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.
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.
Shared decision making (SDM) can reduce overuse of options not associated with benefits for all and respects patient rights, but has not yet been widely adopted in practice.
To determine the ...effectiveness of interventions to improve healthcare professionals' adoption of SDM.
For this update we searched for primary studies in The Cochrane Library, MEDLINE, EMBASE, CINAHL, the Cochrane Effective Practice and Organisation of Care (EPOC) Specialsied Register and PsycINFO for the period March 2009 to August 2012. We searched the Clinical Trials.gov registry and the proceedings of the International Shared Decision Making Conference. We scanned the bibliographies of relevant papers and studies. We contacted experts in the field to identify papers published after August 2012.
Randomised and non-randomised controlled trials, controlled before-and-after studies and interrupted time series studies evaluating interventions to improve healthcare professionals' adoption of SDM where the primary outcomes were evaluated using observer-based outcome measures (OBOM) or patient-reported outcome measures (PROM).
The three overall categories of intervention were: interventions targeting patients, interventions targeting healthcare professionals, and interventions targeting both. Studies in each category were compared to studies in the same category, to studies in the other two categories, and to usual care, resulting in nine comparison groups. Statistical analysis considered categorical and continuous primary outcomes separately. We calculated the median of the standardized mean difference (SMD), or risk difference, and range of effect across studies and categories of intervention. We assessed risk of bias.
Thirty-nine studies were included, 38 randomised and one non-randomised controlled trial. Categorical measures did not show any effect for any of the interventions. In OBOM studies, interventions targeting both patients and healthcare professionals had a positive effect compared to usual care (SMD of 2.83) and compared to interventions targeting patients alone (SMD of 1.42). Studies comparing interventions targeting patients with other interventions targeting patients had a positive effect, as did studies comparing interventions targeting healthcare professionals with usual care (SDM of 1.13 and 1.08 respectively). In PROM studies, only three comparisons showed any effect, patient compared to usual care (SMD of 0.21), patient compared to another patient (SDM of 0.29) and healthcare professional compared to another healthcare professional (SDM of 0.20). For all comparisons, interpretation of the results needs to consider the small number of studies, the heterogeneity, and some methodological issues. Overall quality of the evidence for the outcomes, assessed with the GRADE tool, ranged from low to very low.
It is uncertain whether interventions to improve adoption of SDM are effective given the low quality of the evidence. However, any intervention that actively targets patients, healthcare professionals, or both, is better than none. Also, interventions targeting patients and healthcare professionals together show more promise than those targeting only one or the other.
Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those ...potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation.
This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation.
We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health.
Arthritis patients often take fish oil supplements to alleviate symptoms, but limited evidence exists regarding their efficacy. The objective was to evaluate whether marine oil supplements reduce ...pain and/or improve other clinical outcomes in patients with arthritis. Six databases were searched systematically (24 February 2015). We included randomized trials of oral supplements of all marine oils compared with a control in arthritis patients. The internal validity was assessed using the Cochrane Risk of Bias tool and heterogeneity was explored using restricted maximum of likelihood (REML)-based meta-regression analysis. Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to rate the overall quality of the evidence. Forty-two trials were included; 30 trials reported complete data on pain. The standardized mean difference (SMD) suggested a favorable effect (-0.24; 95% confidence interval, CI, -0.42 to -0.07; heterogeneity,
² = 63%. A significant effect was found in patients with rheumatoid arthritis (22 trials; -0.21; 95% CI, -0.42 to -0.004) and other or mixed diagnoses (3 trials; -0.63; 95% CI, -1.20 to -0.06), but not in osteoarthritis patients (5 trials; -0.17; 95% CI, -0.57-0.24). The evidence for using marine oil to alleviate pain in arthritis patients was overall of low quality, but of moderate quality in rheumatoid arthritis patients.
With the growing movement to engage patients in research, questions are being asked about who is engaging patients and how they are being engaged. Internationally, research groups are supporting and ...funding patient-oriented research studies that engage patients in the identification of research priorities and the design, conduct and uptake of research. As we move forward, we need to know what meaningful patient engagement looks like, how it benefits research and clinical practice, and what are the barriers to patient engagement?We conducted a review of the published literature looking for trials that report engaging patients in the research. We included both randomized controlled trials and non-randomized comparative trials. We looked at these trials for important study characteristics, including how patients were engaged, to better understand the practices used in trials. Importantly, we also discuss the number of trials reporting patient engagement practices relative to all published trials. We found that very few trials report any patient engagement activities even though it is widely supported by many major funding organizations. The findings of our work will advance patient-oriented research by showing how patients can be engaged and by stressing that patient engagement practices need to be better reported.
