Informed Consent and the Duty to Warn: More than the Mere Provision of Information.

Before providing any form of medical treatment, medical practitioners are generally required to discharge their duty to warn. It is argued in this article that the duty to warn, at least as it relates to frail and elderly patients, requires the principles of shared decision-making to be adopted. Doing so will ensure a comprehensive biopsychosocial understanding of the patient and assist in identifying material risks that may not be readily apparent. Such risks include risks that threaten the patient's values, preferences, treatment aims and long-term outcomes. Once such risks are identified, in discharging the duty to warn, they should be contextualised in a manner that makes clear how that risk will manifest in that particular patient. These risks should then also be synthesised within the context of their other medical issues and longer-term interests. Finally, it is suggested that the traditional consent process may need restructuring.

Caesarean section and anal incontinence in women after obstetric anal sphincter injury: A systematic review and meta-analysis.

BACKGROUND: Approximately 50% women who give birth after obstetric anal sphincter injury (OASI) develop anal incontinence (AI) over their lifetime. OBJECTIVE: To evaluate current evidence for a protective benefit of planned caesarean section (CS) to prevent AI after OASI. SEARCH STRATEGY: MEDLINE/PubMed, Embase 1974-2024, CINAHL and Cochrane to 7 February 2024 (PROSPERO CRD42022372442). SELECTION CRITERIA: All studies reporting outcomes after OASI and a subsequent birth, by any mode. DATA COLLECTION AND ANALYSIS: Eighty-six of 2646 screened studies met inclusion criteria, with nine studies suitable to meta-analyse the primary outcome of 'adjusted AI' after OASI and subsequent birth. Subgroups: short-term AI, long-term AI, AI in asymptomatic women. SECONDARY OUTCOMES: total AI, quality of life, satisfaction/regret, solid/liquid/flatal incontinence, faecal urgency, AI in women with and without subsequent birth, change in AI pre- to post- subsequent birth. MAIN RESULTS: There was no evidence of a difference in adjusted AI after subsequent vaginal birth compared with CS after OASI across all time periods (OR = 0.92, 95% CI 0.72-1.20; 9 studies, 2104 participants, I2 = 0% p = 0.58), for subgroup analyses or secondary outcomes. There was no evidence of a difference in AI in women with or without subsequent birth (OR = 1.00 95% CI 0.65-1.54; 10 studies, 970 participants, I2 = 35% p = 0.99), or pre- to post- subsequent birth (OR = 0.79 95% CI 0.51-1.25; 13 studies, 5496 participants, I2 = 73% p = 0.31). CONCLUSIONS: Due to low evidence quality, we are unable to determine whether planned caesarean is protective against AI after OASI. Higher quality evidence is required to guide personalised decision-making for asymptomatic women and to determine the effect of subsequent birth mode on long-term AI outcomes.

DCIS knowledge of women choosing between active surveillance and surgery for low-risk DCIS.

BACKGROUND: Ductal carcinoma in situ (DCIS) can progress to invasive breast cancer (IBC), but often never will. As we cannot predict accurately which DCIS-lesions will or will not progress to IBC, almost all women with DCIS undergo breast-conserving surgery supplemented with radiotherapy, or even mastectomy. In some countries, endocrine treatment is prescribed as well. This implies many women with non-progressive DCIS undergo overtreatment. To reduce this, the LORD patient preference trial (LORD-PPT) tests whether mammographic active surveillance (AS) is safe by giving women with low-risk DCIS a choice between treatment and AS. For this, sufficient knowledge about DCIS is crucial. Therefore, we assessed women's DCIS knowledge in association with socio-demographic and clinical characteristics. METHODS: LORD-PPT participants (N = 376) completed a questionnaire assessing socio-demographic and clinical characteristics, risk perception, treatment choice and DCIS knowledge after being informed about their diagnosis and treatment options. RESULTS: 66 % of participants had poor knowledge (i.e., answered ≤3 out of 7 knowledge items correctly). Most incorrect answers involved overestimating the safety of AS and misunderstanding of DCIS prognostic risks. Overall, women with higher DCIS knowledge score perceived their risk of developing IBC as being somewhat higher than women with poorer knowledge (p = 0.049). Women with better DCIS knowledge more often chose surgery whilst most women with poorer knowledge chose active surveillance (p = 0.049). DISCUSSION: Our findings show that there is room for improvement of information provision to patients. Decision support tools for patients and clinicians could help to stimulate effective shared decision-making about DCIS management.

