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1. Adherence to anti-Parkinson drug therapy in the 'REASON' sample of Italian patients with Parkinson's disease: the linguistic validation of the Italian version of the 'Morisky Medical Adherence Scale-8 items'

Author

Fabbrini, G, Abbruzzese, G, Barone, P, Antonini, A, Tinazzi, M, Castegnaro, G, Rizzoli, S, Morisky, De, Lessi, P, Abbruzzese G, Cr, Ceravolo, R, Melone, M, Schettino, C, Califano, F, Ceravolo, M, Capecci, M, Andrenelli, E, Iemolo, F, Spadaro, D, Carnemolla, A, Pontieri, F, Pellicano, C, Benincasa, D, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, M, Spagnolo, F, Scaglioni, A, Abrignani, G, Avanzino, L, Tamburini, T, Facchini, S, Biundo, R, Altavista, M, Roberti, C, Asteggiano, G, L'Episcopo, M, Saracco, E, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del Sette, M, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Stampanoni Bassi, M, Ottaviani, S, Ajena, D, Trianni, G, My, F, Caggiula, M, Valenti, G, Grioli, S, La Farina, I, Zambito Marsala, S, Marchini, C, Gioulis, M, Picillo, M, Moccia, M, Denaro, A, Sebastianelli, L, Onofrj, M, Thomas, A, Marini, C, De Santis, F, Spagnoli, V, L'Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A, Ori, A, Pirondi, S, Roncari, B, Sala, S, Sgarbi, S, Simoni, L, Trevisan, F, Zanoli, L, Fabbrini, G, Abbruzzese, G, Antonini, A, Barone, P, Ceravolo, R, Tinazzi, M, Melone, Mariarosa Anna Beatrice, Schettino, C, Califano, F, Ceravolo, Mg, Capecci, M, Andrenelli, E, Iemolo, F, Spadaro, D, Carnemolla, A, Pontieri, Fe, Pellicano, C, Benincasa, D, Pietracupa, S, Latorre, A, Tedeschi, Gioacchino, Tessitore, Alessandro, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, Ma, Spagnolo, F, Scaglioni, A, Abrignani, G, Avanzino, L, Tamburini, T, Facchini, S, Biundo, R, Altavista, Mc, Roberti, C, Asteggiano, G, L'Episcopo, Mr, Saracco, E, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Nullm, nullDel Sette, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Nullm, nullStampanoni Bassi, Ottaviani, S, Ajena, D, Trianni, G, My, F, Caggiula, M, Valenti, G, Grioli, S, Nulli, nullLa Farina, Nulls, nullZambito Marsala, Marchini, C, Gioulis, M, Picillo, M, Moccia, M, Denaro, A, Sebastianelli, L, Onofrj, M, Thomas, A, Marini, C, Nullf, nullDe Santi, Spagnoli, V, L'Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A, Lessi, P, Castegnaro, G, Ori, A, Pirondi, S, Rizzoli, S, Roncari, B, Sala, S, Sgarbi, S, Simoni, L, Trevisan, F, Zanoli, L., Fabbrini, G., Abbruzzese, G., Barone, P., Antonini, A., Tinazzi, M., Castegnaro, G., Rizzoli, S., Morisky, D. E., Lessi, P., Ceravolo, R., Melone, M. A., Schettino, C., Califano, F., Ceravolo, M. G., Capecci, M., Andrenelli, E., Iemolo, F., Spadaro, D., Carnemolla, A., Pontieri, F. E., Pellicano, C., Benincasa, D., Pietracupa, S., Latorre, A., Tedeschi, G., Tessitore, A., Giordano, A., Bonuccelli, U., Frosini, D., Vanelli, F., Comi, G., Volonte, M. A., Spagnolo, F., Scaglioni, A., Abrignani, G., Avanzino, L., Tamburini, T., Facchini, S., Biundo, R., Altavista, M. C., Roberti, C., Asteggiano, G., L'Episcopo, M. R., Saracco, E., Avarello, T., Bono, G., Riboldazzi, G., Leva, S., Del Sette, M., Carabelli, E., Traverso, E., Michelucci, R., Nassetti, S., Pasini, E., Padovani, A., Cottini, E., Bigni, B., Ruggieri, S., Modugno, N., Fischetti, M., Stefani, A., Pierantozzi, M., Stampanoni Bassi, M., Ottaviani, S., Ajena, D., Trianni, G., My, F., Caggiula, M., Valenti, G., Grioli, S., La Farina, I., Zambito Marsala, S., Marchini, C., Gioulis, M., Picillo, M., Moccia, M., Denaro, A., Sebastianelli, L., Onofrj, M., Thomas, A., Marini, C., De Santis, F., Spagnoli, V., L'Erario, R., Passadore, P., Belgrado, E., Mucchiut, M., Priori, A., Cogiamanian, F., Marchet, A., Ori, A., Pirondi, S., Roncari, B., Sala, S., Sgarbi, S., Simoni, L., Trevisan, F., Morisky, De, Comi, Giancarlo, and REASON study, Group

