Impact of timing and format of patient decision aids for breast cancer patients on their involvement in and preparedness for decision making - the IMPACTT randomised controlled trial protocol.

BACKGROUND: After curative surgery for early-stage breast cancer, patients face a decision on whether to undergo surgery alone or to receive one or more adjuvant treatments, which may lower the risk of recurrence. Variations in survival outcomes are often marginal but there are differences in the side effects and other features of the options that patients may value differently. Hence, the patient's values and preferences are critical in determining what option to choose. It is well-researched that the use of shared decision making and patient decision aids can support this choice in a discussion between patient and clinician. However, it is still to be investigated what impact the timing and format of the patient decision aid have on shared decision making outcomes. In this trial, we aim to investigate the impact of a digital pre-consult compared to a paper-based in-consult patient decision aid on patients' involvement in shared decision making, decisional conflict and preparedness to make a decision. METHODS: The study is a randomised controlled trial with 204 patients at two Danish oncology outpatient clinics. Eligible patients are newly diagnosed with early-stage breast cancer and offered adjuvant treatments after curative surgery to lower the risk of recurrence. Participants will be randomised to receive either an in-consult paper-based patient decision aid or a pre-consult digital patient decision aid. Data collection includes patient and clinician-reported outcomes as well as observer-reported shared decision making based on audio recordings of the consultation. The primary outcome is the extent to which patients are engaged in a shared decision making process reported by the patient. Secondary aims include the length of consultation, preparation for decision making, preferred role in shared decision making and decisional conflict. DISCUSSION: This study is the first known randomised, controlled trial comparing a digital, pre-consult patient decision aid to an identical paper-based, in-consult patient decision aid. It will contribute evidence on the impact of patient decision aids in terms of investigating if pre-consult digital patient decisions aids compared to in-consult paper-based decision aids support the cancer patients in being better prepared for decision making. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05573022).

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Patient decision aids are interventions designed to support people making health decisions. At a minimum, patient decision aids make the decision explicit, provide evidence-based information about the options and associated benefits/harms, and help clarify personal values for features of options. This is an update of a Cochrane review that was first published in 2003 and last updated in 2017. OBJECTIVES: To assess the effects of patient decision aids in adults considering treatment or screening decisions using an integrated knowledge translation approach. SEARCH METHODS: We conducted the updated search for the period of 2015 (last search date) to March 2022 in CENTRAL, MEDLINE, Embase, PsycINFO, EBSCO, and grey literature. The cumulative search covers database origins to March 2022. SELECTION CRITERIA: We included published randomized controlled trials comparing patient decision aids to usual care. Usual care was defined as general information, risk assessment, clinical practice guideline summaries for health consumers, placebo intervention (e.g. information on another topic), or no intervention. DATA COLLECTION AND ANALYSIS: Two authors independently screened citations for inclusion, extracted intervention and outcome data, and assessed risk of bias using the Cochrane risk of bias tool. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made (informed values-based choice congruence) and the decision-making process, such as knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision-making, and adverse events. Secondary outcomes were choice, confidence in decision-making, adherence to the chosen option, preference-linked health outcomes, and impact on the healthcare system (e.g. consultation length). We pooled results using mean differences (MDs) and risk ratios (RRs) with 95% confidence intervals (CIs), applying a random-effects model. We conducted a subgroup analysis of 105 studies that were included in the previous review version compared to those published since that update (n = 104 studies). We used Grading of Recommendations Assessment, Development, and Evaluation (GRADE) to assess the certainty of the evidence. MAIN RESULTS: This update added 104 new studies for a total of 209 studies involving 107,698 participants. The patient decision aids focused on 71 different decisions. The most common decisions were about cardiovascular treatments (n = 22 studies), cancer screening (n = 17 studies colorectal, 15 prostate, 12 breast), cancer treatments (e.g. 15 breast, 11 prostate), mental health treatments (n = 10 studies), and joint replacement surgery (n = 9 studies). When assessing risk of bias in the included studies, we rated two items as mostly unclear (selective reporting: 100 studies; blinding of participants/personnel: 161 studies), due to inadequate reporting. Of the 209 included studies, 34 had at least one item rated as high risk of bias. There was moderate-certainty evidence that patient decision aids probably increase the congruence between informed values and care choices compared to usual care (RR 1.75, 95% CI 1.44 to 2.13; 21 studies, 9377 participants). Regarding attributes related to the decision-making process and compared to usual care, there was high-certainty evidence that patient decision aids result in improved participants' knowledge (MD 11.90/100, 95% CI 10.60 to 13.19; 107 studies, 25,492 participants), accuracy of risk perceptions (RR 1.94, 95% CI 1.61 to 2.34; 25 studies, 7796 participants), and decreased decisional conflict related to feeling uninformed (MD -10.02, 95% CI -12.31 to -7.74; 58 studies, 12,104 participants), indecision about personal values (MD -7.86, 95% CI -9.69 to -6.02; 55 studies, 11,880 participants), and proportion of people who were passive in decision-making (clinician-controlled) (RR 0.72, 95% CI 0.59 to 0.88; 21 studies, 4348 participants). For adverse outcomes, there was high-certainty evidence that there was no difference in decision regret between the patient decision aid and usual care groups (MD -1.23, 95% CI -3.05 to 0.59; 22 studies, 3707 participants). Of note, there was no difference in the length of consultation when patient decision aids were used in preparation for the consultation (MD -2.97 minutes, 95% CI -7.84 to 1.90; 5 studies, 420 participants). When patient decision aids were used during the consultation with the clinician, the length of consultation was 1.5 minutes longer (MD 1.50 minutes, 95% CI 0.79 to 2.20; 8 studies, 2702 participants). We found the same direction of effect when we compared results for patient decision aid studies reported in the previous update compared to studies conducted since 2015. AUTHORS' CONCLUSIONS: Compared to usual care, across a wide variety of decisions, patient decision aids probably helped more adults reach informed values-congruent choices. They led to large increases in knowledge, accurate risk perceptions, and an active role in decision-making. Our updated review also found that patient decision aids increased patients' feeling informed and clear about their personal values. There was no difference in decision regret between people using decision aids versus those receiving usual care. Further studies are needed to assess the impact of patient decision aids on adherence and downstream effects on cost and resource use.

