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General Guidance for Selecting PROs for Research Studies

Reeve BB, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013; 22(8):1889-1905. PMID: 23288613

ABSTRACT: PURPOSE: An essential aspect of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) is the integration of patient perspectives and experiences with clinical data to evaluate interventions. Thus, PCOR and CER require capturing patient-reported outcome (PRO) data appropriately to inform research, healthcare delivery, and policy. This initiative’s goal was to identify minimum standards for the design and selection of a PRO measure for use in PCOR and CER. METHODS: We performed a literature review to find existing guidelines for the selection of PRO measures. We also conducted an online survey of the International Society for Quality of Life Research (ISOQOL) membership to solicit input on PRO standards. A standard was designated as “recommended” when >50 % respondents endorsed it as “required as a minimum standard.” RESULTS: The literature review identified 387 articles. Survey response rate was 120 of 506 ISOQOL members. The respondents had an average of 15 years experience in PRO research, and 89 % felt competent or very competent providing feedback. Final recommendations for PRO measure standards included: documentation of the conceptual and measurement model; evidence for reliability, validity (content validity, construct validity, responsiveness); interpretability of scores; quality translation, and acceptable patient and investigator burden. CONCLUSION: The development of these minimum measurement standards is intended to promote the appropriate use of PRO measures to inform PCOR and CER, which in turn can improve the effectiveness and efficiency of healthcare delivery. A next step is to expand these minimum standards to identify best practices for selecting decision-relevant PRO measures.

Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN)

The COSMIN initiative aims to improve the selection of health measurement instruments. As part of this initiative, the COSMIN group developed a critical appraisal tool (a checklist) containing standards for evaluating the methodological quality of studies on the measurement properties of health measurement instruments. The COSMIN checklist was developed in an international Delphi study as a multidisciplinary, international collaboration with all relevant expertise involved. The focus was on Health-Related Patient-Reported Outcomes (HR-PROs), but the checklist is also useful for evaluating studies on other kind of health measurement instruments, such as performance-based tests or clinical rating scales. The COSMIN checklist can be used to evaluate the methodological quality of studies on measurement properties, for example in systematic reviews of measurement properties. In systematic reviews it is important to take the methodological quality of the selected studies into account. If the results of high quality studies differ from the results of low quality studies, this can be an indication of bias. The COSMIN checklist can also be used as a guidance for designing or reporting a study on measurement properties. Students can use the COSMIN checklist when learning about measurement properties. Reviewers or editors of journals can use the COSMIN checklist to appraise the methodological quality of submitted studies on measurement properties and to check whether all important design aspects and statistical methods have been clearly reported.

Topic-Specific Instrument Reviews

Symptoms and Health-Related Quality of Life

Reeve BB et al. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. Journal of the National Cancer Institute. 2014; 106(7):1-8. PMID: 25006191.

ABSTRACT: BACKGROUND: The National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). METHODS: We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001–2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. RESULTS: We recommend that a core set of 12 symptoms—specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea—be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. CONCLUSIONS: This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies.

Basch E et al. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol. 2012; 30(34):4249-55. PMID: 23071244.

ABSTRACT: Examining the patient’s subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.

Distress and Anxiety

Luckett, T et al. A review and recommendations for optimal outcome measures of anxiety, depression and general distress in studies evaluating psychosocial interventions for English-speaking adults with heterogeneous cancer diagnoses. Support Care Cancer. 2010; 18(10):1241-1262. PMID: 20596731.

