Atención diaria versus cirugía hospitalaria de catarata según la edad
Resumen
Antecedentes
La catarata senil representa más del 40% de los casos de ceguera en el mundo y la mayoría de las personas ciegas por catarata viven en países de bajos ingresos. Con el aumento del número de personas con cataratas, es importante revisar la evidencia sobre la eficacia de la cirugía de cataratas en la atención de día.
Objetivos
Proporcionar evidencia fidedigna y fiable sobre la seguridad, la viabilidad, la efectividad y el coste‐efectividad de la extracción de cataratas en casos de día, comparando los resultados clínicos, el coste‐efectividad, la satisfacción de los pacientes o una combinación de estos factores en las operaciones de cataratas realizadas en las unidades de atención de día frente a las unidades de hospitalización.
Métodos de búsqueda
Se realizaron búsquedas en CENTRAL (que contiene el Registro de ensayos del Grupo Cochrane de Trastornos de los Ojos y la Visión [Cochrane Eyes and Vision Group]) (2015, número 7), Ovid MEDLINE, Ovid MEDLINE In‐Process and Other Non‐Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (enero 1946 a agosto 2015), EMBASE (enero 1980 hasta agosto 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (enero 1982 hasta agosto 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) y en la Organización Mundial de la Salud (OMS) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). No se aplicaron restricciones de fecha o de idioma en las búsquedas electrónicas de ensayos. Se buscó por última vez en las bases de datos electrónicas el 17 de agosto 2015.
Criterios de selección
Se incluyeron ensayos controlados aleatorizados que comparaban la atención de día y la cirugía hospitalaria para la catarata relacionada con la edad. El resultado principal fue el logro de una agudeza visual satisfactoria seis semanas después de la intervención quirúrgica.
Obtención y análisis de los datos
Dos autores de la revisión evaluaron de forma independiente la calidad de los ensayos y extrajeron los datos. Se estableció contacto con los autores de los estudios para obtener información adicional. Se obtuvo de los ensayos información sobre los efectos adversos.
Resultados principales
Se incluyeron dos ensayos. Se realizó un estudio en los EE.UU. en 1981 (250 personas asignadas al azar y ensayo completado) y un estudio realizado en España en 2001 (1034 asignados al azar, 935 ensayo completado). En ambos ensayos se utilizaron técnicas de extracción de cataratas extracapsulares que actualmente no se utilizan comúnmente en los países de ingresos más altos. La mayoría de los datos de esta revisión proceden del ensayo más grande, que se consideró de bajo riesgo de sesgo.
El cambio medio en la agudeza visual (en líneas de Snellen) del ojo operado cuatro meses después de la operación fue similar en las personas sometidas a una cirugía en la atención de día (media de 4,1 líneas de desviación estándar (DE) 2,3, 464 participantes) en comparación con las personas tratadas como pacientes hospitalizados (media de 4,1 líneas, DE 2,2, 471 participantes) (valor P = 0,74). No se disponía de datos de ninguno de los dos estudios sobre las complicaciones intraoperatorias.
Se informó de fugas de la herida, presión intraocular (PIO) y edema corneal en el primer día postoperatorio y a los cuatro meses después de la cirugía. Hubo un mayor riesgo de PIO alta en el grupo de atención de día en el primer día después de la cirugía (riesgo relativo (RR) 3,33, intervalos de confianza (IC) del 95%: 1,21 a 9,16, 935 participantes) pero no a los cuatro meses (RR 0,61, IC del 95%: 0,14 a 2,55, 935 participantes). Los hallazgos de los otros resultados no fueron concluyentes con amplios IC. Se observaron dos casos de endoftalmitis a los cuatro meses en el grupo de la atención de día y ninguno en el grupo de pacientes hospitalizados. En el estudio más pequeño se afirmó que no había infecciones ni hifemas graves.
En un subconjunto de participantes evaluados en cuanto a la calidad de vida (cuestionario VF14) se observó un cambio similar en la calidad de vida antes y cuatro meses después de la cirugía (cambio medio en la puntuación del VF14: grupo de atención de día 25,2, DE 21,2, 150 participantes; grupo de pacientes hospitalizados: 23.5, DE 25,7, 155 participantes; valor P = 0,30). La evaluación subjetiva de la satisfacción de los pacientes en el estudio más pequeño sugirió que los participantes preferían recuperarse en casa, se sentían más cómodos en su entorno familiar y disfrutaban del apoyo familiar que recibían en casa. Los costes eran de un 20% más para el grupo de pacientes hospitalizados y esto se atribuyó a los costes mayores de la estancia nocturna.