Decisional needs and interventions for young women considering contraceptive options: an umbrella review.

BACKGROUND: Although women face a wide range of contraceptive options, globally, young women are at risk of unintended pregnancies. Our umbrella review aimed to determine the decisional needs of nulligravida women aged 11 to 30 considering contraceptive options and identify effective interventions to support their involvement in making decisions about contraceptive use. METHODS: We followed Joanna Briggs Institute methods for umbrella reviews, theoretically guided by the Ottawa Decision Support Framework. We searched six electronic databases. Two reviewers independently screened citations, extracted data, and appraised quality using AMSTAR2. We analysed findings descriptively. RESULTS: Of 124 citations, we identified 11 reviews of variable quality (critically low to moderate quality): Six reported decisional needs and 5 reported on interventions. Decisional needs of young women were: (a) information needs about contraceptive options (e.g., mechanism of actions, eligibility, administration, side effects); (b) unclear values (concerns about hormone use) and features of different options (based on their religious values); and (c) need for support and resources (support from society and need for privacy). Compared to controls, decision support interventions including patient decision aids and patient education material increased knowledge and improved discussion of options with their clinicians. CONCLUSION: Young women making contraceptive decisions experience unmet decisional needs. Effective interventions such as patient decision aids and general patient education materials may address their decisional needs and enhance their level of participation in making contraception decisions. Implications and contribution to the field: Young women's decisional needs when considering contraceptive use are informational needs, unclear values (including religious influences), need for support and resources when facing this decision. Interventions, such as patient decision aid and patient education material can, address decisional needs by improving young women's knowledge about contraceptive options.

What guidance exists to support patient partner compensation practices? A scoping review of available policies and guidelines.

BACKGROUND: An integral aspect of patient engagement in research, also known as patient and public involvement, is appropriately recognising patient partners for their contributions through compensation (e.g., coauthorship, honoraria). Despite known benefits to compensating patient partners, our previous work suggested compensation is rarely reported and researchers perceive a lack of guidance on this issue. To address this gap, we identified and summarised available guidance and policy documents for patient partner compensation. METHODS: We conducted this scoping review in accordance with methods suggested by the JBI. We searched the grey literature (Google, Google Scholar) in March 2022 and Overton (an international database of policy documents) in April 2022. We included articles, guidance or policy documents regarding the compensation of patient partners for their research contributions. Two reviewers independently extracted and synthesised document characteristics and recommendations. RESULTS: We identified 65 guidance or policy documents. Most documents were published in Canada (57%, n = 37) or the United Kingdom (26%, n = 17). The most common recommended methods of nonfinancial compensation were offering training opportunities to patient partners (40%, n = 26) and facilitating patient partner attendance at conferences (38%, n = 25). The majority of guidance documents (95%) suggested financially compensating (i.e., offering something of monetary value) patient partners for their research contributions. Across guidance documents, the recommended monetary value of financial compensation was relatively consistent and associated with the role played by patient partners and/or specific engagement activities. For instance, the median monetary value for obtaining patient partner feedback (i.e., consultation) was $19/h (USD) (range of $12-$50/h). We identified several documents that guide the compensation of specific populations, including youth and Indigenous peoples. CONCLUSION: Multiple publicly available resources exist to guide researchers, patient partners and institutions in developing tailored patient partner compensation strategies. Our findings challenge the perception that a lack of guidance hinders patient partner financial compensation. Future efforts should prioritise the effective implementation of these compensation strategies to ensure that patient partners are appropriately recognised. PATIENT OR PUBLIC CONTRIBUTIONS: The patient partner coauthor informed protocol development, identified data items, and interpreted findings.

