The radiographic reduction of the intrabony component named radiographic defect fill DF was evaluated as the VDD difference between baseline and follow-up examinations 1 year and 3 years after the reconstructive surgery. A composite outcome, which was also considered a determinant of treatment success, was used to determine whether an implant was successfully treated without requiring any further surgical intervention [ 23 ].
The proposed success criteria were categorized as follows:. Outcome 1: the absence of additional bone loss after the treatments according to baseline radiographs;. The sample size was calculated by a mean radiographic defect depth VDD in 3 years 2. Based on this calculation, 17 subjects were found to be required for each group. For each patient, one implant with the most severe peri-implant defect was taken as a statistical unit. The Kolmogorov—Smirnov test was used to assess the normality of distributions.
A generalized linear mixed model GLMM was used to compare mean differences between groups that included between-subjects and within-subjects factors in terms of time trend increase and decrease. When a significant difference was found based on the time within groups, pairwise comparisons were made to find out which two different time intervals caused the difference. A multivariate logistic regression test was used in order to investigate the influence of patient demographics, implant characteristics, and baseline clinical and radiographic parameters in addition to treatment methods on the composite outcome.
Of the initial 72 patients, who met the inclusion criteria for the study, 51 patients completed the 3-year follow-up examination. During the first year, 2 patients from the CGF group and 3 patients from the CM group did not attend follow-up appointments properly. One implant with progressive bone loss concomitant with Supp and increased PD in the CGF group had to be explanted between the 1- and 3-year follow-ups. Thus, these patients were dropped out from the current study 3 patients The patients, who fully adhered to SPIT were included in the final analysis.
At the end of the 3-year follow-up examination, non-reconstructive surgical therapy, including open flap debridement, was performed on one implant from the CM group, and two implants from the CGF group due to the severe peri-implant inflammation accompanying Supp after their final assessments Fig. Patient demographics, implant and site-level characteristics, and the distribution of peri-implant bone defect types were reported in Table 1.
The mean age was Eleven patients Regarding postoperative complications, three implants from the CM group All cases resulted in almost complete soft tissue coverage within 2—3 weeks postoperatively. However, in the CM group, 9 implants An overall improvement was observed according to the baseline conditions with respect to mean PI, GI, and BOP values during the 3-year study time periods Table 2.
The mean PI reduced significantly to 0. A similar trend was also observed for the mean GI values 0. Eight patients The mean PD was 5. A trend of increase was seen at year 3 CGF group, 3. In line with PD, while a significant decrease was observed at year 1 and year 3 compared to the baseline for the mean CAL values in both groups, it could be observed that the third-year values tended to increase compared to the first year values.
Besides, the changes over time in CAL did not reveal any statistically significant difference between the groups. The mean MR at baseline was 0. In both groups, increases were identified for the mean recession levels at year 1 and year 3 compared to the baseline 0. Although the increases in the CGF group were lower than the CM group in the follow-up examinations, there were not any significant differences between the two groups in terms of the changes over time.
Mean changes in clinical parameters at 1 and 3 years postoperatively. The radiographic evidence of DF between baseline and year 1 and year 3 after the reconstructive surgical therapy were 1. Comparison of the defect fill between the groups. As to the composite outcomes, for outcome 1, For outcome 2, treatment was successful for None of the composite outcomes revealed any statistically significant difference between the groups Fig.
Comparison of the treatment outcomes at 3 years postoperatively. When evaluating the effects of implant- or patient-related variables on composite outcomes, no significant impact was found on outcome 1 or outcome 3. While the present study did not identify an association between the variables tested in multilevel analyses and treatment outcomes, results of univariate analyses with the outcome 2 as the dependent parameter demonstrated that history of periodontitis, baseline VDD values, and the number of residual intrabony defect walls were significantly associated with outcome 2.
Regarding the peri-implant bone defect configurations, four-wall defects showed 6. The present study focused on the evaluation of 3-year outcomes of an RCT on reconstructive surgical treatment of peri-implantitis using a bone substitute combined with CGF or CM.
It was identified that reconstruction of peri-implant vertical bone defects by means of a grafting material with CM yielded better results compared to using CGF at year 3 after surgical intervention. The changes in PD between baseline and year 1 and baseline and year 3 presented significantly greater decreases for the CM group in comparison with the CGF group, although a significantly higher increase between year 1 and year 3 was shown for the CGF group.
The present study also revealed no significant differences between the two treatment modalities in terms of treatment success outcomes. Over the years, it has been proven that surgical augmentative therapies demonstrated promising results in terms of reconstruction of peri-implant bone defects, achieving re-osseointegration, and limiting peri-implant MR [ 10 ].
The materials and combinations of materials would present better outcomes by means of reconstructive surgical approaches that have also been widely debated. To the present date, many studies in which bovine-derived xenografts with or without a barrier membrane were used for the reconstruction of peri-implant bone defects exhibited a PD reduction range of 1. The discrepancies regarding clinical and radiographic outcomes might probably be explained by using or not using a barrier membrane or another biological agent, different baseline bone defects characteristics, different implant surface characteristics, and using different implant surface decontamination methods.
On the other hand, there is a limited supply of data available for evaluating the long-term success of reconstructive surgical therapies and more information is needed about the assessment of reconstructive modalities over a longer period of time. A long-term follow-up study by Rocuzzo et al. The proposed reconstructive treatment exhibited stable clinical and radiographic outcomes, especially for SLA implants, despite the fact that a tendency to relapse was observed in long term 7 and 10 years.
On the other hand, a recent follow-up observation reporting the 5-year results of reconstructive management by means of mineralized dehydrated bone allograft in combination with resorbable membrane was also demonstrated increased PD and a progressive decrease in vertical defect filling although favorable short-term results were presented [ 9 ].
