Domains considered in the meeting in response to the question ‘Is the ‘candidate domain (item)’ important enough to be included in a core domain set for tendinopathy?’
| Domain | Description/definition (example outcome) | Consensus meeting % | Survey (HCP; P) % | Some typical consensus meeting discussion points |
| Core domains (candidate domains (items) agreed ≥70% agree) | ||||
| Participant/patient rating overall condition | A single assessment numerical evaluation (eg, rate your tendon status where 100% is no problems and 0% worst case scenario, global rating of change (how are you now compared with prior treatment),18–20 patient acceptable symptom status (Is your current symptom level acceptable?)). | 100 | 61, 91 | Considered to be the most patient-centred candidate domain. |
| Participation | A patient rating of the level of participation/engagement across areas of their life. (eg, ratings of level of sport and time to return to sport).21 | 94 | * | This resulted from the discussion on the three candidate domains considered in the survey and at the meeting, which were overall, sport and work participation. With the exception of the sport participation domain where the patients agreed it ought to be a core domain, this candidate domain did not reach agreement in the survey. Comments in the survey suggested amalgamation, which was supported at the meeting. |
| Overall (eg, time to return to work, level of work (strenuousness)). | * | 25, 65 | ||
| Sport participation | * | 57, 74 | ||
| Work participation | * | 46, 65 | ||
| Pain on loading/activity | Participant/patient reported intensity of pain on performing a task/activity that loads the tendon. (eg, VAS or NRS for pain intensity when the patient performs a tendon-specific pain-provocative task).22–24 | † | 93, 97 | This was strongly agreed at the survey by both patients and HCP. Note that there were no disagreements. Tendon-specific loading tests would need to be determined (eg, pain on gripping an object by a patient with lateral elbow tendinopathy). |
| Function | Participant/patient rated level of function (and not referring to the intensity of their pain; eg, Patient Specific Function Scale on a VAS or NRS).19 | 88 | 68, 87 | Discussion centred around possible interdependence with Disability, which was resolved by considering this candidate domain as 'how much can the patient do' as opposed to the level of disability due to the pain. |
| Psychological factors | Psychology (eg, pain self efficacy, pain catastrophisation, kinesiophobia, anxiety or depression scales).19 | 88 | 36, 77 | There was some concern regarding interdependence with Quality of Life (QoL), both at the meeting and HCP survey. It was agreed that psychology was sufficiently important and broader than covered in QoL. |
| Physical function capacity | Quantitative measures of physical tasks performed in clinic (eg, number of hops, timed stair walk, number of single limb squats, including dynamometry (strength) and wearable technology).19 25 26 | 88 | 57, 68 | Some discussion about the differences between this and ‘function’, but resolved as this is a quantitative measure of the physical capacity (eg, number of repetitions of or time to do a task, muscle force/torque) and not a patient rating of their function (eg, measured with a patient-specific function scale). |
| Muscle capacity or ‘strength’ as it was considered in the survey and meeting. | * | 36, 91 | Muscle capacity of strength was merged under physical function capacity as it was considered a physical function measure and there was a high patient agreement at survey. It was rejected as a separate domain at the meeting (12.5% agree) | |
| Disability | Composite scores of a mix of patient-rated pain and disability due to the pain, usually relating to tendon-specific activities/tasks (eg, VISA scales,19 20 23 24 patient-rated tennis elbow evaluation,27 disability of the arm, shoulder and hand). | † | 86, 69 | This was agreed at the survey stage and not discussed at the meeting. |
| QoL | The general well being of the individual (specific QoL questionnaires such as European QoL -5 Dimension (EQ-5D), Australian QoL (AQoL), 36-item Short Form survey (SF-36).19 20 27 | 75 | 57, 91 | There was concern that there is no tendon-specific QoL measure, but that the overall well being of the individual was important to include as a domain. |
