Theory in Practice: Increasing Professional Effectiveness

羟氨苄青霉素引起大疱性类天疱疮样疹

Background:Measuring patient-reported outcomes has become increasingly important in cosmetic and reconstructive breast surgery. The objective of this study was to develop a new patient-reported outcome measure to assess the unique outcomes of breast surgery patients.Methods:Patient interviews, focus

Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q.

Social research, issues, methods and process

Placebo

Objectives: 
To provide an evidence-based perspective on the prognostic value of novel markers in localised prostate cancer and to identify the best prognostic model including the three classical markers and investigate whether models incorporating novel markers are better. 

Data sources:
 
Eight electronic bibliographic databases were searched during March–April 2007. The reference lists of relevant articles were checked and various health services research-related resources consulted via the internet. The search was restricted to publications from 1970 onwards in the English language. 

Methods:
 
Selected studies were assessed, data extracted using a standard template, and quality assessed using an adaptation of published criteria. Because of the heterogeneity regarding populations, outcomes and study type, meta-analyses were not undertaken and the results are presented in tabulated format with a narrative synthesis of the results. 

Results:
 
In total 30 papers met the inclusion criteria, of which 28 reported on prognostic novel markers and five on prognostic models. A total of 21 novel markers were identified from the 28 novel marker studies. There was considerable variability in the results reported, the quality of the studies was generally poor and there was a shortage of studies in some categories. The marker with the strongest evidence for its prognostic significance was prostate-specific antigen (PSA) velocity (or doubling time). There was a particularly strong association between PSA velocity and prostate cancer death in both clinical and pathological models. In the clinical model the hazard ratio for death from prostate cancer was 9.8 (95% CI 2.8–34.3, pE<E0.001) in men with an annual PSA velocity of more than 2Eng/ml versus an annual PSA velocity of 2Eng/ml or less; similarly, the hazard ratio was 12.8 (95% CI 3.7–43.7, pE<E0.001) in the pathological model. The quality of the prognostic model studies was adequate and overall better than the quality of the prognostic marker studies. Two issues were poorly dealt with in most or all of the prognostic model studies: inclusion of established markers and consideration of the possible biases from study attrition. Given the heterogeneity of the models, they cannot be considered comparable. Only two models did not include a novel marker, and one of these included several demographic and co-morbidity variables to predict all-cause mortality. Only two models reported a measure of model performance, the C-statistic, and for neither was it calculated in an external data set. It was not possible to assess whether the models that included novel markers performed better than those without. 

Conclusions:
 
This review highlighted the poor quality and heterogeneity of studies, which render much of the results inconclusive. It also pinpointed the small proportion of models reported in the literature that are based on patient cohorts with a mean or median follow-up of at least 5 years, thus making long-term predictions unreliable. PSA velocity, however, stood out in terms of the strength of the evidence supporting its prognostic value and the relatively high hazard ratios. There is great interest in PSA velocity as a monitoring tool for active surveillance but there is as yet no consensus on how it should be used and, in particular, what threshold should indicate the need for radical treatment.

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The harmful health effects of recreational ecstasy: a systematic review of observational evidence

