Perioperative medicine training resources: U1M13 Communication

This document updates previous Faculty of Sexual & Reproductive Healthcare (FSRH) guidance and aims to summarise the available evidence and expert opinion on combined hormonal contraception (CHC). The guideline is intended for use by healthcare practitioners (HCPs) providing CHC.

This guideline was developed in accordance with standard methodology for developing FSRH clinical guidelines. The recommendations made within this document are based on the best available evidence and the consensus opinion of experts and the guideline development group (GDG). The methodology used in developing this guideline and a list of GDG members and other contributors can be found in Appendix 1.

Abstract
Background. Overdiagnosis is an accepted harm of cancer screening, but studies of prostate cancer screening decision aids have not examined provision of information important in communicating the risk of overdiagnosis, including overdiagnosis frequency, competing mortality risk, and the high prevalence of indolent cancers in the population. Methods. We undertook a comprehensive review of all publicly available decision aids for prostate cancer screening, published in (or translated to) the English language, without date restrictions. We included all decision aids from a recent systematic review and screened excluded studies to identify further relevant decision aids. We used a Google search to identify further decision aids not published in peer reviewed medical literature. Two reviewers independently screened the decision aids and extracted information on communication of overdiagnosis. Disagreements were resolved through discussion or by consulting a third author. Results. Forty-one decision aids were included out of the 80 records identified through the search. Most decision aids (n = 32, 79%) did not use the term overdiagnosis but included a description of it (n = 38, 92%). Few (n = 7, 17%) reported the frequency of overdiagnosis. Little more than half presented the benefits of prostate cancer screening before the harms (n = 22, 54%) and only 16, (39%) presented information on competing risks of mortality. Only 2 (n = 2, 5%) reported the prevalence of undiagnosed prostate cancer in the general population. Conclusion. Most patient decision aids for prostate cancer screening lacked important information on overdiagnosis. Specific guidance is needed on how to communicate the risks of overdiagnosis in decision aids, including appropriate content, terminology and graphical display.

Highlights: Most patient decision aids for prostate cancer screening lacks important information on overdiagnosis.Specific guidance is needed on how to communicate the risks of overdiagnosis.

Abstract
Background: Risk perceptions are central to many health behavior theories. However, the relationship between risk perceptions and behavior, muddied by instances of inappropriate assessment and analysis, often looks weak.

Method: A meta-analysis of eligible studies assessing the bivariate association between adult vaccination and perceived likelihood, susceptibility, or severity was conducted.

Results: Thirty-four studies met inclusion criteria (N = 15,988). Risk likelihood (pooled r = .26), susceptibility (pooled r = .24), and severity (pooled r = .16) significantly predicted vaccination behavior. The risk perception-behavior relationship was larger for studies that were prospective, had higher quality risk measures, or had unskewed risk or behavior measures.

Conclusions: The consistent relationships between risk perceptions and behavior, larger than suggested by prior meta-analyses, suggest that risk perceptions are rightly placed as core concepts in theories of health behavior.

Abstract
WHAT ABOUT POLICY REGARDING SDM? SDM is on the national policy agenda and has been prioritised as part of the health reform bill currently going through the Houses of Parliament. The NHS Constitution emphasises patients' right to be involved in decisions and this is reinforced in standards set by professional regulators. WHAT ABOUT TOOLS - DECISION SUPPORT FOR PATIENTS? The UK governments have invested in patient information and a few decision aids are freely available on public websites. WHAT ABOUT PROFESSIONAL INTEREST AND IMPLEMENTATION? There is interest in SDM and in collaborative care planning, but this is not yet the norm in clinical practice and few clinicians have received training in the topic. Several programmes are under way to encourage implementation of SDM. WHAT DOES THE FUTURE LOOK LIKE? Future developments will depend on the extent of clinical commitment and on whether there are sufficient funds available to invest in the promotion of SDM at a time when health care resources are tightly constrained.

