1 Asymptomatic 20 HIV wasting syndrome¥
2 Persistent gen. lymp. (PGL) 21 Pneumocystic carinii pneumonia (PCP)¥
3 Weight loss (<10% of body weight ) 22 Recurrent severe bacterial
pneumonia (≥ 2 episodes in a yr) ¥ 4 Recurrent presumed bacterial
respiratory tract infection ≥ 2 in six months (sinusitis, bronchitis, otitis media, pharyngitis)
23 Chronic herpes simplex (>1 mo.) [Oral/Genital/Anorectal ] ¥
24 Oesophageal candidiasis¥ 5 Herpes zoster (≤ 5yrs)
[Cutaneous/Ophthalmic]
25 Extrapulmonary/disseminated TB¥
6 Angular cheilitis 26 Kaposi’s sarcoma¥
7 Recurrent oral ulcers (≥ 2 in six months) 27 Histoplasmosis¥
8 Papular pruritic eruptions 28 CMV retinitis or of any organ except spleen, liver, lymph nodes ¥
9 Seborrhoeic dermatitis 29 CNS toxoplasmosis¥
10 Fungal nail infections of finger 30 Cryptococcal meningitis or other extrapulmonary Cryptococcus infection¥
11 Severe weight loss (>10% body weight) 31 HIV encephalopathy¥ 12 Unexplained chronic diarrhoea (>1mo.) 32 Mycosis (disseminated) ¥ 13 Unexplained persistent fever (>1 mo.) 33 Lymphoma¥
14 Oral candidiasis (thrush) 34 AIDS dementia complex¥ 15 Pulmonary tuberculosis (current or in
last 2 years)
35 Progressive multifocal leukoencephalopathy (PML) ¥ 16 Acute necrotizing ulcerative gingivitis
or necrotizing ulcerative periodontitis
36 Mycobacterium avium complex ¥ 17 Oral hairy leukoplakia 37 Vulvo-vaginal candidiasis*
18 Severe presumed bacterial infection (pneumonia, meningitis, empyema, pyomyositis, bone or joint infection, bacteraemia)
38 Reccurrent genital ulcers*
39 Peripheral neuropathy**
19 Unexplained anaemia (< 8g/dl) or neutropenia (<1000/mm3) or thrombocytopenia(<5000/mm3) for more than one month
40 Lipodystrophy**
¥AIDS-defining illness
* Additional diagnoses not included in the staging of HIV disease
**Pre-treatment HIV-related diagnoses that may also present as ART side effects
175 APPENDIX IV
DEFINITIONS OF THE HEALTH-RELATED QUALITY OF LIFE MEASURES
Measure Number
of items
Definition Item
placement within the present study questionnaire 1 Physical functioning 10 Extent to which health limits physical activities such
as self-care, walking, climbing hills and stairs,
bending, lifting, and moderate and vigorous activities
19a, 19b, 19c,19d, 19e, 19f, 19g, 19h, 19i, 19j 2 Pain 2 Amount of pain interference in daily activities
(including work and housework)
23, 24 3 Role limitations due
to physical health
4 Including limitations in activities during the past 4 weeks, such as less time spent on activities, limited in kind of work, had difficulty, or accomplished less than wanted
20a, 20b, 20c, 20d
4 Mental Health Index 5 Amount of time during past month very nervous, downhearted, down in dumps; happy, calm, and peaceful
25b, 25c, 25d, 25f, 25h
5 Role limitations due to emotional problems
3 Limitations in work or other regular daily activities due to emotional problems during past 4 weeks, including cutting down amount of time spent, accomplished less than wanted, didn’t do work as carefully as usual
21a, 21b, 21c
6 Vitality
(energy/fatigue)
4 Amount of time in past month felt full of pep, worn out, tired, or had a lot of energy
25a, 25e, 25g, 25i
7 Social functioning 2 Includes the extent of limitations by physical health or emotional problems in normal social activities
22, 26 8 General health 5 Ratings of current health, future health, and
resistance to illness
17, 27a, 27b, 27c, 27d 9 Perceived change in
health*
1 Rating of current health compared to one year ago 18
*Self-evaluated health transition item which is not used in scoring the scales
176 APPENDIX V
DESCRIPTION OF DIMENSIONS/DOMAINS/SCALES
Physical functioning (PF): The content of the 10-item PF scale reflects the importance of distinct aspects of physical functioning and the sampling of a range of severe and minor physical limitations. Items represent levels and kinds of limitations between the extremes of physical activities, including lifting and carrying items; climbing stairs; bending, kneeling or stooping;
and walking moderate distances. One self-care (bathing and dressing) represents limitations in self-care activities. The PF scale captures both the presence and extent of physical limitations.