Patient-centric care in primary immune thrombocytopenia (ITP): shared decision-making and assessment of health-related quality of life.

ABSTRACTImmune thrombocytopenia (ITP), an autoimmune disease characterized by low platelet counts and increased bleeding risk, can impair health-related quality of life (HRQoL), impacting patients' daily lives and mental health. A number of patient-reported outcome (PRO) measures (both generic and specific to ITP) can be used to understand the impact of ITP on HRQoL and generate evidence to guide disease management. As well-developed PRO tools could help in HRQoL assessment, their optimization could help to solidify a patient-centric approach to ITP management. Shared decision-making is a collaborative process between a patient and their healthcare professional in making decisions about care. Treatment decisions based on this shared process between physician and patient are recommended by clinical guidelines. The goal of this narrative review is to discuss treatment decisions with regards to patient-centric ITP management, with a focus on the impact of PRO measures and the process of shared decision-making in practice.

Contraceptive counseling: Shared decision on contraceptive choices.

The promising results achieved in male hormonal contraceptive trials over the last decades suggest that new male contraceptives could hit the market soon. In shared decision-making counseling, couples and their healthcare provider collaborate to make decisions about contraception choices. This model of contraceptive counseling could aid men in taking responsibility for contraception and women in trusting their partners in family planning. The shared decision-making process in contraceptive counseling requires partners to provide input on their preferences, values, and desires, while healthcare professionals share medical knowledge and evidence-based information.It has been proven that this method leads to higher adherence and satisfaction. To ensure that contraceptive counseling is inclusive, fair, and supportive of different reproductive experiences and needs, it is crucial to incorporate the Reproductive Justice Framework into counseling.

Improving sustainability of a patient decision aid for systemic treatment of metastatic colorectal cancer: A qualitative study.

Objective: To improve sustainability of a patient decision aid for systemic treatment of metastatic colorectal cancer, we evaluated real-world experiences and identified ways to optimize decision aid content and future implementation. Methods: Semi-structured interviews with patients and medical oncologists addressed two main subjects: user experience and decision aid content. Content analysis was applied. Fifteen experts discussed the results and devised improvements based on experience and literature review. Results: Thirteen users were interviewed. They confirmed the relevance of the decision aid for shared decision making. Areas for improvement of content concerned; 1) outdated and missing information, 2) an imbalance in presentation of treatment benefits and harms, and 3) medical oncologists' expressed preference for a more center-specific or patient individualized decision aid, presenting a selection of the guideline recommended treatment options. Key points for improvement of implementation were better alignment within the care pathway, and clear instruction to users. Conclusion: We identified relevant opportunities for improvement of an existing decision aid and developed an updated version and accompanying implementation strategy accordingly. Innovation: This paper outlines an approach for continued decision aid and implementation strategy development which will add to sustainability. Implementation success of the improved decision aid is currently being studied in a multi-center mixed-methods implementation study.

A qualitative study on the effect of a decision aid on knowledge of cataract surgery in patients in developing countries.

