Table 2. Summary of studies reporting on lymphedema morbidity management program.

Reference	Study Design & Setting	Timeframe	Study Population	Description of Morbidity Management Program	Measure of Morbidity	Data Obtained
Addiss, et al., 2011 [ 27 ]	Randomized double-blinded clinical trial at clinic at Ste. Croix Hospital in Leogane, Haiti, comparing regular and antibacterial soap used in foot-care.	12 months (beginning in Spring 2001)	197 patients at the lymphedema clinic who lived within 10 km of hospital and were competent in lymphedema self-care.	Clinic-based research staff supplied patients with soap and made monthly visits to patients' home or workplace to resupply soap and monitor compliance.	Self-reported ADLA in previous month. Staff also assessed stage of affected limbs and checked for lesions.	ADLA incidence per person-year, incidence rate ratio (95% CI), comparing before and after entry into the study
Addiss et al., 2010 [ 26 ]	Prospective, two phase intervention study in Leogane, Haiti. Phase I focused on reducing leg volume and included compressive bandaging and a component of "complex decongestive physiotherapy"; Phase II primarily focused on preventing ADLA through hygiene and skin care.	1995–1998	175 people with lymphedema of the leg who enrolled in a lymphedema clinic in Leogane, Haiti	Patients taught to wash legs, apply antifungal and antibiotic creams, elevate limb, and perform range of motion exercises in March 1997 (Phase II, after a phase emphasizing compression bandaging). In Nov 1997, booklet with basic management messages given to each patient, and "soap opera" with a character implementing the management was broadcast over radio. Compliance measured in interviews.	Leg volume assessed using water displacement, classified according to stage, and patient asked about episode(s) of ADLA in past 12 months. Follow up every 4–6 weeks, where patients were asked to report any ADLA for which they hadn’t gone to the clinic.	Change in ADLA incidence (episodes per person-year); change in leg volume
Aggithaya et al., 2013 [ 38 ]	Intervention study in three endemic districts of Kerala province, India.	6 months	446 LF patients who attended a community LF morbidity management day camp.	Self-care integrative treatment camps within community where LF patients trained in skin care and daily yoga/breathing practices. Individual meeting with patients to ensure understanding. One month follow-up over phone to check compliance, final follow-up at six months.	Quality of life (QoL) of LF patients determined using validated and pretested specific questionnaire (LF-specific QoL questionnaire-LFSQQ). Disease burden assessed by asking questions about history of acute attacks and other symptoms.	Change in quality of life (reported as change in mean score on the questionnaire between baseline and 6-month follow-up)
Akogun et al., 2011 [ 28 ]	Intervention study in North-eastern Nigeria comparing three methods of LF care education: community care (CC), patient care (PC), and health facility care (HC).	12 months	Community members with previous experience with filarial episodic attack were asked to register at the health facility nearest them (registration remained open for the duration of the study).	CC arm selected one member to attend training and be responsible for educating people with LF in community. Training included identification of lymphoedema, basic hygiene procedures for management of lymphoedema and ADLA. In PC arm, small groups met in health facility. One leader chosen to attend LF care training and then train rest of group. In HC arm, patients attended clinic to be individually trained by staff and returned for checkups every third day. All received buckets, bowls, wash soap, towels, ointment.	Participants provided data on history of disease progression from onset of acute signs to development of chronic signs. Healthcare worker examined their limbs and recorded degree of morbidity (lesions on skin) and graded limbs according to the level of swelling and appearance of skin.	Change in mean ADLA frequency, change in duration of ADLA
Brantus et al., 2009 [ 29 ]	Education intervention pilot program, with follow-up once a month for 20 months to collect data on self-reported ADLA in previous month.	20 months	32 lymphedema patients living in Zanzibar, Tanzania.	Hygiene education to carefully wash affected limb and treatment of any wounds, regular exercise, elevation of affected limb, use of suitable footwear.	Self-reported incidence of acute attacks in previous month.	Reported ADLA incidence in previous month (reported for 20 months)
Budge et al., 2013 [ 39 ]	Prospective cohort study in 30 villages in Orissa State, India	24 months (2009–2011)	370 patients at least 14 years of age from 30 villages who reported lymphedema lasting more than three months (identified from house-to-house morbidity census).	Indian NGO, Church's Auxiliary for Social Action (CASA) provided community-based treatment of lymphedema using a network of village volunteers who are trained to provide home-based care and instruction in lymphedema management techniques and use of hygiene supplies.	Independent staging of leg(s), photographs taken, staff used 7-stage Dreyer system. ADLA episodes reported by patient for previous 30 days. Patients also given the WHO Disability Assessment Schedule II at baseline (July 2009) and regular intervals (1, 3, 6, 12, 18, 24 months, through July 2011) to assess patients' perceived disability.	Change in perceived disability (WHO Disability Schedule II), change in reported ADLA incidence in previous 30 days, change in stage of most-affected leg, days of work lost
El-Nahas et al., 2011 [ 30 ]	Intervention study for lymphedema management package in Egypt.	24 months (2008–2010)	45 patients attending Mansoura University Hospitals complaining of limb swelling with present or past history of limb redness.	Patients trained for basic lymphedema management, including daily care of affected limb, treatment of wounds with topical antibiotics, treatment of fungal infections with topical antifungal, manual draining, massage, use of compression, and elevation.	Self-reported incidence of acute attacks in previous year (pre-treatment year vs. post-treatment year).	Reported ADLA incidence in previous year
