A Delphi consensus on the management of Spanish patients with osteoporosis at high risk of fracture: OSARIDELPHI study

Summary The OSARIDELPHI study evaluated the level of agreement between specialists in osteoporosis regarding the management of patients with high-risk fractures in Spain. The results provide expert-based recommendations for prevention, diagnosis, and treatment related to fracture risk. Therefore, the study facilitates clinical decision-making for managing this patient’s profile. Purpose To evaluate the level of agreement between specialists in osteoporosis regarding the management of patients with high-risk fractures in Spain. Methods A two-round Delphi study was performed using an online survey. In round 1, panel members rated their level of agreement with assessments on a 9-point Likert scale. Item selection was based on acceptance by ≥ 66.6% of panel experts and the agreement of the scientific committee. In round 2, the same panelists evaluated non-consensus items in round 1. Results A total of 80 panelists participated in round 1; of these, 78 completed the round 2 survey. In round 1, 122 items from 4 dimensions (definition of fracture risk: 11 items, prevention and diagnosis: 38 items, choice of treatment: 24 items, and treatment-associated quality of life: 49 items) were evaluated. The consensus was reached for 90 items (73.8%). Panelists agreed that categorizing high risk, very high risk, or imminent risk determines secondary prevention actions (97.5%). Experts agreed that treatment with bone-forming drugs should be considered in case of a very high risk of fracture, and a sequential change to antiresorptive drugs should be made after 1–2 years (97.5%). Panelists also recommended corrective action plans for non-adherent patients to improve adherence (97.5%). A total of 131 items were finally accepted after round 2. Conclusion This Delphi study provides expert-based recommendations on clinical decision-making for managing patients with osteoporosis at high risk of fracture. Supplementary Information The online version contains supplementary material available at 10.1007/s11657-023-01318-7.

2. Follow-up of patients at high and very high risk of fracture should be done systematically and proactively 80 (100.0)In the early diagnosis of the disease 16 (20.5) Not agreed in round 2 after being reformulated (1)   The evaluation of therapeutic response 53 (67.9) Agreed in round after being reformulated (1)   Prediction of fracture risk and bone mass loss, and its correlation with bone densitometry 33 (42.3)Not agreed in round 2 after being reformulated (1)   Risk assessment 1.The risk of suffering a new fragility fracture increases in the 24 months following a previous fracture 78 (97.5)Agreed in round 2-4.Specific protocols for the assessment and prevention of the risk of a new fracture should be followed in: Supplementary Table 3: Results of the two-step Delphi process for the items regarding to the choice of the most appropriate treatment for the specific patient profile Items Accepted (scores 7-9) n (%)

Result of Delphi process
Availability of current therapeutic alternatives 1.The patient receives information on the nonpharmacological and pharmacological therapeutic alternatives currently available according to the diagnosis of their osteoporosis.74 (92.5)Oral and intravenous bisphosphonates 39 (50.0) Not agreed in round 2 after being reformulated (2)   Teriparatide and biosimilars 76 (97.4) Agreed in round 2 after being reformulated (2)   Denosumab 39 (50.0) Not agreed in round 2 after being reformulated (2)   14-16.The duration of treatment with oral bisphosphonates is currently well defined at: 5 years 56 (71.8) Agreed in round 2 after being reformulated (2)   10 years 29 (37.2) Not agreed in round 2 after being reformulated (2)   < 10 years 9 (11.5) Not agreed in round 2 after being reformulated (2)   17-19.The duration of treatment with intravenous bisphosphonates is currently well defined at: 3 years 54 (69.2) Agreed in round 2 after being reformulated (2)   6 years 32 (41.0) Not agreed in round 2 after being reformulated (2)   > 6 years 6 (7.7) Not agreed in round 2 after being reformulated (2)   20-23.The duration of treatment with teriparatide is currently well defined at: < 1 year 7 (9.0) Not agreed in round 2 after being reformulated (2)   1 year 10 (12.8) Not agreed in round 2 after being reformulated (2)   2 years 74 (94.9) Agreed in round 2 after being reformulated (2)   > 2 years 10 (12.8) Not agreed in round 2 after being reformulated (2)   24-26.The duration of treatment with denosumab is currently well defined at: Not agreed in round 2 after being reformulated (2)   10 years 56 (71.8) Agreed in round 2 after being reformulated (2)   > 10 years 18 (23.1) Not agreed in round 2 after being reformulated (2)   27.The maximum duration defined for each treatment is met in patients in whom the 70 (87.5)2. The adverse events of the different treatment alternatives determine the decision to choose one drug or another 75 (93.8)Agreed in round 1 (1) In round 1, when panellists were asked to rate their level of agreement regarding the use of the treatment with antiresortives in combination with bone-forming therapies.To clarify any possible doubts, the members of the scientific committee decided to reformulate this item into a new statement clarifying that it is the simultaneous use of both treatments at the same time (item 5 of Treatment lines / Optimization).
(2) In round 1, when panellists were asked to rate their level of agreement regarding the current definition in terms of the duration of the different treatments available, the item reached consensus.However, the members of the scientific committee decided to reformulate and break down this item into several new statements in order to gather more detailed information (items 11-26 of Treatment lines / Optimization).
(3) In round 1, panellists were asked to rate their level of agreement regarding the order in the sequence of treatments for this patient profile, but in a very generic way.Consequently, the members of the scientific committee decided to reformulate this item into a new statement in order to gather more detailed information (item 28 of Treatment lines / Optimization).
(4) In round 1, panellists were asked to rate their level of agreement on patient notification when a biosimilar treatment is administered, and the item didn't reach consensus.Consequently, the members of the scientific committee decided to reformulate this item into a new statement in order to gather more detailed information on the need for such notification (item 4 of Biosimilar availability).Primary care physician 51 (65.4)

