Are patient decision aids (PtDAs) associated with (1) improved decision quality defined as a decision informed by the evidence and a value-based decision; (2) improved decision-making processes ...defined as feeling informed, defining clear values related to the decision, and active participation in making the decision; and (3) better patient and health system outcomes compared with either usual care or a non-PtDA intervention?
Patient decision aids are associated with improved decision quality and decision-making processes without worse patient or health system outcomes.
Background
Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence ...between decisions and personal values.
Objectives
To assess the effects of decision aids in people facing treatment or screening decisions.
Search methods
Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008.
Selection criteria
We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids.
Data collection and analysis
Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision‐making process.
Secondary outcomes were behavioural, health, and health system effects.
We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random‐effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence.
Main results
We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.
With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high‐quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate‐quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low‐quality evidence) compared to usual care.
Regarding attributes related to the decision‐making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD −9.28/100; 95% CI −12.20 to −6.36; 27 studies; N = 5707; high‐quality evidence), indecision about personal values (MD −8.81/100; 95% CI −11.99 to −5.63; 23 studies; N = 5068; high‐quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate‐quality evidence).
Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient‐clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision‐making process, and/or the preparation for decision making compared to usual care.
Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate‐specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.
The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition‐specific health outcomes. Studies did not report adverse events associated with the use of decision aids.
In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup.
Authors' conclusions
Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values‐congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost‐effectiveness, and use with lower literacy populations.
Background
Shared decision making (SDM) is a process by which a healthcare choice is made by the patient, significant others, or both with one or more healthcare professionals. However, it has not ...yet been widely adopted in practice. This is the second update of this Cochrane review.
Objectives
To determine the effectiveness of interventions for increasing the use of SDM by healthcare professionals. We considered interventions targeting patients, interventions targeting healthcare professionals, and interventions targeting both.
Search methods
We searched CENTRAL, MEDLINE, Embase and five other databases on 15 June 2017. We also searched two clinical trials registries and proceedings of relevant conferences. We checked reference lists and contacted study authors to identify additional studies.
Selection criteria
Randomized and non‐randomized trials, controlled before‐after studies and interrupted time series studies evaluating interventions for increasing the use of SDM in which the primary outcomes were evaluated using observer‐based or patient‐reported measures.
Data collection and analysis
We used standard methodological procedures expected by Cochrane.
We used GRADE to assess the certainty of the evidence.
Main results
We included 87 studies (45,641 patients and 3113 healthcare professionals) conducted mainly in the USA, Germany, Canada and the Netherlands. Risk of bias was high or unclear for protection against contamination, low for differences in the baseline characteristics of patients, and unclear for other domains.
Forty‐four studies evaluated interventions targeting patients. They included decision aids, patient activation, question prompt lists and training for patients among others and were administered alone (single intervention) or in combination (multifaceted intervention). The certainty of the evidence was very low. It is uncertain if interventions targeting patients when compared with usual care increase SDM whether measured by observation (standardized mean difference (SMD) 0.54, 95% confidence interval (CI) ‐0.13 to 1.22; 4 studies; N = 424) or reported by patients (SMD 0.32, 95% CI 0.16 to 0.48; 9 studies; N = 1386; risk difference (RD) ‐0.09, 95% CI ‐0.19 to 0.01; 6 studies; N = 754), reduce decision regret (SMD ‐0.10, 95% CI ‐0.39 to 0.19; 1 study; N = 212), improve physical (SMD 0.00, 95% CI ‐0.36 to 0.36; 1 study; N = 116) or mental health‐related quality of life (QOL) (SMD 0.10, 95% CI ‐0.26 to 0.46; 1 study; N = 116), affect consultation length (SMD 0.10, 95% CI ‐0.39 to 0.58; 2 studies; N = 224) or cost (SMD 0.82, 95% CI 0.42 to 1.22; 1 study; N = 105).
