Department of Biostatistics and Medical Informatics
Introdução à Medicina 2005/2006
Is self monitoring more effective than usual care?
Barreira, R/ Beirão, D
/ Cardona, R
/ Castro Ferreira, R
Dias Ferreira, R
/ Fernades, R
/ Gaspar, H
/ Medeiros, R
Martins, R
/ Pena, R
/ Silva Ferreira, R
Adviser: João Fonseca,,Class: 19
Abstract
Introduction: Approximately300 million people worldwide now have asthma, and prevalence rates are increasing, especially among children. Self-monitoring of asthma is a central component of guided self-management, a treatment strategy in which patients are taught to understand their symptoms, to monitor their disease status and their treatment in accordance to a plan established with the doctor.
Aim:To compare the clinical benefits of children and adults with asthma that performed self-monitoring with those who do not performed self-monitoring. A secondary aim was to compare the clinical outcomes attained using different self-monitoring instruments/technologies.
Methods:This systematic review included randomized controlled studiespublished between 1996 and 2005, indexed at SCOPUS or MEDLINE,which assessed the benefits of using self monitoring in adults and children with asthma. Selection process had two phases: in the first, articles were included only by abstract, in the second the full text was read to include or exclude the article. After evaluated the quality of the included articles, data related to the studies methods, main results and conclusion were extracted and analysed.
Results:In this study 84 articles were identified, but only 5 articles could be included. Three of them concluded that self-monitoring allows a better control of asthma. Those which compared self-monitoring using different techniques did not show significative advantages.
Discussion:A low number of studies was available in the literature. The included studies suggested consistently that self-monitoring is more effective than usual care, asthma patients who monitor their disease between medical assessments had better outcomes.No differences were observed in the clinical efficacy of different techniques / instruments forself-monitoring. Considering the available studies, different techniques can be used in the self-monitoringof asthma; health professionals must decide the technique for self-monitoring, depending on the resources available and patient preferences.
Key-words: asthma, self care, self-management, monitoring, systematic review
Introdução:Há aproximadamente 300 milhões de pessoas asmáticas em todo o mundo, e o grau de prevalência está a aumentar, especialmente entre as crianças. A auto-monitorização da asma é uma componente central no tratamento orientado dos doentes a si próprios, uma estratégia de tratamento nos quais os pacientes são ensinados a perceber os seus sintomas, a monitorizar o estado da sua doença e o seu tratamento de acordo com um plano estabelecido com o médico.
Objectivo:Comparar os benefícios clínicos da auto-monitorização em crianças e adultos com asma que a fazem com os que não fazem. O objectivo secundário é comparar os resultados obtidos usando diferentes técnicas e instrumentos de auto-monotorização.
Métodos:Esta revisão sistemática incluiu estudos controlados e randomizados, publicados entre 1996 e 2005, indexados no SCOPUS ou na MEDLINE, que referissem os benefícios do fazer auto-monitorização em adultos e crianças com asma. O processo de selecção teve duas fases: na primeira, artigos foram incluídos apenas pelo seu abstract, na segunda, todo o artigo foi lido para se proceder à inclusão ou exclusão do artigo. Depois de avaliada a qualidade do artigo incluído, a informação recolhida sobre os métodos dos estudos, resultados principais e conclusão foi extraída e avaliada.
Resultados: Neste estudo 84 artigos foram identificados, mas só 5 artigos foram incluídos. Três deles concluíram que a auto-monitorização permite um melhor controlo da asma. Aqueles artigos que comparavam diferentes técnicas de auto-monitorização não demonstraram vantagens significativas.
Discussão:Um baixo número de estudos estava disponível na literatura. Os artigos incluídos sugerem consistentemente que auto-monitorização é mais efectiva que o tratamento tradicional, os pacientes com asma que monitorizam o seu estado da doença entre idas ao médico possuem melhores resultados. Não foram observadas diferenças na eficácia clínica de diferentes técnicas/instrumentos de auto-monitorização. Considerando os estudos disponíveis, diferentes técnicas podem ser usadas na auto-monitorização da asma. Os profissionais de saúde devem decidir a técnica a utilizar, dependendo dos fundos disponíveis e na preferência dos pacientes.