Abstract
Background: Combined oral contraceptive (COC) use has been associated with venous thrombosis (VT) (i.e., deep venous thrombosis and pulmonary embolism). The VT risk has been evaluated for many estrogen doses and progestagen types contained in COC but no comprehensive comparison involving commonly used COC is available.

Objectives: To provide a comprehensive overview of the risk of venous thrombosis in women using different combined oral contraceptives.

Search methods: Electronic databases (Pubmed, Embase, Web of Science, Cochrane, CINAHL, Academic Search Premier and ScienceDirect) were searched in 22 April 2013 for eligible studies, without language restrictions.

Selection criteria: We selected studies including healthy women taking COC with VT as outcome.

Data collection and analysis: The primary outcome of interest was a fatal or non-fatal first event of venous thrombosis with the main focus on deep venous thrombosis or pulmonary embolism. Publications with at least 10 events in total were eligible. The network meta-analysis was performed using an extension of frequentist random effects models for mixed multiple treatment comparisons. Unadjusted relative risks with 95% confidence intervals were reported.Two independent reviewers extracted data from selected studies.

Main results: 3110 publications were retrieved through a search strategy; 25 publications reporting on 26 studies were included. Incidence of venous thrombosis in non-users from two included cohorts was 0.19 and 0.37 per 1 000 person years, in line with previously reported incidences of 0,16 per 1 000 person years. Use of combined oral contraceptives increased the risk of venous thrombosis compared with non-use (relative risk 3.5, 95% confidence interval 2.9 to 4.3). The relative risk of venous thrombosis for combined oral contraceptives with 30-35 μg ethinylestradiol and gestodene, desogestrel, cyproterone acetate, or drospirenone were similar and about 50-80% higher than for combined oral contraceptives with levonorgestrel. A dose related effect of ethinylestradiol was observed for gestodene, desogestrel, and levonorgestrel, with higher doses being associated with higher thrombosis risk.

Authors' conclusions: All combined oral contraceptives investigated in this analysis were associated with an increased risk of venous thrombosis. The effect size depended both on the progestogen used and the dose of ethinylestradiol. Risk of venous thrombosis for combined oral contraceptives with 30-35 μg ethinylestradiol and gestodene, desogestrel, cyproterone acetate and drospirenone were similar, and about 50-80% higher than with levonorgestrel. The combined oral contraceptive with the lowest possible dose of ethinylestradiol and good compliance should be prescribed-that is, 30 μg ethinylestradiol with levonorgestrel.

Abstract
Objectives To revise an existing three-talk model for learning how to achieve shared decision making, and to consult with relevant stakeholders to update and obtain wider engagement.Design Multistage consultation process.Setting Key informant group, communities of interest, and survey of clinical specialties.Participants 19 key informants, 153 member responses from multiple communities of interest, and 316 responses to an online survey from medically qualified clinicians from six specialties.Results After extended consultation over three iterations, we revised the three-talk model by making changes to one talk category, adding the need to elicit patient goals, providing a clear set of tasks for each talk category, and adding suggested scripts to illustrate each step. A new three-talk model of shared decision making is proposed, based on "team talk," "option talk," and "decision talk," to depict a process of collaboration and deliberation. Team talk places emphasis on the need to provide support to patients when they are made aware of choices, and to elicit their goals as a means of guiding decision making processes. Option talk refers to the task of comparing alternatives, using risk communication principles. Decision talk refers to the task of arriving at decisions that reflect the informed preferences of patients, guided by the experience and expertise of health professionals.Conclusions The revised three-talk model of shared decision making depicts conversational steps, initiated by providing support when introducing options, followed by strategies to compare and discuss trade-offs, before deliberation based on informed preferences.