ABSTRACT: OBJECTIVE: The objective of this paper is to inform choice of optimal patient-reported outcome measures (PROMs) of anxiety, depression and general distress for studies evaluating psychosocial interventions for English-speaking adults with heterogenous cancer diagnoses. METHODS: A systematic review was conducted to identify all PROMs used to assess anxiety, depression and general distress in randomised controlled trials (RCTs) of psychosocial interventions for people with cancer published between 1999 and May 2009. Candidate PROMs were evaluated for content, evidence of reliability and validity, clinical meaningfulness, comparison data, efficiency, ease of administration, cognitive burden and track record in identifying treatment effects in RCTs of psychosocial interventions. Property ratings were weighted and summed to give an overall score out of 100. RESULTS: The Hospital Anxiety and Depression Scale (HADS) scored highest overall (weighted score = 77.5), followed by the unofficial short-form of the Profile of Mood States (POMS), the POMS-37 (weighted score = 60), and the Centre for Epidemiological Studies Depression Scale (CES-D) and original POMS (weighted score = 55 each). CONCLUSIONS: The HADS’ efficiency and substantial track record recommend its use where anxiety, mixed affective disorders or general distress are outcomes of interest. However, continuing controversy concerning the HADS depression scale cautions against dependence where depressive disorders are of primary interest. Where cost is a concern, the POMS-37 is recommended to measure anxiety or mixed affective disorders but does not offer a suitable index of general distress and, like the HADS, emphasises anhedonia in measuring depression. Where depression is the sole focus, the CES-D is recommended.

Vodermaier, A, Linden, W, Siu, C. Screening for emotional distress in cancer patients: a systematic review of assessment instruments. J Natl Cancer Inst. 2009; 101(21):1464-1488. PMID: 19826136.

ABSTRACT: Screening for emotional distress is becoming increasingly common in cancer care. This systematic review examines the psychometric properties of the existing tools used to screen patients for emotional distress, with the goal of encouraging screening programs to use standardized tools that have strong psychometrics. Systematic searches of MEDLINE and PsycINFO databases for English-language studies in cancer patients were performed using a uniform set of key words (eg, depression, anxiety, screening, validation, and scale), and the retrieved studies were independently evaluated by two reviewers. Evaluation criteria included the number of validation studies, the number of participants, generalizability, reliability, the quality of the criterion measure, sensitivity, and specificity. The literature search yielded 106 validation studies that described a total of 33 screening measures. Many generic and cancer-specific scales satisfied a fairly high threshold of quality in terms of their psychometric properties and generalizability. Among the ultrashort measures (ie, those containing one to four items), the Combined Depression Questions performed best in patients receiving palliative care. Among the short measures (ie, those containing five to 20 items), the Center for Epidemiologic Studies-Depression Scale and the Hospital Anxiety and Depression Scale demonstrated adequate psychometric properties. Among the long measures (ie, those containing 21-50 items), the Beck Depression Inventory and the General Health Questionaire-28 met all evaluation criteria. The PsychoSocial Screen for Cancer, the Questionnaire on Stress in Cancer Patients-Revised, and the Rotterdam Symptom Checklist are long measures that can also be recommended for routine screening. In addition, other measures may be considered for specific indications or disease types. Some measures, particularly newly developed cancer-specific scales, require further validation against structured clinical interviews (the criterion standard for validation measures) before they can be recommended.

Ziegler, L et al. Identifying psychological distress at key stages of the cancer illness trajectory: a systematic review of validated self-report measures. J Pain Symptom Manage. 2011; 41(3):619-636. PMID: 21310585.

ABSTRACT: CONTEXT: To enable study of psychological distress along the cancer journey, we need to be able to select and map validated measures through the cancer trajectory. OBJECTIVES: To examine the performance of self-report measures for identifying clinically significant levels of psychological distress across the cancer patient trajectory. METHODS: Electronic searches of Medline, PsychInfo, CINAHL, EmBase, The Cochrane Library, AMED, BNI, ASSIA, and Web of Science were undertaken. Only studies of self-report measures that used validated diagnostic tools for psychiatric diagnosis as the criterion measure were included. We then further limited our focus to those papers that specified a trajectory stage. RESULTS: Forty-eight different self-report measures were reported in the 85 papers identified. The Hospital Anxiety and Depression Scale (HADS) was the most frequently reported measure (23 times). Several other measures were reported between two and four times, but most (37) measures were reported only once. Twenty-two of the 85 included papers reported measure performance by trajectory stage. Best performing measures based on validation data available could be identified for each trajectory stage: for pretreatment, the HADS for identifying depression; during treatment, the HADS and Mental Health Inventory-5 (MHI-5) together for identifying clinically significant distress; post-treatment, the HADS for identifying depression; and at recurrence and during the palliative phase, the Brief Edinburgh Depression Scale (BEDS) for identifying depression. CONCLUSION: No single measure had evidence to support use throughout the illness trajectory in a longitudinal study, but the HADS, in combination with the MHI-5, was supported during the cancer treatment phase, and BEDS in the palliative care phase.


