of life (QOL) among type 1 and 2 adult diabetes patients in the Islamic Republic of Iran. Diabetes Society, whichever the patient …
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Developing a culturally valid and 3 reliable quality of life questionnaire for diabetes valid and reliable Developing a culturallymellitus quality of life questionnaire for
NM Alavi,1,2 F Ghofranipour,2 F Ahmadi 2 and A Emami 3 ,4
21 104 505 654 68 87 128 098
ABSTRACT The aim of this study was to design a culturally adapted questionnaire for studying quality of life QOL among type 1 and 2 adult diabetes patients in the Islamic Republic of Iran The 41 items Profile of diabetes health care at Benghazi diabetes centre, Libyan Arab on the questionnaire were based on qualitative research and covered general and health-related QOL In a descriptive survey, 104 patients completed the questionnaire; 68 654 were female Mean age was 505 years standard deviation 128 Most patients 865 had type 2 diabetes Cronbachs alpha coefficient for the questionnaire was 098 The questionnaire successfully distinguished the lower QOL of patients suffering from pain in the limbs, loss of appetite, fatigue, constipation and itching The questionnaire could determine both general and health-related QOL
2002 Développer un questionnaire de qualité de
vie pour le diabétique, culturellement valide et 483 805 fiable RÉSUMÉ Cette étude avait pour objectif la conception dun questionnaire détude de la qualité de vie 142 QOL/QDV chez ladulte diabétique de type 1 et 2 adapté à la culture de la République islamique dIran 24 Les 41 items du questionnaire ont été définis sur la base dune recherche qualitative et couvraient le 80 spectre de la qualité de vie générale et en rapport avec la santé Dans le cadre dune enquête descriptive 104 patients, dont 68 femmes 65,4 , ont rempli le questionnaire Lge moyen était de 50,5 ans écart type : 12,8 et la plupart des patients 87 étaient porteurs dun diabète de type 2 Pour ce questionnaire, le coefficient alpha de Cronbach a été de 0,98 Le questionnaire est en outre parvenu à parfaitement distinguer le faible niveau de qualité de vie des patients souffrant de douleurs lombaires, de perte dappétit, de fatigue, de constipation et de prurit Ce questionnaire devrait être à même dévaluer la QOL/QDV généraleinfection ratesanté Malaria signs and et liée à létat de among asymptomatic schoolchildren in Hajr
Faculty of Nursing, Kashan Medical University, Kashan, Islamic Republic of Iran Correspondence to NM
Alavi: alavi@accircom 2 Department of Nursing, Tarbiat Modarres University, Tehran, Islamic Republic of Iran 3 Department of Nursing, Karolinska Institutet, Huddinge, Sweden 4 Research and Development Unit, Stockholm Sjukhem Foundation, Stockholm, Sweden Received: 28/02/05; accepted: 19/05/05
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11 6 113 128
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Introduction
Quality of life QOL is an important outc c come in clinical trials and health care interc c ventions [1] which is receiving increasing focus in the scientific literature, including medical sciences literature [2] Sometimes QOL, health and satisfaction with life are used synonymously [3] The World Health Organization WHO defines QOL as an individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectac c tions, standards and concerns It is a broadc ranging concept, affected in a complex way by the persons physical health, psyc c chological state, personal belief and social relationships to salient features of their environment [4] Other experts suggest that QOL is a multidimensional, subjective and
dynamic concept [5] In medical sciences, QOL is used in 2 ways: general QOL or the general feeling of wellcbeing [2] and healthcrelated QOL, involving healthcrelated problems for difc c ferent diseases A number of questionnaires are available covering both aspects [6] Diabetes mellitus is a common and dec c manding health problem that has a great effect on the everyday life of patients [7] There are several tools for the assessment of QOL in diabetes mellitus, mostly designed in North America [8] According to the WHO definition of QOL, cultural percepc c tions and values play an important role in understanding the concept and the content of QOL by an individual It is, therefore, crucial to culturally validate the existing instruments and to test their reliability or to design some specific reliable and valid instruments bearing in mind the cultural beliefs and understandings of each target group
