A preliminary report of the cost-effectiveness of tooth replacement strategies for partially dentate elders

OBJECTIVE: To compare the cost-effectiveness of conventional treatment using partial dentures with functionally orientated treatment to replace missing teeth for partially dentate elders using a randomised controlled clinical trial.

BACKGROUND: In many countries, including the Republic of Ireland, the only publically funded treatment option offered to partially dentate older patients is a removable partial denture. However, evidence suggests that these removable prostheses are unpopular with patients and can potentially increase the risk of further dental disease and subsequent tooth loss.

MATERIALS AND METHODS: Fourty-four partially dentate patients aged 65 years and older were recruited. Patients were randomly assigned to the two treatment arms of the study. The conventional treatment group received removable partial dentures to replace all missing natural teeth. The functionally orientated group was restored to a Shortened Dental Arch (SDA) of 10 occluding contacts using resin-bonded bridgework (RBB). The costs associated with each treatment were recorded. Effectiveness was measured in terms of the impact on oral health-related quality of life (OHRQoL) using OHIP-14.

RESULTS: Both groups reported improvements in OHRQoL 1 month after completion of treatment. The conventional treatment group required 8.3 clinic visits as compared to 4.4 visits for the functionally orientated group. The mean total treatment time was 183 min 19 s for the conventional group vs. 124 min 8 s for the functionally orientated group. The average cost of treatment for the conventional group was 487.74 Euros compared to 356.20 Euros for the functional group.

CONCLUSIONS: Functionally orientated treatment was more cost-effective than conventional treatment in terms of treatment effect and opportunity costs to the patients' time.

A comparison of the effectiveness of TiO2 photocatalysis and UVA photolysis for the destruction of three pathogenic micro-organisms

TiO₂ photocatalysis has demonstrated efficacy as a treatment process for water contaminated with chemical pollutants. When exposed to UVA light TiO₂ also demonstrates an effective bactericidal activity. The mechanism of this process has been reported to involve attack by valence band generated hydroxyl radicals. In this study when three common bacterial pathogens, Escherichia coli, Salmonella enterica serovar Enteritidis and Pseudomonas aeruginosa, were exposed to TiO₂ and UVA light a substantial decrease in bacterial numbers was observed. Control experiments in which all three pathogens were exposed to UVA light only resulted in a similar reduction in bacterial numbers. Moreover, exposure to UVA light alone resulted in the production of a smaller than average colony phenotype among the surviving bacteria, for all three pathogens examined, a finding which was not observed following treatment with UVA and TiO₂. Small slow growing colonies have been described for several pathogenic bacteria and are referred to as small colony variants. Several studies have demonstrated an association between small colony variants and persistent, recurrent and antibiotic resistant infections. We propose that the production of small colony variants of pathogenic bacteria following UVA treatment of drinking water may represent a health hazard. As these small colony variants were not observed with the UVA/TiO₂ system this potential hazard is not a risk when using this technology. It would also appear that the bactericidal mechanism is different with the UVA/TiO₂ process compared to when UVA light is used alone.

Cost Effectiveness of Tooth Replacement Strategies for Partially Dentate Elders

Objectives: This study aimed to compare the cost effectiveness of conventional treatment using partial dentures with functionally-orientated treatment based on the shortened dental arch concept to replace missing teeth for partially dentate elders.
Methods: 44 partially dentate patients aged 65 years and older were recruited following routine dental assessment at a university dental hospital. Patients consented to and were randomly assigned to the two treatment arms. The conventional treatment group received a removable partial denture to replace all missing natural teeth. The functionally-orientated group were restored to a shortened dental arch of 10 occluding contacts using resin bonded bridgework. The costs associated with each treatment were recorded including laboratory charges, treatment time and opportunity costs. The impact on quality of life (OHRQoL) was measured using the 14-item Oral Health Impact Profile.
Results: Both groups reported improvements in OHRQoL after completion of treatment. For the conventional group, the mean OHIP-14 score decreased from 12.4 pre-operatively to 3.3 post-operatively (p<0.001). In the functionally-orientated group the OHIP-14 score decreased from 11.4 to 1.8 following treatment (p<0.001). On average the conventional treatment group required 8.3 clinic visits as compared to 4.4 visits for the functionally-orientated group. The mean total treatment time was 183 minutes 19 seconds for the conventional group versus 124 minutes 8 seconds for the functionally-orientated group. The conventional treatment group had an average of 6.33 teeth replaced at a laboratory cost of 337.31 Euros. The functionally-orientated group had an average of 2.64 teeth replaced at a laboratory cost of 244.05 Euros.
Conclusions: Restoration to a shortened dental arch using functionally-orientated treatment resulted in a similar improvement in OHRQoL with fewer clinic visits, less operative time and at a lower laboratory cost compared with conventional treatment.

