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Background -- The definition of population-specific outcomes is an essential precondition for the implementation of value-based health care. We developed a minimum standard outcome set for overall adult health (OAH) to facilitate the implementation of value-based health care in tracking, comparing, and improving overall health care outcomes of adults across multiple conditions, which would be of particular relevance for primary care and public health populations. Methods -- The International Consortium for Health Outcomes Measurement (ICHOM) convened an international panel (patients, clinicians, and topic experts). Following the development of a conceptual framework, a modified Delphi method (supported by public consultations) was implemented to identify, in sequence, the relevant domains, the best instruments for measuring them, the timing of measurement, and the relevant adjustment variables. Findings -- Outcomes were identified in relation to overall health status and the domains of physical, mental, and social health. Three instruments covering these domains were identified: PROMIS Scale v1.2—Global Health (10 items), WHO Wellbeing Index (5 items), and the WHO Disability Assessment Schedule 2.0 (12 items). Case-mix variables included a range of sociodemographic and biometric measures. Yearly measurement was proposed for all outcomes and most case-mix variables. Interpretation -- The ICHOM OAH Standard Set has been developed through consensus-based methods based on predefined criteria following high standards for the identification and selection of high-quality measures The involvements of a wide range of stakeholders supports the acceptability of the set, which is readily available for use and feasibility testing in clinical settings.

Introduction and hypothesis Standardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB). Methods The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input. Results The standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included. Conclusions The standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research. Electronic supplementary material The online version of this article (10.1007/s00192-017-3481-6) contains supplementary material, which is available to authorized users.

In lung cancer, outcome measurement has been mostly limited to survival. Proper assessment of the value of lung cancer treatments, and the performance of institutions delivering care, requires more comprehensive measurement of standardised outcomes. The International Consortium for Health Outcomes Measurement convened an international, multidisciplinary working group of patient representatives, medical oncologists, surgeons, radiation oncologists, pulmonologists, palliative care specialists, registry experts and specialist nurses to review existing data and practices. Using a modified Delphi method, the group developed a consensus recommendation (“the set”) on the outcomes most essential to track for patients with lung cancer, along with baseline demographic, clinical and tumour characteristics (case-mix variables) for risk adjustment. The set applies to patients diagnosed with nonsmall cell lung cancer and small cell lung cancer. Our working group recommends the collection of the following outcomes: survival, complications during or within 6 months of treatment and patient-reported domains of health-related quality of life including pain, fatigue, cough and dyspnoea. Case-mix variables were defined to improve interpretation of comparisons. We defined an international consensus recommendation of the most important outcomes for lung cancer patients, along with relevant case-mix variables, and are working to support adoption and reporting of these measures globally., ICHOM Lung Cancer Standard Set of patient-centred outcomes: aligning global efforts to improve lung cancer care http://ow.ly/bFDR300EhY7

Purpose National initiatives, such as the UK Improving Access to Psychological Therapies program (IAPT), demonstrate the feasibility of conducting empirical mental health assessments on a large scale, and similar initiatives exist in other countries. However, there is a lack of international consensus on which outcome domains are most salient to monitor treatment progress and how they should be measured. The aim of this project was to propose (1) an essential set of outcome domains relevant across countries and cultures, (2) a set of easily accessible patient-reported instruments, and (3) a psychometric approach to make scores from different instruments comparable. Methods Twenty-four experts, including ten health outcomes researchers, ten clinical experts from all continents, two patient advocates, and two ICHOM coordinators worked for seven months in a consensus building exercise to develop recommendations based on existing evidence using a structured consensus-driven modified Delphi technique. Results The group proposes to combine an assessment of potential outcome predictors at baseline (47 items: demographics, functional, clinical status, etc.), with repeated assessments of disease-specific symptoms during the treatment process (19 items: symptoms, side effects, etc.), and a comprehensive annual assessment of broader treatment outcomes (45 items: remission, absenteeism, etc.). Further, it is suggested reporting disease-specific symptoms for depression and anxiety on a standardized metric to increase comparability with other legacy instruments. All recommended instruments are provided online (www.ichom.org). Conclusion An international standard of health outcomes assessment has the potential to improve clinical decision making, enhance health care for the benefit of patients, and facilitate scientific knowledge. Electronic supplementary material The online version of this article (doi:10.1007/s11136-017-1659-5) contains supplementary material, which is available to authorized users.