Supplementary Table 4: Results of the two-step
Not agreed in round 2 after being reformulated (2)   Physiotherapist 28 (35.9) Not agreed in round 2 after being reformulated (2)   Rehabilitator 41 (52.6) Not agreed in round 2 after being reformulated (2)   Psychologist 11 (14.1) Not agreed in round 2 after being reformulated (2)   Dentist 14 (17.9) Not agreed in round 2 after being reformulated (2)   Nutritionist 25 (32.1) Not agreed in round 2 after being reformulated (2)   Specific patient support staff 35 (44.9) Not agreed in round 2 after being reformulated (2)   Representative of the osteoporosis patients ' association 19 (24.4)Not agreed in round 2 after being reformulated (2)   16-28.Regardless of what happens currently, the ideal team of an osteoporosis unit should consist of: Traumatologist 55 (70.5) Agreed in round 2 after being reformulated (2)   Rheumatologist 73 (93.6) Agreed in round 2 after being reformulated (2)   Internal medicine specialist 40 (51.3) Not agreed in round 2 after being reformulated (2)   Specialist in geriatrics 65 (83.3)Agreed in round 2 after being reformulated (2)   Specialist nursing 70 (89.7) Agreed in round 2 after being reformulated (2)   Primary care physician 64 (82.1) Agreed in round 2 after being reformulated (2)   Physiotherapist 48 (61.5) Not agreed in round 2 after being reformulated (2)   Rehabilitator 59 (75.6) Agreed in round 2 after being reformulated (2)   Psychologist 29 (37.2) Not agreed in round 2 after being reformulated (2)   Dentist 28 (35.9) Not agreed in round 2 after being reformulated (2)   Nutritionist 49 (62.8) Not agreed in round 2 after being reformulated (2)   Specific patient support staff 53 (67.9) Agreed in round 2 after being reformulated (2)   Representative of the osteoporosis patients' association 33 (42.3) Not agreed in round 2 after being reformulated (2)   29-41.Taking into account the current actual experience, the team of a FLS consists of: Traumatologist 67 (85.9) Agreed in round 2 after being reformulated (2)   Rheumatologist 69 (88.5) Agreed in round 2 after being reformulated (2)  Internal medicine specialist 38 (48.7) Not agreed in round 2 after being reformulated (2)   Specialist in geriatrics 52 (66.7) Agreed in round 2 after being reformulated (2)   Specialist nursing 59 (75.6) Agreed in round 2 after being reformulated (2)   Primary care physician 49 (62.8) Not agreed in round 2 after being reformulated (2)   Physiotherapist 33 (42.3) Not agreed in round 2 after being reformulated (2)   Rehabilitator 48 (61.5) Not agreed in round 2 after being reformulated (2)   Psychologist 18 (23.1) Not agreed in round 2 after being reformulated (2)   Dentist 15 (19.2) Not agreed in round 2 after being reformulated (2)   Nutritionist 27 (34.6) Not agreed in round 2 after being reformulated (2)   Specific patient support staff 36 (46.2) Not agreed in round 2 after being reformulated (2)   Representative of the osteoporosis patients' association 21 (26.9) Not agreed in round 2 after being reformulated (2)   42-54 .Regardless of what happens currently, the ideal team of a FLS should consist of: Traumatologist 71 (91.0) Agreed in round 2 after being reformulated (2)   Rheumatologist 76 (97.4) Agreed in round 2 after being reformulated (2)   Internal medicine specialist 46 (59.0) Not agreed in round 2 after being reformulated (2)   Specialist in geriatrics 71 (91.0) Agreed in round 2 after being reformulated (2)   Specialist nursing 74 (94.9) Agreed in round 2 after being reformulated (2)   Primary care physician 71 (91.0) Agreed in round 2 after being reformulated (2)   Physiotherapist 59 (75.6) Agreed in round 2 after being reformulated (2)   Rehabilitator 65 (83.3)Agreed