Subjects
Predictive validity, Male, Translation, Parkinson's disease, Adherence, Comprehension, Validation, Aged, Antiparkinson Agents, Female, Humans, Parkinson Disease, Translations, Medication Adherence, Surveys and Questionnaires, Neurology (clinical), Psychiatry and Mental Health, 2708, MEDLINE, Dermatology, Disease, Linguistic validation, Pharmacotherapy, Quality of life, Medicine, business.industry, General Medicine, Parkinson’s disease, medicine.disease, Psychiatry and Mental health, Antiparkinson Agent, Settore MED/26 - Neurologia, business, Human, Clinical psychology
Abstract

Information about patients' adherence to therapy represents a primary issue in Parkinson's disease (PD) management. To perform the linguistic validation of the Italian version of the self-rated 8-Item Morisky Medical Adherence Scale (MMAS-8) and to describe in a sample of Italian patients affected by PD the adherence to anti-Parkinson drug therapy and the association between adherence and some socio-demographic and clinical features. MMAS-8 was translated into Italian language by two independent Italian mother-tongue translators. The consensus version was then back-translated by an English mother-tongue translator. This translation process was followed by a consensus meeting between the authors of translation and investigators and then by two comprehension tests. The translated version of the MMAS-8 scale was then administered at the baseline visit of the "REASON" study (Italian Study on the Therapy Management in Parkinson's disease: Motor, Non-Motor, Adherence and Quality Of Life Factors) in a large sample of PD patients. The final version of the MMAS-8 was easily understood. Mean ± SD MMAS-8 score was 6.1 ± 1.2. There were no differences in adherence to therapy in relationship to disease severity, gender, educational level or decision to change therapy. The Italian version of MMAS-8, the key tool of the REASON study to assess the adherence to therapy, has shown to be understandable to patients with PD. Patients enrolled in the REASON study showed medium therapy adherence.

Published
2013

2. Reasons driving treatment modification in Parkinson's disease: Results from the cross-sectional phase of the REASON study

Author

Tinazzi, M, Abbruzzese, G, Antonini, A, Ceravolo, R, Fabbrini, G, Lessi, P, Barone, P, REASON Study Group:Abruzzese, G, Lido, V, Melone, M, Schettino, C, Califano, F, Ceravolo, M, Capecci, M, Andrenelli, E, Iemolo, F, Spadaro, D, Carnemolla, A, Pontieri, F, Pellicano, C, Benincasa, D, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, M, Spagnolo, F, Scaglioni, A, Abrignani, G, Avanzino, L, Tamburini, T, Facchini, S, Biundo, R, Altavista, M, Roberti, C, Asteggiano, G, L'Episcopo, M, Saracco, E, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del, S, Carabelli, M, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Bassi, M, Ottaviani, S, Ajena, D, Trianni, G, My, F, Caggiula, M, Valenti, G, Grioli, S, La Farina, I, Zambito Marsala, S, Marchini, C, Gioulis, M, Picillo, M, Moccia, M, Denaro, A, Sebastianelli, L, Onofrj, M, Thomas, A, Marini, C, De Santis, F, Spagnoli, V, L'Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A, Tinazzi, M, Abbruzzese, G, Antonini, A, Ceravolo, R, Fabbrini, G, Lessi, P, Barone, P, Lido, V, Melone, M, Schettino, C, Califano, F, Ceravolo, Mg, Capecci, M, Andrenelli, E, Iemolo, F, Spadaro, D, Carnemolla, A, Pontieri, F, Pellicano, C, Benincasa, D, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, M, Spagnolo, F, Scaglioni, A, Abrignani, G, Avanzino, L, Tamburini, T, Facchini, S, Biundo, R, Altavista, M, Roberti, C, Asteggiano, G, L'Episcopo, M, Saracco, E, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del, Sette, M, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Bassi, M, Ottaviani, S, Ajena, D, Trianni, G, My, F, Caggiula, M, Valenti, G, Grioli, S, La, Farina, I, Zambito, Marsala, S, Marchini, C, Gioulis, M, Picillo, M, Moccia, M, Denaro, A, Sebastianelli, L, Onofrj, M, Thomas, A, Marini, C, De, Santi, F, Spagnoli, V, L'Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A., Tinazzi, M., Abbruzzese, G., Antonini, A., Ceravolo, R., Fabbrini, G., Lessi, P., Barone, P., Melone, M. A. B., Schettino, C., Califano, F., Ceravolo, M. G., Capecci, M., Andrenelli, E., Iemolo, F., Spadaro, D., Carnemolla, A., Pontieri, F. E., Pellicano, C., Benincasa, D., Pietracupa, S., Latorre, A., Tedeschi, G., Tessitore, A., Giordano, A., Bonuccelli, U., Frosini, D., Vanelli, F., Comi, G., Volonte, M. A., Spagnolo, F., Scaglioni, A., Abrignani, G., Avanzino, L., Tamburini, T., Facchini, S., Biundo, R., Altavista, M. C., Roberti, C., Asteggiano, G., L'Episcopo, M. R., Saracco, E., Avarello, T., Bono, G., Riboldazzi, G., Leva, S., Del Sette, M., Carabelli, E., Traverso, E., Michelucci, R., Nassetti, S., Pasini, E., Padovani, A., Cottini, E., Bigni, B., Ruggieri, S., Modugno, N., Fischetti, M., Stefani, A., Pierantozzi, M., Stampanoni Bassi, M., Ottaviani, S., Ajena, D., Trianni, G., My, F., Caggiula, M., Valenti, G., Grioli, S., La Farina, I., Zambito Marsala, S., Marchini, C., Gioulis, M., Picillo, M., Moccia, M., Denaro, A., Sebastianelli, L., Onofrj, M., Thomas, A., Marini, C., De Santis, F., Spagnoli, V., L'Erario, R., Passadore, P., Belgrado, E., Mucchiut, M., Priori, A., Cogiamanian, F., Lessi, and Comi, Giancarlo