Introduction
Asthma is a chronic inflammatory disorder of the airways with variable obstruction. Chronically inflamed airways are hyperresponsive; they become obstructed and airflow is limited (by bronchoconstriction, mucus plugs, and increased inflammation) when airways are exposed to various risk factors [1]. According to the Global Burden of Asthma Report an estimated 300 million people worldwide now have asthma, and prevalence rates are increasing, especially among children. Although its control and treatment can be possible, it’s not achieved in most patients, so it’s necessary to improved the health care provided[2].
More and more, asthma is being considered an “ambulatory care sensitive condition”[3]. Almost 75% of admissions for asthma are avoidable, and potentially preventable factors are common in deaths from asthma[4]. At least 40% of people with asthma do not react appropriately when their symptoms worsen, and over 50% of patients admitted with acute asthma have had alarming symptoms for at least a week before admission [4].As many as 60% of asthmatic patients are poor at judging their dyspnoea[4].
Guided self management of asthma is a treatment strategy in which patients are taught to understand their symptoms and to monitor their disease status at home, in order to know how to act when signs of asthma deterioration first appear[4].Self management of asthma prevents exacerbations, improves care, and is a cost effective strategy[4].
Self-monitoring is a central component of self-management. Monitoring of asthma status by the patient between observations at medical facilities has the potential to reduce hospitalizations [5]., unplanned doctor visits, emergency room attendance, work absence and nocturnal asthma in adults[6].
Self-monitoring can be done using symptoms diaries and/or pulmonary function parameters (using peak-flow meter or spirometry) [7]. These can be registered in paper by the patients, stored in electronic devices and/or sent to health professionals using communication technologies (telemonitoring) [7]. Patients can use peak-flow meters or other devices to measure their own pulmonary function regularly in order to predict an oncoming attack.
However, there is controversy regarding the efficacy of self-monitoring without other self-management interventions and witch self-monitoring techniques are more efficacious therefore it may be useful to summarize the studies evaluating self-monitoring techniques in asthma trough a systematic review.
This study aims’ to compare the clinical benefits of children and adults with asthma that performed self-monitoring with those who do not performed self-monitoring. A secondary aim is to compare the clinical outcomes attained using different self-monitoring instruments/technologies.
Participants and Methods
- Study participants
This systematic review included studies assessing the clinical outcomes of using self monitoring in adults or children with asthma.
The inclusion criteria were: randomized controlled studies, published between 1996 and 2005,written in English, French, Spanish or Portuguese, indexed at SCOPUS or MEDLINE,which studied the use of self-monitoringin children or adults with asthma. The studies compared the clinical outcomes of patients performing self-monitoring with those who did not performed self-monitoring and/or compared different techniques of self-monitoring were included. The following clinical outcomes were considered: symptom scores, quality of life scores, lung function, peak expiratory flow (PEF), cough and night symptoms, daily consumption of inhaled medicationand compliance with self–management plans.
Studies that were not randomized or not controlled were excluded. In addition, studies that used an intervention other than self-monitoringwere also excluded.
2. Data collection methods
The study search strategy is presented in table 1.
Table1.Search strategy at Medline and at Scopus.
