scholarly journals Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial

2016 ◽  
Vol 20 (29) ◽  
pp. 1-46 ◽  
Author(s):  
Thomas RE Barnes ◽  
Verity C Leeson ◽  
Carol Paton ◽  
Céire Costelloe ◽  
Judit Simon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Negative Symptom ◽  
Antipsychotic Medication ◽  
Functional Outcomes ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Health Technology ◽  
Double Blind

BackgroundNegative symptoms of schizophrenia represent deficiencies in emotional responsiveness, motivation, socialisation, speech and movement. When persistent, they are held to account for much of the poor functional outcomes associated with schizophrenia. There are currently no approved pharmacological treatments. While the available evidence suggests that a combination of antipsychotic and antidepressant medication may be effective in treating negative symptoms, it is too limited to allow any firm conclusions.ObjectiveTo establish the clinical effectiveness and cost-effectiveness of augmentation of antipsychotic medication with the antidepressant citalopram for the management of negative symptoms in schizophrenia.DesignA multicentre, double-blind, individually randomised, placebo-controlled trial with 12-month follow-up.SettingAdult psychiatric services, treating people with schizophrenia.ParticipantsInpatients or outpatients with schizophrenia, on continuing, stable antipsychotic medication, with persistent negative symptoms at a criterion level of severity.InterventionsEligible participants were randomised 1 : 1 to treatment with either placebo (one capsule) or 20 mg of citalopram per day for 48 weeks, with the clinical option at 4 weeks to increase the daily dosage to 40 mg of citalopram or two placebo capsules for the remainder of the study.Main outcome measuresThe primary outcomes were quality of life measured at 12 and 48 weeks assessed using the Heinrich’s Quality of Life Scale, and negative symptoms at 12 weeks measured on the negative symptom subscale of the Positive and Negative Syndrome Scale.ResultsNo therapeutic benefit in terms of improvement in quality of life or negative symptoms was detected for citalopram over 12 weeks or at 48 weeks, but secondary analysis suggested modest improvement in the negative symptom domain, avolition/amotivation, at 12 weeks (mean difference –1.3, 95% confidence interval –2.5 to –0.09). There were no statistically significant differences between the two treatment arms over 48-week follow-up in either the health economics outcomes or costs, and no differences in the frequency or severity of adverse effects, including corrected QT interval prolongation.LimitationsThe trial under-recruited, partly because cardiac safety concerns about citalopram were raised, with the 62 participants recruited falling well short of the target recruitment of 358. Although this was the largest sample randomised to citalopram in a randomised controlled trial of antidepressant augmentation for negative symptoms of schizophrenia and had the longest follow-up, the power of statistical analysis to detect significant differences between the active and placebo groups was limited.ConclusionAlthough adjunctive citalopram did not improve negative symptoms overall, there was evidence of some positive effect on avolition/amotivation, recognised as a critical barrier to psychosocial rehabilitation and achieving better social and community functional outcomes. Comprehensive assessment of side-effect burden did not identify any serious safety or tolerability issues. The addition of citalopram as a long-term prescribing strategy for the treatment of negative symptoms may merit further investigation in larger studies.Future workFurther studies of the viability of adjunctive antidepressant treatment for negative symptoms in schizophrenia should include appropriate safety monitoring and use rating scales that allow for evaluation of avolition/amotivation as a discrete negative symptom domain. Overcoming the barriers to recruiting an adequate sample size will remain a challenge.Trial registrationEuropean Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2009-009235-30 and Current Controlled Trials ISRCTN42305247.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 29. See the NIHR Journals Library website for further project information.

scholarly journals Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

2020 ◽  
pp. 070674372098243
Author(s):  
Alyna Turner ◽  
Andrea Baker ◽  
Olivia M. Dean ◽  
Adam J. Walker ◽  
Seetal Dodd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Schizoaffective Disorder ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Safety Data ◽  
Rate Of Change ◽  
Adjunctive Treatment ◽  
Garcinia Mangostana ◽  
Double Blind