Conclusiones de los autores
Esta revisión aporta evidencia de que hay un ahorro de costes con la cirugía de cataratas en la atención de día en comparación con la cirugía de cataratas en pacientes hospitalizados. Aunque los efectos sobre la agudeza visual y la calidad de vida parecían similares, la evidencia con respecto a las complicaciones postoperatorias no eran concluyentes porque las estimaciones del efecto eran imprecisas. Habida cuenta de la amplia adopción de la cirugía de cataratas en atención de día, las futuras investigaciones sobre las vías clínicas de las cataratas deberían centrarse en la evidencia proporcionada por las bases de datos (registros) clínicos de alta calidad, lo que permitiría a los médicos y planificadores de la atención de salud acordar las indicaciones clínicas y sociales para la atención de los pacientes hospitalizados y así aprovechar mejor los recursos.
PICO
Resumen en términos sencillos
Cirugía del mismo día en comparación con la estancia nocturna para el tratamiento de la catarata causada por la edad
Pregunta de la revisión
¿Es la cirugía de atención de día tan efectiva, segura y factible para el tratamiento de la catarata como la cirugía de hospitalización?
Antecedentes
El cristalino de los ojos puede nublarse con la edad (llamado cataratas), lo que provoca una visión borrosa o la pérdida total de la visión. Las cataratas pueden ser eliminadas quirúrgicamente rompiendo el cristalino y extrayendo los trozos con una aguja (un proceso llamado facoemulsificación), seguido de la colocación de un lente artificial para restaurar la visión. Este método de cirugía es rápido y, junto con un período de recuperación más corto, ha hecho realidad la posibilidad de la cirugía ambulatoria. Se deseaba saber si la operación en una atención de día era tan efectiva y segura como pasar la noche después de una operación para reemplazar el lente y recuperar una mejor visión. Además, se deseaba saber cuáles eran los efectos secundarios, los riesgos y las complicaciones de los dos enfoques diferentes. Se tuvo en cuenta la mejora de la calidad de vida y las diferencias en los costes.
Características de los estudios
La revisión incluyó dos ensayos (hasta agosto de 2015) realizados en España y los EE.UU., con 1284 pacientes con cataratas. Un total de 68 personas fueron tratadas como cirugía en una atención de día, mientras que 598 pasaron la noche en el hospital. La edad media de los participantes era de unos 70 años y había un poco más de mujeres que de hombres. Los estudios no fueron financiados por una compañía farmacéutica.
Resultados clave
Los dos estudios en esta revisión encontraron que, al menos en los países desarrollados, hubo algunas evidencia de que la cirugía ambulatoria para este tipo de extracción de cataratas puede ser no sólo más barata sino tan efectiva como la hospitalización y la estancia nocturna para la extracción de cataratas. Aunque la evidencia sobre las complicaciones después de la cirugía, como la hinchazón de la córnea, la fuga de la herida y el aumento temporal de la presión dentro del ojo no fueron concluyentes, parecía haber pocas diferencias en la agudeza visual y las mejoras en la calidad de vida.
Calidad de la evidencia
Uno de los dos estudios mostró limitaciones en el diseño del estudio y en la forma en que se llevó a cabo, probablemente porque se trataba de un estudio antiguo y se informó de una manera menos sólida. Proporcionó menos datos para la revisión. Las personas incluidas en los estudios eran representativas del grupo de interés.
Authors' conclusions
Background
Age‐related cataract accounts for more than 40% of cases of blindness throughout the world with the majority of people blind from cataract found in the developing world (Limburg 2009; Riaz 2006). In 1999, the World Health Organization (WHO) and the International Agency for the Prevention of Blindness (IAPB) launched a joint initiative known as "VISION 2020: The Right to Sight," which aims to eliminate avoidable blindness by 2020 (WHO 1997). With the development of prevention of blindness programmes in many countries, an increasing number of people with cataracts are gaining access to surgical treatment for their ailment (Kupfer 1994). Nevertheless, the number of people blind as a result of cataract is increasing due to changes in the demographic structure of populations, the most important of which is increased life expectancy (Limburg 1996; Minassian 1990; Thylefors 1998). One study, Rapid Assessments of Avoidable Blindness (RAAB) (Limburg 1997), in Eritrea demonstrated an adjusted prevalence of bilateral blindness with available correction for people aged 50 years and older was 7.5% (95% confidence interval (CI) 6.2% to 8.8%) (Müller 2011). The prevalence of blindness in Eritrea is high if compared with reported blindness rates of about 2.0% for other African countries, China and most Latin American countries (Limburg 2009; Müller 2011; Xiao 2010). Surgery is the only effective treatment for cataract and, therefore, it is important to review the safety, effectiveness and ultimately the cost effectiveness of various modes of surgery.