Taking this into consideration, it was decided to design a reliable, valid and culc c turally adapted questionnaire for studying QOL among adult patients with type 1 and 2 diabetes in Iran
Methods
After receiving approval for the research from the ethical committee of Tarbiat Moc c darres
University, the questionnaire was constructed and validated in 3 stages Drawing up the questionnaire In the first stage, the items of the questionc c naire were drawn up based on a qualitative study Two target groups were selected: patients group A and caregivers group B Group A were adults over 18 years who had had diabetes for 1 year All the participants were members of the Iranian Diabetes Society, the only nongovernmenc c tal educational organization for diabetes mellitus in Tehran We described the study to all the people meeting the inclusion criteria age 18 years and at 1 year of diabetes mellitus who were referred to the Iranian Diabetes Society during a 1cmonth period We exc c plained the research objectives in a lecture to 57 patients After the lecture, 32 of them approached us and agreed to be interviewed Group A Each volunteer completed a form giving information on demographic and clinical details The participant selection process was specifically aimed at choosing people with a range of ages, types of diabetes, treatment modes and complications, and covering both sexes [9] The interviews were carried out by one of the authors at the patients house or at the premises
of the Iranian Diabetes Society, whichever the patient
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preferred Patients were interviewed sec c quentially according to their condition The process continued until data saturation was achieved, ie no new concept emerged from the data [10] We discontinued after interviewing 15 patients 7 females and 8 males Thirteen patients had type 2 diabetes; 8 patients were being treated with insulin injections The mean age of the participants in this group was 526 years range 1975 years; SD 126 and the mean duration of diabetes was 106 years range 125 years; SD 87 The health professionals who particic c pated in this study group B had 5 years experience dealing with diabetes patients or those involved in research on diabetes patients All the staff working in the Iranian Diabetes Society who met the inclusion criteria, along with a number of experts, agreed to participate Group B comprised 11 nurses, 3 physicians, and 1 dietitian After obtaining written consent to be audiotape recorded, the researcher made appointments with these health professionc c als to conduct incdepth, facectocface, semic structured interviews Open
questions were asked regarding patients experiences in living with diabetes, its effects on their everyday life, their feelings about the condic c tion, the problems that it may have caused for them and the experiences that caregivc c ers had with patients Again, the process was discontinued when data saturation was reached Common statements and concepts from both groups were recorded and the relc c evant/appropriate items for a questionnaire were designed based on them For example, most patients declared that they preferred to hide their disease and this had caused them unnecessary stress Based on this statement, an item was devised I prefer to hide my disease with 4 choices as possible answers
never, seldom, most of the time, and always score range 14 Other items such as I think other people feel pity for me and I dont enjoy eating because of diabetes were composed in the same way The complete questionnaire was drawn up in Farsi, and comprised 41 items One item was specific to married patients My wife/husband supports me and another specific to unmarried patients Diabetes has restricted my chance for marriage The possible score was 40160, higher scores indicating better QOL From