The present results were comparable with the aforementioned studies in that an overall improvement was observed for both study groups at year 1 postoperatively. The mean PD dropped by 2. However, a trend towards a slight decrease was identified for the mean PD reduction 2.
Consistent with the present finding, Khoskam et al. Using a barrier membrane over the grafting material, which is the principle of guided bone regeneration GBR , is strictly recommended based on the theoretical understanding that it prevents the soft tissue ingrowth into a defect region, allows the angiogenic and osteogenic cells to migrate into the blood clot, and provides stabilization of the grafting material in the defect [ 32 ].
Nonetheless, considering the clinical outcomes obtained from the related studies, the benefits of barrier membranes in the augmentative surgical treatment of peri-implantitis have not been clarified. While a systematic review and meta-analysis indicated that additional use of barrier membranes in the surgical treatment of peri-implantitis resulted in higher reductions of PD and BOP compared to bone substitutes alone [ 33 ], a 5-year follow-up of a randomized controlled clinical study exhibited no additional benefits to using barrier membranes and also proved a cost-increasing procedure [ 13 ].
In a Consensus Report of Group 4 of the 15th European Workshop on Periodontology, it was highlighted that reconstructive treatment of peri-implant defects by xenogeneic material combined with a membrane showed greater BOP and PD reductions as well as CAL gains [ 9 ]. On the other hand, a recent RCT demonstrated approximately 3 mm of radiographic defect reduction by means of bovine-derived xenografts alone in a reconstructive surgery of peri-implant defects, which was comparable to the findings of other combined approaches of reconstructive treatments [ 25 ].
However, limited success in the resolution of inflammation was also reported in that study, which may be explained by not using a barrier membrane. However, it must be mentioned that limited evidence is available on the impact of platelet concentrates on clinical outcomes of reconstructive surgical therapy of peri-implantitis. It has been stated that platelet membranes act as a cleansing barrier that would be dissolved, allowing bone growth onto the decontaminated implant surface in peri-implantitis cases [ 35 ].
Besides, a recent in vitro study also exhibited that L-PRF membranes significantly reduce bacterial counts on biofilm-infected rough implant surfaces through the release of antimicrobial peptides by platelets inducing osmotic death of the bacteria [ 35 ]. Therefore, the effects of platelet concentrates on peri-implantitis in clinical setting should also be explored in the context of microbiological outcomes in addition to clinical and radiographic outcomes.
On the other hand, platelet membranes are resorbed within 10 to 28 days, which may limit their use as a resorbable barrier membrane because they could barely maintain a sufficient space for reconstruction of bone defects [ 36 ]. Besides, a recent systematic review and meta-analysis has also marked that the use of platelet concentrates has yielded a favorable soft tissue healing compared to hard tissue healing [ 37 ].
However, it has been emphasized that success in bone regeneration might also be linked with anti-infectious action and immune regulation of the leukocytes and neutrophils clustered in the fibrin clot as notably earlier soft tissue healing was observed after the administration of A-PRF and CGF membranes [ 16 ]. Coherently, the present study revealed stable clinical and radiographic parameters following reconstructive surgical therapy where CGF membranes were used for an observation period of three years.
It is also worth noting that the CGF group did not exhibit a remarkable change in peri-implant soft tissue level at follow-up examinations in what was suggested as one of the critical outcomes after reconstructive therapy of peri-implantitis [ 9 ]. This finding could also be explained by the impact of centrifugation protocol on the cells i.
Slower centrifugation speed [ 38 ] or horizontal centrifugation [ 39 ] has exhibited promising results in terms of releasing a greater amount of growth factors and having a higher concentrations of platelets and leukocytes in the matrix. In the reconstructive surgical approaches of peri-implantitis treatment, a promising concept is submerged healing which is based on the understanding of aseptic healing of bone substitute and barrier membrane in a protective environment in GBR procedures.
This approach has been recommended for the fact that submerged post-operative wound closure allows to potentially adapt for better oral hygiene ability [ 5 ] and provides spontaneous augmentation of the keratinized mucosa on the crestal area [ 40 ]. Although no evidence-based superiority of submerge has been demonstrated on the healing site regarding the outcome in comparison with non-submerged healing [ 41 ], reconstructive approach in submerged manner has been documented to yield optimal clinical and radiographic outcomes in terms of disease resolution and PD reduction and radiographic defect fill [ 13 , 40 ].
It is important to note that peri-implant maintenance programs play a critical role in the resolution of inflammation in addition to treatment success following peri-implantitis surgery [ 42 ]. In particular, the stability of clinical outcomes of the reconstructive surgical approaches to peri-implantitis is dependent on optimal plaque control performed by the patient and compliance with a regular maintenance program, similar to regenerative periodontal treatment [ 43 ].
A previous study by Serino, Turri, and Lang demonstrated that no recurrence of peri-implant disease was observed around any of the implants that regained healthy peri-implant conditions following peri-implant surgery for the patients attending SPIT during the 5-year follow-up period [ 44 ].
A recent 5-year follow-up study by Heitz-Mayfield et al. In a recent study, Carcuac et al. This difference may be related to the longer follow-up period of that study. The use of composite therapeutic outcomes has been proposed to evaluate the effectiveness of interventions to treat peri-implantitis [ 19 ].
Multiple studies have reported the efficacy of treatment procedures based on different success criteria [ 24 , 25 , 29 , 30 , 45 , 47 ]. In the present study, three different composite outcomes were assessed to determine treatment success based on the absence of additional radiographic bone loss in combination with clinical landmarks PD with concomitant BOP and Supp.
