Mga outcome score: ano ang sinusukat ng mga ito, at ano ang hindi Impormasyon

Ang pahinang ito ay isinalin ng makina at hindi pa nasusuri ng isang doktor. Ang bersyong Ingles ang siyang opisyal.

Ano ito

Ang patient-reported outcome measure ay isang questionnaire na sasagutan mo tungkol sa iyong sariling kalusugan. Sa halip na isang pagsusuring ginagawa sa iyo, tinatanong nito kung ano ang iyong nararamdaman at kung ano ang kaya mong gawin. Ang mga questionnaire na ito ay umiiral na simula pa noong 1960s, bagaman mas bago ang tawag sa mga ito [1].

Hindi nakikita ng iyong doktor ang sakit o pagkapagod sa X-ray o sa pamamagitan ng physical test. Binibigyang-diin ng pananaliksik na ang mga bagay tulad ng range of motion at lakas ay hindi kasing-reliable ng iyong iniisip, kaya naman mas maraming klinika na ngayon ang direktang nagtatanong sa mga pasyente [2]. Iyan ang puwang na pinupunan ng mga questionnaire na ito: kinukuha nito ang iyong pananaw sa iyong sariling function at wellbeing, na hindi kayang maobserbahan ng anumang scan o clinical test [3].

Ang ilan sa mga questionnaire na ito ay mahahabang listahan ng mga tanong tungkol sa pang-araw-araw na buhay. Ang mga mas bago, tulad ng mga PROMIS measure na binuo sa pamamagitan ng isang US research network, ay mas maikli at mas tumpak [4]. Maaari kang sumagot sa papel gamit ang panulat, o sumagot ng ilang tanong sa pamamagitan ng text message sa iyong telepono. Natuklasan ng mga pag-aaral na ang parehong paraan ay nagbibigay ng magkakatulad na score [5].

Ang iyong mga sagot ay binibigyan ng score at ikinukumpara sa paglipas ng panahon, upang ang mga pagbabago ay masubaybayan bago at pagkatapos ng gamutan. Ginagamit din ito ng mga mananaliksik upang ikumpara ang mga resulta sa malalaking grupo ng mga pasyente, bagaman ang datos na nakolekta ay hindi uniporme o kumpleto sa mga joint registry sa buong mundo, na maaaring magpahirap sa mga paghahambing [6].

Isang bagay na dapat malaman: ang mga score na ito ay sumusukat ng mga average sa mga grupo ng mga pasyente. Hindi nito hinuhulaan kung ano ang mararamdaman ng sinumang indibidwal. Gagamitin ng iyong doktor ang iyong score bilang isang bahagi ng impormasyon kasama ng iyong pagsusuri at ng iyong sariling mga layunin, at hindi bilang isang hatol sa iyong paggaling.

Bakit ito mahalaga

Ang mga questionnaire na ito ay may dalawang magkaibang tungkulin, at nakatutulong ang pag-alam kung alin ang alin.

Ang unang tungkulin ay ang pagsubaybay sa iyo sa paglipas ng panahon. Sasagutan mo ang parehong questionnaire bago ang gamutan at muli pagkatapos nito, upang makita ng iyong care team kung gaano kalaki ang nagbago para sa iyo. Dahil dito, ang iyong sariling score ay pinakamagamit bilang pananda ng iyong sariling pag-unlad, hindi bilang isang numero na ikukumpara sa ibang tao. Ang dalawang tao ay maaaring magsimula sa magkaibang kalagayan at magtapos sa magkaibang score habang pareho silang nagkaroon ng mabuting resulta.

Ang ikalawang tungkulin ay nangyayari sa mas malawak na saklaw. Kapag maraming pasyente ang nakakumpleto ng parehong mga questionnaire, maaaring ikumpara ang mga buong grupo, upang ang mga gamutan at serbisyo ay mabigyang-hatol sa isang buong populasyon. Ito ang paraan kung paano nakatutulong ang mga resulta sa pananaliksik at sa mga desisyon tungkol sa pangangalaga sa mas malawak na antas. Ang rutinang pagkolekta ng impormasyong ito ay inilalarawan bilang kinabukasan ng healthcare na nagbibigay-halaga sa kung ano ang mahalaga para sa mga pasyente [1], at ang pagdaragdag nito sa mga regular na pagbisita sa orthopaedic ay praktikal at nagbibigay sa mga doktor at pasyente ng matibay na impormasyon upang magdesisyon nang magkasama [2].

