Strategies to improve recruitment to randomised trials.

BACKGROUND: Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. OBJECTIVES: To quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment. SEARCH METHODS: We searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015). SELECTION CRITERIA: Randomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants. DATA COLLECTION AND ANALYSIS: We extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison. MAIN RESULTS: We identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in health care.We found 72 comparisons, but just three are supported by high-certainty evidence according to GRADE.1. Open trials rather than blinded, placebo trials. The absolute improvement was 10% (95% CI 7% to 13%).2. Telephone reminders to people who do not respond to a postal invitation. The absolute improvement was 6% (95% CI 3% to 9%). This result applies to trials that have low underlying recruitment. We are less certain for trials that start out with moderately good recruitment (i.e. over 10%).3. Using a particular, bespoke, user-testing approach to develop participant information leaflets. This method involved spending a lot of time working with the target population for recruitment to decide on the content, format and appearance of the participant information leaflet. This made little or no difference to recruitment: absolute improvement was 1% (95% CI -1% to 3%).We had moderate-certainty evidence for eight other comparisons; our confidence was reduced for most of these because the results came from a single study. Three of the methods were changes to trial management, three were changes to how potential participants received information, one was aimed at recruiters, and the last was a test of financial incentives. All of these comparisons would benefit from other researchers replicating the evaluation. There were no evaluations in paediatric trials.We had much less confidence in the other 61 comparisons because the studies had design flaws, were single studies, had very uncertain results or were hypothetical (mock) trials rather than real ones. AUTHORS' CONCLUSIONS: The literature on interventions to improve recruitment to trials has plenty of variety but little depth. Only 3 of 72 comparisons are supported by high-certainty evidence according to GRADE: having an open trial and using telephone reminders to non-responders to postal interventions both increase recruitment; a specialised way of developing participant information leaflets had little or no effect. The methodology research community should improve the evidence base by replicating evaluations of existing strategies, rather than developing and testing new ones.

Optical coherence tomography for the monitoring of neovascular age-related macular degeneration: a systematic review.

TOPIC: To compare the accuracy of optical coherence tomography (OCT) with alternative tests for monitoring neovascular age-related macular degeneration (nAMD) and detecting disease activity among eyes previously treated for this condition. CLINICAL RELEVANCE: Traditionally, fundus fluorescein angiography (FFA) has been considered the reference standard to detect nAMD activity, but FFA is costly and invasive. Replacement of FFA by OCT can be justified if there is a substantial agreement between tests. METHODS: Systematic review and meta-analysis. The index test was OCT. The comparator tests were visual acuity, clinical evaluation (slit lamp), Amsler chart, color fundus photographs, infrared reflectance, red-free images and blue reflectance, fundus autofluorescence imaging, indocyanine green angiography (ICGA), preferential hyperacuity perimetry, and microperimetry. We searched the following databases: MEDLINE, MEDLINE In-Process, EMBASE, Biosis, Science Citation Index, the Cochrane Library, Database of Abstracts of Reviews of Effects, MEDION, and the Health Technology Assessment database. The last literature search was conducted in March 2013. We used the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) to assess risk of bias. RESULTS: We included 8 studies involving more than 400 participants. Seven reported the performance of OCT (3 time-domain [TD] OCT, 3 spectral-domain [SD] OCT, 1 both types) and 1 reported the performance of ICGA in the detection of nAMD activity. We did not find studies directly comparing tests in the same population. The pooled sensitivity and specificity of TD OCT and SD OCT for detecting active nAMD was 85% (95% confidence interval [CI], 72%-93%) and 48% (95% CI, 30%-67%), respectively. One study reported ICGA with sensitivity of 75.9% and specificity of 88.0% for the detection of active nAMD. Half of the studies were considered to have a high risk of bias. CONCLUSIONS: There is substantial disagreement between OCT and FFA findings in detecting active disease in patients with nAMD who are being monitored. Both methods may be needed to monitor patients comprehensively with nAMD.