Decision support for breast cancer screening decisions: A single case pre-/post-test study.

Canadian guidelines recommend shared decision making for women less than 50 years old who are considering breast cancer screening. Nurses can support women in making these decisions. This single case pre-/post-test study measured change in decisional conflict after decision support for a woman less than 50 years old considering whether or not to initiate mammography screening. At baseline, a 44-year-old female at average risk of breast cancer was experiencing decisional conflict. She scored 1 out of 4 on the SURE test indicating feeling uninformed, unclear values, and inadequate support. After receiving decision coaching with a breast cancer screening decision aid by a nurse trained in decision coaching, she scored 4 on the SURE test indicating no decisional conflict. She reached an informed decision consistent with her values about mammography screening. Providing decisional support improved her knowledge, reduced her decisional conflict, and enhanced her confidence in making an informed decision that was consistent with her values.

Evaluation of an educational program for nurses providing cancer symptom management: The pan-Canadian Oncology Symptom Triage and Remote Support Online Tutorial.

Purpose: To evaluate the acceptability of the pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) open-access online tutorial and its impact on nurses' knowledge and perceived confidence in symptom management. Methods: Retrospective pre-/post-test evaluation of nurses who completed the tutorial knowledge test and/or acceptability survey. The tutorial was modeled after the previously evaluated in-person workshop to prepare nurses providing cancer symptom management using COSTaRS practice guides. Results: From 2017-2021, 743 nurses completed the knowledge test, and 749 nurses evaluated the tutorial. Mean knowledge score was 4.4/6 and 83% of participants achieved passing scores. Compared to pre-tutorial, nurses improved their perceived confidence in assessing, triaging, guiding patients in self-care (p<0.001), and ability to use the COSTaRS guides (p<0.001). Nurses rated the tutorial as easy to understand (95%), just the right amount of information (92%), providing new information (75%), overall good to excellent (89%), and would recommend it to others (83%). Conclusions: More than 700 nurses accessed the tutorial. After completion, nurses demonstrated good knowledge and improved perceived confidence in cancer symptom management.

Factors influencing Canadian oncology nurses discussing cannabis use with patients experiencing chemotherapy-induced nausea.

A descriptive, cross-sectional study was conducted to determine factors influencing Canadian oncology nurses discussing cannabis use with patients experiencing chemotherapy-induced nausea (CIN). A survey invitation and three reminders were sent to 678 members of the Canadian Association of Nurses in Oncology (CANO) between February 8 and April 10, 2022. An educator sent an extra invitation to 131 oncology nurses in Eastern Ontario. The survey was based on the Ottawa Model of Research Use. Twenty-seven opened the link to the survey and 25 responded. Of 25 nurses, 11 (47.8%) correctly answered the knowledge question about the effectiveness of cannabis for CIN. The top three barriers to discussing cannabis use were social stigma, nurses' lack of knowledge, and lack of guidance within the workplace. All participants identified needing continuing education and written guidance about use of cannabis for CIN. Although few oncology nurses responded to the survey, most indicated feeling inadequately prepared to discuss cannabis use with patients experiencing CIN.

Nurse-led telehealth interventions for symptom management in patients with cancer receiving systemic or radiation therapy: a systematic review and meta-analysis.

PURPOSE: Patients receiving cancer treatments experience many treatment-related symptoms. Telehealth is increasingly being used to support symptom management. The overall aim was to determine the effectiveness of nurse-led telehealth symptom management interventions for patients with cancer receiving systemic or radiation therapy compared to usual care on health service use, quality of life, and symptom severity. METHODS: A systematic review was conducted following the Cochrane Handbook and PRISMA reporting guidelines. Five electronic databases were searched. Two independent reviewers screened articles and extracted data. Meta-analysis was performed if data were clinically and methodologically homogeneous. Subanalysis was conducted on reactive and scheduled telehealth interventions. RESULTS: Of 7749 citations screened, 10 studies were included (8 randomized control trials, 2 quasi-experimental). Five were reactive telehealth interventions with patient-initiated contact and five evaluated scheduled telehealth interventions initiated by nurses. Compared to usual care (typically patient-initiated calls), nurse-led telehealth interventions for symptom management showed no statistically significant difference in hospitalizations, emergency department visits, or unscheduled clinic visits. Two of three studies of reactive telehealth interventions showed improved quality of life. All telehealth interventions showed reduction in the severity of most symptoms. Pain severity was significantly reduced (standard mean difference - 0.54; 95% CI - 0.88, - 0.19). Significant heterogeneity prevented meta-analysis for most outcomes. CONCLUSION: Few studies evaluated nurse-led telehealth interventions for cancer symptom management. Compared to usual care, patients exposed to telehealth interventions had reduced symptom severity and no difference in health services use. Future research should focus on better reporting intervention characteristics and consistently measuring outcomes.

Online Patient Information for Hysterectomies: A Systematic Environmental Scan of Quality and Readability.

