Correction to: Recommendations from Two Citizens' Juries on the Surgical Management of Obesity.

The spelling of the name of author K. Chalkidou was incorrect in the original article. It is correct here.

Recommendations from Two Citizens' Juries on the Surgical Management of Obesity.

BACKGROUND: It is important that guidelines and criteria used to prioritise access to bariatric surgery are informed by the values of the tax-paying public in combination with the expertise of healthcare professionals. Citizens' juries are increasingly used around the world to engage the public in healthcare decision-making. This study investigated citizens' juries about prioritising patient access to bariatric surgery in two Australian cities. OBJECTIVES: The objective of this study is to examine public priorities for government expenditure on the surgical management of obesity developed through either a one or three-day citizen jury. SUBJECTS/METHODS: A three-day jury was held in Brisbane and a one-day jury in Adelaide. Jurors were selected in Brisbane (n = 18) and in Adelaide (n = 12) according to pre-specified criteria. Expert witnesses from various medical disciplines and consumers were cross-examined by jurors. RESULTS: The verdicts of the juries were similar in that both juries agreed bariatric surgery was an important option in the management of obesity and related comorbidities. Recommendations about who should receive treatment differed slightly across the juries. Both juries rejected the use of age as a rationing tool, but managed their objections in different ways. Participants' experiences of the jury process were positive, but our observations suggested that many variables may influence the nature of the final verdict. CONCLUSIONS: Citizen's juries, even when shorter in duration, can be an effective tool to guide the development of health policy and priorities. However, our study has identified a range of variables that should be considered when designing and running a jury and when interpreting the verdict.

GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research.

BACKGROUND: While the patient and public involvement (PPI) evidence base has expanded over the past decade, the quality of reporting within papers is often inconsistent, limiting our understanding of how it works, in what context, for whom, and why. OBJECTIVE: To develop international consensus on the key items to report to enhance the quality, transparency, and consistency of the PPI evidence base. To collaboratively involve patients as research partners at all stages in the development of GRIPP2. METHODS: The EQUATOR method for developing reporting guidelines was used. The original GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklist was revised, based on updated systematic review evidence. A three round Delphi survey was used to develop consensus on items to be included in the guideline. A subsequent face-to-face meeting produced agreement on items not reaching consensus during the Delphi process. RESULTS: One hundred forty-three participants agreed to participate in round one, with an 86% (123/143) response for round two and a 78% (112/143) response for round three. The Delphi survey identified the need for long form (LF) and short form (SF) versions. GRIPP2-LF includes 34 items on aims, definitions, concepts and theory, methods, stages and nature of involvement, context, capture or measurement of impact, outcomes, economic assessment, and reflections and is suitable for studies where the main focus is PPI. GRIPP2-SF includes five items on aims, methods, results, outcomes, and critical perspective and is suitable for studies where PPI is a secondary focus. CONCLUSIONS: GRIPP2-LF and GRIPP2-SF represent the first international evidence based, consensus informed guidance for reporting patient and public involvement in research. Both versions of GRIPP2 aim to improve the quality, transparency, and consistency of the international PPI evidence base, to ensure PPI practice is based on the best evidence. In order to encourage its wide dissemination this article is freely accessible on The BMJ and Research Involvement and Engagement journal websites.

GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research.

