Table 4.
Outcome Set | Outcome | Stage 2, Round 1 Questionnaire Item and Brief Description | Importance | Mean Panel Rating | Median Panel Rating | Disagreement Index (IPR:IPRAS) | Report | Retain for Stage 2, Round 2 Delphi | Discard |
---|---|---|---|---|---|---|---|---|---|
Core | 3. Age | 3.1. Mean age in years | Important | 7.3 | 8 | 0.16 | ✓ | ||
3.2. % in age bands | Important | 7 | 7 | 0.16 | ✓ | ||||
Core | 4. Weight | 4.1. Mean weight in kg | Important | 8 | 9 | 0.13 | ✓ | ||
4.2. Mean weight change in kg | Important | 7.8 | 9 | 0.29 | ✓ | ||||
4.3. Mean % weight change | Important | 8.1 | 9 | 0.13 | ✓ | ||||
4.4. % achieving ≥3% weight loss | Important | 6.5 | 7 | 0.65 | ✓ | ||||
4.5. % achieving ≥5% weight loss | Important | 7.6 | 8 | 0.29 | ✓ | ||||
4.6. % achieving ≥10% weight loss | Important | 7.5 | 8 | 0.29 | ✓ | ||||
4.7. % achieving ≥3 kg weight loss | Unsure | 5.3 | 5 | 0.85 | ✓ | ||||
4.8. % achieving ≥5 kg weight loss | Unsure | 5.7 | 5 | 1.04 | ✓ | ||||
4.9. % achieving ≥10 kg weight loss | Unsure | 5.8 | 5 | 1.04 | ✓ | ||||
Core | 5. BMI | 5.1. Mean BMI | Important | 7.8 | 8 | 0.29 | ✓ | ||
5.2. % in BMI categories | Important | 7.6 | 8 | 0.29 | ✓ | ||||
5.3. Mean change in BMI | Important | 7.2 | 8 | 0.29 | ✓ | ||||
5.4. % achieving BMI <25 | Unsure | 5.2 | 6 | 0.85 | ✓ | ||||
5.5. % achieving BMI <30 | Unsure | 5.6 | 6 | 0.52 | ✓ | ||||
Core | 6. Diabetes status | 6.1. % with T1DM | Unsure | 5.8 | 5 | 0.52 | ✓ | ||
6.2. % with T2DM | Important | 7.2 | 7 | 0.49 | ✓ | ||||
6.3. Mean HbA1c of those with T2DM | Unsure | 6.2 | 6 | 0.65 | ✓ | ||||
6.4. % of those with T2DM on insulin | Unsure | 5.9 | 6 | 0.65 | ✓ | ||||
6.5. Mean number of diabetes medications per participant with T2DM | Unsure | 5.5 | 6 | 0.97 | ✓ | ||||
6.6. Mean change in HbA1c of those with T2DM | Important | 6 | 7 | 0.52 | ✓ | ||||
6.7. Mean change in % of those with T2DM on insulin | Unsure | 5.5 | 6 | 0.52 | ✓ | ||||
6.8. Mean change in number of diabetes medications per participant with T2DM | Unsure | 5.5 | 6 | 0.52 | ✓ | ||||
Core | 7. QoL score | 7.1. Mean EQ‐5D‐5L scores (baseline) | Important | 6.7 | 7 | 0.65 | ✓ | ||
7.2. Mean SF12 score (baseline) | Unsure | 5.8 | 6 | 0.52 | ✓ | ||||
7.3. Mean SF36 scores (baseline) | Unsure | 5.2 | 6 | 0.52 | ✓ | ||||
7.4. Mean IWQOL‐Lite score (baseline) | Unsure | 5.7 | 6 | 0.52 | ✓ | ||||
7.5. Mean OWLQOL scores (baseline) | Unsure | 5.4 | 5 | 0.52 | ✓ | ||||
7.6. Mean EQ‐5D‐5L scores (follow‐up) | Important | 6.6 | 7 | 0.65 | ✓ | ||||
7.7. Mean SF12 score (follow‐up) | Unsure | 5.8 | 6 | 0.52 | ✓ | ||||
7.8. Mean SF36 scores (follow‐up) | Unsure | 5.3 | 6 | 0.52 | ✓ | ||||
