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Background Morphea (morphoea) is an immune-mediated disease in which excess synthesis and deposition of collagen in the skin and underlying connective tissues results in hardened cutaneous areas. Morphea has different clinical features according to the subtype and stage of evolution of the disease. There is currently no consensus on optimal interventions for morphea. Objectives To assess the effects of treatments for people with any form of morphea. Search methods We searched the following databases up to July 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, and five trial registers. We checked the reference lists of included studies for further references to relevant randomised controlled trials. Selection criteria Randomised controlled trials of topical, intralesional, or systemic treatments (isolated or combined) in anyone who has been clinically diagnosed by a medical practitioner with any form of morphea. Eligible controls were placebo, no intervention, any other treatment, or different doses or duration of a treatment. Data collection and analysis We used standard methodological procedures expected by Cochrane. The primary outcomes were global improvement of disease activity or damage assessed by a medical practitioner or by participants, and adverse effects. Secondary outcomes were improvement of disease activity and improvement of disease damage. We used GRADE to assess the quality of the evidence for each outcome. Main results We included 14 trials, with a total of 429 randomised participants, aged between 3 and 76 years. There were juvenile and adult participants; over half were female, and the majority had circumscribed morphea, followed by linear scleroderma. The settings of the studies (where described) included a dermatologic centre, a national laboratory centre, paediatric rheumatology and dermatology centres, and a university hospital or medical centre.The studies evaluated heterogenous therapies for different types of morphea, covering a wide range of comparisons. We were unable to conduct any meta-analyses. Seven studies investigated topical medications, two evaluated intralesional medications, and five investigated systemic medications. The study duration ranged from seven weeks to 15 months from baseline.We present here results for our primary outcomes for our four key comparisons. All of these results are based on low-quality evidence.The included studies were at high risk of performance, detection, attrition, and reporting bias.Global improvement of disease activity or damage after treatment may be higher with oral methotrexate (15 mg/m², maximum 20 mg, once a week, for 12 months or until disease flare) plus oral prednisone (1 mg/kg a day, maximum of 50 mg, in a single morning dose, for three months, and one month with gradually decreased dose until discontinuation) than with placebo plus oral prednisone in children and adolescents with active morphea (linear scleroderma, generalised morphea or mixed morphea: linear and circumscribed) (risk ratio (RR) 2.31, 95% confidence interval (CI) 1.20 to 4.45; number needed to treat for an additional beneficial outcome (NNTB) 3; 1 randomised controlled trial (RCT); 70 participants, all juvenile). This outcome was measured 12 months from the start of treatment or until flare of the disease. Data were not available separately for each morphea type. There may be little or no difference in the number of participants experiencing at least one adverse event with oral methotrexate (26/46) or placebo (11/24) (RR 1.23, 95% CI 0.75 to 2.04; 1 RCT; 70 participants assessed during the 12-month follow-up). Adverse events related to methotrexate included alopecia, nausea, headache, fatigue and hepatotoxicity, whilst adverse events related to prednisone (given in both groups) included weight gain (more than 5% of body weight) and striae rubrae.One three-armed RCT compared the following treatments: medium-dose (50 J/cm²) UVA-1; low-dose (20 J/cm²) UVA-1; and narrowband UVB phototherapy. There may be little or no difference between treatments in global improvement of disease activity or damage, as assessed through the modified skin score (where high values represent a worse outcome): medium-dose UVA-1 phototherapy versus low-dose UVA-1 group: MD 1.60, 95% CI -1.70 to 4.90 (44 participants); narrowband UVB phototherapy versus medium-dose UVA-1 group: MD -1.70, 95% CI -5.27 to 1.87 (35 participants); and narrowband UVB versus low-dose UVA-1 group: MD -0.10, 95% CI -2.49 to 2.29 (45 participants). This RCT included children and adults with active morphea (circumscribed morphea, linear scleroderma (with trunk/limb variant and head variant), generalised morphea, or mixed morphea), who received phototherapy five times a week, for eight weeks. Outcomes were measured at eight weeks from the start of treatment.Safety data, measured throughout treatment, from the same RCT (62 participants) showed that treatment with UVA-1 phototherapy may cause mild tanning compared to narrowband UVB: narrowband UVB versus medium-dose UVA-1: RR 0.03, 95% CI 0.00 to 0.42; 35 participants; narrowband UVB versus low-dose UVA-1: RR 0.03, 95% CI 0.00 to 0.41; 45 participants. However, there may be no difference in the number of participants reporting mild tanning when comparing medium and low dose UVA-1 phototherapy (RR 1.00, 95% CI 0.91 to 1.10; 44 participants). Transient erythema was reported in three participants with narrowband UVB and no participants in the low- or medium-dose UVA-1 groups. Authors' conclusions Compared to placebo plus oral prednisone, oral methotrexate plus oral prednisone may improve disease activity or damage in juvenile active morphea (linear scleroderma, generalised morphea or mixed morphea: linear and circumscribed), but there may be a slightly increased chance of experiencing at least one adverse event.When medium-dose UVA-1 (50 J/cm²), low-dose UVA-1 (20 J/cm²), and narrowband UVB were compared against each other in treating children and adults with active morphea (circumscribed morphea, linear scleroderma, generalised morphea and mixed morphea), there may be little or no difference between these treatments on global improvement of disease activity or damage. UVA-1 phototherapy may cause more mild tanning than narrowband UVB, but there may be no difference between medium- and low-dose UVA-1 phototherapy. These results are based on low-quality evidence.Limitations of data and analyses include risk of bias and imprecision (small number of participants or events and wide confidence intervals). We encourage multicentre RCTs to increase sample size and evaluate, with validated tools, different treatment responses according to the subtypes of morphea and age groups.