Importance Global health systems are shifting toward value-based care in an effort to drive better outcomes in the setting of rising health care costs. This shift requires a common definition of value, starting with the outcomes that matter most to patients. Objective The International Consortium for Health Outcomes Measurement (ICHOM), a nonprofit initiative, was formed to define standard sets of outcomes by medical condition. In this article, we report the efforts of ICHOM’s working group in colorectal cancer. Evidence Review The working group was composed of multidisciplinary oncology specialists in medicine, surgery, radiation therapy, palliative care, nursing, and pathology, along with patient representatives. Through a modified Delphi process during 8 months (July 8, 2015 to February 29, 2016), ICHOM led the working group to a consensus on a final recommended standard set. The process was supported by a systematic PubMed literature review (1042 randomized clinical trials and guidelines from June 3, 2005, to June 3, 2015), a patient focus group (11 patients with early and metastatic colorectal cancer convened during a teleconference in August 2015), and a patient validation survey (among 276 patients with and survivors of colorectal cancer between October 15, 2015, and November 4, 2015). Findings After consolidating findings of the literature review and focus group meeting, a list of 40 outcomes was presented to the WG and underwent voting. The final recommendation includes outcomes in the following categories: survival and disease control, disutility of care, degree of health, and quality of death. Selected case-mix factors were recommended to be collected at baseline to facilitate comparison of results across treatments and health care professionals. Conclusions A standardized set of patient-centered outcome measures to inform value-based health care in colorectal cancer was developed. Pilot efforts are under way to measure the standard set among members of the working group.

A major challenge in value-based health care is the lack of standardized health outcomes measurements, hindering optimal monitoring and comparison of the quality of health care across different settings globally. The International Consortium for Health Outcomes Measurement (ICHOM) assembled a multidisciplinary international working group, comprised of 26 health care providers and patient advocates, to develop a standard set of value-based patient-centered outcomes for breast cancer (BC). The working group convened via 8 teleconferences and completed a follow-up survey after each meeting. A modified 2-round Delphi method was used to achieve consensus on the outcomes and case-mix variables to be included. Patient focus group meetings (8 early or metastatic BC patients) and online anonymized surveys of 1225 multinational BC patients and survivors were also conducted to obtain patients' input. The standard set encompasses survival and cancer control, and disutility of care (eg, acute treatment complications) outcomes, to be collected through administrative data and/or clinical records. A combination of multiple patient-reported outcomes measurement (PROM) tools is recommended to capture long-term degree of health outcomes. Selected case-mix factors were recommended to be collected at baseline. The ICHOM will endeavor to achieve wide buy-in of this set and facilitate its implementation in routine clinical practice in various settings and institutions worldwide.

We read with interest the comments by MacLennan and colleagues regarding our recent paper [1] outlining a standard set of outcomes we recommend collecting for all men treated with curative intent for prostate cancer. A stated goal of our project was to define a minimum set of outcomes for widespread prospective collection outside of clinical trials, with a focus on what matters to patients. All project members were identified on the basis of their expertise, and the two patient representatives were identified from separate prostate cancer survivorship and advocacy communities. Both had broad experience in representing communities of patients. We are unaware of established data supporting a specific proportion of patients in such a process and whether two were sufficient could be argued. However, both patients were treated equally in the group and provided clear and unique direction, particularly in the prioritization of outcome domains important to patients. For each element of the standard set, a proposal based on a review of the literature was presented to the group to provide evidence for inclusion or exclusion of an outcome, case-mix domain, or their corresponding definition. For patient-reported outcomes, we required tools that could be used across treatment options. Then, according to prioritization by working group members for assessing urinary incontinence, bowel irritation, sexual function, urinary obstruction, and urinary irritation, a range of tools were assessed, including the EORTC PR 25, FACT-P, EPIC, and a tool developed internally at MSKCC. Available information on psychometric properties could not identify one with clear advantages over another. The EPIC was chosen because of its preferred subscale scoring that matched the desired outcome domains of the working group. For clinical outcomes, we attempted to describe with specificity how each should be collected to allow for reliability across centers. As MacLennan and colleagues comment regarding prostate-specific antigen (PSA) for example, we agree that not only is there heterogeneity in testing methodologies, but we also anticipate that definitions of biochemical recurrence will continue to evolve. We suggest the two most common definitions in use today for surgery and radiation, but recommend that ‘‘PSA is measured at least annually and providers record all PSA values and dates’’ to allow for future flexibility. Additional details are provided in the extended data dictionary (www. ichom.org/medical-conditions/localized-prostate-cancer). All such points of discussion were reviewed during the six teleconferences, with feedback elicited from every participating member, including patients. Each outcome, case-mix factor, and domain definition was voted on independently via an anonymous electronic survey, with all members having equal weight. The authors’ work on core outcome sets for clinical trials appears well aligned with work by the National Cancer Institute [2] and we agree is complementary to our effort to collect these data outside the structure of clinical trials. We share the authors’ view that the patient’s voice is crucial. Importantly, implementation of any outcome set is key for testing and improvement. Today, with support from the Movember Foundation, the standard set is being implemented across multiple national registries and institutions. Their combined experience will contribute to continued refinement of the recommendations.