Mayroong isang mahalagang bagay na dapat malaman. Ang kilusang nasa likod ng mga questionnaire na ito ay pinangunahan pangunahin ng mga mananaliksik at ng mga taong nagbabayad para sa pangangalaga, at hindi ito palaging nakatuon sa pagpapabuti ng pangangalaga mula sa pananaw ng pasyente [3]. Ang ilang limitasyon sa kung paano ginagamit ang mga score ay maaaring magpaliwanag kung bakit ang pagsagot sa mga ito ay hindi laging humahantong sa mas mabuting resulta para sa mga pasyente [4].

Kaya ano ang ibig sabihin nito para sa iyo? Ang iyong score ay isang bahagi ng impormasyon na ginagamit ng iyong doktor kasabay ng iyong pagsusuri at ng iyong sariling mga layunin. Hindi ito isang grado, at hindi ito isang prediksyon. Ang inaalok nito ay isang paraan upang mabigyang-salita ang mga pagbabagong nararamdaman mo ngunit hindi nakikita ng iba, at isang paraan upang ang iyong pag-unlad ay maging bahagi ng isang mas malawak na larawan na tumutulong sa paghatol ng pangangalaga para sa lahat.

Ano ang ibig sabihin ng mga resulta

Mayroon ka nang score. Ano nga ba ang aktwal na sinasabi nito sa iyo?

Isang bagay na dapat munang malaman: depende sa questionnaire kung aling direksyon ang mas mabuti. Ang form mismo, o ang taong nagbigay nito sa iyo, ang magsasabi kung paano ito binabasa.

Ang maliit na pagbabago sa numero ay maaaring walang gaanong kahulugan. Pinag-aralan ng mga researcher ang problemang ito, at gumagamit sila ng ilang ideya upang makatulong sa pagbasa ng mga score. Ang isa ay tinatawag na minimal clinically important difference, na siyang pinakamaliit na pagbabagong aktwal na mapapansin ng isang pasyente sa pang-araw-araw na buhay. Ang isa naman ay tinatawag na patient acceptable symptom state, na siyang punto kung saan nararamdaman ng pasyente na sapat na ang kanilang kalagayan upang ituring na katanggap-tanggap ang kanilang mga sintomas [1].

Heto ang problema: walang iisang threshold na gumagana para sa lahat. Ang mga value para sa mga marker na ito ay nag-iiba sa pagitan ng mga ospital at sa pagitan ng mga grupo ng pasyente [2]. Ang iba't ibang paraan ng pag-calculate sa mga ito ay nagbibigay ng magkakaibang sagot [3], at ang anumang iisang value ay dapat basahin bilang isang range sa halip na isang permanenteng linya [4]. Kaya kung ang iyong score ay gumalaw ng maliit na halaga, iyon lamang ay hindi nagsasabi ng marami. Ang parehong score na sinukat muli paglipas ng panahon, at ang direksyong tinatahak nito, ay nagsasabi ng mas marami.

Mahalaga ring malaman na ang isang pagbabago ay maaaring statistically significant nang hindi ito isang bagay na iyong mararamdaman. Binibigyang-diin ng pananaliksik sa mga sukat na ito na ang pagkakaibang lumalabas sa mga numero ay maaaring hindi tumugma sa pagkakaibang mahalaga para sa iyo [5]. Iyan ang dahilan kung bakit tinitingnan ng iyong care team ang iyong score kasabay ng iyong pagsusuri at ng iyong sariling mga layunin, sa halip na ituring ang numero bilang ang buong sagot.

Isa pang limitasyon. Walang iisang questionnaire ang lumitaw bilang standard na paraan upang sukatin ang function. Isang review ang nakatuklas ng 15 iba't ibang tool na ginagamit para sa layuning ito, kung kaya't patuloy na nananawagan ang mga researcher para sa higit pang standardisation [6]. Ang lahat ng mga sukat na ito ay nangangailangan pa ng karagdagang pag-aaral upang kumpirmahin kung gaano sila ka-epektibo [7].

Kaya basahin ang iyong score bilang isang signal sa gitna ng marami. Itanong kung ano ang nagbago, gaano kalaki, at kung nararamdaman mo ba ito.

