Healthcare is full of choices between standard-of-care approaches where one might be better but we do not know which. Examples include ‘at what threshold should magnesium be supplemented for critically ill patients?’ and ‘which insulin formulation should be started in a hospitalised patient with diabetes?’
Observational studies of such questions can be conducted relatively easily but are prone to biases, especially selection bias, that prevent them from reliably showing causal relationships between treatments and outcomes.
Shared decision-making (SDM) has gained acceptance as a preferred and ideal method for medical decision-making.
We developed The Six Steps of SDM to fill gaps in coordination among theory, measurement, interventions and implementation of SDM. That is, ideally, theory should drive both measurement and development of interventions (including skills training and tools such as decision aids), and therefore, influence implementation. However, SDM theories, assessments, decision tools and curricula...]]>
To assess to what extent the clinical trial policies of the largest public and philanthropic funders of clinical research in the United States meet WHO best practices in trial registration and reporting.
Public and philanthropic funders of clinical trials in the USA with >US$50 million annual spend were selected. The funders were assessed using an 11-item scoring tool based on WHO Joint Statement benchmarks. These 11 items fell into 4 categories, namely: trial registration, academic publication, monitoring and sanctions. An additional item captured whether and how funders referred to Consolidated Standards of Reporting Trials (CONSORT) within their trial policies. Each funder was independently assessed by two or three researchers. Funders were contacted to flag possible errors and omissions. Ambiguous or difficult-to-score items were settled by an independent adjudicator.
Fourteen funders were assessed. Our cross-sectional study found that, on average, funders have only implemented 4.1/11 (37%) of WHO best practices in clinical trial transparency. The most frequently adopted requirement was open access publishing (14/14 funders). The least frequently adopted were (1) requiring trial ID to appear in all publications (2/14 funders, 14%) and (2) making compliance reports public (2/14 funders, 14%). Public funders, on average, adopted more policy elements (5.2/11 items, 47%) than philanthropic funders (2.8/11 items, 25%). Only one funder’s policy documents mentioned the CONSORT statement.
There is a significant variation between the number of best practice policy items adopted by medical research funders in the USA. Many funders fell significantly short of WHO Joint Statement benchmarks. Each funder could benefit from policy revision and strengthening.
To evaluate the feasibility and effectiveness of the SHARE TO CARE (S2C) programme, a complex intervention designed for hospital-wide implementation of shared decision-making (SDM).
Pre–post study.
University Hospital Schleswig-Holstein (UKSH), Kiel Campus.
Healthcare professionals as well as inpatients and outpatients from 22 departments of the Kiel Campus of UKSH.
The S2C programme is a comprehensive implementation strategy including four core modules: (1) physician training, (2) SDM support training for and support by nurses as decision coaches, (3) patient activation and (4) evidence-based patient decision aid development and integration into patient pathways. After full implementation, departments received the S2C certificate.
In this paper, we report on the feasibility and effectiveness outcomes of the implementation. Feasibility was judged by the degree of implementation of the four modules of the programme. Outcome measures for effectiveness are patient-reported experience measures (PREMs). The primary outcome measure for effectiveness is the Patient Decision Making subscale of the Perceived Involvement in Care Scale (PICSPDM). Pre–post comparisons were done using t-tests.
The implementation of the four components of the S2C programme was able to be completed in 18 of the 22 included departments within the time frame of the study. After completion of implementation, PICSPDM showed a statistically significant difference (p<0.01) between the means compared with baseline. This difference corresponds to a small to medium yet clinically meaningful positive effect (Hedges’ g=0.2). Consistent with this, the secondary PREMs (Preparation for Decision Making and collaboRATE) also showed statistically significant, clinically meaningful positive effects.
The hospital-wide implementation of SDM with the S2C-programme proved to be feasible and effective within the time frame of the project. The German Federal Joint Committee has recommended to make the Kiel model of SDM a national standard of care.
This study aimed to investigate whether the format and type of conclusion in Cochrane plain language summaries (PLSs) influence readers’ perception of treatment benefit and decision-making.
An online parallel group, three-arm randomised controlled trial was conducted.
The study was conducted online.
The participants were physiotherapy students.
The participants read two Cochrane PLSs, one with a positive conclusion (strong evidence of benefit) and another with a negative conclusion (strong evidence of non-benefit). Each participant read the results of both reviews presented in one of three formats: (1) numerical, (2) textual or (3) numerical and textual.
The primary outcome measure was the participants’ perception of treatment benefit.