Subjects
Male, Pediatrics, Parkinson's disease, anti-Parkinson drugs, motor symptoms, non-motor symptoms, Practice Patterns, Socioeconomic Factor, Motor symptoms, Severity of Illness Index, Antiparkinson Agents, Cohort Studies, Motor symptom, Practice Patterns, Physicians', Stage (cooking), Anti-Parkinson drug, Anti-Parkinson drugs, Non-motor symptoms, Aged, Female, Humans, Middle Aged, Parkinson Disease, Patient Satisfaction, Socioeconomic Factors, Geriatrics and Gerontology, Neurology (clinical), Neurology, musculoskeletal, neural, and ocular physiology, Antiparkinson Agent, cardiovascular system, Settore MED/26 - Neurologia, Treatment modification, Human, medicine.medical_specialty, Non-motor symptom, Disease severity, medicine, In patient, Physicians', business.industry, Advanced stage, medicine.disease, nervous system diseases, Physical therapy, Treatment decision making, Cohort Studie, business
Abstract

OBJECTIVES: To assess the association between clinical and socio-demographic features and anti-Parkinson drug (APD) treatment modifications in patients with PD and to describe neurologist and patient opinions regarding the need for changes in APD therapy. METHODS: Subjects with PD with stable APD treatment over ≥3 months prior to baseline were enrolled and evaluated for socio-demographic data, disability, disease severity and neurologist and patient views on the need to modify APD treatment. RESULTS: 775 Patients were included, 51% with Hoehn and Yahr (HY) stage 1-2 (early PD) and 49% with HY stage 2.5-4 (advanced PD). Neurologists modified APD treatment in 255 patients, 97 (25%) early PD and 158 (41%; p < 0.0001) advanced PD. APD modification was strongly associated with a low educational level and UPDRS part IV score. The most common reasons behind the APD therapy changes among neurologists were presence/worsening of motor or non-motor symptoms (88% and 37% of subjects respectively). Out of 216 patients, 92% and 51% were willing to undergo APD changes to therapy because of the presence/worsening of motor or non-motor symptoms. CONCLUSIONS: Neurologist decision to change APD therapy and patients reasons for dissatisfaction with it can be prevalently attributed to the presence/worsening of motor symptoms and motor fluctuations in the advanced stages. Non-motor symptoms were considered more often by patients. The patient educational level played a key role in treatment decision.