Description of the condition
A cataract is opacity of the cortex or capsule of the lens (or both) and each type of cataract can have different characteristics. People can present with one or more of the following symptoms: gradual diminution of visual acuity, glare, decreased contrast sensitivity, frequent change in glasses prescription and change in colour appreciation (Rosenberg 2008). The condition is usually found by a primary care physician or optometrist, followed by referral to an ophthalmic surgeon for confirmation of the diagnosis and management. Access to eye tests varies by socioeconomic deprivation in England (Shickle 2015) and distance from optician (Simons 2009). Many people with treatable visual impairment from cataract do not access health services, mainly due to socioeconomic considerations (Desai 1999).
Description of the intervention
Surgical removal of the cataract is currently the only treatment option once the lens has opacified. This is usually accompanied by implantation of an artificial intraocular lens (IOL) to replace the natural lens.
How the intervention might work
Present day cataract surgery and IOL implantation allow accurate prediction of postoperative visual acuity. Several refinements have been made in surgical techniques in order to offer better postoperative clinical outcomes. The most notable revolution in cataract surgery in the last two decades was the change from the large 10‐mm incision extracapsular cataract extraction procedure to the small 3‐ to 4‐mm incision operation, which is known as phacoemulsification. Phacoemulsification involves fragmenting the lens inside the eye prior to its aspiration via a wide bore needle. This change is generally perceived to offer greater predictability of refractive outcomes, a shorter convalescence and faster recovery of full visual function. A Cochrane systematic review comparing different surgical approaches for treatment of age‐related cataract was published in The Cochrane Library (Riaz 2006).
Why it is important to do this review
With the advent of phacoemulsification in the early 1990s and the increasing use of local anaesthesia in cataract extraction, there has been a gradual trend towards management of people with cataracts as day cases. Such a trend was initially driven by the necessity of cost containment, the need to shorten waiting list times and to increase the capacity of health care providers in performing more surgeries per unit of time significantly. With increasing demand, 'stand alone' day care centres have opened both in the public and private sectors. These centres are able to offer diagnostic and treatment facilities for people with cataracts including day case cataract extraction operations that are usually performed under local anaesthesia (Cresswell 1996; Mojon‐Azzi 2007). A more recent modification to the method of delivery of cataract surgery under local anaesthesia that is being used increasingly for highly selected cases is 'Cataract Surgery by Appointment'. The direct arrival of the person at the operating theatre, having self prepared for surgery, avoids admission to the ward or time spent in the day case unit and can result in a stay of as little as 20 minutes from arrival to discharge (Mavrikakis 2006).
Initial concerns about the quality of service provided by day care units and purpose‐built centres delayed the wider spread of day care surgery. Most notable were concerns about whether this treatment modality has the same clinical outcome as the classic in‐patient procedure and whether it carries a higher risk of intraoperative or postoperative complications (or both). An equally important aspect was the person's perspective of such an experience; that is would people prefer to undergo surgery done in such day care units or alternatively with full in‐patient admission? However, one study by Tey et al., which examined different ways of streamlining cataract surgery services, found that a multifaceted approach that included increased utilisation of cataract nursing staff based in one‐stop cataract clinics resulted in an increased number of day care surgery cases without any compromise in quality (Tey 2007).
Several non‐controlled studies have compared the clinical outcome and cost‐effectiveness of cataract extraction performed in day care units with those done as in‐patients, (Ahmed 2011; Cillino 2007). This review provides an objective evaluation and comparison between two different concepts in healthcare planning and management. In addition, it serves as a stimulus for examining major changes in treatment modalities driven and supported by evidence‐based patient choice.
Objectives
To provide authoritative, reliable evidence regarding the safety, feasibility, effectiveness and cost‐effectiveness of day case cataract extraction by comparing clinical outcomes, cost‐effectiveness, patient satisfaction or a combination of these in cataract operations performed in day care versus in‐patient units.
Methods
Criteria for considering studies for this review
Types of studies
We included randomised controlled trials.
