacarbazine as a common comparator. We ranked the different treatments in terms of their likelihood of leading to the best results for each endpoint. The cost-utility analysis was based on a probabilistic discrete-time Markov cohort model. The model calculated the costs and quality-adjusted life years (QALYs) with different treatment strategies from a healthcare perspective. Sensitivity analysis was performed by means of Monte Carlo simulation. Results Monotherapies with a programmed cell death 1 (PD-1) immune-checkpoint-inhibitor had a higher probability of good performance for overall survival than monotherapies with ipilimumab or BRAF/MEK inhibitors. The combination treatments had all similar levels of effectiveness to the PD-1 immune-checkpoint-inhibitors. PD-1 immune-checkpoint-inhibitors are more effective and more costly compared with ipilimumab in monotherapy. Nivolumab in combination with ipilimumab had higher costs and the same level of effectiveness as the PD-1 immune-checkpoint-inhibitors in monotherapy. BRAF/MEK inhibitor combinations (dabrafenib and trametinib or vemurafenib and cobimetinib) had both similar effectiveness and cost-effectiveness; however, the combination therapies are more likely to give higher quality adjusted life year gains than BRAF or MEK inhibitor monotherapies, but to a higher cost. Conclusions None of the drugs investigated can be considered cost-effective at what has normally been considered a reasonable willingness-to-pay (WTP) in Norway. Price reductions (from the official list prices) in the region of 63%–84% would be necessary for these drugs to be cost-effective at a WTP of €55 850 per QALY.