A pilot randomised controlled trial (RCT) investigating the effectiveness of reflexology for managing pregnancy low back and/or pelvic pain.

any pregnant women with low back and/or pelvic pain (LBPP) use pain medications to manage this pain, much of which is self-prescribed and potentially harmful. Therefore, there is a need to find effective nonpharmacological treatments for the condition. Reflexology has previously been shown to help nonspecific low back pain. Therefore; a pilot RCT was conducted investigating reflexology in the management of pregnancy-LBPP. 90 primiparous women were randomised to either usual care, a reflexology or footbath intervention. Primary outcome measures were; the Pain Visual Analogue Scale (VAS). 64 women completed the RCT; retention rates for the reflexology group were 80%, usual care group 83.33% and footbath group 50%. The reflexology group demonstrated a Clinically Important Change (CIC) in pain frequency (1.64 cm). Results indicate it is feasible to conduct an RCT in this area, although a footbath is an unsuitable sham treatment. Reflexology may help manage pregnancy-LBPP; however a fully powered trial is needed to confirm this.

Effectiveness of a Multifaceted Intervention for Potentially Inappropriate Prescribing in Older Patients in Primary Care: A Cluster-Randomized Controlled Trial (OPTI-SCRIPT Study)

PURPOSE Potentially inappropriate prescribing (PIP) is common in older people and can result in increased morbidity, adverse drug events, and hospitalizations. The OPTI-SCRIPT study (Optimizing Prescribing for Older People in Primary Care, a cluster-randomized controlled trial) tested the effectiveness of a multifaceted intervention for reducing PIP in primary care.

METHODS We conducted a cluster-randomized controlled trial among 21 general practitioner practices and 196 patients with PIP. Intervention participants received a complex, multifaceted intervention incorporating academic detailing; review of medicines with web-based pharmaceutical treatment algorithms that provide recommended alternative-treatment options; and tailored patient information leaflets. Control practices delivered usual care and received simple, patient-level PIP feedback. Primary outcomes were the proportion of patients with PIP and the mean number of potentially inappropriate prescriptions. We performed intention-to-treat analysis using random-effects regression.

RESULTS All 21 practices and 190 patients were followed. At intervention completion, patients in the intervention group had significantly lower odds of having PIP than patients in the control group (adjusted odds ratio = 0.32; 95% CI, 0.15–0.70; P = .02). The mean number of PIP drugs in the intervention group was 0.70, compared with 1.18 in the control group (P = .02). The intervention group was almost one-third less likely than the control group to have PIP drugs at intervention completion, but this difference was not significant (incidence rate ratio = 0.71; 95% CI, 0.50–1.02; P = .49). The intervention was effective in reducing proton pump inhibitor prescribing (adjusted odds ratio = 0.30; 95% CI, 0.14–0.68; P = .04).

CONCLUSIONS The OPTI-SCRIPT intervention incorporating academic detailing with a pharmacist, and a review of medicines with web-based pharmaceutical treatment algorithms, was effective in reducing PIP, particularly in modifying prescribing of proton pump inhibitors, the most commonly occurring PIP drugs nationally.

A realistic evaluation of track and trigger systems and acute care training for early recognition and treatment of deteriorating ward-based patients: research protocol.

