Caroline Main

Computerised decision support systems in order communication for diagnostic, screening or monitoring test ordering: systematic reviews of the effects and cost-effectiveness of systems

BACKGROUND Order communication systems (OCS) are computer applications used to enter diagnostic and therapeutic patient care orders and to view test results. Many potential benefits of OCS have been identified including improvements in clinician ordering patterns, optimisation of clinical time, and aiding communication processes between clinicians and different departments. Many OCS now include computerised decision support systems (CDSS), which are information systems designed to improve clinical decision-making. CDSS match individual patient characteristics to a computerised knowledge base, and software algorithms generate patient-specific recommendations. OBJECTIVES To investigate which CDSS in OCS are in use within the UK and the impact of CDSS in OCS for diagnostic, screening or monitoring test ordering compared to OCS without CDSS. To determine what features of CDSS are associated with clinician or patient acceptance of CDSS in OCS and what is known about the cost-effectiveness of CDSS in diagnostic, screening or monitoring test OCS compared to OCS without CDSS. DATA SOURCES A generic search to identify potentially relevant studies for inclusion was conducted using MEDLINE, EMBASE, Cochrane Controlled Trials Register (CCTR), CINAHL (Cumulative Index to Nursing and Allied Health Literature), DARE (Database of Abstracts of Reviews of Effects), Health Technology Assessment (HTA) database, IEEE (Institute of Electrical and Electronic Engineers) Xplore digital library, NHS Economic Evaluation Database (NHS EED) and EconLit, searched between 1974 and 2009 with a total of 22,109 titles and abstracts screened for inclusion. REVIEW METHODS CDSS for diagnostic, screening and monitoring test ordering OCS in use in the UK were identified through contact with the 24 manufacturers/suppliers currently contracted by the National Project for Information Technology (NpfIT) to provide either national or specialist decision support. A generic search to identify potentially relevant studies for inclusion in the review was conducted on a range of medical, social science and economic databases. The review was undertaken using standard systematic review methods, with studies being screened for inclusion, data extracted and quality assessed by two reviewers. Results were broadly grouped according to the type of CDSS intervention and study design where possible. These were then combined using a narrative synthesis with relevant quantitative results tabulated. RESULTS Results of the studies included in review were highly mixed and equivocal, often both within and between studies, but broadly showed a beneficial impact of the use of CDSS in conjunction with OCS over and above OCS alone. Overall, if the findings of both primary and secondary outcomes are taken into account, then CDSS significantly improved practitioner performance in 15 out of 24 studies (62.5%). Only two studies covered the cost-effectiveness of CDSS: a Dutch study reported a mean cost decrease of 3% for blood tests orders (639 euros) in each of the intervention clinics compared with a 2% (208 euros) increase in control clinics in test costs; and a Spanish study reported a significant increase in the cost of laboratory tests from 41.8 euros per patient per annum to 47.2 euros after implementation of the system. LIMITATIONS The response rate from the survey of manufacturers and suppliers was extremely low at only 17% and much of the feedback was classified as being commercial-in-confidence (CIC). No studies were identified which assessed the features of CDSS that are associated with clinician or patient acceptance of CDSS in OCS in the test ordering process and only limited data was available on the cost-effectiveness of CDSS plus OCS compared with OCS alone and the findings highly specific. Although CDSS appears to have a potentially small positive impact on diagnostic, screening or monitoring test ordering, the majority of studies come from a limited number of institutions in the USA. CONCLUSIONS If the findings of both primary and secondary outcomes are taken into account then CDSS showed a statistically significant benefit on either process or practitioner performance outcomes in nearly two-thirds of the studies. Furthermore, in four studies that assessed adverse effects of either test cancellation or delay, no significant detrimental effects in terms of additional utilisation of health-care resources or adverse events were observed. We believe the key current need is for a well designed and comprehensive survey, and on the basis of the results of this potentially for evaluation studies in the form of cluster randomised controlled trials or randomised controlled trials which incorporate process, and patient outcomes, as well as full economic evaluations alongside the trials to assess the impact of CDSS in conjunction with OCS versus OCS alone for diagnostic, screening or monitoring test ordering in the NHS. The economic evaluation should incorporate the full costs of potentially developing, testing, and installing the system, including staff training costs. STUDY REGISTRATION Study registration 61.