In a recent RCT, no additional bone loss following the treatment has been suggested to remark healthy peri-implant tissues during the follow-up period [ 24 ]. On the other hand, according to the consensus report of Workgroup 4 of the World Workshop, it can be difficult to define a range of PD values compatible with the differentiation of peri-implant health and disease [ 1 ].
In line with these reports, it should be noted that these assessments might be misleading in identifying peri-implant health. Therefore, in this study, different composite outcomes were created with different combinations of the success criteria. Treatment success did not significantly differ among different groups in terms of all of the defined criteria.
The outcomes were acquired for Recent systemic reviews have identified that the success rate ranged between 11 and It has also been reported that this variety might probably be explained by using different treatment success criteria evaluating different surgical modalities and the diversity in the surface characteristics of treated implants [ 4 ].
Whereas the present study did not reveal an association between the implant- or patient-related variables tested in multilevel analyses and outcomes 1 and 3, history of periodontitis, baseline VDD values, and number of bone defect walls were identified as statistically significant variables affecting outcome 2. This finding highlighted that history of periodontitis and bone defect configurations and vertical extent could have an impact on residual PD around implants after reconstructive therapy of peri-implantitis.
In accordance with the present finding, the efficacy of defect bone configurations on the mean value of PD changes between baseline and after reconstructive treatment has been recently demonstrated in a study by Aghazadeh et al. On the other hand, there is strong evidence that patients with a history of periodontitis have an increased risk for peri-implantitis [ 1 ].
It is worthy to underline that history of periodontitis may have a significant influence on soft and hard tissue morphology around the implants as well as serving like reservoirs for pathogens and therefore may pose an impact on residual peri-implant pockets after therapy of peri-implantitis. The current data identified a history of periodontitis as a prognostic indicator, which is associated with a negative treatment outcome.
However, a previous study evaluating prognostic factors for surgical treatment outcome of peri-implantitis by de Waal et al. This finding could possibly be related to the fact that a significant proportion of the patients included in that study were completely edentulous and the data on the history of periodontitis were mainly based on self-reported information. In the current study, it was shown that the amounts of VDD values at baseline were negatively associated with the treatment outcome in agreement with the findings of previous studies that observed peri-implant bone loss at baseline as a negative predictive factor for the success of treatment outcome [ 50 , 51 , 52 ].
Besides, studies have also exhibited that peri-implant bone defect configuration has a potential impact on the outcome of reconstructive therapy of peri-implantitis [ 49 , 51 , 53 ]. It has also been highlighted in a recent review by Schwarz et al. The present study identified a favorable treatment outcome with four-wall defects compared to the other defect types in reconstructive surgical therapy of peri-implantitis consistent with a recent study conducted by Aghazadeh et al.
The present study had several limitations. One of them was the lack of the assessment of the effect of implant surface characteristics on the success of treatment modalities at year 3 following the operation. The implants included in the present study had modified and non-modified surfaces, depicting no significant difference between the study groups.
On the other hand, surface characteristics could not be found as a prognostic indicator in the multilevel analyses performed in the RCT where the 1-year results were evaluated [ 18 ]. Second, the influence of the present treatment modalities could also be investigated on the dimensions of keratinized mucosa that has been proposed to have a critical role in maintaining peri-implant health.
Lastly, a comparison of the effectiveness of the present treatment modalities is needed to identify a longer follow-up presenting at least 5 years. The present study also revealed no significant difference between the two treatment modalities in terms of treatment success outcomes. The success of the treatment outcome was negatively affected by identified prognostic indicators, i.
Four-wall bone defects seemed to yield a better success compared to the other defect types in reconstructive surgical therapy of peri-implantitis. J Clin Periodontol 45 Suppl 20 — Article Google Scholar. Tomasi C Derks J Etiology, occurrence, and consequences of implant loss. Periodontol — Schwarz F, Ramanauskaite A It is all about peri-implant tissue health.
Periodontol 88 :9— A systematic review and meta-analysis. J Clin Periodontol — Article PubMed Google Scholar. Int Dent J — Periodontol 88 — Clin Oral Implants Res — General Population have the responsibility to learn about the behaviors that promote health "health education" , as well as the characteristics of the early phases of respiratory diseases so they can confirm or disconfirm their existence through the appropriate actions of secondary prevention.
Patients Associations should help associates both patients and relatives or caregivers in the educational process for self-management of disease once it is manifest "education about the disease" as well as advocate for public and political awareness of the burden of the disease. In Italy, as there is no register for such diseases nor a corresponding exemption ticket, precise and reliable official data concerning COPD are lacking.
Moreover, and not only in Italy, a large underestimation of the disease itself has been demonstrated. In Italy in - based on WHO data - out of a total , deaths 64, were due to respiratory causes: of these, 31, deaths were due to lung cancer, 16, to chronic obstructive respiratory diseases, 8, to pneumonia and 8, to other respiratory causes.
In , 37, deaths were registered 6. Of these, the deaths due to asthma were , while those due to COPD, chronic bronchitis, emphysema and other chronic obstructive diseases were 20,[ 7 ]. Respiratory diseases all together thus represent the 3 rd ranking cause of mortality or 2 nd , if lung cancer is included. These are deaths that mostly affect the more advanced age-groups, and approximately half of them are due to COPD; nevertheless, when the moment of death arrives the patient will have already lived many years of invalidity as shown by the European Community Respiratory Health Survey ECRHS which highlighted that in the years age-group new cases of COPD per 1, inhabitants each year range from a little more than 1 to almost 3 depending on the criterion of obstruction utilized[ 8 ].
