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CRF3A
Mathew Thorpe edited this page Aug 30, 2021
·
1 revision
| Variable / Field Name | Section Header | Field Type | Field Label | Choices or Calculations |
|---|---|---|---|---|
| crf3a_version | radio | CRF3 Version Completed | 1, Unversioned ; 2, 1.0 ; 3, 1.1 ; 4, 1.2 ; 5, 1.3 ; 6, 1.4 ; 7, 1.5 ; 8, 1.6 ; 9, 2.0 | |
| crf3a_consent_date | text | Date of consent | ||
| crf3a_visit_date | text | Date of consultation | ||
| crf3a_visit | radio | With which research visit does this clinical visit align? | 3_months_arm_1, 3 months visit ; 12_months_arm_1, 12 months visit | |
| crf3a_rest_spo2_done | Resting observations | radio | a) Pulse Oximetry (SpO2) | 1, Yes ; 0, No |
| crf3a_rest_hr_done | radio | b) Heart rate | 1, Yes ; 0, No | |
| crf3a_rest_bp_done | radio | c) Blood pressure | 1, Yes ; 0, No | |
| crf3a_rest_temp_done | radio | d) Temperature | 1, Yes ; 0, No | |
| crf3a_rest_height_done | radio | e) Height (cm) | 1, Yes ; 0, No | |
| crf3a_rest_weight_done | radio | f) Weight (kg) | 1, Yes ; 0, No | |
| crf3a_rest_spo2 | text | a) Resting Pulse Oximetry (SpO2): | ||
| crf3a_rest_hr | text | b) Resting heart rate: | ||
| crf3a_rest_bp_sys | text | c) Resting blood pressure (systolic): | ||
| crf3a_rest_bp_dia | text | c) Resting blood pressure (diastolic): | ||
| crf3a_rest_temp | text | d) Temperature: | ||
| crf3a_rest_height | text | e) Height (cm): | ||
| crf3a_rest_weight | text | f) Weight (kg): | ||
| crf3a_base_cxr_done | Basic investigations | radio | a) Chest XR | 1, Completed ; 2, Not done |
| crf3a_base_ecg_done | radio | b) ECG | 1, Completed ; 2, Not done | |
| crf3a_base_cxr | radio | a) Chest XR result: | 1, Normal ; 2, Extensive persistent changes >1/3 lung involvement ; 3, Suggestive of fibrotic lung disease ; 4, Indeterminate ; 5, Other | |
| crf3a_ecg | radio | b) ECG result: | 1, Sinus rhythm ; 2, Atrial fibrillation/flutter ; 3, ST segment/T wave changes ; 4, RBBB ; 5, LBBB | |
| crf3a_base_ecg_hr | text | b) ECG heart rate: | ||
| crf3a_outcome_fup | Clinical review Outcome | radio | 1. Further follow up | 1, Yes ; 0, No |
| crf3a_outcome_ras | radio | 2. Referred to another speciality | 1, Yes ; 0, No | |
| crf3a_outcome_rtc | radio | 3. Referred to a tertiary centre for specialised care | 1, Yes ; 0, No | |
| crf3a_outcome_rpc | radio | 4. Referred/discharged to palliative care | 1, Yes ; 0, No | |
| crf3a_outcome_rmhs | radio | 5. Referred to mental health services including IAPT | 1, Yes ; 0, No | |
| crf3a_outcome_rrh | radio | 6. Referred to Rehabilitation | 1, Yes ; 0, No | |
| crf3a_outcome_rdt | radio | 7. Referred to Dietician or similar | 1, Yes ; 0, No | |
| crf3a_outcome_rsss | radio | 8. Referred to a Stop Smoking Service | 1, Yes ; 0, No | |
| crf3a_outcome_dis | radio | 9. Discharged from clinical review | 1, Yes ; 0, No | |
| crf3a_tier | radio | 4. Tier allocation | 1, Tier 1 ; 2, Tier 2 | |
| crf3a_blood_done | Blood tests | yesno | Were any blood tests requested? | 1, Yes ; 0, No |
| crf3a_blood_fbc | radio | FBC | 1, Yes ; 0, No | |
| crf3a_blood_ue | radio | U&Es | 1, Yes ; 0, No | |
| crf3a_blood_egfr | radio | eGFR | 1, Yes ; 0, No | |
| crf3a_blood_lfts | radio | LFTs | 1, Yes ; 0, No | |
| crf3a_blood_crp | radio | CRP | 1, Yes ; 0, No | |
| crf3a_blood_bp | radio | Bone profile | 1, Yes ; 0, No | |
| crf3a_blood_25oh | radio | 25-Hydroxyvitamin D (25-OH) | 1, Yes ; 0, No | |
| crf3a_blood_bnp | radio | BNP/Pro-NT BNP | 1, Yes ; 0, No | |
| crf3a_blood_trop | radio | Troponin | 1, Yes ; 0, No | |
| crf3a_blood_ddim | radio | D Dimer | 1, Yes ; 0, No | |
| crf3a_blood_fib | radio | Fibrinogen | 1, Yes ; 0, No | |
