Patient-reported effects of hospital-wide implementation of shared decision-making at a university medical centre in Germany: a pre-post trial.

OBJECTIVES: 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). DESIGN: Pre-post study. SETTING: University Hospital Schleswig-Holstein (UKSH), Kiel Campus. PARTICIPANTS: Healthcare professionals as well as inpatients and outpatients from 22 departments of the Kiel Campus of UKSH. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.

Challenges and Controversies in the Surgical Treatment of Cervical Cancer: Open Radical Hysterectomy versus Minimally Invasive Radical Hysterectomy.

OBJECTIVE: The aim of the study was to perform a systematic assessment of disease-free survival (DFS), overall survival, and morbidity rates after open radical hysterectomy (ORH) and minimally invasive surgery (MIS) for early-stage cervical cancer and discuss with experts the consequences of the LACC trial (published by Ramirez et al. in 2018) on clinical routine. METHODS: A total of 5428 records were retrieved. After exclusion based on text screening, four records were identified for inclusion. Five experts from three independent large-volume medical centers in Europe were interviewed for their interpretation of the LACC trial. RESULTS: The LACC trial showed a significantly higher risk of disease progression with MIS compared to ORH (HR 3.74, 95% CI 1.63 to 8.58). This was not seen in one epidemiological study and was contradicted by one prospective cohort study reported by Greggi et al. A systematic review by Zhang et al. mentioned a similar DFS for robot-assisted radical hysterectomy (RRH) and LRH. Recurrence rates were significantly higher with MIS compared to ORH in the LACC trial (HR 4.26, 95% CI 1.44 to 12.60). In contrast, four studies presented by Greggi reported no significant difference in recurrence rates between LRH/RRH and ORH, which concurred with the systematic reviews of Zhang and Zhao. The experts mentioned various limitations of the LACC trial and stated that clinicians were obliged to provide patients with detailed information and ensure a shared decision-making process. CONCLUSIONS: The surgical treatment of early-stage cervical cancer remains a debated issue. More randomized controlled trials (RCT) will be needed to establish the most suitable treatment for this condition.

[Shared decision making in breast care centres in North Rhine-Westphalia: results of a 10-year trend analysis]. / Shared Decision Making in Brustzentren in NRW: Ergebnisse einer 10-Jahres-Trendanalyse.

BACKGROUND: Although shared decision making (SDM) has been gaining importance in German health services for some time now, the state of its implementation is still unknown. The aim of this study was to provide a valid trend analysis for SDM in breast care centres in the German federal state of North Rhine-Westphalia (NRW) for a period of 10 years. METHODS: As part of an annual patient survey in breast care centres in NRW, two subscales of the Perceived Involvement in Care Scales (PICS) were used and analysed in multi-level models. RESULTS: Data from nearly 40,000 patients could be analysed with consistently high response rates. In the observation period from 2006 to 2015 doctor facilitation and patient involvement increased on a scale from 1 to 4 of 3.1 to 3.4 and 2.6 to 2.8, respectively. CONCLUSIONS: Despite the slight increases in the 10-year observation period a stable trend cannot be assumed. However, this study might be useful as a baseline for other studies on SDM implementation.

Patients' preferences in periodontal disease treatment elicited alongside an IQWiG benefit assessment: a feasibility study.