Objective.At a previous Outcome Measures in Rheumatology (OMERACT) meeting, participants reflected on the underlying methods of patient-reported outcome (PRO) instrument development. The participants requested proposals for more explicit instrument development protocols that would contribute to an enhanced version of the “Truth” statement in the OMERACT Filter, a widely used guide for outcome validation. In the present OMERACT session, we explored to what extent these new Filter 2.0 proposals were practicable, feasible, and already being applied.Methods.Following overview presentations, discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed PRO development framework, whether these observations had a more general application, and what issues remained to be resolved.Results.Several aspects of PRO development were recognized as particularly important, and the need to directly involve patients at every stage of an iterative PRO development program was endorsed. This included recognition that patients contribute as partners in the research and not merely as subjects. Correct communication of concepts with the words used in questionnaires was central to their performance as measuring instruments, and ensuring this understanding crossed cultural and linguistic boundaries was important in international studies or comparisons.Conclusion.Participants recognized, endorsed, and were generally already putting into practice the principles of PRO development presented in the plenary session. Further work is needed on some existing instruments and on establishing widespread good practice for working in close collaboration with patients.

Background Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty. Objectives To assess the effects of decision aids for people facing treatment or screening decisions. Search methods For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008). Selection criteria We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions. Data collection and analysis Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were: A) 'choice made' attributes; B) 'decision-making process' attributes. Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model. Main results This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each. Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies). A) Criteria involving 'choice made' attributes: Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13). B) Criteria involving 'decision-making process' attributes: Decision aids compared to usual care interventions resulted in: a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18); b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); and c) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18). Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice. C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable. The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. Authors' conclusions There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values. New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.

Objective To identify high-priority research questions for osteoarthritis systematic reviews with consideration of health equity and the social determinants of health (SDH). Study Design and Setting We consulted with experts and conducted a literature search to identify a priority-setting method that could be adapted to address the health equity and SDH. We selected the Global Evidence Mapping priority-setting method, and through consultations and consensus, we adapted the method to meet our objectives. This involves developing an evidence map of the existing systematic reviews on osteoarthritis; conducting one face-to-face workshop with patients and another one with clinicians, researchers, and patients; and conducting an online survey of patients to rank the top 10 research questions. We piloted the adapted method with the Cochrane Musculoskeletal Review Group to set research priorities for osteoarthritis. Results Our focus was on systematic reviews: we identified 34 high-priority research questions for osteoarthritis systematic reviews. Prevention and self-management interventions, mainly diet and exercise, are top priorities for osteoarthritis systematic reviews. Evaluation against our predefined objectives showed that this method did prioritize SDH (50% of the research questions considered SDH). There were marked gaps: no high-priority topics were identified for access to care until patients had advanced disease–lifestyle changes once the disease was diagnosed. This method was felt feasible if conducted annually. Conclusion We confirmed the utility of an adapted priority-setting method that is feasible and considers SDH. Further testing of this method is needed to assess whether considerations of health equity are prioritized and involve disadvantaged groups of the population.

