Table 5.
Respiratory, thoracic and mediastinal outcomes
| Generic Outcome | Clinical trials.gov | Qualitative review | |||
| Number of studies reporting outcome (% of 33 studies) | Number of individual study outcomes grouped into generic outcome | Examples of study reported outcomes grouped into the generic outcome | Number of studies reporting outcome (% of 6 studies) | Text contributing to outcome grouping | |
| Chest pain* | 0 (0) | - | - | 2 (33) | Chest pain |
| Chest tightness | 0 (0) | - | - | 1 (17) | “ This included: chest tightness, choking, congestion, . . .” |
| Choking | 0 (0) | - | - | 1 (17) | |
| Congestion | 0 (0) | - | - | 1 (17) | |
| Cough | 1 (3) | 1 | Cough | 4 (67) | ““It’s mostly a dry cough, just a constant coughing.’” |
| Disease Activity/progression | 9 (27) | 33 | Clinical deterioration, Lupus Pernio Physician’s Global Assessment, assessment of disease severity and activity, Pulmonary Sarcoidosis Flares, The Steroid Sparing Period, Time to Disease Progression, Symptoms, episodes of acute exacerbation, clinical worsening, stabilization, improvement or resolution of the disease, Observation group crossover to treatment group, Cumulative dose of prednisolone, Prednisolone dose between relapse and no relapse groups, Relapse or treatment failure, Sarcoidosis Treatment Score (STS) -prednisone dosage, serum angiotensin converting enzyme (ACE) concentration, Remission | 1 (17) | stress/fear/anxiety (e.g., fear of disease/dying, not being calm) |
| Dyspnea | 3 (9) | 16 | activities that are caused or limited by breathlessness (St Georges Respiratory Questionnaire), Dyspnoea (ATS dyspnea scale), Dyspnea (Borg’s CR10), everity of their shortness of breath before and after treatment, Improvement in dyspnea score |
5 (88) | (). . . a range of health topics that included breathlessness, other respiratory symptoms. . . () “For patients, the most frequently coded statements were related to shortness of breath” “Difficulty breathing” |
| Functional Exercise capacity | 7 (21) | 14 | Cardiopulmonary exercise testing (VO2max), 6-min walk distance (6MWD), Maximum incremental ventilatory performance test (MIVP) | 2 (33) | exercise intolerance, reduced exercise capacity |
| Oxygenation | 1 (3) | 2 | Blood gas analysis (AaDO2) | 0 (0) | - |
| Generic Outcome | Clinical trials.gov | Qualitative review | |||
| Number of studies reporting outcome (% of 33 studies) | Number of individual study outcomes grouped into generic outcome | Examples of study reported outcomes grouped into the generic outcome | Number of studies reporting outcome (% of 6 studies) | Text contributing to outcome grouping | |
| Pulmonary Function | 11 (33) | 45 | Pulmonary function, Forced Vital Capacity, VO2 peak, endurance time at 75% of VO2 peak, Total Lung Capacity, Spirometry, pulmonary function studies, functional capacity, pulmonary status, lung function, Forced Expiratory Volume, Diffusion capacity of Lung for Carbon monoxide | 1 (17) | blood tests/pulmonary function tests |
| Pulmonary inflammation | 2 (6) | 9 | Exhaled nitric oxide and carbon monoxide, severity of lung inflammation, chest X ray, computed tomography, positron emission tomography (PET) scan, pulmonary tissue inflammation. | 0 (0) | - |
| Pulmonary physiology | 1 (3) | 1 | composite physiologic index | 0 (0) | - |
| Radiographic outcomes | 3 (9) | 17 | HRCT (Oberstein score), chest x-ray, chest imaging, computed tomography scan, radiographic parameters, radiographic success, overall response defined as combined clinical and radiographic parameters, FDG-PET outcomes | 1 (17) | imaging |
| Respiratory symptoms | 3 (9) | 8 | Respiratory symptoms (St Georges Respiratory Questionnaire) | 1 (17) | (). . . a range of health topics that included breathlessness, other respiratory symptoms. . .() |
| Wheezing* | 0 (0) | - | - | 1 (17) | “This included: chest tightness, choking, congestion, cough, dyspnea, exercise intolerance, and wheezing.” |
*wheezing and chest pain are included in the St Georges Respiratory questionnaire and are included in the “respiratory symptoms” generic outcome. They have been listed separately here as they were specifically mentioned in the included qualitative research where as trials reported “respiratory symptoms” as an outcome rather than the individual symptoms assessed by the PROM.