Ang mga bagay na hindi nito masasabi sa iyo

Ang score sa isang questionnaire ay hindi maaaring mag-diagnose ng anuman. Itinatala nito kung ano ang iyong nararamdaman, hindi kung ano ang mali sa iyo. Hindi rin nito itinatakda kung anong gamutan ang dapat mong makuha. Ang desisyong iyon ay nakasalalay sa iyo at sa iyong doktor nang magkasama, gamit ang iyong pagsusuri, ang iyong mga layunin, at ang iyong sariling pagpapasya kasabay ng numero.

Ang isang solong resulta ay hindi rin isang hatol sa iyong kalagayan. Sinusukat ng mga score na ito ang mga average sa mga grupo ng pasyente, at ang average ay nagtatago sa saklaw ng mga indibidwal na karanasan. Ang dalawang tao ay maaaring magkaroon ng parehong score ngunit magkaiba ang nararamdaman tungkol dito. Mas mahalaga ang iyong sariling kuwento kaysa sa iyong posisyon sa grupong iyon.

May mga praktikal na bitag na dapat malaman. Maaaring makaligtaan ng ilang mga tanong ang mga bagay na pinakamahalaga sa iyo, dahil walang iisang questionnaire ang nakapagtakda ng isang standard set [1]. Ang ilang mga resulta ay nagkukumpulan sa pinakataas o pinakababa ng scale, kaya ang isang tunay na pagbabago sa iyong nararamdaman ay maaaring hindi lumabas sa numero. At ang mga threshold na ginagamit upang husgahan kung ang isang pagbabago ay makabuluhan ay nag-iiba sa pagitan ng mga ospital at sa pagitan ng mga grupo ng pasyente [2], kaya ang isang maliit na paggalaw sa iyong score ay hindi nagdadala ng parehong kahulugan sa lahat ng lugar.

Ang tapat na buod ay ito: ang iyong score ay isang signal sa gitna ng marami. Maaari itong magbigay ng mga salita sa mga bagay na walang ibang nakakakita, at maaari nitong subaybayan ang iyong pag-unlad sa paglipas ng panahon. Ang hindi nito kayang gawin ay sabihin sa iyo kung ano ang mali, piliin ang iyong gamutan para sa iyo, o ibuod ang iyong paggaling sa isang solong numero.

Ang pinaka-punto

Ang mga questionnaire na ito ay mahusay sa isang bagay: ang paglalagay ng sarili mong mga salita kung ano ang iyong nararamdaman at kung ano ang kaya mong gawin, sa paraang maaaring masubaybayan sa paglipas ng panahon. Hindi ito isang diagnosis, hindi isang pagpili ng gamutan, at hindi isang prediksyon ng iyong paggaling. Ang isang bagay na dapat tandaan ay ang iyong score ay isang signal lamang sa gitna ng marami. Binabasa ito ng iyong care team kasabay ng iyong pagsusuri at ng iyong sariling mga layunin, kaya ang isang numero lamang ay hindi kailanman nagsasabi ng buong kuwento.

Mga Sanggunian

[1] Patient‐reported outcome measures (PROMs): Isang pagsusuri ng mga generic at condition‐specific na panukat at isang talakayan ng mga trend at isyu. Health Expectations. 2021. DOI: 10.1111/hex.13254

[2] Physical outcome measures: Ang papel ng lakas at range of motion sa pananaliksik sa orthopaedic. Injury. 2020. DOI: 10.1016/j.injury.2019.11.017

[3] Ang Patient Reported Outcome Measures (PROMs) ay dumating na sa sports and exercise medicine: Bakit sila mahalaga?. British Journal of Sports Medicine. 2015. DOI: 10.1136/bjsports-2014-093707

[4] Paggamit ng Patient-Reported Outcomes Measurement Information System Measures sa mga Orthopaedic Specialties: Mga Resulta ng isang Scoping Review para sa 2018 hanggang 2022. Journal of the American Academy of Orthopaedic Surgeons. 2025. DOI: 10.5435/jaaos-d-24-00432

[5] Koleksyon ng patient-reported outcomes; - ang mga text message sa mga mobile phone ay nagbibigay ng mga valid na score at mataas na response rate. BMC Medical Research Methodology. 2014. DOI: 10.1186/1471-2288-14-52

[6] CORR Insights®: Koleksyon at Pag-uulat ng Patient-reported Outcome Measures sa mga Arthroplasty Registry: Multinational Survey at mga Rekomendasyon. Clinical Orthopaedics & Related Research. 2021. DOI: 10.1097/corr.0000000000001918

[7] Value-based Healthcare: Patient-reported Outcomes sa Clinical Decision Making. Clinical Orthopaedics & Related Research. 2016. DOI: 10.1007/s11999-016-4813-4

