Development of Core Outcome Sets for People Undergoing Major Lower Limb Amputation for Complications of Peripheral Vascular Disease.

OBJECTIVE: Every year, thousands of patients with peripheral vascular disease undergo major lower limb amputation. Despite this, evidence for optimal management is weak. Core outcome sets capture consensus on the most important outcomes for a patient group to improve the consistency and quality of research. The aim was to define short and medium term core outcome sets for studies involving patients undergoing major lower limb amputation. METHODS: A systematic review of the literature and focus groups involving patients, carers, and healthcare professionals were used to derive a list of potential outcomes. Findings informed a three round online Delphi consensus process, where outcomes were rated for both short and medium term studies. The results of the Delphi process were discussed at a face to face consensus meeting, and recommendations were made for each core outcome set. RESULTS: A systematic review revealed 45 themes to carry forward to the consensus survey. These were supplemented by a further five from focus groups. The consensus survey received responses from 123 participants in round one, and 91 individuals completed all three rounds. In the final round, nine outcomes were rated as "core" for short term studies and a further nine for medium term studies. Wound infection and healing were rated as "core" for both short and medium term studies. Outcomes related to mortality, quality of life, communication, and additional healthcare needs were also rated as "core" for short term studies. In medium term studies, outcomes related to quality of life, mobility, and social integration/independence were rated as "core". The face to face stakeholder meeting ratified inclusion of all outcomes from the Delphi and suggested that deterioration of the other leg and psychological morbidity should also be reported for both short and medium term studies. CONCLUSION: Consensus was established on 11 core outcomes for short and medium term studies. It is recommended that all future studies involving patients undergoing major lower limb amputation should report these outcomes.

Prognostic Risk Modelling for Patients Undergoing Major Lower Limb Amputation: An Analysis of the UK National Vascular Registry.

OBJECTIVE: Major lower limb amputation is the highest risk lower limb procedure in vascular surgery. Despite this, few high quality studies have examined factors contributing to mortality. The aim was to identify independent risk factors for peri-operative morbidity and mortality and develop reliable models for estimating risk. METHODS: All patients undergoing lower limb amputation above the ankle entered into the UK National Vascular Registry (January 2014-December 2016) were included. Missing data were handled using multiple imputation. Models were developed to evaluate independent risk factors for mortality (the primary outcome) and morbidity using logistic regression, minimising the Bayesian information criterion to balance complexity and model fit. Ethical approval for the study was granted (Wales REC 3 ref:16/WA/0353). RESULTS: All 9549 above ankle joint amputations in the registry were included. Overall, 865 patients (9.1%) died before leaving hospital. Independent factors associated with mortality were emergency admission, bilateral operation, age, American Society of Anesthesiologists' grade, abnormal electrocardiogram, and increased white cell count or creatinine (p < .01 for all). Independent factors reducing mortality were transtibial operation, increased albumin or patient weight, and previous ipsilateral revascularisation procedures (p < .01 for all). A risk model incorporating these factors had good discrimination (C-statistic 0.79, 95% confidence interval 0.77-0.80) and excellent calibration. Morbidity rates were high, with 6.6%, 9.7%, and 4.3% of patients suffering cardiac, respiratory, and renal complications, respectively. The risk model was also predictive of morbidity outcomes (C-statistics 0.74, 0.69, and 0.74, respectively). CONCLUSION: Morbidity and mortality after lower limb amputation are high in the UK. Some potentially modifiable factors for quality improvement initiatives have been identified and accurate predictive models that could assist patient counselling and decision making have been developed.

Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures.