BACKGROUND AND PURPOSE: The German Institute for Quality and Efficiency in Health Care (IQWiG) previously tested two preference elicitation methods in pilot projects and regarded them as generally feasible for prioritizing outcome-specific results of benefit assessment. The present study aimed to investigate the feasibility of completing a discrete choice experiment (DCE) within 3 months and to determine the relative importance of attributes of periodontal disease and its treatment. PATIENTS AND METHODS: This preference elicitation was conducted alongside the IQWiG benefit assessment of systematic treatments of periodontal diseases. Attributes were defined based on the benefit assessment, literature review, and patients' and periodontologists' interviews. The DCE survey was completed by patients with a history of periodontal disease. Preferences were elicited for the attributes "tooth loss within next 10 years", "own costs for treatment, follow-up visits, re-treatment", "complaints and symptoms", and "frequency of follow-up visits". Patients completed a self-administered questionnaire including 12 choice tasks. Data were analyzed using a random parameters logit model. The relative attribute importance was calculated based on level ranges. RESULTS: Within 3 months, survey development, data collection among 267 patients, data analysis, and provision of a study report could be completed. The analysis showed that tooth loss (score 0.73) was the most important attribute in patients' decisions, followed by complaints and symptoms (0.22), frequency of follow-up visits (0.02), and costs (0.03) (relative importance scores summing up to 1). CONCLUSION: A preference analysis performing a DCE can be generally feasible within 3 months; however, a good research infrastructure and access to patients is required. Outcomes used in benefit assessments might need to be adapted to be used in preference analyses.

Benefits and harms of screening for and treatment of asymptomatic bacteriuria in pregnancy: a systematic review.

BACKGROUND: Most European and North American clinical practice guidelines recommend screening for asymptomatic bacteriuria (ASB) as a routine pregnancy test. Antibiotic treatment of ASB in pregnant women is supposed to reduce maternal upper urinary tract infections (upper UTIs) and preterm labour. However, most studies supporting the treatment of ASB were conducted in the 1950s to 1980s. Because of subsequent changes in treatment options for ASB and UTI, the applicability of findings from these studies has come into question. Our systematic review had three objectives: firstly, to assess the patient-relevant benefits and harms of screening for ASB versus no screening; secondly, to compare the benefits and harms of different screening strategies; and thirdly, in case no reliable evidence on the overarching screening question was identified, to determine the benefits and harms of treatment of ASB. METHODS: We systematically searched several bibliographic databases, trial registries, and other sources (up to 02/2016) for randomised controlled trials (RCTs) and prospective non-randomised trials. Two authors independently reviewed abstracts and full-text articles and assessed the risk of bias of the studies included. As meta-analyses were not possible, we summarised the results qualitatively. RESULTS: We did not identify any eligible studies that investigated the benefits and harms of screening for ASB versus no screening or that compared different screening strategies. We identified four RCTs comparing antibiotics with no treatment or placebo in 454 pregnant women with ASB. The results of 2 studies published in the 1960s showed a statistically significant reduction in rates of pyelonephritis (odds ratio [OR] = 0.21, 95 % confidence interval [CI] 0.07-0.59) and lower UTI (OR = 0.10, 95 % CI 0.03-0.35) in women treated with antibiotics. By contrast, event rates reported by a recent study were not statistically significantly different, neither regarding pyelonephritis (0 % vs. 2.2 %; OR = 0.37, CI 0.01-9.25, p = 0.515) nor regarding lower UTI during pregnancy (10 % vs. 18 %; Peto odds ratio [POR] = 0.53, CI 0.16-1.79, p = 0.357). Data were insufficient to determine the risk of harms. As three of the four studies were conducted several decades ago and have serious methodological shortcomings, the applicability of their findings to current health care settings is likely to be low. The recent high-quality RCT was stopped early due to a very low number of primary outcome events, a composite of preterm delivery and pyelonephritis. Therefore, the results did not show a benefit of treating ASB. CONCLUSIONS: To date, no reliable evidence supports routine screening for ASB in pregnant women.

The role of PET and PET-CT scanning in assessing response to neoadjuvant therapy in esophageal carcinoma.