Types of participants
We considered trials in which participants were people with age‐related cataract. We placed no restrictions on race, gender or ocular co‐morbidity.
Types of interventions
We included trials in which cataract extraction and IOL implantation done as day cases were compared to in‐patient cases.
Types of outcome measures
Primary outcomes
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Achievement of a best‐corrected visual acuity of 6/18 or better in the operated eye, six weeks after the operation.
Secondary outcomes
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Adverse effects.
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Intraoperative complications including the proportion of participants with posterior capsular rupture with or without vitreous loss, misplaced IOLs and anaesthesia‐related complications.
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Postoperative complications including the proportion of participants with wound leakage and other suture‐related problems, corneal oedema or decompensation (or both), secondary glaucoma and postoperative endophthalmitis.
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Quality of life measures: participant‐reported outcomes using any of the standard questionnaires to assess quality of life and visual function (e.g. VF14, 36‐item Short Form (SF‐36), etc.). We also considered subjective assessment of participant satisfaction of the procedure.
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Economic data: cost‐effectiveness of the procedures carried out as day case and in‐patient.
Search methods for identification of studies
Electronic searches
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2015, Issue 7), Ovid MEDLINE, Ovid MEDLINE In‐Process and Other Non‐Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2015), EMBASE (January 1980 to August 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to August 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 17 August 2015.
See: Appendices for details of search strategies for CENTRAL (Appendix 1), MEDLINE (Appendix 2), EMBASE (Appendix 3), LILACS (Appendix 4), ISRCTN (Appendix 5), ClinicalTrials.gov (Appendix 6) and the ICTRP (Appendix 7).
Searching other resources
We searched the reference lists of relevant articles and the review authors' personal database of trial reports. We contacted investigators of included studies by electronic mail to ask for details of additional published and unpublished trials. We did not handsearch any journals or conference proceedings.
Data collection and analysis
Selection of studies
Two review authors independently assessed the abstracts of studies resulting from the searches. We obtained full copies of all relevant and potentially relevant studies, those appearing to meet the inclusion criteria, or for which there were insufficient data in the title and abstract to make a clear decision. These two review authors assessed the full‐text papers independently and resolved any disagreement on the eligibility of included studies through discussion and consensus, or if necessary through a third party. After assessment, the review authors eliminated from further review any remaining studies that did not match the inclusion criteria and noted the reasons for their exclusion in the Characteristics of excluded studies table.
Data extraction and management
Two review authors independently collected study details and outcomes data using a predetermined form designed for this purpose. We entered study details into the Characteristics of included studies table in Review Manager 5 (RevMan 2014). The review authors only included data if there was an independently reached consensus, any disagreements were resolved by consulting with a third review author.
We extracted the following details.
Study methods
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Method of allocation.
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Masking of participants, investigators and outcomes assessment.
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Exclusion of participants after randomisation and proportion of losses at follow‐up.
Participants
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Country of origin.
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Sample size.
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Age.
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Sex.
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Inclusion and exclusion criteria.
Intervention
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Duration and length of time in follow‐up.
Control
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Duration and length of time in follow‐up.
Outcomes
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Primary and secondary outcomes mentioned in the Types of outcome measures section.
The review authors used this information to help them assess heterogeneity and the external validity of any included trials.
Assessment of risk of bias in included studies
Each review author then assessed the risk of bias of the selected studies independently using Cochrane's tool for assessing risk of bias as described in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). These review authors compared the assessments, and discussed and resolved any inconsistencies in their assessments.
We assessed the following domains as 'low risk of bias', 'unclear risk of bias' (uncertain risk of bias) or 'high risk of bias':
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random sequence generation;
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allocation concealment;
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blinding (masking) of participants and personnel;
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masking of outcomes assessment;
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incomplete outcome data;
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selective outcome reporting;
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other bias.
The 'Risk of bias' section in the Characteristics of included studies table reports these assessments.
We also categorised and reported the overall risk of bias of each of the included studies according to the following:
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low risk of bias (plausible bias unlikely to seriously alter the results) if all criteria were met;
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unclear risk of bias (plausible bias that raises some doubt about the results) if one or more criteria were assessed as unclear or
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high risk of bias (plausible bias that seriously weakens confidence in the results) if one or more criteria were not met.
Assessment of heterogeneity
We included only two trials in this review and thus no assessment of heterogeneity was carried out. If we identify and include further trials in future updates, then we will use the following methods.
