patient outcome and interuption during report

What is the purpose of Patient Reported Outcome?

Patient-Reported Outcome (PRO) is a tool for capturing data on safety and efficacy. Data from patients may be classed as those that are detectable only by clinicians and data detectable only by patients, as exemplified by the following: Data detectable only by clinicians: tachycardia; neutropenia.

Are Patient-Reported Outcomes of a clinical intervention important?

The outcomes of a clinical intervention obtained by the patient i.e. patient-reported outcomes (PROs) are seemed to be of more importance in future than any other outcomes like clinical, physiological or caregiver-reported.

What are the effects of interruptions in patient care?

Tucker[32] reported that interruptions caused short delays in patient care tasks, which caused minor inconvenience and discomfort to patients.

What are Patient-Reported Outcome Measures in adequate and well-controlled trials?

Patient-reported Outcome Measures Measures in adequate and well- controlled trials: • Clear statement of objectives • Distinguish effect of the drug from other influences • Well-defined and reliable assessments Reference 21 CFR 314.126, 21 CFR 201.57(c)(7)

How do you describe patient outcomes?

Based on our concept analysis of the literature, we define 'patient outcomes' more simply as the results of the nursing care that patients receive in hospital including maintenance of patient functional status, maintenance of patient safety, and patient satisfaction.

What is interruption in nursing?

Interruptions during practice may compromise the attention of workers, leading to distractions, and therefore, may represent a risk to the safety of patients. These distractions may be more related to failure in the systems than to individual performance( 9 - 10 ).

What is the meaning of interruption and distraction?

Distractions and interruptions consist of anything that disrupts an individual from the current task by diverting one's attention. Sources for interruptions and distractions include noise, other people, or electronic devices. Noises may include alarms, ringing phones, and other clinicians.

Why do interruptions and distractions lead to errors?

Effects of Distractions and Interruptions Attending to the new task increases the risk of an error with one or both of the tasks because the stress of the distraction or interruption causes cognitive fatigue, which leads to omissions, mental slips or lapses, and mistakes.

What is the effect of the nurses interruptions?

Studies have shown that work interruption is an important cause of medication errors made by nurses.In hospital wards, interruptions of nurses' medication administration process resulted in a 12% increase in surgical failure and a 13% increase in medication errors.

What is distraction in healthcare?

Distraction is an approach that helps a child or young person cope with an invasive procedure or if they are facing a difficult experience in the hospital. It can also be helpful if a child is in pain or discomfort.

How do you praise a patient?

When we intend to praise them, the following techniques can be considered:Closely observe; Provide instant feedback. As we have been living with our family members for long, we may not notice their strengths or room for improvement. ... Make concrete compliments; Explain the reason. ... Express feeling.

Why is Hipaa important for nurses?

With the proliferation of electronic devices, sensitive records are at risk of being stolen. Nurses must follow HIPAA guidelines to ensure that a patient's private records are protected from any unauthorized distribution. Although it is not always easy, nurses have to stay vigilant so they do not violate any rules.

What is the synonym of distraction?

Some common synonyms of distract are bewilder, confound, dumbfound, nonplus, perplex, and puzzle. While all these words mean "to baffle and disturb mentally," distract implies agitation or uncertainty induced by conflicting preoccupations or interests.

Are interventions to reduce interruptions and errors during medication administration effective ?: A systematic review?

Conclusions: There is weak evidence of the effectiveness of interventions to significantly reduce interruption rates and very limited evidence of their effectiveness to reduce medication administration errors.

What are three strategies that can be implemented to reduce distractions while preparing medication?

A "do not disturb" or "quiet zone" sign in the medication preparation area can help minimize distractions. To safeguard against medication errors, nurses must implement the proper procedures for medication administration, including at least these five rights: right patient, drug, dose, route, and time.

What percentage of errors are caused by distraction?

A distraction- affected crash is any crash in which a driver was identi- fied as distracted at the time of the crash. Nine percent of fatal crashes, 15 percent of injury crashes, and 15 percent of all police-reported motor vehicle traffic crashes in 2019 were reported as distraction-affected crashes.

