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परिणाम स्कोरः वे क्या मापते हैं, और क्या नहीं
What PROMs (patient-reported outcome measures) like the DASH, QuickDASH, SPADI, ASES and PRWE actually are, and how to read your own score. They exist to track how YOUR symptoms and function change over time, and to compare groups of patients in research. They are not a test that decides what treatment you should have — a score does not diagnose anything, and two people with the same number can need completely different things. Covers what the numbers mean, why a change matters more than a single reading, what a 'minimal clinically important difference' is, and the limits of a questionnaire.
यह क्या है¶
एक रोगी-रिपोर्ट किया गया परिणाम माप एक प्रश्नावली है जिसे आप अपने स्वास्थ्य के बारे में भरते हैं। एक परीक्षण के बजाय, यह आपसे पूछता है कि आप कैसा महसूस कर रहे हैं और आप क्या कर सकते हैं। ये प्रश्नावली कम से कम 1960 के दशक से आसपास रहे हैं, हालांकि उनके लिए नाम नया है [1].
आपका डॉक्टर एक्स-रे पर या शारीरिक परीक्षण के माध्यम से दर्द या थकान नहीं देख सकता है। अनुसंधान इंगित करता है कि गति की सीमा और ताकत जैसी चीजें उतनी विश्वसनीय नहीं हैं जितनी आप सोच सकते हैं, यही कारण है कि अधिक क्लीनिक अब सीधे मरीजों से पूछते हैं [2]. यह वह अंतर है जो ये प्रश्नावली भरती हैंः वे आपके स्वयं के कार्य और कल्याण के बारे में आपके विचार को पकड़ती हैं, जिसे कोई स्कैन या नैदानिक परीक्षण नहीं देख सकता है [3].
इनमें से कुछ प्रश्नावली दैनिक जीवन से संबंधित प्रश्नों की लंबी सूचियां हैं। नए, जैसे कि एक अमेरिकी अनुसंधान नेटवर्क के माध्यम से विकसित PROMIS उपाय, कम और अधिक सटीक हैं [4]. आप एक पेपर पर एक पेन भर सकते हैं, या अपने फोन पर कुछ पाठ संदेशों के माध्यम से कुछ सवालों का जवाब दे सकते हैं। अध्ययनों में पाया गया है कि दोनों तरीके तुलनात्मक स्कोर देते हैं [5].
आपके उत्तरों को स्कोर किया जाता है और समय के साथ तुलना की जाती है, ताकि उपचार से पहले और बाद में परिवर्तनों को ट्रैक किया जा सके। शोधकर्ता रोगियों के बड़े समूहों में परिणामों की तुलना करने के लिए भी उनका उपयोग करते हैं, हालांकि एकत्रित डेटा दुनिया के संयुक्त रजिस्ट्रियों में समान या पूर्ण नहीं है, जो तुलना को कठिन बना सकता है। [6].
एक बात जानने लायक है: ये स्कोर रोगियों के समूहों में औसत को मापते हैं। वे भविष्यवाणी नहीं करते कि कोई व्यक्ति कैसा महसूस करेगा। आपका डॉक्टर आपके स्कोर का उपयोग आपकी परीक्षा और आपके स्वयं के लक्ष्यों के साथ जानकारी के एक टुकड़े के रूप में करेगा, न कि आपकी वसूली के फैसले के रूप में।
यह क्यों महत्वपूर्ण है¶
ये प्रश्नावली दो अलग-अलग काम करती हैं, और यह जानने में मदद मिलती है कि कौन कौन सा है।
पहला काम समय के साथ आपका अनुसरण करना है। आप उपचार से पहले और उसके बाद एक ही प्रश्नावली भरते हैं, ताकि आपकी देखभाल करने वाली टीम देख सके कि आपके लिए कितना बदल गया है। यह आपके अपने स्कोर को आपकी अपनी प्रगति के मार्कर के रूप में सबसे उपयोगी बनाता है, न कि अन्य लोगों के खिलाफ रैंक करने के लिए एक संख्या के रूप में। दो लोग अलग-अलग स्थानों से शुरू कर सकते हैं और दोनों ने अच्छा किया है, जबकि अलग-अलग अंकों के साथ समाप्त हो सकते हैं।
दूसरा काम बहुत बड़े पैमाने पर होता है। जब कई मरीज एक ही प्रश्नावली भरते हैं, तो पूरे समूहों की तुलना की जा सकती है, इसलिए उपचार और सेवाओं का आकलन पूरी आबादी में किया जा सकता है। इस तरह से परिणाम अनुसंधान में और देखभाल के बारे में फैसलों में अधिक व्यापक रूप से खिलाते हैं। इस जानकारी को नियमित रूप से इकट्ठा करने का वर्णन स्वास्थ्य देखभाल के भविष्य के रूप में किया गया है जो रोगियों के लिए महत्वपूर्ण है [1], और इसे नियमित ऑर्थोपेडिक यात्राओं में जोड़ना व्यवहार्य है और डॉक्टरों और रोगियों को एक साथ निर्णय लेने के लिए ठोस जानकारी देता है [2].