We will assess clinical heterogeneity by examining the characteristics of the studies, the similarity between the types of participants, the interventions and the outcomes as specified in the Criteria for considering studies for this review.
We will assess statistical homogeneity using a Chi2 test and use the I2 test to quantify inconsistency across any included studies. The I2 test describes the percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error (chance) and where a value greater than 50% may be considered substantial heterogeneity (Higgins 2003).
Assessment of reporting biases
If we identify further trials for inclusion in this review, we will assess publication bias according to the recommendations on testing for funnel plot asymmetry as described in Chapter 10 of the Cochrane Handbook for Systematic Reviews of Interventions (Sterne 2011), and explore these in the discussion if appropriate.
Data synthesis
We planned to present risk ratios for visual acuity outcomes and odds ratios for adverse effect outcomes. Since only one study provided adequate data, we did not perform a statistical summary.
Sensitivity analysis
We planned to conduct a sensitivity analysis to assess the robustness of our review results by repeating the analysis with the following adjustments: exclusion of studies of lower methodological quality and unpublished studies.
Results
Description of studies
Results of the search
The initial electronic searches in November 2002 identified 226 references. After review, we excluded all but six papers from the review. We obtained full‐text copies of these papers for further assessment. One paper described a systematic review (Castells 2000). We rejected one trial as the study compared day stay in a peripheral clinic with a main eye hospital and all participants were treated as day stay (Rose 1999). We rejected Ingram 1980 as no IOL implantation was carried out and the technique used (intracapsular cataract extraction) is now considered obsolete and the study cannot be relied on in comparison with the current technique of extracapsular cataract extraction. We were unsuccessful in obtaining additional data from the authors of Percival 1992 and were unable to assess its quality and thus excluded this trial. We discarded Lowe 1992 as the study only considered suitability for day case cataract surgery and did not include a comparison of in‐patient or day care for cataract surgery. Two trials met the inclusion criteria for relevance and quality and were included in the review (Castells 2001; Galin 1981).
Updated searches
We updated the electronic searches in September 2004 and identified a further 85 references but found no new trials. In September 2006, we updated the searches again and identified 86 new reports of studies. After initial assessment by the Trials Search Co‐ordinator for the Cochrane Eyes and Vision Group, we excluded 83 references, as they were not relevant to the scope of the review. We assessed the three remaining reports and obtained hard copies of two trials but neither were eligible for inclusion in the review.
An update search was done in September 2008. The electronic searches retrieved 171 titles and abstracts. After deduplication, the Trials Search Co‐ordinator scanned 114 records and discarded 59 records as they were not relevant to the review. We screened the title and abstracts of the 55 remaining references but none met the inclusion criteria for the review.
We ran an updated search in May 2011. The electronic searches yielded 91 titles and abstracts. After deduplication, the Trials Search Co‐ordinator scanned 83 records and discarded 70 records, as they were not relevant to the review. We screened the title and abstracts of the remaining 13 references but none were eligible for inclusion in the review.
Further searches run in August 2015 identified 142 new records (Figure 1). The Trials Search Co‐ordinator removed 32 duplicate records, screened the remaining 110 records and removed 102 references that were not relevant to the review. We screened the remaining eight references and discarded seven reports, as they were not relevant. We obtained one full‐text report (Cabric 2014), but excluded it, as it did not meet the inclusion criteria, see Characteristics of excluded studies table for details.
Study flow diagram.
Included studies
Summary of trial details
The Castells 2001 study was an unmasked randomised clinical trial of people undergoing cataract surgery in three public hospitals in Barcelona (Spain) in which 1034 participants were randomly assigned to one of two groups: out‐patient hospital and in‐patient hospital. People were eligible if they were scheduled for cataract surgery that did not include any other ophthalmological procedure and if they met certain inclusion criteria for ambulatory surgery. A total of 464 out‐patients and 471 in‐patients completed the trial. For the majority of participants, the planned procedure was extracapsular cataract extraction with IOL implantation. Of these participants, 17.5% out‐patients and 16.6% in‐patients underwent phacoemulsification.
The primary outcomes were postoperative complications within 24 hours of surgery, postoperative complications between 24 hours and four months after surgery, visual acuity of the operated and the better eye four months after surgery, and change in visual acuity pre‐ and postoperatively. Secondary outcomes focused on the evaluation of self reported outcomes that were administered by trained interviewers by telephone in the preoperative and four‐month postoperative period. Visual function was assessed using the VF14 Index. The Cataract Symptom Score was used to measure the degree of difficulty caused by five symptoms common to people with cataracts. Additionally, the trial used the Sickness Impact Profile to assess participant's perceived health status and sickness‐related dysfunction. Economic data relating to direct costs associated with the surgery, in‐patient stay and four‐month follow‐up were estimated and calculated per participant.
