RESUMEN
We present the first systematic review and meta-analysis of sexual function in women with polycystic ovary syndrome (PCOS) compared with women without PCOS. Data on this topic are limited and often contradicting. Sexual function is influenced by endocrine, mental and social factors, which are often compromised in women with PCOS. The main outcome measures were validated sexual function questionnaires and visual analogue scales (VAS). We identified and assessed 1925 original articles; 18 articles were included. Significant small effect sizes were found on sexual function subscales (total score: P = 0.006; arousal: P = 0.019; lubrication: P = 0.023; satisfaction: P = 0.015; orgasm: P = 0.028), indicating impaired sexual function in women with PCOS. Large effect sizes for the effect of body hair on sex were shown on VAS (P = 0.006); social effect of appearance (P = 0.007); sexual attractiveness (P < 0.001). Satisfaction with sex life was impaired (P < 0.001), but sexual satisfaction was rated equally important in women with PCOS and controls. We conclude that a satisfying sex life is important for women with PCOS; however, sexual function and feelings of sexual attractiveness are impaired. The findings imply that sexual function, sexual satisfaction and psychosocial functioning need to be part of every clinical assessment of women with PCOS.
Asunto(s)
Síndrome del Ovario Poliquístico/psicología , Calidad de Vida , Disfunciones Sexuales Fisiológicas/psicología , Adulto , Femenino , Humanos , Satisfacción Personal , Síndrome del Ovario Poliquístico/fisiopatología , Conducta Sexual/psicologíaRESUMEN
OBJECTIVES: The purpose of the present study was to determine whether pain is associated with specific aspects of academic performance, that is, poorer grades, and with factors critical to an adolescent's academic performance, that is, decreased emotional well-being and attention problems. We hypothesized that the association between pain and school grades is mediated by emotional well-being and attention problems. METHODS: In a cross-sectional study, we collected data from 2215 pupils, ages 12 to 13 years. Pain (no, occasional, and frequent), emotional well-being, and attention problems were measured with self-rating scales. Dutch, English, and math grades were taken as an index of academic performance. RESULTS: Frequent pain in adolescents was associated with poorer grades (Dutch P=0.02 and math P=0.01). Both occasional and frequent pain were associated with reduced emotional well-being (P<0.001) and reduced self-reported attention (P<0.001). However, the association between pain and lower grades disappeared when controlling for emotional well-being and attention. DISCUSSION: The present study shows that the association between pain and Dutch adolescents grades is mediated by reduced emotional well-being and attention problems. The association between pain and math grades is mediated by emotional problems. The results suggest that an intervention targeted at pain in adolescents could have a positive effect on their emotional well-being, attention, and school performance.
Asunto(s)
Rendimiento Académico/psicología , Atención , Emociones , Dolor/psicología , Adolescente , Niño , Estudios Transversales , Femenino , Humanos , Masculino , Dolor/epidemiología , AutoinformeRESUMEN
UNLABELLED: Cognitive-behavioral therapy (CBT) is effective in reducing the frequency and intensity of chronic pain in adolescents. However, CBT seems not to be considered acceptable by all adolescents. The main aim of our study was therefore to evaluate the effects of guided Internet-delivered self-help for adolescents with chronic pain. Adolescents (N = 69) were assessed on the outcome measures of pain, coping, disability, catastrophizing, rewarding of pain behavior by parents, and quality of life. Measures were taken 7 weeks before treatment and at pretreatment, posttreatment, and 3-month follow-up. Multilevel modeling was used for longitudinal analysis of the data. Pain intensity, interference caused by pain, rewarding of pain behavior by parents, and sleep problems significantly decreased during the intervention. The quality-of-life scores for pain, general behavior, mental health, family activities, and health changes also significantly improved during the intervention. With regard to coping, only problem-focused avoidance behavior significantly increased. No significant differences were found for pain-related disability and pain catastrophizing. Contrary to expectations, guided Internet-delivered self-help for chronic pain is difficult to use in adolescents, resulting in treatment attrition and loss to follow-up. TRIAL REGISTRATION: Dutch Trial Register NTR1926. PERSPECTIVE: The results of this trial suggest that Internet-based self-management is effective in decreasing pain intensity in adolescents with chronic pain. Because the intervention is grounded in CBT, we expect the underlying mechanism to be a change in self-management skills and in the ability of challenging dysfunctional thoughts.