OBJECTIVE: Hysterectomy is a common gynaecological procedure, and therefore online information is highly valuable to patients. Our objective was to evaluate the quality, readability, and comprehensiveness of online patient information on hysterectomy. METHODS: The first 25 patient-directed websites on hysterectomy, identified using 5 online search engines (Google, Yahoo, AOL, Bing, Ask.com) as well as clinical professional societies, were assessed using validated tools for quality (DISCERN, JAMA benchmark), readability (Flesch-Kincaid Grade Level [FKGL], Gunning Fog, Simple Measure of Gobbledygook [SMOG], Flesch Reading Ease Score [FRES]), and completeness of information. RESULTS: We identified 50 websites for inclusion. Overall, websites were of good quality (median DISCERN score 53/80 [interquartile range {IQR} 47-61]; median JAMA score 3/4 [IQR 1-4]). Most websites described surgical risks (39, 78%), benefits (45, 90%), and types of hysterectomy (48, 96%). Content readability corresponded to grade 11 using FKGL (median 11.1 [IQR 10.2-13.0]) and SMOG (median 10.9 [IQR 10.2-12.4]), or 15 years education using Gunning Fog (median 14.7 [IQR 13.8-16.4]). Websites were assessed as difficult to read using FRES (median 45.6/100 [IQR 37.9-50.9]). No differences were observed in readability scores when we compared websites from clinical professional societies, government, health care, or academic organizations with other websites (P > 0.05). CONCLUSION: Online patient information on hysterectomy is of good quality and comprehensive. However, the content is above the American Medical Association's recommended grade 6 reading level. Website authors should consider readability to make their content more accessible to patients.

Understanding how and under what circumstances decision coaching works for people making healthcare decisions: a realist review.

BACKGROUND: Decision coaching is non-directive support delivered by a trained healthcare provider to help people prepare to actively participate in making healthcare decisions. This study aimed to understand how and under what circumstances decision coaching works for people making healthcare decisions. METHODS: We followed the realist review methodology for this study. This study was built on a Cochrane systematic review of the effectiveness of decision coaching interventions for people facing healthcare decisions. It involved six iterative steps: (1) develop the initial program theory; (2) search for evidence; (3) select, appraise, and prioritize studies; (4) extract and organize data; (5) synthesize evidence; and (6) consult stakeholders and draw conclusions. RESULTS: We developed an initial program theory based on decision coaching theories and stakeholder feedback. Of the 2594 citations screened, we prioritized 27 papers for synthesis based on their relevance rating. To refine the program theory, we identified 12 context-mechanism-outcome (CMO) configurations. Essential mechanisms for decision coaching to be initiated include decision coaches', patients', and clinicians' commitments to patients' involvement in decision making and decision coaches' knowledge and skills (four CMOs). CMOs during decision coaching are related to the patient (i.e., willing to confide, perceiving their decisional needs are recognized, acquiring knowledge, feeling supported), and the patient-decision coach interaction (i.e., exchanging information, sharing a common understanding of patient's values) (five CMOs). After decision coaching, the patient's progress in making or implementing a values-based preferred decision can be facilitated by the decision coach's advocacy for the patient, and the patient's deliberation upon options (two CMOs). Leadership support enables decision coaches to have access to essential resources to fulfill their role (one CMOs). DISCUSSION: In the refined program theory, decision coaching works when there is strong leadership support and commitment from decision coaches, clinicians, and patients. Decision coaches need to be capable in coaching, encourage patients' participation, build a trusting relationship with patients, and act as a liaison between patients and clinicians to facilitate patients' progress in making or implementing an informed values-based preferred option. More empirical studies, especially qualitative and process evaluation studies, are needed to further refine the program theory.

Surrogate Humane Endpoints in Small Animal Models of Acute Lung Injury: A Modified Delphi Consensus Study of Researchers and Laboratory Animal Veterinarians.

OBJECTIVES: In many jurisdictions, ethical concerns require surrogate humane endpoints to replace death in small animal models of acute lung injury. Heterogenous selection and reporting of surrogate endpoints render interpretation and generalizability of findings between studies difficult. We aimed to establish expert-guided consensus among preclinical scientists and laboratory animal veterinarians on selection and reporting of surrogate endpoints, monitoring of these models, and the use of analgesia. DESIGN: A three-round consensus process, using modified Delphi methodology, with researchers who use small animal models of acute lung injury and laboratory animal veterinarians who provide care for these animals. Statements on the selection and reporting of surrogate endpoints, monitoring, and analgesia were generated through a systematic search of MEDLINE and Embase. Participants were asked to suggest any additional potential statements for evaluation. SETTING: A web-based survey of participants representing the two stakeholder groups (researchers, laboratory animal veterinarians). Statements were rated on level of evidence and strength of support by participants. A final face-to-face meeting was then held to discuss results. SUBJECTS: None. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Forty-two statements were evaluated, and 29 were rated as important, with varying strength of evidence. The majority of evidence was based on rodent models of acute lung injury. Endpoints with strong support and evidence included temperature changes and body weight loss. Behavioral signs and respiratory distress also received support but were associated with lower levels of evidence. Participants strongly agreed that analgesia affects outcomes in these models and that none may be necessary following nonsurgical induction of acute lung injury. Finally, participants strongly supported transparent reporting of surrogate endpoints. A prototype composite score was also developed based on participant feedback. CONCLUSIONS: We provide a preliminary framework that researchers and animal welfare committees may adapt for their needs. We have identified knowledge gaps that future research should address.