BACKGROUND: Despite cataract surgery being a safe procedure with a low incidence of perioperative complications rates, poor knowledge, concerns about the effectiveness of treatment and cost-benefit analysis of the procedure significantly hinder cataract surgery uptake rates in Africa. This study describes the effect of a decision aid on knowledge and decision conflict on cataract patients in Africa. METHODS AND ANALYSIS: 120 patients with cataracts reporting to a tertiary hospital in Ghana were randomly assigned to receive a decision aid containing information on the possible outcomes of cataract surgery or a control booklet containing general knowledge about cataracts without information about cataract surgery. The primary outcome measured was the effect of the decision aid on their knowledge of cataract surgery. A score greater than 6/12 (50%) was deemed adequate knowledge. The secondary outcome was the decision conflict experienced by the participants assessed using the Decision Conflict Scale. RESULTS: Compared to the control group, the participants in the intervention group scored higher marks across all sections of the questionnaire (2.92 vs 2.7, p = 0.042 in section "Background"; 2.62 vs 1.77, p < 0.001 in section "Materials"; 1.87 vs 1.55, p = 0.03 in section "Results"). The average total score was higher in the intervention group than in the control (36.7% difference; p < 0.001). Participants in the intervention group also demonstrated lower decision conflict scores than those in the control group (13.00 vs 37.17; p < 0.001). CONCLUSION: The decision aid increased knowledge of cataract surgery and reduced decision conflict among patients in a developing country.

Current Status of Shared Decision-Making in Intraocular Lens Selection for Cataract Surgery: A Cross-Sectional Study.

Purpose: To explore 1) the level of shared decision-making (SDM) participation in intraocular lens (IOL) selection in cataract patients and the factors that influence this participation and 2) the relationships between preparation for decision-making (PrepDM)and the level of SDM participation and satisfaction with the decision (SWD). Provide guidance for improving SDM in ophthalmology. Patients and Methods: 176 cataract patients were asked to complete the PrepDM scale, the 9-item Shared Decision Making Questionnaire (SDM-Q-9) and the SWD instrument in IOL decision-making process. Multiple linear regression was used to analyze the influencing factors of the level of SDM. The Process program and bootstrap sampling method was used to test whether the level of participation in SDM was a mediating variable among the three. Results: The SDM-Q-9 median score was 77.78 (IQR 31.11-88.89). Patients with a history of surgery in the operative eye (P=0.022) or PrepDM <60 points (P<0.001) had lower SDM-Q-9 scores than patients with no history of surgery in the operative eye or PrepDM ≥60 points. Patients with an education level lower than primary school had lower SDM-Q-9 scores than patients with other education levels (P<0.05). The PrepDM of cataract patients was positively correlated with the level of SDM (r=0.768, P<0.001) and with the SWD (r=0.727, P<0.001), and the level of SDM was positively correlated with the SWD (r=0.856, P<0.001). The level of SDM fully mediated PrepDM and SDW, with a mediating effect value of 0.128 and a mediating effect of 86.66% of the total effect. Conclusion: The SDM of cataract patients involved in IOL selection was in the upper middle range. Education, history of surgery in the operated eye, and PrepDM were factors that influenced the level of SDM. The level of participation in SDM fully mediated the relationship between PrepDM and SWD.

Tobacco quitline staffs' knowledge and attitudes about connecting quitline callers to lung cancer screening educational materials.

OBJECTIVE: To evaluate the impact of training quitline staff in lung cancer screening (LCS) on knowledge and attitudes towards connecting quitline callers to LCS educational materials. METHODS: We conducted a pre-post evaluation within a larger implementation project in the U.S. to support LCS among quitline callers. From July 2020 to June 2021, staff from four quitline service providers completed surveys before and after training on LCS knowledge. After training, staff completed the acceptability of intervention measure, intervention appropriateness measure, and feasibility of the intervention measure. RESULTS: A total of 245 staff completed the initial demographic survey (analytic sample), 130 completed the pre-training survey, and 225 completed the post-training survey. Staff were on average 47.4 years old and 76.7% were female. LCS knowledge improved after the training (n = 120, mean difference = +26.5%, 95% CI 21.6, 31.4, p < 0.001). Overall, staff felt that connecting quitline callers to LCS education materials was acceptable (M = 4.0, SD = 0.8), appropriate (M = 4.1, SD = 0.7), and feasible (M = 4.0, SD = 0.7). CONCLUSIONS: Receiving training about LCS eligibility and the benefits and harms of screening improved LCS knowledge among quitline staff. Quitline staff found that connecting callers with LCS educational materials is acceptable, appropriate, and feasible, and aligned with their primary mission.

'I need to understand so we can decide together': Difficult conversations about alopecia areata.