It is uncertain if interventions targeting patients when compared with interventions of the same type increase SDM whether measured by observation (SMD 0.88, 95% CI 0.39 to 1.37; 3 studies; N = 271) or reported by patients (SMD 0.03, 95% CI ‐0.18 to 0.24; 11 studies; N = 1906); (RD 0.03, 95% CI ‐0.02 to 0.08; 10 studies; N = 2272); affect consultation length (SMD ‐0.65, 95% CI ‐1.29 to ‐0.00; 1 study; N = 39) or costs. No data were reported for decision regret, physical or mental health‐related QOL.
Fifteen studies evaluated interventions targeting healthcare professionals. They included educational meetings, educational material, educational outreach visits and reminders among others. The certainty of evidence is very low. It is uncertain if these interventions when compared with usual care increase SDM whether measured by observation (SMD 0.70, 95% CI 0.21 to 1.19; 6 studies; N = 479) or reported by patients (SMD 0.03, 95% CI ‐0.15 to 0.20; 5 studies; N = 5772); (RD 0.01, 95%C: ‐0.03 to 0.06; 2 studies; N = 6303); reduce decision regret (SMD 0.29, 95% CI 0.07 to 0.51; 1 study; N = 326), affect consultation length (SMD 0.51, 95% CI 0.21 to 0.81; 1 study, N = 175), cost (no data available) or physical health‐related QOL (SMD 0.16, 95% CI ‐0.05 to 0.36; 1 study; N = 359). Mental health‐related QOL may slightly improve (SMD 0.28, 95% CI 0.07 to 0.49; 1 study, N = 359; low‐certainty evidence).
It is uncertain if interventions targeting healthcare professionals compared to interventions of the same type increase SDM whether measured by observation (SMD ‐0.30, 95% CI ‐1.19 to 0.59; 1 study; N = 20) or reported by patients (SMD 0.24, 95% CI ‐0.10 to 0.58; 2 studies; N = 1459) as the certainty of the evidence is very low. There was insufficient information to determine the effect on decision regret, physical or mental health‐related QOL, consultation length or costs.
Twenty‐eight studies targeted both patients and healthcare professionals. The interventions used a combination of patient‐mediated and healthcare professional directed interventions. Based on low certainty evidence, it is uncertain whether these interventions, when compared with usual care, increase SDM whether measured by observation (SMD 1.10, 95% CI 0.42 to 1.79; 6 studies; N = 1270) or reported by patients (SMD 0.13, 95% CI ‐0.02 to 0.28; 7 studies; N = 1479); (RD ‐0.01, 95% CI ‐0.20 to 0.19; 2 studies; N = 266); improve physical (SMD 0.08, ‐0.37 to 0.54; 1 study; N = 75) or mental health‐related QOL (SMD 0.01, ‐0.44 to 0.46; 1 study; N = 75), affect consultation length (SMD 3.72, 95% CI 3.44 to 4.01; 1 study; N = 36) or costs (no data available) and may make little or no difference to decision regret (SMD 0.13, 95% CI ‐0.08 to 0.33; 1 study; low‐certainty evidence).
It is uncertain whether interventions targeting both patients and healthcare professionals compared to interventions of the same type increase SDM whether measured by observation (SMD ‐0.29, 95% CI ‐1.17 to 0.60; 1 study; N = 20); (RD ‐0.04, 95% CI ‐0.13 to 0.04; 1 study; N = 134) or reported by patients (SMD 0.00, 95% CI ‐0.32 to 0.32; 1 study; N = 150 ) as the certainty of the evidence was very low. There was insuffient information to determine the effects on decision regret, physical or mental health‐related quality of life, or consultation length or costs.
Authors' conclusions
It is uncertain whether any interventions for increasing the use of SDM by healthcare professionals are effective because the certainty of the evidence is low or very low.
Aim
The aim of the present study was to determine the barriers and motives influencing consumer reporting of adverse drug reactions (ADRs).
Methods
A systematic review, guided by the Cochrane ...Handbook, was conducted. Electronic searches included MEDLINE, EMBASE, PsycINFO, CINAHL, PubMed and the Cochrane Database of Systematic Reviews from 1964 to December 2014. Eligible studies addressed patients' perceptions and factors influencing ADR reporting. Studies about healthcare professional (HCP) reporting of ADRs were excluded. Studies were appraised for quality, and results were analysed descriptively.