| Pain over a specified time | Participant reported pain intensity over a period of time (morning, night, 24 hours, a week; eg, VAS, NRS).27–29 | 75 | 32, 69 | The initial candidate domain was pain over 24 hours, but also referred to a period of time. After discussion, it was agreed that it was the 'timeframe' being specified that provided more utility (eg, for some tendons morning pain, others night). |
| Candidate domains (items) not reaching ≥70% agree | ||||
| Physical activity | Overall physical activity levels (eg, self-report of physical activity levels, wearable sensor technology). | 69 | 54, 81 | Discussion centred around possible interdependence and overlap with other domains. Along with this being less specific to tendinopathy compared with what some of the other domains might be, it did not reach agreement. The 69% agreement could be viewed as indicating the overlap concern, but that this domain was one requiring further consideration. |
| Structure | Tendon tissue characteristics (eg, MRI, US, biopsy). | 69 | 43, 34 | An extended discussion was had on this candidate domain, with some of the issues being: relationship to symptoms, diagnostic utility, technological, and availability of imaging modalities). It was decided to convene a group specific to imaging to deal with this candidate domain. |
| Medication use | Medicines used (eg, patient report or record of type and dose). | 63 | 57, 74 | The direct relevance of medication use to tendinopathy was a feature of the discussion. It was also considered that it would be captured under other reporting guidelines for clinical trials. |
| Adverse effects/events | Unwanted unintended effects of treatments (eg, patient report or medical record). | 56 | 50, 58 | Uncertainty about it being specific to tendinopathy, how to define it (eg, pain after exercise), and how to measure it. Discussion also considered that adverse effects are usually reported under harms as per the CONSORT guidelines. |
| Economic impact: costs | Financial impost of the condition and its management (eg, patient report or medical record). | 40 | 29, 55 | There was an extended discussion, largely around relevancy, societal impact (funding for healthcare and associated research), and how to measure it. |
| Not core domains (≥70% disagree) | ||||
| Pain elicited with clinician applied stress/examination | Rating of pain when a clinician does an examination of the patient (eg, VAS or NRS for pain intensity). | 21 | 18, 61 | Considered more to be for diagnosis and selection into studies. |
| Clinical examination findings | Clinician report of examination findings (eg, usually a composite score of a number of clinical examination tests). | 13 | 29, 75 | Considered important in a clinical examination, but the composite nature was not meaningful as an outcome. |
| Palpation | Manual pressure elicited/evoked pain over the tendon (eg, VAS, NRS). | 13 | 39, 68 | Considered not to be related to resolution and difficult for some tendons (eg, Shoulder vs Achilles). |
| Range of motion | Range of motion (eg, goniometer, inclinometer). | † | 11, 84 | 75% disagree HCP survey and not voted at the meeting. |
| Drop out or discontinue treatment | Ceasing a treatment (eg, patient or clinical record). | 6 | 46, 61 | While considered important to be reported in clinical trials, it was not a key domain. Reiteration that candidate domains like this should still be reported as per other guidelines of reporting. |
| Sensory modality specific pain | Pain thresholds/tolerance to sensory stimulation (eg, quantitative sensory testing). | 6 | 11, 42 | Considered likely useful in subgrouping studies but not as an outcome for trials. |
| Pain without further specification | Patient asked about their pain without reference to activity or timeframe (eg, VAS, NRS). | 0 | 25, 63 | Covered better in pain on loading and over a specified timeframe. |
Note that the citations placed in the definition column are only examples of some authors reporting of indicative outcome measures and they are not to be read as endorsing either the outcomes or their use.
*Amalgamated items (candidate domains).
†Met the agreed criterion prior to meeting and thus not discussed at the meeting.
CONSORT, Consolidated Standards of Reporting Trials; HCP, Health Care Professionals; MRI, Magnetic Resonance Imaging; NRS, Numeric Rating Scale; QoL, Quality of Life; US, Ultrasound; VAS, Visual Analogue Scale; VISA, Victorian Institute of Sports Assessment.