The management of alopecia areata (AA) in pediatric patients poses unique challenges, particularly regarding treatment discussions and decision making involving both patients and their families. This commentary presents findings from unpublished research on treatment-discontinuation discussions between AA patients and their treating providers, shedding light on the hopes, expectations, and disappointments of individuals with severe AA. The study explored patient and guardian satisfaction with these discussions, emphasizing the importance of addressing psychosocial concerns, facilitating contact with support groups, and demonstrating empathy. The role of dermatologists in conversations about treatment, prognosis, and quality of life is examined, emphasizing the need for honesty, empathy, and realistic expectations. The authors propose a patient-centered approach to initiating and guiding discussions, focusing on understanding the impact of AA on patients and their families and collaboratively deciding on treatment options. The mantra: 'I need to understand how this is affecting all of you, so we can decide together what to do next' is central to this proposed approach. Special considerations for different scenarios are discussed, highlighting the importance of individualized care and effective communication. Overall, the commentary emphasizes the significance of actively listening, acknowledging emotions, and prioritizing patient and family goals to optimize care for pediatric AA patients.

Novel Approaches to Patients with Differences of Sex Development.

Patients with differences of sex development (DSDs) have complex anatomy and surgical needs related to both Mullerian and non-Mullerian structures. Approaches to vaginal reconstruction for these conditions are guided by individual anatomy, with the goal of establishing unobstructed outflow for the reproductive, urinary, and gastrointestinal tracts. Patients may have anatomy requiring vaginoplasty for either outflow tract obstruction or chosen sexual function. In this article, the authors focus on management of differences in vaginal anatomy with delayed vaginoplasty for the newborn with DSD.

Design, implementation and usability analysis of patient empowerment in ADLIFE project via patient reported outcome measures and shared decision making.

INTRODUCTION: This paper outlines the design, implementation, and usability study results of the patient empowerment process for chronic disease management, using Patient Reported Outcome Measurements and Shared Decision-Making Processes. BACKGROUND: The ADLIFE project aims to develop innovative, digital health solutions to support personalized, integrated care for patients with severe long-term conditions such as Chronic Obstructive Pulmonary Disease, and/or Chronic Heart Failure. Successful long-term management of patients with chronic conditions requires active patient self-management and a proactive involvement of patients in their healthcare and treatment. This calls for a patient-provider partnership within an integrated system of collaborative care, supporting self-management, shared-decision making, collection of patient reported outcome measures, education, and follow-up. METHODS: ADLIFE follows an outcome-based and patient-centered approach where PROMs represent an especially valuable tool to evaluate the outcomes of the care delivered. We have selected 11 standardized PROMs for evaluating the most recent patients' clinical context, enabling the decision-making process, and personalized care planning. The ADLIFE project implements the "SHARE approach' for enabling shared decision-making via two digital platforms for healthcare professionals and patients. We have successfully integrated PROMs and shared decision-making processes into our digital toolbox, based on an international interoperability standard, namely HL7 FHIR. A usability study was conducted with 3 clinical sites with 20 users in total to gather feedback and to subsequently prioritize updates to the ADLIFE toolbox. RESULTS: User satisfaction is measured in the QUIS7 questionnaire on a 9-point scale in the following aspects: overall reaction, screen, terminology and tool feedback, learning, multimedia, training material and system capabilities. With all the average scores above 6 in all categories, most respondents have a positive reaction to the ADLIFE PEP platform and find it easy to use. We have identified shortcomings and have prioritized updates to the platform before clinical pilot studies are initiated. CONCLUSIONS: Having finalized design, implementation, and pre-deployment usability studies, and updated the tool based on further feedback, our patient empowerment mechanisms enabled via PROMs and shared decision-making processes are ready to be piloted in clinal settings. Clinical studies will be conducted based at six healthcare settings across Spain, UK, Germany, Denmark, and Israel.

A randomized controlled trial of shared decision-making treatment planning process to enhance shared decision-making in patients with MBC.