Aim The aim of the study is to evaluate factors that enable or constrain the implementation and service delivery of early warnings systems or acute care training in practice. Background To date there is limited evidence to support the effectiveness of acute care initiatives (early warning systems, acute care training, outreach) in reducing the number of adverse events (cardiac arrest, death, unanticipated Intensive Care admission) through increased recognition and management of deteriorating ward based patients in hospital [1-3]. The reasons posited are that previous research primarily focused on measuring patient outcomes following the implementation of an intervention or programme without considering the social factors (the organisation, the people, external influences) which may have affected the process of implementation and hence measured end-points. Further research which considers the social processes is required in order to understand why a programme works, or does not work, in particular circumstances [4]. Method The design is a multiple case study approach of four general wards in two acute hospitals where Early Warning Systems (EWS) and Acute Life-threatening Events Recognition and Treatment (ALERT) course have been implemented. Various methods are being used to collect data about individual capacities, interpersonal relationships and institutional balance and infrastructures in order to understand the intended and unintended process outcomes of implementing EWS and ALERT in practice. This information will be gathered from individual and focus group interviews with key participants (ALERT facilitators, nursing and medical ALERT instructors, ward managers, doctors, ward nurses and health care assistants from each hospital); non-participant observation of ward organisation and structure; audit of patients' EWS charts and audit of the medical notes of patients who deteriorated during the study period to ascertain whether ALERT principles were followed. Discussion & progress to date This study commenced in January 2007. Ethical approval has been granted and data collection is ongoing with interviews being conducted with key stakeholders. The findings from this study will provide evidence for policy-makers to make informed decisions regarding the direction for strategic and service planning of acute care services to improve the level of care provided to acutely ill patients in hospital. References 1. Esmonde L, McDonnell A, Ball C, Waskett C, Morgan R, Rashidain A et al. Investigating the effectiveness of Critical Care Outreach Services: A systematic review. Intensive Care Medicine 2006; 32: 1713-1721 2. McGaughey J, Alderdice F, Fowler R, Kapila A, Mayhew A, Moutray M. Outreach and Early Warning Systems for the prevention of Intensive Care admission and death of critically ill patients on general hospital wards. Cochrane Database of Systematic Reviews 2007, Issue 3. www.thecochranelibrary.com 3. Winters BD, Pham JC, Hunt EA, Guallar E, Berenholtz S, Pronovost PJ (2007) Rapid Response Systems: A systematic review. Critical Care Medicine 2007; 35 (5): 1238-43 4. Pawson R and Tilley N. Realistic Evaluation. London; Sage: 1997

Pan-retinal photocoagulation and other forms of laser treatment and drug therapies for non-proliferative diabetic retinopathy: systematic review and economic evaluation

BACKGROUND: Diabetic retinopathy is an important cause of visual loss. Laser photocoagulation preserves vision in diabetic retinopathy but is currently used at the stage of proliferative diabetic retinopathy (PDR).

OBJECTIVES: The primary aim was to assess the clinical effectiveness and cost-effectiveness of pan-retinal photocoagulation (PRP) given at the non-proliferative stage of diabetic retinopathy (NPDR) compared with waiting until the high-risk PDR (HR-PDR) stage was reached. There have been recent advances in laser photocoagulation techniques, and in the use of laser treatments combined with anti-vascular endothelial growth factor (VEGF) drugs or injected steroids. Our secondary questions were: (1) If PRP were to be used in NPDR, which form of laser treatment should be used? and (2) Is adjuvant therapy with intravitreal drugs clinically effective and cost-effective in PRP?

ELIGIBILITY CRITERIA: Randomised controlled trials (RCTs) for efficacy but other designs also used.

REVIEW METHODS: Systematic review and economic modelling.