Data base / Pathology* / Clinical query* / Intervention* / Techniques* / Study designMedline / asthm*[MeSH] OR
asthm*[TIAB] / clinical[Title/Abstract]
AND trial[Title/Abstract])
OR
clinical trials[MeSH Terms]
OR
clinical trial[Publication Type]
OR random*[Title/Abstract]
OR
random allocation[MeSH Terms]
OR
therapeutic use[MeSH Subheading] / "self management"[TIAB]
OR
("self care"[TIAB] OR
“self care”[MeSH]) OR
“self-monitoring”[TIAB] / "peak-flow-meter"[TIAB]
OR (spirometry[TIAB]
OR spirometry[MeSH])
OR telemedicine[TIAB]
OR "communication tecnhologies"[TIAB]
ORehealth[TIAB]
OR“home automated telemanagement”[TIAB]
OR Internet*[TIAB]
ORmobile[TIAB] / Not applicable
Scopus I / TITLE-ABS-KEY(asthm*) / Not applicable / TITLE-ABS-KEY("self-management"
OR
"self care"
OR
"self-monitoring") / TITLE-ABS-KEY("peak-flow-meter"
OR Spirometry
OR telemedicine
OR "communication technologies"
OR ehealth
OR "home automated telemanagement"
OR internet
OR mobile) / TITLE-ABS-KEY(random*
OR
trial
OR
control*)
Scopus II / TITLE-ABS-KEY(asthm*) / Not applicable / TITLE-ABS-KEY(monitor*) / TITLE-ABS-KEY("peak-flow-meter"
OR spirometry
OR telemedicine
OR "communication technologies"
OR ehealth
OR "home automated telemanagement"
OR internet
OR mobile) / TITLE-ABS-KEY(random*
OR
trial
OR
control*)
* Between each column the connectorused was AND
The selection process had two phases. In the first selection each abstract was read independently by two reviewers. To exclude an article it was necessary the agreement of both reviewers. In the second selection, the articles were again divided amongst three groups of two reviewers. The full-text of each article was read independently by the two reviewers in order to decide if the article was included or not. When there wasn’t concordance, a group of 3 reviewers read the article, and it was included or excluded depending on the agreement of at least 2 reviewers.
The quality of the included articles’ full text was evaluated according to the following criteria [refx e y]:
1. Was study described as randomized (this includes the use of words such as randomly, random, and randomization)?
2. Was there a description of withdrawals and dropouts?
3. Was the treatment allocation concealed?
4. Were details of the interventions administered to each group made available?
5. Was participant (i.e., patients) adherence assessed quantitatively?
6. Was the follow-up schedule the same in each group?
7.Were the main outcomes analyzed according to the intention-to-treat principle?
In order to score the items it was given 1 point for each “yes” or 0 points for each “no”.
For the analysis of the included articles, two reviewers independently extracted the data. Review Manager (RevMan) [Computer program]. Version 4.2 for Windows. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2003,SPSS 14.0 for Windows, Release 14.0.1 (18 Nov 2005), Copyright© SPSS Inc, 1989 - 2005 and Microsoft® Office Excel 2003 (11.5612.5606) for MicrosoftOffice Professional Edition 2003 Copyright© 1985-2003 Microsoft Corporation software were used.
4. Variables description
Related to participants’ selection, this study focus the criteria used to select the participants.Groups formed, respective intervention(s) used andinstruments for data collections, like questionnaires, spirometry and peak flow meter (PFM), were the other methods’ variables extracted. Theoutcomes and respective significative differences between groups were also analysed. The dropouts were referredtoo.
5. Statistical analysis
The quality evaluation score is presented with mean and standard deviation (SD). The number of participants is presented with median, minimum and maximum. The dropouts are presented in valid percent.
Results
The search at Pubmed and Scopus identified 84 studies, 15 and 69 respectively. However, in the first selection, only 9 were included. Full text versions of these studies were obtained and read, but only 5 of them were included in this systematic review.
Among the 79 articles excluded, 62 were not related to our aim because the intervention was other than self-monitoring, 13 were not randomized controlled trial (RCT), 2 did not have the full text article available and the other 2 have it but were written in Japanese. The quality of included articles was analysed in SPSS; the scores were: Rasmussen, L.M 2005 - 5 points, Ostojic, V. 2005 – 5 points, Wensley, D. 2004 – 6 points, Turner, MO 1998 – 3 points, Adams, RJ 2001 – 4. The mean was 4.6 with a std. deviation of 1.14.
The methods and the main results of the included studies are summarized in table 2.