Performance Feedback May Not Improve Radical Prostatectomy Outcomes: The Surgical Report Card (SuRep) Study.

PURPOSE: Oncologic, urinary, and sexual outcomes are important to patients receiving prostate cancer surgery. The objective of this study was to determine if providing surgical report cards (SuReps) to surgeons resulted in improved patient outcomes. MATERIALS AND METHODS: A prospective before-and-after study was conducted at The Ottawa Hospital. A total of 422 consecutive patients undergoing radical prostatectomy were enrolled. The intervention was provision of report cards to surgeons. The control cohort was patients treated before report card feedback (pre-SuRep), and the intervention cohort was patients treated after report card feedback (post-SuRep). The primary outcomes were postoperative erectile function, urinary continence, and positive surgical margins. RESULTS: Baseline characteristics were similar between groups. Almost all patients (99%) were continent and the majority (59%) were potent prior to surgery. Complete 1-year followup was available for 400 patients (95%). Nerve sparing surgery increased from 70% pre-SuRep to 82% post-SuRep (p=0.01). There was a nonstatistically significant increase in the proportion of patients with a positive surgical margin post-SuRep (31% pre-SuRep vs 39% post-SuRep, p=0.08). There was no difference in postoperative erectile function (17% vs 18%, p=0.7) and a decrease in continence (75% vs 65%, p=0.02) at 1 year postoperatively. CONCLUSIONS: The SuRep platform allows accurate reporting of surgical outcomes that can be used for patient counseling. However, the provision of surgical report cards did not improve functional or oncologic outcomes. Longer durations of feedback, report card modifications, or targeted interventions are likely necessary to improve outcomes.

Quality of telephone-based cancer symptom management by nurses: a quality improvement project.

PURPOSE: To determine the quality of cancer symptom management when evidence from clinical practice guidelines are used in telephone-based oncology nursing services. METHODS: Guided by the Knowledge to Action Framework, we conducted a quality improvement (QI) project focused on "monitoring knowledge use" (e.g., use of practice guides) and "measuring outcomes." In 2016, 15 Pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) practice guides that synthesize evidence from guidelines were implemented with training for all oncology nurses at a regional ambulatory oncology program. Eighteen months post-implementation, Symptom Management Analysis Tool (SMAT) was used to analyze audio-recorded calls and related documentation of cancer symptom management. RESULTS: Of 113 audio-recorded calls, 66 were COSTaRS symptoms (58%), 43 other symptoms (38%), and 4 medically complex situations (4%). Of 66 recorded calls, 63 (95%) were documented. Average SMAT quality score was 71% (range 21-100%) for audio-recordings and 63% (range 19-100%) for documentation of calls. COSTaRS practice guide use was documented in 33% calls. For these calls, average SMAT quality scores were 74% with COSTaRS versus 69% without COSTaRS for audio-recording and 73% (range 33-100%) with COSTaRS versus 58% without COSTaRS for documentation. Patient outcomes indicated symptom was resolved (38%), worse (25%), unchanged (3%), or unknown (33%). Eight patients (13%) had an ED visit within 14 days post that was related to the symptom discussed. CONCLUSIONS: Only a third of nurses indicated use of COSTaRS practice guides. There were higher quality symptom management scores when COSTaRS use was reported. Nurses documented less than what they discussed.

Decision coaching for people making healthcare decisions.