[8] Pagsasama ng Patient-reported Outcomes sa Orthopaedic Clinical Practice: Proof of Concept Mula sa FORCE-TJR. Clinical Orthopaedics & Related Research. 2013. DOI: 10.1007/s11999-013-3143-z

[9] Patient reported outcome measures sa praktis. BMJ. 2015. DOI: 10.1136/bmj.g7818

[10] Mga nakitang benepisyo at limitasyon ng paggamit ng patient-reported outcome measures sa clinical practice kasama ang mga indibidwal na pasyente: isang systematic review ng mga qualitative study. Quality of Life Research. 2021. DOI: 10.1007/s11136-021-03003-z

[11] Isang Panawagan para sa isang Standardized Approach sa Pag-uulat ng Patient-Reported Outcome Measures. Journal of Bone and Joint Surgery. 2021. DOI: 10.2106/jbjs.21.00030

[12] May Saysay ba ang Pagkalkula ng Minimal Clinically Important Difference? Mga Paraan upang Mapabuti. Arthroscopy. 2024. DOI: 10.1016/j.arthro.2023.11.007

[13] Ang Minimal Clinically Important Difference: Tugon. The American Journal of Sports Medicine. 2023. DOI: 10.1177/03635465231189222

[14] Ang Minimal Clinically Important Difference: Liham sa Editor. The American Journal of Sports Medicine. 2023. DOI: 10.1177/03635465231189223

[15] Mga Alituntunin para sa Wastong Pag-uulat ng Clinical Significance, Kabilang ang Minimal Clinically Important Difference, Patient Acceptable Symptomatic State, Substantial Clinical Benefit, at Maximal Outcome Improvement. Arthroscopy. 2022. DOI: 10.1016/j.arthro.2022.08.020

[16] Patient‐reported outcome measures sa advanced musculoskeletal physiotherapy practice: isang systematic review. Musculoskeletal Care. 2017. DOI: 10.1002/msc.1200

[17] Pagsusuri sa Kalidad ng mga Available na Patient Reported Outcome Measures para sa Intermittent Claudication: Isang Systematic Review Gamit ang COSMIN Checklist. European Journal of Vascular and Endovascular Surgery. 2015. DOI: 10.1016/j.ejvs.2014.12.002


Evidence & references

This is the clinical evidence summary written for health professionals. It is technical, and it lists the research this page was built from. You do not need to read it to understand your treatment or to make a decision about it.

Overview

  • Patient-reported outcome measures (PROMs) are critical for capturing the patient's perspective on health status, which cannot be observed through clinical tests or imaging [48].
  • Standardized health-related outcome measures require evidence for change and a way to interpret change within individuals or difference between groups [3].
  • The minimum clinically important difference (MCID) defines the smallest amount an outcome must change to be meaningful to patients [46].
  • The minimum clinically important difference, the standard error of measurement, and the minimum detectable change are proposed as indicators for the clinical interpretation of test scores [1].
  • Lack of consensus in the literature has led to confusion about which measurement properties are relevant, which concepts they represent, and how to assess these measurement properties in terms of design requirements and preferred statistical methods [16].
  • Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results of a study inform us about the quality of the outcome measurement instrument at issue [2].
  • An appropriate and validated measure that is suitable for both the particular study population and the reason for collecting the PROMs data should be chosen [6].
  • Providing access to PROM scores without clearly understanding how and why surgeons may consider using them can result in expensive and underused systems that add little value [44].
  • Reasons for limited use of PROMs by orthopedic surgeons include a lack of knowledge on how to use them and the perception that it is too time-consuming to add to regular clinical routine [45].
  • Limitations of PROM use in clinical practice shed light on why PROM use may not always improve patient outcomes and provide considerations for the design and implementation of future PROM initiatives [47].
  • PROMIS measures are efficient and precise tools, and their use is expected to continue to increase across medical and surgical specialties as health systems and payers expand their definition of healthcare quality to include patient-reported health outcomes [49].

How It Works

Interpretation and Clinical Utility

  • The minimum clinically important difference, standard error of measurement, and minimum detectable change are proposed as indicators for the clinical interpretation of test scores [1].
  • Scores from tools designed to measure outcomes that matter to patients have been developed over the past 30 years, but few are used routinely at the point of care [21].
  • An appropriate and validated measure suitable for the particular study population and the reason for collecting data should be chosen for patient-reported outcome measures [6].