What are the outcomes of a clinical scenario?

role performance, emotional status) and economical (e.g. expenses, saving).[6] In clinical scenario the outcomes can be clinician reported (e.g. performance of the patient), caregiver reported (e.g. functional status), physiologic (e.g. tumor size by using MRI) or patient reported (e.g. symptoms). If the patient is observed for the outcomes by clinician, researcher or caregiver then the outcomes become observer reported outcomes (OROs).[4] If the patient is revealing in the written questionnaire that he/she is experiencing morning stiffness is PRO but if the clinician is asking to describe about the morning stiffness i.e. severity and nature is considered to be ORO.

What is proxy outcome?

Proxy reported outcome is a measurement based on the reportby someone other than the patient reporting as if he or she is the patient. It is different from a PRO or ORO.[3]

What is a PRO report?

As per US-FDA, a PRO is any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else.[3]

Should a conceptual framework have evidence?

It should have proper evidences for the conceptual framework.

Can data be obtained from a patient?

Data can only be obtained from the patient

Can medical technology give all the data?

Though medical technology allows to measure physical, physiological or biochemical data of the patient; it is not able to give all the data about the treatment or the disease. Some data can be obtained only from the patient. Such data includes the things as mentioned in [Table 1].[4]

Is a symptom a one-dimensional property?

Although symptoms of the patient and health related quality of life (HRQOL) hear to be similar, they are the two different concepts. Symptom is a one-dimensional property while HRQOL is multidimensional. Symptoms are often main objective of treatment, mirror clinician-patient discourse and vary dynamically with time but in case of HRQOL all the above things are rarely. Symptoms are directly related to disease and treatment effect while there is indirect relation of them with HRQOL. In case of PRO concepts symptoms are often considered for behavioral objective measure but seldom for HRQOL. Complexity of the concepts is complex in HRQOL and simple in case of symptoms.[7]

How to capture patient perspectives?

Investigators can use different approaches to capture patient perspectives, including interviews, self-completed questionnaires, diaries, and via different interfaces such as hand-held devices or computers. Review authors must identify the postulated constructs that are important to patients, and then determine the extent to which the PROMs used and reported in the trials address those constructs, the characteristics (measurement properties) of the PROMs used, and communicate this information to the reader (Calvert et al 2013).

When a trial reports results for more than one instrument, should authors create a hierarchy?

When trials report results for more than one instrument, authors should – independent of knowledge of the results and ideally at the protocol stage – create a hierarchy based on reported measurement properties of PROMs (Tendal et al 2011, Christensen et al 2015), considering a detailed understanding of what each PROM measures (see Table 18.2.a ), and its demonstrated reliability, validity, responsiveness and interpretability (see Section 18.3 ). This will allow authors to decide which instruments will be used for data extraction and synthesis. For example, the following instruments are all validated, patient-reported pain instruments that an investigator may use in a primary study to assess an intervention’s usefulness for treating pain:

How to evaluate change over time?

When we are interested in evaluating change over time – that is, in the context of evaluation when measures are available both before and after an intervention – we examine correlations of change scores. For example, patients with COPD who deteriorate in their treadmill exercise capacity should, in general, show increases in dyspnea, while those whose exercise capacity improves should experience less dyspnea. Similarly, a new emotional function instrument should show concurrent improvement in patients who improve on existing measures of emotional function. The technical term for this process is testing an instrument’s longitudinal construct validity. Review authors should look for evidence of the validity of PROMs used in clinical studies. Unfortunately, reports of randomized trials using PROMs seldom review or report evidence of the validity of the instruments they use, but when these are available review authors can gain some reassurance from statements (backed by citations) that the questionnaires have been previously validated, or could seek additional published information on named PROMs. Ideally, review authors should look for systematic reviews of the measurement properties of the instruments in question. The Co nsensus-based s tandards for the selection of health m easurement in struments (COSMIN) website offers a database of such reviews ( COSMIN Database of Systematic Reviews ). In addition, the Patient-Reported Outcomes and Quality of Life Instruments Database ( PROQOLID) provides documentation of the measurement properties for over 1000 PROs.