Systematic review of the clinical and cost effectiveness of cholecystectomy versus observation/conservative management for uncomplicated symptomatic gallstones or cholecystitis.

BACKGROUND: Gallstone disease is a common gastrointestinal disorder in industrialised countries. Although symptoms can be severe, some people can be symptom free for many years after the original attack. Surgery is the current treatment of choice, but evidence suggests that observation is also feasible and safe. We reviewed the evidence on cholecystectomy versus observation for uncomplicated symptomatic gallstones and conducted a cost-effectiveness analysis. METHODS: We searched six electronic databases (last search April 2014). We included randomised controlled trials (RCTs) or non-randomised comparative studies where adults received either cholecystectomy or observation/conservative management for the first episode of symptomatic gallstone disease (biliary pain or cholecystitis) being considered for surgery in secondary care. Meta-analysis was used to combine results. A de novo Markov model was developed to assess the cost effectiveness of the interventions. RESULTS: Two RCTs (201 participants) were included. Eighty-eight percent of people randomised to surgery and 45 % of people randomised to observation underwent cholecystectomy during the 14-year follow-up period. Participants randomised to observation were significantly more likely to experience gallstone-related complications (RR = 6.69, 95 % CI = 1.57-28.51, p = 0.01), in particular acute cholecystitis (RR = 9.55, 95 % CI = 1.25-73.27, p = 0.03), and less likely to undergo surgery (RR = 0.50, 95 % CI = 0.34-0.73, p = 0.0004) or experience surgery-related complications (RR = 0.36, 95 % CI = 0.16-0.81, p = 0.01) than those randomised to surgery. Fifty-five percent of people randomised to observation did not require surgery, and 12 % of people randomised to cholecystectomy did not undergo surgery. On average, surgery costs £1,236 more per patient than conservative management, but was more effective. CONCLUSIONS: Cholecystectomy is the preferred treatment for symptomatic gallstones. However, approximately half the observation group did not require surgery or suffer complications indicating that it may be a valid alternative to surgery. A multicentre trial is needed to establish the effects, safety and cost effectiveness of observation/conservative management relative to cholecystectomy.

Methods for specifying the target difference in a randomised controlled trial: the Difference ELicitation in TriAls (DELTA) systematic review.

BACKGROUND: Randomised controlled trials (RCTs) are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target) difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation. METHODS AND FINDINGS: A comprehensive systematic review of medical and non-medical literature was carried out for methods that could be used to specify the target difference for an RCT sample size calculation. The databases searched were MEDLINE, MEDLINE In-Process, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Methodology Register, PsycINFO, Science Citation Index, EconLit, the Education Resources Information Center (ERIC), and Scopus (for in-press publications); the search period was from 1966 or the earliest date covered, to between November 2010 and January 2011. Additionally, textbooks addressing the methodology of clinical trials and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) tripartite guidelines for clinical trials were also consulted. A narrative synthesis of methods was produced. Studies that described a method that could be used for specifying an important and/or realistic difference were included. The search identified 11,485 potentially relevant articles from the databases searched. Of these, 1,434 were selected for full-text assessment, and a further nine were identified from other sources. Fifteen clinical trial textbooks and the ICH tripartite guidelines were also reviewed. In total, 777 studies were included, and within them, seven methods were identified-anchor, distribution, health economic, opinion-seeking, pilot study, review of the evidence base, and standardised effect size. CONCLUSIONS: A variety of methods are available that researchers can use for specifying the target difference in an RCT sample size calculation. Appropriate methods may vary depending on the aim (e.g., specifying an important difference versus a realistic difference), context (e.g., research question and availability of data), and underlying framework adopted (e.g., Bayesian versus conventional statistical approach). Guidance on the use of each method is given. No single method provides a perfect solution for all contexts.

Reporting methodological search filter performance comparisons: a literature review.