BACKGROUND: Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken.  However, it is a complex process which requires patients be provided with information which they can understand and retain, opportunity to consider their options, and to be able to express their opinions and ask questions.  There is evidence that at present some patients undergo procedures without informed consent being achieved. OBJECTIVES: To assess the effects on patients, clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures. SEARCH METHODS: We searched the following databases using keywords and medical subject headings: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 5, 2012), MEDLINE (OvidSP) (1950 to July 2011), EMBASE (OvidSP) (1980 to July 2011) and PsycINFO (OvidSP) (1806 to July 2011). We applied no language or date restrictions within the search. We also searched reference lists of included studies. SELECTION CRITERIA: Randomised controlled trials and cluster randomised trials of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. We considered an intervention to be intended to promote informed consent when information delivery about the procedure was enhanced (either by providing more information or through, for example, using new written materials), or if more opportunity to consider or deliberate on the information was provided. DATA COLLECTION AND ANALYSIS: Two authors assessed the search output independently to identify potentially-relevant studies, selected studies for inclusion, and extracted data. We conducted a narrative synthesis of the included trials, and meta-analyses of outcomes where there were sufficient data. MAIN RESULTS: We included 65 randomised controlled trials from 12 countries involving patients undergoing a variety of procedures in hospitals. Nine thousand and twenty one patients were randomised and entered into these studies. Interventions used various designs and formats but the main data for results were from studies using written materials, audio-visual materials and decision aids. Some interventions were delivered before admission to hospital for the procedure while others were delivered on admission.Only one study attempted to measure the primary outcome, which was informed consent as a unified concept, but this study was at high risk of bias.  More commonly, studies measured secondary outcomes which were individual components of informed consent such as knowledge, anxiety, and satisfaction with the consent process.  Important but less commonly-measured outcomes were deliberation, decisional conflict, uptake of procedures and length of consultation.Meta-analyses showed statistically-significant improvements in knowledge when measured immediately after interventions (SMD 0.53 (95% CI 0.37 to 0.69) I(2) 73%), shortly afterwards (between 24 hours and 14 days) (SMD 0.68 (95% CI 0.42 to 0.93) I(2) 85%) and at a later date (15 days or more) (SMD 0.78 (95% CI 0.50 to 1.06) I(2) 82%). Satisfaction with decision making was also increased (SMD 2.25 (95% CI 1.36 to 3.15) I(2) 99%) and decisional conflict was reduced (SMD -1.80 (95% CI -3.46 to -0.14) I(2) 99%). No statistically-significant differences were found for generalised anxiety (SMD -0.11 (95% CI -0.35 to 0.13) I(2) 82%), anxiety with the consent process (SMD 0.01 (95% CI -0.21 to 0.23) I(2) 70%) and satisfaction with the consent process (SMD 0.12 (95% CI -0.09 to 0.32) I(2) 76%). Consultation length was increased in those studies with continuous data (mean increase 1.66 minutes (95% CI 0.82 to 2.50) I(2) 0%) and in the one study with non-parametric data (control 8.0 minutes versus intervention 11.9 minutes, interquartile range (IQR) of 4 to 11.9 and 7.2 to 15.0 respectively). There were limited data for other outcomes.In general, sensitivity analyses removing studies at high risk of bias made little difference to the overall results.  AUTHORS' CONCLUSIONS: Informed consent is an important ethical and practical part of patient care.  We have identified efforts by researchers to investigate interventions which seek to improve information delivery and consideration of information to enhance informed consent.  The interventions used consistently improve patient knowledge, an important prerequisite for informed consent.  This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable. Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions. Only one study attempted to measure informed consent as a unified concept.

Psychological interventions for women with metastatic breast cancer.

BACKGROUND: Psychological symptoms are associated with metastatic breast cancer. This is the basis for exploring the impact of psychological interventions on psychosocial and survival outcomes. One early study appeared to show significant survival and psychological benefits from psychological support while subsequent studies have revealed conflicting results. This review is an update of a Cochrane review first published in 2004 and previously updated in 2007. OBJECTIVES: To assess the effects of psychological interventions on psychosocial and survival outcomes for women with metastatic breast cancer. SEARCH METHODS: We searched the Cochrane Breast Cancer Group Specialised Register, MEDLINE (OvidSP), EMBASE (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCO), online trials and research registers in June/July 2011. Further potentially relevant studies were identified from handsearching references of previous trials, systematic reviews and meta-analyses.  SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster RCTs of psychological interventions, which recruited women with metastatic breast cancer. Outcomes selected for analyses were overall survival, psychological outcomes, pain, quality of life, condition-specific outcome measures, relationship and social support measures, and sleep quality. Studies were excluded if no discrete data were available on women with metastatic breast cancer.  DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data and assessed the quality of the studies using the Cochrane Collaboration risk of bias tool. Where possible, authors were contacted for missing information. Data on the nature and setting of the intervention, relevant outcome data, and items relating to methodological quality were extracted. Meta-analyses was performed using a random-effects or fixed-effect Mantel-Haenszel model, depending on expected levels of heterogeneity. MAIN RESULTS: Ten RCTs with 1378 women were identified. Of the seven RCTs on group psychological interventions, three were on cognitive behavioural therapy and four were on supportive-expressive group therapy. The remaining three studies were individual based and the types of psychological interventions were not common to either cognitive behavioural or supportive-expressive therapy. A clear pattern of psychological outcomes could not be discerned as a wide variety of outcome measures and durations of follow-up were used in the included studies. The overall effect of the psychological interventions across six studies, on one-year survival, favoured the psychological intervention group with an odds ratio (OR) of 1.46 (95% confidence interval (CI) 1.07 to 1.99). Pooled data from four studies did not show any survival benefit at five-years follow-up (OR 1.03, 95% CI 0.42 to 2.52). There was evidence of a short-term benefit for some psychological outcomes and improvement in pain scores. AUTHORS' CONCLUSIONS: Psychological interventions appear to be effective in improving survival at 12 months but not at longer-term follow-up, and they are effective in reducing psychological symptoms only in some of the outcomes assessed in women with metastatic breast cancer. However, findings of the review should be interpreted with caution as there is a relative lack of data in this field, and the included trials had reporting or methodological weaknesses and were heterogeneous in terms of interventions and outcome measures.  