RESULTS: The Early Treatment Diabetic Retinopathy Study (ETDRS), published in 1991, was the only trial designed to determine the best time to initiate PRP. It randomised one eye of 3711 patients with mild-to-severe NPDR or early PDR to early photocoagulation, and the other to deferral of PRP until HR-PDR developed. The risk of severe visual loss after 5 years for eyes assigned to PRP for NPDR or early PDR compared with deferral of PRP was reduced by 23% (relative risk 0.77, 99% confidence interval 0.56 to 1.06). However, the ETDRS did not provide results separately for NPDR and early PDR. In economic modelling, the base case found that early PRP could be more effective and less costly than deferred PRP. Sensitivity analyses gave similar results, with early PRP continuing to dominate or having low incremental cost-effectiveness ratio. However, there are substantial uncertainties. For our secondary aims we found 12 trials of lasers in DR, with 982 patients in total, ranging from 40 to 150. Most were in PDR but five included some patients with severe NPDR. Three compared multi-spot pattern lasers against argon laser. RCTs comparing laser applied in a lighter manner (less-intensive burns) with conventional methods (more intense burns) reported little difference in efficacy but fewer adverse effects. One RCT suggested that selective laser treatment targeting only ischaemic areas was effective. Observational studies showed that the most important adverse effect of PRP was macular oedema (MO), which can cause visual impairment, usually temporary. Ten trials of laser and anti-VEGF or steroid drug combinations were consistent in reporting a reduction in risk of PRP-induced MO.

LIMITATION: The current evidence is insufficient to recommend PRP for severe NPDR.

CONCLUSIONS: There is, as yet, no convincing evidence that modern laser systems are more effective than the argon laser used in ETDRS, but they appear to have fewer adverse effects. We recommend a trial of PRP for severe NPDR and early PDR compared with deferring PRP till the HR-PDR stage. The trial would use modern laser technologies, and investigate the value adjuvant prophylactic anti-VEGF or steroid drugs.

STUDY REGISTRATION: This study is registered as PROSPERO CRD42013005408.

FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Assessment of Intervention Fidelity and Recommendations for Researchers Conducting Studies on the Diagnosis and Treatment of Chronic Cough in the Adult: CHEST Guideline and Expert Panel Report

BACKGROUND: Successful management of chronic cough has varied in the primary research studies in the reported literature. One of the potential reasons relates to a lack of intervention fidelity to the core elements of the diagnostic and/or therapeutic interventions that were meant to be used by the investigators.

METHODS: We conducted a systematic review to summarize the evidence supporting intervention fidelity as an important methodologic consideration in assessing the effectiveness of clinical practice guidelines used for the diagnosis and management of chronic cough. We developed and used a tool to assess for five areas of intervention fidelity. Medline (PubMed), Scopus, and the Cochrane Database of Systematic Reviews were searched from January 1998 to May 2014. Guideline recommendations and suggestions for those conducting research using guidelines or protocols to diagnose and manage chronic cough in the adult were developed and voted upon using CHEST Organization methodology.

RESULTS: A total of 23 studies (17 uncontrolled prospective observational, two randomized controlled, and four retrospective observational) met our inclusion criteria. These articles included 3,636 patients. Data could not be pooled for meta-analysis because of heterogeneity. Findings related to the five areas of intervention fidelity included three areas primarily related to the provider and two primarily related to the patients. In the area of study design, 11 of 23 studies appeared to be underpinned by a single guideline/protocol; for training of providers, two of 23 studies reported training, and zero of 23 reported the use of an intervention manual; and for the area of delivery of treatment, when assessing the treatment of gastroesophageal reflux disease, three of 23 studies appeared consistent with the most recent guideline/protocol referenced by the authors. For receipt of treatment, zero of 23 studies mentioned measuring concordance of patient-interventionist understanding of the treatment recommended, and zero of 23 mentioned measuring enactment of treatment, with three of 23 measuring side effects and two of 23 measuring adherence. The overall average intervention fidelity score for all 23 studies was poor (20.74 out of 48).

CONCLUSIONS: Only low-quality evidence supports that intervention fidelity strategies were used when conducting primary research in diagnosing and managing chronic cough in adults. This supports the contention that some of the variability in the reporting of patients with unexplained or unresolved chronic cough may be due to lack of intervention fidelity. By following the recommendations and suggestions in this article, researchers will likely be better able to incorporate strategies to address intervention fidelity, thereby strengthening the validity and generalizability of their results that provide the basis for the development of trustworthy guidelines.