7.9. Mean IWQOL‐Lite score (follow‐up) | Unsure | 5.7 | 6 | 0.52 | ✓ | ||||
7.10. Mean OWLQOL scores (follow‐up) | Unsure | 5.5 | 5 | 0.52 | ✓ | ||||
Core | 8. Learning disability QoL score |
8.1. Mean PWI‐ID score(s) 8.2. Mean score using another suitable instrument |
Unsure Unsure |
5.3 4.8 |
5 5 |
0.52 0.85 |
✓ | ✓ | |
Core | 9. Adverse events/unintended consequences |
9.1. Number experiencing a worsening of pre‐existing medical condition 9.2. Number suffering severe hypoglycaemia |
Important Unsure |
6 5.5 |
7 6 |
0.52 0.97 |
✓ ✓ (merge with 9.1) |
||
9.3. Number sustaining injury during physical activity session | Important | 6.2 | 7 | 0.52 | ✓ | ||||
9.4. Number experiencing other side effects | Unsure | 5.3 | 6 | 0.97 | ✓ | ||||
Core | 10. Repeat referrals | 10.1. % previously referred to service | Important | 6.3 | 7 | 0.65 | ✓ | ||
10.2. % previously referred and attended ≥1 session | Important | 6.3 | 7 | 0.52 | ✓ | ||||
Core | 11. Attendance | 11.1. Mean % core sessions attended | Important | 7.9 | 8 | 0.13 | ✓ | ||
11.2. % attending 100% core sessions | Unsure | 6.3 | 6 | 0.22 | ✓ | ||||
11.3. % attending ≥80% core sessions | Important | 6.8 | 7 | 0.37 | ✓ | ||||
11.4. % attending ≥70% core sessions | Important | 6.5 | 7 | 0.37 | ✓ | ||||
11.5. % attending ≥50% core sessions | Unsure | 5.8 | 6 | 0.32 | ✓ | ||||
Core | 12. Completion | 12.1. % attended 100% core sessions | Important | 6.9 | 7 | 0.49 | ✓ | ||
12.2. % attended 80% core sessions | Important | 6.8 | 7 | 0.49 | ✓ | ||||
12.3. % attended 70% core sessions | Important | 6.3 | 7 | 0.65 | ✓ | ||||
12.4. % attended 50% core sessions | Unsure | 5.6 | 6 | 0.32 | ✓ | ||||
Core | 13. Reason for dropout | 13.1. % dropped out due to dissatisfaction with intervention (unrelated to weight loss) | Important | 6.7 | 7 | 0.37 | ✓ | ||
13.2. % dropped out due to poor weight loss | Important | 6.8 | 7 | 0.37 | ✓ | ||||
13.3. % dropped out due to illness/hospitalisation | Important | 6.8 | 7 | 0.16 | ✓ | ||||
13.4. % dropped out due to pregnancy | Important | 6.5 | 7 | 0.37 | ✓ | ||||
13.5. % dropped out for social reason | Important | 6.3 | 7 | 0.22 | ✓ | ||||
13.6. % dropped out due to moving from the locale | Important | 6.4 | 7 | 0.22 | ✓ | ||||
13.7. % dropped out for another reason | Important | 6.2 | 7 | 0.52 | ✓ | ||||
Core | 14. Participant satisfaction |
14.1. Mean adapted OEQ score 14.2 Mean NHS FFT score |
Important Important |
6.4 6.3 |
7 7 |
0.37 0.65 |
✓ ✓ |
||
Core | 15. Cost effectiveness | 15.1. PHE Weight Management Economic Assessment Tool | Important | 6 | 7 | 0.52 | ✓ | ||
15.2. Cost/kg based on mean weight loss | Unsure | 5.6 | 6 | 0.52 | ✓ | ||||
15.3. Cost/“success” (5% weight loss) | Important | 6 | 7 | 0.52 | ✓ | ||||