Background While the patient and public involvement (PPI) evidence base has expanded over the past decade, the quality of reporting within papers is often inconsistent, limiting our understanding of how it works, in what context, for whom, and why.Objective To develop international consensus on the key items to report to enhance the quality, transparency, and consistency of the PPI evidence base. To collaboratively involve patients as research partners at all stages in the development of GRIPP2.Methods The EQUATOR method for developing reporting guidelines was used. The original GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklist was revised, based on updated systematic review evidence. A three round Delphi survey was used to develop consensus on items to be included in the guideline. A subsequent face-to-face meeting produced agreement on items not reaching consensus during the Delphi process.Results 143 participants agreed to participate in round one, with an 86% (123/143) response for round two and a 78% (112/143) response for round three. The Delphi survey identified the need for long form (LF) and short form (SF) versions. GRIPP2-LF includes 34 items on aims, definitions, concepts and theory, methods, stages and nature of involvement, context, capture or measurement of impact, outcomes, economic assessment, and reflections and is suitable for studies where the main focus is PPI. GRIPP2-SF includes five items on aims, methods, results, outcomes, and critical perspective and is suitable for studies where PPI is a secondary focus.Conclusions GRIPP2-LF and GRIPP2-SF represent the first international evidence based, consensus informed guidance for reporting patient and public involvement in research. Both versions of GRIPP2 aim to improve the quality, transparency, and consistency of the international PPI evidence base, to ensure PPI practice is based on the best evidence. In order to encourage its wide dissemination this article is freely accessible on The BMJ and Research Involvement and Engagement journal websites.

Engaging the public in healthcare decision-making: results from a Citizens' Jury on emergency care services.

BACKGROUND: Policies addressing ED crowding have failed to incorporate the public's perspectives; engaging the public in such policies is needed. OBJECTIVE: This study aimed at determining the public's recommendations related to alternative models of care intended to reduce crowding, optimising access to and provision of emergency care. METHODS: A Citizens' Jury was convened in Queensland, Australia, to consider priority setting and resource allocation to address ED crowding. Twenty-two jurors were recruited from the electoral roll, who were interested and available to attend the jury from 15 to 17 June 2012. Juror feedback was collected via a survey immediately following the end of the jury. RESULTS: The jury considered that all patients attending the ED should be assessed with a minority of cases diverted for assistance elsewhere. Jurors strongly supported enabling ambulance staff to treat patients in their homes without transporting them to the ED, and allowing non-medical staff to treat some patients without seeing a doctor. Jurors supported (in principle) patient choice over aspects of their treatment (when, where and type of health professional) with some support for patients paying towards treatment but unanimous opposition for patients paying to be prioritised. Most of the jurors were satisfied with their experience of the Citizens' Jury process, but some jurors perceived the time allocated for deliberations as insufficient. CONCLUSIONS: These findings suggest that the general public may be open to flexible models of emergency care. The jury provided clear recommendations for direct public input to guide health policy to tackle ED crowding.

What drives junior doctors to use clinical practice guidelines? A national cross-sectional survey of foundation doctors in England & Wales.

BACKGROUND: Clinical practice guidelines (CPGs) aim to improve patient care, but their use remains variable. We explored attitudes that influence CPG use amongst newly qualified doctors. METHODS: A self-completed, anonymous questionnaire was sent to all Foundation Doctors in England and Wales between December 2012 and May 2013. We included questions designed to measure the 11 domains of the validated Theoretical Domains Framework (TDF). We correlated these responses to questions assessing current and future intention to use CPGs. RESULTS: A total of 13,138 doctors were invited of which 1693 [corrected] (13 %) responded. 1,035 (62.5 %) reported regular CPG use with 575 (34.4 %) applying CPGs 2-3 times per week. A significant minority of 606 (36.6 %) declared an inability to critically appraise evidence. Despite efforts to design a questionnaire that captured the domains of the TDF, the domain scales created had low internal reliability. Using previously published studies and input from an expert statistical group, an alternative model was sought using exploratory factor analysis. Five alternative domains were identified. These were judged to represent: "confidence", "familiarity", "commitment and duty", "time" and "perceived benefits". Using regression analyses, the first three were noted as consistent predictors of both current and future intentions to use CPGs in decreasing strength order. CONCLUSIONS: In this large survey of newly qualified doctors, "confidence", "familiarity" and "commitment and duty" were identified as domains that influence use of CPGs in frontline practice. Additionally, a significant minority were not confident in critically appraising evidence. Our findings suggest a number of approaches that may be taken to improve junior doctors' commitment to CPGs through processes that increase their confidence and familiarity in using CPGs. Despite limitations of a self-reported survey and potential non-response bias, these findings are from a large representative sample and a review of existing implementation strategies may be warranted based on these findings.