the interviews, it was apparent that the participants considered general and healthcrelated QOL as interrelated concepts, thus, items referring to both dimensions were included in the questionnaire There were 13 items for assessing general QOL, involving concepts like calmness, anxiety, tension, fatigue, loneliness, spiritual beliefs and economic problems Items assessing healthcrelated QOL focused on the effect of diabetes on physical and psychosocial conditions Possible scores were 1352 for general QOL and 27108 for healthcrelated QOL Higher scores indicated better QOL in both cases Evaluating the questionnaire In the second stage, the basic pilot evaluc c ation of the questionnaire was performed The content validity of the questionnaire, the Iranian Diabetes Quality of Life IRDQOL questionnaire, was reviewed by 15 experts who had published 1 research papers in the QOL area The questionnaire was then revised based on the experts suggestions for minor changes No item was deleted The revised questionnaire was then sent back to the experts for approval The feasibility and basic reliability of the questionnaire were evaluated by conducting a pilot study The questionnaire was filled
in by 10 adult volunteers, diabetes patients
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from the Iranian Diabetes Society The pilot test was rectested on the same sample after 2 weeks and showed a reliability correlation coefficient of 095 Main survey Data collection In the third stage, a descriptive crossc sectional survey was conducted to assess the validity and reliability of the new inc c strument All patients over 18 years old referred to the Iranian Diabetes Society during the 3 months MarchMay 2003 who had been treated for diabetes for 1 year and had not been hospitalized in the 2 weeks prior to the survey were asked to fill in the questionnaire Over the 3cmonth period of the study, 156 patients aged over 20 years were referred to the society; 108 agreed to participate in the study and provided written consent and completed the questionnaire In addition, a blood sample was taken for assessment of HbA1c to indicate the blood glucose level over about 3 months, so it was possible to assess the relationship bec c tween glycemic control and QOL All blood analyses were done in the Endocrinology and Metabolism Research Centre laboratory in Shariati
Hospital, Tehran The WHOc5 questionnaire was also used on the same group of patients for the assessment of concurrent validity of our questionnaire [11] This has been translated into a number of languages, and we used the Farsi version It has 5 items and assesses the general psychological aspects of QOL The possible score on this questionnaire is 0100, higher scores indicating better QOL [11] Patients noted the occurrence of 16 common physical signs and symptoms of diabetes eg pain in the limbs, fatigue, sleep disturbance during the week prior to the day they completed the questionnaire Age, sex, marital status, education, durac c
tion of diabetes, type of diabetes, type of treatment and presence of other conditions were also indicated on a separate sheet History of previous disease and reported signs and symptoms, type of diabetes and type of treatment were confirmed from the patients medical records Body mass index was calculated after measurement of height and weight The total number of signs and symptoms was calculated from the patients reports Data analysis Since 4 of the questionnaires were incomc c plete, they were excluded from the data analysis The answers of the other
104 respondents were analysed for this study Descriptive statistics were used to establish frequency, range, mean and standard deviac c tion SD of the demographic characterisc c tics of the sample [12] Tctest, Pearsons correlation coefficient and noncparametric statistical methods, including the Mann Whitney test and the Spearman correlation coefficient, were used to examine the relac c tionship between IRDQOL scores and each variable [13] Cronbachs alpha coefficient was calculated for IRDQOL to determine reliability and internal consistency [13]
Results
Table 1 displays demographic and clinical data of the respondents Most 865 had type 2 diabetes Thirtycfive patients were injecting insulin and 65 were taking oral pills Mean age was 505 SD 128 years Mean body mass index was 264 SD 40 kg/m2 Mean duration of diabetes was 97 SD 69 years Mean HbA1c was 80 SD 20 Patients reported a mean of 40 SD 32 signs and symptoms: 52 reported fac c tigue, 50 pain in the limbs and 35 sleep
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Table 1 Demographic and clinical data Characteristic Sex Male Female Marital status Married Single Others Education Illiterate Primary school
educationa High school graduate University graduate Type of diabetes Type 1 Type 2 Type of treatment Oral pills Insulin Diet alone Other conditions Cardiac disease Hypertension Severe loss of vision Renal disease