15.4. Cost/“success” (5 kg weight loss) | Unsure | 4.5 | 5 | 0.52 | ✓ | ||||
15.5. Cost/“success” (3% weight loss) | Unsure | 5.5 | 5 | 0.52 | ✓ | ||||
15.6. Cost/kg based on any change in weight data | Unsure | 4.8 | 5 | 0.97 | ✓ | ||||
Core | 16. Presentation of results | 16.1. Report outcomes for all attending ≥1 active weight loss session | Unsure | 5.9 | 6 | 0.52 | ✓ | ||
16.2. Report outcomes for all attending >1 active weight loss session(s)/with weight loss data | Important | 6.4 | 7 | 0.37 | ✓ | ||||
16.3. Report outcomes for all completing programme | Important | 7.3 | 8 | 0.29 | ✓ | ||||
Optional | 17. High blood pressure | 17.1. % with high blood pressure based on patient report/medication/case notes | Important | 6.7 | 7 | 0.37 | ✓ | ||
17.2. % with high blood pressure based on blood pressure readings | Important | 6.2 | 7 | 0.65 | ✓ | ||||
17.3. Mean number blood pressure medications per participant with high blood pressure | Unsure | 5.7 | 6 | 0.52 | ✓ | ||||
17.4. Change in mean blood pressure | Important | 6.4 | 7 | 0.37 | ✓ | ||||
17.5. Change in mean number blood pressure medications per participant with high blood pressure | Unsure | 5.6 | 6 | 0.52 | ✓ | ||||
Optional | 18. Blood pressure | 18.1. Mean systolic and diastolic blood pressure | Important | 6.4 | 7 | 0.65 | ✓ | ||
18.2. % with blood pressure > 140/80 mmHg | Unsure | 5.9 | 6 | 0.52 | ✓ | ||||
18.3. % on blood pressure medication based on self‐report/case records | Unsure | 5.5 | 5 | 0.97 | ✓ | ||||
18.4. Change in mean systolic and diastolic blood pressure | Unsure | 6.3 | 6 | 0.65 | ✓ | ||||
18.5. Change in % with blood pressure > 140/80 mmHg | Unsure | 5.8 | 6 | 0.52 | ✓ | ||||
18.6. Change in % on blood pressure medication based on self‐report/case records | Unsure | 5.6 | 5 | 1.04 | ✓ | ||||
Optional | 19. CV risk | 19.1. % with previous CVD | Important | 6.6 | 7 | 0.22 | ✓ | ||
19.2. % with high CVD risk | Unsure | 6.1 | 6 | 0.52 | ✓ | ||||
19.3. % with high CV risk score (baseline) | Unsure | 5.9 | 6 | 0.52 | ✓ | ||||
19.4. Mean CV risk score | Unsure | 5.3 | 6 | 0.97 | ✓ | ||||
19.5. % on CV medications | Unsure | 5.5 | 6 | 0.52 | ✓ | ||||
19.6. Mean number of CV medications per participant on CV medication(s) | Unsure | 4.8 | 5 | 0.85 | ✓ | ||||
19.7. % with high CV risk score (follow‐up) | Unsure | 5.6 | 6 | 0.52 | ✓ | ||||
19.8. Change in mean CV risk score | Unsure | 5.6 | 6 | 0.52 | ✓ | ||||
19.9. Change in % on CV medications 19.10. Change in mean number of CV medications per participant on CV medication(s) |
Unsure Unsure |
4.9 4.8 |
5 5 |
0.85 0.97 |
✓ ✓ |
||||