This statement is confirmed by a recent Italian study that compared the data of prevalence drawn from administrative records with the general medicine database Health Search and with estimates based on ISTAT data. This study, while it showed good agreement between the three sources concerning diabetes, heart failure and ischemic heart disease, revealed COPD prevalence based on administrative data to be markedly lower with respect to the data from general medicine[ 10 ].
More in line with the picture that emerges from the international literature are the data of Viegi et al. Similar results have been found also in other countries[ 13 ]. These are figures that evidence an epidemic trend, which needs to be faced as a real emergency. An emergency all the greater considering that - as said before - this frequency is high notwithstanding the figures are underestimated[ 14 ].
A classic example are patients who report dyspnea on exercise: they are almost always referred for an electrocardiogram or to a cardiac specialist and consultation by a pulmonologist comes only at a second or even third step. Patients with COPD but also asthma are often undertreated to the point that not even those affected know they have a chronic obstructive disease[ 15 ]. Strange as it may seem, even severe cases, despite the fact they provoke significant respiratory symptoms, are diagnosed in only half of the patients.
The previously cited study[ 18 ] carried out on more than 8, British adults over 35 years of age showed a prevalence of COPD defined with spirometry of Overall, the most reliable estimates for the global burden of COPD range from 3. If the first cause for missed diagnosis of this respiratory disease is low patient sensitivity about the symptoms themselves of the disease, when symptoms finally are reported to the doctor scant use is made by the latter of the procedures that could correctly lead to diagnosis.
In a study carried out a few years ago, only about half of patients who reported symptoms performed a spirometry test[ 22 ]. Besides being harmful for the individual affected, this underestimate and under-awareness involves a cost for society for late diagnosis and inappropriate treatment which in turn lead to a not-inevitable number of cases of invalidity and a drain on healthcare resources for inadequate or nonexistent planning of specific patient care - in Italy there is still no exemption for medical costs related to COPD.
In fact the costs of non-programmed care - a consequence of underdiagnosis - can double those of programmed care[ 28 ]. Last, it is worthwhile noting that COPD care already now represents a high cost for the community: it is the 7 th ranking cause for number of admissions and for cost of hospital stay, and the 2 nd for mean length of stay, with a percentage of hospital admissions that represents 1.
Hospitalizations for COPD constitute more than 6. Also based on the same source, respiratory diseases represent the 2 nd cause for access to the Emergency Ward, after accidental lesions wounds, injuries and poisoning [ 29 ]. A patient treated at home with long-term O 2 therapy costs approximately 4, euro per year[ 30 ]. In conclusion, using with prudence the above-mentioned estimates i.
It is not by chance that WHO recommends the adoption of initiatives to raise awareness about the epidemiological importance of COPD through advocacy both of the wider public and of politicians and decision-makers in general[ 3 ]. In addition to the increase in the number of people affected by these diseases due, as already mentioned, to the growing average age of the population, the cost of their care is rising due to the development of new, effective pharmacological treatments and new rehabilitation protocols that increase still further the life expectancy.
These trends place the accent on the sustainability of the healthcare budget: if today there is 1 person over 65 years for every 2 people of an employable age, this ratio is destined to become inverted in the short term and we will have 2 elderly for every 1 person of an employable age.
For this reason, in the U. In practice, a national health service should, while ensuring care for already existing chronic diseases with the aim to reduce their invalidating consequences through early diagnosis and rehabilitation , implement actions aimed at preventing the onset of new ones. Part of the care for currently existing diseases is an optimization of the existing services which includes a reduction of the inappropriate healthcare practices and their integration.
By way of example, currently care for chronic diseases is prevalently hospital-based, but it will have to organize itself differently to become prevalently based in the local community. In Italy, as in the U. A way to put into practice the general principles outlined above is exemplified in the flow diagram in Figure 1 modified from the joint statement of the three leading scientific societies in Respiratory Medicine in conjunction with a scientific society of General Medicine, The Integrated Management of COPD [ 35 ].
The cited document and relative flow diagram were used - together with the Italian AGE. General flow chart for COPD management. From[ 35 ] mod. The flow chart represents the general management of COPD and can serve for the management of any chronic respiratory condition accordingly modifying the instruments for early diagnosis.
The general population must be stimulated and assisted to keep healthy: this is achieved through health education which means guiding them to choose healthier behaviors together with the elimination of outdoor air pollution through appropriate legislation and continuous monitoring of air quality , education about indoor pollution control, and tobacco control.
For example, as interventions of predictive medicine one can intend actions addressed at evaluating cholesterolemia in the prevention of cardiovascular diseases. Persons identified through the use of risk cards - in one of the possible modes see below - or those who due to presence of respiratory symptoms - even generic - are suspected of COPD undergo an early diagnosis procedure based on spirometry as the method of choice. Once the diagnosis of COPD is made the patient enters a treatment process based on self-management, aided by education about the therapy, programmed integration between hospital and local community, and pulmonary rehabilitation PR , the goal of which is to delay the invalidating consequences of the disease.
With the progressive worsening of the disease, home care must be organized and, in the final phases, pain care and end-of-life care. Through these organizational modalities, and only in this way, COPD care and that of the other chronic diseases is based on an appropriate use of resources and is sustainable by the community, as demonstrated by the U. All points presented in the flow chart - in particular the issue of early diagnosis - will be discussed in the following paragraphs.
Primary prevention signifies prevention of the occurrence of chronic respiratory disease. This is achieved principally, but not only, through a consistent reduction of the number of smokers in the community, together with health education and indoor and outdoor pollution control Figure 2. Reduction in the number of smokers is brought about, at the level of the general population, by legislative and commercial measures bans, sales limitations, taxation rather than through health treatments.
Particular effort hence will be spent on identifying them predictive medicine and directing them a priori to the appropriate care. In reducing the number of smokers one acts not only on the principal cause of COPD but also on the principal risk factor of other prevalent chronic diseases.
