Chapter 18: Patient -reported results (2024)

Bradley C John Chnston, Donald l Patrick, Tahira Devji, Lara j Maxwell, Clifton O Bingham III, Dorcas e Beton, Marten Boers, Matthias Briel, Jason w Busse, Alonso Carrasco-Labra, Robin Christensesen, Bruno r da Costa, Regino rDad Costa, Regino r Dad , Anne Lydatt, Raymond W ostelo, Beverley Shea, Jasvinder Singh, Caroline B Telle, Paula R Williamson, Joel j Gagnier, Peter Tugwell, Gordon H Guytttttttttttttttttttttttttttttttttttttttttttttttttttttt

Citer dette kapitel som: Johnston BC, patrick dl, devji t, maxwell lj, beaton d, Boers m, Beste JW, Carrasco-Labra, Christensen r, COSTA B, EL DIB r, lydiatitatetatetatetatetatetatetatetates, ostelo rw, shea B, Singh J, Terwee CB, Williamson Pr, Gagnier JJ, Tugwell p, Guytt Gh.Kapitel 18: PatientAtrapporterede result., Welch Va (Redaktør).Cochrane -Handbook for Systematic Reviews of InterventionsVersion 6.4 (updated August 2023).Cochrane, 2023. Available fromwww.training.cochrane.org/handbook.

18.1 IntroductionFor Patient -Reported results

18.1.1 What are results reported by the patient?

INPatient -reported result(Pro) is "any report on the status of the health status of a patient who comes directly from the patient without interpreting the patient's patient or someone else" (FDA 2009).Measurements of morbidity (eg stroke, myocardial infarction), load (eg hospitalization) and survival that is used and reported in clinical examinations and non-randomized studies (FDA 2018).

Patient -Reported Performance Goals(PROMs) are instruments that are used to measure the pros, usually self -reporting questionnaires for self -reporting can be done.Reported or observer reported results (Powers et al 2017).

Benefits offer crucial information for patients and clinicians who are confronted with health care choices.

The goals of this chapter are: (i) the category of results that are known as benefits and their importance for making decisions on health care;(ii) illustrate consider when they include benefits;and (iii) tackle the structure and content (domains, items) of benefits and provide guidelines to combine information from different benefits.Systematic assessment process.handling of side effects).

18.1.2 Why did the patient report results?

Advantages offer the perspectives of patients on treatment services and injury, measures direct treatment services and damage beyond survival, large morbid events and biomarkers and are often the results of the most important for patients and families.

Self -reported results often correlate poorly with physiological and other results, such as performance -related results, clinic reported results or biomarkers.% variation in breathing problems on the self -reporting of a patient.

Advantages are important when external perceptible patient -important results are rare or not available.Side effects such as nausea and fear for which physiological measurements are limited or inaccessible.

18.2 Formulation of the assessment

In this section we describe PROMs in more detail and we discuss some questions to consider deciding which proms to process in a review.

A common expression used in the literature on health status is literatureconstruct.

There are many different ways to label and classify Proms and the constructions they measure.Patients' reports contain signs (observable manifestations of a condition), sensations (usually classified as symptoms that can be attributed to diseases and/or treatment), behavior and skills (often classified as functional status), general perceptions or emotions of put certificates,General health, satisfaction with treatment, reports of side effects, compliance with treatment and participation in social or social events and health -related quality of life of life (HRQOL).

Researchers can use different approaches to record patient perspectives, including interviews, self -filled questionnaires, diaries and via various interfaces, such as handheld devices or computers.They Proms, which was used and reported in the experiments, relate to these constructions, the properties (measuring properties) of the PROM used and communicate this information to the reader (Calvert et al 2013).

Now focus on HRQOL, an important professional, some approaches trying to cover the entire spectrum of health -related patient experience, for example self -care and physical, emotional and social functioning and therefore enable a comparison between the effect of treatments on HRQOL about diseases or conditions.Generic instruments) -36) SF -12;These are the field of health profiles dominated (Tarlov et al 1989, Ware et al 1995, Ware et al 1996).can be specific for function (eg sleep, sexual function), for a disease (eg asthma, heart failure), for a population (eg the fragile elderly) or for a symptom (pain, fatigue) (Guyatt et al 1989,Patrick and Deyo 1989).(eg anxiety, depression, pain, social function) Relevant for a wide range of chronic diseases (Cella et al 2007, Witter 2016, Promis2018).

Writers often use the terms 'quality of life', 'health status', 'functional status', 'hrqol' and 'well -bing' loosely and exchange.Do this, they may be able to investigate the things or questions that are included in a PROM.

Another question to consider is whether the individual instruments have been weighted.Is rooted between death and full health.et al 2014).

Tabel 18.2.aPresents a framework to consider PROMS and report in clinical studies, including their constructions and how they were measured.proof.

Bord18.2.AChecklist for description and assessment of Prom's in clinical tests.

18.3 Evaluation of evidence

18.3.1 Measurement of benefits: Some versus several times

To be useful, instruments must be able to distinguish between interesting situations (Boers et al 1998).Distinguish people with more desired scores from those whose scores are less desirable.