Optional | 20. High cholesterol/lipids | 20.1. % with high cholesterol/lipids based on self‐report/case records (baseline) | Unsure | 5.8 | 6 | 0.52 | ✓ | ||
20.2. % on statin/lipid lowering medication based on self‐report/case records (baseline) | Unsure | 5.5 | 5 | 0.97 | ✓ | ||||
20.3. Mean total cholesterol/HDL/triglycerides (baseline) | Unsure | 5.6 | 6 | 0.52 | ✓ | ||||
20.4. % with high cholesterol/lipids based on self‐report/case records (follow‐up) | Unsure | 5.5 | 5 | 0.32 | ✓ | ||||
20.5. % on statin/lipid lowering medication based on self‐report/case records (follow‐up) | Unsure | 5.3 | 5 | 0.97 | ✓ | ||||
20.6. Mean total cholesterol/HDL/triglycerides (follow‐up) | Unsure | 5.4 | 6 | 0.97 | ✓ | ||||
Optional | 21. High future risk of diabetes | 21.1. % with medical record of HDR (baseline) | Unsure | 6 | 6 | 0.52 | ✓ | ||
21.2. % with HDR determined by OGTT (baseline) | Unsure | 4.8 | 5 | 0.85 | ✓ | ||||
21.3. % with HDR determined by HbA1c (baseline) | Unsure | 5.9 | 6 | 0.52 | ✓ | ||||
21.4. % with medical record of HDR (follow‐up) | Unsure | 5.7 | 6 | 0.52 | ✓ | ||||
21.5. % with HDR determined by OGTT (follow‐up) | Unsure | 4.8 | 5 | 0.85 | ✓ | ||||
21.6. % of those with HDR at baseline who still have HDR at follow‐up as determined by OGTT | Unsure | 4.7 | 4 | 0.85 | ✓ | ||||
21.7. % with HDR determined by HbA1c (follow‐up) | Unsure | 5.9 | 6 | 0.52 | ✓ | ||||
21.8. % of those with HDR at baseline who still have HDR at follow‐up as determined by HbA1c | Unsure | 5.6 | 6 | 0.97 | ✓ | ||||
Optional | 22. Overall Measure of comorbidity | 22.1. mean CCI score (baseline) | Unsure | 5 | 5 | 0.85 | ✓ | ||
22.2. Mean EOSS score (baseline) | Unsure | 5.5 | 5 | 0.97 | ✓ | ||||
22.3. Mean Chronic Disease Score (baseline) | Unsure | 5 | 5 | 0.85 | ✓ | ||||
22.4. Mean number dispensed medications per participant (baseline) | Unsure | 5.3 | 5 | 0.52 | ✓ | ||||
22.5. Mean CCI score (follow‐up) | Unsure | 5 | 5 | 0.97 | ✓ | ||||
22.6. Mean EOSS score (follow‐up) | Unsure | 5.3 | 5 | 0.97 | ✓ | ||||
22.7. Mean Chronic Disease Score (follow‐up) | Unsure | 5 | 5 | 0.97 | ✓ | ||||
22.8. Mean number dispensed medications per participant (follow‐up) | Unsure | 5.2 | 6 | 0.97 | ✓ | ||||
Optional | 23. Depression | 23.1. % with depression based on self‐report/medication/case notes (baseline) | Important | 6.2 | 7 | 0.65 | ✓ | ||
23.2. % on medication for depression (baseline) | Important | 5.9 | 7 | 0.52 | ✓ | ||||
23.3. Mean HADS score (baseline) | Unsure | 5.7 | 6 | 0.52 | ✓ | ||||
23.4. Mean PHQ9 score (baseline) | Unsure | 5.9 | 6 | 0.52 | ✓ | ||||
23.5. Mean Beck Depression Inventory score (baseline) | Unsure | 5.5 | 6 | 0.52 | ✓ | ||||
23.6. % on medication for depression (follow‐up) | Unsure | 5.7 | 6 | 0.97 | ✓ | ||||