Reliability and Validity Assessment

  • The two-way mixed-effect analysis of variance model with interaction for the absolute agreement between single scores is recommended to assess test-retest reliability for patient-reported outcome measures [4].
  • Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how results inform about the quality of the outcome measurement instrument [2].
  • The Patient-Reported Outcomes Measurement Information System (PROMIS) item banks demonstrated good reliability across most of the score distributions [43].
  • The MOS short form health survey (SF-36) scales met required internal consistency criteria with Cronbach alpha coefficients equaling or exceeding 0.70 in a study conducted in India [33].
  • An assessment tool for brachial plexus regional anesthesia performance demonstrated construct validity by reliably discriminating between different levels of training, with senior trainees performing significantly better than junior trainees on the global rating scale [35].

Standardization and Data Collection

  • Current data collection of patient-reported outcome measures is neither uniform nor complete across the world's registries, which may impact data validity and the ability to compare outcomes [8].
  • No key measure was identified to capture functional status in advanced musculoskeletal physiotherapy practice, with 15 different tools utilized, highlighting the need for greater standardization of outcome measurement [40].
  • Outcomes assessed on numeric rating scales and reported with text-messages on mobile phones provide comparable scores to questionnaires completed with pen and paper [7].

Limitations and Gaps

  • Physical outcome measures such as range of motion and strength are not as reliable measures as one would think, and are being changed for the use of patient reported outcomes [15].
  • All patient-reported outcome measures for intermittent claudication require further validation studies to fill the gaps in their measurement properties [32].

How It Is Used

  • Clinicians can use the minimum clinically important difference, standard error of measurement, and minimum detectable change to interpret test scores [1].
  • Standardized health-related outcome measures require evidence for change and a method to interpret change within individuals or differences between groups [3].
  • Clinicians must be cautious when accepting a minimal clinically important difference score at face value due to wide variability in established scores for a single outcome scale [5].
  • Outcomes assessed on numeric rating scales via text messages on mobile phones provide comparable scores to those completed with pen and paper questionnaires [7].
  • Investigators can choose thresholds to dichotomize responses on health-related quality of life measures based on absolute scores or change scores to facilitate interpretation [10].
  • Promoting ownership and correct use of the measure by clinicians can improve practice and the quality of care through patient-reported outcome measure data use in clinical decision-making [11].
  • The minimal important difference is not an immutable characteristic and may vary by population and context, meaning no single minimal important difference is valid for all study applications [14].
  • Routine use of patient-reported outcome measures has the potential to help transform healthcare [18].
  • High variability in scale choice and the use of measures not validated in pediatrics make comparative outcomes research difficult in the pediatric sports population [19].
  • High-quality systematic reviews on measurement instruments are advocated to recommend the best available outcome measurement instrument [20].
  • Few outcome measurement tools have been used routinely at the point of care despite being developed over the past 30 years [21].
  • Further studies are needed to provide validated outcome measures to ensure the accuracy of reported results and conclusions after rib fracture [22].
  • Comparative effectiveness research requires accurate assessments of patient numbers, follow-up completeness, clinical outcomes, and care settings [34].
  • Recommendations for the selection of patient-assessed measures of health outcome are needed [36].
  • Limiting follow-up to automated methods has the potential to transform the design and conduct of outcome-based research to provide substantially better research value in large prospective cohorts [38].
  • There are challenges in using patient-reported outcomes in clinical practice [39].
  • The routine use of patient-reported outcomes in clinical practice is assessed for its impact on the process of care, patients' and professionals' experiences of care, and health outcomes [42].

Interpreting the Results

Measurement Properties and Reliability

  • Consensus was reached on deducing a comprehensive research question from the design of a reliability study to determine how results inform the quality of an outcome measurement instrument [2].
  • The two-way mixed-effect analysis of variance model with interaction for the absolute agreement between single scores is recommended for assessing test-retest reliability of patient-reported outcome measures [4].
  • Range of motion and strength are not as reliable measures as one would think [15].