Personalised risk communication for informed decision making about taking screening tests.

BACKGROUND: There is a trend towards greater patient involvement in healthcare decisions. Although screening is usually perceived as good for the health of the population, there are risks associated with the tests involved. Achieving both adequate involvement of consumers and informed decision making are now seen as important goals for screening programmes. Personalised risk estimates have been shown to be effective methods of risk communication. OBJECTIVES: To assess the effects of personalised risk communication on informed decision making by individuals taking screening tests. We also assess individual components that constitute informed decisions. SEARCH METHODS: Two authors searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2012), MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL (EbscoHOST) and PsycINFO (OvidSP) without language restrictions. We searched from 2006 to March 2012. The date ranges for the previous searches were from 1989 to December 2005 for PsycINFO and from 1985 to December 2005 for other databases. For the original version of this review, we also searched CancerLit  and Science Citation Index (March 2001). We also reviewed the reference lists and conducted citation searches of included studies and other systematic reviews in the field, to identify any studies missed during the initial search. SELECTION CRITERIA: Randomised controlled trials incorporating an intervention with a 'personalised risk communication element' for individuals undergoing screening procedures, and reporting measures of informed decisions and also cognitive, affective, or behavioural outcomes addressing the decision by such individuals, of whether or not to undergo screening. DATA COLLECTION AND ANALYSIS: Two authors independently assessed each included trial for risk of bias, and extracted data. We extracted data about the nature and setting of interventions, and relevant outcome data. We used standard statistical methods to combine data using RevMan version 5, including analysis according to different levels of detail of personalised risk communication, different conditions for screening, and studies based only on high-risk participants rather than people at 'average' risk.  MAIN RESULTS: We included 41 studies involving 28,700 people. Nineteen new studies were identified in this update, adding to the 22 studies included in the previous two iterations of the review. Three studies measured informed decision with regard to the uptake of screening following personalised risk communication as a part of their intervention. All of these three studies were at low risk of bias and there was strong evidence that the interventions enhanced informed decision making, although with heterogeneous results. Overall 45.2% (592/1309) of participants who received personalised risk information made informed choices, compared to 20.2% (229/1135) of participants who received generic risk information. The overall odds ratios (ORs) for informed decision were 4.48 (95% confidence interval (CI) 3.62 to 5.53 for fixed effect) and 3.65 (95% CI 2.13 to 6.23 for random effects). Nine studies measured increase in knowledge, using different scales. All of these studies showed an increase in knowledge with personalised risk communication. In three studies the interventions showed a trend towards more accurate risk perception, but the evidence was of poor quality. Four out of six studies reported non-significant changes in anxiety following personalised risk communication to the participants. Overall there was a small non-significant decrease in the anxiety scores. Most studies (32/41) measured the uptake of screening tests following interventions. Our results (OR 1.15 (95% CI 1.02 to 1.29)) constitute low quality evidence, consistent with a small effect, that personalised risk communication in which a risk score was provided (6 studies) or the participants were given their categorised risk (6 studies), increases uptake of screening tests.  AUTHORS' CONCLUSIONS: There is strong evidence from three trials that personalised risk estimates incorporated within communication interventions for screening programmes enhance informed choices. However the evidence for increasing the uptake of such screening tests with similar interventions is weak, and it is not clear if this increase is associated with informed choices. Studies included a diverse range of screening programmes. Therefore, data from this review do not allow us to draw conclusions about the best interventions to deliver personalised risk communication for enhancing informed decisions. The results are dominated by findings from the topic area of mammography and colorectal cancer. Caution is therefore required in generalising from these results, and particularly for clinical topics other than mammography and colorectal cancer screening.

"It's a maybe test": men's experiences of prostate specific antigen testing in primary care.

BACKGROUND: Prostate specific antigen (PSA) testing in primary care is an important and contentious issue. Due to concerns about the test and the value of early detection, countries such as the UK advocate 'informed choice' instead of population screening. It is not known whether this policy is actually adhered to in primary care. Furthermore, little is known of the experiences of men who face this decision. AIM: To explore the experiences, understanding, and views of men who considered or undertook PSA testing in UK primary care. DESIGN OF STUDY: Qualitative interview-based study. SETTING: Primary care, Wales, UK. METHOD: Semi-structured one-to-one interviews were conducted with 28 men, representing a range of clinical outcomes. Transcripts were coded and subjected to thematic analysis. RESULTS: Three themes were identified: the decision-making context, the locus of decision making, and uncertainty related to the PSA test. CONCLUSION: The decision to undertake PSA testing was affected by both social and media factors and it did not appear to be a patient-led decision. The decision created considerable uncertainty for men and this uncertainty persisted after the test, even if the result was normal. Raised PSA led to further investigations and this exacerbated the uncertainty. Anxiety and regret were consequences of this uncertainty.