All three groups of participants perceived the treatment to have positive effects when the Cochrane PLS had a positive conclusion, regardless of the format of presentation (mean perception of treatment benefit score: textual 7.7 (SD 2.3), numerical 7.9 (SD 1.8), numerical and textual 7.7 (SD 1.7), p=0.362). However, when the Cochrane PLS had a negative conclusion, all three groups of participants failed to perceive a negative effect (mean perception of treatment benefit score: textual 5.5 (SD 3.3), numerical 5.6 (SD 2.7), numerical and textual 5.9 (SD 2.8), p=0.019).
The format of Cochrane PLSs does not appear to significantly impact physiotherapy students’ perception of treatment benefit, understanding of evidence, persuasiveness or confidence in their decision. However, participants’ perception of treatment benefit does not align with the conclusion when the Cochrane PLS indicates strong evidence of non-benefit from the intervention.
CTRI/2022/10/046476.
To evaluate the effects of early introduction to allergenic foods compared with late introduction and its impact on food allergy, food sensitisation and autoimmune disease risk.
The systematic review was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. Four electronic databases (MEDLINE, CENTRAL, EMBASE and CINAHL) were searched from inception till 24 October 2022 using keywords and MeSH without limitations on publication’s language or date. A forward and backwards citation analysis was also conducted. Risk of bias was assessed by three authors independently, in pairs using the Cochrane Risk of Bias Tool 2. Findings were narratively and quantitatively synthesised. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.
Randomised controlled trials (RCTs) on allergenic food introduction prior to 12 months of age that evaluated its effect on the development of allergic and autoimmune conditions.
Early introduction to allergenic foods to infants diet.
(1) Food allergy and sensitisation with main measures including oral food challenge, specific-IgE, skin prick testing, physician assessment and parental reporting. (2) Allergic and autoimmune conditions such as asthma and eczema.
Of the 9060 identified records, we included 12 RCTs. We found high to moderate certainty evidence suggested that early introduction of allergen-containing foods reduces the risk of multiple food allergies (4 RCTs, 3854 participants, RR 0.49, 95% CI 0.33 to 0.74), egg (8 RCTs, 5193 participants, RR 0.58, 95% CI 0.44 to 0.78), peanut (3 RCTs, 4183 participants, RR 0.31, 95% CI 0.17 to 0.54) and atopic dermatitis or eczema (4 RCTs, 3579 participants, RR 0.88, 95% CI 0.78 to 1.00). Effects on other food allergies including milk, wheat, fish; autoimmune conditions, and food sensitisation are very uncertain and informed by low and very-low certainty evidence. No important subgroup differences were observed related to baseline risk of allergy and age at introduction. Sensitivity analyses limited to low risk of bias RCTs showed similar results.
This systematic review and meta-analysis shows that early introduction of allergen-containing food from 4 to 12 months of age, was associated with lower risk of multiple food allergy and eczema. Further research on other allergenic foods, and their long-term impact on food allergy and autoimmune risk is essential for enhancing our understanding on development of these conditions and guiding future clinical recommendations.
CRD42022375679.
Racial bias is a distortion arising from systemic, institutional, interpersonal or individual forms of explicit (conscious) or implicit (unconscious) prejudice against individuals or groups based on social constructs of race or ethnicity that influences the planning, methods, results, interpretation, dissemination and application of health research. As a flaw in research design that undermines the validity of results, research-based racial bias should be distinguished from everyday racial bias—a phenomenon characterised by unfair or harmful treatment of specific members of society.
Racial bias in research can take various forms, including the systemic under-representation of ethnic minorities (related to sampling and recruitment bias, impacting external validity), the use of non-validated methods or tools to analyse data from diverse populations (related to measurement bias and impacting construct validity),
Consistent with the principles of evidence-based medicine, effectively communicating evidence (including risks) in medicine is an essential part of shared decision making (SDM). SDM has been defined as ‘an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options, to achieve informed preferences’.
Many studies demonstrate the potential of...]]>
Since there was no rush, I asked her if it could be removed at my local clinic. This was no problem. She would send a referral to my general practitioner that same day. Within 2 weeks, I would be called to schedule an appointment.
Three weeks later, I was still waiting for that call. Although I was not particularly concerned about the mass, it was always in the back of my head since it was discovered. An afterthought ever-so-slowly growing, like the mass itself. My husband...]]>
Most intervention meta-analyses address static interventions, diverging from dynamic clinical practices in multistage diseases such as the facial neuritis, primarily comparing positive interventions to controls or other therapies, overlooking real-world adaptive strategies used at different disease stages. For facial neuritis, the early stage may benefit more from gentle acupuncture and concurrent steroid use to relieve inflammation and compression; as condition stabilises, enhanced acupuncture and targeted neural reconstruction methods may be more appropriate than identical acupuncture parameters, consistent steroid use or...]]>