Asunto(s)
Dolor Crónico/terapia , Internet , Manejo del Dolor/métodos , Autocuidado/métodos , Adaptación Psicológica , Adolescente , Reacción de Prevención , Catastrofización , Niño , Dolor Crónico/psicología , Terapia Cognitivo-Conductual/métodos , Familia/psicología , Femenino , Estudios de Seguimiento , Humanos , Estudios Longitudinales , Masculino , Pacientes Desistentes del Tratamiento , Satisfacción del Paciente , Recompensa , Trastornos del Sueño-Vigilia/fisiopatología , Trastornos del Sueño-Vigilia/terapia , Resultado del TratamientoRESUMEN
The aims of this study were to assess whether Indonesian women with breast cancer havea higher external health locus of control (HLC) than healthy women, and to explore the association between HLC and symptoms of anxiety and depression. In this study, 120 consecutive women with breast cancer were recruited at the outpatient surgical oncology clinic at the Hasan Sadikin Hospital in Bandung. One hundred and twenty two healthy women were recruited from the Bandung area as controls. A standard demographic form, Form C of the Multidimensional Health Locus of Control, as well as the Hospital Anxiety and Depression Scale and patients' medical records were used. Data were analyzed using descriptive statistics, t-test, Pearson's correlation, MANOVA and multiple linear regressions. Women with breast cancer had higher scores on all external HLC subscales, i.e. chance, doctor, powerful others and God, and lower internal HLC compared to healthy women. High God LHC scores were associated with a high level of anxiety (ß=0.21, p<0.05), whereas none of the HLC subscales were associated with depression. Our results suggest that women with breast cancer tend to have high external HLC, while healthy women tend to have high internal HLC. A strong belief in an external source of control, i.e. God, might be negatively associated with patient emotional adjustment. Further research is needed to give an insight into the direction of this association.
Asunto(s)
Neoplasias de la Mama/psicología , Voluntarios Sanos/psicología , Control Interno-Externo , Adulto , Anciano , Ansiedad/psicología , Estudios de Casos y Controles , Depresión/psicología , Escolaridad , Femenino , Humanos , Indonesia , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Religión y PsicologíaRESUMEN
OBJECTIVE: The aim of the present study was to test the association between psychosocial factors and delay in uptake of treatment and treatment non-adherence in Indonesian women with breast cancer. METHODS: Seventy consecutive patients with breast cancer who were treated at the Hasan Sadikin Hospital in Indonesia were recruited. They completed a demographic form, the non-adherence questionnaire, the Breast Cancer Knowledge Test, the Brief Illness Perception Questionnaire, the Multidimensional Health Locus of Control Scales, the Satisfaction with Cancer Information Profile and the Distress Thermometer. RESULTS: Seventeen (24%) out of 70 patients reported that they had delayed initiating treatment at the hospital, and nine (13%) out of 70 patients had missed two or more consecutive treatment sessions. In the bivariate analyses, we found no significant differences on any of the psychological variables between patients who delayed initiating treatment and those patients who did not, whereas patients who had missed two or more consecutive sessions had lower satisfaction with the type and timing of information provided and more negative illness perceptions than patients who had not missed their sessions. In multivariate regression analyses, consulting a traditional healer before diagnosis was associated with treatment delay (ß = 1.27, p = 0.04). More negative illness perceptions (ß = 0.10, p = 0.02) and whether a traditional healer had been consulted after diagnosis (ß = 1.67, p = 0.03) were associated with missing treatment sessions. CONCLUSIONS: Indonesian health professionals need to be aware of patients' negative illness perceptions and their unrealistic belief in traditional healers.