PURPOSE: Opportunities exist for patients with metastatic breast cancer (MBC) to engage in shared decision-making (SDM). Presenting patient-reported data, including patient treatment preferences, to oncologists before or during a treatment plan decision may improve patient engagement in treatment decisions. METHODS: This randomized controlled trial evaluated the standard-of-care treatment planning process vs. a novel treatment planning process focused on SDM, which included oncologist review of patient-reported treatment preferences, prior to or during treatment decisions among women with MBC. The primary outcome was patient perception of shared decision-making. Secondary outcomes included patient activation, treatment satisfaction, physician perception of treatment decision-making, and use of treatment plans. RESULTS: Among the 109 evaluable patients from December 2018 to June 2022, 28% were Black and 12% lived in a highly disadvantaged neighborhood. Although not reaching statistical significance, patients in the intervention arm perceived SDM more often than patients in the control arm (63% vs. 59%; Cramer's V = 0.05; OR 1.19; 95% CI 0.55-2.57). Among patients in the intervention arm, 31% were at the highest level of patient activation compared to 19% of those in the control arm (V = 0.18). In 82% of decisions, the oncologist agreed that the patient-reported data helped them engage in SDM. In 45% of decision, they reported changing management due to patient-reported data. CONCLUSIONS: Oncologist engagement in the treatment planning process, with oncologist review of patient-reported data, is a promising approach to improve patient participation in treatment decisions which should be tested in larger studies. TRIAL REGISTRATION: NCT03806738.

Ethical Considerations in Fetal Cardiology.

Fetal cardiology has evolved over the last 40 years and changed the timing of diagnosis and counseling of congenital heart disease, decision-making, planning for treatment at birth, and predicting future surgery from the postnatal to the prenatal period. Ethical issues in fetal cardiology transect multiple aspects of biomedical ethics including improvement in prenatal detection and diagnostic capabilities, access to equitable comprehensive care that preserves a pregnant person's right to make decisions, access to all reproductive options, informed consent, complexity in shared decision-making, and appropriate use of fetal cardiac interventions. This paper first reviews the literature and then provides an ethical analysis of accurate and timely diagnosis, equitable delivery of care, prenatal counseling and shared decision-making, and innovation through in utero intervention.

Workflow analysis of breast cancer treatment decision-making: challenges and opportunities for informatics to support patient-centered cancer care.

Objective: Decision support can improve shared decision-making for breast cancer treatment, but workflow barriers have hindered widespread use of these tools. The goal of this study was to understand the workflow among breast cancer teams of clinicians, patients, and their family caregivers when making treatment decisions and identify design guidelines for informatics tools to better support treatment decision-making. Materials and Methods: We conducted observations of breast cancer clinicians during routine clinical care from February to August 2022. Guided by the work system model, a human factors engineering model that describes the elements of work, we recorded all aspects of clinician workflow using a tablet and smart pencil. Observation notes were transcribed and uploaded into Dedoose. Two researchers inductively coded the observations. We identified themes relevant to the design of decision support that we classified into the 4 components of workflow (ie, flow of information, tasks, tools and technologies, and people). Results: We conducted 20 observations of breast cancer clinicians (total: 79 hours). We identified 10 themes related to workflow that present challenges and opportunities for decision support design. We identified approximately 48 different decisions discussed during breast cancer visits. These decisions were often interdependent and involved collaboration across the large cancer treatment team. Numerous patient-specific factors (eg, work, hobbies, family situation) were discussed when making treatment decisions as well as complex risk and clinical information. Patients were frequently asked to remember and relay information across the large cancer team. Discussion and Conclusion: Based on these findings, we proposed design guidelines for informatics tools to support the complex workflows involved in breast cancer care. These guidelines should inform the design of informatics solutions to better support breast cancer decision-making and improve patient-centered cancer care.

Perceived Reality and Subjective Importance of Shared Decision-Making During Perinatal Care.