Decision aids prepare people to participate in decisions that involve weighing benefits, harms, and scientific uncertainty.To evaluate the effectiveness of decision aids for people facing treatment or screening decisions.For this update, we searched from January 2006 to December 2009 in MEDLINE (Ovid); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, issue 4 2009); CINAHL (Ovid) (to September 2008 only); EMBASE (Ovid); PsycINFO (Ovid); and grey literature. Cumulatively, we have searched each database since its start date.We included published randomised controlled trials (RCTs) of decision aids, which are interventions designed to support patients' decision making by providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies in which participants were not making an active treatment or screening decision.Two review authors independently screened abstracts for inclusion, extracted data, and assessed potential risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards, were:A) decision attributes;B) decision making process attributes.Secondary outcomes were behavioral, health, and health system effects. We pooled results of RCTs using mean differences (MD) and relative risks (RR), applying a random effects model.Of 34,316 unique citations, 86 studies involving 20,209 participants met the eligibility criteria and were included. Thirty-one of these studies are new in this update. Twenty-nine trials are ongoing. There was variability in potential risk of bias across studies. The two criteria that were most problematic were lack of blinding and the potential for selective outcome reporting, given that most of the earlier trials were not registered.Of 86 included studies, 63 (73%) used at least one measure that mapped onto an IPDAS effectiveness criterion: A) criteria involving decision attributes: knowledge scores (51 studies); accurate risk perceptions (16 studies); and informed value-based choice (12 studies); and B) criteria involving decision process attributes: feeling informed (30 studies) and feeling clear about values (18 studies).A) Criteria involving decision attributes:Decision aids performed better than usual care interventions by increasing knowledge (MD 13.77 out of 100; 95% confidence interval (CI) 11.40 to 16.15; n = 26). When more detailed decision aids were compared to simpler decision aids, the relative improvement in knowledge was significant (MD 4.97 out of 100; 95% CI 3.22 to 6.72; n = 15). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.74; 95% CI 1.46 to 2.08; n = 14). The effect was stronger when probabilities were expressed in numbers (RR 1.93; 95% CI 1.58 to 2.37; n = 11) rather than words (RR 1.27; 95% CI 1.09 to 1.48; n = 3). Exposure to a decision aid with explicit values clarification compared to those without explicit values clarification resulted in a higher proportion of patients achieving decisions that were informed and consistent with their values (RR 1.25; 95% CI 1.03 to 1.52; n = 8).B) Criteria involving decision process attributes:Decision aids compared to usual care interventions resulted in: a) lower decisional conflict related to feeling uninformed (MD -6.43 of 100; 95% CI -9.16 to -3.70; n = 17); b) lower decisional conflict related to feeling unclear about personal values (MD -4.81; 95% CI -7.23 to -2.40; n = 14); c) reduced the proportions of people who were passive in decision making (RR 0.61; 95% CI 0.49 to 0.77; n = 11); and d) reduced proportions of people who remained undecided post-intervention (RR 0.57; 95% CI 0.44 to 0.74; n = 9). Decision aids appear to have a positive effect on patient-practitioner communication in the four studies that measured this outcome. For satisfaction with the decision (n = 12) and/or the decision making process (n = 12), those exposed to a decision aid were either more satisfied or there was no difference between the decision aid versus comparison interventions. There were no studies evaluating the decision process attributes relating to helping patients to recognize that a decision needs to be made or understand that values affect the choice.C) Secondary outcomesExposure to decision aids compared to usual care continued to demonstrate reduced choice of: major elective invasive surgery in favour of conservative options (RR 0.80; 95% CI 0.64 to 1.00; n = 11). Exposure to decision aids compared to usual care also resulted in reduced choice of PSA screening (RR 0.85; 95% CI 0.74 to 0.98; n = 7). When detailed compared to simple decision aids were used, there was reduced choice of menopausal hormones (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable. The effect of decision aids on length of consultation varied from -8 minutes to +23 minutes (median 2.5 minutes). Decision aids do not appear to be different from comparisons in terms of anxiety (n = 20), and general health outcomes (n = 7), and condition specific health outcomes (n = 9). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive.New for this updated review is evidence that: decision aids with explicit values clarification exercises improve informed values-based choices; decision aids appear to have a positive effect on patient-practitioner communication; and decision aids have a variable effect on length of consultation.Consistent with findings from the previous review, which had included studies up to 2006: decision aids increase people's involvement, and improve knowledge and realistic perception of outcomes; however, the size of the effect varies across studies. Decision aids have a variable effect on choices. They reduce the choice of discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, patient-practitioner communication, cost-effectiveness, and use with developing and/or lower literacy populations need further evaluation. Little is known about the degree of detail that decision aids need in order to have positive effects on attributes of the decision or decision-making process.