Tomlinson, D et al. Psychometirc properties of instruments used to measure fatigue in children and adolescents with cancer: a systematic review. J Pain Symptom Manage. 2013; 45(1):83-91. PMID: 22889860.

ABSTRACT: CONTEXT: Despite the recognized distressing symptom of fatigue in children with cancer, little information is available to assist in the selection of an instrument to be used to measure fatigue. OBJECTIVES: The objectives of this study were to 1) describe the instruments that have been used to measure cancer-related fatigue in children and adolescents and 2) summarize the psychometric properties of the most commonly used instruments used to measure fatigue in children and adolescents with cancer. METHODS: Five major electronic databases were systematically searched for studies using a fatigue measurement scale in a population of children or adolescents with cancer. Fatigue scales used in those studies were included in the review. RESULTS: From a total of 1753 articles, 25 were included. We identified two main fatigue measurement instruments used in a pediatric oncology population: 1) the Fatigue Scale-Child/Fatigue Scale-Adolescent and the proxy report versions for parents and staff and 2) the PedsQL Multidimensional Fatigue Scale. These two scales show similar attributes with reasonably good internal consistency and responsiveness. CONCLUSION: Either the Fatigue Scale or PedsQL Multidimensional Fatigue Scale can be incorporated into clinical research. Future research should focus on identifying specific fatigue measures more suited to different purposes such as comparative trials or identification of high-risk groups.

Seyidova-Khoshknabi, D, Davis MP, Walsh, D. Review article: a systematic review of cancer-related fatigue measurement questionnaires. Am J Hosp Palliat Care. 2011; 28(2):119-129. PMID: 21051784.

ABSTRACT: PURPOSE: Cancer-related fatigue (CRF) is a common symptom experienced by patients in all stages and in cancer survivors. The main objectives of this review were to identify validated CRF instruments, and populations in whom these tools have been validated. METHODS: We used a systematic review methodology. Three separate searches were performed using different MeSH terms in Pub Med and Ovid databases. Articles were analyzed for validation and reliability. RESULTS: A total of 1453 papers from 3 different searches identified 40 instruments (3 unidimensional and 37 multidimensional). Instruments varied by psychometric properties, items, scale, dimension, cancer site, and population. Five were optimally tested for validity and reliability. Completion rates, sensitivity to change, and test-retest reliability were reported for a few. DISCUSSION: Most tools had been validated in mixed populations and are relatively insensitive to differences in fatigue to cancer stage. Most instruments are burdensome for those with advanced cancer. The Brief Fatigue Inventory and 3 fatigue items of the European Organization for Research and Treatment Quality of Life Questionnaire Fatigue Scale (EORTC QLQ-C30) are optimal instruments in advanced cancer. CONCLUSIONS: In all, 40 CRF instruments were identified. Validity and reliability varied by questionnaire. The ideal item numbers, scale, and domains are not established and may be population dependent.


Oliver, A, Galiana, L, Benito, E. Evaluation tools for spiritual support in end of life care: increasing evidence for their clinical application. Curr Opin Support Palliat Care. 2015; 9(4):357-360. PMID: 26509861.

ABSTRACT: PURPOSE OF REVIEW: To summarize current evidence on evaluation tools for spiritual care, paying special attention to recent validations and new instruments, systematic reviews, recent consensus on spiritual care and its measurement, plus other emergent topics. RECENT FINDINGS: The systematic review resulted in 45 identified studies, 14 of which were considered: five works addressed the need for development and validation of spiritual tools; three studies reviewed tools for spirituality assessment, interventions, or related concepts; three more covered the efforts to define guidelines and priorities for spiritual care and its measurement. Other topics such as pediatric spiritual care, the use of new technologies, or nationwide surveys, also arose. SUMMARY: Recent contributions outline usability traits such as to shorten scales and measurement protocols for maximum respect of patients’ quality of life. Other works addressed complicated grief or satisfaction with attention to spiritual care, transcending the patients, family and professionals’ focus in on a sort of combined perspective. Further attention to culturally based specific models supporting questionnaires, a deeper understanding of quality of the spiritual care, both for patients and families, or further research on the relation between spiritual care and life span should be welcomed.