Asunto(s)
Pueblo Asiatico/psicología , Neoplasias de la Mama/psicología , Terapias Complementarias/psicología , Conocimientos, Actitudes y Práctica en Salud , Aceptación de la Atención de Salud/psicología , Estrés Psicológico/diagnóstico , Adaptación Psicológica , Adulto , Anciano , Ansiedad/psicología , Pueblo Asiatico/estadística & datos numéricos , Neoplasias de la Mama/etnología , Neoplasias de la Mama/terapia , Terapias Complementarias/estadística & datos numéricos , Estudios Transversales , Depresión/psicología , Femenino , Humanos , Indonesia/epidemiología , Persona de Mediana Edad , Aceptación de la Atención de Salud/estadística & datos numéricos , Percepción , Calidad de Vida/psicología , Derivación y Consulta , Factores Socioeconómicos , Estrés Psicológico/psicología , Encuestas y CuestionariosRESUMEN
OBJECTIVE: The aim of this study was to explore reasons for delay in seeking medical help and nonadherence to treatment in Indonesian women with breast cancer. METHOD: Semistructured interviews were conducted by purposive sampling, using a consecutive sample of 50 breast cancer patients who were treated at the Outpatient Surgical Oncology Clinic of Hasan Sadikin Hospital in Bandung, Indonesia. Interviews were recorded, transcribed verbatim, and coded using qualitative software. Codes were merged into main themes that were subsequently mapped onto the study's aim. RESULTS: Eight main themes concerning reasons for delay in seeking medical help and treatment nonadherence emerged, namely: lack of awareness and knowledge, cancer beliefs, treatment beliefs, financial problems, emotional burden, severe side effects, paternalistic style of communication, and unmet information needs. CONCLUSION: This study has identified several modifiable psychosocial and cultural factors related to delay in seeking help and nonadherence to treatment in breast cancer patients. We suggest that the provision of extensive information through media campaigns, treatment decision aids, and caregiver and patient education are needed to change the illness behaviors of Indonesian breast cancer patients.
Asunto(s)
Neoplasias de la Mama/terapia , Características Culturales , Aceptación de la Atención de Salud/psicología , Cooperación del Paciente/psicología , Tiempo de Tratamiento/estadística & datos numéricos , Adulto , Anciano , Neoplasias de la Mama/psicología , Comunicación , Información de Salud al Consumidor , Femenino , Conocimientos, Actitudes y Práctica en Salud , Necesidades y Demandas de Servicios de Salud , Humanos , Indonesia , Persona de Mediana Edad , Relaciones Médico-Paciente , Investigación Cualitativa , Factores SocioeconómicosRESUMEN
PURPOSE: The aims of this study were to assess the level of satisfaction with the information on illness and treatment among breast cancer patients, to explore its association with patients' illness perceptions and quality of life, and to provide recommendations for improvement of the information provided. METHODS: Seventy breast cancer patients at the Outpatient Surgical Oncology Clinic in Hasan Sadikin Hospital in Indonesia were recruited consecutively in a cross-sectional study design. They completed a demographic form, the Satisfaction with Cancer Information Profile, the Brief Illness Perception Questionnaire, and the World Health Organization Quality of Life. RESULTS: A considerable number of breast cancer patients (41-86 %) were dissatisfied with the amount and content of the information they received, particularly on the information about access to patient support groups and the impact of their treatment on long-term quality of life. The majority of patients were dissatisfied with the amount of written information provided. Patients who were satisfied with the type and timing of information received had stronger beliefs in personal control (ß = -0.30, p < 0.05), lesser concerns about their health condition (ß = -0.47, p < 0.01), and better understanding of their illness (ß = -0.27, p < 0.05), and were less emotionally affected by their illness (ß = -0.27, p < 0.05). In addition, the satisfied patients had a more positive perception of their general health (ß = 0.31, p < 0.05) and better psychological health condition (ß = 0.33, p < 0.05). CONCLUSIONS: Satisfaction with the information provided is associated with better health outcomes, including more positive illness perceptions. This study appears to highlight the importance of providing adequate and sufficient information that meets the needs of patients.
