Objectives Shared decision making (SDM) is a process in which patients and their doctors collaborate in choosing a suitable treatment option by incorporating patient values and preferences, as well ...as the best available evidence. Particularly in vascular surgery, several conditions seem suitable for SDM because there are multiple treatment options. The objective of this study was to assess the degree of SDM behaviour in vascular surgery. Methods Vascular surgeons of four Dutch hospitals selected consultations with patients who were facing a treatment decision. Immediately after the consultation, patients and surgeons completed the (subjective) SDM Q-9 and SDM Q-doc questionnaires respectively, to appreciate the perceived level of SDM behaviour. Two evaluators independently and objectively rated SDM behaviour in the audiotaped consultations, using the Observing Patient Involvement (OPTION-12) scale. Results Nine vascular surgeons and three vascular surgeons in training conducted 54 consultations. The patients' median SDM Q-9 score was high, 93% (IQR 79–100%), and 16/54 (29.6%) of them gave the maximum score. The surgeons' median score was also high, 84% (IQR 73–92%), while 4/54 (7.4%) gave the maximum score. In contrast, mean OPTION score was 31% (SD 11%). Surgeons hardly ever asked the patients for their preferred approach to receive information, whether they had understood the provided information, and how they would like to be involved in SDM. Conclusions Currently, objective SDM behaviour among vascular surgeons is limited, even though the presented disorders allow for SDM. Hence, SDM in vascular surgical consultations could be improved by increasing the patients' and surgeons' awareness and knowledge about the concept of SDM.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background
Multiple treatment options are generally available for most diseases. Shared decision‐making (SDM) helps patients and physicians choose the treatment option that best fits a patient's ...preferences. This review aimed to assess the extent to which SDM is applied during surgical consultations, and the metrics used to measure SDM and SDM‐related outcomes.
Methods
This was a systematic review of observational studies and clinical trials that measured SDM during consultations in which surgery was a treatment option. Embase, MEDLINE and CENTRAL were searched. Study selection, quality assessment and data extraction were conducted by two investigators independently.
Results
Thirty‐two articles were included. SDM was measured using nine different metrics. Thirty‐six per cent of 13 176 patients and surgeons perceived their consultation as SDM, as opposed to patient‐ or surgeon‐driven. Surgeons more often perceived the decision‐making process as SDM than patients (43·6 versus 29·3 per cent respectively). SDM levels scored objectively using the OPTION and Decision Analysis System for Oncology instruments ranged from 7 to 39 per cent. Subjective SDM levels as perceived by surgeons and patients ranged from 54 to 93 per cent. Patients experienced a higher level of SDM during consultations than surgeons (93 versus 84 per cent). Twenty‐five different SDM‐related outcomes were reported.
Conclusion
At present, SDM in surgery is still in its infancy, although surgeons and patients both think of it favourably. Future studies should evaluate the effect of new interventions to improve SDM during surgical consultations, and its assessment using available standardized and validated metrics.
Heterogeneous data
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Shared decision-making improves the quality of patient care. Unfortunately, shared decision-making is not yet common practice among vascular surgeons. Thus, decision support tools were developed to ...assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made.
The study design is a multicentre stepped-wedge cluster-randomised trial. Eligible patients are adult patients, visiting the outpatient clinic of a participating medical centre for whom several treatment options are feasible and who face a primary treatment decision for their abdominal aortic aneurysm, carotid artery disease, intermittent claudication, or varicose veins. Patients and vascular surgeons in the intervention group receive decision support tools that may help them adopt shared decision-making when making the final treatment decision. These decision support tools are decision aids, consultation cards, decision cards, and a practical training. Decision aids are informative websites that help patients become more aware of the pros and cons of the treatment options and their preferences regarding the treatment choice. Consultation cards with text or decision cards with images are used by vascular surgeons during consultation to determine which aspect of a treatment is most important to their patient. In the training vascular surgeons can practice shared decision-making with a patient actor, guided by a medical psychologist. This trial aims to include 502 vascular surgical patients to achieve a clinically relevant improvement in shared decision-making of 10 out of 100 points, using the 5-item OPTION instrument to score the audio-recordings of consultations.
In the OVIDIUS trial the available decision support tools for vascular surgical patients are implemented in clinical practice. We will evaluate whether these tools actually improve shared decision-making in the consultation room. The stepped-wedge cluster-randomised study design will ensure that at the end of the study all participating centres have implemented at least some of the decision support tools and thereby a certain level of shared decision-making.
Netherlands Trial Registry, NTR6487 . Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Shared decision-making (SDM) seeks to involve both patients and clinicians in decision-making about possible health management strategies, using patients' preferences and best available evidence. SDM ...seems readily applicable in anesthesiology. We aimed to determine the current level of SDM among preoperative patients and anesthesiology clinicians.