a
No 36 68 86 13 5 10 44 25 24 14 90 65 35 4 17 33 9 6
346 654 827 125 48 97 427 243 233 135 865 625 337 38 163 317 87 58
Can read and write
disturbance Hypertension was reported by 33 32 patients and 17 16 had cardiac disease The concurrent validity of IRDQOL and WHOc5 questionnaires was 0639 Cronc c bachs alpha for the whole IRDQOL quesc c tionnaire was 098, which showed the high reliability of this scale The exclusion of any single item did not change Cronbachs alpha more than 001, which showed strong internal consistency Cronbachs alpha was 098 for healthcrelated QOL questions and 097 for general QOL questions These results were in agreement with the results
of the pilot test retest assessment carried out prior to the main study Mean total IRDQOL score was 1167 SD 188, mean general QOL score was 3701 SD 64 and mean healthcrelated QOL score was 797 SD 138 Men had higher total and healthcrelated QOL scores than women Our questionnaire as well as the WHOc5
questionnaire did not show any relationship between QOL of any type and type of diabetes, treatment modality, hypertension, cardiac disease, duration of diabetes, age or HbA1c Tables 2 and 3 The mean total IRDQOL score was 1115 SD 184 in patients suffering from limb pain while it was 1212 SD 185 in patients without pain in the limbs, ie significantly lower healthcrelated QOL in the presence of this symptom P 001 Pac c tients who reported fatigue had significantly lower total, healthcrelated and general QOL scores in comparison with patients without fatigue P 0001 Sleep disturbance had a significant relationship with lower scores for total and healthcrelated QOL Constic c pation, itching and loss of appetite also significantly affected QOL P 005 Higher numbers of reported signs and symptoms were associated with lower QOL P 0001 Tables 2 and 3
Discussion
Using the IRDQOL questionnaire, we did not find any relationship between glycemic control and QOL This is in line with the study done by Trief et al in which 3 differc c ent questionnaires were used among adult diabetes patients without finding a relationc c ship between QOL and HbA1c [14] There are, however, other studies that
show such a relationship in children and teenagers with diabetes [15,16] and a less prominent
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Table 2 Relationship between different dimensions of quality of life QOL and other clinical and demographic variables Characteristic General QOL score Mean SD P 362 65 385 60 365 77 374 63 370 77 370 63 374 57 362 77 362 54 372 66 368 66 371 64 356 65 385 62 338 80 376 61 Health-related QOL score Mean SD P 773 135 834 139 774 164 804 135 773 180 800 130 803 139 775 133 752 173 805 130 787 137 801 140 763 139 827 133 680 188 815 121 739 130 814 138 728 135 864 108 734 150 822 126 741 136 824 133 Total IRDQOL score Mean SD P 1139 183 1219 188 1138 238 1178 179 1144 252 1171 177 1178 180 1137 200 1114 214 1177 182 1160 180 1173 192 1115 184 1212 185 WHO-5 index Mean SD 424 245 585 287 489 236 489 283 560 246 470 274 479 274 488 270 426 263 493 273 450 271 495 272 439 229 525 304 426 307 491 266 365 251 519 268 P
Sex Female Male Marital status Single Married Diabetes Type 1 Type 2 Treatment Pills Insulin Cardiac disease Yes No Hypertension Yes No Pain in limbs Yes No Loss of appetite Yes No Constipation Yes No Fatigue
Yes No Itching Yes No
014
002
004
0006
062
055
047
087
073
080
062
016
058
021
030
0716
042
046
021
038
059
086
068
030
003
004
001
015
004
1018 250 0001 1191 168 1078 170 1197 184
002
028
331 65 383 60 0001 341 60 401 56 0001 334 70 386 56 0001
001
0001
001
1070 173 0001 1264 153 1069 205 0001 1210 167 1103 177 0001 1200190
0001
342 191 633 265 0001 360 248 534 265 0001 406 261 523 269
0001
Sleep disturbance Yes 361 58 No 375 68
02
001
003
Possible scores: total QOL 40160; general QOL 1352; health-related QOL 27108; WHO-5 index 0100 Higher score indicates better QOL IRDQOL Iranian Diabetes QOL SD standard deviation P 005 indicates statistically significant relationship
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Table 3 Relationship between different dimensions of quality of life QOL and other clinical and demographic variables Variable General QOL r No of signs symptoms Duration of diabetes BMI HbA1c Age WHO-5 index 0517 0069 0191 0148 0003 0627 P 0001 0487 0056 0137 0973 0001 Health-related QOL r P 0553 0073 0181 0092 0057 0621 0001 0466 0072 0360 0570 0001 Total IRDQOL r 0582 0086 0131 0114