इसके बारे में जानने लायक एक पकड़ है। इन प्रश्नावली के पीछे आंदोलन ज्यादातर शोधकर्ताओं और देखभाल के लिए भुगतान करने वाले लोगों द्वारा संचालित किया गया है, और यह हमेशा रोगी के दृष्टिकोण से देखभाल में सुधार पर ध्यान केंद्रित नहीं किया गया है [3]. स्कोर का उपयोग करने के तरीके में कुछ सीमाएं समझा सकती हैं कि क्यों उन्हें भरने से हमेशा रोगियों के लिए बेहतर परिणाम नहीं मिलते हैं [4].
तो आपके लिए इसका क्या मतलब है? आपका स्कोर आपके डॉक्टर द्वारा आपकी परीक्षा और आपके स्वयं के लक्ष्यों के साथ उपयोग की जाने वाली जानकारी का एक टुकड़ा है। यह एक ग्रेड नहीं है, और यह एक भविष्यवाणी नहीं है। यह क्या प्रदान करता है एक तरीका है शब्दों को बदलने के लिए आप महसूस कर सकते हैं लेकिन कोई और नहीं देख सकता है, और एक तरीका है आपकी प्रगति के लिए एक बड़ी तस्वीर का हिस्सा होने के लिए जो सभी के लिए देखभाल करने में मदद करता है।
परिणाम का क्या अर्थ है¶
तो आप एक स्कोर है. यह वास्तव में आपको क्या बताता है?
पहले एक बात जान लीजिये: कौन सा तरीका बेहतर है यह प्रश्नावली पर निर्भर करता है। फॉर्म स्वयं, या आपको देने वाला व्यक्ति, आपको बताएगा कि यह किस दिशा में घूमता है।
संख्या में एक छोटा सा परिवर्तन बहुत मायने नहीं रखता है। शोधकर्ताओं ने इस समस्या पर काम किया है, और वे स्कोर पढ़ने में मदद करने के लिए कुछ विचारों का उपयोग करते हैं। एक को कहा जाता है न्यूनतम नैदानिक रूप से महत्वपूर्ण अंतर, जो कि सबसे छोटा परिवर्तन है जो एक रोगी वास्तव में रोजमर्रा की जिंदगी में नोटिस करेगा। एक और मरीज को स्वीकार्य लक्षण राज्य कहा जाता है, जो वह बिंदु है जहां एक मरीज पर्याप्त अच्छी तरह से महसूस करता है कि वे अपने लक्षणों को स्वीकार्य मानते हैं [1].
यहाँ पकड़ हैः कोई एकल सीमा नहीं है जो सभी के लिए काम करती है। इन मार्करों के लिए मान अस्पतालों और रोगी समूहों के बीच भिन्न होते हैं [2]. इनकी गणना करने के विभिन्न तरीकों से काफी अलग-अलग उत्तर मिलते हैं [3], और किसी भी एक मूल्य एक फर्म लाइन के बजाय एक सीमा के रूप में पढ़ा जाना चाहिए [4]. इसलिए यदि आपका स्कोर थोड़ी मात्रा में बढ़ता है, तो यह अकेले आपको बहुत कुछ नहीं बताता है। उसी स्कोर को बाद में फिर से मापा गया, और जिस दिशा में यह जा रहा है, वह कहीं अधिक बताता है।
यह भी जानने योग्य है कि एक परिवर्तन सांख्यिकीय रूप से महत्वपूर्ण हो सकता है बिना आपके द्वारा महसूस किए जाने वाले कुछ होने के। इन उपायों पर शोध से पता चलता है कि संख्याओं में दिखाई देने वाला अंतर आपके लिए महत्वपूर्ण अंतर से मेल नहीं खा सकता है [5]. यही कारण है कि आपकी देखभाल टीम आपके परीक्षण और आपके अपने लक्ष्यों के साथ-साथ आपके स्कोर को देखती है, न कि संख्या को पूरे उत्तर के रूप में मानती है।
एक और सीमा। कार्य को मापने के लिए मानक तरीके के रूप में कोई एकल प्रश्नावली सामने नहीं आई है। एक समीक्षा में इस उद्देश्य के लिए 15 अलग-अलग उपकरणों का उपयोग पाया गया, यही कारण है कि शोधकर्ता अधिक मानकीकरण का आह्वान करते रहते हैं। [6]. इन सभी उपायों को अभी भी आगे अध्ययन की आवश्यकता है कि वे कितनी अच्छी तरह से काम करते हैं [7].
