LymphAssistTM at Home (LAAH)

Recruitment phases with no more than 15 participants recruited at a time will be reported, with a total of 40 participants recruited within the expected study time frame (18 months) as captured using the screening and recruitment logs.

Participant compliance with daily use of IPC, as documented in the instruction manual, will be reviewed by self-report including the dose and frequency of IPC use as documented in the participant diary. Dose and frequency of use will be reported as percentages compared to protocol.

Changes in access to health and social-service (primary and secondary care contacts frequency, mode of contact and health / social care professional seen) before and after the study.

Changes in use of prescribed treatment (prescribed medication, creams and dressings) before and after the study.

Number of cellulitis episodes before the study and cellulitis recurrence during the study, including hospital admissions and length of stay, antibiotic use and number of days off work due to cellulitis.

Range of movement will be assessed from 0 percent to 100 percent where a higher number indicates increased range of movement.

Skin appearance, texture and tests will be evaluated using standardised assessments as per the study case report form. All items are measured as the presence or absence of the condition with descriptors used to evaluate further.

Limb volume is measured using standardised guidance within the study case report form (LymcalcTM which uses the cylindrical calculation). Using measurements taken at 4cm intervals for the affected and unaffected limb volumes are calculated and will be reported as changes from baseline to end of study (reported a mls and percent).

Lymphoedema staging / severity scales are not validated and none has achieved international agreement, therefore the ISL Staging of Lymphoedema will be reported alongside two other scales in use. The ISL has five stages; from 0 (a latent lymphoedema or sub-clinical phase where swelling is not yet evident) to stage III (where elephantiac changes are observed / marked skin changes). Stage 1 represents the accumulation of oedema / swelling and is reversible e.g. swelling will resolve upon elevation though there may be some pitting oedema. There are two stage II differentiated by the presence / absence of pitting oedema. Neither will resolve upon elevation and the absence of pitting marks an advanced / late stage of lymphoedema with excess subcutaneous fat / fibrosis developing.

Lymphoedema staging / severity scales are not validated and none has achieved international agreement, therefore the BLS Group of Lymphoedema will be reported alongside two other scales in use. The BLS Groups begin with zero (a latent but high risk of lymphoedema phase) to stage four (palliative / end of life). Group one represents early lymphoedema (present for less than three months) where the swelling may resolve upon elevation for example. Group two represents established uncomplicated lymphoedema which no longer resolves upon elevation. Group three reflects complex lymphoedema with skin changes. There are three further sub categories within group three differentiated by the number of limbs affected or the presence of midline lymphoedema.

Lymphoedema staging / severity scales are not validated and none has achieved international agreement, therefore the LWCN Lymphoedema Severity Outcomes are reported alongside two other scales in use. This scale starts at one (at risk of lymphoedema but with no swelling at present). Outcome two represents mild lymphoedema with 5-10% difference in volumes (between affected and unaffected limbs). Outcome three represents moderate lymphoedema with 10-20% volume difference and four represents severe lymphoedema (21-49% volume difference). The final outcome is group five which has a further sub category to indicate the presence of a wound. Outcome five represents complex lymphoedema (more than or equal to 50% volume difference). This is the only scale to report separately on the presence of wounds.

Changes in quality of life scores and quality adjusted life years Health-related quality of life will be measured using the five-level EuroQol Five Dimensions (EQ-5D-5L). It is a non-disease specific tool to report health-related quality of life. The EQ-5D-5L includes five dimensions and a visual analogue scale (EQ-VAS). Each of the five dimensions are each reported with five responses (from no problems, slight problems, moderate problems, severe problems, and extreme problems). The five dimensions are mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. For each of the five dimensions a 5-digit health state profile can be produced. The VAS records self-perceived health on the present day using a vertical thermometer from 0 (worst imaginable health) to 100 (best imaginable health).

WPAI has six items, the first is a dichotomous item to denote if the individual is in paid employment. The remainder of items are used to report presenteeism / absenteeism, productive loss and activity impairment. WPAI: Lymphoedema scores are presented as percentages where higher numbers indicate greater impairment and less productivity.

The purchase (procurement) costs will be reported and evaluated alongside direct and indirect healthcare costs using the Client Service Receipt Inventory (CSRI) - outcome three. Ongoing costs (clinician time) for home versus clinic-based IPC use will be reported in pound sterling (GBP).

Number and nature of problems found when using IPC for 12-weeks at home will be reported using the Participant Adverse Event Log. This will include reporting on the severity, likelihood and relationship to study treatment.

Loss to follow-up of participants will be enumerated and described where reasons are provided as captured in the case report forms and reported in the study flow diagram.