BACKGROUND: Methodological search filters are tools for retrieving database records reporting studies which use a specific research method. Choosing a filter is likely to be based on filter performance data. This review examines which measures are reported, and the way that filter performance is presented, in filter comparisons. METHODS: Studies were identified from the current content and pending update (2010) of a filter website. Eligible studies compared two or more methodological search filters designed to identify randomised controlled trials, diagnostic test accuracy studies, systematic reviews or economic evaluations. RESULTS: Eighteen studies met the inclusion criteria. The number of filters compared in a single study ranged from 2 to 38. The most commonly reported measures were sensitivity/recall and precision. All studies displayed results in tables and gave results as percentages or proportions. Two studies supplemented results tables with graphical displays of data: a bar graph of the proportion of retrieved and missed gold standard references per filter; a forest plot of the overall sensitivity and specificity of each filter. CONCLUSIONS: Sensitivity/recall and precision are the most frequently reported performance measures. This review highlights the potential for presenting results in novel and innovative ways to aid filter selection.

Choosing and using methodological search filters: searchers' views.

BACKGROUND: Search filters or hedges are search strategies developed to assist information specialists and librarians to retrieve different types of evidence from bibliographic databases. The objectives of this project were to learn about searchers' filter use, how searchers choose search filters and what information they would like to receive to inform their choices. METHODS: Interviews with information specialists working in, or for, the National Institute for Health and Care Excellence (NICE) were conducted. An online questionnaire survey was also conducted and advertised via a range of email lists. RESULTS: Sixteen interviews were undertaken and 90 completed questionnaires were received. The use of search filters tends to be linked to reducing a large amount of literature, introducing focus and assisting with searches that are based on a single study type. Respondents use numerous ways to identify search filters and can find choosing between different filters problematic because of knowledge gaps and lack of time. CONCLUSIONS: Search filters are used mainly for reducing large result sets (introducing focus) and assisting with searches focused on a single study type. Features that would help with choosing filters include making information about filters less technical, offering ratings and providing more detail about filter validation strategies and filter provenance.

Relative effectiveness of robot-assisted and standard laparoscopic prostatectomy as alternatives to open radical prostatectomy for treatment of localised prostate cancer: a systematic review and mixed treatment comparison meta-analysis.

OBJECTIVE: To compare the effectiveness of robot-assisted and standard laparoscopic prostatectomy. METHODS: A care pathway was described. We performed a systematic literature review based on a search of Medline, Medline in Process, Embase, Biosis, Science Citation Index, Cochrane Controlled Trials Register, Current Controlled Trials, Clinical Trials, WHO International Clinical Trials Registry and NIH Reporter, the Health Technology Assessment databases, the Database of Abstracts of Reviews of Effects, and relevant conference abstracts up to 31st October 2010). Additionally, reference lists were scanned, an expert panel consulted, and websites of manufacturers, professional organisations, and regulatory bodies were checked. We selected randomised controlled trials (RCTs) and non-randomised comparative studies, published after 1st January 1995, including men with localised prostate cancer undergoing robot-assisted or laparoscopic prostatectomy compared with the other procedure or with open prostatectomy. Studies where at least 90% of included men had clinical tumour stages T1 to T2 and which reported at least one of our specified outcomes were eligible for inclusion. A mixed-treatment comparison meta-analysis was performed to generate comparative statistics on specified outcomes. RESULTS: We included data from 19 064 men across one RCT and 57 non-randomised comparative reports. Robotic prostatectomy had a lower risk of major intra-operative harms such as organ injury [0.4% robotic vs 2.9% laparoscopic], odds ratio ([OR] {95% credible interval [CrI]} 0.16 [0.03 to 0.76]), and a lower rate of surgical margins positive for cancer [17.6% robotic vs 23.6% laparoscopic], OR [95% CrI] 0.69 [0.51 to 0.96]). There was no evidence of a difference in the proportion of men with urinary incontinence at 12 months (OR [95% CrI] 0.55 [0.09 to 2.84]). There were insufficient data on sexual dysfunction. Surgeon learning rates for the procedures did not differ, although data were limited. CONCLUSIONS: Men undergoing robotic prostatectomy appear to have reduced surgical morbidity, and a lower risk of a positive surgical margin, which may reduce rates of cancer recurrence and the need for further treatment, but considerable uncertainty surrounds these results. We found no evidence that men undergoing robotic prostatectomy are disadvantaged in terms of early outcomes. We were unable to determine longer-term relative effectiveness.