Objectives: Garcinia mangostana Linn. (“mangosteen”) pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. Methods: People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. Results: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. Conclusion: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

scholarly journals Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eva V. Vodegel ◽  
Sandra E. Zwolsman ◽  
Astrid Vollebregt ◽  
Ruben G. Duijnhoven ◽  
Judith E. Bosmans ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Estrogen Therapy ◽  
Double Blind ◽  
Pop Surgery ◽  
Vaginal Estrogen ◽  
Vaginal Estrogen Therapy

Abstract Background Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. Methods The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. Discussion This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853. EudraCT: 2017-003144-21; registered: 24-07-2017.

scholarly journals Idiographic analyses of motivation and related processes in participants with schizophrenia following a therapeutic intervention for negative symptoms

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Bénédicte Thonon ◽  
Evelyne Van Aubel ◽  
Ginette Lafit ◽  
Clara Della Libera ◽  
Frank Larøi
Keyword(s):  
Quality Of Life ◽  
Functional Outcomes ◽  
Negative Symptoms ◽  
Single Case ◽  
Daily Functioning ◽  
Schizophrenia Spectrum Disorders ◽  
Vector Autoregressive ◽  
Registration Number

Abstract Background Motivational negative symptoms hinder quality of life and daily functioning of individuals with schizophrenia spectrum disorders. A recently developed intervention, Switch, has shown promising effects on negative symptoms and functional outcomes. Switch targets multiple cognitive, emotional and behavioural processes associated with motivation and goal directed behaviours. We aimed to investigate its effects on motivation and associated processes in a naturalistic setting, and to explore the dynamics between the processes. Methods We used a single case approach (n = 3), with a pre-post and follow-up assessment design, which also included ambulatory assessments (experience sampling method, ESM; and step count). We computed autoregressive lag 1 models to evaluate the effects of the intervention on daily motivation levels and related processes, descriptive pie-charts, and vector autoregressive modelling to reveal the dynamics of the processes over time. Results The intervention was beneficial for each participant according to traditional evaluations of motivational negative symptoms, apathy, daily functioning and quality of life. The effects on the ESM variables revealed distinct outcomes for each individual. The dynamics between the various processes differed between participants, and fluctuated within participants (when comparing baseline, intervention phase, and follow-up). Conclusions This study used an innovative approach to look at the effectiveness of an intervention. The intervention seems to lead to meaningful improvements in motivational negative symptoms and functional outcomes. The mechanisms of change need to be further investigated. Trial registration number ClinicalTrials.gov, NCT04325100. Registered 27 March 27, 2020 -retrospectively registered. Reporting Guidelines from the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) statement were followed.

scholarly journals Self-Management education for adults with poorly controlled epILEpsy [SMILE (UK)]: a randomised controlled trial

2018 ◽  
Vol 22 (21) ◽  
pp. 1-142 ◽  
Author(s):  
Leone Ridsdale ◽  
Alison McKinlay ◽  
Gabriella Wojewodka ◽  
Emily J Robinson ◽  
Iris Mosweu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Management Education ◽  
Controlled Trial ◽  
Health Technology ◽  
Self Management ◽  
Depression Symptoms ◽  
Randomised Controlled