An evaluation of the effectiveness of an algorithm intervention in reducing inappropriate faecal samples sent for Clostridium difficile testing.

Background: Clostridium difficile (C. difficile) is a leading cause of infectious diarrhoea in hospitals. Sending faecal samples for testing expedites diagnosis and appropriate treatment. Clinical suspicion of C. difficile based on patient history, signs and symptoms is the basis for sampling. Sending faecal samples from patients with diarrhoea ‘just in case’ the patient has C. difficile may be an indication of poor clinical management.

Aim: To evaluate the effectiveness of an intervention by an Infection Prevention and Control Team (IPCT) in reducing inappropriate faecal samples sent for C. difficile testing.

Method: An audit of numbers of faecal samples sent before and after a decision-making algorithm was introduced. The number of samples received in the laboratory was retrospectively counted for 12-week periods before and after an algorithm was introduced.
Findings: There was a statistically significant reduction in the mean number of faecal samples sent post the algorithm. Results were compared to a similar intervention carried out in 2009 in which the same message was delivered by a memorandum. In 2009 the memorandum had no effect on the overall number of weekly samples being sent.

Conclusion: An algorithm intervention had an effect on the number of faecal samples being sent for C. difficile testing and thus contributed to the effective use of the laboratory service.

A Reappraisal of the Safety and Cost-Effectiveness of Statin Therapy in Primary Prevention

Statins are among the most investigated drugs of all time. There is now a wealth of evidence supporting their use in the primary and secondary prevention arenas. The reduction in event recurrence has since been demonstrated across all levels of risk and in elderly patients. As a result, it is now accepted practice for statins to be prescribed universally in secondary prevention unless contraindicated. The extension of this policy into the primary prevention setting is more problematic, with moral and financial issues arising from the long-term treatment of many young apparently healthy individuals. For these reasons it is necessary to prove not only the financial sustainability of such a strategy but also the long-term safety of statins and the degree of benefit that might be expected.

Impact of non-pharmacological interventions on prevention and treatment of delirium in critically ill patients: protocol for a systematic review of quantitative and qualitative research

Background: Critically ill patients have an increased risk of developing delirium during their intensive care stay.To date, pharmacological interventions have not been shown to be effective for delirium management but non-pharmacological interventions have shown some promise. The aim of this systematic review is to identify effective non-pharmacological interventions for reducing the incidence or the duration of delirium in critically ill patients.

Methods: We will search MEDLINE, EMBASE, CINAHL, Web of Science, AMED, psycINFO and the Cochrane Library.We will include studies of critically ill adults and children. We will include randomised trials and controlled trials which measure the effectiveness of one or more non-pharmacological interventions in reducing incidence or duration ofdelirium in critically ill patients. We will also include qualitative studies that provide an insight into patients and their families’ experiences of delirium and non-pharmacological interventions. Two independent reviewers will assess studies for eligibility, extract data and appraise quality. We will conduct meta-analyses if possible or present results narratively.Qualitative studies will also be reviewed by two independent reviewers, and a specially designed quality assessment tool incorporating the CASP framework and the POPAY framework will be used to assess quality.

Discussion: Although non-pharmacological interventions have been studied in populations outside of intensive care units and multicomponent interventions have successfully reduced incidence and duration of delirium, no systematic review of non-pharmacological interventions specifically targeting delirium in critically ill patients have been undertaken to date. This systematic review will provide evidence for the development of a multicomponent intervention for delirium management of critically ill patients that can be tested in a subsequent multicentre randomised trial.

Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial

BACKGROUND: In sub-Saharan Africa, where infectious diseases and nutritional deficiencies are common, severe anaemia is a common cause of paediatric hospital admission, yet the evidence to support current treatment recommendations is limited. To avert overuse of blood products, the World Health Organisation advocates a conservative transfusion policy and recommends iron, folate and anti-helminthics at discharge. Outcomes are unsatisfactory with high rates of in-hospital mortality (9-10 %), 6-month mortality and relapse (6 %). A definitive trial to establish best transfusion and treatment strategies to prevent both early and delayed mortality and relapse is warranted.