Systematic review of the agreement of tonometers with Goldmann applanation tonometry.

OBJECTIVE: To assess the agreement of tonometers available for clinical practice with the Goldmann applanation tonometer (GAT), the most commonly accepted reference device. DESIGN: A systematic review and meta-analysis of directly comparative studies assessing the agreement of 1 or more tonometers with the reference tonometer (GAT). PARTICIPANTS: A total of 11 582 participants (15 525 eyes) were included. METHODS: Summary 95% limits of agreement (LoA) were produced for each comparison. MAIN OUTCOME MEASURES: Agreement, recordability, and reliability. RESULTS: A total of 102 studies, including 130 paired comparisons, were included, representing 8 tonometers: dynamic contour tonometer, noncontact tonometer (NCT), ocular response analyzer, Ocuton S, handheld applanation tonometer (HAT), rebound tonometer, transpalpebral tonometer, and Tono-Pen. The agreement (95% limits) seemed to vary across tonometers: 0.2 mmHg (-3.8 to 4.3 mmHg) for the NCT to 2.7 mmHg (-4.1 to 9.6 mmHg) for the Ocuton S. The estimated proportion within 2 mmHg of the GAT ranged from 33% (Ocuton S) to 66% and 59% (NCT and HAT, respectively). Substantial inter- and intraobserver variability were observed for all tonometers. CONCLUSIONS: The NCT and HAT seem to achieve a measurement closest to the GAT. However, there was substantial variability in measurements both within and between studies.

Using qualitative methods in pilot and feasibility trials to inform recruitment and retention processes in full-scale randomised trials: a qualitative evidence synthesis.

OBJECTIVES: To systematically review published pretrial qualitative research studies and explore how their findings were used to inform recruitment and retention processes in full-scale trials. DESIGN: Qualitative evidence synthesis using thematic analysis. DATA SOURCES AND ELIGIBILITY CRITERIA: We conducted a comprehensive search of databases; Dissertation Abstracts International, CINAHL, Embase, MEDLINE, Sociological Abstracts and PsycINFO. We included all reports of pretrial qualitative data on recruitment and retention in clinical trials up to March 2018. DATA EXTRACTION AND SYNTHESIS: Two authors independently extracted data using a predefined data extraction form that captured study aims, design, methodological approach and main findings, including barriers and facilitators to recruitment and or retention. The synthesis was undertaken using Thomas and Harden's thematic synthesis method and reported following the Enhancing Transparency in Reporting the Synthesis of Qualitative Research guidelines. Confidence was assessed using Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research approach. RESULTS: Thirty-five papers (connected to 31 feasibility studies) from three different countries, published between 2010 and 2017 were included. All studies were embedded in pilot or feasibility studies to inform design aspects in preparation for a subsequent full-scale trial. Twelve themes were identified as recruitment barriers and three as recruitment facilitators. Two themes were identified as barriers for retention and none as retention facilitators. The findings from qualitative research in feasibility or pilot trials are often not explicitly linked to proposed changes to the recruitment and retention strategies to be used in the future or planned full-scale trial. CONCLUSIONS: Many trial teams do pretrial qualitative work with the aim of improving recruitment and retention in future full-scale trials. Just over half of all reports of such work do not clearly show how their findings will change the recruitment and retention strategy of the future trial. The scope of pretrial work needs to expand beyond looking for problems and also look for what might help and spend more time on retention.