In the general population tobacco control is to be understood as a primary prevention measure, i. The control of this cause of diseases is the most important measure in the field of prevention of chronic diseases and can be achieved either by impeding smoking initiation of adolescents not yet smokers or by making already active smokers quit smoking before they develop a disease.
The two approaches are not alternatives but, rather, complement each other; nonetheless of the two strategies the one that obtains best results in the short term is smoking cessation of active smokers. In fact, while the health benefits of non-initiation will be seen after approximately one generation i. Essential for the success of both approaches is that they are implemented in a social and cultural context that is able to control smoking from all points of view - legislative, commercial and price regulation - focused on protecting the health of non-smokers.
The offer of services for smoking cessation made obligatory by article 14 of the FCTC permits - as shown above - to act for the prevention not only of chronic respiratory diseases but also of chronic diseases other than respiratory which represent the great majority of the causes of death and invalidity in our community. Both prevention of smoking initiation in young non-smokers and smoking cessation in adult smokers represent effective strategies of prevention of COPD and of other smoking-related diseases.
However, as shown above, prevention of initiation yields results after years, which is the mean time interval between the beginning of exposure to harm from smoking and the onset of a disease correlated to it. As said at the start, it is also important - though less - to control outdoor and indoor air pollution. This theme is intertwined with the more general one of health promotion[ 42 ] which is not simply healthcare but the result of coordination between all sectors and subjects whose activity is fundamental for the health of the community.
For what concerns indoor pollution, a distinction should be made between that of the workplace and that of the living environment. In the first case legislation and control based on sanctions play a leading role, in that they can regulate the exposure of workers to substances that are potentially dangerous for the respiratory system. Concerning the home and living environment, while in public spaces legislation and repression still have a role, for the home environment only health education is valid.
One should bear in mind that the chief role in domestic pollution in industrialized countries is played not only and not so much by gaseous products originating from combustion but by passive smoking to which about half of European children are allegedly exposed[ 43 ]. The combination of preventive measures includes also education about a healthy lifestyle, which includes eating and physical activity.
In this context - more specifically a matter of the health sector - interdisciplinary collaboration and integration assume a great role: respiratory disease specialists interact with the Department of Prevention, regional health and social welfare services, and GPs. Given the epidemiologic values outlined above, of absolute importance, the National Health Service cannot act only passively passive diagnosis but must become a promoter of a series of actions in the field of primary and secondary prevention, and of rehabilitation.
The document intends thus early diagnosis and not simply the promotion of interventions of information and education in the fight against the main causal agents chief amongst which is smoking , or the activation of programs of reduction of occupational and environmental risk about which we spoke earlier. For this reason the National Health Plan stresses the need to arrive earlier at defining the presence or absence of the disease.
Early diagnosis which should always be understood as a clinical, not just functional, diagnosis: see Figure 3 is considered important because it enables one to act immediately on the causes of disease first of all, cigarette smoking so as to impede or delay the effects of the progression of respiratory disease towards more severe and invalidating symptom levels[ 46 , 47 ]. Interventions for early diagnosis of COPD. It is known that only smoking cessation apart from oxygen therapy in the advanced phases can alter the natural course of COPD and improve survival in those affected[ 48 ].
In addition, by administering the most appropriate pharmacological treatments and - above all - commencing pulmonary rehabilitation in the initial phases of the disease it is possible to reduce exacerbations and improve the quality of life[ 46 ]. Initiating in this phase also interventions of education about the disease enables one to lighten the burden of stigma and depression that follow diagnosis.
If, then, secondary prevention offers these benefits, the next question to ask is who should undergo COPD screening: the general population? There is consensus that diagnosis should be based on screening of people at risk rather than screening the whole population. The latter would be hardly cost-effective given that the prevalence of COPD seems relatively modest in the general population whereas it is markedly elevated in smokers over 40 years of age[ 3 ]. It thus appears more suitable to diagnose unknown cases based on the recognition of symptoms that become manifest i.
All these strategies, however, require greater awareness and sensitivity on the part of GPs and of primary care in general towards respiratory diseases, without forgetting that, according to the aforementioned study[ 45 ] a spirometry test was more often prescribed - and the difference was statistically significant Translated into practice this means that all symptomatic individuals aged over 40 years should undergo spirometry.
A proposal for screening persons with COPD. From[ 3 ]. Consequently, they do not consult the doctor except in the case of episodes of worsening of the symptoms per se due to an exacerbation. More or less often, in such cases, also the GP underestimates the situation, diagnosing the episode simply as an acute expression and not as an epiphenomenon of an unrecognized chronic condition, omitting to examine in more depth the clinical picture.
The use of questionnaires with specifically targeted questions can help throw light on this shadow area, making patients aware of the need to investigate more deeply their own condition. Also the collection of administrative information about the use of healthcare services in the past through a specific algorithm can be a useful screening tool for COPD, endowed with sufficient positive predictive value to be able to identify individuals at risk of having an undiagnosed COPD[ 55 ]. There are numerous possible questionnaires that can be used, followed, in the screened patients, by a simple spirometry test.
Some authors propose, as an alternative to spirometry, to measure the PEF on the basis of some scientific evidence[ 52 , 53 , 56 , 57 ]: this measure, however, is controversial as a diagnostic tool. This is due to the fact that among the determinants of PEF elastic recoil, bronchial resistance and muscle strength the contribution of muscle strength including that of the facial and mouth muscles is all the more preponderant the less compromised the other two factors are.
All this weakens the use of PEF, above all in the earlier phases of disease in which the obstruction is probably not yet very marked. In the following pages we report the Italian versions, modified with respect to the original, of two questionnaires that are easy to use, validated and used in epidemiological research on COPD.
