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Prospective study pain intensity in cancer : (Estudo PROSPIC)
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iNTRODUÇÃO A dor associada ao cancro (DAC) afecta indubitavelmente a qualidade de vida dos doentes. Dada a natureza multidimensional da DAC, o seu tratamento inadequado é muitas vezes atribuído a uma avaliação deficiente e a uma classificação arbitrária. Em doentes com DAC, a identificação de uma dor com componente neuropática (DCN) influencia a selecção das intervenções analgésicas. De igual modo, o reconhecimento de eventos transitórios de exacerbação da dor, amplamente referidos como “dor episódica”, representa um ingrediente importante da atenção multidimensional. Estes surtos de agravamento da DAC, distintos da dor basal (i.e., a dor que dura >12horas por dia), nem sempre são categorizados de forma consensual. O fraco entendimento sobre a DAC e a prescrição inadequada de analgesia, sem considerar todos os alvos terapêuticos, podem condicionar uma adulteração do tempo necessário para controlar e estabilizar a dor (TCED). A intensidade da dor e o seu subtratamento; a DCN; a dor episódica; a angústia psicológica; a adição de álcool ou drogas ilícitas; o uso de opioides (e doses) e de fármacos adjuvantes; e o TCED constituem alguns dos resultados em saúde que podem explicar a complexidade da gestão da dor em doentes oncológicos. OBJECTIVOS Na perspectiva de involucrar o doente na gestão da sua DAC é fundamental que ele tenha a opção de relatar, descrever e avaliar a sua percepção de dor. No fundo, almeja-se uma aproximação à tríade da neuromatriz particular de dor (sensação, emoção, cognição) por via da subjectividade de uma descrição individual. Pode esta subjectividade da dor (quanto lhe dói?), avaliada numa primeira consulta, representar parte da complexidade da gestão da DAC? Pode uma valorização subjectiva da DAC ter uma correspondência clínica, objectivável, num seguimento longitudinal e prospectivo? Numa amostra de doentes com DAC, referenciados consecutivamente para uma Clínica de Dor Oncológica (CDO), pretendeu-se com o estudo PROSPIC (Prospective Study of Pain Intensity in Cancer): • Objectivo 1- determinar as características e os factores associados à intensidade da DAC no momento de admissão dos doentes numa CDO. • Objectivo 2- determinar a adequação do tratamento da DAC e dos seus factores preditivos no momento de admissão dos doentes numa CDO. • Objectivo 3- determinar a prevalência, as características e os preditores de DCN no momento de admissão dos doentes numa CDO. • Objectivo 4- determinar as associações e os preditores de dor episódica, concretamente de dor irruptiva (IRRU) e de dor incidental (INCID), no momento de admissão dos doentes numa CDO. • Objectivo 5- determinar o TCED e identificar os seus preditores no momento de admissão dos doentes numa CDO. MATERIAIS E MÉTODOS O estudo PROSPIC (Prospective Study of Pain Intensity in Cancer) foi realizado de modo longitudinal, prospectivo (70 dias) e observacional, com a participação de doentes com DAC consecutivamente referenciados para uma CDO. Cada doente teve três consultas externas (inicial; na 5.ª e na 10.ª semanas) e recebeu oito telefonemas pré-agendados, semanalmente. Cada doente preenchia o seu “diário de dor”. Para cada participante foram registados os dados relativos a: tumor primário; metástases; tratamentos para a dor e modificadores do cancro (último mês); duração da dor; mecanismo da dor; Eastern Cooperative Oncology Group (ECOG); Escala Hospitalar de Ansiedade e Depressão (HADS); Termómetro de Emoções (TERM); Inventário Breve da Dor (IBD); Índice de Gestão da Dor (IGD) cujo status negativo significava subtratamento da dor; Dor Neuropática em 4 Questões (DN4) cujo status positivo significava DN4>4; IRRU e INCID; dose diária equivalente de morfina (DDEM); Foram definidos como “resultados em saúde” as seguintes variáveis dependentes: • Objectivo 1- intensidade da dor inicial (IDI); • Objectivo 2- IGD; • Objectivo 3- DCN; • Objectivo 4- IRRU (dor episódica espontânea) e INCID (dor episódica com gatilho identificável); • Objectivo 5- TCED. A presença de IRRU ou INCID, segundo a definição do PROSPIC, deveria estar consubstanciada em intensidades de dor ≥4, auto-avaliadas pelos doentes usando uma escala numérica