Harvey et. al., 2011 [ 40 ]	Retrospective analysis of annually collected data from Togo after implementation of a National Lymphoedema Management Programme (NLMP)	2007–2010	Survey cohort was convenience sample of 166 people with lymphedema, with same individuals followed each year.	Togo’s NLMP (began in 2007) teaches lymphoedema patients management techniques in order to improve self-care behavior and outcomes among patients.	Lymphedema-related symptoms were ascertained from the interview. Quality of life questions were asked, and patients were scored on the Duke Anxiety-Depression (DUKE-AD) scale.	Change in ADLA incidence, change in depression levels
Joseph et al., 2004 [ 18 ]	Double-blind, placebo-controlled, clinical study for antibiotic treatment with hygiene education in 22 villages in Vellore district, Southern India	12 months treatment, 12 months follow-up	Screened 430 villagers, accepted 150 subjects who were >15 years, weighed >30 kg, and had experienced at least two ADLA attacks in the preceding year.	Training period before treatment where patients taught about hygienic care of limb, stressing four main components: periodic nail clipping, nightly cleansing of affected area with soap and water, importance of keeping limb dry between washes, and application of salicylic acid ointment to skin (between toes and on sides of feet).	Field workers visited subjects at home every 3 to 4 days during 12 month follow-up during treatment and for following 12 months. Monitored treatment adherence, incidence of ADLA attacks, and any adverse effects of treatment. Also some data on mean volumes of affected limbs, grade, serology.	Change in incidence of ADLA attacks (mean attacks per person-year), change in average limb volume.
Jullien et al., 2011 [ 31 ]	Intervention study for home-based lymphoedema management programme in primary health care system of Burkina Faso	4.5 months	1089 patients suffering from LF-related lymphoedema of leg at any stage who participated in health education and washing project between April 2005 and December 2007.	Health education and washing project which included hygiene, washing, teaching good practices, and treatment of wounds, acute attacks, and other ailments.	Interviewed during monthly consultations at the health facility about acute attacks in preceding month	Change in percentage of patients reporting and/or caregivers observing ADLA in previous month
Kerketta et al., 2005 [ 16 ]	Intervention study of footcare with or without antibiotics in eight randomly selected villages in Khurda district of Orissa, India with follow up every two weeks.	12 months	254 patients identified through house-to-house visits in eight randomly selected villages.	Three arms of the study: (1) penicillin + footcare, (2) diethylcarbamazine (DEC) + footcare, (3) footcare + topical antiseptic ointment.	ADLA history reported by recall every two weeks.	Mean ADLA frequency before and after treatment
Mathieu et. al., 2013 [ 42 ]	National Lymphedema Management Programme in Togo.	24 months	109 patients in randomly-selected villages used in analysis for ADLA	Self-care techniques, including regular washing of the leg with soap and water, drying, elevating the affected limb, and regular exercise were demonstrated to patients by trained health workers. Patients were also provided with an educational booklet with illustrations.	Interview about acute attacks in preceding year	Change in incidence of ADLA attacks, comparing pre-intervention and follow-up periods
McPherson et al., 2003 [ 14 ]	Clinical intervention study in Wismar, Guyana.	April—Jun 2001	14 community members suffering from lymphedema	Each patient individually educated on importance of hygiene, skin care, and elevation, as well as simple exercises. Appropriate treatment given at start (antibiotics, antiseptics, and topical creams) and whenever necessary throughout.	Diagnosis confirmed clinically and classified according to Dreyer staging criteria. Interview about disease history and frequency of acute attacks. Also asked questions regarding knowledge, attitudes, and practices (KAP) and completed dermatology quality of life index (DQLI).	Change in DLQI score
Mues et al., 2014 [ 32 ]	Lymphedema management program implemented in Odisha State, India from 2007–2010 by Church's Auxiliary for Social Action (CASA) in consultation with CDC	24 months	370 lymphedema patients >14 years old reporting leg swelling for at least 3 months, from 30 villages that had not been enrolled in the program and were not in immediate vicinity of a participating town.	Patients trained in basic lymphedema management by physician-trained volunteers, including daily washing of limbs with soap and water, exercise and elevation of affected limb, and use of footwear outside. Patients trained in importance of early treatment and prevention of secondary infections and supplied with 6 months’ of soap and antifungal cream.	Self-reported ADLA episodes in previous month, defined as presence of two or more of following symptoms: redness, pain, or swelling of the leg or foot, with or without the presence of fever or chills.	Change in incidence of ADLA attacks
Narahari et al., 2013 [ 33 ]	Non-randomized interventional study in two LF endemic districts in southern India.	3.5 months	730 patients (851 affected limbs) known to live in area of study. Only those with stage 2 or 3 lymphedema were enrolled.	All patients given training in integrative management which involved patient education and self-care using a domiciliary protocol.	Patient limbs graded in camp, thigh volume assessed, information gathered on inflammatory episodes and skin lesions. Quality of life assessed using an LF-specific questionnaire.	Quality of life, limb volume before and after, number and percentage of patients reporting ADLA in previous 3 months.