BackgroundEpilepsy is a common neurological condition resulting in recurrent seizures. Research evidence in long-term conditions suggests that patients benefit from self-management education and that this may improve quality of life (QoL). Epilepsy self-management education has yet to be tested in a UK setting.ObjectivesTo determine the effectiveness and cost-effectiveness of Self-Management education for people with poorly controlled epILEpsy [SMILE (UK)].DesignA parallel pragmatic randomised controlled trial.SettingParticipants were recruited from eight hospitals in London and south-east England.ParticipantsAdults aged ≥ 16 years with epilepsy and two or more epileptic seizures in the past year, who were currently being prescribed antiepileptic drugs.InterventionA 2-day group self-management course alongside treatment as usual (TAU). The control group received TAU.Main outcome measuresThe primary outcome is QoL in people with epilepsy at 12-month follow-up using the Quality Of Life In Epilepsy 31-P (QOLIE-31-P) scale. Other outcomes were seizure control, impact of epilepsy, medication adverse effects, psychological distress, perceived stigma, self-mastery and medication adherence. Cost-effectiveness analyses and a process evaluation were undertaken.RandomisationA 1 : 1 ratio between trial arms using fixed block sizes of two.BlindingParticipants were not blinded to their group allocation because of the nature of the study. Researchers involved in data collection and analysis remained blinded throughout.ResultsThe trial completed successfully. A total of 404 participants were enrolled in the study [SMILE (UK),n = 205; TAU,n = 199] with 331 completing the final follow-up at 12 months [SMILE (UK),n = 163; TAU,n = 168]. In the intervention group, 61.5% completed all sessions of the course. No adverse events were found to be related to the intervention. At baseline, participants had a mean age of 41.7 years [standard deviation (SD) 14.1 years], and had epilepsy for a median of 18 years. The mean QOLIE-31-P score for the whole group at baseline was 66.0 out of 100.0 (SD 14.2). Clinically relevant levels of anxiety symptoms were reported in 53.6% of the group and depression symptoms in 28.0%. The results following an intention-to-treat analysis showed no change in any measures at the 12-month follow-up [QOLIE-31-P: SMILE (UK) mean: 67.4, SD 13.5; TAU mean: 69.5, SD 14.8]. The cost-effectiveness study showed that SMILE (UK) was possibly cost-effective but was also associated with lower QoL. The process evaluation with 20 participants revealed that a group course increased confidence by sharing with others and improved self-management behaviours.ConclusionsFor people with epilepsy and persistent seizures, a 2-day self-management education course is cost-saving, but does not improve QoL after 12-months or reduce anxiety or depression symptoms. A psychological intervention may help with anxiety and depression. Interviewed participants reported attending a group course increased their confidence and helped them improve their self-management.Future workMore research is needed on self-management courses, with psychological components and integration with routine monitoring.Trial registrationCurrent Controlled Trials ISRCTN57937389.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 21. See the NIHR Journals Library website for further project information.

scholarly journals Design and conduct of a multicenter randomized clinical trial on the impact of a post-intensive care unit multidisciplinary follow-up on the quality of life (suivi-rea) (Preprint)

2021 ◽  
Author(s):  
Friedman Diane ◽  
Lamiae Grimaldi ◽  
Alain Cariou ◽  
Philippe Aegerter ◽  
Stéphane Gaudry ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intensive Care ◽  
Controlled Trial ◽  
Social Evaluation ◽  
Double Blind ◽  
Icu Discharge ◽  
One Year ◽  
The Impact

UNSTRUCTURED Introduction: Critically ill patients are at risk to develop a Post-Intensive Care Syndrome (PICS), which is characterized by physical, psychological and cognitive impairments and dramatically impacts the quality of life. No intervention has been shown to improve the quality of life (QoL). Because of the interdependency of its domains, we hypothesized that a medical, psychological and social follow-up would improve the QoL by mitigating the PICS. Methods and analysis: We conducted a multicenter, double-blind, randomized controlled trial comparing a multidisciplinary to a standard post-ICU follow-up. In the intervention arm, multidisciplinary follow-up consisted of medical, psychological and social evaluation at ICU discharge and at 3, 6 and 12 months after ICU discharge. In the placebo group, patients were seen only at 12 months by the multidisciplinary team. The baseline characteristics at ICU discharge were collected in all patients. The primary outcome was the quality of life at one year, assessed with help of EuroQoL 5 dimensions (EQ5D). Secondary outcomes were mortality, cognitive, psychological and functional status, the social and professional reintegration as well as the rate of re-hospitalization and outpatient consultations at one year. The first patient was randomized on 20/12/2012 and the last patient on 01/09/2017 out of 546 patients who were enrolled across 11 ICUs. At present, data management is still ongoing, and all parties involved in the trial remain blinded. Ethics and dissemination – Research Ethics Committee of Saint-Germain-en-Laye, France, initial approval received on 08/07/2011. Results will be disseminated via peer-reviewed publication and presentation at international conferences. Trial registration: Clinicaltrials.gov identifier NCT01796509 (registered on 21/02/2013).

scholarly journals Idiographic analyses of motivation and related processes in participants with schizophrenia following a therapeutic intervention for negative symptoms