The NHS: assessing new technologies, NICE and value for money.

The healthcare system in the UK, essentially the NHS, is an open economic system subject to the same pressures as any other economic system. The pressures concern limited resources coupled with powerful drivers for increasing spending: invention, demography and inflation. There have only ever been three types of economic system: steady state (everything, as in a feudal system, stays as it was the year before), market capitalism (supply and demand are allowed to find their own equilibrium) and some version of central planning. In healthcare, most advanced countries favour the last of the three. This is for three reasons: distribution (not only are the poor less able to pay for sickness, but sickness exacerbates poverty), information (markets operate poorly when providers can easily outsmart customers) and externalities (it is in the interest of everyone that infectious diseases and the other knock-on consequences of ill health are ameliorated). So in the UK, the state, with a good deal of cross-party consensus, directs most of health service supply. This system has become more complex over the decades since the formation of the NHS in 1948. A notable element of the complexity is the regulation of the introduction of new technologies. A key element of the regulatory system has been the National Institute for Health and Clinical Excellence (NICE), and a key aspect of NICE's decisions has been not just value, but also value for money. This has not been without controversy.

Ambulance economics.

BACKGROUND: Ambulance services produce a large quantity of data, which can yield valuable summary statistics. For strategic planning purposes, an economic framework is proposed, and the following four resource allocation questions are answered, using data from the Surrey Ambulance Service: (1) To satisfy government response time targets, how many additional ambulances will be required, ceteris paribus? (2) To minimize average response time (r*) with given resources, how should ambulances be rostered temporally? (3) Which innovations are worth undertaking? (4) How would an increase in demand affect r*? METHODS: The 'Ambulance Response Curve' --the relation between response time and the number of available but not-in-use ambulances--is used to estimate how much r* will be reduced by deploying an additional ambulance. Estimating the marginal cost of an ambulance allows us to estimate the opportunity cost of each second of response time, and to compare the cost of three 'innovations' with that of increasing resources. The time savings of adding an extra ambulance at each of the 168 h of the week are examined. RESULTS: In 1997-1998, r* was 8 min 52 s. An additional ambulance reduces r* by 8.9 s. Each reduction of 1 s in r* costs 28,000 pounds per year. Fourteen additional ambulances are required to meet response time targets if the 8.9 s reduction per ambulance is maintained. r* reduces by 4.6 s when ambulances are shifted from early mornings to Saturday evenings. Activation time reduces by 38 s when crews sit in their ambulances. A 1 min decrease in overall call time decreases r* by 1.1 s. Answering only 10 per cent of all calls reduces r* by 63 s. An increase of demand of 10 per cent increases r* by 7.8 s. CONCLUSIONS: Ambulance services will be better able to determine which innovations are worth undertaking. Policy makers will be better placed to determine funding levels to achieve response time targets.

Relation between a career and family life for English hospital consultants: qualitative, semistructured interview study.

OBJECTIVE: To explore the relation between work and family life among hospital consultants and their attitude towards the choices and constraints that influence this relation. DESIGN: Qualitative study of consultants' experiences and views based on tape recorded semistructured interviews. SETTING: Former South Thames health region in southeast England. PARTICIPANTS: 202 male and female NHS hospital consultants aged between 40 to 50 years representing all hospital medical specialties. RESULTS: Three types of relation between work and family life (career dominant, segregated, and accommodating) were identified among hospital consultants. Most consultants had a segregated relation, although female consultants were more likely than male consultants to have a career dominant or an accommodating relation. Many male consultants and some female consultants expressed considerable dissatisfaction with the balance between their career and family life. A factor influencing this dissatisfaction was the perceived lack of choice to spend time on their personal or family life, because of the working practices and attitudes within hospital culture, if they wanted a successful career. CONCLUSIONS: Consultants are currently fitting in with the profession rather than the profession adapting to enable doctors to have fulfilling professional and personal lives. Current government policies to increase the medical workforce and promote family friendly policies in the NHS ought to take account of the need for a fundamental change in hospital culture to enable doctors to be more involved in their personal or family life without detriment to their career progress.