Abstract
The warning issued by the UK Committee on Safety Medicines in October 1995, followed by their 'Dear Doctor' letter of October 18, 1995, that oral contraceptive pills containing gestodene or desogestrel were associated with a higher risk of venous thromboembolism has had a negative impact on public heath. A significant number of women either switched brands or ceased contraception altogether following the announcement. National data suggest a strong association between the pill scare and a substantial increase in the number of unintended pregnancies, particularly significant among younger women, with use of oral contraception falling from 40 to 27% of under 16s between 1995-1996 and 1996-1997. The resulting cost of the increase in births and abortions to the National Health Service has been estimated at about Pound Sterling 21 million for maternity care and from Pound Sterling 46 million for abortion provision. The level of risk should, in future, be more carefully assessed and advice more carefully presented in the interests of public health.

Abstract
Objective: To develop, pilot, and evaluate a curriculum for teaching clinical risk communication skills to medical students.

Methods: A new experience-based curriculum, "Risk Talk," was developed and piloted over a 1-year period among students at Tufts University School of Medicine. An experimental study of 2nd-year students exposed vs. unexposed to the curriculum was conducted to evaluate the curriculum's efficacy. Primary outcome measures were students' objective (observed) and subjective (self-reported) risk communication competence; the latter was assessed using an Observed Structured Clinical Examination (OSCE) employing new measures.

Results: Twenty-eight 2nd-year students completed the curriculum, and exhibited significantly greater (p<.001) objective and subjective risk communication competence than a convenience sample of 24 unexposed students. New observational measures of objective competence in risk communication showed promising evidence of reliability and validity. The curriculum was resource-intensive.

Conclusion: The new experience-based clinical risk communication curriculum was efficacious, although resource-intensive. More work is needed to develop the feasibility of curriculum delivery, and to improve the measurement of competence in clinical risk communication.

Practice implications: Risk communication is an important advanced communication skill, and the Risk Talk curriculum provides a model educational intervention and new assessment tools to guide future efforts to teach and evaluate this skill.

Abstract
Importance: Unrealistic patient expectations of the benefits and harms of interventions can influence decision making and may be contributing to increasing intervention uptake and health care costs.

Objective: To systematically review all studies that have quantitatively assessed patients' expectations of the benefits and/or harms of any treatment, test, or screening test.

Evidence review: A comprehensive search strategy was used in 4 databases (MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, PsycINFO) up to June 2013, with no language or study type restriction. We also ran cited reference searches of included studies and contacted experts and study authors. Two researchers independently evaluated methodological quality and extracted participants' estimates of benefit and harms and authors' contemporaneous estimates.

Findings: Of the 15,343 records screened, 36 articles (from 35 studies) involving a total of 27,323 patients were eligible. Fourteen studies focused on a screen, 15 on treatment, 3 a test, and 3 on treatment and screening. More studies assessed only benefit expectations (22 [63%]) than benefit and harm expectations (10 [29%]) or only harm (3 [8%]). Fifty-four outcomes (across 32 studies) assessed benefit expectations: of the 34 outcomes with overestimation data available, the majority of participants overestimated benefit for 22 (65%) of them. For 17 benefit expectation outcomes, we could not calculate the proportion of participants who overestimated or underestimated, although for 15 (88%) of these, study authors concluded that participants overestimated benefits. Expectations of harm were assessed by 27 outcomes (across 13 studies): underestimation data were available for 15 outcomes and the majority of participants underestimated harm for 10 (67%) of these. A correct estimation by at least 50% of participants only occurred for 2 outcomes about benefit expectations and 2 outcomes about harm expectations.

Conclusions and relevance: The majority of participants overestimated intervention benefit and underestimated harm. Clinicians should discuss accurate and balanced information about intervention benefits and harms with patients, providing the opportunity to develop realistic expectations and make informed decisions.

Abstract
Importance: Prostate cancer screening remains controversial because potential mortality or quality-of-life benefits may be outweighed by harms from overdetection and overtreatment.

Objective: To evaluate the effect of a single prostate-specific antigen (PSA) screening intervention and standardized diagnostic pathway on prostate cancer-specific mortality.

Design, setting, and participants: The Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP) included 419 582 men aged 50 to 69 years and was conducted at 573 primary care practices across the United Kingdom. Randomization and recruitment of the practices occurred between 2001 and 2009; patient follow-up ended on March 31, 2016.