In the Galin 1981 study, 273 people who needed cataract surgery were asked to participate and 250 were randomised into three age‐matched groups. Cataract extraction was performed either with or without a Sputnik IOL. After completion of surgery, participants stayed in a hospital or a hotel or went home. Details regarding postoperative outcomes were very sparse. The study provided some detail on the cost of hotel stay but there was no information available on direct costs incurred as a result of the surgical procedure.
Further details of these trials can be found in the Characteristics of included studies table.
Excluded studies
See the Characteristics of excluded studies table.
Risk of bias in included studies
The Castells 2001 study met all but one of the criteria and was graded as 'unclear' risk of bias. Galin 1981 did not match several of the criteria completely and was also graded as 'unclear' risk of bias.
See Assessment of risk of bias in included studies and the summaries in Figure 2 and Figure 3.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Allocation
The methods used to generate the allocation sequence and how the sequence was concealed, such that participants and investigators enrolling participants could not foresee the upcoming assignment, are the most important and sensitive indicators that bias has been minimised in a clinical trial (Schulz 1995). For both studies, we judged sequence generation and concealment of the allocation sequence as low risk of bias (see 'Risk of bias' tables in Characteristics of included studies table).
Blinding
One of the studies was unmasked but while the masking of participants and healthcare providers may not have been feasible, the masking of outcomes assessors was possible and of significant importance in this trial (Castells 2001). In the other study, the surgeon was unaware of the allocated assignment preoperatively but the report was unclear if the outcomes assessors, which may have included the investigators, knew which of the participants had been hospitalised or had been assigned to day care, at the follow‐up assessment on the day after surgery (Galin 1981). We judged both studies as unclear risk of bias for this domain.
Incomplete outcome data
The data in Castells 2001 were adequately addressed in a flowchart. However, as the data in Galin 1981 were presented in a narrative style, it was not possible to confirm if all data had been satisfactorily reported.
Selective reporting
Although the protocols were not available for the two included studies, based on the information in the methods section of the reports, all pre‐specified outcomes appear to have been reported and, therefore, we judged the studies free of selective reporting.
Other potential sources of bias
Castells 2001 appeared to be free of other bias, but there was insufficient information in Galin 1981 to assess whether there were any additional sources of bias.
Effects of interventions
The marked heterogeneity in the two included studies did not support undertaking any statistical analysis. We have presented a descriptive summary of results. All data are from Castells 2001 unless stated otherwise.
Primary outcomes
We had originally proposed to report on primary outcomes six weeks postoperatively but neither of the included studies reported outcomes for this time period. Thus, we reported on best‐corrected visual acuity 6/18 or better in the operated eye four months postoperatively.
Visual acuity
The mean change in visual acuity (in Snellen lines) of the operated eye four months postoperatively was not statistically significant (4.1, standard deviation (SD) 2.3 with day care versus 4.1, SD 2.2 with in‐patient; P value = 0.74) (Table 1).
| Visual acuity | Number of participants (%) | |
| Day care (total n = 464) | In‐patient (total n = 471) | |
| < 6/18* | 92 (19.8%)* | 84 (17.8%)* |
| > 6/18 to 6/15 | 111 (24%) | 128 (27.2%) |
| 6/12 to 6/9 | 149 (32.1%) | 161 (34.2%) |
| 6/9 | 112 (24.1%) | 98 (20.8%) |
| Mean change (SD) | 4.1 (2.3) | 4.1 (2.2) |
*not primary outcomes.
n: number of participants; SD: standard deviation.
Secondary outcomes
Intraoperative complications
No data were available from either study on intraoperative complications.