Aim: The aim of the study is to explore perceived reality and subjective importance of shared decision-making (SDM) during antenatal, intrapartum, and/or postpartum care, provided by the midwife and/or obstetrician. Methods: A cross- sectional study was conducted among women in Flanders, Belgium. SDM was measured with the Observing PatienT InvOlvemeNt scale. Tests examined the differences between perceived reality and subjective importance of SDM. A multivariate generalized linear model tested the main and interaction effects between SDM and the maternity care providers and the perinatal care periods. Bonferroni post hoc tests examined further significance. Results: A total of 1,216 pregnant and postpartum participants completed 1,987 self-reports of perceived reality and subjective importance of SDM. The community midwives' SDM was evaluated 924/1,987 times, the hospital midwives' SDM 309/1,987 times, and the obstetricians' SDM 754/1,987 times. Perceived reality and subjective importance of SDM showed significant differences between care professionals (p < .001; p < .001), explained by the differences between community and hospital midwives' SDM (p < .001, d85; p < .001; d28) and between community midwives and obstetricians' SDM (p < .001, d72; p < .001; d31). Conclusions: The findings indicate optimizing the decision-making process during perinatal care by aligning subjective importance and perceived reality of SDM throughout the perinatal care episodes. Community midwives seem to be benchmarkers of shared decision-making during perinatal care.

Cost-effectiveness of a multicomponent-adherence intervention in fracture liaison services.

BACKGROUND: This study aims to assess the lifetime cost-effectiveness of a multi-component adherence intervention (MCAI), including a patient decision aid and motivational interviewing, compared to usual care in patients with a recent fracture attending fracture liaison services (FLS) and eligible for anti-osteoporosis medication (AOM). RESEARCH DESIGN AND METHODS: Data on AOM initiation and one-year persistence were collected from a quasi-experimental study conducted between 2019 and 2023 in two Dutch FLS centers. An individual level, state-transition Markov model was used to simulate lifetime costs and quality-adjusted life years (QALYs) with a societal perspective of MCAI vs usual care. One-way and probabilistic sensitivity analyses were conducted including variation in additional FLS and MCAI costs (no MCAI cost in baseline). RESULTS: MCAI was associated with gain in QALYs (0.0012) and reduction in costs (-€16) and is therefore dominant. At the Dutch willingness-to-pay threshold of €50,000/QALY, MCAI remained cost-effective when increasing costs of the FLS visit or the yearly maintenance cost for MCAI up to +€60. Probabilistic sensitivity analysis demonstrated MCAI to be dominant in 54% of the simulations and cost-effective in 87% with a threshold of €50,000/QALY. CONCLUSIONS: A MCAI implemented in FLS centers may lead to cost-effective allocation of resources in FLS care, depending on extra costs.

Preferences and considerations for interval cytoreductive surgery in advanced ovarian cancer: The patient's perspective.

OBJECTIVE: Treatment of advanced-stage ovarian cancer contains cytoreductive surgery (CRS) and chemotherapy. Achieving successful CRS (≤ 1 cm residual disease) is prognostically important, but may not be feasible peri-operatively while still risking complications. Therefore, patients' treatment expectations are important to discuss. We investigated patient considerations for interval CRS. METHODS: Patients with advanced-stage ovarian cancer planned for interval CRS completed a questionnaire about the impact of chance of successful CRS, survival benefit and becoming care-dependent on decision-making regarding CRS. The questionnaire included a vignette study, in which patients repeatedly chose between two treatment scenarios with varying levels for chance of successful CRS, survival benefit and risk of complications including stoma. Patient preferences were analyzed, including differences between patients aged < 70 and ≥ 70 years. RESULTS: Among 85 included patients, 31 (37%) patients considered interval CRS worthwhile irrespective of survival benefit and 33 (39%) irrespective of chance of successful surgery. However, 34 patients (41%) considered interval CRS only worthwhile if survival benefit was > 12 months, while 41 (49%) thought so if chance of successful surgery was ≥ 25%. Older patients considered these factors more important. Overall, 27% considered becoming permanently dependent of home care unacceptable. In the vignette study (n = 72) risk of complications and stoma were considered less important than chance of successful CRS and survival benefit. CONCLUSION: Survival benefit, chance of successful surgery and becoming care-dependent are important factors in patient's decision for interval CRS, while risk of complications and stoma are less important. Our results are useful in shared decision-making for interval CRS in ovarian cancer.