Intervention: An invitation to attend a PSA testing clinic and receive a single PSA test vs standard (unscreened) practice.

Main outcomes and measures: Primary outcome: prostate cancer-specific mortality at a median follow-up of 10 years. Prespecified secondary outcomes: diagnostic cancer stage and Gleason grade (range, 2-10; higher scores indicate a poorer prognosis) of prostate cancers identified, all-cause mortality, and an instrumental variable analysis estimating the causal effect of attending the PSA screening clinic.

Results: Among 415 357 randomized men (mean [SD] age, 59.0 [5.6] years), 189 386 in the intervention group and 219 439 in the control group were included in the analysis (n = 408 825; 98%). In the intervention group, 75 707 (40%) attended the PSA testing clinic and 67 313 (36%) underwent PSA testing. Of 64 436 with a valid PSA test result, 6857 (11%) had a PSA level between 3 ng/mL and 19.9 ng/mL, of whom 5850 (85%) had a prostate biopsy. After a median follow-up of 10 years, 549 (0.30 per 1000 person-years) died of prostate cancer in the intervention group vs 647 (0.31 per 1000 person-years) in the control group (rate difference, -0.013 per 1000 person-years [95% CI, -0.047 to 0.022]; rate ratio [RR], 0.96 [95% CI, 0.85 to 1.08]; P = .50). The number diagnosed with prostate cancer was higher in the intervention group (n = 8054; 4.3%) than in the control group (n = 7853; 3.6%) (RR, 1.19 [95% CI, 1.14 to 1.25]; P < .001). More prostate cancer tumors with a Gleason grade of 6 or lower were identified in the intervention group (n = 3263/189 386 [1.7%]) than in the control group (n = 2440/219 439 [1.1%]) (difference per 1000 men, 6.11 [95% CI, 5.38 to 6.84]; P < .001). In the analysis of all-cause mortality, there were 25 459 deaths in the intervention group vs 28 306 deaths in the control group (RR, 0.99 [95% CI, 0.94 to 1.03]; P = .49). In the instrumental variable analysis for prostate cancer mortality, the adherence-adjusted causal RR was 0.93 (95% CI, 0.67 to 1.29; P = .66).

Conclusions and relevance: Among practices randomized to a single PSA screening intervention vs standard practice without screening, there was no significant difference in prostate cancer mortality after a median follow-up of 10 years but the detection of low-risk prostate cancer cases increased. Although longer-term follow-up is under way, the findings do not support single PSA testing for population-based screening.

Abstract
Explaining risks to patients in an effective way is an essential part of ensuring that consent is “informed.” A consultant in risk communication discusses the strategies that can help doctors to communicate risks clearly, and thereby also build closer relationships with their patients

Abstract
Background: Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty.

Objectives: To assess the effects of decision aids for people facing treatment or screening decisions.

Search methods: For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008).

Selection criteria: We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions.

Data collection and analysis: Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were:A) 'choice made' attributes;B) 'decision-making process' attributes.Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model.

Main results: This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each.Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies).A) Criteria involving 'choice made' attributes:Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13).B) Criteria involving 'decision-making process' attributes:Decision aids compared to usual care interventions resulted in:a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18);b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); andc) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18).Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice.C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable.The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive.

Authors' conclusions: There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values.New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.

Abstract
Background: Making evidence-based decisions often requires comparison of two or more options. Research-based evidence may exist which quantifies how likely the outcomes are for each option. Understanding these numeric estimates improves patients' risk perception and leads to better informed decision making. This paper summarises current "best practices" in communication of evidence-based numeric outcomes for developers of patient decision aids (PtDAs) and other health communication tools.

Method: An expert consensus group of fourteen researchers from North America, Europe, and Australasia identified eleven main issues in risk communication. Two experts for each issue wrote a "state of the art" summary of best evidence, drawing on the PtDA, health, psychological, and broader scientific literature. In addition, commonly used terms were defined and a set of guiding principles and key messages derived from the results.