| crf3a_blood_inr | radio | INR | 1, Yes ; 0, No | |
| crf3a_blood_fer | radio | Ferritin | 1, Yes ; 0, No | |
| crf3a_blood_hba1c | radio | HbA1C | 1, Yes ; 0, No | |
| crf3a_blood_lp | radio | Lipid profile (non-fasting) | 1, Yes ; 0, No | |
| crf3a_blood_covid19 | radio | SARS-Cov-2 Serology | 1, Yes ; 0, No | |
| crf3a_link_routine_blood | yesno | If any blood tests performed, please enter results in the Laboratory Results Collection Log - Routine blood tests | 1, Yes ; 0, No | |
| crf3a_link_add_blood_sars | yesno | If Sars-CoV-2 Serology performed, please enter results in the Laboratory Results Collection Log - Additional blood tests | 1, Yes ; 0, No | |
| crf3a_inv_resp | Additional investigations/procedures | checkbox | Respiratory | 1, Spirometry ; 2, Full pulmonary function tests ; 3, Fractional exhaled nitric oxide (FeNO) ; 4, Nijmegen questionnaire ; 5, Incremental shuttle walk test (ISWT) ; 6, Six-minute walk test ; 7, Cardio-pulmonary exercise test ; 8, CT chest with contrast ; 9, HRCT ; 10, CTPA ; 11, Pulmonary perfusion scan |
| crf3a_inv_cardiac | checkbox | Cardiac | 1, Cardiac MRI ; 2, Echocardiogram ; 3, 24/48 hrs tape ; 4, Right heart catheterisation ; 5, Coronary angiogram/CT angiogram ; 6, Cardiac perfusion scan | |
| crf3a_inv_haema | checkbox | Haematological | 1, Thyroid function tests ; 2, Blood borne viruses (BBV) screen ; 3, Haematinics | |
| crf3a_link_add_blood_haema | yesno | If Thyroid Function Tests or Haematinics (Haematological Profile) performed, please enter results in the Laboratory Results Collection Log - Additional Blood Tests. If BBV Screen performed, please enter results in the Laboratory Results Collection Log - Immunological Profile. |
1, Yes ; 0, No | |
| crf3a_inv_renal | checkbox | Renal | 1, USS abdomen ; 2, USS Kidneys ; 3, CT abdomen/pelvis ; 4, Urinalysis ; 5, Urine albumin: creatinine ratio ; 6, Urine protein: creatinine ratio ; 7, Renal biopsy | |
| crf3a_link_blood_urine | yesno | If Urinalysis, Urine albumin : creatinine ratio or Urine protein : creatinine ratio performed, please enter results in the Laboratory Results Collection Log - Urine Profile. | 1, Yes ; 0, No | |
| crf3a_inv_immu | checkbox | Immunological | 1, Vasculitis screen ; 2, Complements factors ; 3, Immunoglobulins ; 4, Rheumatoid factor/Anti-CCP | |
| crf3a_link_blood_immun | yesno | If any immunological procedures performed, please enter results in the Laboratory Results Collection Log - Immunological Profile. | 1, Yes ; 0, No | |
| crf3a_inv_neuro | checkbox | Neurology/Mental health | 1, CT brain ; 2, MRI brain ; 3, Nerve conduction studies ; 4, Mini-International Neuro-psychiatric Interview (M.I.N.I.) ; 5, Columbia-Suicide Severity Rating Scale ; 6, Sleep Condition Indicator | |
| crf3a_inv_other | notes | Other, please specify | ||
| crf3a_quest | Questionnaires | checkbox | Questionnaires completed | 1, MRC dyspnoea scale ; 2, EQ-5D-5L ; 3, Generalised Anxiety Disorder Assessment (GAD-7) ; 4, Patient Health Questionnaire (PHQ-9) ; 5, Sarcopenia screen (SARC-F) ; 6, General Practice Physical Activity Questionnaire (GPPAQ) ; 7, Dyspnoea-12 ; 8, Fatigue (FACIT) ; 9, Brief Pain Inventory (BPI) ; 10, Post-Traumatic Stress Disorder (PTSD) checklist (PCL-5) ; 11, Nottingham extended activity of daily living (NEADL) |
| crf3a_quest_mrc | yesno | 1. Have you completed a MRC dyspnoea scale form? | 1, Yes ; 0, No | |
| crf3a_quest_eq5d5l | yesno | 2. Have you completed a EQ-5D-5L form? | 1, Yes ; 0, No | |
| crf3a_quest_gad7 | yesno | 3. Have you completed a GAD-7 form? | 1, Yes ; 0, No | |
| crf3a_quest_phq9 | yesno | 4. Have you completed a PHQ-9 form? | 1, Yes ; 0, No | |