The number of participants of the included articles varied between 16 (minimum)[11] and 300 (maximum)[10], and had a median of 92[13]. In the other 2 studies took part 90[12] and 134[14] asthmatic patients. However, only 40% of the included articles [11, 13] had no dropouts, other 40% [12, 14] had less than 80% of dropouts and the remain 20% [10] had more than 80% of dropouts.
Related to the instruments for data collection, questionnaires on asthma QoL were often used [10, 12, 13]. Bronchial hyperresponsiveness was measured using methacholine[10], Cockcroft tidal breathing method[13] and histamine[14];spirometry[10,11,12,14] and PFM[12,13,14] were the pulmonary function parameters most used to self-monitoring. Paper diary was also used to record symptoms’ scores, medication used and PEF measurement. [11,13].
Table2. Description of the methods and main results of included articles
Rasmussen, L.M2005 / Ostojic, V.
2005 / Wensley, D.
2004 / Turner, MO
1998 / Adams, RJ
2001
Participants' selection / →18-45 years from Copenhagen, Denmark → asthma diagnoses: respiratory symptoms + ≥1 objective
measurement of asthma / →moderate persistent asthma: ≥ 6 months treated with ICS and LABA →no history of smoking, chronic bronchitis, or emphysema. →access to a cell telephone and able to use SMS / →7-14 years old →physician diagnosed asthma →at least step 2 of the BTSGAM - regular inhaled corticosteroid therapy
→stable treatment (1month), no other respiratory problem, competent at spirometry + a successful 4-week run-in period / → asthma diagnosis: defined by ATS enrolled from a primary care clinic in Vancouver, BCanada →completed ≥5 visits to be included in the final analysis / →Exclusion criteria: previous life-threatening asthma attack; current or previous asthma plan based on either symptoms or PEF, Pregnancy, poor perception of bronchoconstriction during histamine inhalation test and baselined FEV1< 1,5 L
→Inclusion criteria - 16-70 years old, physician's diagnosis of asthma as defined by the ATS, ability to use a PFM, telephone access at home, read and sign a consent form in English
Groups and interventions / →IG (n=100) - electronic diary + an action plan + a decision support system for the physician; access to a PFM; instructed in the use of the internet diary →SG (n=100) - taught to adjust their medication; access to PFM + a written action plan → GP group (n=100)- did not receive any treatment or information from the physician; contacted their GP and passed on a letter describing the study and the result / → both groups: 1-hour asthma education session with a specialist at the clinic for each patient. PEF determined 3 times per day →SMSG (n=8) - PEF results sent via sms their; received by sms weekly instructions, based on PEF values; when data received from a patient in this group indicated significant asthma exacerbation, instructed to go to office visit →CG (n=8) - were seen in the office at the end of the study period when their diary data were reviewed / →SymG (n=46) - symptom-based management alone for 12 months →PFMG (n=44) - symptom-based management plus PE / →PFMG (n=44)
→SymG(n=48) / →PFMG (n=73) - PEF plus symptom-based action plans →SBAPG (n=61)
Instruments for data collection / →questionnaires on asthma QoL, asthma self-care, smoking habits, education, salary, sick leave and hospitalization
→questionnaires-based physician (respiratory symptoms, current medication, compliance and adverse reactions)
→spirometry
→measurement of airway responsiveness with methacholine / →symptom diary made by patients, →paper diary with PEF measurement, medication use and symptoms;
→in the SMS group PEF results were daily sent via SMS or GSM mobile telephone (the software automatically processed data);
→office spirometry (before and after the study) / →questionnaires of asthma QoL →spirometry
→PFM / →bronchial hyperresponsiveness (Cockcroft tidal breathing method)
→symptom scores and medication used were recorded daily in the patients’
diaries
→asthma QoL questionnaire