Narahari et. al., 2007 [ 34 ]	Intervention study of "reverse pharmacology design" in India.	194 days of treatment over 3 years (2003–2006)	240 patients having lymphedema of one or both lower limbs with ability to withstand a variety of yoga exercises.	Ayurveda, yoga, and biomedicine components applied together: soap wash, soaking affected limb, Indian manual lymph drainage (IMLD), yoga, compression, dietary restrictions, oral herbal medication for elephantiasis.	Limb circumference at various locations, limb volume by water displacement.	Change in limb volume and circumference, "history of inflammatory episodes"
Shenoy et al., 1998 [ 35 ]	Double-blind, placebo-controlled, clinical study comparing efficacy of local treatment of affected limb combined with repeated doses of ivermectin, DEC, or placebo.	24 months	120 patients attending filariasis clinic who had experienced at least 2 ADLA attacks in the past year.	Patients in all arms of study instructed on local care and hygiene of affected limbs.	Reported ADLA attacks in previous year.	Total reported ADLA attacks in the year before and after treatment.
Shenoy et al., 1999 [ 17 ]	Randomized control trial for antibiotics and footcare (including antibiotic cream) in Alappuzha, India.	12 months treatment, 12 months follow-up	Patients attending clinic of the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital who had underlying filarial oedema and had experienced at least 2 attacks of ADLA in past 12 months.	All patients were asked to clean limbs with soap and water every night, keep affected limbs dry, clip nails, and apply salicylic acid ointment between toes, on nails, and on sides of feet each night. Overall compliance checked at regular intervals using surprise checks and pill counts.	Pre-study, all patients hospitalized for 4 days. Initial examination and interview about previous attacks, then a year of study and a year of follow-up. Follow-up every two weeks plus any time there was an ADLA attack.	Change in ADLA incidence (mean no. attacks/year) from pre-treatment year to treatment year, to follow-up year.
Suma et al., 2002 [ 13 ]	Cross-sectional evaluation of patients one year following clinical trial for antibiotics and footcare programme in Alappuzha district, India	—	150 patients who participated in antibiotics/footcare clinical trial >1 year ago (see Shenoy et al., 1999).	Unsupervised, post-intervention foot care included cleaning affected limb every night with soap and water, keeping limb dry, applying salicylic acid ointment to webs of toes, nails, and sides of feet each night, clipping nails regularly, and encouraging regular use of footwear.	Medical officer asked about footcare procedures in the unsupervised period, as well as the occurrence of ADLA attacks in the previous year (number, intensity, duration, precipitating factors, treatment received). Also examined and graded lymphoedema and checked skin condition.	Change in ADLA incidence, comparing pre-intervention and follow-up periods
WHO, 2004 [ 36 ]	Three pilot projects on washing affected limbs in Madagascar, Sri Lanka and Zanzibar.	2004	n/a	Washing affected limb daily, with home visits by volunteer health workers.	Self-reported acute attacks in previous month.	Reduction in ADLA attacks in previous month; change in percentage of sufferers reporting at least one acute attack in previous month.
Wijesinghe et. al., 2007 [ 37 ]	Quasi-experimental, interventional study with a pre-test/post-test design, carried out over 18 months in Colombo, Sri Lanka.	18 months in 2004–2005	Consecutive sample of 163 patients with lymphoedema attending two filariasis clinics in Colombo, Sri Lanka.	Principal investigator individually taught each patient the WHO-recommended comprehensive regime of limb care, emphasizing washing limbs with soap and water, especially toe webs and skin folds, keeping clean limbs dry, elevating limbs, and exercising affected limbs. Provided WHO booklet with explanatory pictures and text.	Lymphedema diagnosed in clinic (non-filarial causes excluded) and graded according to WHO recommendations, then interviewed about ADLA suffered in the last year (number, duration and intensity of attacks, and details of any precipitating factors, management measures taken, and treatment received). Patients asked to come into hospital monthly for any symptoms and to follow-up one year after initial training. Attacks treated with oral antibiotics/creams. Post-intervention assessment at 12 months.	Change in percentage of patients reporting ADLA in past year, change in duration of ADLA, change in frequency of ADLA, change in grade, change in compliance with washing.
Wilson et al., 2004 [ 41 ]	Intervention study evaluating the effect of lymphedema management on histologic features of skin punch biopsies in Leogane, Haiti	12 months	91 patients living <10 miles from the lymphedema treatment clinic who reported no ADLA episodes in previous 2 weeks.	Patients instructed in lymphedema self-care, with emphasis on daily washing, basic skin care to treat/prevent entry lesions, range of motion exercises, and elevation of limb.	Patients tested for filarial infection and lymphedema stage was assessed using an adaptation of a three-stage system recommended by WHO. Punch biopsies obtained at beginning of treatment and approximately 1 year later	Change in histologic features on punch biopsy