Low scores indicate significant limitations in performing physical activities, while high scores reflect little or no such limitations.
Role-physical (RP): The four-item RP scale covers a range of physical health-related role limitations, including: limitations in the kind of work or other usual activities; reductions in the amount of time spent on work or other usual activities; difficulty performing work or other usual activities; and accomplishing less. Low scores on the RP scale reflect problems with work or other activities as a result of physical problems. High scores indicate little or no problems with work or other daily activities.
Role-emotional (RE): The three-item RE scale assesses mental health-related role limitations in terms of: time spent on work or other usual activities; amount of work or activities accomplished; and the care with which work or other activities were performed. Low scores on this scale reflect problems with work or other activities as a result of emotional problems. High scores reflect no limitations due to emotional problems.
Social functioning (SF): The two-item scale assesses health-related effects on quantity and quality of social activities, asking specifically about the impact of either physical or emotional
177 problems on social activities. The degree to which physical and emotional problems interfere with normal social activities increases with decreasing SF scores. The lowest score is related to extreme or frequent interference with normal social activities due to physical and emotional problems; the highest score indicates that the individual performs normal social activities without interference from physical or emotional problems.
Bodily pain (BP): The BP scale comprises two items: one pertaining to the intensity of bodily pain and one measuring the extent of interference with normal work activities due to pain. Low scores indicate high levels of pain that impact normal activities, while high scores indicate no pain and no impact on normal activities.
General health (GH): The GH scale consists of five items, including a rating of health (excellent to poor) and four items addressing the respondent’s views and expectations of his/her health. Low scores indicate evaluation of general health as poor and likely to get worse. High scores indicate that the respondent evaluates his/her health most favorably.
Vitality (VT): The four-item measure of vitality (i.e., energy level and fatigue) captures differences in subjective well-being. Low scores indicate feelings of tiredness and being worn out. High scores indicate feeling full of energy all or most of the time.
Mental health (MH): The five-item MH scale includes one or more items from each of four major mental health dimensions (anxiety, depression, loss of behavioral/emotional control and psychological wellbeing). Low scores on MH are indicative of frequent feelings of nervousness and depression, while high scores indicate feelings of peace, happiness, and calm all or most of the time.
Self-evaluated transition (SET): This general health item asks respondents to rate the amount of change they experienced in their health, in general, over a 1-year period on the standard
(4-178 week) form [or over a 1-week period on the acute (1-week) form]. This item is not used to score any of the eight health domain scales or component summary measures; however, it does provide useful information about perceived changes in health status that occurred during the year (standard form) [or week (acute form) prior to survey administration].
Furthermore, five scales (PF, RP, BP, SF and RE) define health status as the absence of limitations or disability. For these scales, the highest possible score is achieved when no limitations or disabilities are observed. Three of the scales (GH, VT and MH) are bipolar in nature, measuring a much wider range of positive and negative health states. For these scales, a mid-range score is earned when respondents report no limitations or disability. A high score on these bipolar scales is earned only when respondents report positive states and favorably evaluate their health.
The eight SF-36v2 scales may be aggregated to form two summary measures: the physical component summary (PCS) and the mental component summary (MCS), using norm-based scoring algorithms. The PCS combines PF, RP, BP and GH; while the MCS combines VT, SF, RE and MH.115-116 All but one of the 36 items (SET) are used to score the eight SF-36 scales.