Guidelines for evaluation.

Before implementing a guideline, reassurance is needed that the guideline is valid, reproducible and reliable. A method for assessing guideline validity has now been developed for general use. Guideline producers need to consider suitable strategies for implementing their guidelines. When designing and evaluating a guideline implementation strategy, three key questions need to be addressed: what are the most suitable intervention techniques; what are the desired effects of the guideline; and what will be the relevance of changes achieved? The time scale for the evaluation should also be determined carefully.

Appraising clinical practice guidelines in England and Wales: the development of a methodologic framework and its application to policy.

BACKGROUND: Clinical guidelines are pervading all aspects of health care. Their potential benefits are vast--from decreasing unjustified variation in treatment, to improving outcomes for patient, to containing escalating costs. However, there is increasing concern that many of the guidelines produced may be of low quality and recommend ineffective treatment. A framework to appraise the methodologic quality of clinical guidelines, commissioned by the NHS in 1997, was developed and validated in the United Kingdom (UK) under the auspices of the National Research and Development Programme. THE INDEPENDENT APPRAISAL SERVICE: This framework is now used to assess all national guidelines funded by the National Health Service (NHS) in the UK as part of an independent appraisal service. The appraisal provides a basis for policymakers to decide which guidelines should be commended for use in the NHS. Each guideline is appraised by a minimum of six appraisers. Twenty-one guidelines had been appraised as of July 1999. The mean time for completion of the appraisals, from receipt of the guidelines to dispatch of the reports, was just over ten weeks. There has been a marked improvement in the quality of documentation for national guidelines--including the search strategy and synthesis of evidence--in the past three years, although some areas of development remain inadequately reported. POLICY IMPLICATIONS: Ensuring that the clinical guidelines are sound before recommending their use is essential to policymakers responsible for guideline programs, and a formal appraisal should be an integral part of those programs.

Evaluating computerized health information systems: hardware, software and human ware: experiences from the Northern Province, South Africa.

Despite enormous investment world-wide in computerized health information systems their overall benefits and costs have rarely been fully assessed. A major new initiative in South Africa provides the opportunity to evaluate the introduction of information technology from a global perspective and assess its impact on public health. The Northern Province is implementing a comprehensive integrated hospital information system (HIS) in all of its 42 hospitals. These include two mental health institutions, eight regional hospitals (two acting as a tertiary complex with teaching responsibilities) and 32 district hospitals. The overall goal of the HIS is to improve the efficiency and effectiveness of health (and welfare) services through the creation and use of information, for clinical, administrative and monitoring purposes. This multi-site implementation is being undertaken as a single project at a cost of R130 million (which represents 2.5 per cent of the health and welfare budget on an annual basis). The implementation process commenced on 1 September 1998 with the introduction of the system into Mankweng Hospital as the pilot site and is to be completed in the year 2001. An evaluation programme has been designed to maximize the likelihood of success of the implementation phase (formative evaluation) as well as providing an overall assessment of its benefits and costs (summative evaluation). The evaluation was designed as a form of health technology assessment; the system will have to prove its worth (in terms of cost-effectiveness) relative to other interventions. This is more extensive than the traditional form of technical assessment of hardware and software functionality, and moves into assessing the day-to-day utility of the system, the clinical and managerial environment in which it is situated (humanware), and ultimately its effects on the quality of patient care and public health. In keeping with new South African legislation the evaluation process sought to involve as many stakeholders as possible at the same time as creating a methodologically rigorous study that lived within realistic resource limits. The design chosen for the summative assessment was a randomized controlled trial (RCT) in which 24 district hospitals will receive the HIS either early or late. This is the first attempt to carry out an RCT evaluation of a multi-site implementation of an HIS in the world. Within this design the evaluation will utilize a range of qualitative and quantitative techniques over varying time scales, each addressing specific aims of the evaluation programme. In addition, it will attempt to provide an overview of the general impact on people and organizations of introducing high-technology solutions into a relatively unprepared environment. The study should help to stimulate an evaluation culture in the health and welfare services in the Northern Province as well as building the capacity to undertake such evaluations in the future.