Surveillance mammography for detecting ipsilateral breast tumour recurrence and metachronous contralateral breast cancer: a systematic review.

OBJECTIVES: To determine the diagnostic accuracy of surveillance mammography for detecting ipsilateral breast tumour recurrence and metachronous contralateral breast cancer in women previously treated for primary breast cancer. METHODS: A systematic review of surveillance mammography compared with ultrasound, magnetic resonance imaging (MRI), specialist-led clinical examination or unstructured primary care follow-up, using histopathological assessment for test positives and follow-up for test negatives as the reference standard. RESULTS: Nine studies met our inclusion criteria. Variations in study comparisons precluded meta-analysis. For routine ipsilateral breast tumour detection, surveillance mammography sensitivity ranged from 64-67% and specificity ranged from 85-97%. For MRI, sensitivity ranged from 86-100% and specificity was 93%. For non-routine ipsilateral breast tumour detection, sensitivity and specificity for surveillance mammography ranged from 50-83% and 57-75% and for MRI 93-100% and 88-96%. For routine metachronous contralateral breast cancer detection, one study reported sensitivity of 67% and specificity of 50% for both surveillance mammography and MRI. CONCLUSION: Although mammography is associated with high sensitivity and specificity, MRI is the most accurate test for detecting ipsilateral breast tumour recurrence and metachronous contralateral breast cancer in women previously treated for primary breast cancer. Results should be interpreted with caution because of the limited evidence base. Key Points • Surveillance mammography is associated with high sensitivity and specificity • Findings suggest that MRI is the most accurate test for detecting further breast cancer • Robust conclusions cannot be made due to the limited evidence base • Further research comparing surveillance mammography and other diagnostic tests is required.

Photodynamic diagnosis of bladder cancer compared with white light cystoscopy: Systematic review and meta-analysis.

OBJECTIVES: The aim of this study was to assess the test performance and clinical effectiveness of photodynamic diagnosis (PDD) compared with white light cystoscopy (WLC) in people suspected of new or recurrent bladder cancer. METHODS: A systematic review was conducted of randomized controlled trials (RCTs), nonrandomized comparative studies, or diagnostic cross-sectional studies comparing PDD with WLC. Fifteen electronic databases and Web sites were searched (last searches April 2008). For clinical effectiveness, only RCTs were considered. RESULTS: Twenty-seven studies (2,949 participants) assessed test performance. PDD had higher sensitivity than WLC (92 percent, 95 percent confidence interval [CI], 80-100 percent versus 71 percent, 95 percent CI, 49-93 percent) but lower specificity (57 percent, 95 percent CI, 36-79 percent versus 72 percent, 95 percent CI, 47-96 percent). For detecting higher risk tumors, median range sensitivity of PDD (89 percent [6-100 percent]) was higher than WLC (56 percent [0-100 percent]) whereas for lower risk tumors it was broadly similar (92 percent [20-95 percent] versus 95 percent [8-100 percent]). Four RCTs (709 participants) using 5-aminolaevulinic acid (5-ALA) as the photosensitising agent reported clinical effectiveness. Using PDD at transurethral resection of bladder tumor (TURBT) resulted in fewer residual tumors at check cystoscopy (relative risk [RR], 0.37, 95 percent CI, 0.20-0.69) and longer recurrence-free survival (RR, 1.37, 95 percent CI, 1.18-1.59), compared with WLC. CONCLUSIONS: PDD detects more bladder tumors than WLC, including more high-risk tumors. Based on four RCTs reporting clinical effectiveness, 5-aminolaevulinic acid-mediated PDD at TURBT facilitates a more complete resection and prolongs recurrence-free survival.

The clinical effectiveness of transurethral incision of the prostate: a systematic review of randomised controlled trials.