0049 0672 P 0001 0393 0196 0255 0696 0001 WHO-5 index r 0094 0203 0070 0037 1000 P 0357 0046 0483 0713
0487 0001
IRDQOL Iranian Diabetes QOL r Pearsons correlation coefficient P 005 indicates statistically significant relationship
relationship has been demonstrated in adult patients [17] In a study on 2048 patients over 18 years old with type 1 or type 2 diabetes, among those who had type 2 diabetes, there was a relationship between complications of diabetes and QOL but no relationship bec c tween age or duration of diabetes and QOL [18] Our study too showed no relationship between age or duration of diabetes and any dimensions of QOL There was, however, a relationship between some physical signs and symptoms and QOL In our study, 50 of patients reported pain in the limbs, mainly the feet This is in line with the study conducted by Quatc c trini and Tesfaye who reported that painful lower limb symptoms occurred in 321 of patients with type 2 diabetes [19] Our study showed that patients with this comc c mon physical problem had a lower QOL The association between physical signs and symptoms and lower QOL in diabetes patients has been demonstrated in a number of studies
[17,20,21] Physical signs and symptoms can be considered indicators for construction validity in studies regarding QOL questionnaires in diabetes mellitus Our questionnaire successfully distinguished
lower QOL in patients suffering from anc c noying signs and symptoms such as pain in limbs, itching and sleep disturbance which showed acceptable construct validity Quality of life has been found to be higher in males than females [2224] It seems sex can be considered a predictor variable in QOL studies This study showed significantly better healthcrelated and total QOL in males, confirming the criterion prec c dictive validity of the scale In observational studies, an increasing degree of obesity has been associated with healthcrelated QOL [18,25] Although there was a significant inverse relationship between the WHOc5 and BMI in our study, other QOL measures did not show such a relationship Findings regarding the relationship between QOL and treatment regimen are ambivalent in the literature Some studies report that patients who are treated with insulin have lower QOL [17,23] Others, along with our own study, do not show such a relationship [18,24] The correlation coefficient of the
IRDQOL questionnaire and WHOc5 quesc c tionnaire was 0639, which is fairly acceptc c able as the concurrent criterion validity The scale might be able to predict QOL as
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an important outcome in the followcup of diabetic patients, although the predictive criterion validity of the questionnaire needs more assessment The scale can determine the general and healthcrelated QOL in both type 1 and type 2 adult diabetic patients, which is an advantage of the scale
Conclusions
Quality of life is a subjective and complic c cated experience which is widely used as an indicator in different clinical trials and descriptive studies There are a number of general and healthcrelated QOL questionc c naires for diabetes mellitus In addition to translation and validation of questionnaires in different countries, designing new quesc c tionnaires with qualitative approaches may give better understanding of cultural effects on quality of life The questionnaire we dec c vised has acceptable validity and reliability and has a number of advantages The items have been derived from the people involved in the actual situation regarding
living with diabetes in the cultural milieu of the Islamic Republic of Iran It can also determine both general and healthcrelated QOL
The IRDQOL questionnaire successc c fully distinguished the lower QOL in all 3 dimensions, in patients suffering from pain in limbs, loss of appetite, fatigue, constipac c tion and itching, the most frequent signs and symptoms, indicating acceptable construct validity of the questionnaire Our questionnaire might be appropriate for assessment of QOL in persons with diac c betes in other countries with similar cultural backgrounds and other Islamic countries in the region However, this would need further research; in particular, concurrent validity should be studied using other healthcrelated QOL questionnaires for diabetes