23.7. % of those identified as having depression at baseline on medication for depression (follow‐up) | Unsure | 5.6 | 6 | 0.52 | ✓ | ||||
23.8. mean HADS score (follow‐up) | Unsure | 5.6 | 6 | 0.52 |
✓ |
||||
23.9. Mean PHQ9 score (follow‐up) 23.10. mean Beck Depression Inventory score (follow‐up) |
Unsure Unsure |
5.8 5.3 |
6 6 |
0.52 0.32 |
✓ ✓ |
||||
Optional | 24. Self‐confidence and self‐esteem | 24.1. Mean Tennesse Self‐concept Scale score (baseline) | Unsure | 4.4 | 5 | 0.52 | ✓ | ||
24.2. Mean Rosenberg Self‐esteem Scale score (baseline) | Unsure | 5.3 | 5 | 0.97 | ✓ | ||||
24.3. Mean General Well‐being Schedule score (baseline) | Unsure | 5.1 | 5 | 0.85 | ✓ | ||||
24.4. Mean ICECAP‐A score (baseline) | Unsure | 4.9 | 5 | 0.85 | ✓ | ||||
24.5. Mean WEMWBS score (baseline) | Unsure | 5.8 | 6 | 0.52 | ✓ | ||||
24.6. Mean Tennesse Self‐concept Scale score (follow‐up) | Unsure | 4.2 | 4 | 0.52 | ✓ | ||||
24.7. Mean Rosenberg Self‐esteem Scale score (follow‐up) | Unsure | 5.3 | 5 | 0.97 | ✓ | ||||
24.8. Mean General Well‐being Schedule score (follow‐up) | Unsure | 5 | 5 | 0.85 | ✓ | ||||
24.9. Mean ICECAP‐A score (follow‐up) 24.10. mean WEMWBS score (follow‐up) |
Unsure Unsure |
4.8 5.7 |
5 6 |
0.85 0.97 |
✓ |
✓ | |||
Optional | 25. Importance of weight loss | 25.1. Mean Dieting Readiness Scale score(s) (baseline) | Unsure | 5.4 | 5 | 0.97 | ✓ | ||
25.2. Mean DIET score(s) (baseline) | Unsure | 5 | 5 | 0.85 | ✓ | ||||
25.3. Mean Self‐Efficacy for Eating Behaviours Scale score(s) (baseline) | Unsure | 5.1 | 5 | 0.97 | ✓ | ||||
25.4. Mean Dieting Readiness Scale score(s) (follow‐up) | Unsure | 5.3 | 5 | 0.97 | ✓ | ||||
25.5. Mean DIET score(s) (follow‐up) | Unsure | 4.9 | 5 | 0.97 | ✓ | ||||
25.6. Mean Self‐Efficacy for Eating Behaviours Scale score(s) (follow‐up) | Unsure | 5 | 5 | 0.97 | ✓ | ||||
Optional | 26. Disordered eating | 26.1. % with disordered eating (defined as per service) (baseline) | Important | 6 | 7 | 0.52 | ✓ | ||
26.2. Mean TEFQ score (baseline) | Unsure | 4.8 | 5 | 0.85 | ✓ | ||||
26.3. Mean EDEQ score (baseline) | Unsure | 5 | 5 | 0.85 | ✓ | ||||
26.4. Mean BES score (baseline) | Unsure | 5.2 | 5 | 0.97 | ✓ | ||||
26.5. Mean QEWP (baseline) | Unsure | 4.5 | 5 | 0.97 | ✓ | ||||
26.6. % with disordered eating (defined as per service) (follow‐up) | Unsure | 5.8 | 6 | 0.97 | ✓ | ||||
26.7. Mean TEFQ score (follow‐up) | Unsure | 4.8 | 5 | 0.85 | ✓ | ||||
26.8. Mean EDEQ score (follow‐up) | Unsure | 4.8 | 5 | 0.97 | ✓ | ||||
26.9. Mean BES score (follow‐up) 26.10. mean QEWP (follow‐up) |
Unsure Unsure |
5.2 4.5 |
5 5 |
0.97 0.97 |
✓ ✓ |
||||
Optional | 27. Reach | 27.1. Age < 30 | Unsure | 5.6 | 6 | 0.52 | ✓ | ||