We invited 115 consecutive preoperative patients, visiting the pre-assessment outpatient clinic of the department of Anesthesiology at the Academic Medical Center of Amsterdam. Inclusion criteria were patients who needed surgery in the arms, lower abdomen or legs, and in whom three anesthesia techniques were feasible. The SDM-level of the consultation was scored objectively by independent observers who judged audio-recordings of the consultation using the OPTION
-scale, ranging from 0% (no SDM) to 100% (optimum SDM), as well as subjectively by patients (using the SDM-Q-9 and CollaboRATE questionnaires) and clinicians (SDM-Q-Doc questionnaire). Objective and subjective SDM-levels were assessed on five-point and six-point Likert scales, respectively. Both scores were expressed as percentages.
Data of 80 patients could be analysed. Objective SDM-scores were low (30.5%). Subjective scores of the SDM-Q-9 and CollaboRATE were high among patients (91.7% and 96.3%, respectively) and among clinicians (SDM-Q-Doc; 84.3%). Apparently, they appreciated satisfaction rather than SDM, being poorly aware of what SDM entails.
The level of SDM in an outpatient anesthesiology clinic where preoperative patients receive information about various possible anesthesia options, was found to be low. Thus, there is room for improving the level of SDM. Some suggestions are given how this can be achieved.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Although patients with vascular diseases often face multiple treatment options with different risks and benefits, the application of shared decision making (SDM) remains low. In SDM, clinicians and ...their patients work together to decide upon the treatment option that best fits the patient’s situation and preference. This study aimed to reveal predictors of the extent to which the SDM process occurs in vascular surgery.
This was a cross sectional cohort substudy of the OVIDIUS trial, a multicentre, randomised, stepped wedge trial on the effect of implementing SDM supporting tools. The data of outpatients visiting university and general hospitals and suffering from abdominal aortic aneurysms (AAAs), intermittent claudication (IC), or varicose veins (VV) were used. Consultations were audio recorded. SDM levels were scored independently by two evaluators, using the OPTION-5 instrument, on a scale from 0% (no SDM effort) to 100% (exemplary SDM effort). Possible associations between the OPTION-5 scores and patient, clinician, and consultation characteristics were investigated using multivariable linear regression analysis.
Of the 342 patients included (AAA, n = 87; VV, n = 143; IC, n = 112), 60% were male and mean age was 64 years. Overall, the SDM score was relatively low; mean ± SD 33.8% ± 13.2%, mainly due to insufficient support for the patient in deliberating their options. Regression analysis showed that the mean SDM scores in consultation with patients with IC and patients with VV were –9.9 (95% confidence interval CI –13.2 – –6.5; p < .001) and –12.7 (95% CI –17.3 – –8.0; p < .001) points lower than in patients with AAA, respectively. Consultations by a resident in training or nurse practitioner resulted in a –8.6 (95% CI –13.1 – –4.0; p < .001) and –4.2 (95% CI –7.9 – –0.42; p = .029) point lower SDM score than by a surgeon, respectively. A consultation longer than 30 minutes resulted in a 5.8 (95% CI 1.3 – 10.3; p = .011) point higher SDM score than consultations lasting fewer than 10 minutes.
In this study, it was found that SDM can still be improved, especially by helping patients understand and deliberate about their options. Spending time weighing up the options, notably with patients with IC and VV, will help improve the SDM process. Training in SDM consultations is important, particularly for junior clinicians.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background
Standardized reporting methods facilitate comparisons between studies. Reporting of data on benefits and harms of treatments in surgical RCTs should support clinical decision‐making. ...Correct and complete reporting of the outcomes of clinical trials is mandatory to appreciate available evidence and to inform patients properly before asking informed consent.
Methods
RCTs published between January 2005 and January 2017 in 15 leading journals comparing a surgical treatment with any other treatment were reviewed systematically. The CONSORT checklist, including the extension for harms, was used to appraise the publications. Beneficial and harmful treatment outcomes, their definitions and their precision measures were extracted.
Results
Of 1200 RCTs screened, 88 trials were included. For the differences in effect size of beneficial outcomes, 68 per cent of the trials reported a P value only but not a 95 per cent confidence interval. For harmful effects, this was 67 per cent. Only five of the 88 trials (6 per cent) reported a number needed to treat, and no study a number needed to harm. Only 61 per cent of the trials reported on both the beneficial and harmful outcomes of the intervention studied in the same paper.
Conclusion
Despite CONSORT guidelines, current reporting of benefits and harms in surgical trials does not facilitate clear communication of treatment outcomes with patients. Researchers, reviewers and journal editors should ensure proper reporting of treatment benefits and harms in trials.
Antecedentes
Los métodos para la estandarización en la descripción de los resultados facilitan la comparación entre estudios. La toma de decisiones clínicas debe estar respaldada por los resultados que se obtienen en los ensayos clínicos aleatorizados (randomized clinical trials, RCTs) quirúrgicos sobre los efectos beneficiosos y nocivos de los tratamientos. Es obligado que la descripción de los resultados de los ensayos clínicos sea correcta y completa a fin de estimar la evidencia disponible y poder informar a los pacientes de forma adecuada antes de solicitar el consentimiento informado.