इसलिए अपने स्कोर को कई के बीच एक संकेत के रूप में पढ़ें। पूछें कि क्या बदल गया, कितना, और क्या आप इसे महसूस कर सकते हैं।
यह आपको क्या नहीं बता सकता है¶
एक प्रश्नावली स्कोर कुछ भी निदान नहीं कर सकता है। यह रिकॉर्ड करता है कि आप कैसा महसूस करते हैं, यह नहीं कि आपके साथ क्या गलत है। यह यह भी तय नहीं करता है कि आपको कौन सा उपचार लेना चाहिए। यह निर्णय आपके और आपके डॉक्टर के बीच होता है, आप अपनी जांच, अपने लक्ष्यों और संख्या के साथ-साथ अपने स्वयं के निर्णय का उपयोग करते हैं।
एक एकल परिणाम यह भी नहीं बताता कि आप कैसे कर रहे हैं। ये स्कोर रोगियों के समूहों के बीच औसत को मापते हैं, और एक औसत व्यक्तिगत अनुभवों की सीमा को छुपाता है। दो लोगों के पास एक ही स्कोर हो सकता है और इसके बारे में पूरी तरह से अलग महसूस कर सकते हैं। आपकी अपनी कहानी उस समूह में आपकी जगह से ज्यादा मायने रखती है।
इसके बारे में जानने लायक कुछ व्यावहारिक जाल हैं। कुछ प्रश्नों में आपके लिए जो सबसे महत्वपूर्ण है, वह छूट सकता है, क्योंकि कोई भी एकल प्रश्नावली एक मानक सेट पर बस नहीं गई है [1]. कुछ परिणाम स्केल के बहुत ऊपर या नीचे होते हैं, इसलिए आप जो महसूस करते हैं उसमें वास्तविक परिवर्तन संख्या में नहीं दिखाया जा सकता है। और इस बात के लिए उपयोग की जाने वाली सीमाएं कि क्या कोई परिवर्तन सार्थक है, अस्पतालों के बीच और रोगी समूहों के बीच भिन्न होता है। [2], तो आपके स्कोर में एक छोटा सा बदलाव हर जगह एक ही अर्थ नहीं रखता है।
ईमानदार सारांश यह है: आपका स्कोर कई में से एक संकेत है। यह उन चीज़ों पर शब्द डाल सकता है जिन्हें कोई और नहीं देख सकता, और यह समय के साथ आपकी प्रगति को ट्रैक कर सकता है। यह आपको बता नहीं सकता कि क्या गलत है, आपके लिए उपचार चुनें, या एक संख्या में आपकी वसूली का सारांश दें।
निचली रेखा¶
ये प्रश्नावली एक चीज़ में अच्छी होती हैं: अपने शब्दों में यह बताना कि आप कैसा महसूस कर रहे हैं और आप क्या कर सकते हैं, एक तरह से जिसे समय के साथ ट्रैक किया जा सके। वे एक निदान नहीं हैं, एक उपचार विकल्प नहीं हैं, और आपकी वसूली की भविष्यवाणी नहीं हैं। याद रखने योग्य एक बात यह है कि आपका स्कोर कई में से एक संकेत है। आपकी देखभाल टीम इसे आपकी परीक्षा और आपके अपने लक्ष्यों के साथ पढ़ती है, इसलिए एक संख्या अकेले पूरी कहानी नहीं बताती है।
संदर्भ¶
[1] रोगी-रिपोर्ट किए गए परिणाम उपाय (पीआरओएम): सामान्य और स्थिति-विशिष्ट उपायों की समीक्षा और रुझानों और मुद्दों की चर्चा। स्वास्थ्य संबंधी अपेक्षाएं. 2021 डीओआईः 10.1111/hex.13254
[2] शारीरिक परिणाम माप: आर्थोपेडिक अनुसंधान में शक्ति और गति की सीमा की भूमिका। चोट. 2020 डीओआईः 10.1016/j.injury.2019.11.017
[3] रोगी रिपोर्ट किए गए परिणाम उपाय (पीआरओएम) खेल और व्यायाम चिकित्सा में आ गए हैं: वे क्यों मायने रखते हैं? ब्रिटिश जर्नल ऑफ स्पोर्ट्स मेडिसिन2015 में। डीओआईः 10.1136/bjsports-2014-093707
[4] ऑर्थोपेडिक विशेषताओं में रोगी-रिपोर्ट किए गए परिणाम माप सूचना प्रणाली उपायों का उपयोगः 2018 से 2022 के लिए एक स्कोपिंग समीक्षा के परिणाम। अमेरिकन एकेडमी ऑफ ऑर्थोपेडिक सर्जन का जर्नल2025 तक। डीओआईः 10.5435/jaaos-d-24-00432