Background: Value-based health care has been proposed as a unifying force to drive improved outcomes and cost containment. Objective: To develop a standard set of multidimensional patient-centered health outcomes for tracking, comparing, and improving localized prostate cancer (PCa) treatment value. Design, setting, and participants: We convened an international working group of patients, registry experts, urologists, and radiation oncologists to review existing data and practices. Outcome measurements and statistical analysisThe group defined a recommended standard set representing who should be tracked, what should be measured and at what time points, and what data are necessary to make meaningful comparisons. Using a modified Delphi method over a series of teleconferences, the group reached consensus for the Standard Set. Results and limitations: We recommend that the Standard Set apply to men with newly diagnosed localized PCa treated with active surveillance, surgery, radiation, or other methods. The Standard Set includes acute toxicities occurring within 6 mo of treatment as well as patient-reported outcomes tracked regularly out to 10 yr. Patient-reported domains of urinary incontinence and irritation, bowel symptoms, sexual symptoms, and hormonal symptoms are included, and the recommended measurement tool is the Expanded Prostate Cancer Index Composite Short Form. Disease control outcomes include overall, cause-specific, metastasis-free, and biochemical relapse-free survival. Baseline clinical, pathologic, and comorbidity information is included to improve the interpretability of comparisons. Conclusions: We have defined a simple, easily implemented set of outcomes that we believe should be measured in all men with localized PCa as a crucial first step in improving the value of care. Patient summary: Measuring, reporting, and comparing identical outcomes across treatments and treatment centers will provide patients and providers with information to make informed treatment decisions. We defined a set of outcomes that we recommend being tracked for every man being treated for localized prostate cancer.

Background and purpose - Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set.Patients and methods - An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions.Results - Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on preexisting tools.Interpretation - The outcome measures recommended here are structured around specific etiologies of LBP, span a patient's entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver.

753 Background: While there are tools to measure outcomes relevant to patients with colorectal cancer, none is universally accepted and none incorporates components of long-term clinical outcomes, acute complications, and patient-reported outcomes (PROs). Methods: The International Consortium for Health Outcomes Measurement convened an international multidisciplinary working group to develop a comprehensive patient-centered outcome measurement set for patients with all stages of colorectal cancer. The working group utilized a literature review, patient focus group and their own clinical expertise to reach consensus on outcomes and case mix factors through a modified Delphi process. Measurement tools were selected by International Society of Quality of Life Research standards. The final list of PROs was validated through a patient survey. Results: The 29 members of the working group included patient representatives and palliative care, nursing, pathology, medical oncology, colorectal surgery and radiation oncology specialists from academic and nonacademic practices in Europe, Australia, Asia and the USA. The international focus group included 11 patients with colorectal cancer treated with palliative and curative intents. The working group defined four clinical outcomes applicable to all and eight specific to subgroups, such as presence of ostomy for patients with rectal cancer and hospital admission in the last 30 days of life for patients with advanced disease. An algorithm for documenting acute complications was developed. The working group defined 11 PROs applicable to all and eight specific to subgroups, such as erectile dysfunction for patients who received radiotherapy/surgery and neuropathy for those who received chemotherapy. 276 colorectal cancer patients completed the validation survey. Conclusions: Through use of extensive patient input, the international multidisciplinary group developed a patient-centered outcome measurement set incorporating clinical outcomes, acute complications and PROs for patients with colorectal cancer. This comprehensive measurement set allows for standardized international comparison on quality of care outcomes and will be revised annually.

271 Background: The prospective collection of standardized, patient-centered outcomes for men with prostate cancer will allow intra- and inter-institutional comparisons, patient education, self-assessment and dissemination of best practices. We lack recommended standardized sets of such outcomes. Methods: Through the International Consortium for Health Outcomes Measurement, a working group of urologists, radiation oncologists, registry representatives and patient advocates convened to develop a recommended minimum set of measures which institutions would collect on all prostate patients. Using a modified Delphi method over a series of in-person meetings and conference calls, a final set of recommendations was developed. Results: Approximately 30 experts in prostate cancer care from North America, Europe, Australia, and the Middle East participated in the process, representing academic centers, registries and patients. We defined the scope of this initial effort as outcomes related to the management of localized prostate cancer. The group recommended cross-disciplinary measures applicable to a variety of treatment approaches from surveillance to radiation and prostatectomy. Standards were identified for disease control definitions as well as baseline patient and disease-specific risk stratification factors. Domains of patient reported outcomes to be tracked in follow up were identified including urinary incontinence, urinary irritation, bowel irritation, sexual function, and symptoms related to hormonal therapy. Finally, specific tools to assess these domains and gaps in our current tools were identified. The final recommended set will be presented. Conclusions: Standardized outcome reporting is a necessary component in the movement towards high-value health care. Patient-centered outcomes related to toxicity and disease control can be identified and systemized by a multidisciplinary group of experts. The result of this project is an initial step in what will be an iterative process with the goal of improving the care of all men with prostate cancer. An international pilot project has been proposed based on implementing the final set of recommendations.