Results
Of 1435 citations identified, 21 studies were eligible. Studies were primarily conducted in the UK, the Netherlands and Australia. The identified barriers to patient reporting of ADRs (n = 15 studies) included poor awareness, confusion about who should report the ADR, difficulties with reporting procedures, lack of feedback on submitted reports, mailing costs, ADRs resolved and prior negative reporting experiences. The identified motives for patients reporting ADRs (n = 10 studies) were: preventing others from having similar ADRs, wanting personal feedback, improving medication safety, informing regulatory agencies, improving HCP practices, responding to HCPs not reporting their ADRs and having been asked to report ADRs by HCPs.
Conclusions
Most patients were not aware of reporting systems and others were confused about reporting. Patients were mainly motivated to make their ADRs known to prevent similar suffering in other patients. By increasing patient familiarity and providing clear reporting processes, reporting systems could better achieve patient reporting of ADRs.
Introduction. The Ottawa Decision Support Framework (ODSF) has guided practitioners and patients facing difficult decisions for 20 years. It asserts that decision support interventions that address ...patients’ decisional needs improve decision quality. Purpose. To update the ODSF based on a synthesis of evidence. Methods. We conducted an overview of systematic reviews, searching 9 electronic databases. Eligible reviews included decisional needs assessments, decision support interventions, and decisional outcome measures guided by the ODSF. We extracted data and synthesized results narratively. Eight ODSF developers/expert users from 4 disciplines revised the ODSF. Results. Of 4656 citations, we identified 4 eligible reviews (>250 studies, >100 different decisions, >50,000 patients, 18 countries, 5 continents). They reported current ODSF decisional needs and their most frequent manifestations in the areas of inadequate knowledge/information, unclear values, decisional conflict/uncertainty, and inadequate support. They uncovered 11 new manifestations of 6 decisional needs. Using the Decisional Conflict Scale (DCS) to assess decisional needs, average scores were elevated at baseline and declined shortly after decision making, even without information interventions. Patient decision aids were superior to usual care in reducing total DCS scores and improving decision quality. We revised the ODSF by refining definitions of 6 decisional needs and adding new interventions to address 4 needs. We added a decision process outcome and eliminated secondary outcomes unlikely to improve across a range of decisions, retaining the implementation/continuance of the chosen option and appropriate use/costs of health services. Conclusions. We updated the ODSF to reflect the current evidence and identified implications for practice and further research.
Background. The Ottawa Decision Support Framework (ODSF) has been used for 20 years to assess and address people’s decisional needs. The evidence regarding ODSF decisional needs has not been ...synthesized. Objectives. To synthesize evidence from ODSF-based decisional needs studies, identify new decisional needs, and validate current ODSF decisional needs. Methods. A mixed-studies systematic review. Nine electronic databases were searched. Inclusion criteria: studies of people’s decisional needs when making health or social decisions for themselves, a child, or a mentally incapable person, as reported by themselves, families, or practitioners. Two independent authors screened eligibility, extracted data, and quality appraised studies using the Mixed Methods Appraisal Tool. Data were analyzed using narrative synthesis. Results. Of 4532 citations, 45 studies from 7 countries were eligible. People’s needs for 101 unique decisions (85 health, 16 social) were reported by 2857 patient decision makers (n = 36 studies), 92 parent decision makers (n = 6), 81 family members (n = 5), and 523 practitioners (n = 21). Current ODSF decisional needs were reported in 2 to 40 studies. For 6 decisional needs, there were 11 new (manifestations): 1) information (overload, inadequacy regarding others’ experiences with options), 2) difficult decisional roles (practitioner, family involvement, or deliberations), 3) unrealistic expectations (difficulty believing outcome probabilities apply to them), 4) personal needs (religion/spirituality), 5) difficult decision timing (unpredictable), and 6) unreceptive decisional stage (difficulty accepting condition/need for treatment, powerful emotions limiting information processing, lacking motivation to consider delayed/unpredictable decisions). Limitations. Possible publication bias (only peer-reviewed journals included). Possible missed needs (non-ODSF studies, patient decision aid development studies, 3 ODSF needs added in 2006). Conclusion. We validated current decisional needs, identified 11 new manifestations of 6 decisional needs, and recommended ODSF revisions.