in round 2 after being reformulated (2)   Psychologist 41 (52.6) Not agreed in round 2 after being reformulated (2)   Dentist 33 (42.3)Not agreed in round 2 after being reformulated (2)   Nutritionist 56 (71.8) Agreed in round 2 after being reformulated (2)   Specific patient support staff 58 (74.4) Agreed in round 2 after being reformulated (2)   Representative of the osteoporosis patients' association 40 (51.3) Not agreed in round 2 after being reformulated (2)   55.Taking into account the current experience, a FLS monitors the management of the patient at high and very high risk of fragility fracture 56 (71.8)Agreed in round 2 after being reformulated (2)   56.Regardless of what happens currently, a FLS should monitor the management of the patient at high and very high risk of fragility fracture 76 (97.4) Agreed in round 2 after being reformulated (2)  57-59.Based on the current experience, FLSs monitor the management of the patient at high and very high risk of fragility fracture at the level of: Hospital 70 (89.7) Agreed in round 2 after being reformulated (2)   Primary care centers 30 (38.5) Not agreed in round 2 after being reformulated (2)   Intermediate care centres (if available) 28 (47.5)Primary care physician and nurses 23 (29.5) Not agreed in round 2 after being reformulated (2)   Intermediate care staff (physicians and nurses) 20 (35.7) (3)   Not agreed in round 2 after being reformulated (2)   66-68.Regardless of what happens currently, FLSs should be coordinated by: Physician and nursing staff specialised in the management of patients with osteoporosis 77 (98.7) Agreed in round 2 after being reformulated (2)   Primary care physician and nurses 53 (67.9) Agreed in round 2 after being reformulated (2)   Intermediate care staff (physicians and nurses) 45 (70.3) (4)   Agreed in round 2 after being reformulated (2)   69.Based on the current experience, primary care centres have a specialised plan for the management of patients with high-risk osteoporosis.
14 (17.9) Not agreed in round 2 after being reformulated (2)   70.Regardless of what happens currently, primary care centres should have a specialised plan for the management of patients with high-risk osteoporosis.

(89.7)
Agreed in round 2 after being reformulated (2)   71.Based on the current experience, the primary care physician for each patient is informed of the specific care plan for the management of high-risk osteoporosis.

(47.4)
Not agreed in round 2 after being reformulated (2)   72.Regardless of what happens currently, the primary care physician for each patient should be 75 (96.2)Not agreed in round 1 Eliminated (1)   Abbreviations: FLS = Fracture-liaison service.
(1) The removal of this item was due to the opinion of the scientific committee that the level of agreement was not going to change substantially in the round 2.
(2) In round 1, panellists were asked to rate their level of agreement regarding the structure of specialised units and FLS.However, the members of the scientific committee decided to reformulate and break down round 1 items into several new statements in order to gather more detailed information (items 3-72 of Patient care programmes).
(3) This item was evaluated by n= 56 due to the fact that intermediate care centers are only available in some regions in Spain.
(4) This item was evaluated by n= 64 due to the fact that intermediate care centers are only available in some regions in Spain.
Delphi process for the items regarding to the treatment-associated quality of life in patients with osteoporosis at high risk of adherence to treatment for osteoporosis determines the choice of the most appropriate therapeutic alternative in each case 80 (100.0)