Minimal Clinically Important Difference (MCID)

  • Clinicians must be cautious in accepting an MCID score at face value given the wide variability of established MCID scores available for a single outcome scale [5].
  • The recommended approach for estimating the minimal important difference is to use several anchor-based methods with relevant clinical or patient-based indicators, examine distribution-based estimates as supportive information, and triangulate on a single value or small range of values [9].
  • The Minimal Clinically Important Difference (MCID) is a point estimate that should always be reported with its associated 95% CI, as there is no basis for considering a sample-derived MCID a singular threshold to be crossed [12].
  • The minimal clinically important difference (MCID) is an imperfect solution to a complicated problem, and different methods used to calculate MCID lead to highly heterogeneous values [13].
  • The minimal important difference (MID) is not an immutable characteristic but may vary by population and context, and no one MID may be valid for all study applications [14].
  • The minimal clinically important difference (MCID) is a low bar that patients do not seek when undergoing surgery; instead, they aim for substantial clinical benefit or a patient acceptable symptom state (PASS) [17].
  • The calculation of the minimal clinically important difference (MCID) needs to be correlated with changes in scores on the rating scale and external anchors [24].
  • A systematic approach exists to triangulate on the Minimal Clinically Important Difference (MCID) using both distribution-based and anchor-based methods [29].

Reporting and Interpretation Frameworks

  • Outcomes assessed on numeric rating scales and reported with text-messages on mobile phones or with questionnaires completed with pen and paper provide comparable scores [7].
  • Investigators can choose thresholds to dichotomize responses on HRQL based on absolute scores or change scores to facilitate interpretation [10].
  • A standardized reporting of patient-reported outcome measures (PROMs) has been proposed that incorporates the minimum clinically important difference (MCID) and the patient acceptable symptom state (PASS), introducing a 'clinical relevance ratio' to report the proportion of patients achieving clinical importance rather than relying solely on mean changes [23].
  • Routine use of patient reported outcome measures (PROMs) has the potential to help transform healthcare [18].

Limitations and Pitfalls

Measurement Properties and Reliability

  • Lack of consensus in the literature has led to confusion about which measurement properties are relevant, which concepts they represent, and how to assess these properties in terms of design requirements and preferred statistical methods [16].
  • To assess test-retest reliability for patient-reported outcome measures, the two-way mixed-effect analysis of variance model with interaction for the absolute agreement between single scores is recommended [4].
  • Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results inform about the quality of the outcome measurement instrument [2].
  • A 10-item computerized adaptive test (CAT) eliminated floor and decreased ceiling effects, achieving a small standard error (≤ 2.2) across scores from 20 to 50 with reliability ≥ 0.95 for a representative US sample [31].

Minimal Clinically Important Difference (MCID)

  • The recommended approach is to estimate the minimal important difference based on several anchor-based methods with relevant clinical or patient-based indicators, examine various distribution-based estimates as supportive information, and triangulate on a single value or small range of values [9].
  • MCIDs expressed as effect sizes reduce bias, which mainly results from dependency on the baseline score [41].
  • Researchers, clinicians, and healthcare policy decision makers can consider using a specific instrument to evaluate the design, conduct, and analysis of studies estimating anchor based minimal important differences [30].

Data Collection and Standardization

  • The current data collection of patient-reported outcome measures (PROMs) is neither uniform nor complete across the world's registries, which may impact data validity and the ability to compare outcomes [8].
  • The high variability in scale choice and the use of measures not validated in pediatrics make comparative outcomes research difficult [19].
  • Only 57% of primary medical providers are using patient reported outcome measures within their practice, with the information largely used for research rather than clinical decision-making [27].
  • Further studies are needed to provide validated outcome measures to ensure accuracy of the reported results and conclusions [22].

Clinical Application and Interpretation

  • The authors propose using the minimum clinically important difference, the standard error of measurement, and the minimum detectable change as indicators for the clinical interpretation of test scores [1].
  • Integrating standardized patient-reported outcomes into routine orthopaedic visits is feasible and improves practice efficiency by providing actionable objective data for shared decision-making [26].
  • The ability to collect patient-reported outcome (PRO) data in real time and share this information with patients to inform clinical decision making represents the future of value-based healthcare, moving beyond research-focused assessments to guide treatment consistent with patient preferences [25].
  • Promoting ownership and correct use of the measure by clinicians can potentially improve practice and the quality of care provided through patient-reported outcome measure data use in clinical decision-making [11].