[5] रोगी द्वारा रिपोर्ट किए गए परिणामों का संग्रह; - मोबाइल फोन पर पाठ संदेश वैध स्कोर और उच्च प्रतिक्रिया दर प्रदान करते हैं। बीएमसी चिकित्सा अनुसंधान पद्धति२०१४। डीओआईः 10.1186/1471-2288-14-52
[6] कॉर इनसाइट्स®: आर्थ्रोप्लास्टी रजिस्ट्रियों में रोगी-रिपोर्ट किए गए परिणाम उपायों का संग्रह और रिपोर्टिंग: बहुराष्ट्रीय सर्वेक्षण और सिफारिशें। क्लिनिकल ऑर्थोपेडिक्स और संबंधित अनुसंधान. 2021 डीओआईः 10.1097/corr.0000000000001918
[7] मूल्य-आधारित स्वास्थ्य सेवा: नैदानिक निर्णय लेने में रोगी-रिपोर्ट किए गए परिणाम। क्लिनिकल ऑर्थोपेडिक्स और संबंधित अनुसंधानवर्ष 2016 डीओआईः 10.1007/s11999-016-4813-4
[8] ऑर्थोपेडिक क्लिनिकल प्रैक्टिस में रोगी-रिपोर्ट किए गए परिणामों को एकीकृत करना: फोर्स-टीजेआर से अवधारणा का प्रमाण। क्लिनिकल ऑर्थोपेडिक्स और संबंधित अनुसंधान2013 में। डीओआईः 10.1007/s11999-013-3143-z
[9] रोगी ने व्यवहार में परिणाम उपायों की सूचना दी। बीएमजे2015 में। डीओआईः 10.1136/bmj.g7818
[10] व्यक्तिगत रोगियों के साथ नैदानिक अभ्यास में रोगी-रिपोर्ट किए गए परिणाम उपायों के उपयोग के कथित लाभ और सीमाएंः गुणात्मक अध्ययनों की एक व्यवस्थित समीक्षा। जीवन की गुणवत्ता अनुसंधान. 2021 डीओआईः 10.1007/s11136-021-03003-z
[11] रोगी-रिपोर्ट किए गए परिणाम उपायों की रिपोर्टिंग के लिए एक मानकीकृत दृष्टिकोण का आह्वान। जर्नल ऑफ बोन एंड जॉइंट सर्जरी. 2021 डीओआईः 10.2106/jbjs.21.00030
[12] क्या न्यूनतम नैदानिक रूप से महत्वपूर्ण अंतर की गणना समझ में आती है? सुधार के तरीके आर्थ्रोस्कोपी. 2024. डीओआईः 10.1016/j.arthro.2023.11.007
[13] न्यूनतम नैदानिक रूप से महत्वपूर्ण अंतर: प्रतिक्रिया। अमेरिकन जर्नल ऑफ स्पोर्ट्स मेडिसिन. 2023. डीओआईः 10.1177/03635465231189222
[14] न्यूनतम नैदानिक रूप से महत्वपूर्ण अंतर: संपादक को पत्र। अमेरिकन जर्नल ऑफ स्पोर्ट्स मेडिसिन. 2023. डीओआईः 10.1177/03635465231189223
[15] नैदानिक महत्व की उचित रिपोर्टिंग के लिए दिशानिर्देश, जिसमें न्यूनतम नैदानिक रूप से महत्वपूर्ण अंतर, रोगी की स्वीकार्य लक्षण स्थिति, पर्याप्त नैदानिक लाभ और अधिकतम परिणाम सुधार शामिल हैं। आर्थ्रोस्कोपी2022 तक। डीओआईः 10.1016/j.arthro.2022.08.020
[16] उन्नत मस्कुलोस्केलेटल फिजियोथेरेपी अभ्यास में रोगी-रिपोर्ट किए गए परिणाम उपायः एक व्यवस्थित समीक्षा। मस्कुलोस्केलेटल देखभालवर्ष 2017 डीओआईः 10.1002/msc.1200
[17] इंटरमिटेंट क्लॉडिकेशन के लिए उपलब्ध रोगी रिपोर्ट किए गए परिणाम उपायों की गुणवत्ता का आकलन करनाः COSMIN चेकलिस्ट का उपयोग करके एक व्यवस्थित समीक्षा। संवहनी और अंतःसंवहनी सर्जरी का यूरोपीय जर्नल2015 में। डीओआईः 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)
References¶
[1] Patient-reported outcome measures (PROMs): how should I interpret reports of measurement properties? A practical guide for clinicians and researchers who are not biostatisticians. British Journal of Sports Medicine. 2012. DOI: 10.1136/bjsports-2012-091704
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