Is there evidence that palliative care teams alter end-of-life experiences of patients and their caregivers?

Palliative care provision varies widely, and the effectiveness of palliative and hospice care teams (PCHCT) is unproven. To determine the effect of PCHCT, 10 electronic databases (to 2000), 4 relevant journals, associated reference lists, and the grey literature were searched. All PCHCT evaluations were included. Anecdotal and case reports were excluded. Forty-four studies evaluated PCHCT provision. Teams were home care (22), hospital-based (9), combined home/hospital care (4), inpatient units (3), and integrated teams (6). Studies were mostly Grade II or III quality. Funnel plots indicated slight publication bias. Meta-regression (26 studies) found slight positive effect, of approximately 0.1, of PCHCTs on patient outcomes, independent of team make-up, patient diagnosis, country, or study design. Meta-analysis (19 studies) demonstrated small benefit on patients' pain (odds ratio [OR]: 0.38, 95% confidence interval [CI]: 0.23-0.64), other symptoms (OR: 0.51, CI: 0.30-0.88), and a non-significant trend towards benefits for satisfaction, and therapeutic interventions. Data regarding home deaths were equivocal. Meta-synthesis (all studies) found wide variations in the type of service delivered by each team; there was no discernible difference in outcomes between city, urban, and rural areas. Evidence of benefit was strongest for home care. Only one study provided full economic cost-benefit evaluation. This is the first study to quantitatively demonstrate benefit from PCHCTs. Such comparisons were limited by the quality of the research.

An evaluation of systematic reviews of palliative care services.

This review aimed to identify and appraise all systematic reviews of palliative care services, to examine their findings in relation to methods used, and to explore whether further methods such as meta-analysis and meta-regression may be worthwhile. Ten databases were searched and augmented by hand searching specific journals, contacting authors, and examining the reference lists of all papers retrieved. Five systematic reviews met the inclusion criteria, and the update electronic search identified a further systematic review which found similar studies. A total of 39 studies were identified by the five systematic reviews. Of the 39 studies, 15 were RCTS, and 12 of those were North American. In comparison, the majority of U.K. studies were retrospective. Each review concluded similarly that there was a lack of good quality evidence on which to base conclusions. The more recent reviews were more rigorous, but none used a quantitative analysis. Despite the difficulties in combining heterogeneous interventions and outcomes in meta-analysis or meta-regression, such techniques may be valuable. More high quality evidence is needed to compare the relative merits of the differences in models of palliative care services, so that countries can learn from other appropriate systems of care at end of life.

Do hospital-based palliative teams improve care for patients or families at the end of life?

To determine whether hospital-based palliative care teams improve the process or outcomes of care for patients and families at the end of life, a systematic literature review was performed employing a qualitative meta-synthesis and quantitative meta-analysis. Ten databases were searched. This was augmented by hand searching specific journals, contacting authors, and examining the reference lists of all papers retrieved. Studies were included if they evaluated palliative care teams working in hospitals. Data were extracted by two independent reviewers. Studies were graded using two independent hierarchies of evidence. A Signal score was used to assess the relevance of publications. Two analyses were conducted. In a qualitative meta-synthesis data were extracted into standardized tables to compare relevant features and findings. In quantitative meta-analysis we calculated the effect size of each outcome (dividing the estimated mean difference or difference in proportions by the sample's standard deviation). Nine studies specifically examined the intervention of a hospital-based palliative care team or studies. A further four studies considered interventions that included a component of a hospital or support team, although the total intervention was broader. The nature of the interventions varied. The studies were usually in large teaching hospitals, in cities, and mainly in the United Kingdom. Outcomes considered symptoms, quality of life, time in hospital, total length of time in palliative care, or professional changes, such as prescribing practices. Only one of the studies was a randomized controlled trial and this considered a hospital team as part of other services. Most method scores indicated limited research quality. Comparison groups were subject to bias and the analyses were not adjusted for confounding variables. In addition, there were problems of attrition and small sample sizes. Nevertheless, all studies indicated a small positive effect of the hospital team, except for one study in Italy, which documented deterioration in patient symptoms. The Signal scores indicated that the studies were relevant. No study compared different models of hospital team. This review suggests that hospital-based palliative care teams offer some benefits, although this finding should be interpreted with caution. The study designs need to be improved and different models of providing support at the end of life in hospital need comparison. Standardized outcome measures should be used in such research and in practice.