→PFM / →spirometry → Histamine to mesure bronchial hiperresponsiveness - survey questionnaire - self-management plans based on the Australian National Asthma Campaign
→PFM
Dropouts / 253 subjects completed both the screening and follow-up visits. No significant difference was found in the dropout rate of the three groups (15,12 and 20 subjects, respectively) / NR / Among 90 participants only one withdrawaled / NR / From the original group of one 134 patients, 21(15%) completed between 3 and 5 months of follow-up, 25(19%) between 6-11 months and 88(66%) completed the 12 months of follow-up
Main Results / →Asthma symptoms:
IG vs. SG: odds ratio of 2.64, p= 0.002;
IG vs. GP: odds ratio of 3.26, p< 0.001;
→QoL:
IG vs. SG: odds ratio of 2.21, p= 0.03;
IG vs. GP: odds ratio of 2.10, p= 0.04;
→Lung function:
IG vs. SG: odds ratio of 3.26, p= 0.002;
IG vs. GP: odds ratio of 4.86, p< 0.001;
→Airway responsiveness:
IG vs. GP: odds ratio of 3.06, p=0.02; / →Absolute PEF: no significant difference
→Cough and night symptoms: CG had significantly higher scores (1.85 +/- 0.43 vs. 1.42 +/- 0.28, p < 0.05+D15 and 1.22 +/- 0.23 vs. 0.85 +/- 0.32, p < 0.05)
→ Daily consumption of inhaled medicine, forced vital capacity, or compliance: no significant difference / →Asthma Symptom: no significant differences →Lung function: no significant differences →QoL scores: no differences between-group →Episodes: SG 26 (58%) and PFG 16 (36%) (p=0,06) / →Symptoms score: no significant differences (p>0.39) →QoL : moderate increase for both groups →medications: no significant difference →compliance with self –management plans: 65% adherence in PFMG and 52% adherence in SG / →Lung function: no significant differences →Compliance with self-management active plans:
56 (76%) of PFMG + 47 (78%) of SG had an excellent understanding
SMS- Short messaging system; NR- not reported: ATS- American Thoracic Society, IG- Internet-group; SG- Specialist group; GP- General Practitioner; SMSG- SMS group; CG- Control group; SymG- Symptom group; PFMG- Peak Flow meter group; SBAPG- Symptom Based Action Plans group; QoL- Quality of life
In order to have a better comprehension of the clinic benefits of self-monitoring, the outcomes and respective significative differences were summarized in table 3.
Table 3. Overviewof the included articles
Study / Rasmussen, L.M 2005 / Ostojic, V. 2005 / Wensley, D. 2004 / Turner, MO 1998 / Adams, RJ 2001Aim / compare the outcomes of patients how perform home monitoring and usual care / determine the benefits of GSM and SMS, in relation to usual care / compare the use of PEF and symptom self-management plans / - compare the efficiency of PEF and symptom self-management
- compare the evolution of asthma with or without self-monitoring / compare the use of PEF and symptom self-management plans
Self monitoring technique of intervention(s) group / internet based monitoring / SMS or GSM mobile telephone / PFM
symptom-based management / PFM
symptom-based management / PFM
symptom based-management
Outcomes / • asthma symptoms ↓
• quality of life ↑
• lung function ↑ / • cough and night symptoms↓
• forced expiratory flow =
• PEF absolute =
• daily consumption of inhaled medication = / • quality of life =
• lung function =
• asthma symptoms = / • quality of life =↑
• medications =
• compliance with self--management plans: 65% - PEF
52% - symptom / • lung function =
• compliance with self-management plans:
76% PEF
78% symptom
Message / when physicians and patients use internet based home monitoring, better asthma control is achieved / SMS as a mean of telemedicine may contribute to better disease control / PFM doesn't have a significant advantage in relation to symptom self-management plans of children with asthma / there is no difference in PFM and symptom techniques but both are advantageous when the patients have a proper asthma education / PEF doesn't have a significant advantage when compared with symptom self-management plans of adults with asthma
Significative increasein intervention(s) group ; Significative diminution in intervention(s) group ; No significative differences between groups =; SMS- Short messaging system; PEF- Peak Expiratory Flow