Postoperative complications
Castells 2001 reported statistically significant differences in early postoperative complication rates (Table 2) with an increased risk of increased IOP in the day care group that appeared to have no clinical relevance to visual outcomes four months postoperatively (Table 3). Although the four‐month postoperative outcomes were similar between groups, there were nevertheless two participants with endophthalmitis in the day care group versus none in the in‐patient group. Galin 1981 stated that there were no infections or severe hyphaemas.
| Complications | Number of participants (%) | Risk ratio (95% CI) | |
| Day care (total n = 464) | In‐patient (total n = 471) | ||
| Wound leakage | 5 (1.1%) | 4 (0.8%) | 1.27 (0.34 to 4.77) |
| Corneal oedema | 49 (10.6%) | 36 (7.6%) | 1.42 (0.91 to 2.24) |
| Intraocular pressure > 30 mm Hg | 16 (3.4%) | 5 (1.1%) | 3.33 (1.21 to 9.16) |
CI: confidence interval; n: number of participants.
| Complications | Number of participants (%) | Risk ratio (95% CI) | |
| Day care (total n = 464) | In‐patient (total n = 471) | ||
| Corneal oedema | 32 (6.9%) | 24 (5.1%) | 1.38 (0.80 to 2.38) |
| Wound leakage | 4 (0.9%) | 7 (1.5%) | 0.76 (0.17 to 1.98) |
| Intraocular pressure > 30 mm Hg | 3 (0.6%) | 5 (1.1%) | 0.61 (0.14 to 2.55) |
| Endophthalmitis | 2 (0.4%) | 0 (0.0%) | ‐ |
CI: confidence interval; n: number of participants.
Quality of life measures
At four months postoperative, VF14 scores were higher for the day care group (92.8 with day care versus 87.6 with in‐patient) and the mean change VF14 scores showed minimal differences between the two groups (25.2, SD 21.2 with day care versus 23.5, SD 25.7 with in‐patient; P value = 0.30) (Table 4). Additional data provided were the Cataract Symptom Score to assess cataract‐related symptoms and the Sickness Impact Profile Score, which assesses the overall perceived health status by measuring sickness‐related dysfunction and confirmed that the perceived health outcomes were similar in both groups. The mean Cataract Symptom Score (range 0 to 15) four months after surgery was 0.6 (1.2) for the day care group and 0.8 (1.7) for the in‐patient group. The Mean Sickness Impact Profile score (range 0 to 100) four months after surgery was 8.4 (8.9) for the day care group and 8.8 (8.8) for the in‐patient group. Galin 1981 provided further subjective assessment of participant satisfaction who noted that participants preferred to recuperate at home, were more comfortable in their familiar surroundings and enjoyed the family support that they received at home.
| VF14 scores | Day care (n = 150) | In‐patient (n = 155) |
| Mean (SD) (range 0‐100) | 92.8 (12.2) | 87.6 (20.3) |
| Change score pre‐postoperative | 25.2 (21.2) | 23.5 (25.7) |
n: number of participants; SD: standard deviation.
Economic data
Direct costs including a four‐month follow‐up reported by Castells 2001 were 20% more for in‐patient versus day care groups and attributed to higher costs for overnight stay (Table 5). Galin 1981 only reported hotel costs for the non‐hospitalised participants making aggregation of data on costs impossible.
| Costs | Day care (n = 150) | In‐patient (n = 155) |
| Total costs in Euros (SD) | 1001.3 (251.4) | 1218.0 (187.3) |
n: number of participants; SD: standard deviation.
Discussion
Summary of main results
The lack of high quality trials to synthesise was disappointing as the significance of this review in supporting a shift in methodology from in‐patient to day care surgery can at present only be assessed by subjective means. However, it is readily apparent that this shift has already taken place, seemingly validated by experientially based opinion. The data that we reviewed produced no surprises and appears to provide confirmatory evidence of the safety, effectiveness and cost‐effectiveness of day care cataract surgery. By way of further confirmation of the results, the Castells 2001 study showed similar mean changes in visual acuity between the two groups, which compared favourably with those found in the US National Study of Surgery Outcomes (Steinberg 1994). It was apparent from this study that the effectiveness of cataract surgery performed as a day case procedure, assessed by visual acuity, equals that of the corresponding in‐patient procedure and thereby provides clinicians with a certain degree of confidence in the selection of a day care approach.
Overall completeness and applicability of evidence
Although there were statistically significant differences in immediate postoperative complications between the two groups, these did not appear to have a marked effect on the overall postoperative complications, which should further minimise any unease with day care cataract surgery. The more subjective quality of life measures and visual function results provided further corroborative evidence of the effectiveness of day care surgery as a preferred modality. Additionally, in this era of soaring healthcare costs and cost containment there is a perception that day care surgery should provide a more cost‐effective approach in the treatment of cataract surgery, a premise that the two included studies appear to confirm. However, care should be taken in examining the balance sheet as there are hidden community costs that need to be included in the day care surgery equation, costs that may in the end support the change solely as a cost‐shifting economic exercise.