BACKGROUND: Decision coaching is non-directive support delivered by a healthcare provider to help patients prepare to actively participate in making a health decision. 'Healthcare providers' are considered to be all people who are engaged in actions whose primary intent is to protect and improve health (e.g. nurses, doctors, pharmacists, social workers, health support workers such as peer health workers). Little is known about the effectiveness of decision coaching. OBJECTIVES: To determine the effects of decision coaching (I) for people facing healthcare decisions for themselves or a family member (P) compared to (C) usual care or evidence-based intervention only, on outcomes (O) related to preparation for decision making, decisional needs and potential adverse effects. SEARCH METHODS: We searched the Cochrane Library (Wiley), Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid), CINAHL (Ebsco), Nursing and Allied Health Source (ProQuest), and Web of Science from database inception to June 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) where the intervention was provided to adults or children preparing to make a treatment or screening healthcare decision for themselves or a family member. Decision coaching was defined as: a) delivered individually by a healthcare provider who is trained or using a protocol; and b) providing non-directive support and preparing an adult or child to participate in a healthcare decision. Comparisons included usual care or an alternate intervention. There were no language restrictions. DATA COLLECTION AND ANALYSIS: Two authors independently screened citations, assessed risk of bias, and extracted data on characteristics of the intervention(s) and outcomes. Any disagreements were resolved by discussion to reach consensus. We used the standardised mean difference (SMD) with 95% confidence intervals (CI) as the measures of treatment effect and, where possible, synthesised results using a random-effects model. If more than one study measured the same outcome using different tools, we used a random-effects model to calculate the standardised mean difference (SMD) and 95% CI. We presented outcomes in summary of findings tables and applied GRADE methods to rate the certainty of the evidence. MAIN RESULTS: Out of 12,984 citations screened, we included 28 studies of decision coaching interventions alone or in combination with evidence-based information, involving 5509 adult participants (aged 18 to 85 years; 64% female, 52% white, 33% African-American/Black; 68% post-secondary education). The studies evaluated decision coaching used for a range of healthcare decisions (e.g. treatment decisions for cancer, menopause, mental illness, advancing kidney disease; screening decisions for cancer, genetic testing). Four of the 28 studies included three comparator arms.  For decision coaching compared with usual care (n = 4 studies), we are uncertain if decision coaching compared with usual care improves any outcomes (i.e. preparation for decision making, decision self-confidence, knowledge, decision regret, anxiety) as the certainty of the evidence was very low.  For decision coaching compared with evidence-based information only (n = 4 studies), there is low certainty-evidence that participants exposed to decision coaching may have little or no change in knowledge (SMD -0.23, 95% CI: -0.50 to 0.04; 3 studies, 406 participants). There is low certainty-evidence that participants exposed to decision coaching may have little or no change in anxiety, compared with evidence-based information. We are uncertain if decision coaching compared with evidence-based information improves other outcomes (i.e. decision self-confidence, feeling uninformed) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with usual care (n = 17 studies), there is low certainty-evidence that participants may have improved knowledge (SMD 9.3, 95% CI: 6.6 to 12.1; 5 studies, 1073 participants). We are uncertain if decision coaching plus evidence-based information compared with usual care improves other outcomes (i.e. preparation for decision making, decision self-confidence, feeling uninformed, unclear values, feeling unsupported, decision regret, anxiety) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with evidence-based information only (n = 7 studies), we are uncertain if decision coaching plus evidence-based information compared with evidence-based information only improves any outcomes (i.e. feeling uninformed, unclear values, feeling unsupported, knowledge, anxiety) as the certainty of the evidence was very low. AUTHORS' CONCLUSIONS: Decision coaching may improve participants' knowledge when used with evidence-based information. Our findings do not indicate any significant adverse effects (e.g. decision regret, anxiety) with the use of decision coaching. It is not possible to establish strong conclusions for other outcomes. It is unclear if decision coaching always needs to be paired with evidence-informed information. Further research is needed to establish the effectiveness of decision coaching for a broader range of outcomes.

What Is the Best Evidence to Guide Management of Acute Achilles Tendon Ruptures? A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Uncertainty exists regarding the best treatment for acute Achilles tendon ruptures. Simultaneous comparison of the multiple treatment options using traditional study designs is problematic; multiarm clinical trials often are logistically constrained to small sample sizes, and traditional meta-analyses are limited to comparisons of only two treatments that have been compared in head-to-head trials. Network meta-analyses allow for simultaneous comparison of all existing treatments utilizing both direct (head-to-head comparison) and indirect (not previously compared head-to-head) evidence. QUESTIONS/PURPOSES: We performed a network meta-analysis of randomized controlled trials (RCTs) to answer the following questions: Considering open repair, minimally invasive surgery (MIS) repair, functional rehabilitation, or primary immobilization for acute Achilles tendon ruptures, (1) which intervention is associated with the lowest risk of rerupture? (2) Which intervention is associated with the lowest risk of complications resulting in surgery? METHODS: This study was conducted with methods guided by the Cochrane Handbook for Systematic Reviews of Interventions and is reported in adherence with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension statement for incorporating network meta-analysis. Five databases and grey literature sources (such as major orthopaedic meeting presentation lists) were searched from inception to September 30, 2019. Included studies were RCTs comparing treatment of acute Achilles tendon ruptures using two or more of the following interventions: primary immobilization, functional rehabilitation, open surgical repair, or MIS repair. We excluded studies enrolling patients with chronic ruptures, reruptures, and preexisting Achilles tendinopathy as well as studies with more than 20% loss to follow-up or less than 6 months of follow-up. Nineteen RCTs (1316 patients) were included in the final analysis. The mean number of patients per study treatment arm was 35 ± 16, mean age was 41 ± 5 years, mean sex composition was 80% ± 10% males, and mean follow-up was 22 ± 12 months. The four treatment groups were compared for the main outcomes of rerupture and complications resulting in operation. The analysis was conducted using random-effects Bayesian network meta-analysis with vague priors. Evidence quality was evaluated using Grades of Recommendation, Assessment, Development, and Evaluation methodology. We found risk of selection, attrition, and reporting bias to be low across treatments, and we found the risk of performance and detection bias to be high. Overall risk of bias between treatments appeared similar. RESULTS: We found that treatment with primary immobilization had a greater risk of rerupture than open surgery (odds ratio 4.06 [95% credible interval {CrI} 1.47 to 11.88]; p < 0.05). There were no other differences between treatments for risk of rerupture. Minimally invasive surgery was ranked first for fewest complications resulting in surgery and was associated with a lower risk of complications resulting in surgery than functional rehabilitation (OR 0.16 [95% CrI 0.02 to 0.90]; p < 0.05), open surgery (OR 0.22 [95% CrI 0.04 to 0.93]; p < 0.05), and primary immobilization (OR < 0.01 [95% CrI < 0.01 to 0.01]; p < 0.05). Risk of complications resulting in surgery was no different between primary immobilization and open surgery (OR 1.46 [95% CrI 0.35 to 5.36]). Data for patient-reported outcome scores and return to activity were inappropriate for pooling secondary to considerable clinical heterogeneity and imprecision associated with small sample sizes. CONCLUSION: Faced with acute Achilles tendon rupture, patients should be counseled that, based on the best-available evidence, the risk of rerupture likely is no different across contemporary treatments. Considering the possibly lower risk of complications resulting in surgery associated with MIS repair, patients and surgeons must balance any benefit with the potential risks of MIS techniques. As treatments continue to evolve, consistent reporting of validated patient-reported outcome measures is critically important to facilitate analysis with existing RCT evidence. Infrequent but serious complications such as rerupture and deep infection should be further explored to determine whether meaningful differences exist in specific patient populations. LEVEL OF EVIDENCE: Level I, therapeutic study.