In longitudinal studies, such as randomized studies, researchers usually obtain measurements on several times, for example at the start of the research and again after administration of interventions.Of those who have experienced negative changes, those who have experienced fewer positive changes, or those who have not experienced any changes, and to estimate the size of DEM changes.

18.3.2 Reliability

Intuitive thinking Many people of reliability as achieving the same scores through repeated administration of an instrument among stable respondents.

Reliability statistics therefore look at the relationship between the variation between the respondents (usually the counter of reliability statistics) and the total variation (the variation between respondents and the variation within the respondents).Correlation coefficient for continuous data (they Vet et al 2011).

Restrictions on reliability are of most care for the evaluation author when randomized attempts have not found the superiority of an experimental intervention in relation to a comparative intervention.Real intervention effects due to random errors.If a systematic study does not find evidence that an intervention influences a PROM, assessment writers must consider whether this can be due to poor reliability (for example if reliability coefficients are less than 0.7) instead of the lack of effect.

18.3.3 Validity

Validity has to do with whether the instrument measures what it is intended to measure.Content validityEvaluation includes the patient and clinical evaluation of the relevance and the understanding of the content in the measures, usually achieved through qualitative research with patients and families (Johnston et al 2012).

Construct validityIncludes investigating the logical circ*mstances that must exist between assessment measures.F.X of emotional function and existing emotional functional questionnaires.

When we are interested in evaluating changes in time - that is, in the context of evaluation, when there are measures, both before and after an intervention - we investigate correlations of change results.must generally show an increase in dyspneu, while whose training capacity has improved, they must experience less dyspnea.Instrument longitudinal longitudinal construction -validity.The assessment writers must look for proof of the validity of Proms used in clinical studies., Review writers can receive insurance from statements (supported by quotations) that the questionnaires have been validated earlier or possibly have an additional published information about the name Prompt.CoConsensus -BasedSStandards for selecting healthMmeasurementiStarss (Cosmin) website offers a database with such assessments (Cosmin database of systematic assessments).Burtercall) Offers documentation of the electricity properties for more than 1000 benefits.

If the validity of the PROMs used in a systematic review remains unclear, assessment writers must consider whether PROM is an appropriate measure of the planned results of the assessment of whether this should be excluded (Ideally, this would be considered on the protocol), and whatever included results must be interpreted with appropriate caution.Simple and gave intuitive significance, so that the absence of formal validation problems is built up about whether these measures can offer meaningful data to distinguish between intervention and its comparators.

A final concern about validity arises when the measuring instrument is used with a different population or in a culturally and linguistic environment than that in which it is developed.not just not to be criticized for this basis.

18.3.4 ResponsiveTet

In the evaluative context, randomized experimental participants are usually available before and after the intervention.Often refer to this measuring possession as an response capacity;Alternatives are sensitivity to change or ability to detect change.

As with reliability, responsiveness becomes a problem when a Meta analysis does not suggest evidence of a difference between an intervention and control.Nevertheless, the instrument cannot detect the improvement.Wiebe et al 2003, Johnston et al 2016a).Previous proof of responsiveness, this is a possible cause of less sure of evidence from a series of randomized studies.A PROM used instruments without established reaction power (Smith et al 1992).

18.3.5 Report bias

Studies that focus on benefits often use a number of proms to measure the same or similar constructions.They indicate larger intervention effects or statistically significant P values ​​(Kirkham et al 2010).Chapter 7 (Section 7.2.3.3);Also seeChapter 8 (Section 8.7).

Systematic assessments that focus on professionals must be aware of this problem.Evidence as part of their character assessment (seeChapter 14) (Guyatt et al 2011).For example, writers came across a systematic review that evaluated the responsiveness of benefits in patients with rare lysosomal storage diseases, eligible studies, describing the use of a pro in the methods, but there was no data or limited pro data in theresult.When authors presented some information about results, the reports sometimes only contain provisional or final study results.If the results have shown clear benefits for the pros, researchers would state a pro in the methods and then not report the results (Johnston et al 2016b).

18.4 Synthesis and interpretation of evidence

18.4.1 Selection of multiple Proms

The definition of a certain pro can vary between studies, and this can justify the use of different instruments (ie different PROMs).SELV If the definitions are the same (or if the researchers who occur more often), the researchers can choose different instruments to measure the pros, especially if there is a lack of agreement on which instrument to use (the Prince just already 2016).

When tests report results for more than one instrument, writers - regardless of knowledge of the results and ideally in the protocolase - must create a hierarchy on the basis of reported alternative properties for PROMs (Tende et al 2011, Christensen et al 2015), considering the end-Tailed understanding of what every promer meter (seeTabel 18.2.a), and the proven reliability, validity, responsiveness and interpreting power (see section18.3).This enables writers to decide which instruments will be used for data extraction and synthesis. The following instruments are all validated, the patient reported pain instruments that a researcher can use in a primary investigation to assess the usefulness of an intervention to assessto treat pain:

• 7-verients integrated pain score;
• 10-point visual analogue scale for pain;
• 20-Goods McGill Pain Questionnaire;
• 56-point short pain inventory (Proqolid 2018).