2020 ◽  
Author(s):  
Bénédicte Thonon ◽  
Evelyne Van Aubel ◽  
Ginette Lafit ◽  
Clara Della Libera ◽  
Frank Laroi
Keyword(s):  
Quality Of Life ◽  
Functional Outcomes ◽  
Negative Symptoms ◽  
Single Case ◽  
Daily Functioning ◽  
Schizophrenia Spectrum Disorders ◽  
Vector Autoregressive ◽  
Assessment Design

Abstract Background : Motivational negative symptoms hinder quality of life and daily functioning of individuals with schizophrenia spectrum disorders. A recently developed intervention, Switch, has shown promising effects on negative symptoms and functional outcomes. Switch targets multiple cognitive, emotional and behavioural processes associated with motivation and goal directed behaviours. We aimed to investigate its effects on motivation and associated processes in a naturalistic setting, and to explore the dynamics between the processes. Methods : We used a single case approach ( n = 3), with a pre-post and follow-up assessment design, which also included ambulatory assessments (experience sampling method, ESM; and step count). We computed autoregressive lag 1 models to evaluate the effects of the intervention on daily motivation levels and related processes, descriptive pie-charts, and vector autoregressive modelling to reveal the dynamics of the processes over time. Results : The intervention was beneficial for each participant according to traditional evaluations of motivational negative symptoms, apathy, daily functioning and quality of life. The effects on the ESM variables revealed distinct outcomes for each individual. The dynamics between the various processes differed between participants, and fluctuated within participants (when comparing baseline, intervention phase, and follow-up). Conclusions : This study used an innovative approach to look at the effectiveness of an intervention. The intervention seems to lead to meaningful improvements in motivational negative symptoms and functional outcomes. The mechanisms of change need to be further investigated.

scholarly journals Idiographic analyses of motivation and related processes in participants with schizophrenia following a therapeutic intervention for negative symptoms

2020 ◽  
Author(s):  
Bénédicte Thonon ◽  
Evelyne Van Aubel ◽  
Ginette Lafit ◽  
Clara Della Libera ◽  
Frank Laroi
Keyword(s):  
Quality Of Life ◽  
Functional Outcomes ◽  
Negative Symptoms ◽  
Single Case ◽  
Daily Functioning ◽  
Schizophrenia Spectrum Disorders ◽  
Vector Autoregressive ◽  
Assessment Design

Abstract Background : Motivational negative symptoms hinder quality of life and daily functioning of individuals with schizophrenia spectrum disorders. A recently developed intervention, Switch, has shown promising effects on negative symptoms and functional outcomes. Switch targets multiple cognitive, emotional and behavioural processes associated with motivation and goal directed behaviours. We aimed to investigate its effects on motivation and associated processes in a naturalistic setting, and to explore the dynamics between the processes. Methods : We used a single case approach ( n = 3), with a pre-post and follow-up assessment design, which also included ambulatory assessments (experience sampling method, ESM; and step count). We computed autoregressive lag 1 models to evaluate the effects of the intervention on daily motivation levels and related processes, descriptive pie-charts, and vector autoregressive modelling to reveal the dynamics of the processes over time. Results : The intervention was beneficial for each participant according to traditional evaluations of motivational negative symptoms, apathy, daily functioning and quality of life. The effects on the ESM variables revealed distinct outcomes for each individual. The dynamics between the various processes differed between participants, and fluctuated within participants (when comparing baseline, intervention phase, and follow-up). Conclusions : This study used an innovative approach to look at the effectiveness of an intervention. The intervention seems to lead to meaningful improvements in motivational negative symptoms and functional outcomes. The mechanisms of change need to be further investigated.

scholarly journals The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years

2016 ◽  
Vol 20 (75) ◽  
pp. 1-158 ◽  
Author(s):  
David J Keene ◽  
Dipesh Mistry ◽  
Julian Nam ◽  
Elizabeth Tutton ◽  
Robert Handley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Close Contact ◽  
Controlled Trial ◽  
Health Technology ◽  
Mean Difference ◽  
Ankle Fractures ◽  
Randomised Controlled ◽  
Ankle Function