Published
2013

3. Clinical variables associated with treatment changes in Parkinson’s disease: results from the longitudinal phase of the REASON study

Author

Abbruzzese, Giovanni, Barone, Paolo, Ceravolo, Roberto, Fabbrini, Giovanni, Lessi, Patrizia, Ori, Alessandra, Simoni, Lucia, Tinazzi, Michele, Antonini, Angelo, Melone, MAB, Schettino, C, Capaldo, G, Iemolo, F, Sanzaro, E, Ceravolo, MG, Capecci, M, Andrenelli, E, Pontieri, FE, Pellicano, C, Benincasa, D, Fabbrini, G, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, MA, Spagnolo, F, Scaglioni, A, Abrignani, G, Abbruzzese, G, Avanzino, L, Tamburini, T, Antonini, A, Facchini, S, Biundo, R, Altavista, MC, Roberti, C, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del Sette, M, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Stampanoni Bassi, M, Tinazzi, M, Ottaviani, S, Ajena, D, Trianni, G, Caggiula, M, Valenti, G, My, F, Grioli, S, La Farina, I, Zambito Marsala, S, Marchini, C, Gioulis, M, Asteggiano, G, L’Episcopo, MR, Saracco, E, Barone, P, Picillo, M, Moccia, M, Onofrj, M, Thomas, A, Denaro, A, Marini, C, De Santis, F, Spagnoli, V, L’Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, Marchet, A., Abbruzzese, Giovanni, Barone, Paolo, Ceravolo, Roberto, Fabbrini, Giovanni, Lessi, Patrizia, Ori, Alessandra, Simoni, Lucia, Tinazzi, Michele, Antonini, Angelo, Melone, Mab, Schettino, C, Capaldo, G, Iemolo, F, Sanzaro, E, Ceravolo, Mg, Capecci, M, Andrenelli, E, Pontieri, Fe, Pellicano, C, Benincasa, D, Fabbrini, G, Pietracupa, S, Latorre, A, Tedeschi, G, Tessitore, A, Giordano, A, Bonuccelli, U, Frosini, D, Vanelli, F, Comi, G, Volonté, Ma, Spagnolo, F, Scaglioni, A, Abrignani, G, Abbruzzese, G, Avanzino, L, Tamburini, T, Antonini, A, Facchini, S, Biundo, R, Altavista, Mc, Roberti, C, Avarello, T, Bono, G, Riboldazzi, G, Leva, S, Del Sette, M, Carabelli, E, Traverso, E, Michelucci, R, Nassetti, S, Pasini, E, Padovani, A, Cottini, E, Bigni, B, Ruggieri, S, Modugno, N, Fischetti, M, Stefani, A, Pierantozzi, M, Stampanoni Bassi, M, Tinazzi, M, Ottaviani, S, Ajena, D, Trianni, G, Caggiula, M, Valenti, G, My, F, Grioli, S, La Farina, I, Zambito Marsala, S, Marchini, C, Gioulis, M, Asteggiano, G, L’Episcopo, Mr, Saracco, E, Barone, P, Picillo, M, Moccia, M, Onofrj, M, Thomas, A, Denaro, A, Marini, C, De Santis, F, Spagnoli, V, L’Erario, R, Passadore, P, Belgrado, E, Mucchiut, M, Priori, A, Cogiamanian, F, and Marchet, A.

Subjects
Male, medicine.medical_specialty, Clinical variables, Neurology, Parkinson's disease, Motor symptoms, Non-motor symptoms, Parkinson’s disease, Treatment persistence, Aged, Female, Humans, Longitudinal Studies, Middle Aged, Parkinson Disease, Physician's Role, Severity of Illness Index, Treatment Outcome, Neurology (clinical), Psychiatry and Mental Health, 2708, Longitudinal Studie, Dermatology, Disease, Internal medicine, motor symptoms,non-motor symptoms, Parkinson’s disease,treatment persistence, Severity of illness, Medicine, Neuroradiology, business.industry, musculoskeletal, neural, and ocular physiology, General Medicine, medicine.disease, nervous system diseases, cardiovascular system, Physical therapy, Neurosurgery, business, Human
Abstract

To assess over a period of 9 months in a sample of Italian Parkinson’s disease (PD) patients reasons leading the neurologist to modify dopaminergic treatment and patients’ causes of dissatisfaction with ongoing therapy. To evaluate the influence of disease severity on therapy persistence. A disease severity balanced sample of PD patients with stable anti-parkinsonian drugs (APD) treatment was enrolled and evaluated every 3 months. Patients requiring APD treatment modifications were discontinued from the study. The probability to modify APD treatment is greater for higher motor (UPDRS scores) and non-motor symptoms (NMSS score) severity. Both from neurologist’s and patient’s perspective, motor symptoms were the main determinants underlying APD treatment modifications. Non-motor symptoms were cause of dissatisfaction with ongoing APD treatment for 52 % of the patients, while only 36 % of the neurologists considered these as valid reasons for therapy change. REASON is the first study in PD patients that prospectively examined reasons driving APD treatment changes. Results show that the disease severity significantly increases the probability of APD treatment change. Patients attribute greater relevance than neurologists to non-motor symptoms as reason requiring treatment changes. This confirms that patient and neurologist perceptions only partially overlap.

Published
2015

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