An 11-Item Measure of User- and Human-Centered Design for Personal Health Tools (UCD-11): Development and Validation.

BACKGROUND: Researchers developing personal health tools employ a range of approaches to involve prospective users in design and development. OBJECTIVE: The aim of this paper was to develop a validated measure of the human- or user-centeredness of design and development processes for personal health tools. METHODS: We conducted a psychometric analysis of data from a previous systematic review of the design and development processes of 348 personal health tools. Using a conceptual framework of user-centered design, our team of patients, caregivers, health professionals, tool developers, and researchers analyzed how specific practices in tool design and development might be combined and used as a measure. We prioritized variables according to their importance within the conceptual framework and validated the resultant measure using principal component analysis with Varimax rotation, classical item analysis, and confirmatory factor analysis. RESULTS: We retained 11 items in a 3-factor structure explaining 68% of the variance in the data. The Cronbach alpha was .72. Confirmatory factor analysis supported our hypothesis of a latent construct of user-centeredness. Items were whether or not: (1) patient, family, caregiver, or surrogate users were involved in the steps that help tool developers understand users or (2) develop a prototype, (3) asked their opinions, (4) observed using the tool or (5) involved in steps intended to evaluate the tool, (6) the process had 3 or more iterative cycles, (7) changes between cycles were explicitly reported, (8) health professionals were asked their opinion and (9) consulted before the first prototype was developed or (10) between initial and final prototypes, and (11) a panel of other experts was involved. CONCLUSIONS: The User-Centered Design 11-item measure (UCD-11) may be used to quantitatively document the user/human-centeredness of design and development processes of patient-centered tools. By building an evidence base about such processes, we can help ensure that tools are adapted to people who will use them, rather than requiring people to adapt to tools.

Development and field testing of a patient decision aid for management of acute Achilles tendon rupture: a study protocol.

BACKGROUND: Achilles tendon ruptures are common injuries in an otherwise healthy, active population. Several treatment options exist, with both surgical and non-surgical options. Each treatment option has a unique set of risks and harms, which may present patients with decisional conflict. The aim of the proposed study is to develop, alpha test and field test a patient decision aid for patients presenting with acute Achilles tendon ruptures. METHODS: This is a three-stage study protocol. First, we will assemble a multi-disciplinary steering group including patients, clinicians, educators, and researchers to develop the patient decision aid prototype using the Ottawa Decision Support Framework. Second, we will perform a mixed-methods alpha test of the decision aid prototype with patients and clinicians experienced in acute Achilles tendon ruptures. Outcomes measured will include acceptability and usability of the patient decision aid measured using validated outcome scales and semi-structured interviews. A minimum of three rounds of feedback will be obtained. Results will be analyzed using descriptive statistics, reviewed by the steering group, to guide revisions to decision aid prototype at each round. The third stage will be field testing the revised decision aid prototype in usual clinical care. A pre-/post-study will be performed with patients with acute Achilles tendon ruptures. Patients will be recruited from the emergency department and complete the pre-consultation decision aid prior to a one-week follow up with their surgeon. The primary outcome of field testing will be feasibility of implementing the decision aid in the clinical setting and will be measured with recruitment and completion metrics. Secondary outcomes include acceptability of the decision aid, knowledge, preparedness for decision making, and decisional conflict, measured using validated outcome measures. Statistical analysis will be performed using descriptive analysis for primary outcomes and a student t-test and Wilcoxon Rank-Sum test for secondary outcomes. DISCUSSION: This comprehensive study protocol outlines the development, alpha testing, and field testing of a patient decision aid for patients with acute Achilles tendon rupture. Systematic and transparent development and testing of patient decision aids is critical to improve decision aid quality. Trial registration Not Applicable.