What is a PRO in medical terms?

A patient-reported outcome (PRO) is “any report of the status of a patient’s health condition that comes directly from the patient without interpretation of the patient’s response by a clinician or anyone else” (FDA 2009).

Why is summary data important?

Summary data on patient-reported outcomes (PROs) are important to ensure healthcare decision makers are informed about the outcomes most meaningful to patients.

When deciding if statistical synthesis is appropriate, review authors will often find themselves reading between the lines?

When deciding if statistical synthesis is appropriate, review authors will often find themselves reading between the lines to try and get a precise notion of the underlying construct for the PROMs used. They may have to consult the articles that describe the development and prior use of PROMs included in the primary studies, or look at the instruments to understand the concepts being measured.

Can a PRO be used in different studies?

The definition of a particular PRO may vary between studies, and this may justify use of different instruments (i.e. different PROMs). Even if the definitions are similar (or if, as happens more commonly, the investigators do not define the PRO), the investigators may choose different instruments to measure the PROs, especially if there is a lack of consensus on which instrument to use (Prinsen et al 2016).

Who should be involved in discussions about important, clinically relevant PROs and, corresponding appropriate and valid PRO measures?

Clinicians, patients, researchers, and other relevant stakeholders should be involved in discussions about important, clinically relevant PROs and, corresponding appropriate and valid PRO measures. Kluetz et al state that “The goal [of PRO measure selection] should be to achieve a comprehensive evaluation of the patient experience most affected by the therapy, while maximizing the relevance of individual questions and minimizing overall burden and duplication” (p. 1557).36

What is a PRO in clinical trials?

Patient-reported outcomes (PROs) are defined as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else” (Food and Drug Administration [FDA], p. 6).1PRO is an umbrella term which may refer to patient-reported: 1) disease symptoms or treatment side effects, such as pain, fatigue, or anxiety; 2) functional outcomes such as physical, sexual, social, role, emotional, or cognitive functioning; or 3) multidimensional constructs such as health-related quality of life (HRQOL) or health utility. HRQOL is defined as “the subjective assessment of the impact of disease and treatment across the physical, psychological, social and somatic domains of functioning and well-being” (Revicki et al, p. 888).2In the present review, we focus on PROs as clinical trial endpoints and differentiate PROs from other types of patient-reported data, such as patient-reported experiences or patient-reported behaviors, which may also be included as clinical trial endpoints.

What percentage of RCTs did not name the PRO measure?

Furthermore, five (8%) of the 66 HNT RCT publications did not name the PRO measure that had been used. Many more RCTs modified validated PRO measures without specifying the nature of the modifications.35Modifications may have involved rewording, removing or adding items, or altering scoring procedures and may have compromised the psychometric properties of the PRO measures. None of these RCTs assessed the impact of these modifications on the psychometric integrity and performance of the measure. A follow-on issue is that the publication of RCTs using modified questionnaires may set a precedent for future RCTs to use the modified version rather than the validated version, thereby potentially perpetuating the problem of use of poor quality PRO measures.

How to develop a measurement strategy for prospective labeling claims?

Snyder et al describe how to develop a measurement strategy for prospective labeling claims.37This involves identifying relevant PRO domains, developing a conceptual framework around these domains, identifying approaches to measure these domains, and designing a measurement strategy based on this information. Snyder acknowledges that existing scales may not fit the purpose of some studies and advocates that modifications to PRO measures should be subject to reliability and validity tests prior to implementation.37

Why has the FDA declined to label pro?

As noted earlier, the FDA has declined to provide PRO labeling on the basis that clinical trials have not selected an appropriate PRO measure or that the measure had not been appropriately developed and validated.25This suggests that the problem occurs even among well-funded and well-resourced trials presented to the FDA.

How are PROs assessed?