graduada de zero a dez. O TCED foi definido como o tempo decorrido (dias) desde a avaliação inicial até se alcançar uma situação em que, cumulativamente, o doente: durante 3 dias consecutivos; avaliasse a sua dor como sendo ≤3 (escala numérica de zero a dez); necessitasse de <3 doses de resgates de opioides. Para concretizar os Objectivos 1 a 4 foram implementados quatro estudos de desenho transversal com análises relativas ao momento de admissão dos doentes na primeira consulta da CDO. Para concretizar o Objectivo 5, a investigação foi longitudinal, prospectiva, com análise de sobrevivência do “tempo até ao evento” durante os 70 dias de seguimento dos doentes. RESULTADOS Nos quatro estudos transversais do PROSPIC foram escrutinados 459 doentes, sendo excluídos 88 por terem dor não oncológica (n=69), não terem cancros activos (n=16) e recusarem o consentimento (n=3). A amostra final incluiu 371 doentes: mulheres (n=199, 53.6%); idade 62.1±14.3 anos; alta proporção de tumores da cabeça/pescoço (n=92, 24.8%) e baixa de tumores do pulmão (n=10, 2.7%); doença metastática (n=263, 71%), sobretudo óssea (n=129, 34.8%); ECOG 0-2 (n=309, 83.3%); depressão (n=280, 75.5%) e ansiedade (n=262, 70.6%); história de adição de substâncias (n=86, 23.2%); com dor moderada a severa (n=285, 77%); duração da dor >3 meses (n=179, 48.2%). Tratamentos à admissão, feitos há <30 dias: quimioterapia (n=167, 45.0%); radioterapia (n=176, 47.4%); cirurgia (n=112, 30.2%); nenhum opioide (n=42, 11.3%); adjuvantes (n=210, 56.6%); objectivo paliativo (n=176, 47.4%). A DDEM mediana era baixa, de 30 mg (20-60). No seguimento longitudinal e prospectivo, para além dos 88 excluídos, outros 52 doentes foram eliminados da análise por já terem alcançado o TCED no início do estudo. Da amostra final (n=319), morreram 72 (22.6%) e 14 (4.4%) foram “perdidos” no seguimento. A idade média era 62.4±14.4 anos e 163 (51.1%) eram mulheres. A doença metastática estava presente em 240 (71%) participantes, sobretudo a óssea (37%). O cancro da cabeça/pescoço foi o mais comum, afectando 86 (27%) doentes. O objectivo paliativo do tratamento foi documentado em 52.7% da amostra e a maioria (81.5%) tinha ECOG de 0-2. Antes da admissão no estudo, os participantes tinham realizado cirurgia (32%), quimioterapia (46.7%) e radioterapia (50.8%). CONCLUSÕES São factores explicativos de IDI: maior rendimento mensal; status funcional baixo; tumores da cabeça/pescoço, genito-urinários e gastro-intestinais; uso de fármacos 14 Paulo Reis Pina – Tese de Doutoramento – FMUL – 2020 adjuvantes; e DDEM inicial. A diversidade de factores associados à IDI e a explicação limitada da sua variância enfatizam a complexidade biopsicossocial da DAC. Um em cada quatro doentes oncológicos apresenta subtratamento da sua DAC, o qual está associado independentemente ao género feminino; pontuações elevadas da "interferência da dor com a actividade geral"; radioterapia recente; prescrição de adjuvantes; DCN; necessidade de ajuda emocional; e maior alívio sentido com a medicação prescrita antes da primeira consulta. Um em cada três doentes oncológicos tem DCN, que está associada independentemente a quimioterapia e cirurgia recentes; uso de analgésicos adjuvantes; IRRU e INCID; maior duração da dor; maior IDI; e localização pélvica ou perineal da dor. A DCN deve ser diagnosticada precocemente e tratada de forma adequada para melhorar a qualidade de vida dos doentes com cancro. Entre os doentes referenciados para uma CDO, a IRRU e a INCID ocorrem frequentemente, com prevalências de 37.7% e 48.8%, respectivamente. A IRRU e a INCID estão ambas associadas a: DCN, maiores IDI e DDEM. Ademais, foram encontradas associações independentes positivas entre a IRRU e a dor localizada na cabeça/pescoço; a INCID e a radioterapia recente; a INCID e a dor afectando os tecidos moles. As associações independentes foram negativas, quer entre a IRRU e a dor abdominal, quer entre a IRRU e a INCID. A maioria dos doentes oncológicos consegue controlar e estabilizar a sua dor, embora possa demorar algumas semanas. A mediana do TCED foi de 22 (19-25) dias. O género feminino, a DCN, a utilização de adjuvantes e uma história de abuso de álcool/drogas predizem um TCED mais longo, enquanto a dor associada a tecidos moles e a idade mais avançada predizem um TCED mais curto. A avaliação global da DAC, a sua classificação apropriada e a adequação do seu tratamento deveriam ser mais investigadas. Urgem medidas apropriadas, quer de âmbito educacional, quer a nível das políticas de saúde, que pudessem combater o subtratamento da DAC e, consequentemente, o sofrimento evitável. A melhoria do conhecimento científico sobre a DAC conduzirá, inevitavelmente, ao exercício pleno de um direito fundamental: toda a pessoa humana deve ter acesso a um plano eficiente para controlar e estabilizar a sua dor.