Accuracy of magnetic resonance imaging for the diagnosis of multiple sclerosis: systematic review.

Abstract Objective To determine the accuracy of magnetic resonance imaging criteria for the early diagnosis of multiple sclerosis in patients with suspected disease. Design Systematic review. Data sources 12 electronic databases, citation searches, and reference lists of included studies. Review methods Studies on accuracy of diagnosis that compared magnetic resonance imaging, or diagnostic criteria incorporating such imaging, to a reference standard for the diagnosis of multiple sclerosis. Results 29 studies (18 cohort studies, 11 other designs) were included. On average, studies of other designs (mainly diagnostic case-control studies) produced higher estimated diagnostic odds ratios than did cohort studies. Among 15 studies of higher methodological quality (cohort design, clinical follow-up as reference standard), those with longer follow-up produced higher estimates of specificity and lower estimates of sensitivity. Only two such studies followed patients for more than10 years. Even in the presence of many lesions (> 10 or > 8), magnetic resonance imaging could not accurately rule multiple sclerosis in (likelihood ratio of a positive test result 3.0 and 2.0, respectively). Similarly, the absence of lesions was of limited utility in ruling out a diagnosis of multiple sclerosis (likelihood ratio of a negative test result 0.1 and 0.5). Conclusions Many evaluations of the accuracy of magnetic resonance imaging for the early detection of multiple sclerosis have produced inflated estimates of test performance owing to methodological weaknesses. Use of magnetic resonance imaging to confirm multiple sclerosis on the basis of a single attack of neurological dysfunction may lead to over-diagnosis and over-treatment.

Surgical procedures and non-surgical devices for the management of non-apnoeic snoring: a systematic review of clinical effects and associated treatment costs

OBJECTIVES To review the evidence on the clinical effects and associated treatment costs of surgical procedures and non-surgical devices for the management of non-apnoeic snoring. DATA SOURCES Major electronic databases were searched for relevant studies published between 1980 and 2007. All treatment costs were estimated based on data from NHS reference costs, device manufacturers and clinical opinion. REVIEW METHODS Studies were screened, data extracted and quality assessed according to standard methods. Results were broadly grouped according to the intervention and comparator when applicable, and further subgrouped according to the specific intervention type and study design. Results were combined using a narrative synthesis with relevant quantitative results tabulated. Differences between studies assessing the same intervention were explored narratively by examining differences in the intervention, study duration and study quality. RESULTS The systematic review included 27 studies (three randomised controlled trials, two controlled clinical trials and 22 pre-post studies) reported in 30 publications assessing uvulopalatopharyngoplasty (UP3) versus laser-assisted uvulopalatoplasty (LAUP), UP3 alone, LAUP alone, palatal stiffening techniques (Pillar implants and injection snoreplasty), radiofrequency ablation (RFA) of the soft palate or tongue base, continuous positive airway pressure (CPAP) devices and mandibular advancement splints (MAS). Studies were generally of a low methodological quality with small sample sizes. A total of 1191 patients was included. Both UP3 and LAUP reduced the number of snores per hour and produced a modest reduction in snoring loudness. UP3 was effective in reducing a number of subjectively reported snoring indices, but results on objective measures were equivocal. Limited evidence indicates that subjectively assessed snoring is improved after LAUP; no objective measures were assessed. RFA was associated with a reduction in partner-assessed snoring intensity, though evidence for an objective reduction in snoring sound levels was mixed. Pillar implants were moderately effective at reducing partner-rated snoring intensity, but had no effect on objective snoring indices. Use of CPAP reduced the number of snores per hour; no subjective measures were evaluated. Use of MAS improved objective snoring outcomes, including the maximal snoring sound volume, the mean snoring sound volume and the percentage of time spent in loud snoring; no subjective measures were evaluated. The cost for UP3 ranges from approximately 1230 pounds to approximately 1550 pounds. For LAUP the cost varies from 790 pounds to 2070 pounds depending on the number of stages of the procedure. The treatment costs associated with the use of Pillar implants range from 1110 pounds to 1160 pounds. The approximate annual treatment costs associated with the use of a CPAP machine and MAS are 220 pounds and 130 pounds respectively. CONCLUSIONS This study highlighted the paucity and poor quality of the evidence available on the effects of both surgical procedures and non-surgical devices for the management of primary snoring. Any conclusions to be drawn from the results are therefore somewhat tentative. There was no procedure that was clearly the least-cost option. Further research should focus on standardising methods of measuring outcomes and reporting, undertaking active controlled trials, and investigating the longer-term effects of treatments.