Best, M et al. Assessment of spiritual suffering in the cancer context: A systematic literature review. Palliat Support Care. 2015; 13(5):1335-1361. PMID: 25386699.

ABSTRACT: OBJECTIVE: An important goal of cancer medicine is relief of patients’ suffering. In view of the clinical challenges of identifying suffering patients, we sought to identify valid instruments for assessing the spiritual suffering of people diagnosed with cancer. METHOD: A systematic review of the literature was conducted in the Medline, Embase, the Cochrane Library, and PsycINFO databases seeking assessment instruments that measure either suffering or one of its synonyms or symptoms. The psychometric properties of the identified measures were compared. RESULTS: A total of 90 articles were identified that supplied information about 58 measures. The constructs examined were: suffering, hopelessness/demoralization, hope, meaning, spiritual well-being, quality of life where a spiritual/existential dimension was included, distress in the palliative care setting and pain, distress or struggle of a spiritual nature. The Pictorial Representation of Illness and Self Measure (PRISM) (patient completed) was the most promising measure identified for measuring the burden of suffering caused by illness due to its ease of use and the inclusion of a subjective component. SIGNIFICANCE OF RESULTS: Although the appropriateness of any measure for the assessment of spiritual suffering in cancer patients will depend on the context in which it is intended to be utilized, the PRISM is promising for measuring the burden of suffering due to illness.

Selman, L et al. the measurement of spirituality in palliative care and the content of tools validated cross-culturally: a systematic review. J Pain Symptom Manage. 2011; 41(4):728-753. PMID: 21306866.

ABSTRACT: CONTEXT: Despite the need to assess spiritual outcomes in palliative care, little is known about the properties of the tools currently used to do so. In addition, measures of spirituality have been criticized in the literature for cultural bias, and it is unclear which tools have been validated cross-culturally. OBJECTIVES: This systematic review aimed to identify and categorize spiritual outcome measures validated in advanced cancer, human immunodeficiency virus (HIV), or palliative care populations; to assess the tools’ cross-cultural applicability; and for those measures validated cross-culturally, to determine and categorize the concepts used to measure spirituality. METHODS: Eight databases were searched to identify relevant validation and research studies. An extensive search strategy included search terms in three categories: palliative care, spirituality, and outcome measurement. Tools were evaluated according to two criteria: 1) validation in advanced cancer, HIV, or palliative care and 2) validation in an ethnically diverse context. Tools that met Criterion 1 were categorized by type; tools that also met Criterion 2 were subjected to content analysis to identify and categorize the spiritual concepts they use. RESULTS: One hundred ninety-one articles were identified, yielding 85 tools. Fifty different tools had been reported in research studies; however, 30 of these had not been validated in palliative care populations. Thirty-eight tools met Criterion 1: general multidimensional measures (n=21), functional measures (n=11), and substantive measures (n=6). Nine measures met Criterion 2; these used spiritual concepts relating to six themes: Beliefs, practices, and experiences; Relationships; Spiritual resources; Outlook on life/self; Outlook on death/dying; and Indicators of spiritual well-being. A conceptual model of spirituality is presented on the basis of the content analysis. Recommendations include consideration of both the clinical and cultural population in which spiritual instruments have been validated when selecting an appropriate measure for research purposes. Areas in need of further research are identified. CONCLUSION: The nine tools identified in this review are those that have currently been validated in cross-cultural palliative care populations and, subject to appraisal of their psychometric properties, may be suitable for cross-cultural research.

Selman, L et al. A psychometric evaluation of measures of spirituality validated in culturally diverse palliative care populations. J Pain Symptom Manage. 2011; 42(4):604-622. PMID: 21640549.