Patient-Oriented Research (POR) is research informed by patients and is centred on what is of importance to them. A fundamental component of POR is that patients are included as an integral part of the research process from conception to dissemination and implementation, and by extension, across the research continuum from basic research to pragmatic trials J Comp Eff Res 2012, 1:181-94, JAMA 2012, 307:1587-8. Since POR's inception, questions have been raised as to how best to achieve this goal.We conducted a systematic review of randomized controlled trials and non-randomized comparative trials that report engaging patients in their research. Our main goal was to describe the characteristics of published trials engaging patients in research, and to identify the extent of patient engagement activities reported in these trials.
The MEDLINE®, EMBASE®, Cinahl, PsycINFO, Cochrane Methodology Registry, and Pubmed were searched from May 2011 to June 16th, 2016. Title, abstract and full text screening of all reports were conducted independently by two reviewers. Data were extracted from included trials by one reviewer and verified by a second. All trials that report patient engagement for the purposes of research were included.
Of the 9490 citations retrieved, 2777 were reviewed at full text, of which 23 trials were included. Out of the 23 trials, 17 were randomized control trials, and six were non-randomized comparative trials. The majority of these trials (83%, 19/23) originated in the United States and United Kingdom. The trials engaged a range of 2-24 patients/ community representatives per study. Engagement of children and minorities occurred in 13% (3/23) and 26% (6/23) of trials; respectively. Engagement was identified in the development of the research question, the selection of study outcomes, and the dissemination and implementation of results.
The prevalence of patient engagement in patient-oriented interventional research is very poor with 23 trials reporting activities engaging patients. Research dedicated to determining the best practice for meaningful engagement is still needed, but adequate reporting measures also need to be defined.
Objective
Peer support is important for psychosocial well-being in patients with rheumatoid arthritis (RA). Our objective was to assess the interactions, engagement, and perceptions of participants ...in an online support group for patients with RA.
Methods
Participants were 18 years or older, diagnosed with RA within 10 years, and residing in the USA or Canada. All participated in a closed Facebook online support group. Membership was by invitation only, and discussions were visible only to members, moderators, and two research staff. Each week, participants discussed a topic posted by a moderator. They also shared other disease-relevant information beside the topics posted. We assessed participants’ engagement and qualitatively analyzed the content of their postings in the first 5 weeks of participation.
Results
The group had 90 participants: 94% were female and 83% white. Median age was 54 (24–84) years. Mean number of contributors per week was 50 (range, 42–62); 10% of participants never contributed to the discussions. Participation in discussions declined over time. Over three-quarters of participant posting were about information sharing. Participants shared information on disease experiences, medications, social lives (including pictures of themselves, families, and pets), online resources on RA, frustrations, messages of encouragement, and satirical depictions of their disease experience. Many expressed gratitude for the social support provided.
Conclusion
Participants were generally enthusiastic and shared disease-related information and personal experiences. Social media groups may provide alternative means of providing education and peer support often lacking in traditional models of care.
Key Points
•
The study examines how patients with rheumatoid arthritis engage in an online support group and the nature of their interactions.
• This study reveals that social media platforms could provide viable options or complements to the traditional face-to-face small group patient support system.
• It may be necessary to pay special attention to how to ensure a sustained participant interest in online social support group among patients with rheumatoid arthritis
.
Full text
Available for:
EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Background
Fatigue is prevalent and impactful in rheumatoid arthritis (RA). There is no standardized measure for its assessment nor data concerning the performance of PROMIS-Fatigue short forms (SFs) ...in people with RA. We evaluated the construct validity of 4-, 7-, and 8-item PROMIS-Fatigue SFs in RA patients across the range of disease activity.
Methods
Adult RA patients were recruited from an online patient community and an observational cohort from three academic medical centers. Measures included PROMIS-Fatigue SFs, other PROMIS measures, and other patient reported outcomes including RAND-36 Vitality, Fatigue NRS, and patient global assessment of disease activity. Other measures from the observational cohort included 28-joint swollen and tender joints, physician global assessment, and the composite RA clinical disease activity index (CDAI).
Results
Two-hundred online participants and 348 participants from the observational cohort were included. PROMIS Fatigue SF scores spanned the measurement continuum and correlated highly with each other (r’s ≥ 0.91) and other fatigue measures (r’s ≥ 0.85). PROMIS-Fatigue SF scores were highly and inversely associated with Physical Function and Participation (r’s − 0.77 to − 0.78), and moderately-highly and positively correlated with pain, sleep disturbance, anxiety, and depression (r’s 0.60 to 0.75). PROMIS-Fatigue SF scores showed dose-response relationships across fatigue severity descriptors and CDAI categories.
Conclusions
These results provide robust evidence supporting the construct validity of the 4, 7, and 8-item PROMIS-Fatigue SFs. They capture fatigue across the spectrum of RA disease activity in diverse groups of individuals and should be considered for use as patient-centered assessments of disease control and treatment efficacy.
PDF