Each item is used in scoring only one scale. The standard form of the SF-36v2 measures HRQL in the past 4 weeks, while the acute form measures HRQL in the past one week by changing the recall period for six of the eight scales RP, BP, VT, SF, RE and MH from “the past 4 weeks” to
“the past week”. The SF-36v2 is suitable for self-administration, computerized administration, or administration by a trained interviewer in person or by telephone, to persons aged 14 years and older.
179 APPENDIX VI
THE SF-36v2 HEALTH SURVEY: HRQL SCORING INSTRUCTIONS Step 1: Recoding items
Item numbers Change original
response category from
To recoded value of 3a, 3b, 3c, 3d, 3e, 3f, 3g, 3h, 3i, 3j 1
2 3
0 50 100 2, 4a, 4b, 4c, 4d, 5a, 5b, 5c, 9b, 9c,
9f, 9g, 9i, 10, 11a, 11c
1 2 3 4 5
0 25 50 75 100
7 1
2 3 4 5 6
100 80 60 40 20 0 1, 6, 8, 9a, 9d, 9e, 9h, 11b, 11d 1
2 3 4 5
100 75 50 25 0 Step 2: Averaging recoded items into scales
Scale Number scale of items Average the following
recoded items
Physical functioning 10 3a,3b,3c,3d,3e,3f,3g,3h,3i,3j
Role limitations due to physical health problems
4 4a,4b,4c,4d
Role limitations due to emotional problems
3 5a,5b,5c
Vitality 4 9a,9e,9g,9i
Mental health 5 9b,9c,9d,9f,9h
Social functioning 2 6,10
Bodily Pain 2 7,8
General health 5 1,11a,11b,11c,11d
[Self-evaluated transition] 1 2
The SF-36v2 is scored in two steps. First, the response for each item is recoded with a value from 0-100 according to the table. Second, an average value is calculated for the items in each of the eight scales, according to the table. Missing data are ignored and the scale score is calculated without the missing item. If more than 50% of the items are missing from any one scale, it cannot be calculated.
180 APPENDIX VII
HIV-RELATED CLINICAL EVENTS
NON-AIDS- DEFINING EVENTS AIDS-DEFINING EVENTS
Opportunistic infections Opportunistic infections Recurrent presumed bacterial respiratory tract
infection ≥ 2 in six months (e.g. sinusitis, bronchitis, otitis media pharyngitis)
Pneumocystic carinii pneumonia (PCP)
Recurrent severe bacterial pneumonia (≥ 2 episodes within one year)
Herpes zoster within last 5 years Chronic herpes simplex (oral, genital or anorectal) >1 month
Fungal nail infections of finger Oesophageal candidiasis
Unexplained chronic diarrhoea (>1 month) Extrapulmonary/disseminated tuberculosis Oral candidiasis Cytomegalovirus: retinitis or of any organ except
spleen, liver, lymph nodes Pulmonary tuberculosis (current or in last 2yr) CNS toxoplasmosis Acute necrotizing ulcerative gingivitis or
necrotizing ulcerative periodontitis
Cryptococcal meningitis or other extrapulmonary Cryptococcus infection
Oral hairy leukolplakia Mycosis (disseminated)
Severe presumed bacterial infection (e.g.
pneumonia, meningitis, empyema, pyomyositis, bone or joint infection, bacteraemia)
Histoplasmosis Cryptosporidiosis
Mycobacterium avium complex
Progressive multifocal leukoencephalopathy (PML)
Others Others
Weight loss (<10% of body weight HIV wasting syndrome
Angular cheilitis HIV encephalopathy
Recurrent oral ulcers (≥ 2 in six months) AIDS dementia complex Papular pruritic eruptions
Seborrhoeic dermatitis Cancers
Severe weight loss (>10% body weight) Lymphoma Unexplained persistent fever (>1 month) Kaposi’s sarcoma Unexplained anaemia (< 8g/dl) or neutropenia
(<1000/mm3) or thrombocytopenia(<5000/mm3) for more than one month
Cervical cancer - invasive