METHODS/DESIGN: TRACT is a multicentre randomised controlled trial of 3954 children aged 2 months to 12 years admitted to hospital with severe anaemia (haemoglobin < 6 g/dl). Children will be enrolled over 2 years in 4 centres in Uganda and Malawi and followed for 6 months. The trial will simultaneously evaluate (in a factorial trial with a 3 x 2 x 2 design) 3 ways to reduce short-term and longer-term mortality and morbidity following admission to hospital with severe anaemia in African children. The trial will compare: (i) R1: liberal transfusion (30 ml/kg whole blood) versus conservative transfusion (20 ml/kg) versus no transfusion (control). The control is only for children with uncomplicated severe anaemia (haemoglobin 4-6 g/dl); (ii) R2: post-discharge multi-vitamin multi-mineral supplementation (including folate and iron) versus routine care (folate and iron) for 3 months; (iii) R3: post-discharge cotrimoxazole prophylaxis for 3 months versus no prophylaxis. All randomisations are open. Enrolment to the trial started September 2014 and is currently ongoing. Primary outcome is cumulative mortality to 4 weeks for the transfusion strategy comparisons, and to 6 months for the nutritional support/antibiotic prophylaxis comparisons. Secondary outcomes include mortality, morbidity (haematological correction, nutritional and infectious), safety and cost-effectiveness.

DISCUSSION: If confirmed by the trial, a cheap and widely available 'bundle' of effective interventions, directed at immediate and downstream consequences of severe anaemia, could lead to substantial reductions in mortality in a substantial number of African children hospitalised with severe anaemia every year, if widely implemented.

Monitoring ocular hypertension, how much and how often? A cost-effectiveness perspective

OBJECTIVE: To assess the efficiency of alternative monitoring services for people with ocular hypertension (OHT), a glaucoma risk factor.

DESIGN: Discrete event simulation model comparing five alternative care pathways: treatment at OHT diagnosis with minimal monitoring; biennial monitoring (primary and secondary care) with treatment if baseline predicted 5-year glaucoma risk is ≥6%; monitoring and treatment aligned to National Institute for Health and Care Excellence (NICE) glaucoma guidance (conservative and intensive).

SETTING: UK health services perspective.

PARTICIPANTS: Simulated cohort of 10 000 adults with OHT (mean intraocular pressure (IOP) 24.9 mm Hg (SD 2.4).

MAIN OUTCOME MEASURES: Costs, glaucoma detected, quality-adjusted life years (QALYs).

RESULTS: Treating at diagnosis was the least costly and least effective in avoiding glaucoma and progression. Intensive monitoring following NICE guidance was the most costly and effective. However, considering a wider cost-utility perspective, biennial monitoring was less costly and provided more QALYs than NICE pathways, but was unlikely to be cost-effective compared with treating at diagnosis (£86 717 per additional QALY gained). The findings were robust to risk thresholds for initiating monitoring but were sensitive to treatment threshold, National Health Service costs and treatment adherence.

CONCLUSIONS: For confirmed OHT, glaucoma monitoring more frequently than every 2 years is unlikely to be efficient. Primary treatment and minimal monitoring (assessing treatment responsiveness (IOP)) could be considered; however, further data to refine glaucoma risk prediction models and value patient preferences for treatment are needed. Consideration to innovative and affordable service redesign focused on treatment responsiveness rather than more glaucoma testing is recommended.

The design and implementation of a study to investigate the effectiveness of community vs hospital eye service follow-up for patients with neovascular age-related macular degeneration with quiescent disease

Introduction
Standard treatment for neovascular age-related macular degeneration (nAMD) is intravitreal injections of anti-VEGF drugs. Following multiple injections, nAMD lesions often become quiescent but there is a high risk of reactivation, and regular review by hospital ophthalmologists is the norm. The present trial examines the feasibility of community optometrists making lesion reactivation decisions.