PURPOSE: Transurethral incision of the prostate gland (TUIP) is perceived as a less morbid surgical alternative to standard transurethral resection of the prostate gland (TURP) for treatment of symptomatic mild to moderate benign prostate enlargement (BPE). We aimed to evaluate comparative clinical effectiveness of the two procedures. METHODS: Systematic review and meta-analysis of short- and long-term data from randomised controlled trials comparing TUIP with TURP. RESULTS: This review considered data from 795 randomised participants across 10 RCTs of moderate to poor quality 8 of which stated an upper limit for prostate size. No difference in the degree of symptomatic improvement was seen between the two procedures. Improvement in peak urine flow rate was lower for TUIP compared to TURP whilst the rate of blood transfusion and TUR syndrome was higher after TURP. Urinary retention, urinary tract infection, strictures and incontinence did not differ between the two approaches, although clinically important differences could not be ruled-out. TUIP was associated with a shorter duration of operation and length of hospital stay but a higher re-operation rate. CONCLUSION: TUIP and TURP appear to offer equivalent symptomatic improvement for men with mild to moderate BPE. Choosing TUIP involves a trade-off between the lower risk of peri-operative morbidity and the higher risk of subsequent re-operation.

The fate of conference abstracts: systematic review and meta-analysis of surgical treatments for men with benign prostatic enlargement.

OBJECTIVE: From the literature search for a government-commissioned systematic review on surgical treatments for benign prostatic enlargement (BPE), we identified the relevant conference abstracts of randomised controlled trials (RCTs) which failed to reach full publication and their data were not utilised. We aimed to ascertain, first, the reasons of failure to reach full publication and second, to estimate the impact of including the abstracts' data. DESIGN: A two-part study, consisting of a questionnaire survey and a sensitivity analysis of the above said review. METHODS: An ad hoc questionnaire was sent to each author of the relevant abstracts, as to determine the reasons of failure to reach full publication. The data from the abstracts were then extracted and incorporated into sensitivity analysis of the review. RESULTS: Forty-seven questionnaires were completed for 47 abstracts. Of these abstracts, 32 of them were claimed to have reached full publication. A number of reasons of failure to reach full publication were identified, for example: 'being written up' and 'lack of time'. Utilizable, relevant data were obtained from eight of the 47 abstracts, and put into sensitivity analysis. There were small changes in effect sizes and directions for three of 14 reviews' secondary outcomes. CONCLUSION: Common reasons of failure to reach full publication were also identified in the context for the BPE review. Inclusion of abstract data did not affect primary outcome defined in the original review. Identification, summarisation of conference abstracts and other grey literature should form an essential exercise for any systematic review.

Systematic review of the efficacy and safety of using mesh in surgery for uterine or vaginal vault prolapse.

INTRODUCTION AND HYPOTHESIS: The aim of this study is to estimate efficacy and safety of mesh in surgery for uterine or vault prolapse. METHODS: Seventeen electronic databases were searched for relevant studies that were published from 1980 onwards. RESULTS: Fifty-four studies involving 7,054 women were included. For sacrocolpopexy (average follow-up 23 months), the risk of clinical recurrence ranged from 0% to 6%, persistent symptoms ranged from 3% to 31% and mesh erosion from 0% to 12%. For infracoccygeal sacropexy (average follow-up 13 months), the risk of clinical recurrence ranged from 0% to 25%, persistent symptoms from 2% to 21% and mesh erosion 0% to 21%. Limited evidence was available for sacrocolpoperineopexy and uterine suspension sling to draw reliable estimates. CONCLUSIONS: Sacrocolpopexy was associated with a low risk of recurrence but with a relatively high risk of mesh erosion. Ranges of estimates for outcomes for other mesh techniques were wide.

Non-randomised evaluations of strategies to increase participant retention in randomised controlled trials: a systematic review.