Introduction Uncontrolled cancer pain (CP) may impair quality of life. Given the multidimensional nature of CP, its poor control is often attributed to poor assessment and classification. In patients with CP, identifying a neuropathic pain component (NPC) may inform the selection of subsequent therapeutic interventions. Moreover, better understanding of the episodic CP spectrum, including patient-reported pain flares, may inform CP assessment and management. These outbreaks of worsening of CP, distinct from the patient's background CP (i.e., pain that lasts >12 hours a day), are not always categorized consensually. Poor recognition and inappropriate therapeutic targeting of CP domains may result in poor pain control, affecting the time to achieve stable pain control (TSPC). Pain intensity and its undertreatment; NPC; episodic pain; emotional distress; history of alcohol and drug abuse; opioid use; adjuvant drugs use; and TSPC are some of the health outcomes that may explain the complexity of pain management in cancer patients Objectives From the point of view of involving the patient in the management of his/her pain, it is essential that the patient has the option to report, describe and evaluate his/her perception of CP. It is intended an approximation to the neuromatrix of pain (sensation, emotion, cognition) through the subjectivity of an individual description. Can this subjectivity of pain (how much does it hurt?), evaluated in a first consultation, represent part of the complexity of pain management? Can a subjective appreciation of pain have a clinical, objective correspondence at a longitudinal and prospective follow-up? In a sample of consecutive patients with CP who were referred to a specialist Cancer Pain Clinic (CPC), the “Prospective Study of Pain Intensity in Cancer” (PROSPIC) aimed: • Objective 1 - to determine the characteristics and associations of CP intensity at admission. • Objective 2 - to determine the adequacy of CP management and its patient-related predictors at admission. • Objective 3 - to determine the prevalence and predictors of CP with an NPC at admission. • Objective 4 - to determine the prevalence of episodic patient-reported CP, specifically episodic incident (INCID) and breakthrough CP (BTCP), at admission. • Objective 5 - to determine the median TSPC and identify its predictors at admission Methods The “Prospective Study of Pain Intensity in Cancer” (PROSPIC) is a longitudinal, prospective (70 day-period), observational study of patients attending a CPC. Three scheduled clinic attendances (initial, at week 5, and final) and eight weekly investigator-led phone calls enabled monitoring of patients’ daily pain diary, opioid use, and other analgesic interventions. Consecutive patients referred to a CPC had standardized initial assessments and status documentation of the following: cancer diagnosis; metastases; pain and cancer modifying treatments (<30 days); pain mechanism and duration; Eastern Cooperative Oncology Group (ECOG) rating; Hospital Anxiety Depression Scale and Emotional Thermometer scores; Brief Pain Inventory (BPI); Pain Management Index (PMI), with a negative status indicating undertreatment of CP; Douleur Neuropathique 4 tool; INCID and BTCP; morphine equivalent daily dose (MEDD). The following dependent variables were defined as "health outcomes": • Objective 1- initial pain intensity (IPI); • Objective 2- PMI; • Objective 3- NPC; • Objective 4- BTCP (spontaneous pain) and INCID (trigger identified); • Objective 5- TSPC. Study-defined BTCP and INCID were based on a preceding 7-day history of episodic or transitory pain flares and BPI-worst pain or BPI-now pain intensities ≥4 (self-assessment using a numerical scale, from 0 to 10). TSPC was achieved when: pain intensity <3 and <3 breakthrough