A further method is recruiting by invitation to specific people with certain characteristics to participate in the spirometry screening - the candidates for screening are thus self-selected[ 62 ]. This latter method, addressing smokers aged between 40 and 55 years, seems to improve the efficiency of the screening procedure, given that the frequency of disease carriers is particularly high.
Summing up, the best approach is one of the sequences illustrated in the flow chart Figure 5 , in which two health professionals characteristic of the Italian situation are involved, i. Inserting them within the online healthcare files in use would make it extremely easy to identify subjects at risk.
Such activity Table 5 could be carried out by the nursing staff present in group practices, community primary care units, healthcare homes, healthcare co-operatives, and all those forms of collaborative association that offer the possibility of using such personnel.
We are referring here, besides the contact with Occupational health physicians and Sport doctors already mentioned, to use of Emergency services for acute respiratory problems. If certain specific characteristics are present, the emergency care doctor can - when the acute event is resolved and the person is discharged home - address the patient in case of suspicion to a follow - up pulmonary specialist evaluation.
Among the array of possible initiatives, besides the individual intervention of the GP and Occupational health doctor, other healthcare professionals can collaborate with these two professional figures, integrating their activities. In public health initiatives, the effective instrument of prevention, once the target population to address has been identified, is that of the active call.
The various subjects of the National Health Service involved in activities of primary and secondary prevention are involved in it in an integrated and coordinated way. Besides these, active prevention presupposes the conscious adhesion on the part of the citizen, whose will to participate in the screening programs and successive initiatives of prevention is requested.
The active call has the advantage of soliciting interested subjects so as to implement the necessary actions and optimize the interventions of diagnosis and care. In Italy some models have already been experimented and are in the course of experimentation - although not in respiratory medicine - and can have as their objective both early diagnosis e.
A good model for intervention based on the use of risk cards could be that proposed by a study begun in in the Veneto Region regarding cardiovascular disease which is about to be published[ 66 ]. The organizational model proposed is managed by the Departments of Prevention and has as its target the proactive assessment through active call of healthy individuals aged between 45 and 59 years. The Screening Center SC of the Department of Prevention operates in collaboration with the local health district and GPs: the SC prepares the lists of residents and submits them to the GPs, who help in the selection of subjects to contact, excluding those among their patients who bear any of the causes for exclusion i.
The GP should also exclude any persons who result to the GP already under treatment for ischemic heart or cerebral disease, arterial hypertension or diabetes mellitus with therapeutic indication. Computer management is provided by a specific software program. To those who adhere, a healthcare assistant HA administers a standardized questionnaire and records data such as weight, height, body mass index BMI , waist circumference, arterial blood pressure, and fasting glycemia.
On these premises the following flow chart has been created Figure 6. Proposed model of respiratory disease prevention by active prevention. From[ 66 ] mod. The above model presupposes an increased availability of spirometry tests with respect to the present and to achieve this there are diverse options:. Spirometry performed at a Pharmacy by specially trained personnel [ 67 ]. In such cases and always with planning of the appointments, outpatient specialists or trained nursing staff linked to the outpatient clinic when available can be requested to perform the spirometry test.
If not available, the feasibility of carrying out the test by technical staff made available by the Pulmonology or Respiratory Pathophysiology Unit can be evaluated. For each of these approaches it is also possible to have the diagnosis made or a comment given by the reference specialist, possibly where available through telemedicine. In other words, whoever performs and, in any case, records the result of the test must have adequate training and experience, given that the diagnostic significance of spirometry is both patient- and operator-dependent, with full collaboration required between the two figures involved[ 68 ].
The most frequent error in the phase of execution is that of a forced expiratory phase which is too-short this occurs often in severely obstructed patients and interrupted early. This error can be detected only if one can visualize in real time the expiratory curve, which therefore needs to be visible in the spirometer used for the screening. The fact that the spirometer contains the predicted values enables one to make an immediate judgment.
If the device is able to print out immediately a report or if it is connectable to a printer make the service complete and enables the results of the test to be saved. Different types of portable spirometers exist that can be used and managed in outpatient clinics not dedicated to respiratory pathophysiology.
The element for measuring transducer can be a turbine or a pneumotachograph. Whatever device one wishes to use, for reliable results the device must not only be able to memorize the data collected for purposes of making a report - also at a distance - and storing data but also to show in real time on the display both the numerical values and, above all, the curves generated by the patient, in order to allow an assessment of the reliability and reproducibility of the test. In alternative, the spirometer must possess these characteristics when interfaced with a computer.
Being able to view in real time the curves enables, as we said, to detect immediately the size of the effort made by the patient and other errors in the performance of the test. The performance of these portable spirometers has been compared particularly in the pediatric setting with conventional spirometers. Comparing three groups of children with clinical asthma, suspected asthma, and healthy controls no significant differences were found between the two categories of spirometer[ 70 ].
In general all devices showed a mild overestimation mean 25 mL both of FEV 1 and forced vital capacity FVC a , but some of them showed substantial deviations. Significantly greater deviations with respect to the turbine spirometers were observed in the pneumotachograph type concerning FEV 1 and FVC.
Finally, the long term reliability of turbine spirometers has been demonstrated by a 3-year study carried out in Denmark[ 72 ]. In general, the values measured by portable spirometers although repeatable should not be considered as interchangeable with those obtained by conventional spirometers[ 73 ], so their use is best as a first step in diagnosing obstruction and to monitor its evolution in time. Naturally, the technical quality of the device does not guarantee the quality of the execution of the test given that, as we said, the periodic calibration, and constant adjustment based on pressure, temperature and humidity, plus experience in performing the test are all equally influential on the success of the test and its reliability[ 68 ].