Methods
The Effectiveness of Community vs Hospital Eye Service (ECHoES) trial is a virtual trial; lesion reactivation decisions were made about vignettes that comprised clinical data, colour fundus photographs, and optical coherence tomograms displayed on a web-based platform. Participants were either hospital ophthalmologists or community optometrists. All participants were provided with webinar training on the disease, its management, and assessment of the retinal imaging outputs. In a balanced design, 96 participants each assessed 42 vignettes; a total of 288 vignettes were assessed seven times by each professional group.The primary outcome is a participant's judgement of lesion reactivation compared with a reference standard. Secondary outcomes are the frequency of sight threatening errors; judgements about specific lesion components; participant-rated confidence in their decisions about the primary outcome; cost effectiveness of follow-up by optometrists rather than ophthalmologists.

Discussion
This trial addresses an important question for the NHS, namely whether, with appropriate training, community optometrists can make retreatment decisions for patients with nAMD to the same standard as hospital ophthalmologists. The trial employed a novel approach as participation was entirely through a web-based application; the trial required very few resources compared with those that would have been needed for a conventional randomised controlled clinical trial.

The effectiveness, acceptability and cost-effectiveness of psychosocial interventions for maltreated children and adolescents: An evidence synthesis

DESIGN We will address our research objectives by searching the published and unpublished literature and conducting an evidence synthesis of i) studies of the effectiveness of psychosocial interventions provided for children and adolescents who have suffered maltreatment, ii) economic evaluations of these interventions and iii) studies of their acceptability to children, adolescents and their carers. SEARCH STRATEGY: Evidence will be identified via electronic databases for health and allied health literature, social sciences and social welfare, education and other evidence based depositories, and economic databases. We will identify material generated by user-led,voluntary sector enquiry by searching the internet and browsing the websites of relevant UK government departments and charities. Additionally, studies will be identified via the bibliographies of retrieved articles/reviews; targeted author searches; forward citation searching. We will also use our extensive professional networks, and our planned consultations with key stakeholders and our study steering committee. Databases will be searched from inception to time of search. REVIEW STRATEGY Inclusion criteria: 1) Infants, children or adolescents who have experienced maltreatment between the ages of 0 17 years. 2) All psychosocial interventions available for maltreated children and adolescents, by any provider and in any setting, aiming to address the sequelae of any form of maltreatment, including fabricated illness. 3) For synthesis of evidence of effectiveness: all controlled studies in which psychosocial interventions are compared with no-treatment, treatment as usual, waitlist or other-treated controls. For a synthesis of evidence of acceptability we will include any design that asks participants for their views or provides data on non-participation. For decision-analytic modelling we may include uncontrolled studies. Primary and secondary outcomes will be confirmed in consultation with stakeholders. Provisional primary outcomes are psychological distress/mental health (particularly PTSD, depression and anxiety, self-harm); ii) behaviour; iii) social functioning; iv) cognitive / academic attainment, v) quality of life, and vi) costs. After studies that meet the inclusion criteria have been identified (independently by two reviewers), data will be extracted and risk of bias (RoB) assessed (independently by two reviewers) using the Cochrane Collaboration RoB Tool (effectiveness), quality hierarchies of data sources for economic analyses (cost-effectiveness) and the CASP tool for qualitative research (acceptability). Where interventions are similar and appropriate data are available (or can be obtained) evidence synthesis will be performed to pool the results. Where possible, we will explore the extent to which age, maltreatment history (including whether intra- or extra-familial), time since maltreatment, care setting (family / out-of-home care including foster care/residential), care history, and characteristics of intervention (type, setting, provider, duration) moderate the effects of psychosocial interventions. A synthesis of acceptability data will be undertaken, using a narrative approach to synthesis. A decision-analytic model will be constructed to compare the expected cost-effectiveness of the different types of intervention identified in the systematic review. We will also conduct a Value of information analysis if the data permit. EXPECTED OUTPUTS: A synthesis of the effectiveness and cost effectiveness of psychosocial interventions for maltreated children (taking into account age, maltreatment profile and setting) and their acceptability to key stakeholders.