opioid doses over three consecutive days. To achieve Objectives 1 to 4, four cross-sectional studies were implemented with analyses at the point of admission of patients in CPC. To achieve Objective 5, a longitudinal and prospective study, with survival analysis of the "time to the event" during the 70 days of follow-up of patients. Results In four cross-sectional studies of PROSPIC, 459 patients were screened and 88 excluded because of non-CP (n=69), non-active cancer (n=16) and failure to consent (n=3). Of 371 participants, 199 (53.6%) were women; mean age= 62.1+14.3 years; high proportion of head and neck cancers (n=92, 24.8%) and low of lung cancers (n=10, 2.7%); 263 (71%) had metastatic disease, mainly bone (n=179, 48.2%); ECOG 0-2 (n=309, 83.3%); depression (n=280, 75.5%) and anxiety (n=262, 70.6%); history of alcohol/drug abuse (n=86, 23.2%); 285 (77%) had moderate to severe pain; for >3 months (n=179, 48.2%). Treatments done <30 days before the CPC attendance: chemotherapy (n=167, 45.0%); radiotherapy (n=176, 47.4%); surgery (n=112, 30.2%); no opioids prescribed (n=42, 11.3%); adjuvant analgesics (n=210, 56.6%); goal documented as palliative (n=176, 47.4%). The initial median MEDD was relatively low 30 mg (20-60). In the longitudinal and prospective study, a part from patients who were initially excluded (n=88), more patients had to be excluded due to pre-study presence of stable pain control (n=52). Of the final study sample (n=319), 72 (22.6%) died and 14 (4.4%) were lost to follow-up. The mean age was 62.4+14.4 years and 163 (51.1%) were female. Metastatic disease was present in 240 (71%) participants; bone (37%) was the most common site. The most common cancer was head and neck, which occurred in 86 (27%) participants. A palliative treatment goal was documented for 52.7% of the participants and most (81.5%) had an ECOG score in the 0-2 range. Before the CPC attendance participants had undergone surgery (32%), chemotherapy (46.7%) and radiotherapy (50.8%). Conclusions IPI is significatively associated with higher income; ECOG 3 -4; head and neck, genitourinary and gastrointestinal cancers; use of adjuvant analgesics; and initial MEDD. One in four cancer patients presents CP undertreatment, which is independently associated with: female gender; high scores of "pain interference with general activity"; recent radiotherapy; prescription of adjuvant analgesics; NPC; more need for emotional help; feeling greater relief with the prescribed medication before the first consultation. One in three cancer patients have a NPC, which is independently associated with recent chemotherapy and surgery; adjuvant analgesic use; INCID and BTCP; longer pain duration; higher IPI; and pelvic or perineal pain location. NPC should be diagnosed early and treated appropriately to improve the quality of life of cancer patients. Among patients referred to a CPC, BTCP and INCID often occur, with a prevalence of 37.7% and 48.8%, respectively. The variety of definitions used for BTCP and INCID makes it difficult to compare prevalence rates. Patients usually report transient exacerbations of pain that do not fit in conventional criteria published for BTCP and INCID, but should be included in a more aggregating term, episodic pain. Both BTCP and INCID are associated with NPC, higher IPI and higher MEDD. Moreover, positive independent associations were found between BTCP and pain localized in the head/neck; INCID and recent radiotherapy; INCID and soft tissues pain. Independent associations were negative, between BTCP and abdominal pain, and between BTCP and INCID. Most cancer patients may achieve stable pain control. The median TSPC was 22 (19- 25) days. Female gender, NPC, use of adjuvants and history of alcohol/drug abuse predict longer TSPC; while soft tissue related pain and older age predict shorter TSPC. The comprehensive assessment of CP, its appropriate classification and adequacy of its treatment should be further investigated. Appropriate educational and health policies are needed, which would eliminate the undertreatment of CP and, consequently, avoidable suffering. Improving scientific knowledge about CP will, inevitably, lead to the full exercise of a fundamental right: every human being must have access to an efficient plan to achieve stable pain control.