Secondary analysis of economic data: a review of cost-benefit studies of neonatal screening for phenylketonuria.

STUDY OBJECTIVE: To estimate the net financial benefit of neonatal screening for phenylketonuria (PKU): by a simple pooling of cost data from the literature; and by a more complex modelling approach. DESIGN: A systematic literature review was conducted to identify papers containing data on the monetary costs and benefits of neonatal screening for PKU. The methodological quality of the studies was appraised, and data were extracted on resource use and expenditure. Monetary data were converted to common currency units, and standardised to UK incidence rates. Net benefits were calculated for median, best case and worst case scenarios, and the effect of excluding poor quality studies and data was tested. The net benefit was also estimated from a model based on data from the literature and assumptions appropriate for the current UK situation. Extensive sensitivity analysis was conducted. MAIN RESULTS: The direct net benefit of screening based on the median costs and benefits from the 13 studies identified was 143,400 Pounds per case detected and treated (39,000 Pounds and 241,800 Pounds for worst case and best case scenarios respectively). The direct net benefit obtained by the modelling approach was lower at 93,400 Pounds per case detected and treated. Screening remained cost saving under sensitivity analysis, except with low residential care costs (less than 12,300 Pounds per annum), or very low incidence rates (less than 1 in 27,000). CONCLUSIONS: The economic literature on PKU screening is of variable quality. The two methods of secondary analysis lead to the same conclusion: that neonatal PKU screening is worthwhile in financial terms alone in the UK, and that it justifies the infrastructure for collecting and testing neonatal blood samples. This result cannot necessarily be extrapolated to other countries.

Development and application of a generic methodology to assess the quality of clinical guidelines.

BACKGROUND: Despite clinical guidelines penetrating every aspect of clinical practice and health policy, doubts persist over their ability to improve patient care. We have designed and tested a generic critical appraisal instrument, that assesses whether developers have minimized the biases inherent in creating guidelines, and addressed the requirements for effective implementation. DESIGN: Thirty-seven items describing suggested predictors of guideline quality were grouped into three dimensions covering the rigour of development, clarity of presentation (including the context and content) and implementation issues. The ease of use, reliability and validity of the instrument was tested on a national sample of guidelines for the management of asthma, breast cancer, depression and coronary heart disease, with 120 appraisers. A numerical score was derived to allow comparison of guidelines within and between diseases. RESULTS: The instrument has acceptable reliability (Cronbach's alpha coefficient, 0.68-0.84; intra-class correlation coefficient, (0.82-0.90)). The results provided some evidence of validity (Pearson's correlation coefficient between appraisers' dimension scores and their global assessment was 0.49 for dimension one, 0.63 for dimension two and 0.40 for dimension three). The instrument could differentiate between national and local guidelines and was easy to apply. There was variation in the performance of guidelines with most not achieving a majority of criteria in each dimension. CONCLUSIONS: Use of this instrument should encourage developers to create guidelines that reflect relevant research evidence more accurately. Potential users or groups adapting guidelines for local use could apply the instrument to help decide which one to follow. The National Health Service Executive is using the instrument to assist in deciding which guidelines to recommend to the UK National Health Service. This methodology forms the basis of a common approach to assessing guideline quality in Europe.

The quantity and quality of clinical practice guidelines for the management of depression in primary care in the UK.