ABSTRACT: CONTEXT: Despite the need to accurately measure spiritual outcomes in diverse palliative care populations, little attention has been paid to the properties of the tools currently in use. OBJECTIVES: This systematic review aimed to appraise the psychometric properties, multifaith appropriateness, and completion time of spiritual outcome measures validated in multicultural advanced cancer, HIV, or palliative care populations. METHODS: Eight databases were searched to identify relevant validation and research studies. A comprehensive search strategy included search terms in three categories: palliative care, spirituality, and outcome measurement. Inclusion criteria were: validated in advanced cancer, HIV, or palliative care populations and in an ethnically diverse context. Included tools were evaluated with respect to psychometric properties (validity, reproducibility, responsiveness, and interpretability), multifaith appropriateness, and time to complete. RESULTS: A total of 191 articles were identified, yielding 85 tools. Twenty-six tools (representing four families of measures and five individual tools) met the inclusion criteria. Twenty-four tools demonstrated good content validity and 12 demonstrated adequate internal consistency. Only eight tools demonstrated adequate construct validity, usually because specific hypotheses were not stated and tested. Seven tools demonstrated adequate test-retest reliability; two tools showed adequate responsiveness, and two met the interpretability criterion. Data on the religious faith of the population of validation were available for 11 tools; of these, eight were tested in multifaith populations. CONCLUSION: Results suggest that, at present, the McGill Quality of Life Questionnaire, the Measuring the Quality of Life of Seriously Ill Patients Questionnaire, and the Palliative Outcome Scale are the most appropriate multidimensional measures containing spiritual items for use in multicultural palliative care populations. However, none of these measures score perfectly on all psychometric criteria, and their multifaith appropriateness requires further testing.


Huntley AL et al. Measures of multimorbidity and morbidity burden for use in primary care and community settings: a systematic review and guide. Ann Fam Med. 2012; 10(2):134-141. PMID: 22412005.

ABSTRACT: PURPOSE: Many patients consulting in primary care have multiple conditions (multimorbidity). Aims of this review were to identify measures of multimorbidity and morbidity burden suitable for use in research in primary care and community populations, and to investigate their validity in relation to anticipated associations with patient characteristics, process measures, and health outcomes. METHODS: Studies were identified using searches in MEDLINE and EMBASE from inception to December 2009 and bibliographies. RESULTS: Included were 194 articles describing 17 different measures. Commonly used measures included disease counts (n = 98), Chronic Disease Score (CDS)/RxRisk (n = 17), Adjusted Clinical Groups (ACG) System (n = 25), the Charlson index (n = 38), the Cumulative Index Illness Rating Scale (CIRS; n = 10) and the Duke Severity of Illness Checklist (DUSOI; n = 6). Studies that compared measures suggest their predictive validity for the same outcome differs only slightly. Evidence is strongest for the ACG System, Charlson index, or disease counts in relation to care utilization; for the ACG System in relation to costs; for Charlson index in relation to mortality; and for disease counts or Charlson index in relation to quality of life. Simple counts of diseases or medications perform almost as well as complex measures in predicting most outcomes. Combining measures can improve validity. CONCLUSIONS: The measures most commonly used in primary care and community settings are disease counts, Charlson index, ACG System, CIRS, CDS, and DUSOI. Different measures are most appropriate according to the outcome of interest. Choice of measure will also depend on the type of data available. More research is needed to directly compare performance of different measures.

Hospice and Palliative Care

Hanson, LC et al. The PEACE project review of clinical instruments for hospice and palliative care. J Palliat Med. 2010; 13(10)1253-1260. PMID: 20874234.