The 2008 World Health Report emphasizes the need for patient-centered primary care service delivery models in which patients are equal partners in the planning and management of their health. It is argued that this involvement will lead to improved management of disease, improved health outcomes and patient satisfaction, better informed decision-making, increased compliance with healthcare decisions, and better resource utilization. This article investigates the domains captured by the Effective Consumer Scale (EC-17) in relation to vulnerable population groups that experience health inequity. Particular focus is paid to the domain of health literacy as an area fundamental to patients’ involvement in managing their condition and negotiating the healthcare system. In examining the possible influence of Outcome Measures in Rheumatology Clinical Trials (OMERACT) on health equity, we used the recent translation and validation of the EC-17 scale into Spanish and tested Argentina as an example. Future plans to use the EC-17 with vulnerable groups include formal collaboration and needs assessment with the community to tailor an intervention to meet its needs in a culturally relevant manner. Some systematic reviews have questioned whether interventions to improve effective consumer skills are appropriate in vulnerable populations. We propose that these populations may have the most to gain from such interventions since they might be expected to have relatively lower skills and health literacy than other groups.

Background Shared decision making (SDM) is a process by which a healthcare choice is made jointly by the practitioner and the patient and is said to be the crux of patient-centred care. Policy makers perceive SDM as desirable because of its potential to a) reduce overuse of options not clearly associated with benefits for all (e.g., prostate cancer screening); b) enhance the use of options clearly associated with benefits for the vast majority (e.g., cardiovascular risk factor management); c) reduce unwarranted healthcare practice variations; d) foster the sustainability of the healthcare system; and e) promote the right of patients to be involved in decisions concerning their health. Despite this potential, SDM has not yet been widely adopted in clinical practice. Objectives To determine the effectiveness of interventions to improve healthcare professionals’ adoption of SDM. Search methods We searched the following electronic databases up to 18 March 2009: Cochrane Library (1970-), MEDLINE (1966-), EMBASE (1976-), CINAHL (1982-) and PsycINFO (1965-). We found additional studies by reviewing a) the bibliographies of studies and reviews found in the electronic databases; b) the clinicaltrials.gov registry; and c) proceedings of the International Shared Decision Making Conference and the conferences of the Society for Medical Decision Making. We included all languages of publication. Selection criteria We included randomised controlled trials (RCTs) or well-designed quasi-experimental studies (controlled clinical trials, controlled before and after studies, and interrupted time series analyses) that evaluated any type of intervention that aimed to improve healthcare professionals' adoption of shared decision making. We defined adoption as the extent to which healthcare professionals intended to or actually engaged in SDM in clinical practice or/and used interventions known to facilitate SDM. We deemed studies eligible if the primary outcomes were evaluated with an objective measure of the adoption of SDM by healthcare professionals (e.g., a third-observer instrument). Data collection and analysis At least two reviewers independently screened each abstract for inclusion and abstracted data independently using a modified version of the EPOC data collection checklist. We resolved disagreements by discussion. Statistical analysis considered categorical and continuous primary outcomes. We computed the standard effect size for each outcome separately with a 95% confidence interval. We evaluated global effects by calculating the median effect size and the range of effect sizes across studies. Main results The reviewers identified 6764 potentially relevant documents, of which we excluded 6582 by reviewing titles and abstracts. Of the remainder, we retrieved 182 full publications for more detailed screening. From these, we excluded 176 publications based on our inclusion criteria. This left in five studies, all RCTs. All five were conducted in ambulatory care: three in primary clinical care and two in specialised care. Four of the studies targeted physicians only and one targeted nurses only. In only two of the five RCTs was a statistically significant effect size associated with the intervention to have healthcare professionals adopt SDM. The first of these two studies compared a single intervention (a patient-mediated intervention: the Statin Choice decision aid) to another single intervention (also patient-mediated: a standard Mayo patient education pamphlet). In this study, the Statin Choice decision aid group performed better than the standard Mayo patient education pamphlet group (standard effect size = 1.06; 95% CI = 0.62 to 1.50). The other study compared a multifaceted intervention (distribution of educational material, educational meeting and audit and feedback) to usual care (control group) (standard effect size = 2.11; 95% CI = 1.30 to 2.90). This study was the only one to report an assessment of barriers prior to the elaboration of its multifaceted intervention. Authors' conclusions The results of this Cochrane review do not allow us to draw firm conclusions about the most effective types of intervention for increasing healthcare professionals' adoption of SDM. Healthcare professional training may be important, as may the implementation of patient-mediated interventions such as decision aids. Given the paucity of evidence, however, those motivated by the ethical impetus to increase SDM in clinical practice will need to weigh the costs and potential benefits of interventions. Subsequent research should involve well-designed studies with adequate power and procedures to minimise bias so that they may improve estimates of the effects of interventions on healthcare professionals' adoption of SDM. From a measurement perspective, consensus on how to assess professionals' adoption of SDM is desirable to facilitate cross-study comparisons.