Key Evidence

  • [L5] The authors propose using the minimum clinically important difference, the standard error of measurement, and the minimum detectable change as indicators for the clinical interpretation of test scores. [1] (10.1136/bjsports-2012-091704)
  • [Paper] Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results of a study inform us about the quality of the outcome measurement instrument at issue. [2] (10.1186/s12874-020-01179-5)
  • [L4] Standardized health-related outcome measures require evidence for change and a way to interpret change within individuals or difference between groups. [3] (10.1016/j.rdc.2018.01.011)
  • [L5] To assess test-retest reliability for patient-reported outcome measures, the two-way mixed-effect analysis of variance model with interaction for the absolute agreement between single scores is recommended. [4] (10.1007/s11136-018-2076-0)
  • [L5] Clinicians must be cautious in accepting an MCID score at face value given the wide variability of established MCID scores available for a single outcome scale. [5] (10.1179/2042618612y.0000000001)
  • [Paper] An appropriate and validated measure that is suitable for both the particular study population and the reason for collecting the PROMs data should be chosen. [6] (10.1136/bmj.c186)
  • [L4] Outcomes assessed on numeric rating scales and reported with text-messages on mobile phones or with questionnaires completed with pen and paper provide comparable scores. [7] (10.1186/1471-2288-14-52)
  • [L4] The current data collection of patient-reported outcome measures (PROMs) is neither uniform nor complete across the world's registries, which may impact data validity and the ability to compare outcomes. [8] (10.1097/corr.0000000000001918)
  • [L5] The recommended approach is to estimate the minimal important difference based on several anchor-based methods, with relevant clinical or patient-based indicators, and to examine various distribution-based estimates (i.e., effect size, standardized response mean, standard error of measurement) as supportive information, and then to triangulate on a single value or small range of values for the MID. [9] (10.1186/1477-7525-4-70)
  • [L5] Investigators can choose thresholds to dichotomize responses on HRQL based on absolute scores or change scores to facilitate interpretation. [10] (10.1186/1477-7525-4-62)
  • [L2] This could promote ownership and correct use of the measure by clinicians, potentially improving practice and the quality of care provided through patient-reported outcome measure data use in clinical decision-making. [11] (10.1177/0269216313491619)
  • [L5] The Minimal Clinically Important Difference (MCID) is a point estimate that should always be reported with its associated 95% CI, as there is no basis for considering a sample-derived MCID a singular threshold to be crossed. [12] (10.1177/03635465231189223)
  • [L5] The minimal clinically important difference (MCID) is an imperfect solution to a complicated problem, and different methods used to calculate MCID lead to highly heterogeneous values. [13] (10.1177/03635465231189222)
  • [L5] The minimal important difference (MID) is not an immutable characteristic but may vary by population and context, and no one MID may be valid for all study applications. [14] (10.1016/j.jclinepi.2007.03.012)
  • [Paper] Physical outcome measures are being changed for the use of patient reported outcomes, and range of motion and strength are not as reliable measures as one would think. [15] (10.1016/j.injury.2019.11.017)
  • [L5] Lack of consensus in the literature has lead to confusion about which measurement properties are relevant, which concepts they represent, and how to assess these measurement properties in terms of design requirements and preferred statistical methods. [16] (10.1016/j.jclinepi.2010.02.006)
  • [L5] The minimal clinically important difference (MCID) is a low bar that patients do not seek when undergoing surgery; instead, they aim for substantial clinical benefit or a patient acceptable symptom state (PASS). [17] (10.1016/j.arthro.2023.10.014)
  • [L5] Routine use of patient reported outcome measures (PROMs) has the potential to help transform healthcare. [18] (10.1136/bmj.f167)
  • [L4] The high variability in scale choice and the use of measures not validated in pediatrics make comparative outcomes research difficult. [19] (10.1177/2325967119s00036)
  • [L5] They advocate for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended. [20] (10.1590/bjpt-rbf.2014.0143)
  • [L5] Scores of tools to measure outcomes that matter to patients have been developed over the past 30 years but few are used routinely at the point of care. [21] (10.1136/bmj.g7818)
  • [L2] Further studies are needed to provide validated outcome measures to ensure accuracy of the reported results and conclusions. [22] (10.1016/j.injury.2019.07.002)
  • [L5] The authors propose a standardized reporting of patient-reported outcome measures (PROMs) that incorporates the minimum clinically important difference (MCID) and the patient acceptable symptom state (PASS), introducing a 'clinical relevance ratio' to report the proportion of patients achieving clinical importance rather than relying solely on mean changes. [23] (10.2106/jbjs.21.00030)