Objectives To investigate whether it is clinically effective and cost-effective to provide (i) a unilateral cochlear implant for severely to profoundly deaf people (using or not using hearing aids), and (ii) a bilateral cochlear implant for severely to profoundly deaf people with a single cochlear implant (unilateral or unilateral plus hearing aid). Data sources Main electronic databases [MEDLINE; EMBASE; Cochrane Database of Systematic Reviews; CENTRAL; NHS EED; DARE; HTA (NHS-CRD); EconLit; National Research Register; and ClinicalTrials.gov] searched in October 2006, updated July 2007. Review methods A systematic review of the literature was undertaken according to standard methods. A state-transition (Markov) model of the main care pathways deaf people might follow and the main complications and device failures was developed. Results The clinical effectiveness review included 33 papers, of which only two were RCTs. They used 62 different outcome measures and overall were of moderate to poor quality. All studies in children comparing one cochlear implant with non-technological support or an acoustic hearing aid reported gains on all outcome measures, some demonstrating greater gain from earlier implantation. The strongest evidence for an advantage from bilateral over unilateral implantation was for understanding speech in noisy conditions (mean improvement 13.2%, p < 0.0001); those receiving their second implant earlier made greater gains. Comparison of bilateral with unilateral cochlear implants plus an acoustic hearing aid was compromised by small sample sizes and poor reporting, but benefits were seen with bilateral implants. Cochlear implants improved children’s quality of life, and those who were implanted before attending school were more likely to do well academically and attend mainstream education than those implanted later. In adults, there was a greater benefit from cochlear implants than from non-technological support in terms of speech perception. Increased age at implantation may reduce effectiveness and there is a negative correlation between duration of deafness and effectiveness. Speech perception measures all showed benefits for cochlear implants over acoustic hearing aids [e.g. mean increase in score of 37 points in noisy conditions (p < 0.001) with BKB sentences]; however, prelingually deafened adults benefited less than those postlingually deafened (mean change scores 20% versus 62%). For unilateral versus bilateral implantation, benefits in speech perception were significant in noisy conditions on all measures [e.g. 76% for HINT sentences (p < 0.0001)]. Quality of life measured with generic and disease-specific instruments or by interview mostly showed significant gains or positive trends from using cochlear implants. The Markov model base-case analysis estimated that, for prelingually profoundly deaf children, the incremental cost-effectiveness ratio (ICER) for unilateral implantation compared with no implantation was £13,413 per quality-adjusted life-year (QALY). Assuming the utility gain for bilateral implantation is the same for adults and children, the ICERs for simultaneous and sequential bilateral implantation versus unilateral implantation were £40,410 and £54,098 per QALY respectively. For postlingually sensorineurally profoundly deaf adults, the corresponding ICERs were £14,163, £49,559 and £60,301 per QALY respectively. Probabilistic threshold analyses suggest that unilateral implants are highly likely to be cost-effective for adults and children at willingness to pay thresholds of £20,000 or £30,000 per QALY. There are likely to be overall additional benefits from bilateral implantation, enabling children and adults to hold conversations more easily in social situations. Conclusions Unilateral cochlear implantation is safe and effective for adults and children and likely to be cost-effective in profoundly deaf adults and profoundly and prelingually deaf children. However, decisions on the cost-effectiveness of bilateral cochlear implants should take into account the high degree of uncertainty within the model regarding the probable utility gain.

https://njl-admin.nihr.ac.uk/document/download/2001757

The effectiveness and cost-effectiveness of cochlear implants for severe to profound deafness in children and adults: a systematic review and economic model

Documentary analysis has been widely used in the comparative analysis of health care policy implementation in England. However, the value of the method is rarely debated, and the process whereby it is carried out rarely described in detail, or justified. Documentary analysis has obvious appeal. Documents may be the only source of data at an early stage of a policy innovation. They also present none of the problems (practical, ethical, interactive) of human subjects of research, and can provide a useful supplement to data collected from human subjects by other means. However, official documents are likely to be partial or superficial, representing aspirations rather than realities. The scope for analysis is therefore limited. Analysis may also tend to be positivist in philosophy, taking at face value the ‘apparent’ meanings of texts. It will be argued in this article, however, that a more interpretative analysis is also possible, when implied assumptions or underlying ideologies are identified and discusse...

Comparative analysis of health policy implementation

Social prescribing is the topic of the moment. Many national organisations and individuals from policy, practice, and academia (such as NHS England, the RCGP, the Mayor of London, and National Institute for Health Research) are rightly advocating social prescriptions as an important way to expand the options available for GPs and other community-based practitioners to provide individualised care for people’s physical and mental health through social interventions. No robust figures exist but it is thought that around 20% of patients consult their GP for primarily social issues, given this and the driving forces of an ageing population, increased complex health and social needs, and increasing demand on services, social prescribing is rapidly gaining popularity.