Cochrane corner: oral hormone therapy and cardiovascular outcomes in post-menopausal women

![Graphic][1] Hormone therapy (HT) is commonly prescribed for the relief of climacteric symptoms in post-menopausal women; 54% (620490) of women enrolled in the Million Women Study1 in the UK (mean age 56 years) have tried it and 31% (358252) use it. Observational studies have shown oral HT is associated with lower rates of cardiovascular disease in post-menopausal women2; however randomised controlled trials (RCTs) have presented mixed results. The 2002 publication of the Womens Health Initiative I (WHI I) reported an association between combined oestrogen and progestin use and increased rates of both coronary heart disease and stroke. Subsequent publication of the Womens Health Initiative II (WHI II) reported an association between oestrogen and increased rates of stroke. These publications, and the significant publicity that they received, led to a reduction in prescriptions of oral HT. It also led to several RCTs assessing HT and cardiovascular outcomes stopping before their planned end date. However, post hoc analysis of the WHI data has suggested that associations between oral HT and cardiovascular outcomes are not uniform across all age groups. The mean ages at recruitment in WHI I and WHI II were early to mid-60s; more than a decade after the mean age of initiation of menopause, when post-menopausal women most commonly suffer from climacteric symptoms. This subgroup analysis demonstrated there was a trend to reduced likelihood of cardiovascular outcomes in women who started HT before the age of 60.3 In 2012, the Danish Osteoporosis Prevention Study (DOPS) was published. It was designed to assess the effect of oral HT on osteoporosis and cardiovascular outcomes and … [1]: /embed/inline-graphic-1.gif

The effectiveness and safety of proton beam radiation therapy in children with malignant central nervous system (CNS) tumours: protocol for a systematic review

BackgroundThe aim of this study is to use a systematic review framework to identify and synthesise the evidence on the use of proton beam therapy (PBT) for the treatment of children with CNS tumours and where possible compare this to the use of photon radiotherapy (RT).MethodsStandard systematic review methods aimed at minimising bias will be employed for study identification, selection and data extraction. Twelve electronic databases have been searched, and further citation, hand searching and reference checking will be employed. Studies assessing the effects of PBT used either alone or as part of a multimodality treatment regimen in children with CNS tumours will be included. Relevant economic evaluations will also be identified. The outcomes are survival (overall, progression-free, event-free, disease-free), local and regional control rates, short- and long-term adverse events, functional status measures and quality of survival. Two reviewers will independently screen and select studies for inclusion in the review. All interventional study designs will be eligible for inclusion in the review. However, initial scoping searches indicate the evidence base is likely to be limited to case series studies, with no studies of a higher quality being identified. Quality assessment will be undertaken using pre-specified criteria and tailored to study design if applicable. Studies will be combined using a narrative synthesis, with differences in results between studies highlighted and discussed in relation to the patient population, intervention and study quality. Where appropriate, if no studies of a comparative design are identified, outcomes will be compared against a range of estimates from the literature for similar populations and treatment regimens from the best available evidence from studies that include the use of advanced conventional photon therapy.DiscussionThe evidence base for the use of PBT in children with CNS tumours is likely to be relatively sparse, highly heterogeneous and potentially of a low quality with small sample sizes. Furthermore, selection and publication biases may limit the internal and external validity of studies. However, any tentative results from the review on potential treatment effects can be used to plan better quality research studies that are of a design appropriate for outcome comparison with conventional therapy.Systematic review registrationPROSPERO CRD42015029583