BackgroundClose contact casting (CCC) may offer an alternative to open reduction and internal fixation (ORIF) surgery for unstable ankle fractures in older adults.ObjectivesWe aimed to (1) determine if CCC for unstable ankle fractures in adults aged over 60 years resulted in equivalent clinical outcome compared with ORIF, (2) estimate cost-effectiveness to the NHS and society and (3) explore participant experiences.DesignA pragmatic, multicentre, equivalence randomised controlled trial incorporating health economic evaluation and qualitative study.SettingTrauma and orthopaedic departments of 24 NHS hospitals.ParticipantsAdults aged over 60 years with unstable ankle fracture. Those with serious limb or concomitant disease or substantial cognitive impairment were excluded.InterventionsCCC was conducted under anaesthetic in theatre by surgeons who attended training. ORIF was as per local practice. Participants were randomised in 1 : 1 allocation via remote telephone randomisation. Sequence generation was by random block size, with stratification by centre and fracture pattern.Main outcome measuresFollow-up was conducted at 6 weeks and, by blinded outcome assessors, at 6 months after randomisation. The primary outcome was the Olerud–Molander Ankle Score (OMAS), a patient-reported assessment of ankle function, at 6 months. Secondary outcomes were quality of life (as measured by the European Quality of Life 5-Dimensions, Short Form questionnaire-12 items), pain, ankle range of motion and mobility (as measured by the timed up and go test), patient satisfaction and radiological measures. In accordance with equivalence trial US Food and Drug Administration guidance, primary analysis was per protocol.ResultsWe recruited 620 participants, 95 from the pilot and 525 from the multicentre phase, between June 2010 and November 2013. The majority of participants, 579 out of 620 (93%), received the allocated treatment; 52 out of 275 (19%) who received CCC later converted to ORIF because of loss of fracture reduction. CCC resulted in equivalent ankle function compared with ORIF at 6 months {OMAS 64.5 points [standard deviation (SD) 22.4 points] vs. OMAS 66.0 points (SD 21.1 points); mean difference –0.65 points, 95% confidence interval (CI) –3.98 to 2.68 points; standardised effect size –0.04, 95% CI –0.23 to 0.15}. There were no differences in quality of life, ankle motion, pain, mobility and patient satisfaction. Infection and/or wound problems were more common with ORIF [29/298 (10%) vs. 4/275 (1%)], as were additional operating theatre procedures [17/298 (6%) vs. 3/275 (1%)]. Malunion was more common with CCC [38/249 (15%) vs. 8/274 (3%);p < 0.001]. Malleolar non-union was lower in the ORIF group [lateral: 0/274 (0%) vs. 8/248 (3%);p = 0.002; medial: 3/274 (1%) vs. 18/248 (7%);p < 0.001]. During the trial, CCC showed modest mean cost savings [NHS mean difference –£644 (95% CI –£1390 to £76); society mean difference –£683 (95% CI –£1851 to £536)]. Estimates showed some imprecision. Incremental quality-adjusted life-years following CCC were no different from ORIF. Over common willingness-to-pay thresholds, the probability that CCC was cost-effective was very high (> 95% from NHS perspective and 85% from societal perspective). Experiences of treatments were similar; both groups endured the impact of fracture, uncertainty regarding future function and the need for further interventions.LimitationsAssessors at 6 weeks were necessarily not blinded. The learning-effect analysis was inconclusive because of limited CCC applications per surgeon.ConclusionsCCC provides a clinically equivalent outcome to ORIF at reduced cost to the NHS and to society at 6 months.Future workLonger-term follow-up of trial participants is under way to address concerns over potential later complications or additional procedures and their potential to impact on ankle function. Further study of the patient factors, radiological fracture patterns and outcomes, treatment responses and prognosis would also contribute to understanding the treatment pathway.Trial registrationCurrent Controlled Trials ISRCTN04180738.FundingThe National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 75. See the NIHR Journals Library website for further project information. This report was developed in association with the National Institute for Health Research Oxford Biomedical Research Unit funding scheme. The pilot phase was funded by the AO Research Foundation.

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