BACKGROUND: Retention of participants is essential to ensure the statistical power and internal validity of clinical trials. Poor participant retention reduces power and can bias the estimates of intervention effect. There is sparse evidence from randomised comparisons of effective strategies to retain participants in randomised trials. Currently, non-randomised evaluations of trial retention interventions embedded in host clinical trials are rejected from the Cochrane review of strategies to improve retention because it only included randomised evaluations. However, the systematic assessment of non-randomised evaluations may inform trialists' decision-making about retention methods that have been evaluated in a trial context.Therefore, we performed a systematic review to synthesise evidence from non-randomised evaluations of retention strategies in order to supplement existing randomised trial evidence. METHODS: We searched MEDLINE, EMBASE, and Cochrane CENTRAL from 2007 to October 2017. Two reviewers independently screened abstracts and full-text articles for non-randomised studies that compared two or more strategies to increase participant retention in randomised trials. The retention trials had to be nested in real 'host' trials ( including feasibility studies) but not hypothetical trials. Two investigators independently rated the risk of bias of included studies using the ROBINS-I tool and determined the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. RESULTS: Fourteen non-randomised studies of retention were included in this review. Most retention strategies (in 10 studies) aimed to increase questionnaire response rate. Favourable strategies for increasing questionnaire response rate were telephone follow-up compared to postal questionnaire completion, online questionnaire follow-up compared to postal questionnaire, shortened version of questionnaires versus longer questionnaires, electronically transferred monetary incentives compared to cash incentives, cash compared with no incentive and reminders to non-responders (telephone or text messaging). However, each retention strategy was evaluated in a single observational study. This, together with risk of bias concerns, meant that the overall GRADE certainty was low or very low for all included studies. CONCLUSIONS: This systematic review provides low or very low certainty evidence on the effectiveness of retention strategies evaluated in non-randomised studies. Some strategies need further evaluation to provide confidence around the size and direction of the underlying effect.

Developing a sensitive search strategy in MEDLINE to retrieve studies on assessment of the diagnostic performance of imaging techniques.

PURPOSE: To prospectively develop a search strategy in MEDLINE for identifying studies on the diagnostic performance of any imaging modality, with maximized and minimized retrieval of relevant and irrelevant studies, respectively. MATERIALS AND METHODS: Predefined inclusion criteria were used to conduct a hand search of two sets of radiologic journal articles for studies on assessment of the diagnostic performance of imaging techniques. These two sets of articles formed independent derivation and validation record sets for developing and evaluating the search strategy. The sensitivity and positive predictive values (PPVs) of search terms from the derivation reference-standard set of records were used to select terms and develop two components of the search strategy. The first component was used to identify any study (from the imaging literature) in which diagnostic test performance was assessed. The second component was used to identify studies of any imaging modality. The two components were combined in the final search strategy. The sensitivity, specificity, and PPV of the search strategy in the derivation and validation record sets were calculated. RESULTS: The final search strategy had a sensitivity of 92.8%, a specificity of 58.5%, and a PPV of 25.1% for retrieval of the derivation set of records. Validation with an independent set of records gave a sensitivity of 91.9% (95% confidence interval [CI]: 87.1%, 95.1%), a specificity of 52.2% (95% CI: 49.2%, 55.2%), and a PPV of 25.1% (95% CI: 22.0%, 28.5%). Removal of irrelevant publication types further improved specificity and PPV in the validation set: to 77.6% (95% CI: 75.0%, 80.0%) and 40.9% (95% CI: 36.2%, 45.7%), respectively. The volume of imaging literature retrieved from MEDLINE by using the described search strategy has tripled since 1975. CONCLUSION: A sensitive search strategy to identify studies of the diagnostic performance of any imaging test was developed and validated. The retrieval estimates of this strategy in MEDLINE are adequate to develop a register of studies.

Screening for open angle glaucoma: systematic review of cost-effectiveness studies.