BACKGROUND: The response to neoadjuvant (radio-)chemotherapy for esophageal carcinoma is often assessed with the aid of positron-emission tomography (PET), either alone or in combination with computed tomography (PET-CT). In this review, we discuss the diagnostic validity and clinical benefit of these imaging techniques. METHODS: We systematically searched the Medline, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing PET-CT with conventional techniques such as endosonography and CT. We then determined the diagnostic validity of these methods on the basis of information from published systematic reviews, updated with further information from more recent primary studies. RESULTS: We did not find any RCTs that addressed the question of the patient-relevant benefit of PET-CT. We found 20 studies of diagnostic methods, carried out on a total of 854 patients, of whom 82.2% were male. These studies had a high potential for bias. In two of them, PET-CT was directly compared with endosonography or CT. Estimates of sensitivity and specificity varied widely across studies. 54% of all patients (median value across studies) had no histopathological response to therapy at the end of treatment. Taking a reduction of the standard uptake value (SUV) by at least 35% as a threshold criterion, we found that the median negative predictive value of PET across all studies was 86.5. CONCLUSION: There is no robust evidence for a patient-relevant benefit of PET and PET-CT in patients with esophageal carcinoma. PET could potentially be used to distinguish treatment responders from non-responders after the first cycle of treatment. RCTs with patient-relevant endpoints will be needed in order to determine whether this is useful.

A descriptive review on methods to prioritize outcomes in a health care context.

BACKGROUND: Evidence synthesis has seen major methodological advances in reducing uncertainty and estimating the sizes of the effects. Much less is known about how to assess the relative value of different outcomes. OBJECTIVE: To identify studies that assessed preferences for outcomes in health conditions. SEARCH STRATEGY: we searched MEDLINE, EMBASE, PsycINFO and the Cochrane Library in February 2014. INCLUSION CRITERIA: eligible studies investigated preferences of patients, family members, the general population or healthcare professionals for health outcomes. The intention of this review was to include studies which focus on theoretical alternatives; studies which assessed preferences for distinct treatments were excluded. DATA EXTRACTION: study characteristics as study objective, health condition, participants, elicitation method, and outcomes assessed in the study were extracted. MAIN RESULTS: One hundred and twenty-four studies were identified and categorized into four groups: (1) multi criteria decision analysis (MCDA) (n = 71), (2) rating or ranking (n = 25), (3) utility eliciting (n = 5) and (4) studies comparing different methods (n = 23). The number of outcomes assessed by method group varied. The comparison of different methods or subgroups within one study often resulted in different hierarchies of outcomes. CONCLUSIONS: A dominant method most suitable for application in evidence syntheses was not identified. As preferences of patients differ from those of other stakeholders (especially medical professionals), the choice of the group to be questioned is consequential. Further research needs to focus on validity and applicability of the identified methods.

F-18-fluoro-2-deoxyglucose positron emission tomography (PET) and PET/computed tomography imaging in primary staging of patients with malignant melanoma: a systematic review.

PURPOSE: The aim of this systematic review was to systematically assess the potential patient-relevant benefit (primary aim) and diagnostic and prognostic accuracy (secondary aim) of positron emission tomography (PET) and PET/computed tomography (CT) in primary staging of malignant melanoma. This systematic review updates the previous evidence for PET(/CT) in malignant melanoma. MATERIALS AND METHODS: For the first aim, randomized controlled trials (RCTs) investigating patient-relevant outcomes and comparing PET and PET(/CT) with each other or with conventional imaging were considered. For the secondary aim, a review of reviews was conducted, which was amended by an update search for primary studies. MEDLINE, EMBASE and four databases of the Cochrane Library were searched. The risk of bias was assessed using a modified QUADAS tool. RESULTS: No RCTs investigating the patient-relevant benefit of PET(/CT) and no prognostic accuracy studies were found. Seventeen diagnostic accuracy studies of varying quality were identified. For patients with American Joint Committee on Cancer (AJCC) stages I and II, sensitivity mostly ranged from 0 to 67%. Specificity ranged from 77 to 100%. For AJCC stages III and IV, sensitivity ranged from 68 to 87% and specificity from 92 to 98%. CONCLUSION: There is currently no evidence of a patient-relevant benefit of PET(/CT) in the primary staging of malignant melanoma. RCTs investigating patient-relevant outcomes are therefore required. The diagnostic accuracy of PET(/CT) appears to increase with higher AJCC stages.

Randomized controlled trials on PET: a systematic review of topics, design, and quality.