Asunto(s)
Neoplasias de la Mama/psicología , Neoplasias de la Mama/terapia , Conocimientos, Actitudes y Práctica en Salud , Educación del Paciente como Asunto/normas , Satisfacción del Paciente , Calidad de Vida , Adulto , Anciano , Pueblo Asiatico , Estudios Transversales , Femenino , Humanos , Indonesia , Persona de Mediana Edad , Percepción , Encuestas y CuestionariosRESUMEN
PURPOSE: This study aims to translate the Distress Thermometer (DT) into Indonesian, test its validity in Indonesian women with breast cancer and determine norm scores of the Indonesian DT for clinically relevant distress. METHODS: First, the original version of the DT was translated using a forward and backward translation procedure according to the guidelines. Next, a group of 120 breast cancer patients who were treated at the Outpatient Surgical Oncology Clinic in Hasan Sadikin Hospital in Indonesia completed a standard socio-demographic form, the DT and the Problem List, the Hospital Anxiety and Depression Scale (HADS) and the WHO Quality of Life (WHOQOL-BREF). RESULTS: Receiver operating characteristic (ROC) curve analyses identified an area under the curveâ=â0.81 when compared to the HADS cutoff score of 15. A cutoff score of 5 on the DT had the best sensitivity (0.81) and specificity (0.64). Patients who scored above this cutoff reported more problems in the practical, family, emotional, spiritual/religious and physical domains (30 out of 36 problems, p-value<0.05) than patients below the cutoff score. Patients at advanced stages of cancer experienced more emotional and physical problems. Patient's distress level was negatively correlated with overall quality of life, general health and all quality of life domains. CONCLUSIONS: The DT was found to be a valid tool for screening distress in Indonesian breast cancer patients. We recommend using a cutoff score of 5 in this population.
Asunto(s)
Neoplasias de la Mama/psicología , Psicometría , Estrés Psicológico/diagnóstico , Encuestas y Cuestionarios , Adulto , Ansiedad/diagnóstico , Ansiedad/psicología , Depresión/diagnóstico , Depresión/psicología , Femenino , Humanos , Indonesia , Persona de Mediana Edad , Calidad de Vida/psicología , Curva ROC , Reproducibilidad de los Resultados , Estrés Psicológico/psicología , TraducciónRESUMEN
PURPOSE: Several guidelines on the treatment of cancer-related fatigue recommend optimizing treatment of accompanying symptoms. However, evidence for this recommendation from randomized clinical trials is lacking. We investigated whether monitoring and protocolized treatment of physical symptoms alleviates fatigue. PATIENTS AND METHODS: In all, 152 fatigued patients with advanced cancer were randomly assigned to protocolized patient-tailored treatment (PPT) of symptoms or care as usual. The PPT group had four appointments with a nurse who assessed nine symptoms on a 0 to 10 numeric rating scale (NRS). Patients received a nonpharmacologic intervention for symptoms with a score ≥ 1 and a medical intervention for symptoms with a score ≥ 4. Fatigue dimensions, fatigue NRS score, interference of fatigue with daily life, symptom burden, quality of life, anxiety, and depression were measured at baseline and after 1, 2, and 3 months. Differences between the groups over time were assessed by using mixed modeling. RESULTS: Seventy-six patients were randomly assigned to each study arm. Mean age was 58 ± 10 years, 57% were female, and 65% were given palliative chemotherapy. We found significant improvements over time in favor of PPT for the primary outcome general fatigue (P = .01), with significant group differences at month 1 (effect size, 0.26; P = .007) and month 2 (effect size, 0.35; P = .005). Improvements in favor of PPT were also found for the following secondary outcomes: fatigue dimensions "reduced activity" and "reduced motivation," fatigue NRS, symptom burden, interference of fatigue with daily life, and anxiety (all P ≤ .03). CONCLUSION: In fatigued patients with advanced cancer, nurse-led monitoring and protocolized treatment of physical symptoms is effective in alleviating fatigue.