Finally, a problem that should not be overlooked is the risk of crossed infections associated to the use of turbine or pneumotachograph spirometers. These can be prevented by use of disposable filters[ 76 ]. Also disposable transducers have recently been put on the market. From what has been said above, it appears evident that carrying out spirometry in the GP setting is a burdensome task in terms of the human and economic resources and time involved.
Confirmation of this, in Italy, comes from a large study carried out a few years ago on symptomatic patients only that showed that spirometry is certainly performable in the general medicine setting, but GPs are not very enthusiastic about it mainly because of lack of time and it is further complicated by non-negligible problems regarding the maintenance of adequate standards of performance and interpretation[ 77 ].
While not denying that an associated GP clinic or a GP with particular specific interest can offer such a service possible especially if the technical personnel comes from or has been instructed in a specialized hospital department , this latter does not appear currently feasible for the average Italian context, also because of the time required for performance of the spirometry, a burden difficult to support for general medicine that is not strongly organized, considering the population group which theoretically needs such a test.
This consideration is not limited only to the Italian situation. Enright, well-known American respiratory pathophysiologist, in fact showed that it is better not to do spirometries at all in the primary care setting rather than do them incorrectly[ 78 ] and in an editorial accompanying a study on spirometries performed by local community nurses he concluded that it is recommendable to provide GPs with good quality spirometries rather than spirometers[ 79 ].
The test consists generally of two maneuvers, a slow one and a forced one: in both cases the patient breathes to the maximum capacity inspiratory and expiratory , but in the first case in a slow mode and in the second case with as intense an expiratory force as possible. For a correct analysis of the forced maneuvers it is necessary to have at least 3 reproducible trials, utilizing for the subsequent analysis the one with the highest sum of FVC and FEV 1.
The results are compared with theoretic, or predicted, values gathered from healthy subjects who are presumed to represent the normal population of reference. The theoretic values should be periodically updated, however, in that the rapid improvement of social, physical and nutritional conditions can lead to variations of the reference values. It is known, moreover, that one of the determining factors for the calculation of predicted values is race besides age, height and gender , and the mixture of races typical of the present era is further cause for caution in using predicted values.
The comparison is thus expressed as a percentage of the measured to theoretic value and the presence of alterations is defined by measured values below the normal values. To assess bronchial obstruction a measured value in the forced expiration i. If even after the bronchodilator doubt should persist this is an indication for the execution of a global spirometry, which include the measure of residual volume that should also be performed in all with proven obstruction for a better functional characterization of the obstruction: see below.
There exist two criteria for defining the presence of bronchial obstruction: the so-called fixed ratio and the lower limit of normality LLN. This diagnostic criterion for obstruction is suggested also by the recommendations contained in a joint ERS-ATS statement on the interpretation of spirometry[ 82 ].
S[ 36 ] guidelines, inasmuch as there exist arguments also in favor of use of this latter criterion. The first is the AGE. Secondly, the excess of prevalence that one observes with the fixed ratio in the elderly is not the same for all classes of severity of obstruction, there being in GOLD class II a greater correlation to the clinical diagnosis with the fixed ratio than with the LLN[ 84 ].
In addition, the disadvantage derived from an excess of prevalence described less specificity by the fixed ratio may be counter-balanced by the advantage of its greater sensitivity, at least in some age-classes. In fact, those who are diagnosed as obstructed with the fixed ratio have more hospital admissions and a higher rate of mortality than those who are diagnosed with the LLN; in other words, it could be that the LLN underestimates COPD which is not solely bronchial obstruction - see section How to organize treatment: defining the disease severity [ 85 ].
This, for so long as the still missing epidemiologic data are not available. In practice for the clinician it is thus sufficient to know that the use of the fixed ratio determines an area of uncertainty due to the potential cases of under- and overdiagnosis, respectively, in young people and in the elderly.
Once the presence of obstruction has been diagnosed with simple spirometry, a person with suspected COPD should be referred to functional respiratory unit for diagnostic confirmation that includes global spirometry with reversibility testing. Once diagnosis has been confirmed and the level of severity established, the course of treatment will consist always in smoking cessation, pulmonary rehabilitation in practice, training in exercise tolerance , reduction of exposure to pollutants, pharmacological therapy correlated to the disease severity not simply to the severity of obstruction - see below , prevention and treatment of exacerbations, this latter both at home and in hospital.
Accompanying these measures, of not less importance is education about the disease c which makes the patient a conscious and co-responsible partner of the treatment Figure 7. The aim of early diagnosis is to detect patients who are affected by COPD without knowing at the earliest possible stage, if possible when still at a mild or moderate functional stage of obstruction.
At such stages, in fact, the cited interventions smoking cessation, rehabilitation, pharmacological therapy, etc. We repeat that early diagnosis must be followed by a staging of the severity and by the therapy that is most appropriate. It is worth repeating here also that one must stage and treat the patient considering the severity of the disease and not that of bronchial obstruction: it has been demonstrated in fact that bronchial obstruction is not the only index of severity that correlates with survival[ 87 ] and that equivalent levels of obstruction can correspond to very different levels of invalidity and prognosis[ 88 ].
This is because disease severity appears to be determined not only by the impairment of pulmonary function per se but also by other characteristics such as symptoms, tendency for exacerbations, nutritional status and presence of comorbidities. S guidelines, according to the scheme in Table 7. Besides these criteria, in addition to spirometry, also information about the frequency of episodes of exacerbation helps to define the severity of the disease[ 89 ] as well as modifying substantially the impact on the healthcare costs.