UNLABELLED: Randomized controlled trials (RCTs) add important information to diagnostic accuracy studies in the evaluation of PET and PET/CT. We evaluated how many RCTs on PET existed, which clinical topics they addressed, and what their design and quality were. METHODS: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (Clinical Trials) up to August 2010. We also searched in ClinicalTrials.gov and the International Clinical Trials Registry Platform for ongoing RCTs up to March 2011. Titles and abstracts and full texts were screened independently by 2 reviewers. Study characteristics were extracted with standard extraction sheets for ongoing and published RCTs, and risk of bias was assessed for published ones. RESULTS: We identified 54 RCTs, 12 of which were published. The main topics in published studies were non-small cell lung cancer and colorectal cancer; only 3 were conducted in nononcologic fields (this trend was similar in ongoing studies, in which the most common topic was Hodgkin disease). The main indications in the oncologic PET studies were staging in published studies and restaging (mostly including an early assessment of treatment response) in ongoing ones. All except 1 of the published studies applied a marker-based strategy design, whereas about 43% (18/42) of ongoing studies use a more efficient design (Enrichment Design or Marker by Treatment Interaction Design). CONCLUSION: A relatively high number of ongoing RCTs of PET in several oncologic fields are expected to produce robust results over the next few years. For nononcologic topics, further high-quality studies are still needed to ascertain the benefit of this technique for patients. As funding is usually difficult in nondrug topics, alternative concepts of funding, which should also involve the manufacturers of diagnostic devices, but also more efficient study designs, should be applied to bridge the evidence gap on PET in the near future.

Turning signals into meaning--'shared decision making' meets communication theory.

Shared decision making (SDM) is being increasingly challenged for promoting an innovative role model while adhering to an archaic approach to patient-clinician communication, both in clinical practice and the research field. Too often, SDM has been studied at the individual level, which ignores the interpersonal system between patients and physicians. We aimed to encourage debate by reflecting on the essentials of SDM in terms of epistemology. We operationalized the SDM core concept of information exchange in terms of social systems theory. An epistemological analysis of the term information refers to its inherent process character. Exchange of information thereby becomes synonymous with social sense construction, indicating that, rather than just being a vehicle, the act of communication itself is the information. We plead for the adoption of existing dyadic analytical methods such as those offered by the interpersonal paradigm. Implications of an updated concept of information for the use of SDM-evaluation methods, for SDM-goal setting, and for clinical practice of SDM are described.

Choosing health technology assessment and systematic review topics: the development of priority-setting criteria for patients' and consumers' interests.

BACKGROUND: The Institute for Quality and Efficiency in Health Care (IQWiG) was established in 2003 by the German parliament. Its legislative responsibilities are health technology assessment, mostly to support policy making and reimbursement decisions. It also has a mandate to serve patients' interests directly, by assessing and communicating evidence for the general public. OBJECTIVES: To develop a priority-setting framework based on the interests of patients and the general public. METHODS: A theoretical framework for priority setting from a patient/consumer perspective was developed. The process of development began with a poll to determine level of lay and health professional interest in the conclusions of 124 systematic reviews (194 responses). Data sources to identify patients' and consumers' information needs and interests were identified. RESULTS: IQWiG's theoretical framework encompasses criteria for quality of evidence and interest, as well as being explicit about editorial considerations, including potential for harm. Dimensions of "patient interest" were identified, such as patients' concerns, information seeking, and use. Rather than being a single item capable of measurement by one means, the concept of "patients' interests" requires consideration of data and opinions from various sources. CONCLUSIONS: The best evidence to communicate to patients/consumers is right, relevant and likely to be considered interesting and/or important to the people affected. What is likely to be interesting for the community generally is sufficient evidence for a concrete conclusion, in a common condition. More research is needed on characteristics of information that interest patients and consumers, methods of evaluating the effectiveness of priority setting, and methods to determine priorities for disinvestment.

Population-based screening of children for specific speech and language impairment in Germany: a systematic review.