Asunto(s)
Ansiedad/terapia , Trastorno Depresivo/terapia , Fatiga/terapia , Neoplasias/terapia , Anciano , Ansiedad/complicaciones , Ansiedad/psicología , Trastorno Depresivo/complicaciones , Trastorno Depresivo/psicología , Fatiga/complicaciones , Fatiga/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/complicaciones , Neoplasias/psicología , Rol de la Enfermera , Educación del Paciente como Asunto/métodos , Calidad de Vida , Factores de Tiempo , Resultado del TratamientoRESUMEN
CONTEXT: To improve the management of cancer-related symptoms, systematic screening is necessary, often performed by using 0-10 numeric rating scales. Cut points are used to determine if scores represent clinically relevant burden. OBJECTIVES: The aim of this systematic review was to explore the evidence on cut points for the symptoms of the Edmonton Symptom Assessment Scale. METHODS: Relevant literature was searched in PubMed, CINAHL®, Embase, and PsycINFO®. We defined a cut point as the lower bound of the scores representing moderate or severe burden. RESULTS: Eighteen articles were eligible for this review. Cut points were determined using the interference with daily life, another symptom-related method, or a verbal scale. For pain, cut point 5 and, to a lesser extent, cut point 7 were found as the optimal cut points for moderate pain and severe pain, respectively. For moderate tiredness, the best cut point seemed to be cut point 4. For severe tiredness, both cut points 7 and 8 were suggested frequently. A lack of evidence exists for nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. Few studies suggested a cut point below 4. CONCLUSION: For many symptoms, there is no clear evidence as to what the optimal cut points are. In daily clinical practice, a symptom score ≥4 is recommended as a trigger for a more comprehensive symptom assessment. Until there is more evidence on the optimal cut points, we should hold back using a certain cut point in quality indicators and be cautious about strongly recommending a certain cut point in guidelines.
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Neoplasias/diagnóstico , Neoplasias/epidemiología , Dimensión del Dolor/métodos , Dolor/diagnóstico , Dolor/epidemiología , Índice de Severidad de la Enfermedad , Evaluación de Síntomas/métodos , Humanos , Dimensión del Dolor/estadística & datos numéricos , Prevalencia , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Encuestas y Cuestionarios , Evaluación de Síntomas/estadística & datos numéricosRESUMEN
CONTEXT: Fatigue is a multidimensional symptom experienced physically, cognitively, and emotionally. Research on fatigue experiences in various stages of cancer might help to elucidate the nature of cancer-related fatigue. OBJECTIVES: To compare fatigue experiences in advanced cancer patients (ACPs), cancer survivors (CSs), and controls from the general population (GenPop). METHODS: Sixty-three ACPs (no antitumor therapy in the last month and no options for future therapy) were matched for age, sex and diagnosis with 63 CSs (last treatment one to five years ago) and 315 controls. Fatigue was measured unidimensionally with the Numeric Rating Scale and multidimensionally with the Multidimensional Fatigue Inventory. RESULTS: All fatigue levels (general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue) were higher in ACPs than in CSs and controls (P<0.01), whereas fatigue levels were not different between CSs and controls. NRS scores in ACPs and CSs were significantly predicted by the fatigue dimensions physical fatigue and mental fatigue only. Although physical fatigue and mental fatigue were strongly related in the GenPop, the relation was weaker in CSs and not significant in ACPs. In multivariate analyses, only physical fatigue differentiated ACPs from CSs and controls (P<0.01). CONCLUSION: ACPs experience fatigue more intensely than CSs and controls when fatigue is measured multidimensionally. Although mental and physical dimensions of fatigue contribute to the overall experience of fatigue in both groups of cancer patients, physical fatigue best differentiated ACPs from both CSs and controls.