It appears worthwhile to recall that some of the cited indices - in particular the MRC scale - could easily be used also by GPs in their clinical practice. In summary, to be able to correctly evaluate the treatment outcomes that truly count for persons with COPD[ 90 ] one must pass from an assessment of spirometry alone to an assessment that takes into account all the above dimensions Table Hence - in practice - one has to pass from the established traditional scheme Table 11 see A.
Desirable approach to COPD which clearly shows, together with what has been said above, that the key to obtaining results cannot but be through integration between the different health services and, hence, a reappraisal of the respective roles of the hospital and local community services.
Treatment is composed of non-pharmacological therapy and pharmacological therapy that are well described and analyzed in the AGE. S document and in the joint societies statement on the integrated management of COPD[ 35 ], and will be outlined in more detail in paragraph 3. This global treatment can improve pulmonary function and quality of life and reduce exacerbations, as long as all the phases of care are managed in a coordinated and integrated mode, and the person affected by the disease knowingly collaborates, i.
The programmed follow up, i. The suggested schedule of these visits is reported in Table 12 , taken from the joint society document[ 35 ]. As specified earlier, patient education about the disease plays a key role in the management of chronic diseases, and has the aim to make patients themselves an ally in the care and treatment plan, seeking to change their role from that of a passive object of the health intervention to the subject on which this latter is focused.
It includes diverse components, aimed at giving the person essential information about the characteristics of their disease, increasing their motivation and understanding in order to modify the behaviors, transmitting skills, and providing support for the emotive aspects of symptoms. Still in the context of disease education, i. By this term is intended the use of technologies that go beyond the telephone made available for bi-directional contacts and include also telemonitoring which today makes possible control at a distance of spirometry, pulse oximetry, walked distance and symptoms , telecameras and internet.
Such exchange of information finds its chief indication in the variations of clinical stability such as are perceived by the patient and allows the doctor to take into account the vital parameters of their own patient before they decide to seek hospitalization or emergency care[ 95 ]. Care of the psycho-social aspects of the disease is another aspect of disease education: lack of breath induces the patient to a reduction of physical exercise and autonomy, with consequent anxiety and depression.
There is not strong evidence that interventions of this type substantially influence the use of healthcare resources and quality of life, but nevertheless the studies carried out on asthma recommend their use[ 97 ]. Smoking cessation is able to modify the natural history of the disease and, together with pharmacological therapy and pulmonary rehabilitation, help to improve symptoms, exercise tolerance and, as a result, quality of life.
In COPD it has been demonstrated that such adherence is very low. For these latter the challenge is not only to develop devices that make the administration as practical as possible as has been done for insulin therapy but also to simplify the treatment plan, given that the more complex the therapy is, the greater the risk of lack of compliance, also in view of the fact that the patients concerned are often elderly, affected by chronic comorbidities and receiving different therapies, often prescribed by specialists who are not aware of the overall treatment panorama[ 98 ].
There is no doubt, thus, that attention to the education of people affected by disease is an integral part of the overall management that should be implemented, and that such implementation should be without any elements that are not controllable or a source of confusion. Patient Associations could play an important role in this process: they can help associates both patients and relatives or caregivers in the educational process not only by producing booklets or other printed or online material but also organizing groups for self - help.
Patient Associations could also seek to influence politicians on the problems encountered by patients and caregivers in the management of the disease. It is well established that smoking cessation slows down the progression of COPD towards more severe levels of disease and invalidity this is due also to its effect on the frequent smoking-related comorbidities [ 36 , 83 ].
In the context of COPD smoking cessation is an essential therapeutic measure and as such it must be understood, above all by the doctor that has charge of the patient; putting it in another way, smoking cessation should be the first provision made at the moment of diagnosis of COPD in an active smoker[ 36 , ]. If disease is present, the doctor will add to the usual message i.
It has in fact been demonstrated that combining the use of spirometry with help in the attempt to quit smoking yields higher percentages of abstinence than not using the respiratory function test[ , ]. The desirability and necessity of a more intense intervention than the minimum are justified first of all by the fact that there exists a direct dose-response correlation between the intensity of the intervention minutes of contact and its efficacy expressed as the percentage of long term abstinence[ ] and also by the fact that cigarette smoking is capable of creating a very strong physical and psychological dependence.
A person who continues smoking in the presence of symptoms and notwithstanding a diagnosis of smoking-correlated disease is considered as showing a high level of dependence. Thus solely the advice to quit which is the most widespread approach used in Italy may, in the majority of cases, not be sufficient, and also the minimum intervention, which in any case should be always implemented, may not be enough in persons who almost always have previously attempted on their own to quit but always relapsed.
This type of intervention —which obtains the maximum percentage of long-term abstinence — can be provided both directly by the pulmonologist, if adequately trained and flanked by a psychologist also part-time , and by specialized centers[ ] that can be contacted directly by the patient through the toll-free telephone number of the National Health Institute anti-smoking toll-free number: It is important to remember that smokers affected by respiratory disease urgently need to quit and consequently it is the specialist who must assume a proactive and continuative role, i.
The best mode for judging if the therapy is sufficient is the disappearance or containment of the symptoms of abstinence, in particular craving to smoke; in the case of persistence of craving the drug dose should be increased or accompanied by a diverse formulation if NRT or by an additional drug.
Doctors who consider themselves not sufficiently trained for this type of assistance should refer the patient to a specialized outpatient clinic information about which can be found in the annual register edited and updated yearly by the National Health Institute[ ]. Whatever the health professional who assists the patient, all persons affected by COPD should be assessed for smoking at least twice a year, better at each programmed checkup.
The prescription of drugs to quit smoking must be directly linked to the prescription of the respiratory drugs. The final goal is to quit completely within months.
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