The electronic searches identified one systematic review published in Spanish, which included the trials that we assessed in our review (Castells 2000). We arranged to have the review translated into English. In the translated copy, the authors indicated that the quality assessment of their included studies followed the guidelines of the Evidence‐Based Medicine Working Group and the CONSORT (CONsolidated Standards Of Reporting Trials) Statement, which they further added; evaluate primary criteria (randomisation of assigned treatment, attrition and intention‐to‐treat analyses) and secondary criteria (masking). We reviewed all the included studies and found ourselves unable to concur with all of the quality assessments made by the authors of some of these studies and additionally noted that this Spanish systematic review was not referenced in the Database of Abstracts of Reviews of Effects (DARE) in The Cochrane Library.
Quality of the evidence
Limitations in study design and implementation
Our assessments of risk of bias in Galin 1981 highlighted some of the limitations in the quality of this study, whereas the Castells 2001 study was more robust in design and reporting and allowed some conclusions to be drawn about the effectiveness, safety and cost‐effectiveness of day care cataract surgery.
Indirectness of the evidence
The two trials compared in‐patient care with day care and reported both clinician and participant preferred outcomes that provided evidence of direct relevance to clinical decision making.
Unexplained heterogeneity or inconsistency of results
Only two trials were included in this review and, although there was a degree of clinical diversity between the studies, it was not possible to pool any of their data and, therefore, we did not carry out an assessment of heterogeneity.
Imprecision of results
A lack of outcomes data from both trials did not enable any pooling or any assessment of the degree of precision of effect.
Publication bias
In view of the low number of trials included in this review, this assessment was not estimable.
Potential biases in the review process
Stringent attempts were made to limit bias in the review process by ensuring a comprehensive search for potentially eligible studies. The review authors' independent assessments of eligibility of studies for inclusion in this review and the extraction of data minimised the potential for additional bias beyond that detailed in the 'Risk of bias' tables.
Agreements and disagreements with other studies or reviews
We are not aware of any other reviews that have covered this research question. There are no disagreements with earlier versions of this review.
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
| Visual acuity | Number of participants (%) | |
| Day care (total n = 464) | In‐patient (total n = 471) | |
| < 6/18* | 92 (19.8%)* | 84 (17.8%)* |
| > 6/18 to 6/15 | 111 (24%) | 128 (27.2%) |
| 6/12 to 6/9 | 149 (32.1%) | 161 (34.2%) |
| 6/9 | 112 (24.1%) | 98 (20.8%) |
| Mean change (SD) | 4.1 (2.3) | 4.1 (2.2) |
| *not primary outcomes. n: number of participants; SD: standard deviation. | ||
| Complications | Number of participants (%) | Risk ratio (95% CI) | |
| Day care (total n = 464) | In‐patient (total n = 471) | ||
| Wound leakage | 5 (1.1%) | 4 (0.8%) | 1.27 (0.34 to 4.77) |
| Corneal oedema | 49 (10.6%) | 36 (7.6%) | 1.42 (0.91 to 2.24) |
| Intraocular pressure > 30 mm Hg | 16 (3.4%) | 5 (1.1%) | 3.33 (1.21 to 9.16) |
| CI: confidence interval; n: number of participants. | |||
| Complications | Number of participants (%) | Risk ratio (95% CI) | |
| Day care (total n = 464) | In‐patient (total n = 471) | ||
| Corneal oedema | 32 (6.9%) | 24 (5.1%) | 1.38 (0.80 to 2.38) |
| Wound leakage | 4 (0.9%) | 7 (1.5%) | 0.76 (0.17 to 1.98) |
| Intraocular pressure > 30 mm Hg | 3 (0.6%) | 5 (1.1%) | 0.61 (0.14 to 2.55) |
| Endophthalmitis | 2 (0.4%) | 0 (0.0%) | ‐ |
| CI: confidence interval; n: number of participants. | |||
| VF14 scores | Day care (n = 150) | In‐patient (n = 155) |
| Mean (SD) (range 0‐100) | 92.8 (12.2) | 87.6 (20.3) |
| Change score pre‐postoperative | 25.2 (21.2) | 23.5 (25.7) |
| n: number of participants; SD: standard deviation. | ||
| Costs | Day care (n = 150) | In‐patient (n = 155) |
| Total costs in Euros (SD) | 1001.3 (251.4) | 1218.0 (187.3) |
| n: number of participants; SD: standard deviation. | ||