Ready for SDM: evaluating a train-the-trainer program to facilitate implementation of SDM training in Norway.

BACKGROUND: Healthcare providers need training to implement shared decision making (SDM). In Norway, we developed "Ready for SDM", a comprehensive SDM curriculum tailored to various healthcare providers, settings, and competence levels, including a course targeting interprofessional healthcare teams. The overall aim was to evaluate a train-the-trainer (TTT) program for healthcare providers wanting to offer this course within their hospital trust. METHODS: Our observational descriptive design was informed by Kirkpatrick´s Model of Educational Outcomes. The South-Eastern Regional Health Authority invited healthcare providers from all health trusts in its jurisdiction to attend. The TTT consisted of a one-day basic course with lectures on SDM, exercises and group reflections followed by a two-day advanced course including an SDM observer training. Immediately after each of the two courses, reaction and learning (Kirkpatrick levels 1 and 2) were assessed using a self-administered questionnaire. After the advanced course, observer skills were operationalized as accuracy of the participants' assessment of a consultation compared to an expert assessment. Within three months post-training, we measured number of trainings conducted and number of healthcare providers trained (Kirkpatrick level 3) using an online survey. Qualitative and quantitative descriptive analysis were performed. RESULTS: Twenty-one out of 24 (basic) and 19 out of 22 (advanced) healthcare providers in 9 health trusts consented to participate. The basic course was evaluated as highly acceptable, the advanced course as complex and challenging. Participants identified a need for more training in pedagogical skills and support for planning implementation of SDM-training. Participants achieved high knowledge scores and were positive about being an SDM trainer. Observer skills regarding patient involvement in decision-making were excellent (mean of weighted t = .80). After three months, 67% of TTT participants had conducted more than two trainings each and trained a total of 458 healthcare providers. CONCLUSION: Findings suggest that the TTT is a feasible approach for supporting large-scale training in SDM. Our study informed us about how to improve the advanced course. Further research shall investigate the efficacy of the training in the context of a comprehensive multifaceted strategy for implementing SDM in clinical practice. TRIAL REGISTRATION: Retrospectively registered at ISRCTN (99432465) March 25, 2020.

Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial.

BACKGROUND: MyDiabetesPlan is a web-based, interactive patient decision aid that facilitates patient-centred, diabetes-specific, goal-setting and shared decision-making (SDM) with interprofessional health care teams. OBJECTIVE: Assess the feasibility of (1) conducting a cluster randomized controlled trial (RCT) and (2) integrating MyDiabetesPlan into interprofessional primary care clinics. METHODS: We conducted a cluster RCT in 10 interprofessional primary care clinics with patients living with diabetes and at least two other comorbidities; half of the clinics were assigned to MyDiabetesPlan and half were assigned to usual care. To assess recruitment, retention, and resource use, we used RCT conduct logs and financial account summaries. To assess intervention fidelity, we used RCT conduct logs and website usage logs. To identify barriers and facilitators to integration of MyDiabetesPlan into clinical care across the IP team, we used audiotapes of clinical encounters in the intervention groups. RESULTS: One thousand five hundred and ninety-seven potentially eligible patients were identified through searches of electronic medical records, of which 1113 patients met the eligibility criteria upon detailed chart review. A total of 425 patients were randomly selected; of these, 213 were able to participate and were allocated (intervention: n = 102; control: n = 111), for a recruitment rate of 50.1%. One hundred and fifty-one patients completed the study, for a retention rate of 70.9%. A total of 5745 personnel-hours and $6104 CAD were attributed to recruitment and retention activities. A total of 179 appointments occurred (out of 204 expected appointments-two per participant over the 12-month study period; 87.7%). Forty (36%), 25 (23%), and 32 (29%) patients completed MyDiabetesPlan at least twice, once, and zero times, respectively. Mean time for completion of MyDiabetesPlan by the clinician and the patient during initial appointments was 37 min. From the clinical encounter transcripts, we identified diverse strategies used by clinicians and patients to integrate MyDiabetesPlan into the appointment, characterized by rapport building and individualization. Barriers to use included clinician-related, patient-related, and technical factors. CONCLUSION: An interprofessional approach to SDM using a decision aid was feasible. Lower than expected numbers of diabetes-specific appointments and use of MyDiabetesPlan were observed. Addressing facilitators and barriers identified in this study will promote more seamless integration into clinical care. Trial registration Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: February 11, 2015. Protocol version: Version 1; February 26, 2015.

Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.

BACKGROUND: Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences. OBJECTIVE: The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD. METHODS: A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice. RESULTS: A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively). CONCLUSION: It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.