Acknowledgements
This research project has been supportc c ed by the Endocrinology and Metabolism Research Centre h in Tehran Medical University and Tarbiat Modarres University in Tehran We wish to express our gratitude to the participants who generously shared their reflections with us We are also gratec c ful for the support received from the Iranian Diabetes Society for providing the research environment
References
1 Fayers
PM, Machin D Quality of life: assessment, analysis, and interpretation New York, John Wiley, 2000:27 Polonsky WH Understanding and assessing diabetes specific quality of life Diabetes spectrum, 2000, 131:3642 Snoek FJ Quality of life: a closer look at measuring patients well-being Diabetes spectrum, 2000, 131:249 Study protocol for the World Health Organisation project to develop a Quality of 6 Life assessment instument WHOQOL Quality of life research, 1993, 22:1539 5 Wood-Dauphinee S Assessing quality of life in clinical research: from where have we come and where are we going? Journal of clinical epidemiology, 1999, 524:35563 Haberman MR, Bush N Quality of life methodological and measurement issues In: King CR, Hinds PS, eds Quality of life from nursing and patient perspectives:
2
3
4
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theory, research, practice, 1st ed Toronto, Canada, Jones Bartlett, 1998:11739 7 Faro B The effect of diabetes on adolescent quality of life Pediatric nursing, 1999, 253:24754 Watkins K, Connell C Measurement of health related QOL in diabetes mellitus Pharmacoeconomics, 2004, 2217:1109 26 Streubert HJ, Carpenter DR Qualitative
research in nursing, advancing the humanistic imperative, 2nd ed Philadelphia, Lippincott, 1999
diabetes Diabetes care, 1998, 21suppl 3:C4452 18 Coffey et al Valuing health-related quality of life in diabetes Diabetes care, 2002, 2512:223843 19 Quattrini C, Tesfaye S Understanding the impact of painful diabetic neuropathy Diabetes metabolic research review, 2003, 19suppl 1:S28 20 Zetina-Lopez A et al Impacto de los síntomas gastrointestinales sobre la calidad de vida de los pacientes diabéticos tipo 2 [Impact of gastrointestinal symptoms on health related quality of life in patients with type 2 diabetes mellitus] Revista de investigación clínica, 2003, 556:5949 21 Brown MM et al Quality of life associated with visual loss: a time trade-off utility analysis comparison with medical health states Ophthalmology, 2003, 1106:107681 22 Senez B et al Evaluation de la qualité de vie des patients diabétiques de type 2 en médecine générale [Quality of life assessment of type 2 diabetic patients in general medicine] Presse médicale, 2004, 333:1616 23 Mata Cases M et al Impacto de la diabetes mellitus tipo 2 en la calidad de vida de los pacientes tratados en las consultas de atención primaria
en España [Effect of type 2 diabetes mellitus on the quality of life of patients treated at primary care consultations in Spain] Aten primaria, 2003, 318:4939 24 Huang GH et al Self-rated health among young people with type 1 diabetes in relation to risk factors in longitudinal study American journal of epidemiology, 2004, 1594:36472 25 Kaukua JK, Pekkarinen TA, Rissanen AM Health-related quality of life in a randomised placebo-controlled trial of sibutramine in obese patients with type II diabetes International journal of obesity, 2004, 284:6005
8
9
10 Kendall J Axial coding and the grounded theory controversy Western journal of nursing research, 1999, 216:74357 11 Bech P, Gudex C, Johansen KS The WHO Ten well-being index: validation in diabetes Psychotherapy psychosomatics, 1996, 654:18390 12 Burnes N, Grove SK The practice of nursing research: conduct, critique and utilization, 4th ed Philadelphia, WB Saunders Co, 2001 13 Gillis A, Jackson W Research for nurses: methods and interpretation Philadelphia, FA Davis, 2002:403 14 Trief PM et al A prospective analysis of marital relationship factors and quality of life in diabetes Diabetes care, 2002, 257:11548 15 Mortensen HB
Findings from the Hvidore Study Group on Childhood Diabetes: metabolic control and quality of life Hormone research, 2002, 57suppl 1:11720 16 Varni JW et al The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module Diabetes care, 2003, 263:6317 17 Testa MA, Simonson DC, Turner RR Valuing quality of life and improvement in glycemic control in people with type 2
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