ABSTRACT: BACKGROUND: Hospice and palliative care organizations are expanding their use of standardized instruments and other approaches to measure quality. We undertook a systematic review and evaluation of published patient-level instruments for potential application in hospice and palliative care clinical quality measurement. METHODS: We searched prior reviews and computerized reference databases from 1990 through February 2007 for studies of instruments relevant to physical, psychological, social, cultural, spiritual, or ethical aspects of palliative care, or measuring prognosis, function or continuity of care. Publications were selected for full review if they provided evidence of psychometric properties or practical application of an instrument tested in or appropriate for a hospice or palliative care population. Selected instruments were evaluated and scored for scientific soundness and potential application in clinical quality measurement. RESULTS: The search found 1427 publications, with 229 selected for full manuscript review. Manuscripts provided information on 129 instruments which were evaluated using a structured scoring guide for psychometric properties. Thirty-nine instruments scoring near or above the 75th percentile were recommended. Most instruments covered multiple domains or focused on care for physical symptoms, psychological or social aspects of care. Few instruments were available to measure cultural aspects of care, structure and process of care, and continuity of care. CONCLUSION: Numerous patient-level instruments are available to measure physical, psychological and social aspects of palliative care with adequate evidence for scientific soundness and practical clinical use for quality improvement and research. Other aspects of palliative care may benefit from further instrument development research.

Albers, G et al. Evaluation of quality-of-life measures for use in palliative care: a systematic review. Palliat Med. 2010; 24(1)17-37. PMID: 19843620.

ABSTRACT: PURPOSE: In this literature review we evaluated the feasibility and clinimetric quality of quality-of-life (QoL) measurement instruments suitable for use in palliative care. METHODS: We conducted a systematic literature review to identify instruments measuring (at least one domain of) QoL. We selected articles that present data on patients receiving palliative care and at least one measurement property. A checklist was used to describe the characteristics of the instruments, and a widely accepted rating list was used to evaluate the clinimetric aspects. RESULTS: 29 instruments were identified and evaluated, most of which were targeted at palliative patients in general. None of the instruments demonstrated satisfactory results for all measurement properties. Fourteen instruments received positive ratings for construct validity. Thirteen instruments were tested for reliability, but only two were tested adequately and had positive results (ICC>0.70). Responsiveness was not tested adequately for any of the instruments. Very few of the studies provided information on the interpretation of the scores. Overall, the MQOL, followed by the QUAL-E and the QODD, received the best ratings for their measurement properties. CONCLUSIONS: Many measurement instruments were identified, but most had not yet been adequately evaluated. The evaluation of existing instruments with good content validity should have priority over the development of new instruments.

Shared Decision Making

Austin, CA et al. Tools to Promote Shared Decision Making in Serious Illness: A Systematic Review. JAMA Intern Med. 2015; 175(7):1213-1221. PMID: 25985438.

ABSTRACT: IMPORTANCE: Serious illness impairs function and threatens survival. Patients facing serious illness value shared decision making, yet few decision aids address the needs of this population. OBJECTIVE: To perform a systematic review of evidence about decision aids and other exportable tools that promote shared decision making in serious illness, thereby (1) identifying tools relevant to the treatment decisions of seriously ill patients and their caregivers, (2) evaluating the quality of evidence for these tools, and (3) summarizing their effect on outcomes and accessibility for clinicians. EVIDENCE REVIEW: We searched PubMed, CINAHL, and PsychInfo from January 1, 1995, through October 31, 2014, and identified additional studies from reference lists and other systematic reviews. Clinical trials with random or nonrandom controls were included if they tested print, video, or web-based tools for advance care planning (ACP) or decision aids for serious illness. We extracted data on the study population, design, results, and risk for bias using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Each tool was evaluated for its effect on patient outcomes and accessibility. FINDINGS: Seventeen randomized clinical trials tested decision tools in serious illness. Nearly all the trials were of moderate or high quality and showed that decision tools improve patient knowledge and awareness of treatment choices. The available tools address ACP, palliative care and goals of care communication, feeding options in dementia, lung transplant in cystic fibrosis, and truth telling in terminal cancer. Five randomized clinical trials provided further evidence that decision tools improve ACP documentation, clinical decisions, and treatment received. CONCLUSIONS AND RELEVANCE: Clinicians can access and use evidence-based tools to engage seriously ill patients in shared decision making. This field of research is in an early stage; future research is needed to develop novel decision aids for other serious diagnoses and key decisions. Health care delivery organizations should prioritize the use of currently available tools that are evidence based and effective.

Continuity of Care

Uijen AA et al. Measurement properties of questionnaires measuring continuity of care: a systematic review. PLoS One. 2012; 7(7):e42256. PMID: 22860100.