Asunto(s)
Fatiga/diagnóstico , Fatiga/mortalidad , Neoplasias/diagnóstico , Neoplasias/mortalidad , Sobrevivientes/estadística & datos numéricos , Distribución por Edad , Comorbilidad , Fatiga/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Actividad Motora , Neoplasias/psicología , Países Bajos/epidemiología , Pacientes Ambulatorios/estadística & datos numéricos , Prevalencia , Factores de Riesgo , Distribución por Sexo , Análisis de Supervivencia , Tasa de Supervivencia , Sobrevivientes/psicologíaRESUMEN
BACKGROUND: Chronic pain is prevalent among young people and negatively influences their quality of life. Furthermore, chronic pain in adolescence may persist into adulthood. Therefore, it is important early on to promote the self-management skills of adolescents with chronic pain by improving signaling, referral, and treatment of these youngsters. In this study protocol we describe the designs of two complementary studies: a signaling study and an intervention study. METHODS AND DESIGN: The signaling study evaluates the Pain Barometer, a self-assessed signaling instrument for chronic pain in adolescents. To evaluate the feasibility of the Pain Barometer, the experiences of youth-health care nurses will be evaluated in semi-structured interviews. Also, we will explore the frequencies of referral per health-care provider. The intervention study evaluates Move It Now, a guided self-help intervention via the Internet for teenagers with chronic pain. This intervention uses cognitive behavioural techniques, including relaxation exercises and positive thinking. The objective of the intervention is to improve the ability of adolescents to cope with pain. The efficacy of Move It Now will be examined in a randomized controlled trial, in which 60 adolescents will be randomly assigned to an experimental condition or a waiting list control condition. DISCUSSION: If the Pain Barometer is proven to be feasible and Move It Now appears to be efficacious, a health care pathway can be created to provide the best tailored treatment promptly to adolescents with chronic pain. Move It Now can be easily implemented throughout the Netherlands, as the intervention is Internet based. TRIAL REGISTRATION: Dutch Trial Register NTR1926.
Asunto(s)
Dolor Crónico , Manejo del Dolor/métodos , Dimensión del Dolor/métodos , Derivación y Consulta , Adolescente , Niño , Dolor Crónico/diagnóstico , Dolor Crónico/terapia , Protocolos Clínicos , Terapia Cognitivo-Conductual , Estudios de Factibilidad , Humanos , Internet , Entrevistas como Asunto , Países Bajos , Terapia por Relajación , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
OBJECTIVE: Lifestyle programs can reduce the level of overweight in children; however, maintenance results and adherence to treatment are difficult to achieve. New technologies, such as the Short Message Service (SMS), might be a promising tool for enhancing interventions. The effect of an SMS approach aimed at improving treatment results and reducing dropout rates in a pediatric lifestyle intervention, is explored. METHOD: Overweight and obese children (N = 141; age 7-12 years) participating in a lifestyle program were randomly assigned to an intervention group receiving an SMS Maintenance Treatment (SMSMT) for 38 weeks (n = 73) or to a control group receiving no SMSMT (n = 68). Children were asked to send weekly self-monitoring data on exercise, eating behavior, and emotional well-being. In return, they received tailored feedback messages. A differential decrease in BMI was analyzed with repeated measures ANOVA and dropout with logistic regression analysis. RESULTS: We found no significant difference in BMI decrease between the two groups after 12 months; however, we showed that the SMSMT group had 3.25 times less probability of dropping out after 1 year (p = .01) than controls. In the first 3 months of SMSMT, the SMSMT completers sent 0.80 SMSs per week, which reduced to 0.50 SMSs in the final 3 months. Younger children sent more SMSs (p = .03). CONCLUSIONS: These results indicate that SMSMT is effective in reducing dropout rates from a pediatric lifestyle intervention. Future research should examine the effectiveness of SMSMT on weight management and related psychosocial variables.