In some clinical areas, core outcome packages are available to guide the use of appropriate benefits (Comet 2018).Has the performance goals in Rheumatology (Omeract) initiative, ie that Prom to use) (Boers et al 2014).

As an example of a pre -defined hierarchy for knee osteoarthritis, Omeract has used a published hierarchy based on responsiveness for extraction of AM that evaluates pain and physical functioning to perform systematic reviews (Juhl et al 2012).

Writers must decide in advance whether they do not exclude PROMs that are not included in the hierarchy or include additional measures if none of the preferred measures are available.

18.4.2 Synthesis of data from multiple PROMs

Although a hierarchy can be useful for identifying the reporting author's preferred measures and the exclusion of some measures that are considered inappropriate, it is likely that authors encounter studies with different proms to measure a certain structure or within aResearch or over several studies.Must decide how the synthesis of multiple goals should be approached and consider which measures must be included in a single meta analysis on a certain construction (Tende et al 2011, Christensen et al 2015).

When decision or statistical synthesis is suitable, authors will be viewed, they often read between the lines to try to get a precise notion of the underlying construction for the instructions used.In the primary studies, or look at the instruments to understand the concepts that are measured.

For example, writers of a Cochrane overview of cognitive behavioral therapy (CBT) included for Tinnitus HRQOL as Pro (Martinez -desa et al 2007), rated with different PROMs: four attempts using interviewing

The most convincing proof of the suitability of including different PROMs in the same meta analysis would result from a finding of significant relationships between the instruments.CRQ) and St.George's respiratory questionnaire (SGRQ).et al 2001, Schünemannemannsmanet Al 2003, Schünemann et al 2005).

Ideally, the decision to combine scores of different PROMs would not only be based on their measurement of comparable constructions, but also on their satisfactory validity, and depending on or before and after intervention or only after intervention measurements were available, and on their response or orReliability.For example, extensive evidence of validity is available for both CRQ and SGRQ.CRQ is more to more responsive than SGRQ: in a study with 15 studies with both instruments, standardized answers for CRQ (Mediaan 0.51, Interkvartil row (IQR) 0, were 0,19 to 0.98) significantly higher (p <0.001) than that associated with SGRQ (Mediaan 0.26, IQR -0.03 to 0.40) (Puhan et al 2006).lead to underestimation of intervention effect in studies using SGRQ (Puhan et al 2006, Johnston et al 2010).

Normally detailed data as described above will not be available.The treatment of pre-menstrual syndrome for an abundance of outcome measures, with 25 PROMs used in their nine eligible studies (Busse et al 2009).In the review, research is investigating every instrument - including all domains - and group 16 proms in six discreet conceptual categories.Tabel 18.4.aDescribes the categories and the included instruments in each category.

Authors must follow the instructions elsewhereManuallyAbout suitable methods for synthesis of different performance goals in a single analysis (Chapter 10) and interpretation of these results in a way that is most useful for decision makers (Chapter 15).

Bord18.4.AExamples of potentially combined proms that measure similar constructions from an overview of psychosocial interventions in the treatment of pre-menstrual syndrome (Busse et al 2009).

After taking the decision what benefits and the subsequent proms must be included in a Meta analysis, review writers are faced with the challenge of ensuring that the results presented can be interpreted for their target groups.And standard care in a number of randomized studies with CRQ was 1.0 (95% CL 0.6 to 1.5), many readers would not be sure whether this represents a trivial, small, but important, moderate, moderate or large effect (Guyatt et al 1998, Broezek et al 2006, Schünemann et al 2006) is the interpretation of a standardized average difference for most (Johnston et al 2016b).Chapter 15Summarize the various statistical presentation methods that can be used to improve the interpretability of the summary of the estimates.'Summary of the Fund' Tables (Thorlund et al 2011, Guyatt et al 2013, Johnston et al 2013).

18.5 Chapter information

Auteurs:Bradley C John chnston, Donald l Patrick, Tahira Devji, Lara J Maxwell, Clifton O Bingham III, Dorcas Beton, Marten Bors, Matthias Briel, Jason W Busse, Alonso Carrasco-labra, Robin Christensen, Bruno R da Costa, Regino R DaseCosta, Anne Lyddatt, Raymond W Ostelo, Beverley Shea, Jasvinder Singh, Caroline B Terwe, Paula R Williamson, Joel J Gagnier, Peter Tugwell, Gordon H Guyttt

Financing:DB is busy exercising omeract (output measurement in rheumatology) (unpaid position). OPRACT is supported by a partnership with different industries and omeract funds support staff to help with the development of methods and materials about the development of the core development that chapterhas influenced.Parker Institute, Bispebjerg and Frederiksberg Hospital (RC) are supported by a nuclear fair from the OAK Foundation (OCAY-13-309) .TD has received financing from the Canadian Health Research Institute for research related results and minimal important differences.(paid to the Institute) of the Dutch Organization Scientific Research (NWO);(SENTENCE);

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