  • [L5] The calculation of the minimal clinically important difference (MCID) needs to be correlated with changes in scores on the rating scale and external anchors. [24] (10.1177/03635465231193405)
  • [L5] The ability to collect patient-reported outcome (PRO) data in real time and share this information with patients to inform clinical decision making represents the future of value-based healthcare, moving beyond research-focused assessments to guide treatment consistent with patient preferences. [25] (10.1007/s11999-016-4813-4)
  • [L4] The authors conclude that integrating standardized patient-reported outcomes into routine orthopaedic visits is feasible and improves practice efficiency by providing actionable objective data for shared decision-making. [26] (10.1007/s11999-013-3143-z)
  • [L4] Only 57% of primary medical providers are using patient reported outcome measures within their practice, with the information largely used for research rather than clinical decision-making. [27] (10.1177/2325967119s00107)
  • [L5] The authors describe a systematic approach to triangulate on the Minimal Clinically Important Difference (MCID) using both distribution-based and anchor-based methods. [29] (10.1016/j.apmr.2019.12.008)
  • [L4] Researchers, clinicians, and healthcare policy decision makers can consider using this instrument to evaluate the design, conduct, and analysis of studies estimating anchor based minimal important differences. [30] (10.1136/bmj.m1714)
  • [L5] A 10-item CAT eliminated floor and decreased ceiling effects, achieving a small standard error (≤ 2.2) across scores from 20 to 50 with reliability ≥ 0.95 for a representative US sample. [31] (10.1016/j.jclinepi.2006.06.025)
  • [L1] However, all PROMs require further validation studies to fill the gaps in their measurement properties. [32] (10.1016/j.ejvs.2014.12.002)
  • [L4] The questionnaire was well understood by the respondents, and all scales met the required internal consistency criteria with Cronbach alpha coefficients equaling or exceeding 0.70. [33] (10.4103/0970-0218.106623)
  • [L5] Comparative effectiveness research requires accurate assessments of patient numbers, follow-up completeness, clinical outcomes, and care settings. [34] (10.1007/s11999-013-3194-1)
  • [L4] The assessment tool demonstrated construct validity by reliably discriminating between different levels of training, as senior trainees performed significantly better than junior trainees on the global rating scale. [35] (10.1016/j.rapm.2006.10.009)
  • [L4] Recommendations for the selection of patient assessed measures of health outcome are needed. [36] (10.1136/bmj.324.7351.1417)
  • [L2] Limiting follow-up to automated methods may have the potential to transform the way that outcome-based research is designed and conducted to provide substantially better research value in large prospective cohorts. [38] (10.2106/jbjs.19.00531)
  • [L5] However, there are a number of challenges in using patient-reported outcomes in clinical practice. [39] (10.1007/s11136-008-9379-5)
  • [L2] No key measure was identified to capture functional status, with 15 different tools utilized, highlighting the need for greater standardization of outcome measurement in musculoskeletal clinical practice, service evaluation and research. [40] (10.1002/msc.1200)
  • [Paper] MCIDs expressed as effect sizes reduce bias, which mainly results from dependency on the baseline score. [41] (10.1016/j.jclinepi.2016.11.016)
  • [Paper] The objectives are to assess the impact of the routine use of patient-reported outcomes in clinical practice on the process of care, patients' and professionals' experiences of care, and health outcomes. [42] (10.1002/14651858.cd011589)
  • [L5] All item banks demonstrated good reliability across most of the score distributions. [43] (10.1016/j.jclinepi.2010.04.011)
  • [L4] Providing access to PROM scores without clearly understanding how and why surgeons may consider using them can result in expensive and underused systems that add little value. [44] (10.1097/corr.0000000000002059)
  • [L4] The reasons provided included a lack of knowledge on how to use PROMs and the perception that it is too time-consuming to add to regular clinical routine. [45] (10.1186/s13018-020-02135-1)
  • [Paper] The MCID defines the smallest amount an outcome must change to be meaningful to patients. [46] (10.1001/jama.2014.13128)
  • [L4] These limitations shed some light on why PROM use may not always improve patient outcomes and provide considerations for the design and implementation of future PROM initiatives. [47] (10.1007/s11136-021-03003-z)
  • [L5] This editorial argues that Patient Reported Outcome Measures (PROMs) are critical for capturing the patient's perspective on health status, which cannot be observed through clinical tests or imaging. [48] (10.1136/bjsports-2014-093707)
  • [L4] PROMIS measures are efficient and precise tools, and their use is expected to continue to increase across medical and surgical specialties as health systems and payers expand their definition of healthcare quality to include patient-reported health outcomes. [49] (10.5435/jaaos-d-24-00432)

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