27.2. Male | Important | 7.1 | 7 | 0.16 | ✓ | ||||
27.3. People with T2DM | Important | 7.2 | 7 | 0.16 | ✓ | ||||
27.4. Other subgroups | Unsure | 5.7 | 6 | 0.52 | ✓ | ||||
Optional | 28. Representativeness | 28.1. Based on age | Important | 6.1 | 7 | 0.52 | ✓ | ||
28.2. Based on sex | Important | 6.6 | 7 | 0.22 | ✓ | ||||
28.3. Based on BMI | Important | 6.7 | 7 | 0.37 | ✓ | ||||
28.4. Based on deprivation category | Important | 6.9 | 7 | 0.16 | ✓ | ||||
28.5. Based on ethnicity | Important | 6.6 | 7 | 0.37 | ✓ | ||||
28.6. Based on diabetes status | Important | 6.5 | 7 | 0.22 | ✓ | ||||
28.7. Based on other criteria | Unsure | 4.9 | 5 | 0.32 | ✓ | ||||
Optional | 29. Prescription of anti‐obesity medication | 29.1. % on any anti‐obesity medication (baseline) | Important | 6.5 | 7 | 0.00 | ✓ | ||
29.2. % on specific anti‐obesity medications (baseline) | Unsure | 5.7 | 6 | 0.52 | ✓ | ||||
29.3. % on anti‐obesity medication (follow‐up) | Important | 6.2 | 7 | 0.22 | ✓ | ||||
29.4. % on specific anti‐obesity medications (follow‐up) | Unsure | 5.6 | 6 | 0.52 | ✓ |
Note. Fifty‐six of 163 definitions/instruments were rated as appropriate by the expert group (median rating greater than or equal to 7) with no disagreement between experts. One hundred seven definitions/instruments were rated as unsure (median rating less than or equal to 6.5). The expert group was in agreement (disagreement index less than 1.0) for 104 of these 107 items.
Abbreviations: BES, Binge Eating Scale; BMI, body mass index; CCI, Charlson Comorbidity Index; CV, cardiovascular; CVD, cardiovascular disease; DIET, Dieter's Inventory of Eating Temptations; EDEQ, Eating Disorder Examination Questionnaire; EOSS, Edmonton Obesity Staging System; EQ‐5D‐5L, EuroQol 5‐level EQ‐5D version; FFT, Friends and Family Test; HADS, Hospital Anxiety and Depression Scale; HbA1c, haemoglobin A1c; HDL, high‐density lipoprotein; HDR, high diabetes risk; ICECAP‐A, ICEpop CAPability measure for Adults; IPR, inter‐percentile range;IPRAS, inter‐percentile range adjusted for symmetry; IWQOL‐Lite, 31‐Item Impact of Weight on Quality of Life; NHS, National Health Service; OEQ, Outcomes and Experiences Questionnaire; OGTT, oral glucose tolerance test; OWLQOL, Obesity and Weight‐Loss Quality of Life; PHE, Public Health England; PHQ‐9, Patient Health Questionnaire‐9; PWI‐ID, Personal Wellbeing Index–Intellectual Disability; QEWP, Questionnaire on Eating and Weight PatternsQoL, quality of life; SF12, 12‐Item Short Form Health Survey; SF36, 36‐Item Short Form Health Survey; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus; TFEQ, Three Factor Eating Questionnaire; WEMWBS, Warwick‐Edinburgh Mental Wellbeing Scale.