ABSTRACT: BACKGROUND: Continuity of care is widely acknowledged as a core value in family medicine. In this systematic review, we aimed to identify the instruments measuring continuity of care and to assess the quality of their measurement properties. METHODS: We did a systematic review using the PubMed, Embase and PsycINFO databases, with an extensive search strategy including ‘continuity of care’, ‘coordination of care’, ‘integration of care’, ‘patient centered care’, ‘case management’ and its linguistic variations. We searched from 1995 to October 2011 and included articles describing the development and/or evaluation of the measurement properties of instruments measuring one or more dimensions of continuity of care (1) care from the same provider who knows and follows the patient (personal continuity), (2) communication and cooperation between care providers in one care setting (team continuity), and (3) communication and cooperation between care providers in different care settings (cross-boundary continuity). We assessed the methodological quality of the measurement properties of each instrument using the COSMIN checklist. RESULTS: We included 24 articles describing the development and/or evaluation of 21 instruments. Ten instruments measured all three dimensions of continuity of care. Instruments were developed for different groups of patients or providers. For most instruments, three or four of the six measurement properties were assessed (mostly internal consistency, content validity, structural validity and construct validity). Six instruments scored positive on the quality of at least three of six measurement properties. CONCLUSIONS: Most included instruments have problems with either the number or quality of its assessed measurement properties or the ability to measure all three dimensions of continuity of care. Based on the results of this review, we recommend the use of one of the four most promising instruments, depending on the target population Diabetes Continuity of Care Questionnaire, Alberta Continuity of Services Scale-Mental Health, Heart Continuity of Care Questionnaire, and Nijmegen Continuity Questionnaire.

Assessment Tools

NCI Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

The purpose of the PRO-CTCAE project is to develop an electronic-based system for patient self-reporting of symptom adverse events (AEs) listed in the CTCAE in an effort to improve the accuracy and precision of grading of this class of AEs. The accurate reporting of AEs that occur to patients on clinical trials is a federal requirement that facilitates evaluation of new therapies.

NIH Toolbox for Neurologic and Behavioral Research.

NIH Toolbox is a multidimensional set of brief measures assessing cognitive, emotional, motor and sensory function from ages 3 to 85, meeting the need for a standard set of measures that can be used as a “common currency” across diverse study designs and settings. NIH Toolbox monitors neurological and behavioral function over time, and measures the domain constructs across developmental stages. This facilitates the study of functional changes across the lifespan, including evaluating intervention and treatment effectiveness.

NIH Patient-Reported Outcomes Measurement Information System (PROMIS).

PROMIS stands for Patient Reported Outcomes Measurement Information System. Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients’ state of wellbeing or suffering as well as their ability or lack of ability to function. The NIH funded leading PRO and clinical investigators to develop a “psychometrically validated, dynamic system to measure PROs efficiently in study participants with a wide range of chronic diseases and demographic characteristics. “The PROMIS initiative is part of the NIH goal to develop systems to support NIH-funded research supported by all of its institutes and centers. PROMIS measures cover physical, mental, and social health and can be used across chronic conditions.

PROMIS consists of three areas:

  1. PRO Measure Development Standards: PROMIS stands for a particular set of methods used to develop PRO measures. This methodology was developed by leading PRO researchers from across the country and can be used as a model for future PRO development.
  2. PRO measures: PROMIS used this methodology to create a large number of PRO measures of health in multiple languages, for adults and children.
  3. PRO Administration Software: PROMIS developed software, called “Assessment Center” to facilitate using these new PRO measures with patients.

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires.

The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It is supplemented by disease-specific modules, e.g., Breast, Lung, Head & Neck, Oesophageal, Ovarian, Gastric, Cervical cancer, Multiple Myeloma, Oesophago-Gastric, Prostate, Colorectal Liver Metastases, Colorectal and Brain cancer. Other disease specific modules are under development but not yet validated. Additional EORTC instruments include the Satisfaction with Care measure (EORTC-IN-PATSAT32) and a Palliative Care questionnaire (QLQ-C15-PAL).