BACKGROUND: Despite research evidence that guidelines can improve patient care, concerns remain over their cost-effectiveness. This is particularly so when there is a proliferation of guidelines for the same condition. Faced with differing recommendations, users will wish to make informed decisions on which guideline to follow. In creating a guideline appraisal instrument we have assessed guidelines developed in the United Kingdom (UK) for the management of a range of disorders including depression in primary care. AIM: To identify the number of UK clinical guidelines for the management of depression in primary care and to describe their quality and clinical content. METHOD: A survey was undertaken to identify all depression guidelines developed in the UK between January 1991 and January 1996. All guidelines produced by national organizations and a random sample of local guidelines were appraised using a validated instrument by six assessors: a national expert in the disease area, a general practitioner, a public health physician, a hospital consultant, a nurse specializing in the disease area, and a researcher on guideline methodology. The clinical content of each guideline was then assessed by one of the researchers (RB) according to a defined framework. RESULTS: Forty-five depression guidelines were identified. While there was a considerable range in the quality of the six national and three local guidelines appraised, at a group level their performance was similar to guidelines for other diseases. Clinical recommendations tended to reflect the joint consensus statement produced by the Royal College of General Practitioners and Royal College of Psychiatrists in 1992. The most obvious difference was in the style in which the guidelines were written and presented. CONCLUSION: A 'national template' was the starting place for most guidelines. Steps need to be taken to ensure that these templates are based on the best possible research evidence and professional opinion. Local clinicians should concentrate on effective dissemination and implementation strategies, rather than creating new guidelines.

Influence of delay on survival in patients with breast cancer: a systematic review.

BACKGROUND: Most patients with breast cancer are detected after symptoms occur rather than through screening. The impact on survival of delays between the onset of symptoms and the start of treatment is controversial and cannot be studied in randomised controlled trials. We did a systematic review of observational studies (worldwide) of duration of symptoms and survival. METHODS: We identified 87 studies (101,954 patients) with direct data linking delay (including delay by patients) and survival. We classified studies for analysis by type of data in the original reports: category I studies had actual 5-year survival data (38 studies, 53,912 patients); category II used actuarial or multivariate analyses (21 studies, 25,102 patients); and category III was all other types of data (28 studies, 22,940 patients). We tested the main hypothesis that longer delays would be associated with lower survival, and a secondary hypothesis that longer delays were associated with more advanced stage, which would account for lower survival. FINDINGS: In category I studies, patients with delays of 3 months or more had 12% lower 5-year survival than those with shorter delays (odds ratio for death 1.47 [95% CI 1.42-1.53]) and those with delays of 3-6 months had 7% lower survival than those with shorter delays (1.24 [1.17-1.30]). In category II, 13 of 14 studies with unrestricted samples showed a significant adverse relation between longer delays and survival, whereas four of five studies of only patients with operable disease showed no significant relation. In category III, all three studies with unrestricted samples supported the primary hypothesis. The 13 informative studies showed that longer delays were associated with more advanced stage. In studies that controlled for stage, longer delay was not associated with shorter survival when the effect of stage on survival was taken into account. INTERPRETATION: Delays of 3-6 months are associated with lower survival. These effects cannot be accounted for by lead-time bias. Efforts should be made to keep delays by patients and providers to a minimum.

Factors predicting delayed presentation of symptomatic breast cancer: a systematic review.

BACKGROUND: Delayed presentation of symptomatic breast cancer is associated with lower survival. Understanding of the factors that influence delay is important for the development of strategies to shorten delays. We did a systematic review to assess the quality and strength of evidence on risk factors for delays by patients and providers. METHODS: We generated hypotheses about the relation between each putative risk factor and delay, against which we tested studies. We did searches to identify papers containing original data related to risk factors for delays by patients (n=86) and providers (n=28). We critically appraised the papers for inclusion in the review according to predefined criteria. The small number of studies of adequate quality did not allow formal meta-analysis. We therefore assigned strength of evidence according to a combination of the number and size of studies supporting, not supporting, or refuting the hypotheses. FINDINGS: Most studies were deemed to be of poor quality and were excluded. Among 23 studies of adequate quality, however, there was strong evidence for an association between older age and delay by patients, and strong evidence that marital status was unrelated to delays by patients. Younger age and presentation with a breast symptom other than a lump were strong risk factors for delays by providers. Moderate evidence was shown for several other factors. INTERPRETATION: The strength of the current evidence is inadequate to inform the development of specific strategies to shorten delays by patients or providers. Clarification of the findings of this review through a major programme of primary research is urgently required.