As a concept and a model for delivering health and social interventions, social prescribing has proliferated without a concomitant evidence base.1 This is partly due to resource limitations on evaluators and partly due to difficulties in conceptualising what social prescribing is and what good evidence for a complex service might look like. Here, we briefly outline different models of social prescribing, the current evidence base and its limitations, explore problems relating to what constitutes good evidence, and discuss some potential ways forward.

An immediate difficulty is the range of activity that the term ‘social prescribing’ embraces. Such heterogeneity is a function of social prescribing being the demand-driven formalisation of referrals to existing community services and organisations, which is necessarily locally different. More generally, at one extreme there are narrow interventions that focus on one clinical area and aim to prevent or reduce progression to chronic disease. Such interventions tend to include targeted life-style interventions (for example physical activity, healthy eating or cooking), medicines management or group mentoring, and are typically accessed through the healthcare system. At the other extreme, a large number of schemes are …

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Social prescribing: where is the evidence?

Objective: To explore the use of surrogate outcomes in Health Technology Assessment (HTA) and provide a basis for guidance for their future use, validation and reporting. This report focuses on the role of surrogate outcomes in cost-effectiveness models (CEMs) within UK HTA Programme reports.

Data sources: Reports published in the UK HTA Programme monograph series in 2005 and 2006 formed the sampling frame for this study.

Review methods: Reports were selected on the basis that they addressed a treatment effectiveness/efficacy question, that they included a CEM and that the CEM was primarily based on a surrogate outcome. Reports addressing diagnostic, screening, aetiology, prognostic and methodological questions were excluded. Information was extracted from included reports by two reviewers using a standardised proforma. Surrogate outcomes were assessed according to two published validation frameworks [Journal of the American Medical Association (JAMA) criteria and Outcomes Measures in Rheumatology Clinical Trials (OMERACT) scoring schema]. A narrative synthesis of findings is presented in the form of tabular summaries and illustrative qualitative quotations.

Results: A total of 35 UK HTA reports published in 2005 and 2006 addressed an effectiveness/efficacy question and contained a CEM. Of these, four were found to have based their CEM on a surrogate outcome. All four reports sourced treatment-related changes in surrogate outcomes through a systematic review of the literature; however, there was some variability in the consistency and transparency by which these reports provided evidence of the validation for the surrogate–final outcome relationship. Only one of the reports undertook a systematic review to specifically seek the evidence base for the association between surrogate and final outcomes. Furthermore, this was the only report to provide level 1 surrogate–final outcome validation evidence, i.e. RCT data showing a strong association between the change in surrogate outcome (BPAR) and the change in final outcome (graft survival) at an individual patient level. This report met the JAMA criteria for acceptable evidence of a surrogate. Two reports provided level 2 evidence, i.e. observational study data showing the relationship between the surrogate and final outcome, and one report provided level 3 evidence, i.e. a review of disease natural history. None of the four reports achieved a sufficient score on the OMERACT schema to be judged to have acceptable evidence of a surrogate outcome by its authors.

Conclusions: In this survey of UK HTA reports about 10% of the CEMs therein were explicitly based on surrogate outcomes. The strength of evidence for the surrogate–final outcome relationship, transparency of quantification and exploration of uncertainty of this relationship were found to vary considerably. Recommendations are made for the use of surrogate outcomes in future HTA reports.

https://njl-admin.nihr.ac.uk/document/download/2001721

Julian Elston

Papers

The harmful health effects of recreational ecstasy: a systematic review of observational evidence

The effectiveness and cost-effectiveness of cochlear implants for severe to profound deafness in children and adults: a systematic review and economic model

Comparative analysis of health policy implementation

Social prescribing: where is the evidence?

The use of surrogate outcomes in model-based cost-effectiveness analyses: a survey of UK Health Technology Assessment reports.