| crf3a_quest_sarcf | yesno | 5. Have you completed a SARC-F form? | 1, Yes ; 0, No | |
| crf3a_quest_gppaq | yesno | 6. Have you completed a GPPAQ form? | 1, Yes ; 0, No | |
| crf3a_quest_dys12 | yesno | 7. Have you completed a Dyspnoea-12 form? | 1, Yes ; 0, No | |
| crf3a_quest_facit | yesno | 8. Have you completed a FACIT form? | 1, Yes ; 0, No | |
| crf3a_quest_bpi | yesno | 9. Have you completed a BPI form? | 1, Yes ; 0, No | |
| crf3a_quest_pcl5 | yesno | 10. Have you completed a PCL-5 form? | 1, Yes ; 0, No | |
| crf3a_quest_neadl | yesno | 11. Have you completed a NEADL form? | 1, Yes ; 0, No | |
| crf3a_inv_quest | Investigator completed assessments | checkbox | Assessments completed | 1, Montreal Cognitive Assessment (MoCA) ; 2, Clinical Frailty Scale |
| crf3a_quest_moca | yesno | 1. Have you completed a MoCA form? | 1, Yes ; 0, No | |
| crf3a_quest_rcfs | yesno | 2. Have you completed a Rockwood Clinical Frailty Scale form? | 1, Yes ; 0, No | |
| crf3a_pft_done | Pulmonary function tests | yesno | Have you completed a PFTs form? | 1, Yes ; 0, No |
| crf3a_echo_date | Additional investigations/procedures results | text | Echocardiogram: Date performed | |
| crf3a_echo_right | radio | Echocardiogram: Results - Right ventricle | 1, Normal ; 2, Mild dysfunction ; 3, Moderate dysfunction ; 4, Severe dysfunction ; 5, Unable to visualise | |
| crf3a_echo_left | radio | Echocardiogram: Results - Left ventricle | 1, Normal ; 2, Mild dysfunction ; 3, Moderate dysfunction ; 4, Severe dysfunction ; 5, Unable to visualise | |
| crf3a_echo_pap | text | Echocardiogram: Estimated PAP | ||
| crf3a_tape_done | yesno | 24/48 hours tape: Symptom diary completed | 1, Yes ; 0, No | |
| crf3a10_tape_date | text | 24/48 hours tape: Date performed | ||
| crf3a_tape_finding | checkbox | 24/48 hours tape: Findings | 1, Sinus rhythm ; 2, Atrial flutter/fibrillation ; 3, Significant bradycardia ; 4, Significant tachycardia ; 5, Heart block ; 6, Sinus pause > 3 seconds ; 7, Burden of ectopic > 10% | |
| crf3a10_tape_heartblock | text | 24/48 hours tape: Heart block details | ||
| crf3a_nijm_date | text | Nijmegen questionnaire: Date performed | ||
| crf3a_nijm_result | text | Nijmegen questionnaire: Result | ||
| crf3a_cpet_date | text | Cardio-pulmonary exercise test: Date performed | ||
| crf3a_cpet_result | text | Cardio-pulmonary exercise test: Result (Peak Vo2) | ||
| crf3a_feno_date | text | Fractional exhaled nitric oxide (FeNO): Date performed | ||
| crf3a_feno_result | text | Fractional exhaled nitric oxide (FeNO): Result | ||
| crf3a_6mwt_done | 6 Minute Walk Test | yesno | Have you completed a Walk Test form? | 1, Yes ; 0, No |
Contents
Case Report Form Definitions
- Forms
- Timepoints
- PHOSP ID
- eConsent Tier 1
- eConsent Tier 2
- Informed Consent Form
- Split Tier Consent
- Eligibility Checklist
- CRF1A Part 1
- CRF1A Part 2
- CRF1A Part 3
- CRF1B
- CRF2A
- CRF2B
- CRF3A
- CRF3B
- CRF3C
- CRF4A
- CRF4B
- CRF Emergency Visit
- Adverse Event Log
- Withdrawals
- CRF Early Termination
- CRF Tier 2 Withdrawal
- Medications Log
- Activity Monitor Log
- Mental Health Assessment
- Nutrition
- Social History
- EQ-5D-5L
- GAD-7
- PHQ-9
- MRC Dyspnoea
- SARC-F
- GPPAQ
- Dyspnoea-12
- FACIT Fatigue
- PCL-5
- BPI
- NEADL
- MoCA
- Rockwood Clinical Frailty
- PSQI
- MEQ
- LCQ
- PFTs
- Walk Tests
- Tier 2 Core Test Checklist
- Tier 2 Research Samples
- Tier 2 Notification - Blood
- Tier 2 Notification - Oral Wash
- Tier 2 Notification - Sputum
- Tier 2 Notification - Urine
- QRISK3
- BIA
- DXA
- Muscle Strength
- SPPB
- Pre-PSQ
- PSQ
- Lab Log - Routine Blood
- Lab Log - Urine
- Lab Log - Immuno
- Lab Log - Additional Tests
- PCR Swab Tests