PROs are assessed in trials using questionnaires, often referred to as “PRO measures.” Validated PRO measures are used in clinical trials, as opposed to asking participants open-ended questions about their outcomes, to ensure that the questions, response options, and the general approach to assessment are standardized for all participants. This enables the research team to attribute any differences between patient responses to real differences in perceptions of their outcomes, as opposed to methodological differences or biases. PRO measures are typically developed with input from clinicians, patients, and psychometric experts to ensure that the PRO measure assesses clinically relevant issues that are meaningful to patients in a robust manner.

Why are PROs important in clinical trials?

PROs provide unique information on the impact of a medical condition and its treatment from the patient’s perspective; therefore, PROs can be included in clinical trials to ensure the impact of a trial intervention is comprehensively assessed . This review first discusses examples of how PRO endpoints have added value to clinical trial interpretation. Second, it describes the problems with current practices in designing, implementing, and reporting PRO studies, and how these problems may be addressed by complying with guidance for protocol development, selecting appropriate PRO measures to match clinically motivated PRO hypotheses, minimizing the rates of avoidable missing PRO data, analyzing and interpreting PRO data, and transparently reporting PRO findings.

What is MID in clinical trials?

Specifically, in the draft PRO guidance, MID was defined as ‘the amount of difference or change observed in a PRO measure between treatment groups in a clinical trial that will be interpreted as a treatment benefit’ [101]. The draft PRO guidance suggested “it would be logical to establish the null hypothesis to rule out a difference less than or equal to the MID” but also acknowledged that in practice this was rarely carried out [102]. In the final PRO guidance, the elimination of MID is accompanied by an emphasis on establishing meaningful change in PRO measures at the individual level (i.e., defining a responder) versus at the treatment group level. This new focus is demonstrated by the definition provided for a responder in the final PRO guidance as being “a score change in a measure, experienced by an individual patient over a predetermined time period that has been demonstrated in the target population to have a significant treatment benefit” [102]. This article examines in detail the FDA-recommended methodology for defining a responder and analyzing responder-based PRO measure results. We also present other responder analysis approaches for consideration in order to further the precision and interpretation of this methodology in the context of interpreting the results of clinical trials and supporting eventual label claims.

How to determine appropriateness of responder thresholds?

Another approach for assessing the appropriateness of responder thresholds combines an anchor-based approach and receiver operating characteristic (ROC) curves to identify the responder thresholds that best predict classification based on an external criterion. First, an external anchor (or another external criterion that is appropriate to identify responders) is used to classify all participants into responder or nonresponder groups. Then, to check for appropriateness, the relationship between the external criterion and the PRO measure is examined through correlation analyses. Finally, the predictive accuracy of how well the specific PRO change scores relate to the classifications is evaluated using logistic regression analyses and graphically displayed as an ROC curve. Each point on the curve provides the sensitivity (true positives) versus one minus the specificity (false positives) trade-off for identifying responders for a specific unit of change on the PRO measure. The entire range of change scores and the likelihood classifications are provided within the one curve. Figure 3provides an example of an ROC curve with the change at zero points and at five points illustrated. At zero points, the PRO measure achieves sensitivity of 65% and specificity of 77%. At five points, the sensitivity is 83% and specificity is 56%, for this example. A diagonal line is included in the figure as a reference. Evaluations that produce curves close to the diagonal line should be viewed with caution because the diagonal line represents chance classification.

What is the anchor based method?

The final PRO guidance describes the anchor-based method as the primary method for establishing responder thresholds , but also mentions distribution-based methods as providing support for defining responder thresholds. Distribution-based methods identify the raw score change on a PRO measure that will produce a prespecified effect size. The most common effect size specified is the half standard deviation (0.5 SD). Another distribution-based approach is the standard error of measurement (SEM):

What is the purpose of the Study Endpoints and Label Development group?

To facilitate decisions related to the approval of drugs, labels and promotional claims based on PROs, the FDA created the Study Endpoints and Label Development (SEALD) group. Members of SEALD are often included in pivotal meetings with study sponsors to provide feedback regarding proposed PRO endpoints. SEALD also serves as an advisory group to all reviewing divisions of the FDA and has developed both a draft and final version of a guidance related to the use of PRO measures used to support drug approvals and label claims.

What is the measure used to interpret the PRO?