Shared decision-making (SDM) is rarely implemented in pediatric practice. Pediatric health decision-making differs from that of adult practice. Yet, little is known about the factors that influence ...the implementation of pediatric shared decision-making (SDM). We synthesized pediatric SDM barriers and facilitators from the perspectives of healthcare providers (HCP), parents, children, and observers (i.e., persons who evaluated the SDM process, but were not directly involved).
We conducted a systematic review guided by the Ottawa Model of Research Use (OMRU). We searched MEDLINE, EMBASE, Cochrane Library, CINAHL, PubMed, and PsycINFO (inception to March 2017) and included studies that reported clinical pediatric SDM barriers and/or facilitators from the perspective of HCPs, parents, children, and/or observers. We considered all or no comparison groups and included all study designs reporting original data. Content analysis was used to synthesize barriers and facilitators and categorized them according to the OMRU levels (i.e., decision, innovation, adopters, relational, and environment) and participant types (i.e., HCP, parents, children, and observers). We used the Mixed Methods Appraisal Tool to appraise study quality.
Of 20,008 identified citations, 79 were included. At each OMRU level, the most frequent barriers were features of the options (decision), poor quality information (innovation), parent/child emotional state (adopter), power relations (relational), and insufficient time (environment). The most frequent facilitators were low stake decisions (decision), good quality information (innovation), agreement with SDM (adopter), trust and respect (relational), and SDM tools/resources (environment). Across participant types, the most frequent barriers were insufficient time (HCPs), features of the options (parents), power imbalances (children), and HCP skill for SDM (observers). The most frequent facilitators were good quality information (HCP) and agreement with SDM (parents and children). There was no consistent facilitator category for observers. Overall, study quality was moderate with quantitative studies having the highest ratings and mixed-method studies having the lowest ratings.
Numerous diverse and interrelated factors influence SDM use in pediatric clinical practice. Our findings can be used to identify potential pediatric SDM barriers and facilitators, guide context-specific barrier and facilitator assessments, and inform interventions for implementing SDM in pediatric practice.
PROSPERO CRD42015020527.
Background. The Ottawa Decision Support Framework (ODSF) has guided the development of patient decision aids (PtDAs) for 20 years and needs updating across a range of decisions and hypothesized ...outcomes. Purpose. To determine the effectiveness of ODSF-developed PtDAs on hypothesized outcomes and to recommend framework changes. Data Source. A subanalysis of randomized controlled trials included in the 2017 Cochrane review of PtDAs comparing PtDAs to usual care in adults considering health treatment or screening decisions (searched to 2015). Study Selection. Trials in the original review that evaluated ODSF-developed PtDAs. Data Synthesis. Meta-analyses of ODSF outcomes with similar measurements and descriptions of other reported outcomes. Results. Of 105 trials, 24 evaluated ODSF-developed PtDAs. Compared with usual care, ODSF PtDAs improved knowledge (mean difference MD 13.85; 95% confidence interval CI 10.32−17.37; 14 trials), increased accurate risk perceptions (risk ratio RR 2.41; 95% CI 1.66−3.48; 7 trials), and increased congruence between informed values and chosen options (RR 1.32; 95% CI 1.09−1.59; 4 trials). They reduced perceived decisional needs as measured using the Decisional Conflict Scale (MD −5.92; 95% CI −8.58 to −3.26; 15 trials) and the proportion of undecided patients (RR 0.65; 95% CI 0.50−0.83; 13 trials). Non-ODSF PtDAs, designed with or without a specific framework, also outperformed usual care. Few ODSF trials measured secondary outcomes. Limitations. The included trials had heterogeneity. Conclusion. ODSF PtDAs address decisional needs and improve decision quality; the best indicator of addressing perceived uncertainty is “proportion undecided.” Secondary ODSF outcomes should be reduced to adherence to one’s chosen option and use/costs of health services, which warrant further research.
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