Asunto(s)
Obesidad/prevención & control , Pacientes Desistentes del Tratamiento/estadística & datos numéricos , Envío de Mensajes de Texto , Índice de Masa Corporal , Niño , Femenino , Estudios de Seguimiento , Humanos , Masculino , Resultado del TratamientoRESUMEN
OBJECTIVE: When comparing the efficacy of different interventions for cancer patients, there should be certainty that these types are sufficiently different in the way they are actually presented. The aim of the present study is to develop a method for assessing differences between the content of social support groups and experiential-existential therapy groups. METHODS: Independent and blind raters assessed video fragments of both intervention types, using a self-developed checklist of five questions. This checklist was first evaluated by a group of experts for appropriateness, importance, and rateability. RESULTS: Three out of the five questions were selected on the basis of these experts' evaluation and on inter-rater reliability. The scores on these questions were used to evaluate five social support groups and six experiential-existential therapy groups for breast cancer patients. According to the independent and blind raters the content of the two intervention forms appeared to be significantly different. CONCLUSION: The assessment method we developed appeared reliable and valid. PRACTICE IMPLICATIONS: Our assessment method is feasible as a check to compare the content of psycho-oncological interventions and can be easily adjusted into a test for other intervention types.
Asunto(s)
Neoplasias de la Mama/psicología , Lista de Verificación/normas , Psicoterapia de Grupo/métodos , Grupos de Autoayuda , Apoyo Social , Adaptación Psicológica , Terapia Conductista , Neoplasias de la Mama/terapia , Humanos , Variaciones Dependientes del Observador , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Psicometría , Psicoterapia , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Grabación en VideoRESUMEN
BACKGROUND: Mild in-vitro fertilisation (IVF) treatment might lessen both patients' discomfort and multiple births, with their associated risks. We aimed to test the hypothesis that mild IVF treatment can achieve the same chance of a pregnancy resulting in term livebirth within 1 year compared with standard treatment, and can also reduce patients' discomfort, multiple pregnancies, and costs. METHODS: We did a randomised, non-inferiority effectiveness trial. 404 patients were randomly assigned to undergo either mild treatment (mild ovarian stimulation with gonadotropin-releasing hormone [GnRH] antagonist co-treatment combined with single embryo transfer) or a standard treatment (stimulation with a GnRH agonist long-protocol and transfer of two embryos). Primary endpoints were proportion of cumulative pregnancies leading to term livebirth within 1 year after randomisation (with a non-inferiority threshold of -12.5%), total costs per couple up to 6 weeks after expected date of delivery, and overall discomfort for patients. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Clinical Trial, number ISRCTN35766970. FINDINGS: The proportions of cumulative pregnancies that resulted in term livebirth after 1 year were 43.4% with mild treatment and 44.7% with standard treatment (absolute number of patients=86 for both groups). The lower limit of the one-sided 95% CI was -9.8%. The proportion of couples with multiple pregnancy outcomes was 0.5% with mild IVF treatment versus 13.1% (p<0.0001) with standard treatment, and mean total costs were 8333 euros and 10745 euros, respectively (difference 2412 euros, 95% CI 703-4131). There were no significant differences between the groups in the anxiety, depression, physical discomfort, or sleep quality of the mother. INTERPRETATION: Over 1 year of treatment, cumulative rates of term livebirths and patients' discomfort are much the same for mild ovarian stimulation with single embryos transferred and for standard stimulation with two embryos transferred. However, a mild IVF treatment protocol can substantially reduce multiple pregnancy rates and overall costs.