As recommended in the final PRO guidance, to be useful as an anchor, the measure used to interpret the PRO must be both a valid measure of change and easier to interpret than the PRO measure. In addition to global ratings, changes in related measures that have established consensus-based thresholds can be used to define the responder threshold for the PRO measure. For example, for a PRO measuring annoyance of incontinence, the PRO guidance presents a 50% reduction in incontinence episodes as measured in a daily incontinence diary as a proposed viable anchor in estimating meaningful change.

What is the FDA's final guidance?

The primary approach recommended in the final guidance is an empirical anchor-based approach. The guidance recommends distribution-based methods as supportive or secondary approaches to provide additional evidence for the resulting responder definitions [102].

What is MID in pro measure?

In essence, the MID is the average change in the domain of interest on the target measure among the subgroup of people deemed to change by a minimal (but important) amount according to an ‘anchor’. Hence, the MID estimate is the expected group mean change for people who have improved by enough (but not too much) according to the external standard.

What is a PRO in health care?

Patient-reported outcomes (PROs) such as pain and other symptoms are commonly measured not only in research, but more commonly now in routine clinical care for symptom screening and to enhance communication, particularly those addressing chronic illnesses that impact patient quality of life and their activities of daily living. Use of PROs in performance evaluation is closely related to a growing interest in integrating PROs into electronic health records systems and patient portals [14]. Evidence demonstrates that patient reporting can improve communication, satisfaction, and symptom management [15,16]. There is evidence to support PRO in assessing baseline pain and changes in pain, analgesia, and analgesic-induced side effects in an effort to improve analgesia [17] ( Tables 6.1 and 6.2 ).

What is a PRO in medicine?

This chapter reviews the definition, development, and utilization of PROs for both research and clinical purposes, including developmental considerations for administration of PROs with children. Health-related quality of life measures (HRQoL) are one type of PRO, and several condition-specific PROs have been developed for a variety of pediatric respiratory diseases, including vocal cord dysfunction, asthma, cystic fibrosis, sleep-related breathing disorders, and primary ciliary dyskinesia. A substantial body of literature has demonstrated that condition-specific, rather than generic measures, are more sensitive to change and better reflect the patient's symptoms and functioning. This chapter reviews the currently available PROs for pediatric respiratory conditions, including a description of the instrument, the domains of functioning it measures, the appropriate developmental age for administration, and the psychometric properties of the instrument, including its reliability and validity. Use of PROs is becoming standard practice for both randomized clinical trials and clinical care. The current shift in medicine toward patient-centered care is consistent with development and use of PROs. These measures provide unique information about patient symptoms, level of daily functioning, and systematic response to treatment. These measures have also been shown to facilitate patient-provider communication and shared decision-making. Integration of PROs into clinical care is a critical step in promoting patient-centered, quality health care practice.

Can a clinician interview a patient?

Clinicians can interview study subjects on data that is only patient-reportable. Special instruments (questionnaires) are available for capturing patient-reported data. For example, the NCI provides the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) ( 387 ). Where a clinician interviews a patient, and where the patient responds, the clinician needs to find counterparts of terms, used by the patient, in the MedDRA dictionary ( 388 ).

1 Introduction to Patient-Reported Outcomes#Section-18-1

• 18.1.1 What are patient-reported outcomes?#section-18-1-1
  A patient-reported outcome(PRO) is “any report of the status of a patient’s health condition that comes directly from the patient without interpretation of the patient’s response by a clinician or anyone else” (FDA 2009). PROs are one of several clinical outcome assessment methods that c…
• 18.1.2 Why patient-reported outcomes?#section-18-1-2
  PROs provide patients’ perspectives regarding treatment benefit and harm, directly measure treatment benefit and harm beyond survival, major morbid events and biomarkers, and are often the outcomes of most importance to patients and families. Self-reported outcomes often correl…

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2 Formulation of The Review#Section-18-2

3 Appraisal of Evidence#Section-18-3

4 Synthesis and Interpretation of Evidence#Section-18-4

5 Chapter Information#Section-18-5

6 References#Section-18-6