Results: The eleven key components of risk communication were: 1) Presenting the chance an event will occur; 2) Presenting changes in numeric outcomes; 3) Outcome estimates for test and screening decisions; 4) Numeric estimates in context and with evaluative labels; 5) Conveying uncertainty; 6) Visual formats; 7) Tailoring estimates; 8) Formats for understanding outcomes over time; 9) Narrative methods for conveying the chance of an event; 10) Important skills for understanding numerical estimates; and 11) Interactive web-based formats. Guiding principles from the evidence summaries advise that risk communication formats should reflect the task required of the user, should always define a relevant reference class (i.e., denominator) over time, should aim to use a consistent format throughout documents, should avoid "1 in x" formats and variable denominators, consider the magnitude of numbers used and the possibility of format bias, and should take into account the numeracy and graph literacy of the audience.

Conclusion: A substantial and rapidly expanding evidence base exists for risk communication. Developers of tools to facilitate evidence-based decision making should apply these principles to improve the quality of risk communication in practice.

Abstract
Background: Unlike reduced mortality rates, improved survival rates and increased early detection do not prove that cancer screening tests save lives. Nevertheless, these 2 statistics are often used to promote screening.

Objective: To learn whether primary care physicians understand which statistics provide evidence about whether screening saves lives.

Design: Parallel-group, randomized trial (randomization controlled for order effect only), conducted by Internet survey. (ClinicalTrials.gov registration number: NCT00981019)

Setting: National sample of U.S. primary care physicians from a research panel maintained by Harris Interactive (79% cooperation rate).

Participants: 297 physicians who practiced both inpatient and outpatient medicine were surveyed in 2010, and 115 physicians who practiced exclusively outpatient medicine were surveyed in 2011.

Intervention: Physicians received scenarios about the effect of 2 hypothetical screening tests: The effect was described as improved 5-year survival and increased early detection in one scenario and as decreased cancer mortality and increased incidence in the other.

Measurements: Physicians' recommendation of screening and perception of its benefit in the scenarios and general knowledge of screening statistics.

Results: Primary care physicians were more enthusiastic about the screening test supported by irrelevant evidence (5-year survival increased from 68% to 99%) than about the test supported by relevant evidence (cancer mortality reduced from 2 to 1.6 in 1000 persons). When presented with irrelevant evidence, 69% of physicians recommended the test, compared with 23% when presented with relevant evidence (P < 0.001). When asked general knowledge questions about screening statistics, many physicians did not distinguish between irrelevant and relevant screening evidence; 76% versus 81%, respectively, stated that each of these statistics proves that screening saves lives (P = 0.39). About one half (47%) of the physicians incorrectly said that finding more cases of cancer in screened as opposed to unscreened populations "proves that screening saves lives."

Limitation: Physicians' recommendations for screening were based on hypothetical scenarios, not actual practice.

Conclusion: Most primary care physicians mistakenly interpreted improved survival and increased detection with screening as evidence that screening saves lives. Few correctly recognized that only reduced mortality in a randomized trial constitutes evidence of the benefit of screening.

Primary funding source: Harding Center for Risk Literacy, Max Planck Institute for Human Development.

Abstract
Women tend to overestimate their risk of breast cancer (BC) and underestimate their risk of coronary heart disease (CHD). Perceived risk of illness has been shown to influence health behavior practices. This study assessed the relationship between perceived future risk of BC and CHD and relevant cognitive/emotional and behavioral variables in a sample of 133 racially/ethnically diverse female undergraduates. Results indicate unrealistic pessimism regarding risk of BC among peers and unrealistic optimism regarding personal risk of CHD. When compared to CHD, participants were significantly more worried about getting BC but less aware of BC risks. Perceived CHD risk was associated with exercise and diet; perceived BC risk was not associated with breast self-exams. Health promotion efforts may need to vary based on target illness.

CVD is by far the biggest cause of death in women but is still underestimated as a health problem.