Introduction Uncontrolled cancer pain (CP) may impair quality of life. Given the multidimensional nature of CP, its poor control is often attributed to poor assessment and classification. In patients with CP, identifying a neuropathic pain component (NPC) may inform the selection of subsequent therapeutic interventions. Moreover, better understanding of the episodic CP spectrum, including patient-reported pain flares, may inform CP assessment and management. These outbreaks of worsening of CP, distinct from the patient's background CP (i.e., pain that lasts >12 hours a day), are not always categorized consensually. Poor recognition and inappropriate therapeutic targeting of CP domains may result in poor pain control, affecting the time to achieve stable pain control (TSPC). Pain intensity and its undertreatment; NPC; episodic pain; emotional distress; history of alcohol and drug abuse; opioid use; adjuvant drugs use; and TSPC are some of the health outcomes that may explain the complexity of pain management in cancer patients Objectives From the point of view of involving the patient in the management of his/her pain, it is essential that the patient has the option to report, describe and evaluate his/her perception of CP. It is intended an approximation to the neuromatrix of pain (sensation, emotion, cognition) through the subjectivity of an individual description. Can this subjectivity of pain (how much does it hurt?), evaluated in a first consultation, represent part of the complexity of pain management? Can a subjective appreciation of pain have a clinical, objective correspondence at a longitudinal and prospective follow-up? In a sample of consecutive patients with CP who were referred to a specialist Cancer Pain Clinic (CPC), the “Prospective Study of Pain Intensity in Cancer” (PROSPIC) aimed: • Objective 1 - to determine the characteristics and associations of CP intensity at admission. • Objective 2 - to determine the adequacy of CP management and its patient-related predictors at admission. • Objective 3 - to determine the prevalence and predictors of CP with an NPC at admission. • Objective 4 - to determine the prevalence of episodic patient-reported CP, specifically episodic incident (INCID) and breakthrough CP (BTCP), at admission. • Objective 5 - to determine the median TSPC and identify its predictors at admission Methods The “Prospective Study of Pain Intensity in Cancer” (PROSPIC) is a longitudinal, prospective (70 day-period), observational study of patients attending a CPC. Three scheduled clinic attendances (initial, at week 5, and final) and eight weekly investigator-led phone calls enabled monitoring of patients’ daily pain diary, opioid use, and other analgesic interventions. Consecutive patients referred to a CPC had standardized initial assessments and status documentation of the following: cancer diagnosis; metastases; pain and cancer modifying treatments (<30 days); pain mechanism and duration; Eastern Cooperative Oncology Group (ECOG) rating; Hospital Anxiety Depression Scale and Emotional Thermometer scores; Brief Pain Inventory (BPI); Pain Management Index (PMI), with a negative status indicating undertreatment of CP; Douleur Neuropathique 4 tool; INCID and BTCP; morphine equivalent daily dose (MEDD). The following dependent variables were defined as "health outcomes": • Objective 1- initial pain intensity (IPI); • Objective 2- PMI; • Objective 3- NPC; • Objective 4- BTCP (spontaneous pain) and INCID (trigger identified); • Objective 5- TSPC. Study-defined BTCP and INCID were based on a preceding 7-day history of episodic or transitory pain flares and BPI-worst pain or BPI-now pain intensities ≥4 (self-assessment using a numerical scale, from 0 to 10). TSPC was achieved when: pain intensity <3 and <3 breakthrough opioid doses over three consecutive days. To achieve Objectives 1 to 4, four cross-sectional studies were implemented with analyses at the point of admission of patients in CPC. To achieve Objective 5, a longitudinal and prospective study, with survival analysis of the "time to the event" during the 70 days of follow-up of patients. Results In