OBJECTIVE: The study was aimed at evaluating the effectiveness of a systematic population-based screening programme for specific language impairment (SLI) in preschool children in Germany. METHODS: The study question was divided into a review of (1) evidence from studies evaluating screening programmes, (2) diagnostic instruments in the German language, and (3) studies evaluating speech and language interventions. A systematic database search was conducted between June and October 2007 and was updated in January and again in May 2008. Relevant studies were identified by 2 independent reviewers based on screened titles/abstracts and full texts. RESULTS: 4,806 studies were screened. The only existing controlled screening study did not provide data for SLI. No diagnostic study met the inclusion criteria. Sixteen randomized intervention studies were included, 3 studies contributed to the appraisal of earlier against later initiation of treatment. Most studies were of limited quality. We found indications of short-term positive effects from language therapies in children with SLI. Long-term outcomes were not investigated. No evidence supporting the advantage of earlier treatment initiation was identified. CONCLUSIONS: The benefit of population-based language screening of preschool children with SLI is not proven. Controlled screening studies are therefore necessary. For Germany, the accuracy of existing diagnostic instruments has not yet been sufficiently examined.

[Shared decision-making and communication theory: grounding the tango]. / Shared Decision-Making und Kommunikationstheorie: "Grounding the tango"

Shared decision-making (SDM) has the potential to overcome outdated social role models in the health care system. The concept, however, adheres to archaic epistemological assumptions as can be inferred from the rudimentary stage of the measurement methods used and from the information monopoly that the physician still holds in this concept. Advantages of an up-to-date model of knowledge for understanding and operationalising SDM are outlined. To this purpose, essential definitions of the concept are reflected in terms of epistemology. Accordingly, information emerges through a process of social construction. Likewise, interpersonal relations do not represent a static condition; rather, they develop anew with each interaction. Therefore, constructs suitable to focus on dyadic interaction processes can be used as indicators of sharing in SDM. Theories and methods of the interpersonal paradigm are advocated.

[Patient participation in defining and assigning importance to treatment outcomes--status quo and potential developments]. / Patientenpartizipation bei Festlegung und Gewichtung von Behandlungszielen--Status quo und Entwicklungspotenziale.

In health care, patient participation takes place on different levels. This article gives two examples of possible patient involvement on the micro level (evidence-based patient information and shared decision making) and, as examples for the macro level, a description of the opportunities for patient participation in decision making processes of the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care in Germany (IQWiG). Future possibilities to enhance patient participation on the micro level include more rigorous evaluation of patient information and decision aids. The involvement of professional caregivers in the development of these tools might improve their use in health care. On the macro level, participation of patients in decision making should be further established (e.g., by increasing their resources). The involvement of patients in the weighting of patient-important outcomes before health technology assessment takes place could be a further enhancement.

[Shared decision-making as a new quality indicator in nephrology: a nationwide survey in Germany]. / Partizipative Entscheidungsfindung als neuer Qualitätsindikator in der Nephrologie Eine bundesweite empirische Untersuchung.

BACKGROUND AND PURPOSE: Shared decision-making (SDM) as a model in physician-patient interaction is gaining relevance in the German health system. By applying this model, mid- and long-term improvements are expected especially in the outcomes of chronic diseases. Up to now, there has hardly been any empirical data available in German health services research regarding the state and development of SDM. This study establishes a baseline and provides actual data on this subject based on a German-wide survey of end-stage renal disease (ESRD) patients. METHODS: Standardized German-wide survey of 6,614 patients with ESRD. The questionnaire included an instrument to measure the patients' perceived involvement in care (PICS) which had been translated and validated before. RESULTS: 82% of the questioned patients feel their physicians facilitated involvement in decision making. 81% of the patients actively inform themselves concerning their disease and treatment options. 69% state that SDM has taken place. Age, years on dialysis and gender correlate with perceived involvement. CONCLUSION: This paper provides a valid baseline for the prospective research of SDM in ESRD. The results indicate that dialysis patients are willing to participate in the process of medical decision-making. Characteristics and preferences of the patients should be taken into account not only in everyday clinical interactions. They could be monitored systematically within the framework of quality management and used as potential for quality improvement.