Métodos
Se revisaron de forma sistemática los RCTs publicados entre enero de 2005 y enero de 2017 en las 15 revistas principales en los que se comparaba un tratamiento quirúrgico con cualquier otro. Para evaluar las publicaciones, se utilizó la guía de comprobación del CONsolidated Standard of Reporting Trials (CONSORT), haciéndola extensiva también a los efectos nocivos. Se obtuvieron los resultados sobre los efectos beneficiosos y nocivos del tratamiento, sus definiciones y sus medidas de precisión.
Resultados
De 1.200 RCTs seleccionados, se incluyeron 88 ensayos. Para comparar las diferencias de los efectos beneficiosos de los resultados, en el 68% de los ensayos se aportó sólo un valor de la P pero no el intervalo de confianza del 95%. Para efectos nocivos, el porcentaje fue del 67%. En sólo 5 de 88 ensayos (6%) se informó del número de pacientes que es necesario tratar (number needed to treat, NNT), y en ningún estudio se precisó el número de pacientes que es necesario para perjudicar (number needed to harm, NNH). En sólo el 61% de los ensayos se informó de los resultados beneficiosos y nocivos de la intervención analizada en el mismo artículo.
Conclusión
A pesar de la guía CONSORT, la descripción actual de los efectos beneficiosos y nocivos en los ensayos quirúrgicos no permite obtener una clara información del resultado del tratamiento obtenido en los pacientes. Los investigadores, los revisores y los editores de las revistas deben garantizar una descripción adecuada los beneficios y efectos nocivos del tratamiento en los ensayos clínicos.
This systematic review assessed current reporting of the benefits and harms of treatments in surgical trials in leading medical journals. Despite the CONSORT guidelines, reporting of outcomes and effect sizes is still insufficient. This hampers evidence‐based and shared decision‐making.
Inadequate reporting limits information to patients
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Background
The complications discussed with patients by surgeons prior to surgery vary, because no consensus on major complications exists. Such consensus may improve informed consent and shared ...decision-making. This study aimed to achieve consensus among vascular surgeons on which complications are considered ‘major’ and which ‘minor,’ following surgery for abdominal aortic aneurysm (AAA), carotid artery disease (CAD) and peripheral artery disease (PAD).
Methods
Complications following vascular surgery were extracted from Cochrane reviews, national guidelines, and reporting standards. Vascular surgeons from Europe and North America rated complications as major or minor on five-point Likert scales via an electronic Delphi method. Consensus was reached if ≥ 80% of participants scored 1 or 2 (minor) or 4 or 5 (major).
Results
Participants reached consensus on 9–12 major and 6–10 minor complications per disease. Myocardial infarction, stroke, renal failure and allergic reactions were considered to be major complications of all three diseases. All other major complications were treatment specific or dependent on disease severity, e.g., spinal cord ischemia, rupture following AAA repair, stroke for CAD or deep wound infection for PAD.
Conclusion
Vascular surgeons reached international consensus on major and minor complications following AAA, CAD and PAD treatment. This consensus may be helpful in harmonizing the information patients receive and improving standardization of the informed consent procedure. Since major complications differed between diseases, consensus on disease-specific complications to be discussed with patients is necessary.
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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
To compare CollaboRATE and SDM-Q-9 questionnaires when appreciating patient-perceived level of shared decision-making (SDM) in doctor-patient consultations.
Data were harvested from five separate ...studies on SDM, conducted in three university and one large community hospital in the Netherlands, using Dutch versions of both questionnaires.
CollaboRATE and SDM-Q-9 scores were expressed as percentages. Correlation was assessed using Spearman’s Rho coefficient. Bland&Altman analysis was used to assess the degree of agreement. Top scores were calculated to assess possible ceiling effects.
The five studies included 442 patients. Median CollaboRATE scores (88.9%, IQR 81.5–100%) were significantly higher (p < 0.001) than SDM-Q-9 scores (80.0%, IQR 64.4–100%). Correlation was moderate (Rho=0.53, p < 0.001). A systematic, 12.5-point higher score was found across the range of scores when using CollaboRATE. Top scores for CollaboRATE and SDM-Q-9 were present in 37.5% and 17% of questionnaires, respectively.
Overall, CollaboRATE and SDM-Q-9 questionnaires showed a high level of patient-perceived SDM. However, CollaboRATE only moderately correlated with SDM-Q-9 and had a stronger ceiling effect.
When choosing a SDM-measurement tool, its benefits and limitations should be weighed. These metrics should be combined with objective scores of SDM, as these may differ from the patients’ subjective interpretation.
•CollaboRATE and SDM-Q-9 are used to appreciate patient-reported levels of SDM.•However, both show different scores and ceiling effects, and correlate moderately.•Subjective and objective metrics should be used to score SDM in clinical practice.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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