four cross-sectional studies of PROSPIC, 459 patients were screened and 88 excluded because of non-CP (n=69), non-active cancer (n=16) and failure to consent (n=3). Of 371 participants, 199 (53.6%) were women; mean age= 62.1+14.3 years; high proportion of head and neck cancers (n=92, 24.8%) and low of lung cancers (n=10, 2.7%); 263 (71%) had metastatic disease, mainly bone (n=179, 48.2%); ECOG 0-2 (n=309, 83.3%); depression (n=280, 75.5%) and anxiety (n=262, 70.6%); history of alcohol/drug abuse (n=86, 23.2%); 285 (77%) had moderate to severe pain; for >3 months (n=179, 48.2%). Treatments done <30 days before the CPC attendance: chemotherapy (n=167, 45.0%); radiotherapy (n=176, 47.4%); surgery (n=112, 30.2%); no opioids prescribed (n=42, 11.3%); adjuvant analgesics (n=210, 56.6%); goal documented as palliative (n=176, 47.4%). The initial median MEDD was relatively low 30 mg (20-60). In the longitudinal and prospective study, a part from patients who were initially excluded (n=88), more patients had to be excluded due to pre-study presence of stable pain control (n=52). Of the final study sample (n=319), 72 (22.6%) died and 14 (4.4%) were lost to follow-up. The mean age was 62.4+14.4 years and 163 (51.1%) were female. Metastatic disease was present in 240 (71%) participants; bone (37%) was the most common site. The most common cancer was head and neck, which occurred in 86 (27%) participants. A palliative treatment goal was documented for 52.7% of the participants and most (81.5%) had an ECOG score in the 0-2 range. Before the CPC attendance participants had undergone surgery (32%), chemotherapy (46.7%) and radiotherapy (50.8%). Conclusions IPI is significatively associated with higher income; ECOG 3 -4; head and neck, genitourinary and gastrointestinal cancers; use of adjuvant analgesics; and initial MEDD. One in four cancer patients presents CP undertreatment, which is independently associated with: female gender; high scores of "pain interference with general activity"; recent radiotherapy; prescription of adjuvant analgesics; NPC; more need for emotional help; feeling greater relief with the prescribed medication before the first consultation. One in three cancer patients have a NPC, which is independently associated with recent chemotherapy and surgery; adjuvant analgesic use; INCID and BTCP; longer pain duration; higher IPI; and pelvic or perineal pain location. NPC should be diagnosed early and treated appropriately to improve the quality of life of cancer patients. Among patients referred to a CPC, BTCP and INCID often occur, with a prevalence of 37.7% and 48.8%, respectively. The variety of definitions used for BTCP and INCID makes it difficult to compare prevalence rates. Patients usually report transient exacerbations of pain that do not fit in conventional criteria published for BTCP and INCID, but should be included in a more aggregating term, episodic pain. Both BTCP and INCID are associated with NPC, higher IPI and higher MEDD. Moreover, positive independent associations were found between BTCP and pain localized in the head/neck; INCID and recent radiotherapy; INCID and soft tissues pain. Independent associations were negative, between BTCP and abdominal pain, and between BTCP and INCID. Most cancer patients may achieve stable pain control. The median TSPC was 22 (19- 25) days. Female gender, NPC, use of adjuvants and history of alcohol/drug abuse predict longer TSPC; while soft tissue related pain and older age predict shorter TSPC. The comprehensive assessment of CP, its appropriate classification and adequacy of its treatment should be further investigated. Appropriate educational and health policies are needed, which would eliminate the undertreatment of CP and, consequently, avoidable suffering. Improving scientific knowledge about CP will, inevitably, lead to the full exercise of a fundamental right: every human being must have access to an efficient plan to achieve stable pain control.
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Palavras-chave
Controlo da dor Dor Irruptiva Dor neuropática Dor Oncológica Opioides Analgésicos Teses de doutoramento - 2020