The impact of routine surveillance screening with magnetic resonance imaging (MRI) to detect tumour recurrence in children with central nervous system (CNS) tumours: protocol for a systematic review and meta-analysis

BackgroundThe aim of this study is to assess the impact of routine MRI surveillance to detect tumour recurrence in children with no new neurological signs or symptoms compared with alternative follow-up practices, including periodic clinical and physical examinations and the use of non-routine imaging upon presentation with disease signs or symptoms.MethodsStandard systematic review methods aimed at minimising bias will be employed for study identification, selection and data extraction. Ten electronic databases have been searched, and further citation searching and reference checking will be employed. Randomised and non-randomised controlled trials assessing the impact of routine surveillance MRI to detect tumour recurrence in children with no new neurological signs or symptoms compared to alternative follow-up schedules including imaging upon presentation with disease signs or symptoms will be included.The primary outcome is time to change in therapeutic intervention. Secondary outcomes include overall survival, surrogate survival outcomes, response rates, diagnostic yield per set of images, adverse events, quality of survival and validated measures of family psychological functioning and anxiety. Two reviewers will independently screen and select studies for inclusion. Quality assessment will be undertaken using the Cochrane Collaboration’s tools for assessing risk of bias. Where possible, data will be summarised using combined estimates of effect for time to treatment change, survival outcomes and response rates using assumption-free methods. Further sub-group analyses and meta-regression models will be specified and undertaken to explore potential sources of heterogeneity between studies within each tumour type if necessary.DiscussionAssessment of the impact of surveillance imaging in children with CNS tumours is methodologically complex. The evidence base is likely to be heterogeneous in terms of imaging protocols, definitions of radiological response and diagnostic accuracy of tumour recurrence due to changes in imaging technology over time. Furthermore, the delineation of tumour recurrence from either pseudo-progression or radiation necrosis after radiotherapy is potentially problematic and linked to the timing of follow-up assessments. However, given the current routine practice of MRI surveillance in the follow-up of children with CNS tumours in the UK and the resource implications, it is important to evaluate the cost-benefit profile of this practice.Systematic review registrationPROSPERO CRD42016036802

Does ‘mapping’ the evidence usefully inform the research question prioritisation process in systematic reviews?

Background Defining the research questions in systematic reviews is a very important first stage in the process, providing the framework for subsequent stages. With numerous questions and uncertainty regarding the strength and size of the evidence base for undertaking reviews on the effectiveness of interventions for children’s central nervous system (CNS) tumours a ‘map’ of the evidence was produced.

The role of high-dose myeloablative chemotherapy with haematopoietic stem cell transplantation (HSCT) in children with central nervous system (CNS) tumours: protocol for a systematic review and meta-analysis

ObjectivesThe objective of the study is to conduct a systematic review to compare the effects of high-dose chemotherapy (HDCT) with autologous haematopoietic stem cell transplantation (HSCT) versus standard-dose chemotherapy (SDCT) in children with malignant central nervous system (CNS) tumours.MethodsStandard systematic review methods aimed at minimising bias will be employed for study identification, selection and data extraction. Ten electronic databases will be searched, along with citation searching and reference checking. Studies assessing the effects of HDCT with HSCT in children with CNS tumours will be included. The outcomes are survival (overall, progression-free, event-free, disease-free), response rates, short- and long-term adverse events and health-related quality of life (HRQoL). Two reviewers will independently screen and select randomised and non-randomised controlled trials and controlled and uncontrolled observational studies for inclusion. Quality assessment will be tailored to the different study designs. Where possible data will be summarised using combined estimates of effect for the hazard ratio for survival outcomes and the risk ratio for response rates. A fixed effect model will be used; sub-group analyses and meta-regression will be used to explore potential sources of heterogeneity between studies.DiscussionGiven the poor prognosis of malignant brain tumours in children in terms of survival and quality of life, this review will help guide clinical practice by summarising the current evidence on the use of high-dose myeloblative chemotherapy with stem cell support in children with CNS tumours.