PURPOSE: To systematically review current evidence on the cost-effectiveness of screening strategies for open angle glaucoma (OAG). MATERIALS AND METHODS: Studies that reported both costs and outcomes of alternative screening strategies for OAG were identified by a highly sensitive search of electronic databases (eg, MEDLINE, EMBASE, NHS EED, HTA Database), last search December 2005. Data on costs regarding cases and years of visual impairment prevented, cases of blindness prevented, and cases of OAG detected were extracted. Incremental cost-effectiveness ratios were calculated using data provided in the included studies. RESULTS: Four studies met the inclusion criteria. The latest of these was published in 1997. The screening tests and treatments reported in these studies are now not considered to be best practice. Furthermore, data were not reported in sufficient detail to reinterpret the results of the studies in terms of a common outcome measure. Finally, these studies suffered from methodologic weaknesses that further limit their usefulness for decision making. CONCLUSIONS: Currently, there is insufficient economic evidence on which to base recommendations regarding screening for OAG. New technologies, potentially suitable as screening devices, and new treatments are available. Further research, both in terms of economic models and conduct of clinical trials with concurrent economic evaluation, may help inform policy makers regarding cost-effectiveness and acceptability of screening for OAG.

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.

Evaluation of a primary care nurse case management intervention for chronically ill community dwelling older people.

AIM: The purpose of this study was to test the effectiveness of a collaborative primary care nurse case management intervention emphasising collaboration between physicians, nurses and patients, risk identification, comprehensive assessment, collaborative planning, health monitoring, patient education and transitional care on healthcare utilisation and cost for community dwelling chronically ill older persons. BACKGROUND: Primary care teams comprised of nurses and primary care physicians have been suggested as a model for providing quality care to the chronically ill, but this type of intervention has not been systematically evaluated. DESIGN: A non-randomised, 36 month comparison of two geographically distinct primary care populations was conducted. METHODS: Six hundred and seventy-seven persons aged 65 and older were determined to be at high-risk for mortality, functional decline, or increased health service use. The treatment group (n = 400) received the intervention and the comparison group (n = 277) received usual care. Health plan claims files provided data on number of hospitalisations and bed days, emergency department (ED) visits, physician visits and total cost of care. RESULTS: After adjustment for baseline variables, there were no significant differences between the treatment and comparison group in the percentage of patients hospitalised or ED visits. However, among those hospitalised in the treatment group, the likelihood of being re-hospitalised was significantly reduced by 34% (p = 0·032). After adjusting for the cost of the intervention, although not statistically significant, the reduced hospital use resulted in cost savings of $106 per patient per month in the treatment group. CONCLUSIONS: The results indicate that a collaborative primary care nurse case management intervention has the potential to be an effective alternative to current primary care delivery system practice. RELEVANCE TO CLINICAL PRACTICE: The study suggests that a chronic care intervention emphasising collaboration between physicians, nurses and patients, may be more effective when implemented in integrated provider networks.

So many filters, so little time: the development of a search filter appraisal checklist.

OBJECTIVES: The authors developed a tool to assess the quality of search filters designed to retrieve records for studies with specific research designs (e.g., diagnostic studies). METHODS: The UK InterTASC Information Specialists' Sub-Group (ISSG), a group of experienced health care information specialists, reviewed the literature to evaluate existing search filter appraisal tools and determined that existing tools were inadequate for their needs. The group held consensus meetings to develop a new filter appraisal tool consisting of a search filter appraisal checklist and a structured abstract. ISSG members tested the final checklist using three published search filters. RESULTS: The detailed ISSG Search Filter Appraisal Checklist captures relevance criteria and methods used to develop and test search filters. The checklist includes categorical and descriptive responses and is accompanied by a structured abstract that provides a summary of key quality features of a filter. DISCUSSION: The checklist is a comprehensive appraisal tool that can assist health sciences librarians and others in choosing search filters. The checklist reports filter design methods and search performance measures, such as sensitivity and precision. The checklist can also aid filter developers by indicating information on core methods that should be reported to help assess filter suitability. The generalizability of the checklist for non-methods filters remains to be explored.